Psoriatic Arthritis ICYMI

Women with psoriatic arthritis and ankylosing spondylitis generally have favorable pregnancy outcomes, but high disease activity during pregnancy could increase the risk of adverse labor and delivery outcomes, according to 2004-2018 data from the Organization of Teratology Information Specialists (OTIS) Autoimmune Disease Project.

Corticosteroid use further increased risk for preterm delivery among women with ankylosing spondylitis.

While more research is needed, these findings suggest that better obstetric outcomes might be achieved via better disease control and minimal use of corticosteroids, according to Chelsey J. F. Smith, MD, of the University of California, San Diego, and colleagues.

“Future studies are needed to confirm the novel findings seen in our study, as well as to continue to analyze the effect of different disease activity measures and medication use on pregnancy outcomes in these two chronic conditions,” Dr. Smith and coauthors said in a report on the study in Arthritis Care and Research.

Many women affected by psoriatic arthritis and ankylosing spondylitis are of child-bearing age and consider planning a family, according to the researchers. Data on pregnancy outcomes are lacking, they said, “often making it difficult for rheumatologists and obstetricians to counsel their patients effectively.”

The study from Dr. Smith and coinvestigators comprised 963 women who enrolled in the OTIS prospective cohort study within 20 weeks of gestation and delivered at least one live-born infant. Of that cohort, 129 had ankylosing spondylitis, 117 had psoriatic arthritis, and the remaining 717 served as a control group.

Psoriatic arthritis conferred an 81% increased risk for moderate preterm delivery at 32-36 weeks gestation, compared with healthier women, 13.7% and 7.7% respectively. Risk was increased among women with psoriatic arthritis for preterm labor, 16.2% and 8.4% (adjusted risk ratio, 2.05, 95% confidence interval, 1.21-3.48), caesarean delivery, 48.7% and 26.2% (aRR, 1.63, 95% CI, 1.26-2.12), and oligohydramnios, 25% and 11% (aRR, 3.79, 95% CI, 1.34-10.74). Women with psoriatic arthritis were 2 years older on average and their average body mass index was 27 kg/m² vs. 24.5 kg/m² in the control group.

In women with ankylosing spondylitis, risk of infant hospitalization in the neonatal intensive care unit was increased by 67%, 17.2% vs. 11.9% in the control group.

Active disease measured by the Health Assessment Questionnaire (HAQ) or Routine Assessment of Patient Index Data 3 (RAPID3) was linked to increased risk of adverse obstetric outcomes in some cases, the investigators said.

For example, risk of preterm delivery was increased in women with psoriatic arthritis who had active disease at 32 weeks as measured by HAQ (27 women) and RAPID3 (28 women) scores, while in ankylosing spondylitis, active disease measured at intake by RAPID3 (46 women) was associated with increased risk of caesarean delivery.

Medication use in women with psoriatic arthritis was not associated with increased preterm delivery risk. However, women with ankylosing spondylitis who used corticosteroids in the second trimester had an increased risk of preterm delivery.

The rate of corticosteroid use was “surprisingly high” at 38% among the women with ankylosing spondylitis, Dr. Smith and coinvestigators said.

“The 2016 American College of Rheumatology guidelines in fact recommend against the use of systemic corticosteroids for the treatment of ankylosing spondylitis, with the exception of short-term treatment with rapid tapering in circumstances such as flares during pregnancy, flares of concomitant inflammatory bowel disease, or flare of peripheral arthritis,” they said in their report.

Dr. Smith and coauthors reported no conflicts of interest. The OTIS Collaborative Research Group has received research funding from AbbVie, Amgen, Bristol-Myers Squibb, Janssen, Pfizer, and others.

SOURCE: Smith CJF et al. Arthritis Care Res. 2019 May 10. doi: 10.1002/acr.23924.

Women with psoriatic arthritis and ankylosing spondylitis generally have favorable pregnancy outcomes, but high disease activity during pregnancy could increase the risk of adverse labor and delivery outcomes, according to 2004-2018 data from the Organization of Teratology Information Specialists (OTIS) Autoimmune Disease Project.

Corticosteroid use further increased risk for preterm delivery among women with ankylosing spondylitis.

While more research is needed, these findings suggest that better obstetric outcomes might be achieved via better disease control and minimal use of corticosteroids, according to Chelsey J. F. Smith, MD, of the University of California, San Diego, and colleagues.

“Future studies are needed to confirm the novel findings seen in our study, as well as to continue to analyze the effect of different disease activity measures and medication use on pregnancy outcomes in these two chronic conditions,” Dr. Smith and coauthors said in a report on the study in Arthritis Care and Research.

Many women affected by psoriatic arthritis and ankylosing spondylitis are of child-bearing age and consider planning a family, according to the researchers. Data on pregnancy outcomes are lacking, they said, “often making it difficult for rheumatologists and obstetricians to counsel their patients effectively.”

The study from Dr. Smith and coinvestigators comprised 963 women who enrolled in the OTIS prospective cohort study within 20 weeks of gestation and delivered at least one live-born infant. Of that cohort, 129 had ankylosing spondylitis, 117 had psoriatic arthritis, and the remaining 717 served as a control group.

Psoriatic arthritis conferred an 81% increased risk for moderate preterm delivery at 32-36 weeks gestation, compared with healthier women, 13.7% and 7.7% respectively. Risk was increased among women with psoriatic arthritis for preterm labor, 16.2% and 8.4% (adjusted risk ratio, 2.05, 95% confidence interval, 1.21-3.48), caesarean delivery, 48.7% and 26.2% (aRR, 1.63, 95% CI, 1.26-2.12), and oligohydramnios, 25% and 11% (aRR, 3.79, 95% CI, 1.34-10.74). Women with psoriatic arthritis were 2 years older on average and their average body mass index was 27 kg/m² vs. 24.5 kg/m² in the control group.

In women with ankylosing spondylitis, risk of infant hospitalization in the neonatal intensive care unit was increased by 67%, 17.2% vs. 11.9% in the control group.

Active disease measured by the Health Assessment Questionnaire (HAQ) or Routine Assessment of Patient Index Data 3 (RAPID3) was linked to increased risk of adverse obstetric outcomes in some cases, the investigators said.

For example, risk of preterm delivery was increased in women with psoriatic arthritis who had active disease at 32 weeks as measured by HAQ (27 women) and RAPID3 (28 women) scores, while in ankylosing spondylitis, active disease measured at intake by RAPID3 (46 women) was associated with increased risk of caesarean delivery.

Medication use in women with psoriatic arthritis was not associated with increased preterm delivery risk. However, women with ankylosing spondylitis who used corticosteroids in the second trimester had an increased risk of preterm delivery.

The rate of corticosteroid use was “surprisingly high” at 38% among the women with ankylosing spondylitis, Dr. Smith and coinvestigators said.

“The 2016 American College of Rheumatology guidelines in fact recommend against the use of systemic corticosteroids for the treatment of ankylosing spondylitis, with the exception of short-term treatment with rapid tapering in circumstances such as flares during pregnancy, flares of concomitant inflammatory bowel disease, or flare of peripheral arthritis,” they said in their report.

Dr. Smith and coauthors reported no conflicts of interest. The OTIS Collaborative Research Group has received research funding from AbbVie, Amgen, Bristol-Myers Squibb, Janssen, Pfizer, and others.

SOURCE: Smith CJF et al. Arthritis Care Res. 2019 May 10. doi: 10.1002/acr.23924.

Women with psoriatic arthritis and ankylosing spondylitis generally have favorable pregnancy outcomes, but high disease activity during pregnancy could increase the risk of adverse labor and delivery outcomes, according to 2004-2018 data from the Organization of Teratology Information Specialists (OTIS) Autoimmune Disease Project.

