EULAR (European League Against Rheumatism): 2016 Congress

LONDON – Bone mineral density (BMD) and estimated bone strength in the hip significantly increased during 1 year of treatment with the investigational monoclonal antibody romosozumab in comparison with teriparatide in women with postmenopausal osteoporosis who had previous fracture history and had been taking bisphosphonates for at least the previous 3 years in an open-label, randomized trial.

The investigators in the phase III, international, multicenter STRUCTURE trial sought to compare the monoclonal anti-sclerostin antibody romosozumab, which works dually to increase bone formation and decrease bone resorption, against the bone-forming agent teriparatide (Forteo) to see if it would increase total hip bone mineral density to a significantly greater extent by 12 months. Teriparatide is known to take longer to build bone at the hip following bisphosphonate use.

“These results in our minds suggest that romosozumab may offer a unique benefit to patients at high risk for fracture, transitioning from bisphosphonates,” first author Bente L. Langdahl, Ph.D., of Aarhus (Denmark) University Hospital said at the European Congress of Rheumatology. She discussed the study results in this video interview.

When Dr. Langdahl was asked after her presentation about the foreseen role of the drug in clinical practice, she noted that ongoing phase III trials looking at fracture endpoints should indicate whether it works faster at preventing fractures. Because there does not seem to be a restriction to the repeated use of romosozumab, she suggested it might be given initially for 12 months to build bone, followed by bisphosphonates to stabilize gains made, and then it could be used again if needed in a treat-to-target fashion.

The trial randomized 436 patients to receive either subcutaneous romosozumab 210 mg once monthly or subcutaneous teriparatide 20 mcg once daily for 12 months. All patients received a loading dose of 50,000-60,000 IU vitamin D3 to make sure they were vitamin D replete. The patients were postmenopausal, aged 55-90 years, and required to have taken oral bisphosphonate therapy at a dose equivalent to 70 mg weekly of alendronate for at least 3 years before enrollment (with at least 1 year of alendronate therapy prior to enrollment). They had a T score of –2.5 or less in total hip, lumbar spine, or femoral neck BMD and a history of a nonvertebral fracture after 50 years of age or a vertebral fracture at any age.

At 12 months, the primary endpoint of total hip BMD percentage change from baseline, which was calculated by averaging dual-energy x-ray absorptiometry (DXA) measurements at 6 and 12 months, increased significantly by 2.6% in the romosozumab group, compared with a loss of –1.6% in the teriparatide group.

“Why did we choose this rather unusual endpoint? It’s because we wanted to capture what happened throughout the first year,” Dr. Langdahl said.

The respective changes from baseline total hip BMD at month 12 were 2.9% vs. –0.5%; in the femoral neck, the 12-month change was 3.2% vs. –0.2%; and in the lumbar spine, the change was 9.8% vs. 5.4%.

The trial participants had a mean age of about 71 years, and T scores ranging from –2.87 to –2.83 in the lumbar spine, –2.27 to –2.21 in total hip, and –2.49 to –2.43 in the femoral neck.

Secondary endpoints of volumetric BMD measured by quantitative CT at 12 months supported the results for DXA measurements at the total hip: integral BMD changed 3.4% with romosozumab vs. –0.2% with teriparatide, cortical BMD changed 1.1% with romosozumab vs. –3.6% with teriparatide, and trabecular BMD increased 15.6% vs. 9.9%, respectively. Total hip strength at 12 months as estimated by finite element analysis rose by 2.5% with romosozumab, compared with a loss of –0.7% with teriparatide. The loss in estimated bone strength at the hip occurred mainly in the first 6 months of treatment with teriparatide and had started to recover by 12 months.

The main difference between the two treatments in total hip BMD came from romosozumab’s bone-building effect on cortical bone, Dr. Langdahl said. The significant loss of total hip cortical BMD observed with teriparatide matches what has been seen in other studies, and it occurs “because the way that teriparatide works initially on cortical bone is to open up the remodeling space; therefore, a decrease in BMD is seen.”

While romosozumab’s speed in increasing BMD and building bone strength is likely to be clinically meaningful for patients at high risk of fracture, the short duration of the trial likely left out the possibility of seeing the same sort of late increases in hip BMD and bone strength during the second year of treatment with teriparatide that have been observed in other studies. Dr. Langdahl suggested that the decline in total hip cortical bone volumetric BMD may have increased had there been more time for measurement in the study; after bisphosphonate treatment, teriparatide’s mechanism of action is thought to open up the bone remodeling space by stimulating bone resorption and formation, particularly in cortical bone.

“You will see an increased porosity in the cortical bone, and I think that is what explains the initial decrease. You’ll also see that it’s kind of catching up [to romosozumab]. This is only a 12-month study, unfortunately. I’m sure if it had been continued for 24 months, there would be an increase in strength because that has been demonstrated in other studies.”

The trial’s comparison of romosozumab versus teriparatide alone also leaves open the question of whether adding teriparatide to bisphosphonate or switching to a combination of teriparatide plus denosumab or teriparatide plus zoledronic acid might have yielded results comparable with romosozumab alone.

Furthermore, The study is not large enough to determine the overall side-effect profile of romosozumab and will have to wait until the larger, ongoing phase III studies are completed, Dr. Langdahl said. In the STRUCTURE study, the overall side effect profile was well balanced between the two groups. More women who received teriparatide developed hypercalcemia, and patients who received romosozumab developed antibodies, although they did not neutralize the agent’s effects.

The study was sponsored by UCB Pharma and Amgen. One investigator is an employee of UCB, and one is an employee of Amgen. Dr. Langdahl reported receiving research grants, consulting fees, and/or honoraria from Amgen, UCB, Eli Lilly, Merck, and Orkla. Most other investigators also reported financial relationships to Amgen and other pharmaceutical companies.

jevans@frontlinemedcom.com

LONDON – Bone mineral density (BMD) and estimated bone strength in the hip significantly increased during 1 year of treatment with the investigational monoclonal antibody romosozumab in comparison with teriparatide in women with postmenopausal osteoporosis who had previous fracture history and had been taking bisphosphonates for at least the previous 3 years in an open-label, randomized trial.

The investigators in the phase III, international, multicenter STRUCTURE trial sought to compare the monoclonal anti-sclerostin antibody romosozumab, which works dually to increase bone formation and decrease bone resorption, against the bone-forming agent teriparatide (Forteo) to see if it would increase total hip bone mineral density to a significantly greater extent by 12 months. Teriparatide is known to take longer to build bone at the hip following bisphosphonate use.

“These results in our minds suggest that romosozumab may offer a unique benefit to patients at high risk for fracture, transitioning from bisphosphonates,” first author Bente L. Langdahl, Ph.D., of Aarhus (Denmark) University Hospital said at the European Congress of Rheumatology. She discussed the study results in this video interview.

When Dr. Langdahl was asked after her presentation about the foreseen role of the drug in clinical practice, she noted that ongoing phase III trials looking at fracture endpoints should indicate whether it works faster at preventing fractures. Because there does not seem to be a restriction to the repeated use of romosozumab, she suggested it might be given initially for 12 months to build bone, followed by bisphosphonates to stabilize gains made, and then it could be used again if needed in a treat-to-target fashion.

The trial randomized 436 patients to receive either subcutaneous romosozumab 210 mg once monthly or subcutaneous teriparatide 20 mcg once daily for 12 months. All patients received a loading dose of 50,000-60,000 IU vitamin D3 to make sure they were vitamin D replete. The patients were postmenopausal, aged 55-90 years, and required to have taken oral bisphosphonate therapy at a dose equivalent to 70 mg weekly of alendronate for at least 3 years before enrollment (with at least 1 year of alendronate therapy prior to enrollment). They had a T score of –2.5 or less in total hip, lumbar spine, or femoral neck BMD and a history of a nonvertebral fracture after 50 years of age or a vertebral fracture at any age.

At 12 months, the primary endpoint of total hip BMD percentage change from baseline, which was calculated by averaging dual-energy x-ray absorptiometry (DXA) measurements at 6 and 12 months, increased significantly by 2.6% in the romosozumab group, compared with a loss of –1.6% in the teriparatide group.

“Why did we choose this rather unusual endpoint? It’s because we wanted to capture what happened throughout the first year,” Dr. Langdahl said.

The respective changes from baseline total hip BMD at month 12 were 2.9% vs. –0.5%; in the femoral neck, the 12-month change was 3.2% vs. –0.2%; and in the lumbar spine, the change was 9.8% vs. 5.4%.

The trial participants had a mean age of about 71 years, and T scores ranging from –2.87 to –2.83 in the lumbar spine, –2.27 to –2.21 in total hip, and –2.49 to –2.43 in the femoral neck.

Secondary endpoints of volumetric BMD measured by quantitative CT at 12 months supported the results for DXA measurements at the total hip: integral BMD changed 3.4% with romosozumab vs. –0.2% with teriparatide, cortical BMD changed 1.1% with romosozumab vs. –3.6% with teriparatide, and trabecular BMD increased 15.6% vs. 9.9%, respectively. Total hip strength at 12 months as estimated by finite element analysis rose by 2.5% with romosozumab, compared with a loss of –0.7% with teriparatide. The loss in estimated bone strength at the hip occurred mainly in the first 6 months of treatment with teriparatide and had started to recover by 12 months.

The main difference between the two treatments in total hip BMD came from romosozumab’s bone-building effect on cortical bone, Dr. Langdahl said. The significant loss of total hip cortical BMD observed with teriparatide matches what has been seen in other studies, and it occurs “because the way that teriparatide works initially on cortical bone is to open up the remodeling space; therefore, a decrease in BMD is seen.”

While romosozumab’s speed in increasing BMD and building bone strength is likely to be clinically meaningful for patients at high risk of fracture, the short duration of the trial likely left out the possibility of seeing the same sort of late increases in hip BMD and bone strength during the second year of treatment with teriparatide that have been observed in other studies. Dr. Langdahl suggested that the decline in total hip cortical bone volumetric BMD may have increased had there been more time for measurement in the study; after bisphosphonate treatment, teriparatide’s mechanism of action is thought to open up the bone remodeling space by stimulating bone resorption and formation, particularly in cortical bone.

“You will see an increased porosity in the cortical bone, and I think that is what explains the initial decrease. You’ll also see that it’s kind of catching up [to romosozumab]. This is only a 12-month study, unfortunately. I’m sure if it had been continued for 24 months, there would be an increase in strength because that has been demonstrated in other studies.”

The trial’s comparison of romosozumab versus teriparatide alone also leaves open the question of whether adding teriparatide to bisphosphonate or switching to a combination of teriparatide plus denosumab or teriparatide plus zoledronic acid might have yielded results comparable with romosozumab alone.

Furthermore, The study is not large enough to determine the overall side-effect profile of romosozumab and will have to wait until the larger, ongoing phase III studies are completed, Dr. Langdahl said. In the STRUCTURE study, the overall side effect profile was well balanced between the two groups. More women who received teriparatide developed hypercalcemia, and patients who received romosozumab developed antibodies, although they did not neutralize the agent’s effects.

The study was sponsored by UCB Pharma and Amgen. One investigator is an employee of UCB, and one is an employee of Amgen. Dr. Langdahl reported receiving research grants, consulting fees, and/or honoraria from Amgen, UCB, Eli Lilly, Merck, and Orkla. Most other investigators also reported financial relationships to Amgen and other pharmaceutical companies.

jevans@frontlinemedcom.com

LONDON – Bone mineral density (BMD) and estimated bone strength in the hip significantly increased during 1 year of treatment with the investigational monoclonal antibody romosozumab in comparison with teriparatide in women with postmenopausal osteoporosis who had previous fracture history and had been taking bisphosphonates for at least the previous 3 years in an open-label, randomized trial.

The investigators in the phase III, international, multicenter STRUCTURE trial sought to compare the monoclonal anti-sclerostin antibody romosozumab, which works dually to increase bone formation and decrease bone resorption, against the bone-forming agent teriparatide (Forteo) to see if it would increase total hip bone mineral density to a significantly greater extent by 12 months. Teriparatide is known to take longer to build bone at the hip following bisphosphonate use.

“These results in our minds suggest that romosozumab may offer a unique benefit to patients at high risk for fracture, transitioning from bisphosphonates,” first author Bente L. Langdahl, Ph.D., of Aarhus (Denmark) University Hospital said at the European Congress of Rheumatology. She discussed the study results in this video interview.

When Dr. Langdahl was asked after her presentation about the foreseen role of the drug in clinical practice, she noted that ongoing phase III trials looking at fracture endpoints should indicate whether it works faster at preventing fractures. Because there does not seem to be a restriction to the repeated use of romosozumab, she suggested it might be given initially for 12 months to build bone, followed by bisphosphonates to stabilize gains made, and then it could be used again if needed in a treat-to-target fashion.

The trial randomized 436 patients to receive either subcutaneous romosozumab 210 mg once monthly or subcutaneous teriparatide 20 mcg once daily for 12 months. All patients received a loading dose of 50,000-60,000 IU vitamin D3 to make sure they were vitamin D replete. The patients were postmenopausal, aged 55-90 years, and required to have taken oral bisphosphonate therapy at a dose equivalent to 70 mg weekly of alendronate for at least 3 years before enrollment (with at least 1 year of alendronate therapy prior to enrollment). They had a T score of –2.5 or less in total hip, lumbar spine, or femoral neck BMD and a history of a nonvertebral fracture after 50 years of age or a vertebral fracture at any age.

At 12 months, the primary endpoint of total hip BMD percentage change from baseline, which was calculated by averaging dual-energy x-ray absorptiometry (DXA) measurements at 6 and 12 months, increased significantly by 2.6% in the romosozumab group, compared with a loss of –1.6% in the teriparatide group.

“Why did we choose this rather unusual endpoint? It’s because we wanted to capture what happened throughout the first year,” Dr. Langdahl said.

The respective changes from baseline total hip BMD at month 12 were 2.9% vs. –0.5%; in the femoral neck, the 12-month change was 3.2% vs. –0.2%; and in the lumbar spine, the change was 9.8% vs. 5.4%.

The trial participants had a mean age of about 71 years, and T scores ranging from –2.87 to –2.83 in the lumbar spine, –2.27 to –2.21 in total hip, and –2.49 to –2.43 in the femoral neck.

Secondary endpoints of volumetric BMD measured by quantitative CT at 12 months supported the results for DXA measurements at the total hip: integral BMD changed 3.4% with romosozumab vs. –0.2% with teriparatide, cortical BMD changed 1.1% with romosozumab vs. –3.6% with teriparatide, and trabecular BMD increased 15.6% vs. 9.9%, respectively. Total hip strength at 12 months as estimated by finite element analysis rose by 2.5% with romosozumab, compared with a loss of –0.7% with teriparatide. The loss in estimated bone strength at the hip occurred mainly in the first 6 months of treatment with teriparatide and had started to recover by 12 months.

The main difference between the two treatments in total hip BMD came from romosozumab’s bone-building effect on cortical bone, Dr. Langdahl said. The significant loss of total hip cortical BMD observed with teriparatide matches what has been seen in other studies, and it occurs “because the way that teriparatide works initially on cortical bone is to open up the remodeling space; therefore, a decrease in BMD is seen.”

While romosozumab’s speed in increasing BMD and building bone strength is likely to be clinically meaningful for patients at high risk of fracture, the short duration of the trial likely left out the possibility of seeing the same sort of late increases in hip BMD and bone strength during the second year of treatment with teriparatide that have been observed in other studies. Dr. Langdahl suggested that the decline in total hip cortical bone volumetric BMD may have increased had there been more time for measurement in the study; after bisphosphonate treatment, teriparatide’s mechanism of action is thought to open up the bone remodeling space by stimulating bone resorption and formation, particularly in cortical bone.

“You will see an increased porosity in the cortical bone, and I think that is what explains the initial decrease. You’ll also see that it’s kind of catching up [to romosozumab]. This is only a 12-month study, unfortunately. I’m sure if it had been continued for 24 months, there would be an increase in strength because that has been demonstrated in other studies.”

The trial’s comparison of romosozumab versus teriparatide alone also leaves open the question of whether adding teriparatide to bisphosphonate or switching to a combination of teriparatide plus denosumab or teriparatide plus zoledronic acid might have yielded results comparable with romosozumab alone.

Furthermore, The study is not large enough to determine the overall side-effect profile of romosozumab and will have to wait until the larger, ongoing phase III studies are completed, Dr. Langdahl said. In the STRUCTURE study, the overall side effect profile was well balanced between the two groups. More women who received teriparatide developed hypercalcemia, and patients who received romosozumab developed antibodies, although they did not neutralize the agent’s effects.

The study was sponsored by UCB Pharma and Amgen. One investigator is an employee of UCB, and one is an employee of Amgen. Dr. Langdahl reported receiving research grants, consulting fees, and/or honoraria from Amgen, UCB, Eli Lilly, Merck, and Orkla. Most other investigators also reported financial relationships to Amgen and other pharmaceutical companies.

jevans@frontlinemedcom.com

LONDON – The first European guidelines developed to help the transition of young people from pediatric to adult rheumatology care within Europe were announced at the European Congress of Rheumatology.

The key aim of the guidelines, which have been jointly written by the European League Against Rheumatism (EULAR) and the Paediatric Rheumatology European Society (PReS), is to make the transition process more consistent across rheumatology practices throughout Europe, which in turn should help to ensure both the continuity and the quality of clinical care, explained Dr. Helen E. Fosterof Newcastle (England) University.

“There is evidence that there has been a long-standing problem of young people growing up with their condition moving to adult care and either falling between the services or being lost to follow-up, or there has not been continuity of care,” she said in an interview ahead of presenting the new EULAR/PReS guidelines at the congress.

“All in all, that’s translated into poorer health outcomes for young people,” said Dr. Foster, who was one of the main convenors of the EULAR/PReS Working Party for Transitional Care Management for Adolescents and Young People. 

The premise is to try to provide practical recommendations that clinicians can use to help young people in their care from the age of 11 years and older as they get ready for the transfer to adult services. The latter process can occur anywhere from 16 to 19 years of age, Dr. Foster said, but it is important to try start the transition process early and get young people more involved and responsible for their own care.

“The idea is that young people are supported to be in control of their condition, that they can cope with being seen on their own in clinic, that they are getting on with their lives, and ultimately that they have a better outcome, which includes becoming healthy, getting a job, living independently, and having a family,” she said. The age at transfer is flexible and needs to fit with the young person’s home and school life. Ideally, it occurs at a time when their disease and medication are stable, they are attending routine appointments, and generally able to be independent and cope with their condition.

EULAR/PReS transition guidelines: 12 recommendations

• Access to high-quality coordinated transition care services should be available to all young people.

• Transition should ‘start early’ (11 years of age) or directly after diagnosis.

• Direct communication is needed between young people and their families and pediatric and adult care providers.

• Each young person should have an individualized transition plan.

• There should be a written transition policy within all relevant services; this should be regularly agreed and updated.

• The multidisciplinary team involved in transitional care should be clearly defined in a written document.

• Transition services should address the complexity of adolescent and young adult development.

• There must be an agreed upon and written transfer document.

• Health care teams should be given appropriate training in adolescent and young adult rheumatic diseases.

• Secure funding is needed for uninterrupted clinical care and transition into adult services.

• An open digital platform should host the recommendations and support tools and information.

• More evidence is needed to demonstrate the outcomes of the transition to adult services.

Developing the guidelines

Together with Dr. Kirsten Minden of the German Rheumatism Research Centre Berlin (DRFZ), Dr. Foster chaired the international, multidisciplinary EULAR/PReS Working Party to review existing national and international guidelines, consensus statements, and other supporting evidence on transitional care management in childhood-onset rheumatic illness.

The remit was to develop recommendations to facilitate optimal transitional care management in rheumatology across different European countries. As such, the recommendations cover both the ideal situation as well as the bare minimum requirements to hopefully allow widespread adoption. To this end, the working party performed a systematic literature review according to EULAR standard operating procedures. They developed a set of 12 recommendations based on the evidence they reviewed.

There are 47 different health systems within Europe, all running according to different health policies set by different governments, Dr. Minden observed. In fact, only a handful of countries have specific transition care policies or pathways, so the aim was to try to develop recommendations that would work across the board while giving some ideas on how to improve existing strategies further.

She noted that some examples of existing transition programs are “Growing up and moving on” in the United Kingdom (Pediatr Transplant. 2005;9:364-72), “On your own feet ahead” in the Netherlands (BMC Health Serv Res. 2014;14:47), and “Devices for Optimization of Transfer and Transition of Adolescents with Rheumatic Disorders (DON’T RETARD)” in Belgium (Rheumatology [Oxford]. 2016;55:133-42). Of these, two are specific to the transition of young people with juvenile idiopathic arthritis (JIA) and one is for rheumatologic conditions in general.

Core elements of these programs are the need to provide written information and have a transition care plan, the allocation of a dedicated transition coordinator, and an individualized transition plan for each patient, Dr. Minden said. These elements are also part of the EULAR/PReS transition guidelines.

One of the issues to be addressed, however, is whether these transition programs actually work in the long term. “Transitional care services in rheumatology are beginning to happen and their further development can surely be facilitated by the provision of tool kits and resources for health care providers and patients,” she noted. Some of the tools already exist, so the challenge now is to get these available to all so that there can be a wider dissemination of knowledge.

The North American perspective

Both the American Academy of Pediatrics and the Canadian Pediatric Society have issued general guidance on how to transition young people from pediatric to adult services, said Dr. Lori. B. Tucker, a pediatric specialist working at BC Children’s Hospital in Vancouver, which runs the ON TRAC (Transitioning Responsibly to Adult Care) program. This is a province-wide program aimed at supporting young people between the ages of 12 and 24 years with chronic health conditions and their families to transition from pediatric to adult health care services.

The ON TRAC program includes online and mobile-enabled checklists that can be used with young people and their families, although Dr. Tucker noted that the program had perhaps not been as successful as had been hoped. Another Canadian initiative specific to rheumatology practice is the RACER (Readiness for Adult Care in Rheumatology) questionnaire. This was developed to assess how ready young people with chronic ailments were to transition to adult service.

Dr. Tucker also highlighted the YARD (Young Adult Rheumatic Diseases) clinic at her institution, set up for those aged 18 years or older with a definite diagnosis of rheumatic disease. Parents are not allowed within the clinic so as to enable young adults to take responsibility for their overall care and collaborate with their health care providers. The clinic provides education, assistance with separation independence, and other issues pertinent to this young population of patients, and it also aims to encourage adherence to appointments and treatments.

“Collaboration between pediatric rheumatologists and adult colleagues is critical to improve the outcomes of young adults with rheumatic diseases,” Dr. Tucker said. She added, “Better articulated guidelines for transition care and use of new tools have great potential to improve the care of these patients ‘lost in-between.’ ”

Why the need for the EULAR/PReS recommendations?

Dr. Foster noted that, in many countries, there is a natural break between pediatric and adult care, with young people often moving from one center to another, perhaps in another part of the country. An important part of the transition process is therefore ensuring that there are appropriately trained staff members and good communication between centers to ensure that young people don’t get lost during the move. 

“This is everyone’s business,” Dr. Foster said at the congress. “It is a shared responsibility to get it right.” That means adult and pediatric health care teams work together. Care needs to be “holistic,” she added, and cover medical, psychosocial, vocational issues, and be “developmentally appropriate throughout.” Young people also need to be involved from the start of the process, beginning early and continuing into young adulthood.

The recommendations aim to be flexible so that they can be widely implemented by health care teams throughout Europe. “It is not ‘one size fits all,” Dr. Foster acknowledged in the interview, noting the importance of being realistic and recognizing the differences between health systems, resources, and access across Europe. 

Dr. Foster, who trained in adult rheumatology before turning to pediatric rheumatology, noted that there are existing resources that can be used and although funding will be an issue on some levels, there are things that can be done by using existing tools and resources.

“We don’t want to reinvent the wheel. We want to share best practice and resources,” she said. Indeed, one of the recommendations is that all the guidelines and all the resources used to develop them are made publicly available via an electronic platform so that anybody involved in the care of a young person with rheumatic disease, as well as the young person and their family, can access them.

“Transitional care is key to improving long-term outcomes for young people with rheumatic disease,” Dr. Foster concluded. The EULAR/PReS transition care management guidelines have been developed with the engagement of all relevant stakeholders, she said, so they should be widely applicable and “important levers for change” throughout Europe. “Implementation will require funding, but also our will and energy to make them actually work in practice.”

The EULAR/PReS transition guidelines are being finalized and will be published soon in Annals of the Rheumatic Diseases.

Dr. Foster, Dr. Minden, and Dr. Tucker had no disclosures relevant to the development of the recommendations.  

rhnews@frontlinemedcom.com

LONDON – The first European guidelines developed to help the transition of young people from pediatric to adult rheumatology care within Europe were announced at the European Congress of Rheumatology.

The key aim of the guidelines, which have been jointly written by the European League Against Rheumatism (EULAR) and the Paediatric Rheumatology European Society (PReS), is to make the transition process more consistent across rheumatology practices throughout Europe, which in turn should help to ensure both the continuity and the quality of clinical care, explained Dr. Helen E. Fosterof Newcastle (England) University.

“There is evidence that there has been a long-standing problem of young people growing up with their condition moving to adult care and either falling between the services or being lost to follow-up, or there has not been continuity of care,” she said in an interview ahead of presenting the new EULAR/PReS guidelines at the congress.

“All in all, that’s translated into poorer health outcomes for young people,” said Dr. Foster, who was one of the main convenors of the EULAR/PReS Working Party for Transitional Care Management for Adolescents and Young People. 

The premise is to try to provide practical recommendations that clinicians can use to help young people in their care from the age of 11 years and older as they get ready for the transfer to adult services. The latter process can occur anywhere from 16 to 19 years of age, Dr. Foster said, but it is important to try start the transition process early and get young people more involved and responsible for their own care.

“The idea is that young people are supported to be in control of their condition, that they can cope with being seen on their own in clinic, that they are getting on with their lives, and ultimately that they have a better outcome, which includes becoming healthy, getting a job, living independently, and having a family,” she said. The age at transfer is flexible and needs to fit with the young person’s home and school life. Ideally, it occurs at a time when their disease and medication are stable, they are attending routine appointments, and generally able to be independent and cope with their condition.

EULAR/PReS transition guidelines: 12 recommendations

• Access to high-quality coordinated transition care services should be available to all young people.

• Transition should ‘start early’ (11 years of age) or directly after diagnosis.

• Direct communication is needed between young people and their families and pediatric and adult care providers.

• Each young person should have an individualized transition plan.

• There should be a written transition policy within all relevant services; this should be regularly agreed and updated.

• The multidisciplinary team involved in transitional care should be clearly defined in a written document.

• Transition services should address the complexity of adolescent and young adult development.

• There must be an agreed upon and written transfer document.

• Health care teams should be given appropriate training in adolescent and young adult rheumatic diseases.

• Secure funding is needed for uninterrupted clinical care and transition into adult services.

• An open digital platform should host the recommendations and support tools and information.

• More evidence is needed to demonstrate the outcomes of the transition to adult services.

Developing the guidelines

Together with Dr. Kirsten Minden of the German Rheumatism Research Centre Berlin (DRFZ), Dr. Foster chaired the international, multidisciplinary EULAR/PReS Working Party to review existing national and international guidelines, consensus statements, and other supporting evidence on transitional care management in childhood-onset rheumatic illness.

The remit was to develop recommendations to facilitate optimal transitional care management in rheumatology across different European countries. As such, the recommendations cover both the ideal situation as well as the bare minimum requirements to hopefully allow widespread adoption. To this end, the working party performed a systematic literature review according to EULAR standard operating procedures. They developed a set of 12 recommendations based on the evidence they reviewed.

There are 47 different health systems within Europe, all running according to different health policies set by different governments, Dr. Minden observed. In fact, only a handful of countries have specific transition care policies or pathways, so the aim was to try to develop recommendations that would work across the board while giving some ideas on how to improve existing strategies further.

She noted that some examples of existing transition programs are “Growing up and moving on” in the United Kingdom (Pediatr Transplant. 2005;9:364-72), “On your own feet ahead” in the Netherlands (BMC Health Serv Res. 2014;14:47), and “Devices for Optimization of Transfer and Transition of Adolescents with Rheumatic Disorders (DON’T RETARD)” in Belgium (Rheumatology [Oxford]. 2016;55:133-42). Of these, two are specific to the transition of young people with juvenile idiopathic arthritis (JIA) and one is for rheumatologic conditions in general.

Core elements of these programs are the need to provide written information and have a transition care plan, the allocation of a dedicated transition coordinator, and an individualized transition plan for each patient, Dr. Minden said. These elements are also part of the EULAR/PReS transition guidelines.

One of the issues to be addressed, however, is whether these transition programs actually work in the long term. “Transitional care services in rheumatology are beginning to happen and their further development can surely be facilitated by the provision of tool kits and resources for health care providers and patients,” she noted. Some of the tools already exist, so the challenge now is to get these available to all so that there can be a wider dissemination of knowledge.

The North American perspective

Both the American Academy of Pediatrics and the Canadian Pediatric Society have issued general guidance on how to transition young people from pediatric to adult services, said Dr. Lori. B. Tucker, a pediatric specialist working at BC Children’s Hospital in Vancouver, which runs the ON TRAC (Transitioning Responsibly to Adult Care) program. This is a province-wide program aimed at supporting young people between the ages of 12 and 24 years with chronic health conditions and their families to transition from pediatric to adult health care services.