Corticosteroid use further increased risk for preterm delivery among women with ankylosing spondylitis.

While more research is needed, these findings suggest that better obstetric outcomes might be achieved via better disease control and minimal use of corticosteroids, according to Chelsey J. F. Smith, MD, of the University of California, San Diego, and colleagues.

“Future studies are needed to confirm the novel findings seen in our study, as well as to continue to analyze the effect of different disease activity measures and medication use on pregnancy outcomes in these two chronic conditions,” Dr. Smith and coauthors said in a report on the study in Arthritis Care and Research.

Many women affected by psoriatic arthritis and ankylosing spondylitis are of child-bearing age and consider planning a family, according to the researchers. Data on pregnancy outcomes are lacking, they said, “often making it difficult for rheumatologists and obstetricians to counsel their patients effectively.”

The study from Dr. Smith and coinvestigators comprised 963 women who enrolled in the OTIS prospective cohort study within 20 weeks of gestation and delivered at least one live-born infant. Of that cohort, 129 had ankylosing spondylitis, 117 had psoriatic arthritis, and the remaining 717 served as a control group.

Psoriatic arthritis conferred an 81% increased risk for moderate preterm delivery at 32-36 weeks gestation, compared with healthier women, 13.7% and 7.7% respectively. Risk was increased among women with psoriatic arthritis for preterm labor, 16.2% and 8.4% (adjusted risk ratio, 2.05, 95% confidence interval, 1.21-3.48), caesarean delivery, 48.7% and 26.2% (aRR, 1.63, 95% CI, 1.26-2.12), and oligohydramnios, 25% and 11% (aRR, 3.79, 95% CI, 1.34-10.74). Women with psoriatic arthritis were 2 years older on average and their average body mass index was 27 kg/m² vs. 24.5 kg/m² in the control group.

In women with ankylosing spondylitis, risk of infant hospitalization in the neonatal intensive care unit was increased by 67%, 17.2% vs. 11.9% in the control group.

Active disease measured by the Health Assessment Questionnaire (HAQ) or Routine Assessment of Patient Index Data 3 (RAPID3) was linked to increased risk of adverse obstetric outcomes in some cases, the investigators said.

For example, risk of preterm delivery was increased in women with psoriatic arthritis who had active disease at 32 weeks as measured by HAQ (27 women) and RAPID3 (28 women) scores, while in ankylosing spondylitis, active disease measured at intake by RAPID3 (46 women) was associated with increased risk of caesarean delivery.

Medication use in women with psoriatic arthritis was not associated with increased preterm delivery risk. However, women with ankylosing spondylitis who used corticosteroids in the second trimester had an increased risk of preterm delivery.

The rate of corticosteroid use was “surprisingly high” at 38% among the women with ankylosing spondylitis, Dr. Smith and coinvestigators said.

“The 2016 American College of Rheumatology guidelines in fact recommend against the use of systemic corticosteroids for the treatment of ankylosing spondylitis, with the exception of short-term treatment with rapid tapering in circumstances such as flares during pregnancy, flares of concomitant inflammatory bowel disease, or flare of peripheral arthritis,” they said in their report.

Dr. Smith and coauthors reported no conflicts of interest. The OTIS Collaborative Research Group has received research funding from AbbVie, Amgen, Bristol-Myers Squibb, Janssen, Pfizer, and others.

SOURCE: Smith CJF et al. Arthritis Care Res. 2019 May 10. doi: 10.1002/acr.23924.

Neither baseline Th17-associated cytokines nor C-reactive protein levels were predictive of response to ustekinumab in patients with psoriatic arthritis, despite significant reductions following treatment, according to Stefan Siebert, PhD, of the University of Glasgow (Scotland) and associates.

In a study published in Arthritis & Rheumatology, the authors retrospectively analyzed serum samples collected from 927 patients with psoriatic arthritis who participated in the phase 3 PSUMMIT trials. Patients received ustekinumab (Stelara) or placebo, and samples were collected at baseline, 4 weeks, and 24 weeks.

At baseline, interleukin-17A, -17F, and -23 levels were associated with skin disease scores, but neither these nor C-reactive protein (CRP) were associated with joint disease scores. While IL-17A, IL-17F, and CRP were reduced in patients who responded to ustekinumab, baseline levels of IL-17A, IL-17F, IL-23, and CRP were not associated with ustekinumab response in either skin or joints.

In patients who achieved a 75% reduction in their Psoriasis Area and Severity Index scores or a 20% reduction in their American College of Rheumatology response score after 24 weeks, CRP levels were significantly lower than in patients who did not achieve these scores (51%-58% vs. 32%-33%; P less than .05). However, IL-17A and IL-17F levels were not significantly different in these patients.

“While the biomarkers studied in the PSUMMIT program did not translate into therapeutic utility, it is important that relevant biomarker studies associated with phase 3 clinical trial programs are published in order to increase our understanding of this complex disease and further dissect the role of the IL-23/IL-17 pathway,” the investigators concluded.

The study was funded by Janssen; four coauthors reported being employed with Janssen.

lfranki@mdedge.com

SOURCE: Siebert S et al. Arthritis Rheumatol. 2019 May 9. doi: 10.1002/art.40921.

Neither baseline Th17-associated cytokines nor C-reactive protein levels were predictive of response to ustekinumab in patients with psoriatic arthritis, despite significant reductions following treatment, according to Stefan Siebert, PhD, of the University of Glasgow (Scotland) and associates.

In a study published in Arthritis & Rheumatology, the authors retrospectively analyzed serum samples collected from 927 patients with psoriatic arthritis who participated in the phase 3 PSUMMIT trials. Patients received ustekinumab (Stelara) or placebo, and samples were collected at baseline, 4 weeks, and 24 weeks.

At baseline, interleukin-17A, -17F, and -23 levels were associated with skin disease scores, but neither these nor C-reactive protein (CRP) were associated with joint disease scores. While IL-17A, IL-17F, and CRP were reduced in patients who responded to ustekinumab, baseline levels of IL-17A, IL-17F, IL-23, and CRP were not associated with ustekinumab response in either skin or joints.

In patients who achieved a 75% reduction in their Psoriasis Area and Severity Index scores or a 20% reduction in their American College of Rheumatology response score after 24 weeks, CRP levels were significantly lower than in patients who did not achieve these scores (51%-58% vs. 32%-33%; P less than .05). However, IL-17A and IL-17F levels were not significantly different in these patients.

“While the biomarkers studied in the PSUMMIT program did not translate into therapeutic utility, it is important that relevant biomarker studies associated with phase 3 clinical trial programs are published in order to increase our understanding of this complex disease and further dissect the role of the IL-23/IL-17 pathway,” the investigators concluded.

The study was funded by Janssen; four coauthors reported being employed with Janssen.

lfranki@mdedge.com

SOURCE: Siebert S et al. Arthritis Rheumatol. 2019 May 9. doi: 10.1002/art.40921.

Neither baseline Th17-associated cytokines nor C-reactive protein levels were predictive of response to ustekinumab in patients with psoriatic arthritis, despite significant reductions following treatment, according to Stefan Siebert, PhD, of the University of Glasgow (Scotland) and associates.

In a study published in Arthritis & Rheumatology, the authors retrospectively analyzed serum samples collected from 927 patients with psoriatic arthritis who participated in the phase 3 PSUMMIT trials. Patients received ustekinumab (Stelara) or placebo, and samples were collected at baseline, 4 weeks, and 24 weeks.