The ON TRAC program includes online and mobile-enabled checklists that can be used with young people and their families, although Dr. Tucker noted that the program had perhaps not been as successful as had been hoped. Another Canadian initiative specific to rheumatology practice is the RACER (Readiness for Adult Care in Rheumatology) questionnaire. This was developed to assess how ready young people with chronic ailments were to transition to adult service.

Dr. Tucker also highlighted the YARD (Young Adult Rheumatic Diseases) clinic at her institution, set up for those aged 18 years or older with a definite diagnosis of rheumatic disease. Parents are not allowed within the clinic so as to enable young adults to take responsibility for their overall care and collaborate with their health care providers. The clinic provides education, assistance with separation independence, and other issues pertinent to this young population of patients, and it also aims to encourage adherence to appointments and treatments.

“Collaboration between pediatric rheumatologists and adult colleagues is critical to improve the outcomes of young adults with rheumatic diseases,” Dr. Tucker said. She added, “Better articulated guidelines for transition care and use of new tools have great potential to improve the care of these patients ‘lost in-between.’ ”

Why the need for the EULAR/PReS recommendations?

Dr. Foster noted that, in many countries, there is a natural break between pediatric and adult care, with young people often moving from one center to another, perhaps in another part of the country. An important part of the transition process is therefore ensuring that there are appropriately trained staff members and good communication between centers to ensure that young people don’t get lost during the move. 

“This is everyone’s business,” Dr. Foster said at the congress. “It is a shared responsibility to get it right.” That means adult and pediatric health care teams work together. Care needs to be “holistic,” she added, and cover medical, psychosocial, vocational issues, and be “developmentally appropriate throughout.” Young people also need to be involved from the start of the process, beginning early and continuing into young adulthood.

The recommendations aim to be flexible so that they can be widely implemented by health care teams throughout Europe. “It is not ‘one size fits all,” Dr. Foster acknowledged in the interview, noting the importance of being realistic and recognizing the differences between health systems, resources, and access across Europe. 

Dr. Foster, who trained in adult rheumatology before turning to pediatric rheumatology, noted that there are existing resources that can be used and although funding will be an issue on some levels, there are things that can be done by using existing tools and resources.

“We don’t want to reinvent the wheel. We want to share best practice and resources,” she said. Indeed, one of the recommendations is that all the guidelines and all the resources used to develop them are made publicly available via an electronic platform so that anybody involved in the care of a young person with rheumatic disease, as well as the young person and their family, can access them.

“Transitional care is key to improving long-term outcomes for young people with rheumatic disease,” Dr. Foster concluded. The EULAR/PReS transition care management guidelines have been developed with the engagement of all relevant stakeholders, she said, so they should be widely applicable and “important levers for change” throughout Europe. “Implementation will require funding, but also our will and energy to make them actually work in practice.”

The EULAR/PReS transition guidelines are being finalized and will be published soon in Annals of the Rheumatic Diseases.

Dr. Foster, Dr. Minden, and Dr. Tucker had no disclosures relevant to the development of the recommendations.  

rhnews@frontlinemedcom.com

LONDON – The first European guidelines developed to help the transition of young people from pediatric to adult rheumatology care within Europe were announced at the European Congress of Rheumatology.

The key aim of the guidelines, which have been jointly written by the European League Against Rheumatism (EULAR) and the Paediatric Rheumatology European Society (PReS), is to make the transition process more consistent across rheumatology practices throughout Europe, which in turn should help to ensure both the continuity and the quality of clinical care, explained Dr. Helen E. Fosterof Newcastle (England) University.

“There is evidence that there has been a long-standing problem of young people growing up with their condition moving to adult care and either falling between the services or being lost to follow-up, or there has not been continuity of care,” she said in an interview ahead of presenting the new EULAR/PReS guidelines at the congress.

“All in all, that’s translated into poorer health outcomes for young people,” said Dr. Foster, who was one of the main convenors of the EULAR/PReS Working Party for Transitional Care Management for Adolescents and Young People. 

The premise is to try to provide practical recommendations that clinicians can use to help young people in their care from the age of 11 years and older as they get ready for the transfer to adult services. The latter process can occur anywhere from 16 to 19 years of age, Dr. Foster said, but it is important to try start the transition process early and get young people more involved and responsible for their own care.

“The idea is that young people are supported to be in control of their condition, that they can cope with being seen on their own in clinic, that they are getting on with their lives, and ultimately that they have a better outcome, which includes becoming healthy, getting a job, living independently, and having a family,” she said. The age at transfer is flexible and needs to fit with the young person’s home and school life. Ideally, it occurs at a time when their disease and medication are stable, they are attending routine appointments, and generally able to be independent and cope with their condition.

EULAR/PReS transition guidelines: 12 recommendations

• Access to high-quality coordinated transition care services should be available to all young people.

• Transition should ‘start early’ (11 years of age) or directly after diagnosis.

• Direct communication is needed between young people and their families and pediatric and adult care providers.

• Each young person should have an individualized transition plan.

• There should be a written transition policy within all relevant services; this should be regularly agreed and updated.

• The multidisciplinary team involved in transitional care should be clearly defined in a written document.

• Transition services should address the complexity of adolescent and young adult development.

• There must be an agreed upon and written transfer document.

• Health care teams should be given appropriate training in adolescent and young adult rheumatic diseases.

• Secure funding is needed for uninterrupted clinical care and transition into adult services.

• An open digital platform should host the recommendations and support tools and information.

• More evidence is needed to demonstrate the outcomes of the transition to adult services.

Developing the guidelines

Together with Dr. Kirsten Minden of the German Rheumatism Research Centre Berlin (DRFZ), Dr. Foster chaired the international, multidisciplinary EULAR/PReS Working Party to review existing national and international guidelines, consensus statements, and other supporting evidence on transitional care management in childhood-onset rheumatic illness.

The remit was to develop recommendations to facilitate optimal transitional care management in rheumatology across different European countries. As such, the recommendations cover both the ideal situation as well as the bare minimum requirements to hopefully allow widespread adoption. To this end, the working party performed a systematic literature review according to EULAR standard operating procedures. They developed a set of 12 recommendations based on the evidence they reviewed.

There are 47 different health systems within Europe, all running according to different health policies set by different governments, Dr. Minden observed. In fact, only a handful of countries have specific transition care policies or pathways, so the aim was to try to develop recommendations that would work across the board while giving some ideas on how to improve existing strategies further.

She noted that some examples of existing transition programs are “Growing up and moving on” in the United Kingdom (Pediatr Transplant. 2005;9:364-72), “On your own feet ahead” in the Netherlands (BMC Health Serv Res. 2014;14:47), and “Devices for Optimization of Transfer and Transition of Adolescents with Rheumatic Disorders (DON’T RETARD)” in Belgium (Rheumatology [Oxford]. 2016;55:133-42). Of these, two are specific to the transition of young people with juvenile idiopathic arthritis (JIA) and one is for rheumatologic conditions in general.

Core elements of these programs are the need to provide written information and have a transition care plan, the allocation of a dedicated transition coordinator, and an individualized transition plan for each patient, Dr. Minden said. These elements are also part of the EULAR/PReS transition guidelines.

One of the issues to be addressed, however, is whether these transition programs actually work in the long term. “Transitional care services in rheumatology are beginning to happen and their further development can surely be facilitated by the provision of tool kits and resources for health care providers and patients,” she noted. Some of the tools already exist, so the challenge now is to get these available to all so that there can be a wider dissemination of knowledge.

The North American perspective

Both the American Academy of Pediatrics and the Canadian Pediatric Society have issued general guidance on how to transition young people from pediatric to adult services, said Dr. Lori. B. Tucker, a pediatric specialist working at BC Children’s Hospital in Vancouver, which runs the ON TRAC (Transitioning Responsibly to Adult Care) program. This is a province-wide program aimed at supporting young people between the ages of 12 and 24 years with chronic health conditions and their families to transition from pediatric to adult health care services.

The ON TRAC program includes online and mobile-enabled checklists that can be used with young people and their families, although Dr. Tucker noted that the program had perhaps not been as successful as had been hoped. Another Canadian initiative specific to rheumatology practice is the RACER (Readiness for Adult Care in Rheumatology) questionnaire. This was developed to assess how ready young people with chronic ailments were to transition to adult service.

Dr. Tucker also highlighted the YARD (Young Adult Rheumatic Diseases) clinic at her institution, set up for those aged 18 years or older with a definite diagnosis of rheumatic disease. Parents are not allowed within the clinic so as to enable young adults to take responsibility for their overall care and collaborate with their health care providers. The clinic provides education, assistance with separation independence, and other issues pertinent to this young population of patients, and it also aims to encourage adherence to appointments and treatments.

“Collaboration between pediatric rheumatologists and adult colleagues is critical to improve the outcomes of young adults with rheumatic diseases,” Dr. Tucker said. She added, “Better articulated guidelines for transition care and use of new tools have great potential to improve the care of these patients ‘lost in-between.’ ”

Why the need for the EULAR/PReS recommendations?

Dr. Foster noted that, in many countries, there is a natural break between pediatric and adult care, with young people often moving from one center to another, perhaps in another part of the country. An important part of the transition process is therefore ensuring that there are appropriately trained staff members and good communication between centers to ensure that young people don’t get lost during the move. 

“This is everyone’s business,” Dr. Foster said at the congress. “It is a shared responsibility to get it right.” That means adult and pediatric health care teams work together. Care needs to be “holistic,” she added, and cover medical, psychosocial, vocational issues, and be “developmentally appropriate throughout.” Young people also need to be involved from the start of the process, beginning early and continuing into young adulthood.

The recommendations aim to be flexible so that they can be widely implemented by health care teams throughout Europe. “It is not ‘one size fits all,” Dr. Foster acknowledged in the interview, noting the importance of being realistic and recognizing the differences between health systems, resources, and access across Europe. 

Dr. Foster, who trained in adult rheumatology before turning to pediatric rheumatology, noted that there are existing resources that can be used and although funding will be an issue on some levels, there are things that can be done by using existing tools and resources.

“We don’t want to reinvent the wheel. We want to share best practice and resources,” she said. Indeed, one of the recommendations is that all the guidelines and all the resources used to develop them are made publicly available via an electronic platform so that anybody involved in the care of a young person with rheumatic disease, as well as the young person and their family, can access them.

“Transitional care is key to improving long-term outcomes for young people with rheumatic disease,” Dr. Foster concluded. The EULAR/PReS transition care management guidelines have been developed with the engagement of all relevant stakeholders, she said, so they should be widely applicable and “important levers for change” throughout Europe. “Implementation will require funding, but also our will and energy to make them actually work in practice.”

The EULAR/PReS transition guidelines are being finalized and will be published soon in Annals of the Rheumatic Diseases.

Dr. Foster, Dr. Minden, and Dr. Tucker had no disclosures relevant to the development of the recommendations.  

rhnews@frontlinemedcom.com

LONDON – The European League Against Rheumatism guidelines on the use of disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis have been updated in line with current evidence and made more concise.

Dr. Josef S. Smolen of the department of rheumatology at the Medical University of Vienna who presented the 2016 guidelines at the European Congress of Rheumatology, noted that they now consist of 12 rather than the 14 recommendations that were included in the 2013 update (Ann Rheum Dis. 2014;73:492-509) and the 15 recommendations that were in the original 2010 version.

These 12 recommendations cover treatment targets and general approaches in the management of rheumatoid arthritis that incorporate disease-modifying antirheumatic drugs (DMARDs) and the use of glucocorticoids, and present treatment options as a hierarchy to help guide clinicians through appropriate procedures when initial and subsequent treatment fails. All DMARDs are considered in the recommendations, from the long-standing conventional synthetic (cs)DMARDs, such as methotrexate, sulfasalazine, and leflunomide, and the newer biologic DMARDs, such as the anti–tumor necrosis factor (TNF)–targeting drugs, to the newer biosimilar DMARDs, and targeted synthetic (ts)DMARDS, such as the Janus kinase (JAK) inhibitors tofacitinib and baricitinib.

The recommendations have been developed in accordance with EULAR’s standard operating procedure for the development of guidelines, Dr. Smolen observed, and involved three systematic literature reviews and expert opinion garnered from a task force of 50 experts and patients.

“This was the largest task force I have ever convened,” Dr. Smolen said, noting that rheumatologists from outside Europe had been invited to contribute their expertise and knowledge for the first time. Altogether 42 rheumatologists, three clinical fellows, two health professionals, and three patients were involved in revising the recommendations.

There are now four rather than three overarching principles, two of which are shared with early inflammatory arthritis recommendations that were also presented at the congress. The first two principles state that shared decision making is key to optimizing care and that rheumatologists should be the primary specialists looking after patients. The third principle recognizes the high burden that RA can have not only on an individual level but also on health care systems and society in general, which rheumatologists should be aware of. The fourth and final principle states that treatment decisions should be based on patients’ disease activity but that other factors, such as patients’ age, risk for progression, coexisting disease, and likely tolerance of treatment should also be kept in mind.

In an interview, Dr. Smolen highlighted that the EULAR recommendations cover three main phases of DMARD treatment: First is the DMARD-naive group of patients, who may be at an early or late stage of their disease. Second is the group in whom initial treatment has failed, and third is the group for whom subsequent treatment has not worked.

“In all these phases, we have some changes,” Dr. Smolen said. As an example, he noted that in the DMARD-naive setting, the use of csDMARDs has always been recommended but that the prior advice to consider combination csDMARD treatment has been edited out.

“We now say methotrexate should be part of the first treatment strategy, and the treatment strategy encompasses the use of additional, at least conventional synthetic, DMARDs.” Glucocorticoids are also more strongly recommended as part of the initial treatment strategy in combination with methotrexate, he said, although there is the proviso to use these for as short a time as possible.

In situations where patients do not respond to methotrexate plus glucocorticoids or they cannot tolerate methotrexate, then the recommendations advise stratifying patients into two groups. Those with poor prognostic factors might be switched to a biologic therapy, such as an anti-TNF agent or a tsDMARD. In regard to the latter, there is now more evidence behind the use of JAK inhibitors, notably tofacitinib, Dr. Smolen observed. Biologic DMARDs should be combined with csDMARDs, but if the latter is not tolerated then there is the option to use an IL-6 pathway inhibitor.

“There is now compelling evidence that all biologic DMARDs, including tocilizumab, convey better clinical, functional, and structural outcomes in combination with conventional synthetic DMARDs, especially methotrexate,” Dr. Smolen observed during his presentation of the recommendations. This may not be the case for the JAK inhibitors based on the current evidence.

When asked how the EULAR recommendations match up to those issued earlier this year by the American College of Rheumatology (Arthritis Care Res. 2016;68:1-25), Dr. Smolen observed that the two had become “much closer.” There remain differences in recommendations on glucocorticoid use, which are “somewhat clearer” in the European than in the American guidelines, and EULAR proposes combining biologic DMARDs with csDMARDs rather than using them as monotherapy. The EULAR recommendations also do not distinguish patients by disease duration but by treatment phase, and use prognostic factors for stratification.

The recommendations are currently in draft format and once finalized they will be published in Annals of the Rheumatic Diseases and also made freely available via the EULAR website, joining the organization’s many other recommendations for the management of rheumatic diseases. Dr. Smolen noted that these are intended as a template to provide national societies, health systems, and regulatory bodies a guide to the best evidence-based use of DMARDS in RA throughout Europe.

Dr. Smolen has received grant support and/or honoraria for consultations and/or for presentations from: AbbVie, Amgen, AstraZeneca, Astro-Pharma, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, ILTOO Pharma, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, and UCB.

LONDON – The European League Against Rheumatism guidelines on the use of disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis have been updated in line with current evidence and made more concise.

Dr. Josef S. Smolen of the department of rheumatology at the Medical University of Vienna who presented the 2016 guidelines at the European Congress of Rheumatology, noted that they now consist of 12 rather than the 14 recommendations that were included in the 2013 update (Ann Rheum Dis. 2014;73:492-509) and the 15 recommendations that were in the original 2010 version.

These 12 recommendations cover treatment targets and general approaches in the management of rheumatoid arthritis that incorporate disease-modifying antirheumatic drugs (DMARDs) and the use of glucocorticoids, and present treatment options as a hierarchy to help guide clinicians through appropriate procedures when initial and subsequent treatment fails. All DMARDs are considered in the recommendations, from the long-standing conventional synthetic (cs)DMARDs, such as methotrexate, sulfasalazine, and leflunomide, and the newer biologic DMARDs, such as the anti–tumor necrosis factor (TNF)–targeting drugs, to the newer biosimilar DMARDs, and targeted synthetic (ts)DMARDS, such as the Janus kinase (JAK) inhibitors tofacitinib and baricitinib.

The recommendations have been developed in accordance with EULAR’s standard operating procedure for the development of guidelines, Dr. Smolen observed, and involved three systematic literature reviews and expert opinion garnered from a task force of 50 experts and patients.

“This was the largest task force I have ever convened,” Dr. Smolen said, noting that rheumatologists from outside Europe had been invited to contribute their expertise and knowledge for the first time. Altogether 42 rheumatologists, three clinical fellows, two health professionals, and three patients were involved in revising the recommendations.

There are now four rather than three overarching principles, two of which are shared with early inflammatory arthritis recommendations that were also presented at the congress. The first two principles state that shared decision making is key to optimizing care and that rheumatologists should be the primary specialists looking after patients. The third principle recognizes the high burden that RA can have not only on an individual level but also on health care systems and society in general, which rheumatologists should be aware of. The fourth and final principle states that treatment decisions should be based on patients’ disease activity but that other factors, such as patients’ age, risk for progression, coexisting disease, and likely tolerance of treatment should also be kept in mind.

In an interview, Dr. Smolen highlighted that the EULAR recommendations cover three main phases of DMARD treatment: First is the DMARD-naive group of patients, who may be at an early or late stage of their disease. Second is the group in whom initial treatment has failed, and third is the group for whom subsequent treatment has not worked.

“In all these phases, we have some changes,” Dr. Smolen said. As an example, he noted that in the DMARD-naive setting, the use of csDMARDs has always been recommended but that the prior advice to consider combination csDMARD treatment has been edited out.

“We now say methotrexate should be part of the first treatment strategy, and the treatment strategy encompasses the use of additional, at least conventional synthetic, DMARDs.” Glucocorticoids are also more strongly recommended as part of the initial treatment strategy in combination with methotrexate, he said, although there is the proviso to use these for as short a time as possible.

In situations where patients do not respond to methotrexate plus glucocorticoids or they cannot tolerate methotrexate, then the recommendations advise stratifying patients into two groups. Those with poor prognostic factors might be switched to a biologic therapy, such as an anti-TNF agent or a tsDMARD. In regard to the latter, there is now more evidence behind the use of JAK inhibitors, notably tofacitinib, Dr. Smolen observed. Biologic DMARDs should be combined with csDMARDs, but if the latter is not tolerated then there is the option to use an IL-6 pathway inhibitor.

“There is now compelling evidence that all biologic DMARDs, including tocilizumab, convey better clinical, functional, and structural outcomes in combination with conventional synthetic DMARDs, especially methotrexate,” Dr. Smolen observed during his presentation of the recommendations. This may not be the case for the JAK inhibitors based on the current evidence.

When asked how the EULAR recommendations match up to those issued earlier this year by the American College of Rheumatology (Arthritis Care Res. 2016;68:1-25), Dr. Smolen observed that the two had become “much closer.” There remain differences in recommendations on glucocorticoid use, which are “somewhat clearer” in the European than in the American guidelines, and EULAR proposes combining biologic DMARDs with csDMARDs rather than using them as monotherapy. The EULAR recommendations also do not distinguish patients by disease duration but by treatment phase, and use prognostic factors for stratification.

The recommendations are currently in draft format and once finalized they will be published in Annals of the Rheumatic Diseases and also made freely available via the EULAR website, joining the organization’s many other recommendations for the management of rheumatic diseases. Dr. Smolen noted that these are intended as a template to provide national societies, health systems, and regulatory bodies a guide to the best evidence-based use of DMARDS in RA throughout Europe.

Dr. Smolen has received grant support and/or honoraria for consultations and/or for presentations from: AbbVie, Amgen, AstraZeneca, Astro-Pharma, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, ILTOO Pharma, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, and UCB.

LONDON – The European League Against Rheumatism guidelines on the use of disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis have been updated in line with current evidence and made more concise.

Dr. Josef S. Smolen of the department of rheumatology at the Medical University of Vienna who presented the 2016 guidelines at the European Congress of Rheumatology, noted that they now consist of 12 rather than the 14 recommendations that were included in the 2013 update (Ann Rheum Dis. 2014;73:492-509) and the 15 recommendations that were in the original 2010 version.

These 12 recommendations cover treatment targets and general approaches in the management of rheumatoid arthritis that incorporate disease-modifying antirheumatic drugs (DMARDs) and the use of glucocorticoids, and present treatment options as a hierarchy to help guide clinicians through appropriate procedures when initial and subsequent treatment fails. All DMARDs are considered in the recommendations, from the long-standing conventional synthetic (cs)DMARDs, such as methotrexate, sulfasalazine, and leflunomide, and the newer biologic DMARDs, such as the anti–tumor necrosis factor (TNF)–targeting drugs, to the newer biosimilar DMARDs, and targeted synthetic (ts)DMARDS, such as the Janus kinase (JAK) inhibitors tofacitinib and baricitinib.

The recommendations have been developed in accordance with EULAR’s standard operating procedure for the development of guidelines, Dr. Smolen observed, and involved three systematic literature reviews and expert opinion garnered from a task force of 50 experts and patients.

“This was the largest task force I have ever convened,” Dr. Smolen said, noting that rheumatologists from outside Europe had been invited to contribute their expertise and knowledge for the first time. Altogether 42 rheumatologists, three clinical fellows, two health professionals, and three patients were involved in revising the recommendations.

There are now four rather than three overarching principles, two of which are shared with early inflammatory arthritis recommendations that were also presented at the congress. The first two principles state that shared decision making is key to optimizing care and that rheumatologists should be the primary specialists looking after patients. The third principle recognizes the high burden that RA can have not only on an individual level but also on health care systems and society in general, which rheumatologists should be aware of. The fourth and final principle states that treatment decisions should be based on patients’ disease activity but that other factors, such as patients’ age, risk for progression, coexisting disease, and likely tolerance of treatment should also be kept in mind.

In an interview, Dr. Smolen highlighted that the EULAR recommendations cover three main phases of DMARD treatment: First is the DMARD-naive group of patients, who may be at an early or late stage of their disease. Second is the group in whom initial treatment has failed, and third is the group for whom subsequent treatment has not worked.

“In all these phases, we have some changes,” Dr. Smolen said. As an example, he noted that in the DMARD-naive setting, the use of csDMARDs has always been recommended but that the prior advice to consider combination csDMARD treatment has been edited out.

“We now say methotrexate should be part of the first treatment strategy, and the treatment strategy encompasses the use of additional, at least conventional synthetic, DMARDs.” Glucocorticoids are also more strongly recommended as part of the initial treatment strategy in combination with methotrexate, he said, although there is the proviso to use these for as short a time as possible.

In situations where patients do not respond to methotrexate plus glucocorticoids or they cannot tolerate methotrexate, then the recommendations advise stratifying patients into two groups. Those with poor prognostic factors might be switched to a biologic therapy, such as an anti-TNF agent or a tsDMARD. In regard to the latter, there is now more evidence behind the use of JAK inhibitors, notably tofacitinib, Dr. Smolen observed. Biologic DMARDs should be combined with csDMARDs, but if the latter is not tolerated then there is the option to use an IL-6 pathway inhibitor.

“There is now compelling evidence that all biologic DMARDs, including tocilizumab, convey better clinical, functional, and structural outcomes in combination with conventional synthetic DMARDs, especially methotrexate,” Dr. Smolen observed during his presentation of the recommendations. This may not be the case for the JAK inhibitors based on the current evidence.

When asked how the EULAR recommendations match up to those issued earlier this year by the American College of Rheumatology (Arthritis Care Res. 2016;68:1-25), Dr. Smolen observed that the two had become “much closer.” There remain differences in recommendations on glucocorticoid use, which are “somewhat clearer” in the European than in the American guidelines, and EULAR proposes combining biologic DMARDs with csDMARDs rather than using them as monotherapy. The EULAR recommendations also do not distinguish patients by disease duration but by treatment phase, and use prognostic factors for stratification.

The recommendations are currently in draft format and once finalized they will be published in Annals of the Rheumatic Diseases and also made freely available via the EULAR website, joining the organization’s many other recommendations for the management of rheumatic diseases. Dr. Smolen noted that these are intended as a template to provide national societies, health systems, and regulatory bodies a guide to the best evidence-based use of DMARDS in RA throughout Europe.

Dr. Smolen has received grant support and/or honoraria for consultations and/or for presentations from: AbbVie, Amgen, AstraZeneca, Astro-Pharma, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, ILTOO Pharma, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, and UCB.

LONDON – Cardiovascular disease (CVD) risk assessment for patients with rheumatic diseases can be simple and integrated into general practice or rheumatology clinics, experts said during an Outcomes Science Session at the European Congress of Rheumatology

Patients with rheumatoid arthritis have a 50% higher risk of heart disease than do their counterparts without the disease, but “just having RA on its own isn’t sufficient to render that individual at high risk,” Dr. Naveed Sattar, professor of metabolic medicine at the University of Glasgow’s Institute of Cardiovascular and Medical Sciences in Scotland, said in an interview.

It’s simple enough to use traditional CVD risk factors in an RA population by including a patient’s age, gender, smoking status, and family history of heart disease, in addition to measuring blood pressure and blood lipid levels. Most risk scores will compile those features into a 10-year risk of a fatal CVD event. To account for the contribution of RA, Dr. Sattar said, simply multiply that score by 1.5.

While “there’s a fixation in some parts of Europe for [measuring] fasting lipids,” it is not necessary, Dr. Sattar said. The two lipid parameters that go in risk scores tend to be cholesterol and HDL cholesterol, he said, which change only minimally in fasting versus nonfasting states.

“The evidence overwhelmingly shows that nonfasting lipids, which can be done easily on the same sample as other clinic tests, are just as predictive of CVD risk as fasting lipids,” he said. “That really matters because many of our patients with RA or other conditions come to the hospital when they’re not fasting, and we shouldn’t be sending them away to come back fasting to do risk scores for CVD. That just doesn’t make sense.”

Updated guidelines from the European Society of Cardiology and guidelines soon to be released from the European League Against Rheumatism suggest that risk scores can be calculated every 5 years for most patients, a change from previous recommendations to calculate risk annually. Risk scoring is not perfect, however, and there is some debate about whether additional blood tests or ultrasound scanning of the carotid artery could augment the ability to predict heart disease risk. “We’re not quite there yet,” Dr. Sattar said. “I think we should do the simple things first and do them well.”

CV risk raised in all inflammatory arthritic diseases

During the same session, Dr. Paola de Pablo of the University of Birmingham, England, focused on how immune-mediated diseases predispose to premature, accelerated atherosclerosis and subsequent increased cardiovascular morbidity and mortality.

Cardiovascular risk is not only elevated in those with RA, she observed, but also in those with systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, vasculitides, and inflammatory myopathies. The risk varies but as a rule is more than 50% higher than the rate seen in the general population.

The underlying mechanisms are not clear, but chronic inflammation is closely linked with atherosclerosis, which in turn ups the risk for myocardial infarction and cerebrovascular accident.

Despite treatment, the risk often remains, Dr. de Pablo said. She highlighted how treatment with methotrexate and anti–tumor necrosis factor (TNF)–alpha drugs in RA had been associated with a reduction in the risk for heart attack of 20% and 40%, respectively (Ann Rheum Dis. 2014;74:480–89) so targeting inflammation with these drugs may have positive effects, at least in RA.

Managing traditional cardiovascular risk factors remains important, Dr. de Pablo said. That was a sentiment echoed by Dr. Sattar and by rheumatologist Dr. Michael Nurmohamed of the VU Medical Center in Amsterdam. This includes controlling blood pressure with antihypertensive medications and blood lipids with statins, and advocating smoking cessation and perhaps other appropriate lifestyle changes such as increasing physical exercise and controlling weight.

Dr. Nurmohamed, who was involved in the 2015 update of the EULAR recommendations on cardiovascular risk management, noted that traditional risk factor management in patients with arthritis in current clinical practice is often poor and that strategies to address this were urgently needed.

Although treating to-target and preventing disease flares in the rheumatic diseases is important, it lowers but does not normalize cardiovascular risk. “This appears to be irrespective of the drug used,” Dr. Nurmohamed said. Rheumatologists need to be careful when tapering medication, particularly the biologics, as these are perhaps helping to temper cardiovascular inflammation, which could worsen when doses are reduced. “Antirheumatic treatment only is not good enough to decrease or normalize the cardiovascular risk of our patients”, he emphasized.

Norwegian project shows how to integrate CVD assessment into routine practice

In a separate presentation, Dr. Eirik Ikdahl, a PhD student at Diakonhjemmet Hospital in Oslo, discussed how some rheumatology clinics in Norway are successfully incorporating CVD risk screening.