At baseline, interleukin-17A, -17F, and -23 levels were associated with skin disease scores, but neither these nor C-reactive protein (CRP) were associated with joint disease scores. While IL-17A, IL-17F, and CRP were reduced in patients who responded to ustekinumab, baseline levels of IL-17A, IL-17F, IL-23, and CRP were not associated with ustekinumab response in either skin or joints.

In patients who achieved a 75% reduction in their Psoriasis Area and Severity Index scores or a 20% reduction in their American College of Rheumatology response score after 24 weeks, CRP levels were significantly lower than in patients who did not achieve these scores (51%-58% vs. 32%-33%; P less than .05). However, IL-17A and IL-17F levels were not significantly different in these patients.

“While the biomarkers studied in the PSUMMIT program did not translate into therapeutic utility, it is important that relevant biomarker studies associated with phase 3 clinical trial programs are published in order to increase our understanding of this complex disease and further dissect the role of the IL-23/IL-17 pathway,” the investigators concluded.

The study was funded by Janssen; four coauthors reported being employed with Janssen.

lfranki@mdedge.com

SOURCE: Siebert S et al. Arthritis Rheumatol. 2019 May 9. doi: 10.1002/art.40921.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has recommended that patients at high risk of blood clots in the lungs should not be prescribed the 10-mg, twice-daily dose of tofacitinib (Xeljanz).

The PRAC recommendation is based on results from an ongoing study of patients with rheumatoid arthritis (RA), which has shown that patients receiving the 10-mg, twice-daily dose – twice the approved dose for RA – are at an increased risk of blood clots in the lungs and death.

Patients at risk include those with heart failure, cancer, inherited blood clotting disorders, or a history of blood clots, as well as patients who take combined hormonal contraceptives, are receiving hormone replacement therapy, or are undergoing major surgery. In addition, age, obesity, smoking, or immobilization should also be considered as risk factors.

In Europe, tofacitinib is indicated for the treatment of RA, psoriatic arthritis, and severe ulcerative colitis. Because the 10-mg dose is the only indicated treatment for ulcerative colitis, patients with the disease and who are at high risk should not be started on tofacitinib, and patients who are already taking the drug should be switched to a different treatment.

“The new recommendations are temporary and follow previous PRAC advice not to exceed the recommended 5-mg, twice-daily dose when treating rheumatoid arthritis. The PRAC will now carry out a review of all available evidence, and updated guidance will be provided to patients and healthcare professionals once the review is concluded,” according to the European Medicines Agency.

Find the full press release on the European Medicines Agency website.

lfranki@mdedge.com

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has recommended that patients at high risk of blood clots in the lungs should not be prescribed the 10-mg, twice-daily dose of tofacitinib (Xeljanz).

The PRAC recommendation is based on results from an ongoing study of patients with rheumatoid arthritis (RA), which has shown that patients receiving the 10-mg, twice-daily dose – twice the approved dose for RA – are at an increased risk of blood clots in the lungs and death.

Patients at risk include those with heart failure, cancer, inherited blood clotting disorders, or a history of blood clots, as well as patients who take combined hormonal contraceptives, are receiving hormone replacement therapy, or are undergoing major surgery. In addition, age, obesity, smoking, or immobilization should also be considered as risk factors.

In Europe, tofacitinib is indicated for the treatment of RA, psoriatic arthritis, and severe ulcerative colitis. Because the 10-mg dose is the only indicated treatment for ulcerative colitis, patients with the disease and who are at high risk should not be started on tofacitinib, and patients who are already taking the drug should be switched to a different treatment.

“The new recommendations are temporary and follow previous PRAC advice not to exceed the recommended 5-mg, twice-daily dose when treating rheumatoid arthritis. The PRAC will now carry out a review of all available evidence, and updated guidance will be provided to patients and healthcare professionals once the review is concluded,” according to the European Medicines Agency.

Find the full press release on the European Medicines Agency website.

lfranki@mdedge.com

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has recommended that patients at high risk of blood clots in the lungs should not be prescribed the 10-mg, twice-daily dose of tofacitinib (Xeljanz).

The PRAC recommendation is based on results from an ongoing study of patients with rheumatoid arthritis (RA), which has shown that patients receiving the 10-mg, twice-daily dose – twice the approved dose for RA – are at an increased risk of blood clots in the lungs and death.

Patients at risk include those with heart failure, cancer, inherited blood clotting disorders, or a history of blood clots, as well as patients who take combined hormonal contraceptives, are receiving hormone replacement therapy, or are undergoing major surgery. In addition, age, obesity, smoking, or immobilization should also be considered as risk factors.

In Europe, tofacitinib is indicated for the treatment of RA, psoriatic arthritis, and severe ulcerative colitis. Because the 10-mg dose is the only indicated treatment for ulcerative colitis, patients with the disease and who are at high risk should not be started on tofacitinib, and patients who are already taking the drug should be switched to a different treatment.

“The new recommendations are temporary and follow previous PRAC advice not to exceed the recommended 5-mg, twice-daily dose when treating rheumatoid arthritis. The PRAC will now carry out a review of all available evidence, and updated guidance will be provided to patients and healthcare professionals once the review is concluded,” according to the European Medicines Agency.

Find the full press release on the European Medicines Agency website.

lfranki@mdedge.com

MADISON, WISC. – Only half of United States veterans with inflammatory arthritis received disease-modifying medication within 90 days of diagnosis if they received care within the Veterans Health Administration, according to a study presented at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

Over the study period, 58.2% of all inflammatory arthritis patients began a disease-modifying antirheumatic drug (DMARD) within 12 months of diagnosis. Rates of DMARD initiation were similar for patients with rheumatoid arthritis (RA, 57.7%) and psoriatic arthritis (PsA, 64.3%), said the first author of the poster presentation, Sogol S. Amjadi, DO, a resident physician at Bingham Memorial Hospital, Blackfoot, Idaho.

However, at 12 months after diagnosis, only 29.6% of ankylosing spondylitis (AS) patients had not been started on a DMARD. “The ankylosing spondylitis group really had the lowest DMARD initiation over time,” said Dr. Amjadi in an interview.

The study used diagnosis codes and natural language processing to look for incident cases of the three inflammatory arthritides (IAs) among patients receiving care within the Veterans Health Administration from 2007 through 2015.

In all, 12,118 patients with incident IA were identified. Of these, 9,711 had RA, 1,472 had PsA, and 935 had AS. Patients were mostly (91.3%) male, with a mean age of 63.7 years.

Over the study period, 41.2% of IA patients were dispensed a DMARD within 30 days of diagnosis, and 50% received a DMARD within 90 days of diagnosis. Patients with PsA or RA had similar rates of DMARD prescription within 30 days of diagnosis (about 42% and 43%, respectively).

The investigators discovered in their analysis that another factor in prompt treatment was access to specialty care.“Timely access to a rheumatology provider is likely important for early DMARD treatment,” wrote Dr. Amjadi and her coauthors in the poster accompanying the presentation. Of patients who did receive a DMARD, 82.7% had received rheumatology specialty care before nonbiologic DMARD dispensing, as had 90.0% of patients receiving biologic DMARDs. Over the entire study period, about 10% of all IA patients had biologic DMARD exposure.

There was a trend over time for increased DMARD dispensing, said the investigators. “The percentage of IA patients with DMARD exposure during the 12-month follow-up period increased from 48.8% in 2008 to 66.4% in 2015.”

For AS patients, early DMARD prescribing rates rose from about 20% in 2007 to nearly 30% in 2015. “DMARD treatment rates during the initial 12 months after diagnosis increased between 2007 and 2015, but nontreatment remained common, particularly in patients with AS,” wrote the investigators. “Delays in treatment for inflammatory arthritis are associated with unfavorable outcomes, including impaired quality of life, irreversible joint damage, and disability.”