Through the Norwegian Collaboration on Atherosclerotic disease in patients with Rheumatic joint diseases (NOCAR), which started in April 2014, annual cardiovascular disease risk evaluations of patients with inflammatory joint diseases are being implemented into the practices of 11 rheumatology outpatient clinics. While waiting for clinic appointments, patients are given electronic devices through which they can report CVD risk factors via an electronic patient journal program called GoTreatIt Rheuma. From there, the clinic can order nonfasting lipid measurements and nurses can record patients’ blood pressure. 

Then, using the ESC Systematic Coronary Risk Evaluation (SCORE) algorithm, the program automatically calculates a patient’s 10-year risk of a fatal CVD event. If the SCORE estimate is 5% or greater, the rheumatologist forwards a note to the patient’s primary care physician or cardiologist saying there is an indication for initiation of CVD-preventive measures such as medication or lifestyle changes. Rheumatologists and rheumatology nurses also deliver brief advice regarding smoking cessation and healthy diet.

“The main aim of the project is to raise awareness of the cardiovascular burden that these patients experience, and to ensure that patients with inflammatory joint diseases receive guideline-recommended cardiovascular preventive treatment,” Dr. Ikdahl said.

Of 6,150 patients defined as eligible for the NOCAR project in three of the centers, 41% (n = 2,519) received a CVD risk assessment during the first year and a half of the program, officers found in a recent review. Of those, 1,569 had RA, 418 had ankylosing spondylitis, 350 had psoriatic arthritis, and 122 had other spondyloarthritides. 

Through the program, “a large number of high-risk patients have received screening that they would not otherwise have been offered,” Dr. Ikdahl said.

The major obstacles to successful implementation were time scarcity, defining a date for annual CVD risk assessment among patients who visit the clinics multiple times per year, and making sure lipids were measured before seeing the rheumatologist, he said. “We acknowledge there is room for improvement. It is challenging to implement new work tasks in an already busy rheumatology outpatient clinic, and since the project does not offer financial incentives to the participating centers, we rely on a collective effort and voluntary work based on resources already available.”

Remember CVD, but don’t forget other comorbidities

Other research presented by Dr. Laure Gossec, professor of rheumatology at Pitie-Salpétriere Hospital and Pierre & Marie Curie University in Paris highlighted the importance of identifying all comorbidities and their risk factors in patients with rheumatic diseases, and not just cardiovascular disease.

Dr. Gossec presented the results of an initiative aiming to make the collection and management of comorbidities easier in routine rheumatologic practice. The aim was to develop a simple, more pragmatic form that could be used to help rheumatologists manage selected comorbidities, and know when to refer for other specialist assessment. The focus was on ischemic cardiovascular disease, malignancies, infections such as chronic bronchitis, gastrointestinal disease such as diverticulitis, osteoporosis, and depression.

A committee of 18 experts, both physicians and nurses, was convened to examine the results of a systematic literature review of recommendations on comorbidity management and come up with concise recommendations for rheumatologists. Each of their recommendations covered whether or not the comorbidity was present (yes/no/don’t know) and if screening had been undertaken, such as measurement of blood lipids, and when this had occurred if known. There was then guidance on how to interpret these findings, calculate risk, and what to do if findings were abnormal.

The project is ongoing, and so far the expert panel has developed a pragmatic document with forms to help collect, report, and manage each specific comorbidity and its known risk factors. But it is still perhaps too long to be feasibly used in everyday practice, Dr. Gossec conceded. So the aim is to create a short, 2-page form that could summarize the recommendations briefly, and also develop a questionnaire for the patient to fill out and understand how to self-manage some comorbidities.

“We feel that this is a way to disseminate and adapt to the national context for France the EULAR comorbidities initiative,” Dr. Gossec said. “It also defines exactly what rheumatologists should be doing and when they should refer, hopefully to the benefit of our patients.”

Dr. Sattar has participated in advisory boards for Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lily and UCB. He has also consulted for Merck and is a member of Roche’s speakers’ bureau. Dr. de Paolo and Dr. Nurmohamed reported no relevant financial disclosures. Dr. Ikdahl has received speaker’s honoraria from Pfizer. Dr. Gossec and coauthors have received honoraria from Abbvie France.

LONDON – Cardiovascular disease (CVD) risk assessment for patients with rheumatic diseases can be simple and integrated into general practice or rheumatology clinics, experts said during an Outcomes Science Session at the European Congress of Rheumatology

Patients with rheumatoid arthritis have a 50% higher risk of heart disease than do their counterparts without the disease, but “just having RA on its own isn’t sufficient to render that individual at high risk,” Dr. Naveed Sattar, professor of metabolic medicine at the University of Glasgow’s Institute of Cardiovascular and Medical Sciences in Scotland, said in an interview.

It’s simple enough to use traditional CVD risk factors in an RA population by including a patient’s age, gender, smoking status, and family history of heart disease, in addition to measuring blood pressure and blood lipid levels. Most risk scores will compile those features into a 10-year risk of a fatal CVD event. To account for the contribution of RA, Dr. Sattar said, simply multiply that score by 1.5.

While “there’s a fixation in some parts of Europe for [measuring] fasting lipids,” it is not necessary, Dr. Sattar said. The two lipid parameters that go in risk scores tend to be cholesterol and HDL cholesterol, he said, which change only minimally in fasting versus nonfasting states.

“The evidence overwhelmingly shows that nonfasting lipids, which can be done easily on the same sample as other clinic tests, are just as predictive of CVD risk as fasting lipids,” he said. “That really matters because many of our patients with RA or other conditions come to the hospital when they’re not fasting, and we shouldn’t be sending them away to come back fasting to do risk scores for CVD. That just doesn’t make sense.”

Updated guidelines from the European Society of Cardiology and guidelines soon to be released from the European League Against Rheumatism suggest that risk scores can be calculated every 5 years for most patients, a change from previous recommendations to calculate risk annually. Risk scoring is not perfect, however, and there is some debate about whether additional blood tests or ultrasound scanning of the carotid artery could augment the ability to predict heart disease risk. “We’re not quite there yet,” Dr. Sattar said. “I think we should do the simple things first and do them well.”

CV risk raised in all inflammatory arthritic diseases

During the same session, Dr. Paola de Pablo of the University of Birmingham, England, focused on how immune-mediated diseases predispose to premature, accelerated atherosclerosis and subsequent increased cardiovascular morbidity and mortality.

Cardiovascular risk is not only elevated in those with RA, she observed, but also in those with systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, vasculitides, and inflammatory myopathies. The risk varies but as a rule is more than 50% higher than the rate seen in the general population.

The underlying mechanisms are not clear, but chronic inflammation is closely linked with atherosclerosis, which in turn ups the risk for myocardial infarction and cerebrovascular accident.

Despite treatment, the risk often remains, Dr. de Pablo said. She highlighted how treatment with methotrexate and anti–tumor necrosis factor (TNF)–alpha drugs in RA had been associated with a reduction in the risk for heart attack of 20% and 40%, respectively (Ann Rheum Dis. 2014;74:480–89) so targeting inflammation with these drugs may have positive effects, at least in RA.

Managing traditional cardiovascular risk factors remains important, Dr. de Pablo said. That was a sentiment echoed by Dr. Sattar and by rheumatologist Dr. Michael Nurmohamed of the VU Medical Center in Amsterdam. This includes controlling blood pressure with antihypertensive medications and blood lipids with statins, and advocating smoking cessation and perhaps other appropriate lifestyle changes such as increasing physical exercise and controlling weight.

Dr. Nurmohamed, who was involved in the 2015 update of the EULAR recommendations on cardiovascular risk management, noted that traditional risk factor management in patients with arthritis in current clinical practice is often poor and that strategies to address this were urgently needed.

Although treating to-target and preventing disease flares in the rheumatic diseases is important, it lowers but does not normalize cardiovascular risk. “This appears to be irrespective of the drug used,” Dr. Nurmohamed said. Rheumatologists need to be careful when tapering medication, particularly the biologics, as these are perhaps helping to temper cardiovascular inflammation, which could worsen when doses are reduced. “Antirheumatic treatment only is not good enough to decrease or normalize the cardiovascular risk of our patients”, he emphasized.

Norwegian project shows how to integrate CVD assessment into routine practice

In a separate presentation, Dr. Eirik Ikdahl, a PhD student at Diakonhjemmet Hospital in Oslo, discussed how some rheumatology clinics in Norway are successfully incorporating CVD risk screening.

Through the Norwegian Collaboration on Atherosclerotic disease in patients with Rheumatic joint diseases (NOCAR), which started in April 2014, annual cardiovascular disease risk evaluations of patients with inflammatory joint diseases are being implemented into the practices of 11 rheumatology outpatient clinics. While waiting for clinic appointments, patients are given electronic devices through which they can report CVD risk factors via an electronic patient journal program called GoTreatIt Rheuma. From there, the clinic can order nonfasting lipid measurements and nurses can record patients’ blood pressure. 

Then, using the ESC Systematic Coronary Risk Evaluation (SCORE) algorithm, the program automatically calculates a patient’s 10-year risk of a fatal CVD event. If the SCORE estimate is 5% or greater, the rheumatologist forwards a note to the patient’s primary care physician or cardiologist saying there is an indication for initiation of CVD-preventive measures such as medication or lifestyle changes. Rheumatologists and rheumatology nurses also deliver brief advice regarding smoking cessation and healthy diet.

“The main aim of the project is to raise awareness of the cardiovascular burden that these patients experience, and to ensure that patients with inflammatory joint diseases receive guideline-recommended cardiovascular preventive treatment,” Dr. Ikdahl said.

Of 6,150 patients defined as eligible for the NOCAR project in three of the centers, 41% (n = 2,519) received a CVD risk assessment during the first year and a half of the program, officers found in a recent review. Of those, 1,569 had RA, 418 had ankylosing spondylitis, 350 had psoriatic arthritis, and 122 had other spondyloarthritides. 

Through the program, “a large number of high-risk patients have received screening that they would not otherwise have been offered,” Dr. Ikdahl said.

The major obstacles to successful implementation were time scarcity, defining a date for annual CVD risk assessment among patients who visit the clinics multiple times per year, and making sure lipids were measured before seeing the rheumatologist, he said. “We acknowledge there is room for improvement. It is challenging to implement new work tasks in an already busy rheumatology outpatient clinic, and since the project does not offer financial incentives to the participating centers, we rely on a collective effort and voluntary work based on resources already available.”

Remember CVD, but don’t forget other comorbidities

Other research presented by Dr. Laure Gossec, professor of rheumatology at Pitie-Salpétriere Hospital and Pierre & Marie Curie University in Paris highlighted the importance of identifying all comorbidities and their risk factors in patients with rheumatic diseases, and not just cardiovascular disease.

Dr. Gossec presented the results of an initiative aiming to make the collection and management of comorbidities easier in routine rheumatologic practice. The aim was to develop a simple, more pragmatic form that could be used to help rheumatologists manage selected comorbidities, and know when to refer for other specialist assessment. The focus was on ischemic cardiovascular disease, malignancies, infections such as chronic bronchitis, gastrointestinal disease such as diverticulitis, osteoporosis, and depression.

A committee of 18 experts, both physicians and nurses, was convened to examine the results of a systematic literature review of recommendations on comorbidity management and come up with concise recommendations for rheumatologists. Each of their recommendations covered whether or not the comorbidity was present (yes/no/don’t know) and if screening had been undertaken, such as measurement of blood lipids, and when this had occurred if known. There was then guidance on how to interpret these findings, calculate risk, and what to do if findings were abnormal.

The project is ongoing, and so far the expert panel has developed a pragmatic document with forms to help collect, report, and manage each specific comorbidity and its known risk factors. But it is still perhaps too long to be feasibly used in everyday practice, Dr. Gossec conceded. So the aim is to create a short, 2-page form that could summarize the recommendations briefly, and also develop a questionnaire for the patient to fill out and understand how to self-manage some comorbidities.

“We feel that this is a way to disseminate and adapt to the national context for France the EULAR comorbidities initiative,” Dr. Gossec said. “It also defines exactly what rheumatologists should be doing and when they should refer, hopefully to the benefit of our patients.”

Dr. Sattar has participated in advisory boards for Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lily and UCB. He has also consulted for Merck and is a member of Roche’s speakers’ bureau. Dr. de Paolo and Dr. Nurmohamed reported no relevant financial disclosures. Dr. Ikdahl has received speaker’s honoraria from Pfizer. Dr. Gossec and coauthors have received honoraria from Abbvie France.

LONDON – Cardiovascular disease (CVD) risk assessment for patients with rheumatic diseases can be simple and integrated into general practice or rheumatology clinics, experts said during an Outcomes Science Session at the European Congress of Rheumatology

Patients with rheumatoid arthritis have a 50% higher risk of heart disease than do their counterparts without the disease, but “just having RA on its own isn’t sufficient to render that individual at high risk,” Dr. Naveed Sattar, professor of metabolic medicine at the University of Glasgow’s Institute of Cardiovascular and Medical Sciences in Scotland, said in an interview.

It’s simple enough to use traditional CVD risk factors in an RA population by including a patient’s age, gender, smoking status, and family history of heart disease, in addition to measuring blood pressure and blood lipid levels. Most risk scores will compile those features into a 10-year risk of a fatal CVD event. To account for the contribution of RA, Dr. Sattar said, simply multiply that score by 1.5.

While “there’s a fixation in some parts of Europe for [measuring] fasting lipids,” it is not necessary, Dr. Sattar said. The two lipid parameters that go in risk scores tend to be cholesterol and HDL cholesterol, he said, which change only minimally in fasting versus nonfasting states.

“The evidence overwhelmingly shows that nonfasting lipids, which can be done easily on the same sample as other clinic tests, are just as predictive of CVD risk as fasting lipids,” he said. “That really matters because many of our patients with RA or other conditions come to the hospital when they’re not fasting, and we shouldn’t be sending them away to come back fasting to do risk scores for CVD. That just doesn’t make sense.”

Updated guidelines from the European Society of Cardiology and guidelines soon to be released from the European League Against Rheumatism suggest that risk scores can be calculated every 5 years for most patients, a change from previous recommendations to calculate risk annually. Risk scoring is not perfect, however, and there is some debate about whether additional blood tests or ultrasound scanning of the carotid artery could augment the ability to predict heart disease risk. “We’re not quite there yet,” Dr. Sattar said. “I think we should do the simple things first and do them well.”

CV risk raised in all inflammatory arthritic diseases

During the same session, Dr. Paola de Pablo of the University of Birmingham, England, focused on how immune-mediated diseases predispose to premature, accelerated atherosclerosis and subsequent increased cardiovascular morbidity and mortality.

Cardiovascular risk is not only elevated in those with RA, she observed, but also in those with systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, vasculitides, and inflammatory myopathies. The risk varies but as a rule is more than 50% higher than the rate seen in the general population.

The underlying mechanisms are not clear, but chronic inflammation is closely linked with atherosclerosis, which in turn ups the risk for myocardial infarction and cerebrovascular accident.