The authors reported no conflicts of interest and no outside sources of funding.

koakes@mdedge.com

MADISON, WISC. – Only half of United States veterans with inflammatory arthritis received disease-modifying medication within 90 days of diagnosis if they received care within the Veterans Health Administration, according to a study presented at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

Over the study period, 58.2% of all inflammatory arthritis patients began a disease-modifying antirheumatic drug (DMARD) within 12 months of diagnosis. Rates of DMARD initiation were similar for patients with rheumatoid arthritis (RA, 57.7%) and psoriatic arthritis (PsA, 64.3%), said the first author of the poster presentation, Sogol S. Amjadi, DO, a resident physician at Bingham Memorial Hospital, Blackfoot, Idaho.

However, at 12 months after diagnosis, only 29.6% of ankylosing spondylitis (AS) patients had not been started on a DMARD. “The ankylosing spondylitis group really had the lowest DMARD initiation over time,” said Dr. Amjadi in an interview.

The study used diagnosis codes and natural language processing to look for incident cases of the three inflammatory arthritides (IAs) among patients receiving care within the Veterans Health Administration from 2007 through 2015.

In all, 12,118 patients with incident IA were identified. Of these, 9,711 had RA, 1,472 had PsA, and 935 had AS. Patients were mostly (91.3%) male, with a mean age of 63.7 years.

Over the study period, 41.2% of IA patients were dispensed a DMARD within 30 days of diagnosis, and 50% received a DMARD within 90 days of diagnosis. Patients with PsA or RA had similar rates of DMARD prescription within 30 days of diagnosis (about 42% and 43%, respectively).

The investigators discovered in their analysis that another factor in prompt treatment was access to specialty care.“Timely access to a rheumatology provider is likely important for early DMARD treatment,” wrote Dr. Amjadi and her coauthors in the poster accompanying the presentation. Of patients who did receive a DMARD, 82.7% had received rheumatology specialty care before nonbiologic DMARD dispensing, as had 90.0% of patients receiving biologic DMARDs. Over the entire study period, about 10% of all IA patients had biologic DMARD exposure.

There was a trend over time for increased DMARD dispensing, said the investigators. “The percentage of IA patients with DMARD exposure during the 12-month follow-up period increased from 48.8% in 2008 to 66.4% in 2015.”

For AS patients, early DMARD prescribing rates rose from about 20% in 2007 to nearly 30% in 2015. “DMARD treatment rates during the initial 12 months after diagnosis increased between 2007 and 2015, but nontreatment remained common, particularly in patients with AS,” wrote the investigators. “Delays in treatment for inflammatory arthritis are associated with unfavorable outcomes, including impaired quality of life, irreversible joint damage, and disability.”

The authors reported no conflicts of interest and no outside sources of funding.

koakes@mdedge.com

MADISON, WISC. – Only half of United States veterans with inflammatory arthritis received disease-modifying medication within 90 days of diagnosis if they received care within the Veterans Health Administration, according to a study presented at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

Over the study period, 58.2% of all inflammatory arthritis patients began a disease-modifying antirheumatic drug (DMARD) within 12 months of diagnosis. Rates of DMARD initiation were similar for patients with rheumatoid arthritis (RA, 57.7%) and psoriatic arthritis (PsA, 64.3%), said the first author of the poster presentation, Sogol S. Amjadi, DO, a resident physician at Bingham Memorial Hospital, Blackfoot, Idaho.

However, at 12 months after diagnosis, only 29.6% of ankylosing spondylitis (AS) patients had not been started on a DMARD. “The ankylosing spondylitis group really had the lowest DMARD initiation over time,” said Dr. Amjadi in an interview.

The study used diagnosis codes and natural language processing to look for incident cases of the three inflammatory arthritides (IAs) among patients receiving care within the Veterans Health Administration from 2007 through 2015.

In all, 12,118 patients with incident IA were identified. Of these, 9,711 had RA, 1,472 had PsA, and 935 had AS. Patients were mostly (91.3%) male, with a mean age of 63.7 years.

Over the study period, 41.2% of IA patients were dispensed a DMARD within 30 days of diagnosis, and 50% received a DMARD within 90 days of diagnosis. Patients with PsA or RA had similar rates of DMARD prescription within 30 days of diagnosis (about 42% and 43%, respectively).

The investigators discovered in their analysis that another factor in prompt treatment was access to specialty care.“Timely access to a rheumatology provider is likely important for early DMARD treatment,” wrote Dr. Amjadi and her coauthors in the poster accompanying the presentation. Of patients who did receive a DMARD, 82.7% had received rheumatology specialty care before nonbiologic DMARD dispensing, as had 90.0% of patients receiving biologic DMARDs. Over the entire study period, about 10% of all IA patients had biologic DMARD exposure.

There was a trend over time for increased DMARD dispensing, said the investigators. “The percentage of IA patients with DMARD exposure during the 12-month follow-up period increased from 48.8% in 2008 to 66.4% in 2015.”

For AS patients, early DMARD prescribing rates rose from about 20% in 2007 to nearly 30% in 2015. “DMARD treatment rates during the initial 12 months after diagnosis increased between 2007 and 2015, but nontreatment remained common, particularly in patients with AS,” wrote the investigators. “Delays in treatment for inflammatory arthritis are associated with unfavorable outcomes, including impaired quality of life, irreversible joint damage, and disability.”

The authors reported no conflicts of interest and no outside sources of funding.

koakes@mdedge.com

The development of biosimilars such as etanercept SB4 offers a “significant opportunity to decrease medical care cost and increase treatment options,” Alessandro Giunta, MD, of the department of dermatology at the University of Rome Tor Vergata, and associates reported in a letter to the editor in the British Journal of Dermatology.

Dr. Giunta and his associates performed an observational, retrospective, single-center study to investigate etanercept biosimilar SB4 in patients being treated for plaque type psoriasis and psoriatic arthritis (PsA). They evaluated 40 patients – 21 men and 19 women – mean age 55, ranging from 19 to 79 years. The patients received the etanercept biosimilar SB4 between Oct. 21, 2016, and March 31, 2017, at University of Rome Tor Vergata’s department of dermatology. (The etanercept biosimilar SB4 was approved April 29 by the Food and Drug Administration under the brand name Eticovo [etanercept-ykro]. It is also approved in other countries under the names Benepali and Brenzys.)

Accounting for erythrocyte sedimentation rate as a variable, Dr. Giunta and colleagues calculated disease activity scores based on 28 joints; 14 patients (35%) had plaque psoriasis (mean Psoriasis Area Severity Index [PASI] of 9.61 at baseline), while 26 (65%) had psoriatic arthritis (mean PASI, 4.69). All patients reported prior treatment with systemic conventional and biologic treatments. A group of 10 patients (25%) who had been previously treated with etanercept originator underwent an intermittent treatment regimen of 24 weeks with etanercept biosimilar, which was interrupted once clinical resolution was achieved. No treatments were prescribed between etanercept originator and etanercept biosimilar. Mean exposure was 50.4 weeks, ranging from 24 to 96 weeks, with an average washout period of 12.1 weeks from originator to biosimilar (range 8-24).

A significant improvement in mean PASI score was observed in plaque type psoriasis patients as well as psoriatic arthritis patients at week 24 (P less than .0001 and P less than .001, respectively), noted Dr. Giunta and associates.

“All scores achieved a statistical significant improvement with the exception of [swollen joint count] that markedly improved but not significantly,” they added. One patient experienced injection site reaction, but no serious adverse events were observed.

Despite low sample size and limited follow-up time, the authors concluded that etanercept biosimilar achieved effectiveness as a treatment for psoriatic patients even in cases involving previous exposure to originator etanercept. Cost savings of 61.58% for 50-mg treatment and 62.55% for 25-mg treatment respectively guaranteed “the continuity of etanercept-treated patients’ care and gave us the opportunity to allocate patients in innovative but more expensive agents with marginal increase in our annual budget,” they noted.

The authors reported serving as consultants and speakers for AbbVie, Biogen, Eli Lilly, Janssen, Pfizer, and Novartis.

SOURCE: Giunta A et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18090.

The development of biosimilars such as etanercept SB4 offers a “significant opportunity to decrease medical care cost and increase treatment options,” Alessandro Giunta, MD, of the department of dermatology at the University of Rome Tor Vergata, and associates reported in a letter to the editor in the British Journal of Dermatology.

Dr. Giunta and his associates performed an observational, retrospective, single-center study to investigate etanercept biosimilar SB4 in patients being treated for plaque type psoriasis and psoriatic arthritis (PsA). They evaluated 40 patients – 21 men and 19 women – mean age 55, ranging from 19 to 79 years. The patients received the etanercept biosimilar SB4 between Oct. 21, 2016, and March 31, 2017, at University of Rome Tor Vergata’s department of dermatology. (The etanercept biosimilar SB4 was approved April 29 by the Food and Drug Administration under the brand name Eticovo [etanercept-ykro]. It is also approved in other countries under the names Benepali and Brenzys.)

Accounting for erythrocyte sedimentation rate as a variable, Dr. Giunta and colleagues calculated disease activity scores based on 28 joints; 14 patients (35%) had plaque psoriasis (mean Psoriasis Area Severity Index [PASI] of 9.61 at baseline), while 26 (65%) had psoriatic arthritis (mean PASI, 4.69). All patients reported prior treatment with systemic conventional and biologic treatments. A group of 10 patients (25%) who had been previously treated with etanercept originator underwent an intermittent treatment regimen of 24 weeks with etanercept biosimilar, which was interrupted once clinical resolution was achieved. No treatments were prescribed between etanercept originator and etanercept biosimilar. Mean exposure was 50.4 weeks, ranging from 24 to 96 weeks, with an average washout period of 12.1 weeks from originator to biosimilar (range 8-24).

A significant improvement in mean PASI score was observed in plaque type psoriasis patients as well as psoriatic arthritis patients at week 24 (P less than .0001 and P less than .001, respectively), noted Dr. Giunta and associates.

“All scores achieved a statistical significant improvement with the exception of [swollen joint count] that markedly improved but not significantly,” they added. One patient experienced injection site reaction, but no serious adverse events were observed.

Despite low sample size and limited follow-up time, the authors concluded that etanercept biosimilar achieved effectiveness as a treatment for psoriatic patients even in cases involving previous exposure to originator etanercept. Cost savings of 61.58% for 50-mg treatment and 62.55% for 25-mg treatment respectively guaranteed “the continuity of etanercept-treated patients’ care and gave us the opportunity to allocate patients in innovative but more expensive agents with marginal increase in our annual budget,” they noted.

The authors reported serving as consultants and speakers for AbbVie, Biogen, Eli Lilly, Janssen, Pfizer, and Novartis.

SOURCE: Giunta A et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18090.

The development of biosimilars such as etanercept SB4 offers a “significant opportunity to decrease medical care cost and increase treatment options,” Alessandro Giunta, MD, of the department of dermatology at the University of Rome Tor Vergata, and associates reported in a letter to the editor in the British Journal of Dermatology.

Dr. Giunta and his associates performed an observational, retrospective, single-center study to investigate etanercept biosimilar SB4 in patients being treated for plaque type psoriasis and psoriatic arthritis (PsA). They evaluated 40 patients – 21 men and 19 women – mean age 55, ranging from 19 to 79 years. The patients received the etanercept biosimilar SB4 between Oct. 21, 2016, and March 31, 2017, at University of Rome Tor Vergata’s department of dermatology. (The etanercept biosimilar SB4 was approved April 29 by the Food and Drug Administration under the brand name Eticovo [etanercept-ykro]. It is also approved in other countries under the names Benepali and Brenzys.)

Accounting for erythrocyte sedimentation rate as a variable, Dr. Giunta and colleagues calculated disease activity scores based on 28 joints; 14 patients (35%) had plaque psoriasis (mean Psoriasis Area Severity Index [PASI] of 9.61 at baseline), while 26 (65%) had psoriatic arthritis (mean PASI, 4.69). All patients reported prior treatment with systemic conventional and biologic treatments. A group of 10 patients (25%) who had been previously treated with etanercept originator underwent an intermittent treatment regimen of 24 weeks with etanercept biosimilar, which was interrupted once clinical resolution was achieved. No treatments were prescribed between etanercept originator and etanercept biosimilar. Mean exposure was 50.4 weeks, ranging from 24 to 96 weeks, with an average washout period of 12.1 weeks from originator to biosimilar (range 8-24).

A significant improvement in mean PASI score was observed in plaque type psoriasis patients as well as psoriatic arthritis patients at week 24 (P less than .0001 and P less than .001, respectively), noted Dr. Giunta and associates.

“All scores achieved a statistical significant improvement with the exception of [swollen joint count] that markedly improved but not significantly,” they added. One patient experienced injection site reaction, but no serious adverse events were observed.

Despite low sample size and limited follow-up time, the authors concluded that etanercept biosimilar achieved effectiveness as a treatment for psoriatic patients even in cases involving previous exposure to originator etanercept. Cost savings of 61.58% for 50-mg treatment and 62.55% for 25-mg treatment respectively guaranteed “the continuity of etanercept-treated patients’ care and gave us the opportunity to allocate patients in innovative but more expensive agents with marginal increase in our annual budget,” they noted.

The authors reported serving as consultants and speakers for AbbVie, Biogen, Eli Lilly, Janssen, Pfizer, and Novartis.

SOURCE: Giunta A et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18090.

Almost 31% of the estimated 54 million adults in the United States with arthritis have severe joint pain, according to the Centers for Disease Control and Prevention.

Nationally, the prevalence of severe joint pain was 30.8% in adults with arthritis in 2017, but state-specific, age-standardized prevalences varied from a low of 20.8% in Colorado to 45.2% in Mississippi. Regionally, prevalences of both severe joint pain and physical inactivity in arthritis patients were highest in the Southeast, noted Dana Guglielmo, MPH, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, and associates (MMWR 2019 May 3;68(17):381-7).

The prevalence of arthritis itself was lowest in the District of Columbia at 15.7% and highest in West Virginia at 34.6%. Alabama, at 30.4%, was the only other state above 30%. Colorado had the lowest physical inactivity rate (23.2%), while Kentucky had the highest (44.4%), the investigators said.

The differences among arthritis patients were demographic as well as geographic in 2017. The prevalence of severe joint pain was 33.0% among those aged 18-44 years and 35.6% in those 45-64 but only 25.1% in those aged 65 and older. Whites had a 27.4% prevalence of severe joint pain, compared with 42.0% for Hispanics and 50.9% for blacks. For arthritis patients with a college degree, the age-standardized prevalence of severe joint pain was 15.1%, compared with 35.5% for high school graduates and 54.1% for those with less than a high school degree, based on data from the Behavioral Risk Factor Surveillance System.

“Although persons with arthritis report that pain, or fear of causing or worsening it, is a substantial barrier to exercising, physical activity is an inexpensive intervention that can reduce pain, prevent or delay disability and limitations, and improve mental health, physical functioning, and quality of life with few adverse effects,” wrote Ms. Guglielmo and associates. Adults with severe joint pain “should engage in regular physical activity according to their abilities and avoid physical inactivity [since] even small amounts of physical activity can improve physical functioning in adults with joint conditions.”

rfranki@mdedge.com

SOURCE: Guglielmo D et al. MMWR 2019 May 3;68(17):381-7.