Despite treatment, the risk often remains, Dr. de Pablo said. She highlighted how treatment with methotrexate and anti–tumor necrosis factor (TNF)–alpha drugs in RA had been associated with a reduction in the risk for heart attack of 20% and 40%, respectively (Ann Rheum Dis. 2014;74:480–89) so targeting inflammation with these drugs may have positive effects, at least in RA.

Managing traditional cardiovascular risk factors remains important, Dr. de Pablo said. That was a sentiment echoed by Dr. Sattar and by rheumatologist Dr. Michael Nurmohamed of the VU Medical Center in Amsterdam. This includes controlling blood pressure with antihypertensive medications and blood lipids with statins, and advocating smoking cessation and perhaps other appropriate lifestyle changes such as increasing physical exercise and controlling weight.

Dr. Nurmohamed, who was involved in the 2015 update of the EULAR recommendations on cardiovascular risk management, noted that traditional risk factor management in patients with arthritis in current clinical practice is often poor and that strategies to address this were urgently needed.

Although treating to-target and preventing disease flares in the rheumatic diseases is important, it lowers but does not normalize cardiovascular risk. “This appears to be irrespective of the drug used,” Dr. Nurmohamed said. Rheumatologists need to be careful when tapering medication, particularly the biologics, as these are perhaps helping to temper cardiovascular inflammation, which could worsen when doses are reduced. “Antirheumatic treatment only is not good enough to decrease or normalize the cardiovascular risk of our patients”, he emphasized.

Norwegian project shows how to integrate CVD assessment into routine practice

In a separate presentation, Dr. Eirik Ikdahl, a PhD student at Diakonhjemmet Hospital in Oslo, discussed how some rheumatology clinics in Norway are successfully incorporating CVD risk screening.

Through the Norwegian Collaboration on Atherosclerotic disease in patients with Rheumatic joint diseases (NOCAR), which started in April 2014, annual cardiovascular disease risk evaluations of patients with inflammatory joint diseases are being implemented into the practices of 11 rheumatology outpatient clinics. While waiting for clinic appointments, patients are given electronic devices through which they can report CVD risk factors via an electronic patient journal program called GoTreatIt Rheuma. From there, the clinic can order nonfasting lipid measurements and nurses can record patients’ blood pressure. 

Then, using the ESC Systematic Coronary Risk Evaluation (SCORE) algorithm, the program automatically calculates a patient’s 10-year risk of a fatal CVD event. If the SCORE estimate is 5% or greater, the rheumatologist forwards a note to the patient’s primary care physician or cardiologist saying there is an indication for initiation of CVD-preventive measures such as medication or lifestyle changes. Rheumatologists and rheumatology nurses also deliver brief advice regarding smoking cessation and healthy diet.

“The main aim of the project is to raise awareness of the cardiovascular burden that these patients experience, and to ensure that patients with inflammatory joint diseases receive guideline-recommended cardiovascular preventive treatment,” Dr. Ikdahl said.

Of 6,150 patients defined as eligible for the NOCAR project in three of the centers, 41% (n = 2,519) received a CVD risk assessment during the first year and a half of the program, officers found in a recent review. Of those, 1,569 had RA, 418 had ankylosing spondylitis, 350 had psoriatic arthritis, and 122 had other spondyloarthritides. 

Through the program, “a large number of high-risk patients have received screening that they would not otherwise have been offered,” Dr. Ikdahl said.

The major obstacles to successful implementation were time scarcity, defining a date for annual CVD risk assessment among patients who visit the clinics multiple times per year, and making sure lipids were measured before seeing the rheumatologist, he said. “We acknowledge there is room for improvement. It is challenging to implement new work tasks in an already busy rheumatology outpatient clinic, and since the project does not offer financial incentives to the participating centers, we rely on a collective effort and voluntary work based on resources already available.”

Remember CVD, but don’t forget other comorbidities

Other research presented by Dr. Laure Gossec, professor of rheumatology at Pitie-Salpétriere Hospital and Pierre & Marie Curie University in Paris highlighted the importance of identifying all comorbidities and their risk factors in patients with rheumatic diseases, and not just cardiovascular disease.

Dr. Gossec presented the results of an initiative aiming to make the collection and management of comorbidities easier in routine rheumatologic practice. The aim was to develop a simple, more pragmatic form that could be used to help rheumatologists manage selected comorbidities, and know when to refer for other specialist assessment. The focus was on ischemic cardiovascular disease, malignancies, infections such as chronic bronchitis, gastrointestinal disease such as diverticulitis, osteoporosis, and depression.

A committee of 18 experts, both physicians and nurses, was convened to examine the results of a systematic literature review of recommendations on comorbidity management and come up with concise recommendations for rheumatologists. Each of their recommendations covered whether or not the comorbidity was present (yes/no/don’t know) and if screening had been undertaken, such as measurement of blood lipids, and when this had occurred if known. There was then guidance on how to interpret these findings, calculate risk, and what to do if findings were abnormal.

The project is ongoing, and so far the expert panel has developed a pragmatic document with forms to help collect, report, and manage each specific comorbidity and its known risk factors. But it is still perhaps too long to be feasibly used in everyday practice, Dr. Gossec conceded. So the aim is to create a short, 2-page form that could summarize the recommendations briefly, and also develop a questionnaire for the patient to fill out and understand how to self-manage some comorbidities.

“We feel that this is a way to disseminate and adapt to the national context for France the EULAR comorbidities initiative,” Dr. Gossec said. “It also defines exactly what rheumatologists should be doing and when they should refer, hopefully to the benefit of our patients.”

Dr. Sattar has participated in advisory boards for Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lily and UCB. He has also consulted for Merck and is a member of Roche’s speakers’ bureau. Dr. de Paolo and Dr. Nurmohamed reported no relevant financial disclosures. Dr. Ikdahl has received speaker’s honoraria from Pfizer. Dr. Gossec and coauthors have received honoraria from Abbvie France.

LONDON, ENGLAND – Prompt referral to a rheumatologist and early initiation of treatment remain 2 of the 12 key recommendations in the updated European League Against Rheumatism guidelines for early arthritis.

There are now three specific recommendations dealing with referral and diagnosis; four that cover initial drug treatment with disease-modifying antirheumatic drugs (DMARDs), nonsteroidal anti-inflammatory drugs (NSAIDs), and glucocorticoids; two that cover management strategy and monitoring; and three that cover nonpharmacologic interventions, prevention, and patient information and education.

While many of the recommendations have not radically changed, there have been revisions to the wording. In line with other EULAR recommendations for the management of rheumatic disease, the updated early arthritis guidelines also now contain three overarching principles. The first states that the management of early arthritis should aim to achieve the best possible care and emphasizes the need for shared decision making between rheumatologist and patient. The second states that a rheumatologist should be the main specialist looking after a patient with early arthritis, and the third states that a definitive diagnosis should be made only after a careful medical history and clinical examination have been undertaken.

“[The EULAR] recommendations deal especially with early-stage inflammatory arthritis,” said Dr. Bernard Combe of Hôpital Lapeyronie in Montpellier, France, who was the convener of the task force behind the updated guidelines. As such, they are universal for all rheumatologic arthritis conditions when diagnosed early, before they differentiate into more specifics, he said in an interview. That includes progression from early inflammatory arthritis to rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis.

Dr. Combe, who is also professor of rheumatology at Montpellier University and head of the bone and joint diseases department at Montpellier University Hospital, presented the updated EULAR guidance at the European Congress of Rheumatology. He noted that the guidelines were first written almost 10 years ago (Ann Rheum Dis. 2007 Jan;66(1):34-45) and so were in need of an update. A task force of 20 rheumatologists, two patients, and one health care professional representing 12 European countries were involved in the update that adhered to EULAR standard operating procedure of developing guidelines.

Although EULAR had published guidance on the management of arthritis in the intervening years, he said, this had focused more on management, and the aim of the early arthritis guidelines was to cover the “entire spectrum of the management of early inflammatory arthritis.”

The updated recommendations start and end with patient-centered statements, he observed. The first notes that patients with any joint swelling associated with pain or stiffness should be referred to and seen by a rheumatologist within 6 weeks of the onset of symptoms. The final recommendation deals with patient information and education about the disease, and programs aiming to help patients cope with pain, disability, and ensure their continued ability to work and participate in their usual social activities.

The concept of early identification and treatment is not new, Dr. Combe observed, but there is so much more evidence in support of initiating DMARD therapy within the first 3 months of referral, even if patients do not fulfill classification criteria for a specific inflammatory rheumatic disease.

In terms of diagnosis, the recommendations now hinge on performing a thorough clinical examination and using ultrasonography to confirm the presence of arthritis if needed. Magnetic resonance imaging (MRI) is no longer recommended in this initial diagnostic work up. This is due to the cost and often lack of widespread access in all European countries, Dr. Combe said. MRI might be considered later, however, if a diagnosis cannot be reached. Assessment of the number of swollen joints, acute phase reactants, and antibody tests (rheumatoid factor and anti-citrullinated protein antibody) also might be of use at this point.

Among the various DMARDs, methotrexate is recommended as the “anchor drug”; it should be used as part of the first treatment strategy in patients who are at risk of persistent disease, unless it contraindicated. The goal of treatment with DMARDs is to achieve clinical remission. Regular monitoring of disease activity, side effects, and comorbidities should be performed alongside their use. Regular monitoring of all pharmacologic therapy should include assessment of tender and swollen joint counts, global health assessments by the patient and the physician, and acute phase reactants.

As for NSAIDs, they are recommended for symptomatic relief, but “at the minimum effective dose for the shortest time possible.” The risks for gastrointestinal, renal, and cardiovascular complications should be carefully weighed against the likely benefits. Glucocorticoids also are recommended for reducing pain and swelling, and structural progression, but again these need to be used at the lowest possible dose and for no more than 6 months to avoid potential long-term side effects.

A recommendation on nonpharmacologic interventions also is included, which states that physical exercise and occupational therapy should be considered as adjunctive therapy.

In addition, the task force came up with a list of 10 research questions that need to be answered, which included items on risk prediction, optimal treatment combinations, and dosing regimens.

As with other EULAR guidelines, a flow chart is included that summarizes the recommendations to help guide physicians on when and how to treat, when to adapt dosing or change medication, and other treatments and approaches to consider.

There is a new recommendation on prevention highlighting the importance of smoking cessation, dental care, weight control, vaccination, and managing comorbidities.

Once the guidelines have been finalized, they will be published in the EULAR journal, Annals of the Rheumatic Diseases, later in the year.

Dr. Combe has received research grants and honoraria from Pfizer, Roche-Chugai, and UCB, and honoraria from Bristol-Myers Squibb, Janssen, Eli Lilly, Merck Sharpe and Dohme, and Novartis.

LONDON, ENGLAND – Prompt referral to a rheumatologist and early initiation of treatment remain 2 of the 12 key recommendations in the updated European League Against Rheumatism guidelines for early arthritis.

There are now three specific recommendations dealing with referral and diagnosis; four that cover initial drug treatment with disease-modifying antirheumatic drugs (DMARDs), nonsteroidal anti-inflammatory drugs (NSAIDs), and glucocorticoids; two that cover management strategy and monitoring; and three that cover nonpharmacologic interventions, prevention, and patient information and education.

While many of the recommendations have not radically changed, there have been revisions to the wording. In line with other EULAR recommendations for the management of rheumatic disease, the updated early arthritis guidelines also now contain three overarching principles. The first states that the management of early arthritis should aim to achieve the best possible care and emphasizes the need for shared decision making between rheumatologist and patient. The second states that a rheumatologist should be the main specialist looking after a patient with early arthritis, and the third states that a definitive diagnosis should be made only after a careful medical history and clinical examination have been undertaken.

“[The EULAR] recommendations deal especially with early-stage inflammatory arthritis,” said Dr. Bernard Combe of Hôpital Lapeyronie in Montpellier, France, who was the convener of the task force behind the updated guidelines. As such, they are universal for all rheumatologic arthritis conditions when diagnosed early, before they differentiate into more specifics, he said in an interview. That includes progression from early inflammatory arthritis to rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis.

Dr. Combe, who is also professor of rheumatology at Montpellier University and head of the bone and joint diseases department at Montpellier University Hospital, presented the updated EULAR guidance at the European Congress of Rheumatology. He noted that the guidelines were first written almost 10 years ago (Ann Rheum Dis. 2007 Jan;66(1):34-45) and so were in need of an update. A task force of 20 rheumatologists, two patients, and one health care professional representing 12 European countries were involved in the update that adhered to EULAR standard operating procedure of developing guidelines.

Although EULAR had published guidance on the management of arthritis in the intervening years, he said, this had focused more on management, and the aim of the early arthritis guidelines was to cover the “entire spectrum of the management of early inflammatory arthritis.”

The updated recommendations start and end with patient-centered statements, he observed. The first notes that patients with any joint swelling associated with pain or stiffness should be referred to and seen by a rheumatologist within 6 weeks of the onset of symptoms. The final recommendation deals with patient information and education about the disease, and programs aiming to help patients cope with pain, disability, and ensure their continued ability to work and participate in their usual social activities.

The concept of early identification and treatment is not new, Dr. Combe observed, but there is so much more evidence in support of initiating DMARD therapy within the first 3 months of referral, even if patients do not fulfill classification criteria for a specific inflammatory rheumatic disease.

In terms of diagnosis, the recommendations now hinge on performing a thorough clinical examination and using ultrasonography to confirm the presence of arthritis if needed. Magnetic resonance imaging (MRI) is no longer recommended in this initial diagnostic work up. This is due to the cost and often lack of widespread access in all European countries, Dr. Combe said. MRI might be considered later, however, if a diagnosis cannot be reached. Assessment of the number of swollen joints, acute phase reactants, and antibody tests (rheumatoid factor and anti-citrullinated protein antibody) also might be of use at this point.

Among the various DMARDs, methotrexate is recommended as the “anchor drug”; it should be used as part of the first treatment strategy in patients who are at risk of persistent disease, unless it contraindicated. The goal of treatment with DMARDs is to achieve clinical remission. Regular monitoring of disease activity, side effects, and comorbidities should be performed alongside their use. Regular monitoring of all pharmacologic therapy should include assessment of tender and swollen joint counts, global health assessments by the patient and the physician, and acute phase reactants.

As for NSAIDs, they are recommended for symptomatic relief, but “at the minimum effective dose for the shortest time possible.” The risks for gastrointestinal, renal, and cardiovascular complications should be carefully weighed against the likely benefits. Glucocorticoids also are recommended for reducing pain and swelling, and structural progression, but again these need to be used at the lowest possible dose and for no more than 6 months to avoid potential long-term side effects.

A recommendation on nonpharmacologic interventions also is included, which states that physical exercise and occupational therapy should be considered as adjunctive therapy.

In addition, the task force came up with a list of 10 research questions that need to be answered, which included items on risk prediction, optimal treatment combinations, and dosing regimens.

As with other EULAR guidelines, a flow chart is included that summarizes the recommendations to help guide physicians on when and how to treat, when to adapt dosing or change medication, and other treatments and approaches to consider.

There is a new recommendation on prevention highlighting the importance of smoking cessation, dental care, weight control, vaccination, and managing comorbidities.

Once the guidelines have been finalized, they will be published in the EULAR journal, Annals of the Rheumatic Diseases, later in the year.

Dr. Combe has received research grants and honoraria from Pfizer, Roche-Chugai, and UCB, and honoraria from Bristol-Myers Squibb, Janssen, Eli Lilly, Merck Sharpe and Dohme, and Novartis.

LONDON, ENGLAND – Prompt referral to a rheumatologist and early initiation of treatment remain 2 of the 12 key recommendations in the updated European League Against Rheumatism guidelines for early arthritis.

There are now three specific recommendations dealing with referral and diagnosis; four that cover initial drug treatment with disease-modifying antirheumatic drugs (DMARDs), nonsteroidal anti-inflammatory drugs (NSAIDs), and glucocorticoids; two that cover management strategy and monitoring; and three that cover nonpharmacologic interventions, prevention, and patient information and education.

While many of the recommendations have not radically changed, there have been revisions to the wording. In line with other EULAR recommendations for the management of rheumatic disease, the updated early arthritis guidelines also now contain three overarching principles. The first states that the management of early arthritis should aim to achieve the best possible care and emphasizes the need for shared decision making between rheumatologist and patient. The second states that a rheumatologist should be the main specialist looking after a patient with early arthritis, and the third states that a definitive diagnosis should be made only after a careful medical history and clinical examination have been undertaken.

“[The EULAR] recommendations deal especially with early-stage inflammatory arthritis,” said Dr. Bernard Combe of Hôpital Lapeyronie in Montpellier, France, who was the convener of the task force behind the updated guidelines. As such, they are universal for all rheumatologic arthritis conditions when diagnosed early, before they differentiate into more specifics, he said in an interview. That includes progression from early inflammatory arthritis to rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis.

Dr. Combe, who is also professor of rheumatology at Montpellier University and head of the bone and joint diseases department at Montpellier University Hospital, presented the updated EULAR guidance at the European Congress of Rheumatology. He noted that the guidelines were first written almost 10 years ago (Ann Rheum Dis. 2007 Jan;66(1):34-45) and so were in need of an update. A task force of 20 rheumatologists, two patients, and one health care professional representing 12 European countries were involved in the update that adhered to EULAR standard operating procedure of developing guidelines.

Although EULAR had published guidance on the management of arthritis in the intervening years, he said, this had focused more on management, and the aim of the early arthritis guidelines was to cover the “entire spectrum of the management of early inflammatory arthritis.”

The updated recommendations start and end with patient-centered statements, he observed. The first notes that patients with any joint swelling associated with pain or stiffness should be referred to and seen by a rheumatologist within 6 weeks of the onset of symptoms. The final recommendation deals with patient information and education about the disease, and programs aiming to help patients cope with pain, disability, and ensure their continued ability to work and participate in their usual social activities.

The concept of early identification and treatment is not new, Dr. Combe observed, but there is so much more evidence in support of initiating DMARD therapy within the first 3 months of referral, even if patients do not fulfill classification criteria for a specific inflammatory rheumatic disease.

In terms of diagnosis, the recommendations now hinge on performing a thorough clinical examination and using ultrasonography to confirm the presence of arthritis if needed. Magnetic resonance imaging (MRI) is no longer recommended in this initial diagnostic work up. This is due to the cost and often lack of widespread access in all European countries, Dr. Combe said. MRI might be considered later, however, if a diagnosis cannot be reached. Assessment of the number of swollen joints, acute phase reactants, and antibody tests (rheumatoid factor and anti-citrullinated protein antibody) also might be of use at this point.

Among the various DMARDs, methotrexate is recommended as the “anchor drug”; it should be used as part of the first treatment strategy in patients who are at risk of persistent disease, unless it contraindicated. The goal of treatment with DMARDs is to achieve clinical remission. Regular monitoring of disease activity, side effects, and comorbidities should be performed alongside their use. Regular monitoring of all pharmacologic therapy should include assessment of tender and swollen joint counts, global health assessments by the patient and the physician, and acute phase reactants.

As for NSAIDs, they are recommended for symptomatic relief, but “at the minimum effective dose for the shortest time possible.” The risks for gastrointestinal, renal, and cardiovascular complications should be carefully weighed against the likely benefits. Glucocorticoids also are recommended for reducing pain and swelling, and structural progression, but again these need to be used at the lowest possible dose and for no more than 6 months to avoid potential long-term side effects.

A recommendation on nonpharmacologic interventions also is included, which states that physical exercise and occupational therapy should be considered as adjunctive therapy.

In addition, the task force came up with a list of 10 research questions that need to be answered, which included items on risk prediction, optimal treatment combinations, and dosing regimens.

As with other EULAR guidelines, a flow chart is included that summarizes the recommendations to help guide physicians on when and how to treat, when to adapt dosing or change medication, and other treatments and approaches to consider.

There is a new recommendation on prevention highlighting the importance of smoking cessation, dental care, weight control, vaccination, and managing comorbidities.

Once the guidelines have been finalized, they will be published in the EULAR journal, Annals of the Rheumatic Diseases, later in the year.

Dr. Combe has received research grants and honoraria from Pfizer, Roche-Chugai, and UCB, and honoraria from Bristol-Myers Squibb, Janssen, Eli Lilly, Merck Sharpe and Dohme, and Novartis.

LONDON – The option of treating axial spondyloarthritis with an interleukin-17 inhibitor has become an officially recommended option for the first time in a new update to management recommendations for this disease released by a task force assembled jointly by the Assessment of SpondyloArthritis International Society and the European League Against Rheumatism.

The update replaces recommendations last released by the two groups for managing patients with ankylosing spondylitis in 2010 (Ann Rheum Dis. 2011 June;70[6]:896-904), as well as the prior recommendations from the two organizations for using tumor necrosis factor (TNF) inhibitors on these patients (Ann Rheum Dis. 2011 June;70[6]:905-8). The new update also broadens the disease spectrum from ankylosing spondylitis to axial spondyloarthritis (SpA).

Mitchel L. Zoler/Frontline Medical News

The latest recommendations continue to place nonsteroidal anti-inflammatory drugs (NSAIDs) as first-line pharmacotherapy for patients with axial SpA to control pain and stiffness, and continue to place treatment with a biological disease modifying antirheumatic drug (DMARD) – identified in the recommendations as most typically a TNF inhibitor by current practice – as second-line treatment after NSAIDs. The recommendations specify that initiation of a biological DMARD should target patients who have both failed treatment with at least two different NSAIDs over the course of at least 4 weeks of treatment, and who have active disease documented by either of two standard measures of disease activity in patients with axial SpA: either a score of at least 2.1 on the ankylosing spondylitis disease activity score (ASDAS) or a score of at least 4 on the Bath ankylosing spondylitis disease activity index (BASDAI).

Incorporation of the ASDAS as a potential alternative to the BASDAI for assessing disease activity in these patients is another new feature of these recommendations, noted Dr. Désirée van der Heijde, convenor of the update task force, who presented the new recommendations at the European Congress of Rheumatology.

The new recommendations place use of an interleukin (IL)-17 inhibitor as a third-line management option, for patients who fail to adequately respond to a first TNF inhibitor, and they also say that an alternative to starting an IL-17 inhibitor at this stage of management is to instead try treatment with a second type of TNF inhibitor. The IL-17 inhibitor class includes secukinumab (Cosentyx), which received approval from the Food and Drug Administration for treating active ankylosing spondylitis in January 2016, and which also has approval for the same indication from the European Medicines Agency.

The updated recommendations leave unchanged from the prior version advice to use biological DMARDs only after failure of other treatments, as well as advocacy of nondrug therapy with regular exercise, smoking cessation, and physical therapy when appropriate as the very first therapeutic step to take, before even starting a NSAID regimen. For patients with axial SpA who have peripheral arthritis, the recommendations say that clinicians can consider treatment with a local injection of a glucocorticoid, and a treatment course with sulfasalazine. The recommendations do not endorse treatment with a conventional, synthetic DMARD for patients with purely axial disease, and they also recommend against long-term treatment with a systemic corticosteroid. The update calls analgesics contraindicated.

Another new feature of the updated recommendations is endorsement of treating axial SpA patients to a predefined treatment target, although the recommendations left the nature of that target undefined and is something for the treating clinician to discuss and tailor to each patient individually, said Dr. van der Heijde, professor of rheumatology at Leiden University Medical Center in The Netherlands. The update also introduces for the first time the recommendation to consider tapering down treatment with a biological DMARD for patients who achieve remission.

Dr. van der Heijde said that she has been a consultant to 17 drug companies.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

LONDON – The option of treating axial spondyloarthritis with an interleukin-17 inhibitor has become an officially recommended option for the first time in a new update to management recommendations for this disease released by a task force assembled jointly by the Assessment of SpondyloArthritis International Society and the European League Against Rheumatism.

The update replaces recommendations last released by the two groups for managing patients with ankylosing spondylitis in 2010 (Ann Rheum Dis. 2011 June;70[6]:896-904), as well as the prior recommendations from the two organizations for using tumor necrosis factor (TNF) inhibitors on these patients (Ann Rheum Dis. 2011 June;70[6]:905-8). The new update also broadens the disease spectrum from ankylosing spondylitis to axial spondyloarthritis (SpA).

Mitchel L. Zoler/Frontline Medical News

The latest recommendations continue to place nonsteroidal anti-inflammatory drugs (NSAIDs) as first-line pharmacotherapy for patients with axial SpA to control pain and stiffness, and continue to place treatment with a biological disease modifying antirheumatic drug (DMARD) – identified in the recommendations as most typically a TNF inhibitor by current practice – as second-line treatment after NSAIDs. The recommendations specify that initiation of a biological DMARD should target patients who have both failed treatment with at least two different NSAIDs over the course of at least 4 weeks of treatment, and who have active disease documented by either of two standard measures of disease activity in patients with axial SpA: either a score of at least 2.1 on the ankylosing spondylitis disease activity score (ASDAS) or a score of at least 4 on the Bath ankylosing spondylitis disease activity index (BASDAI).

Incorporation of the ASDAS as a potential alternative to the BASDAI for assessing disease activity in these patients is another new feature of these recommendations, noted Dr. Désirée van der Heijde, convenor of the update task force, who presented the new recommendations at the European Congress of Rheumatology.

The new recommendations place use of an interleukin (IL)-17 inhibitor as a third-line management option, for patients who fail to adequately respond to a first TNF inhibitor, and they also say that an alternative to starting an IL-17 inhibitor at this stage of management is to instead try treatment with a second type of TNF inhibitor. The IL-17 inhibitor class includes secukinumab (Cosentyx), which received approval from the Food and Drug Administration for treating active ankylosing spondylitis in January 2016, and which also has approval for the same indication from the European Medicines Agency.

The updated recommendations leave unchanged from the prior version advice to use biological DMARDs only after failure of other treatments, as well as advocacy of nondrug therapy with regular exercise, smoking cessation, and physical therapy when appropriate as the very first therapeutic step to take, before even starting a NSAID regimen. For patients with axial SpA who have peripheral arthritis, the recommendations say that clinicians can consider treatment with a local injection of a glucocorticoid, and a treatment course with sulfasalazine. The recommendations do not endorse treatment with a conventional, synthetic DMARD for patients with purely axial disease, and they also recommend against long-term treatment with a systemic corticosteroid. The update calls analgesics contraindicated.

Another new feature of the updated recommendations is endorsement of treating axial SpA patients to a predefined treatment target, although the recommendations left the nature of that target undefined and is something for the treating clinician to discuss and tailor to each patient individually, said Dr. van der Heijde, professor of rheumatology at Leiden University Medical Center in The Netherlands. The update also introduces for the first time the recommendation to consider tapering down treatment with a biological DMARD for patients who achieve remission.

Dr. van der Heijde said that she has been a consultant to 17 drug companies.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

LONDON – The option of treating axial spondyloarthritis with an interleukin-17 inhibitor has become an officially recommended option for the first time in a new update to management recommendations for this disease released by a task force assembled jointly by the Assessment of SpondyloArthritis International Society and the European League Against Rheumatism.

The update replaces recommendations last released by the two groups for managing patients with ankylosing spondylitis in 2010 (Ann Rheum Dis. 2011 June;70[6]:896-904), as well as the prior recommendations from the two organizations for using tumor necrosis factor (TNF) inhibitors on these patients (Ann Rheum Dis. 2011 June;70[6]:905-8). The new update also broadens the disease spectrum from ankylosing spondylitis to axial spondyloarthritis (SpA).

Mitchel L. Zoler/Frontline Medical News

The latest recommendations continue to place nonsteroidal anti-inflammatory drugs (NSAIDs) as first-line pharmacotherapy for patients with axial SpA to control pain and stiffness, and continue to place treatment with a biological disease modifying antirheumatic drug (DMARD) – identified in the recommendations as most typically a TNF inhibitor by current practice – as second-line treatment after NSAIDs. The recommendations specify that initiation of a biological DMARD should target patients who have both failed treatment with at least two different NSAIDs over the course of at least 4 weeks of treatment, and who have active disease documented by either of two standard measures of disease activity in patients with axial SpA: either a score of at least 2.1 on the ankylosing spondylitis disease activity score (ASDAS) or a score of at least 4 on the Bath ankylosing spondylitis disease activity index (BASDAI).

Incorporation of the ASDAS as a potential alternative to the BASDAI for assessing disease activity in these patients is another new feature of these recommendations, noted Dr. Désirée van der Heijde, convenor of the update task force, who presented the new recommendations at the European Congress of Rheumatology.

The new recommendations place use of an interleukin (IL)-17 inhibitor as a third-line management option, for patients who fail to adequately respond to a first TNF inhibitor, and they also say that an alternative to starting an IL-17 inhibitor at this stage of management is to instead try treatment with a second type of TNF inhibitor. The IL-17 inhibitor class includes secukinumab (Cosentyx), which received approval from the Food and Drug Administration for treating active ankylosing spondylitis in January 2016, and which also has approval for the same indication from the European Medicines Agency.

The updated recommendations leave unchanged from the prior version advice to use biological DMARDs only after failure of other treatments, as well as advocacy of nondrug therapy with regular exercise, smoking cessation, and physical therapy when appropriate as the very first therapeutic step to take, before even starting a NSAID regimen. For patients with axial SpA who have peripheral arthritis, the recommendations say that clinicians can consider treatment with a local injection of a glucocorticoid, and a treatment course with sulfasalazine. The recommendations do not endorse treatment with a conventional, synthetic DMARD for patients with purely axial disease, and they also recommend against long-term treatment with a systemic corticosteroid. The update calls analgesics contraindicated.