Almost 31% of the estimated 54 million adults in the United States with arthritis have severe joint pain, according to the Centers for Disease Control and Prevention.

Nationally, the prevalence of severe joint pain was 30.8% in adults with arthritis in 2017, but state-specific, age-standardized prevalences varied from a low of 20.8% in Colorado to 45.2% in Mississippi. Regionally, prevalences of both severe joint pain and physical inactivity in arthritis patients were highest in the Southeast, noted Dana Guglielmo, MPH, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, and associates (MMWR 2019 May 3;68(17):381-7).

The prevalence of arthritis itself was lowest in the District of Columbia at 15.7% and highest in West Virginia at 34.6%. Alabama, at 30.4%, was the only other state above 30%. Colorado had the lowest physical inactivity rate (23.2%), while Kentucky had the highest (44.4%), the investigators said.

The differences among arthritis patients were demographic as well as geographic in 2017. The prevalence of severe joint pain was 33.0% among those aged 18-44 years and 35.6% in those 45-64 but only 25.1% in those aged 65 and older. Whites had a 27.4% prevalence of severe joint pain, compared with 42.0% for Hispanics and 50.9% for blacks. For arthritis patients with a college degree, the age-standardized prevalence of severe joint pain was 15.1%, compared with 35.5% for high school graduates and 54.1% for those with less than a high school degree, based on data from the Behavioral Risk Factor Surveillance System.

“Although persons with arthritis report that pain, or fear of causing or worsening it, is a substantial barrier to exercising, physical activity is an inexpensive intervention that can reduce pain, prevent or delay disability and limitations, and improve mental health, physical functioning, and quality of life with few adverse effects,” wrote Ms. Guglielmo and associates. Adults with severe joint pain “should engage in regular physical activity according to their abilities and avoid physical inactivity [since] even small amounts of physical activity can improve physical functioning in adults with joint conditions.”

rfranki@mdedge.com

SOURCE: Guglielmo D et al. MMWR 2019 May 3;68(17):381-7.

Almost 31% of the estimated 54 million adults in the United States with arthritis have severe joint pain, according to the Centers for Disease Control and Prevention.

Nationally, the prevalence of severe joint pain was 30.8% in adults with arthritis in 2017, but state-specific, age-standardized prevalences varied from a low of 20.8% in Colorado to 45.2% in Mississippi. Regionally, prevalences of both severe joint pain and physical inactivity in arthritis patients were highest in the Southeast, noted Dana Guglielmo, MPH, of the CDC’s National Center for Chronic Disease Prevention and Health Promotion, Atlanta, and associates (MMWR 2019 May 3;68(17):381-7).

The prevalence of arthritis itself was lowest in the District of Columbia at 15.7% and highest in West Virginia at 34.6%. Alabama, at 30.4%, was the only other state above 30%. Colorado had the lowest physical inactivity rate (23.2%), while Kentucky had the highest (44.4%), the investigators said.

The differences among arthritis patients were demographic as well as geographic in 2017. The prevalence of severe joint pain was 33.0% among those aged 18-44 years and 35.6% in those 45-64 but only 25.1% in those aged 65 and older. Whites had a 27.4% prevalence of severe joint pain, compared with 42.0% for Hispanics and 50.9% for blacks. For arthritis patients with a college degree, the age-standardized prevalence of severe joint pain was 15.1%, compared with 35.5% for high school graduates and 54.1% for those with less than a high school degree, based on data from the Behavioral Risk Factor Surveillance System.

“Although persons with arthritis report that pain, or fear of causing or worsening it, is a substantial barrier to exercising, physical activity is an inexpensive intervention that can reduce pain, prevent or delay disability and limitations, and improve mental health, physical functioning, and quality of life with few adverse effects,” wrote Ms. Guglielmo and associates. Adults with severe joint pain “should engage in regular physical activity according to their abilities and avoid physical inactivity [since] even small amounts of physical activity can improve physical functioning in adults with joint conditions.”

rfranki@mdedge.com

SOURCE: Guglielmo D et al. MMWR 2019 May 3;68(17):381-7.

MAUI, HAWAII – Serious weight loss brings big improvement in psoriatic arthritis in obese patients, at least short term, according to a Swedish, single-arm, prospective, proof-of-concept study.

Bruce Jancin/MDedge News

A dose-response effect was evident: the greater the lost poundage, the bigger the improvement across multiple dimensions of psoriatic arthritis.

The short-term efficacy was eye-catching, especially in view of the well-recognized increased prevalence of obesity in psoriatic arthritis patients. But the jury is still out as to the long-term impact of this nonpharmacologic therapy, Eric M. Ruderman, MD, said at the 2019 Rheumatology Winter Clinical Symposium.

He has spoken with the Swedish investigators and was happy to learn they’re continuing to follow study participants long term.

“That’s going to be the key, right? Because if you do this for 12 weeks, like every other fad crash diet, and then you let the weight go right back on again, you haven’t really accomplished anything. I think the key will be what happens at a year,” according to Dr. Ruderman, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University, Chicago.

Bruce Jancin/MDedge News

The study included 46 obese psoriatic arthritis patients who signed on for a structured, medically supervised very-low-energy diet lasting 12-16 weeks, depending upon their baseline obesity level. The commercially available liquid diet (Cambridge Weight Plan Limited) is a type of therapy widely prescribed by Swedish physicians, clocking in at a mere 640 kcal/day.

“I don’t know about you, but I ate that at breakfast this morning,” quipped symposium director Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego.

Following completion of the strict very-low-energy diet, patients were gradually reintroduced to a less-draconian, solid-food, energy-restricted diet, to be followed through the 12-month mark. The full 12-month protocol was supervised by staff in the obesity unit at Sahlgrenska University Hospital in Gothenburg, Sweden. The 12-month results will be presented at the annual European Congress of Rheumatology in Madrid.

Of the 46 starters, 41 made it to the 6-month follow-up assessment. At that point they’d lost a median of 18.2 kg, or 18.6% of their baseline body weight. Their body mass index had dropped from an average of 35.2 to 29.8 kg/m². And their psoriatic arthritis had improved significantly. For example, their median Disease Activity Score using 28 joint counts based upon C-reactive protein (DAS28-CRP) decreased from 2.9 at baseline to 2.4 at 6 months, with ACR 20, -50, and -70 responses of 51.2%, 34.1%, and 7.3% while disease-directed medications were held constant (Arthritis Res Ther. 2019 Jan 11;21[1]:17. doi: 10.1186/s13075-019-1810-5).

The investigators reported the very-low-energy diet phase was generally well tolerated. A total of 34 of the 41 patients deemed it “easier or much easier” than expected, prompting Dr. Ruderman to comment: “Because they thought it was going to be awful.”

Dr. Ruderman and Dr. Kavanaugh reported serving as consultants to numerous pharmaceutical companies.
 

bjancin@mdedge.com

MAUI, HAWAII – Serious weight loss brings big improvement in psoriatic arthritis in obese patients, at least short term, according to a Swedish, single-arm, prospective, proof-of-concept study.

Bruce Jancin/MDedge News

A dose-response effect was evident: the greater the lost poundage, the bigger the improvement across multiple dimensions of psoriatic arthritis.

The short-term efficacy was eye-catching, especially in view of the well-recognized increased prevalence of obesity in psoriatic arthritis patients. But the jury is still out as to the long-term impact of this nonpharmacologic therapy, Eric M. Ruderman, MD, said at the 2019 Rheumatology Winter Clinical Symposium.

He has spoken with the Swedish investigators and was happy to learn they’re continuing to follow study participants long term.

“That’s going to be the key, right? Because if you do this for 12 weeks, like every other fad crash diet, and then you let the weight go right back on again, you haven’t really accomplished anything. I think the key will be what happens at a year,” according to Dr. Ruderman, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University, Chicago.

Bruce Jancin/MDedge News

The study included 46 obese psoriatic arthritis patients who signed on for a structured, medically supervised very-low-energy diet lasting 12-16 weeks, depending upon their baseline obesity level. The commercially available liquid diet (Cambridge Weight Plan Limited) is a type of therapy widely prescribed by Swedish physicians, clocking in at a mere 640 kcal/day.

“I don’t know about you, but I ate that at breakfast this morning,” quipped symposium director Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego.

Following completion of the strict very-low-energy diet, patients were gradually reintroduced to a less-draconian, solid-food, energy-restricted diet, to be followed through the 12-month mark. The full 12-month protocol was supervised by staff in the obesity unit at Sahlgrenska University Hospital in Gothenburg, Sweden. The 12-month results will be presented at the annual European Congress of Rheumatology in Madrid.

Of the 46 starters, 41 made it to the 6-month follow-up assessment. At that point they’d lost a median of 18.2 kg, or 18.6% of their baseline body weight. Their body mass index had dropped from an average of 35.2 to 29.8 kg/m². And their psoriatic arthritis had improved significantly. For example, their median Disease Activity Score using 28 joint counts based upon C-reactive protein (DAS28-CRP) decreased from 2.9 at baseline to 2.4 at 6 months, with ACR 20, -50, and -70 responses of 51.2%, 34.1%, and 7.3% while disease-directed medications were held constant (Arthritis Res Ther. 2019 Jan 11;21[1]:17. doi: 10.1186/s13075-019-1810-5).

The investigators reported the very-low-energy diet phase was generally well tolerated. A total of 34 of the 41 patients deemed it “easier or much easier” than expected, prompting Dr. Ruderman to comment: “Because they thought it was going to be awful.”

Dr. Ruderman and Dr. Kavanaugh reported serving as consultants to numerous pharmaceutical companies.
 

bjancin@mdedge.com

MAUI, HAWAII – Serious weight loss brings big improvement in psoriatic arthritis in obese patients, at least short term, according to a Swedish, single-arm, prospective, proof-of-concept study.

Bruce Jancin/MDedge News

A dose-response effect was evident: the greater the lost poundage, the bigger the improvement across multiple dimensions of psoriatic arthritis.

The short-term efficacy was eye-catching, especially in view of the well-recognized increased prevalence of obesity in psoriatic arthritis patients. But the jury is still out as to the long-term impact of this nonpharmacologic therapy, Eric M. Ruderman, MD, said at the 2019 Rheumatology Winter Clinical Symposium.

He has spoken with the Swedish investigators and was happy to learn they’re continuing to follow study participants long term.

“That’s going to be the key, right? Because if you do this for 12 weeks, like every other fad crash diet, and then you let the weight go right back on again, you haven’t really accomplished anything. I think the key will be what happens at a year,” according to Dr. Ruderman, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University, Chicago.

Bruce Jancin/MDedge News

The study included 46 obese psoriatic arthritis patients who signed on for a structured, medically supervised very-low-energy diet lasting 12-16 weeks, depending upon their baseline obesity level. The commercially available liquid diet (Cambridge Weight Plan Limited) is a type of therapy widely prescribed by Swedish physicians, clocking in at a mere 640 kcal/day.

“I don’t know about you, but I ate that at breakfast this morning,” quipped symposium director Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego.

Following completion of the strict very-low-energy diet, patients were gradually reintroduced to a less-draconian, solid-food, energy-restricted diet, to be followed through the 12-month mark. The full 12-month protocol was supervised by staff in the obesity unit at Sahlgrenska University Hospital in Gothenburg, Sweden. The 12-month results will be presented at the annual European Congress of Rheumatology in Madrid.

Of the 46 starters, 41 made it to the 6-month follow-up assessment. At that point they’d lost a median of 18.2 kg, or 18.6% of their baseline body weight. Their body mass index had dropped from an average of 35.2 to 29.8 kg/m². And their psoriatic arthritis had improved significantly. For example, their median Disease Activity Score using 28 joint counts based upon C-reactive protein (DAS28-CRP) decreased from 2.9 at baseline to 2.4 at 6 months, with ACR 20, -50, and -70 responses of 51.2%, 34.1%, and 7.3% while disease-directed medications were held constant (Arthritis Res Ther. 2019 Jan 11;21[1]:17. doi: 10.1186/s13075-019-1810-5).

The investigators reported the very-low-energy diet phase was generally well tolerated. A total of 34 of the 41 patients deemed it “easier or much easier” than expected, prompting Dr. Ruderman to comment: “Because they thought it was going to be awful.”

Dr. Ruderman and Dr. Kavanaugh reported serving as consultants to numerous pharmaceutical companies.
 

bjancin@mdedge.com

The intravenous formulation of the TNF inhibitor golimumab (Simponi Aria) produced durable responses and no new safety signals through 1 year of treatment in patients with active psoriatic arthritis, according to follow-up results of a randomized clinical trial.

The improvements in joint disease, skin disease, and health-related quality of life seen at 24 weeks in the phase 3 GO-VIBRANT study were maintained at this 52-week follow-up, according to M. Elaine Husni, MD, of the Cleveland Clinic, and coinvestigators.

Patients who crossed over to golimumab treatment after 24 weeks of placebo had similar rates of clinical response at 52 weeks, while patients receiving concomitant methotrexate had similar ACR response rates, compared with patients on golimumab monotherapy, Dr. Husni and colleagues reported.

Many patients who were not ACR20 responders at week 52 nevertheless had improvements in skin disease, enthesitis, and dactylitis, an exploratory analysis showed.

“These factors may have contributed to these patients remaining in the trial and continuing golimumab therapy despite not achieving an ACR20 response,” wrote Dr. Husni and coauthors. The report is in Arthritis Care & Research.

The Food and Drug Administration approved a once-monthly subcutaneous formulation of golimumab (Simponi) in 2009 for treatment of moderate to severe active psoriatic arthritis, rheumatoid arthritis, and active ankylosing spondylitis. The intravenous formulation of this TNF inhibitor (Simponi Aria) received a psoriatic arthritis indication in 2017 based on GO-VIBRANT data. Published results at the time showed that compared with placebo, intravenous golimumab given as a 2-mg/kg infusion at weeks 0, 4, and then every 8 weeks produced greater improvements in psoriatic arthritis signs and symptoms and less radiographic progression through week 24 of the study, and had adverse events consistent with other TNF inhibitors, according to investigators.

The follow-up report includes efficacy and safety data for golimumab-treated patients beyond 24 weeks, as well as data for patients on the placebo arm, who crossed over to receive golimumab at week 24, week 28, and then every 8 weeks thereafter.


The results show ACR response rates were maintained from week 24 to 52 in golimumab-treated patients, and were similar in the placebo crossover patients. The ACR20, ACR50, and ACR70 response rates in the golimumab group were 76.8%, 58.1%, and 38.6%, respectively, while in the crossover group, they were 77.0%, 53.6%, and 33.9%, respectively.

Radiographic progression was measured using van der Heijde-Sharp (vdH-S) score with modifications for psoriatic arthritis. The mean change in vdH-S score at 24 weeks was –0.4 and 2.0 in the golimumab and placebo groups, respectively; by week 52, the mean change was –0.5 and 0.8 for golimumab and placebo crossover.

Infection was the most common adverse event throughout 60 weeks of safety evaluation, occurring in 22.8% of all golimumab-treated patients, investigators said. Four infusion reactions occurred following golimumab administration, though none were considered serious or severe.

The GO-VIBRANT study, which comprised 480 adults, had limited follow-up and was not powered to identify rare safety events, investigators said.

“However, the totality of results through 1 year of the GO-VIBRANT study show a durable response to IV golimumab 2 mg/kg across several clinical efficacy, HRQoL, and radiographic endpoints with no new safety signals,” they concluded.

Study authors reported disclosures with AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Horizon, Janssen, Novartis, Pfizer, Sanofi, and UCB. Several study authors reported current or former employment with Janssen Research & Development and stock or stock options in Johnson & Johnson.

SOURCE: Husni ME et al. Arthritis Care Res. 2019 Apr 12. doi: 10.1002/acr.23905.

The intravenous formulation of the TNF inhibitor golimumab (Simponi Aria) produced durable responses and no new safety signals through 1 year of treatment in patients with active psoriatic arthritis, according to follow-up results of a randomized clinical trial.

The improvements in joint disease, skin disease, and health-related quality of life seen at 24 weeks in the phase 3 GO-VIBRANT study were maintained at this 52-week follow-up, according to M. Elaine Husni, MD, of the Cleveland Clinic, and coinvestigators.

Patients who crossed over to golimumab treatment after 24 weeks of placebo had similar rates of clinical response at 52 weeks, while patients receiving concomitant methotrexate had similar ACR response rates, compared with patients on golimumab monotherapy, Dr. Husni and colleagues reported.

Many patients who were not ACR20 responders at week 52 nevertheless had improvements in skin disease, enthesitis, and dactylitis, an exploratory analysis showed.

“These factors may have contributed to these patients remaining in the trial and continuing golimumab therapy despite not achieving an ACR20 response,” wrote Dr. Husni and coauthors. The report is in Arthritis Care & Research.

The Food and Drug Administration approved a once-monthly subcutaneous formulation of golimumab (Simponi) in 2009 for treatment of moderate to severe active psoriatic arthritis, rheumatoid arthritis, and active ankylosing spondylitis. The intravenous formulation of this TNF inhibitor (Simponi Aria) received a psoriatic arthritis indication in 2017 based on GO-VIBRANT data. Published results at the time showed that compared with placebo, intravenous golimumab given as a 2-mg/kg infusion at weeks 0, 4, and then every 8 weeks produced greater improvements in psoriatic arthritis signs and symptoms and less radiographic progression through week 24 of the study, and had adverse events consistent with other TNF inhibitors, according to investigators.

The follow-up report includes efficacy and safety data for golimumab-treated patients beyond 24 weeks, as well as data for patients on the placebo arm, who crossed over to receive golimumab at week 24, week 28, and then every 8 weeks thereafter.


The results show ACR response rates were maintained from week 24 to 52 in golimumab-treated patients, and were similar in the placebo crossover patients. The ACR20, ACR50, and ACR70 response rates in the golimumab group were 76.8%, 58.1%, and 38.6%, respectively, while in the crossover group, they were 77.0%, 53.6%, and 33.9%, respectively.

Radiographic progression was measured using van der Heijde-Sharp (vdH-S) score with modifications for psoriatic arthritis. The mean change in vdH-S score at 24 weeks was –0.4 and 2.0 in the golimumab and placebo groups, respectively; by week 52, the mean change was –0.5 and 0.8 for golimumab and placebo crossover.

Infection was the most common adverse event throughout 60 weeks of safety evaluation, occurring in 22.8% of all golimumab-treated patients, investigators said. Four infusion reactions occurred following golimumab administration, though none were considered serious or severe.

The GO-VIBRANT study, which comprised 480 adults, had limited follow-up and was not powered to identify rare safety events, investigators said.

“However, the totality of results through 1 year of the GO-VIBRANT study show a durable response to IV golimumab 2 mg/kg across several clinical efficacy, HRQoL, and radiographic endpoints with no new safety signals,” they concluded.

Study authors reported disclosures with AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Horizon, Janssen, Novartis, Pfizer, Sanofi, and UCB. Several study authors reported current or former employment with Janssen Research & Development and stock or stock options in Johnson & Johnson.

SOURCE: Husni ME et al. Arthritis Care Res. 2019 Apr 12. doi: 10.1002/acr.23905.

The intravenous formulation of the TNF inhibitor golimumab (Simponi Aria) produced durable responses and no new safety signals through 1 year of treatment in patients with active psoriatic arthritis, according to follow-up results of a randomized clinical trial.

The improvements in joint disease, skin disease, and health-related quality of life seen at 24 weeks in the phase 3 GO-VIBRANT study were maintained at this 52-week follow-up, according to M. Elaine Husni, MD, of the Cleveland Clinic, and coinvestigators.

Patients who crossed over to golimumab treatment after 24 weeks of placebo had similar rates of clinical response at 52 weeks, while patients receiving concomitant methotrexate had similar ACR response rates, compared with patients on golimumab monotherapy, Dr. Husni and colleagues reported.

Many patients who were not ACR20 responders at week 52 nevertheless had improvements in skin disease, enthesitis, and dactylitis, an exploratory analysis showed.

“These factors may have contributed to these patients remaining in the trial and continuing golimumab therapy despite not achieving an ACR20 response,” wrote Dr. Husni and coauthors. The report is in Arthritis Care & Research.

The Food and Drug Administration approved a once-monthly subcutaneous formulation of golimumab (Simponi) in 2009 for treatment of moderate to severe active psoriatic arthritis, rheumatoid arthritis, and active ankylosing spondylitis. The intravenous formulation of this TNF inhibitor (Simponi Aria) received a psoriatic arthritis indication in 2017 based on GO-VIBRANT data. Published results at the time showed that compared with placebo, intravenous golimumab given as a 2-mg/kg infusion at weeks 0, 4, and then every 8 weeks produced greater improvements in psoriatic arthritis signs and symptoms and less radiographic progression through week 24 of the study, and had adverse events consistent with other TNF inhibitors, according to investigators.

The follow-up report includes efficacy and safety data for golimumab-treated patients beyond 24 weeks, as well as data for patients on the placebo arm, who crossed over to receive golimumab at week 24, week 28, and then every 8 weeks thereafter.


The results show ACR response rates were maintained from week 24 to 52 in golimumab-treated patients, and were similar in the placebo crossover patients. The ACR20, ACR50, and ACR70 response rates in the golimumab group were 76.8%, 58.1%, and 38.6%, respectively, while in the crossover group, they were 77.0%, 53.6%, and 33.9%, respectively.

Radiographic progression was measured using van der Heijde-Sharp (vdH-S) score with modifications for psoriatic arthritis. The mean change in vdH-S score at 24 weeks was –0.4 and 2.0 in the golimumab and placebo groups, respectively; by week 52, the mean change was –0.5 and 0.8 for golimumab and placebo crossover.

Infection was the most common adverse event throughout 60 weeks of safety evaluation, occurring in 22.8% of all golimumab-treated patients, investigators said. Four infusion reactions occurred following golimumab administration, though none were considered serious or severe.

The GO-VIBRANT study, which comprised 480 adults, had limited follow-up and was not powered to identify rare safety events, investigators said.

“However, the totality of results through 1 year of the GO-VIBRANT study show a durable response to IV golimumab 2 mg/kg across several clinical efficacy, HRQoL, and radiographic endpoints with no new safety signals,” they concluded.

Study authors reported disclosures with AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Horizon, Janssen, Novartis, Pfizer, Sanofi, and UCB. Several study authors reported current or former employment with Janssen Research & Development and stock or stock options in Johnson & Johnson.

SOURCE: Husni ME et al. Arthritis Care Res. 2019 Apr 12. doi: 10.1002/acr.23905.