Another new feature of the updated recommendations is endorsement of treating axial SpA patients to a predefined treatment target, although the recommendations left the nature of that target undefined and is something for the treating clinician to discuss and tailor to each patient individually, said Dr. van der Heijde, professor of rheumatology at Leiden University Medical Center in The Netherlands. The update also introduces for the first time the recommendation to consider tapering down treatment with a biological DMARD for patients who achieve remission.

Dr. van der Heijde said that she has been a consultant to 17 drug companies.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

LONDON – The new EULAR recommendations for fibromyalgia incorporate a decade’s worth of new evidence collected since the last edition appeared in 2008.

Although the 2016 recommendations do not reflect a novel understanding of the pathophysiology of fibromyalgia or a radically different approach to managing the disease, compared with those published in 2008, they differ vastly in the level and quality of supporting evidence behind them, said Dr. Gary J. Macfarlane, convener of the fibromyalgia recommendations panel and clinical professor of epidemiology at the University of Aberdeen, Scotland.

Mitchel L. Zoler/Frontline Medical News

Dr. Macfarlane said that the past decade has seen “an explosion of evidence from randomized trials” around the management of fibromyalgia. “I think this will be one of the first EULAR guidelines in which all the recommendations are going to be based on systematic reviews or meta-analysis” – 107 altogether, he said in an interview.

Fibromyalgia – a heterogeneous pain condition that involves abnormal pain processing and can affect sleep, function, and quality of life – can be complex to diagnose and treat. Pain is a signature feature of fibromyalgia, but it is not the only treatment target: sleep, ability to function, and quality of life all are important, Dr. Macfarlane said.

The guidelines emphasize that optimal management of fibromyalgia requires not just a prompt diagnosis but “a comprehensive assessment of the patient’s ability to function and about the psychosocial context in which symptoms occur,” he said.

Patient education, including written information, is key and is the first step in management. Initial management should focus on nonpharmacologic interventions, specifically exercise. In patients for whom educational materials alone are insufficient to provide benefit, the next step is enrollment of the patient into a physical therapy program that involves an individualized program of graded physical exercise. Other nonpharmacologic interventions that can be introduced at this stage include hydrotherapy and acupuncture.

If there is insufficient response to these first two intervention steps, the next phase should start with a second round of patient assessment to develop an individualized intervention program. This involves characterizing the dominant features of the patient’s complaints into one of the three main categories: pain-related depression and anxiety, or behavior indicating abnormal coping strategies; severe pain, sleep disturbance, or both; or severe disability or sick leave, Dr. Macfarlane said at the European Congress of Rheumatology.

For patients in the first subgroup – pain-related depression and anxiety, or behavior indicating abnormal coping strategies – the intervention should consist of psychological therapies, primarily cognitive-behavioral therapy (CBT). For patients with more severe depression or anxiety, psychopharmacologic treatment is also an option.

For patients in the second subgroup – those with severe pain, sleep disturbance, or both – the main intervention is pharmacotherapy. For severe pain, this can involve duloxetine, pregabalin, or tramadol either alone or in combination with paracetamol (acetaminophen). For sleep disturbance, recommended drug interventions are low-dose amitriptyline, cyclobenzaprine, or pregabalin administered at bedtime.

For patients in the third subgroup – with severe disability or sick leave – the recommended intervention is a multimodal rehabilitation program.

“We made the decision to consider all therapies whether they were licensed in Europe or not because we felt that helps to contribute to the debate,” Dr. Macfarlane said. He also highlighted several interventions that have been proposed in the past, but which his working group refrained from recommending because of either lack of demonstrated effectiveness or the poor quality of the studies that appeared to document efficacy. These nonrecommended interventions are biofeedback, capsaicin, hypnotherapy, massage, S-adenosyl methinone or SAMe, and other complementary and alternative therapies.

Dr. Macfarlane noted that, despite a decade’s worth of findings, many questions still hover over the ideal management of fibromyalgia. Although the guidelines strongly promote exercise, “we still don’t have enough information about what specific type of exercise would be most beneficial.”

And while studies show overwhelmingly that CBT is effective, the size of the benefit is modest. Dr. Macfarlane said that it will be important to learn whether combined pharmacologic and nonpharmacologic approaches might be more effective from the get-go for certain patients – in contrast to the stepped approach outlined in the guidelines – and whether there is a way to identify patients for whom such interventions as CBT are most likely to be effective.

Another question still unanswered is whether fibromyalgia should remain primarily the domain of rheumatologists. While this was not a question addressed in the guidelines, the writing committee involved not only rheumatologists but also specialists in pain, internal medicine, occupational health, and nursing – underscoring the multidisciplinary direction that fibromyalgia treatment is taking.

“I think rheumatologists have an important role to play because pain is a dominant feature and because fibromyalgia is often comorbid with inflammatory rheumatic conditions,” Dr. Macfarlane said. “But I think we should be looking at other models of care for these patients as well.”

Because patients are referred in and out of various specialties, “there is no one really looking at the overall management, thinking about them holistically,” he said. “There’s a need for us to organize health care services better, so when we have a patient with fibromyalgia-like symptoms, we manage their journey through the system effectively instead of ping-ponging them around.”

Dr. Macfarlane has given lectures on behalf of Janssen and has received research support from Pfizer.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

LONDON – The new EULAR recommendations for fibromyalgia incorporate a decade’s worth of new evidence collected since the last edition appeared in 2008.

Although the 2016 recommendations do not reflect a novel understanding of the pathophysiology of fibromyalgia or a radically different approach to managing the disease, compared with those published in 2008, they differ vastly in the level and quality of supporting evidence behind them, said Dr. Gary J. Macfarlane, convener of the fibromyalgia recommendations panel and clinical professor of epidemiology at the University of Aberdeen, Scotland.

Mitchel L. Zoler/Frontline Medical News

Dr. Macfarlane said that the past decade has seen “an explosion of evidence from randomized trials” around the management of fibromyalgia. “I think this will be one of the first EULAR guidelines in which all the recommendations are going to be based on systematic reviews or meta-analysis” – 107 altogether, he said in an interview.

Fibromyalgia – a heterogeneous pain condition that involves abnormal pain processing and can affect sleep, function, and quality of life – can be complex to diagnose and treat. Pain is a signature feature of fibromyalgia, but it is not the only treatment target: sleep, ability to function, and quality of life all are important, Dr. Macfarlane said.

The guidelines emphasize that optimal management of fibromyalgia requires not just a prompt diagnosis but “a comprehensive assessment of the patient’s ability to function and about the psychosocial context in which symptoms occur,” he said.

Patient education, including written information, is key and is the first step in management. Initial management should focus on nonpharmacologic interventions, specifically exercise. In patients for whom educational materials alone are insufficient to provide benefit, the next step is enrollment of the patient into a physical therapy program that involves an individualized program of graded physical exercise. Other nonpharmacologic interventions that can be introduced at this stage include hydrotherapy and acupuncture.

If there is insufficient response to these first two intervention steps, the next phase should start with a second round of patient assessment to develop an individualized intervention program. This involves characterizing the dominant features of the patient’s complaints into one of the three main categories: pain-related depression and anxiety, or behavior indicating abnormal coping strategies; severe pain, sleep disturbance, or both; or severe disability or sick leave, Dr. Macfarlane said at the European Congress of Rheumatology.

For patients in the first subgroup – pain-related depression and anxiety, or behavior indicating abnormal coping strategies – the intervention should consist of psychological therapies, primarily cognitive-behavioral therapy (CBT). For patients with more severe depression or anxiety, psychopharmacologic treatment is also an option.

For patients in the second subgroup – those with severe pain, sleep disturbance, or both – the main intervention is pharmacotherapy. For severe pain, this can involve duloxetine, pregabalin, or tramadol either alone or in combination with paracetamol (acetaminophen). For sleep disturbance, recommended drug interventions are low-dose amitriptyline, cyclobenzaprine, or pregabalin administered at bedtime.

For patients in the third subgroup – with severe disability or sick leave – the recommended intervention is a multimodal rehabilitation program.

“We made the decision to consider all therapies whether they were licensed in Europe or not because we felt that helps to contribute to the debate,” Dr. Macfarlane said. He also highlighted several interventions that have been proposed in the past, but which his working group refrained from recommending because of either lack of demonstrated effectiveness or the poor quality of the studies that appeared to document efficacy. These nonrecommended interventions are biofeedback, capsaicin, hypnotherapy, massage, S-adenosyl methinone or SAMe, and other complementary and alternative therapies.

Dr. Macfarlane noted that, despite a decade’s worth of findings, many questions still hover over the ideal management of fibromyalgia. Although the guidelines strongly promote exercise, “we still don’t have enough information about what specific type of exercise would be most beneficial.”

And while studies show overwhelmingly that CBT is effective, the size of the benefit is modest. Dr. Macfarlane said that it will be important to learn whether combined pharmacologic and nonpharmacologic approaches might be more effective from the get-go for certain patients – in contrast to the stepped approach outlined in the guidelines – and whether there is a way to identify patients for whom such interventions as CBT are most likely to be effective.

Another question still unanswered is whether fibromyalgia should remain primarily the domain of rheumatologists. While this was not a question addressed in the guidelines, the writing committee involved not only rheumatologists but also specialists in pain, internal medicine, occupational health, and nursing – underscoring the multidisciplinary direction that fibromyalgia treatment is taking.

“I think rheumatologists have an important role to play because pain is a dominant feature and because fibromyalgia is often comorbid with inflammatory rheumatic conditions,” Dr. Macfarlane said. “But I think we should be looking at other models of care for these patients as well.”

Because patients are referred in and out of various specialties, “there is no one really looking at the overall management, thinking about them holistically,” he said. “There’s a need for us to organize health care services better, so when we have a patient with fibromyalgia-like symptoms, we manage their journey through the system effectively instead of ping-ponging them around.”

Dr. Macfarlane has given lectures on behalf of Janssen and has received research support from Pfizer.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

LONDON – The new EULAR recommendations for fibromyalgia incorporate a decade’s worth of new evidence collected since the last edition appeared in 2008.

Although the 2016 recommendations do not reflect a novel understanding of the pathophysiology of fibromyalgia or a radically different approach to managing the disease, compared with those published in 2008, they differ vastly in the level and quality of supporting evidence behind them, said Dr. Gary J. Macfarlane, convener of the fibromyalgia recommendations panel and clinical professor of epidemiology at the University of Aberdeen, Scotland.

Mitchel L. Zoler/Frontline Medical News

Dr. Macfarlane said that the past decade has seen “an explosion of evidence from randomized trials” around the management of fibromyalgia. “I think this will be one of the first EULAR guidelines in which all the recommendations are going to be based on systematic reviews or meta-analysis” – 107 altogether, he said in an interview.

Fibromyalgia – a heterogeneous pain condition that involves abnormal pain processing and can affect sleep, function, and quality of life – can be complex to diagnose and treat. Pain is a signature feature of fibromyalgia, but it is not the only treatment target: sleep, ability to function, and quality of life all are important, Dr. Macfarlane said.

The guidelines emphasize that optimal management of fibromyalgia requires not just a prompt diagnosis but “a comprehensive assessment of the patient’s ability to function and about the psychosocial context in which symptoms occur,” he said.

Patient education, including written information, is key and is the first step in management. Initial management should focus on nonpharmacologic interventions, specifically exercise. In patients for whom educational materials alone are insufficient to provide benefit, the next step is enrollment of the patient into a physical therapy program that involves an individualized program of graded physical exercise. Other nonpharmacologic interventions that can be introduced at this stage include hydrotherapy and acupuncture.

If there is insufficient response to these first two intervention steps, the next phase should start with a second round of patient assessment to develop an individualized intervention program. This involves characterizing the dominant features of the patient’s complaints into one of the three main categories: pain-related depression and anxiety, or behavior indicating abnormal coping strategies; severe pain, sleep disturbance, or both; or severe disability or sick leave, Dr. Macfarlane said at the European Congress of Rheumatology.

For patients in the first subgroup – pain-related depression and anxiety, or behavior indicating abnormal coping strategies – the intervention should consist of psychological therapies, primarily cognitive-behavioral therapy (CBT). For patients with more severe depression or anxiety, psychopharmacologic treatment is also an option.

For patients in the second subgroup – those with severe pain, sleep disturbance, or both – the main intervention is pharmacotherapy. For severe pain, this can involve duloxetine, pregabalin, or tramadol either alone or in combination with paracetamol (acetaminophen). For sleep disturbance, recommended drug interventions are low-dose amitriptyline, cyclobenzaprine, or pregabalin administered at bedtime.

For patients in the third subgroup – with severe disability or sick leave – the recommended intervention is a multimodal rehabilitation program.

“We made the decision to consider all therapies whether they were licensed in Europe or not because we felt that helps to contribute to the debate,” Dr. Macfarlane said. He also highlighted several interventions that have been proposed in the past, but which his working group refrained from recommending because of either lack of demonstrated effectiveness or the poor quality of the studies that appeared to document efficacy. These nonrecommended interventions are biofeedback, capsaicin, hypnotherapy, massage, S-adenosyl methinone or SAMe, and other complementary and alternative therapies.

Dr. Macfarlane noted that, despite a decade’s worth of findings, many questions still hover over the ideal management of fibromyalgia. Although the guidelines strongly promote exercise, “we still don’t have enough information about what specific type of exercise would be most beneficial.”

And while studies show overwhelmingly that CBT is effective, the size of the benefit is modest. Dr. Macfarlane said that it will be important to learn whether combined pharmacologic and nonpharmacologic approaches might be more effective from the get-go for certain patients – in contrast to the stepped approach outlined in the guidelines – and whether there is a way to identify patients for whom such interventions as CBT are most likely to be effective.

Another question still unanswered is whether fibromyalgia should remain primarily the domain of rheumatologists. While this was not a question addressed in the guidelines, the writing committee involved not only rheumatologists but also specialists in pain, internal medicine, occupational health, and nursing – underscoring the multidisciplinary direction that fibromyalgia treatment is taking.

“I think rheumatologists have an important role to play because pain is a dominant feature and because fibromyalgia is often comorbid with inflammatory rheumatic conditions,” Dr. Macfarlane said. “But I think we should be looking at other models of care for these patients as well.”

Because patients are referred in and out of various specialties, “there is no one really looking at the overall management, thinking about them holistically,” he said. “There’s a need for us to organize health care services better, so when we have a patient with fibromyalgia-like symptoms, we manage their journey through the system effectively instead of ping-ponging them around.”

Dr. Macfarlane has given lectures on behalf of Janssen and has received research support from Pfizer.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler