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Preterm Delivery a Risk in Systemic Sclerosis

Pregnancy in SSc: Talk About It
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Preterm Delivery a Risk in Systemic Sclerosis

Many women with systemic sclerosis can have successful pregnancies, but the rates of preterm birth, low birth weight, and intrauterine growth restriction are approximately twice as high in these women compared to the general population of pregnant women, based on data from 109 pregnancies in 99 women with systemic sclerosis.

The findings were published in Arthritis & Rheumatism (Arthritis Rheum. 2011 Dec. 28 [doi:10.1002/art.34350]).

Data from previous studies have suggested negative outcomes for pregnancies in women with systemic sclerosis (SSc), but these have been small case series or large database reviews that did not allow for the identification of individual patients, said Dr. Mara Taraborelli of Spedali Civili and University, Brescia, Italy, and colleagues.

In this prospective study, the researchers followed 99 women with SSc who had 109 pregnancies between 2000 and 2011. The women attended one of 25 participating research centers in Italy.

The average age at conception was 32 years, and most of the women were white. A total of 107 pregnancies were spontaneous, and 2 were achieved with assisted reproductive techniques.

Preterm deliveries were significantly more common in the SSc women, compared to the general obstetric population that served as a control group (25% vs. 12%, respectively). Severe preterm delivery (defined as delivery at less than 34 weeks) also was significantly more common in SSc women, compared to the controls (10% vs. 5%, respectively).

In addition, very low birth weight babies and cases of intrauterine growth restriction were significantly more common in the SSc women, compared to the controls (5% vs. 1%, respectively, and 6% vs. 1%, respectively).

The researchers found no increase in hypertensive disorders of pregnancy or spontaneous pregnancy losses in SSc women, compared to the general pregnant population.

"We observed a low rate of disease progression shortly after the end of pregnancy; this risk might be greater in aSCL-70 positive patients with recent-onset disease," the researchers noted. All four cases of internal organ disease evolution within 12 months after delivery occurred in women who were aSCL-70 positive, and 3 of 23 (13%) of women who were aSCL-70 positive whose disease had lasted less than 3 years had some disease progression after delivery.

A total of six newborns spent a median of 15 days in the intensive care unit. Of these, one was severely premature and died of multi-organ failure.

The study findings were limited by the use of retrospective analysis and the use of controls for only one year, but the results suggest that successful pregnancies are possible for SSc women despite the increased risks for poor maternal and fetal outcomes, with multidisciplinary management, the researchers said. However, pregnancy may not be advisable for patients with severe organ damage or recent onset of SSc, especially those who are antitopoisomerase positive, they added.

The researchers had no financial conflicts to disclose. The study was supported in part by three patients’ associations: the Gruppo Italiano Lotta alla Sclerodermia, Gruppo Lupus Eritematoso Sistemico Lombardia, and the Associazone Lombarda Malati Reumatici.

Body

Findings from this study and other studies on pregnancy in women with systemic sclerosis are important because many affected patients are in their child-bearing years.

This is one of several studies on the topic of SSc and pregnancy, and findings from the other studies do not agree fully with these data. Findings from other studies have shown that the babies of women with SSc are more likely to have low weight for gestational age. Also, data from previous studies have shown that patients with severe SSc disease, just like all patients with any illness in the connective tissue disease realm, need to be very cautious when considering pregnancy. As always, good communication between the patient and physician and good clinical judgment are paramount.

When physicians counsel patients about pregnancy, the discussion should include specifics of cardiac, pulmonary, gastrointestinal, and renal involvement as they relate to the patient’s condition. Other issues include family history, whether there are other children in the family, what kind of support systems the patient has, other medications needed to control disease, and the psychological status of the individual patient.

As for avenues for further research, larger prospective data sets are needed, including data on patients with concomitant illnesses, different medications, serologies, microchimerism, physiology, and genetics when possible. Of course, data are needed on both the short-term and long-term outcomes of the children as well as the mothers. In cases of poor outcomes, studies of tissue are warranted.

Dr. Daniel E. Furst is the Carl M. Pearson professor in rheumatology at the University of California, Los Angeles and a member of the Rheumatology News Editorial Advisory Board.

Dr. Furst has received research grants from multiple companies including Bristol-Myers Squibb, Celgene, Genentech, National Institutes of Health, and UCB. He has served as a consultant for multiple companies including Abbott, Bristol-Myers Squibb, Centocor, Novartis, and Xoma. He has served on the speaker's bureau for Abbott and Genentech, and has received honoraria from Abbott, Actelion, Bristol-Myers Squibb, Genentech, Encysive, and UCB.

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Body

Findings from this study and other studies on pregnancy in women with systemic sclerosis are important because many affected patients are in their child-bearing years.

This is one of several studies on the topic of SSc and pregnancy, and findings from the other studies do not agree fully with these data. Findings from other studies have shown that the babies of women with SSc are more likely to have low weight for gestational age. Also, data from previous studies have shown that patients with severe SSc disease, just like all patients with any illness in the connective tissue disease realm, need to be very cautious when considering pregnancy. As always, good communication between the patient and physician and good clinical judgment are paramount.

When physicians counsel patients about pregnancy, the discussion should include specifics of cardiac, pulmonary, gastrointestinal, and renal involvement as they relate to the patient’s condition. Other issues include family history, whether there are other children in the family, what kind of support systems the patient has, other medications needed to control disease, and the psychological status of the individual patient.

As for avenues for further research, larger prospective data sets are needed, including data on patients with concomitant illnesses, different medications, serologies, microchimerism, physiology, and genetics when possible. Of course, data are needed on both the short-term and long-term outcomes of the children as well as the mothers. In cases of poor outcomes, studies of tissue are warranted.

Dr. Daniel E. Furst is the Carl M. Pearson professor in rheumatology at the University of California, Los Angeles and a member of the Rheumatology News Editorial Advisory Board.

Dr. Furst has received research grants from multiple companies including Bristol-Myers Squibb, Celgene, Genentech, National Institutes of Health, and UCB. He has served as a consultant for multiple companies including Abbott, Bristol-Myers Squibb, Centocor, Novartis, and Xoma. He has served on the speaker's bureau for Abbott and Genentech, and has received honoraria from Abbott, Actelion, Bristol-Myers Squibb, Genentech, Encysive, and UCB.

Body

Findings from this study and other studies on pregnancy in women with systemic sclerosis are important because many affected patients are in their child-bearing years.

This is one of several studies on the topic of SSc and pregnancy, and findings from the other studies do not agree fully with these data. Findings from other studies have shown that the babies of women with SSc are more likely to have low weight for gestational age. Also, data from previous studies have shown that patients with severe SSc disease, just like all patients with any illness in the connective tissue disease realm, need to be very cautious when considering pregnancy. As always, good communication between the patient and physician and good clinical judgment are paramount.

When physicians counsel patients about pregnancy, the discussion should include specifics of cardiac, pulmonary, gastrointestinal, and renal involvement as they relate to the patient’s condition. Other issues include family history, whether there are other children in the family, what kind of support systems the patient has, other medications needed to control disease, and the psychological status of the individual patient.

As for avenues for further research, larger prospective data sets are needed, including data on patients with concomitant illnesses, different medications, serologies, microchimerism, physiology, and genetics when possible. Of course, data are needed on both the short-term and long-term outcomes of the children as well as the mothers. In cases of poor outcomes, studies of tissue are warranted.

Dr. Daniel E. Furst is the Carl M. Pearson professor in rheumatology at the University of California, Los Angeles and a member of the Rheumatology News Editorial Advisory Board.

Dr. Furst has received research grants from multiple companies including Bristol-Myers Squibb, Celgene, Genentech, National Institutes of Health, and UCB. He has served as a consultant for multiple companies including Abbott, Bristol-Myers Squibb, Centocor, Novartis, and Xoma. He has served on the speaker's bureau for Abbott and Genentech, and has received honoraria from Abbott, Actelion, Bristol-Myers Squibb, Genentech, Encysive, and UCB.

Title
Pregnancy in SSc: Talk About It
Pregnancy in SSc: Talk About It

Many women with systemic sclerosis can have successful pregnancies, but the rates of preterm birth, low birth weight, and intrauterine growth restriction are approximately twice as high in these women compared to the general population of pregnant women, based on data from 109 pregnancies in 99 women with systemic sclerosis.

The findings were published in Arthritis & Rheumatism (Arthritis Rheum. 2011 Dec. 28 [doi:10.1002/art.34350]).

Data from previous studies have suggested negative outcomes for pregnancies in women with systemic sclerosis (SSc), but these have been small case series or large database reviews that did not allow for the identification of individual patients, said Dr. Mara Taraborelli of Spedali Civili and University, Brescia, Italy, and colleagues.

In this prospective study, the researchers followed 99 women with SSc who had 109 pregnancies between 2000 and 2011. The women attended one of 25 participating research centers in Italy.

The average age at conception was 32 years, and most of the women were white. A total of 107 pregnancies were spontaneous, and 2 were achieved with assisted reproductive techniques.

Preterm deliveries were significantly more common in the SSc women, compared to the general obstetric population that served as a control group (25% vs. 12%, respectively). Severe preterm delivery (defined as delivery at less than 34 weeks) also was significantly more common in SSc women, compared to the controls (10% vs. 5%, respectively).

In addition, very low birth weight babies and cases of intrauterine growth restriction were significantly more common in the SSc women, compared to the controls (5% vs. 1%, respectively, and 6% vs. 1%, respectively).

The researchers found no increase in hypertensive disorders of pregnancy or spontaneous pregnancy losses in SSc women, compared to the general pregnant population.

"We observed a low rate of disease progression shortly after the end of pregnancy; this risk might be greater in aSCL-70 positive patients with recent-onset disease," the researchers noted. All four cases of internal organ disease evolution within 12 months after delivery occurred in women who were aSCL-70 positive, and 3 of 23 (13%) of women who were aSCL-70 positive whose disease had lasted less than 3 years had some disease progression after delivery.

A total of six newborns spent a median of 15 days in the intensive care unit. Of these, one was severely premature and died of multi-organ failure.

The study findings were limited by the use of retrospective analysis and the use of controls for only one year, but the results suggest that successful pregnancies are possible for SSc women despite the increased risks for poor maternal and fetal outcomes, with multidisciplinary management, the researchers said. However, pregnancy may not be advisable for patients with severe organ damage or recent onset of SSc, especially those who are antitopoisomerase positive, they added.

The researchers had no financial conflicts to disclose. The study was supported in part by three patients’ associations: the Gruppo Italiano Lotta alla Sclerodermia, Gruppo Lupus Eritematoso Sistemico Lombardia, and the Associazone Lombarda Malati Reumatici.

Many women with systemic sclerosis can have successful pregnancies, but the rates of preterm birth, low birth weight, and intrauterine growth restriction are approximately twice as high in these women compared to the general population of pregnant women, based on data from 109 pregnancies in 99 women with systemic sclerosis.

The findings were published in Arthritis & Rheumatism (Arthritis Rheum. 2011 Dec. 28 [doi:10.1002/art.34350]).

Data from previous studies have suggested negative outcomes for pregnancies in women with systemic sclerosis (SSc), but these have been small case series or large database reviews that did not allow for the identification of individual patients, said Dr. Mara Taraborelli of Spedali Civili and University, Brescia, Italy, and colleagues.

In this prospective study, the researchers followed 99 women with SSc who had 109 pregnancies between 2000 and 2011. The women attended one of 25 participating research centers in Italy.

The average age at conception was 32 years, and most of the women were white. A total of 107 pregnancies were spontaneous, and 2 were achieved with assisted reproductive techniques.

Preterm deliveries were significantly more common in the SSc women, compared to the general obstetric population that served as a control group (25% vs. 12%, respectively). Severe preterm delivery (defined as delivery at less than 34 weeks) also was significantly more common in SSc women, compared to the controls (10% vs. 5%, respectively).

In addition, very low birth weight babies and cases of intrauterine growth restriction were significantly more common in the SSc women, compared to the controls (5% vs. 1%, respectively, and 6% vs. 1%, respectively).

The researchers found no increase in hypertensive disorders of pregnancy or spontaneous pregnancy losses in SSc women, compared to the general pregnant population.

"We observed a low rate of disease progression shortly after the end of pregnancy; this risk might be greater in aSCL-70 positive patients with recent-onset disease," the researchers noted. All four cases of internal organ disease evolution within 12 months after delivery occurred in women who were aSCL-70 positive, and 3 of 23 (13%) of women who were aSCL-70 positive whose disease had lasted less than 3 years had some disease progression after delivery.

A total of six newborns spent a median of 15 days in the intensive care unit. Of these, one was severely premature and died of multi-organ failure.

The study findings were limited by the use of retrospective analysis and the use of controls for only one year, but the results suggest that successful pregnancies are possible for SSc women despite the increased risks for poor maternal and fetal outcomes, with multidisciplinary management, the researchers said. However, pregnancy may not be advisable for patients with severe organ damage or recent onset of SSc, especially those who are antitopoisomerase positive, they added.

The researchers had no financial conflicts to disclose. The study was supported in part by three patients’ associations: the Gruppo Italiano Lotta alla Sclerodermia, Gruppo Lupus Eritematoso Sistemico Lombardia, and the Associazone Lombarda Malati Reumatici.

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Preterm Delivery a Risk in Systemic Sclerosis
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Major Finding: Preterm deliveries were twice as common in pregnant women with systemic sclerosis, compared with pregnant women in the general population (25% vs. 12%, respectively).

Data Source: A prospective study of 99 women with systemic sclerosis.

Disclosures: The researchers had no financial conflicts to disclose. The study was supported in part by three patients’ associations: the Gruppo Italiano Lotta alla Sclerodermia, Gruppo Lupus Eritematoso Sistemico Lombardia, and the Associazone Lombarda Malati Reumatici.

The Whys and How of Stopping Biologics

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The Whys and How of Stopping Biologics

The vast majority of medical talks on biologic therapy for psoriasis focus on starting and maintaining the medications. Stopping biologics is a seldom-discussed topic, yet one that physicians often need to address.

"We’ve all got patients who are on biologic therapy who are completely clear of their psoriasis, and you’re constantly wondering, ‘Should I stop the biologic? Do they need to have that treatment anymore? Can I reduce the dosing frequency?’ The simplest answer is that in most cases, it’s probably not a good idea to stop unless there’s a good reason for doing so. It has been shown in most of the big clinical trials that if you stop therapy, the psoriasis will relapse at some point," Dr. Christopher Griffiths said at the annual congress of the European Academy of Dermatology and Venereology.

Dr. Christopher E. M. Griffiths

"With long-term therapy beyond 6-12 months, can biologics be stopped or produce remission? In most cases, no. And there’s no biomarker for disease activity as of yet to guide us," added Dr. Griffiths, professor of dermatology and associate dean for research at the University of Manchester (England).

Compelling reasons to stop biologic therapy include failure to achieve or maintain significant clinical improvement, serious adverse events, impending elective major surgery, certain vaccinations, and pregnancy. Dr. Griffiths highlighted the following points:

Lack of Effectiveness. Today’s biologics are not curative. In a recent French report, only 31 of 86 psoriasis patients (36%) who started on etanercept (Enbrel), infliximab (Remicade), or efalizumab were still on the same biologic agent 24 months later (J. Dermatol. Treat. 2011;22:151-2). Similarly, the Danish national psoriasis database experience has been that roughly 40% of patients started on etanercept or adalimumab (Humira) were still on the medication 4 years later, as were 70% of those who started on infliximab (Br. J. Dermatol. 2011;164:1091-6).

The good news, Dr. Griffiths continued, is that lack of effectiveness for anti–tumor necrosis factor agents is not a class effect. He and his coinvestigators have reported that 21 of 31 psoriasis patients who switched to adalimumab from another anti-TNF biologic for lack of efficacy met the NICE (U.K. National Institute for Health and Clinical Excellence) criteria for adalimumab treatment continuation at 16 weeks (Br. J. Dermatol. 2010;163:859-62).

"Each anti-TNF drug is different, so if you fail one it doesn’t mean you’re going to fail another. That’s a very important point, and a very strong argument in your favor when dealing with payers. And it’s an observation that can only come from real-life data from a cohort study; you’re not going to get that information from clinical trials," the dermatologist explained.

The NICE criteria for continuation of biologic therapy bring an element of strict objectivity to treatment decision making in a rationed health care system. For British psoriasis patients to continue on a given biologic agent, they have to demonstrate a PASI 75 response (that is, a 75% improvement over the baseline Psoriasis Area and Severity Index score) at 16 weeks, or a PASI 50 response plus a 5-point drop in the Dermatology Life Quality Index (DLQI).

When physicians switch biologics, Dr. Griffiths recommends that they skip a lengthy washout period because of the associated risk of a severe, hard-to-control flare. His practice is to stop one and start another.

Major Elective Surgery. There is a dearth of data on stopping biologics in psoriasis patients who plan to undergo elective surgery. The best practice for now, in Dr. Griffiths’ view, is to follow the British Society for Rheumatology guidance, which is based on an extensive biologics register the group maintains for rheumatoid arthritis.

The rheumatologists’ advice is to halt effective biologic therapy only for truly major surgery, and to stop anti-TNF drugs more than four half-lives before the operation. That’s 2-3 weeks beforehand for etanercept, 6-8 weeks for adalimumab, and 4-6 weeks for infliximab. There are no firm data for ustekinumab (Stelara) as yet, but experts advise halting it 12 weeks before surgery. Biologic therapy should be resumed as soon as possible postoperatively.

Pregnancy. Again, a paucity of data exists on biologics for psoriasis in pregnancy. But the data accumulating in the British Society for Rheumatology Biologics Register (BSRBR) is reassuring. Although the rheumatologists recommend that pregnancy be avoided in patients on biologics, the experience to date in pregnant rheumatoid arthritis patients suggests there is little to no risk to the fetus. Breastfeeding should be avoided by women on biologic therapy other than infliximab, which is not excreted in breast milk, Dr. Griffiths continued.

 

 

Vaccinations. British Association of Dermatologists guidelines on the use of biologics for psoriasis (Br. J. Dermatol. 2009;161:987-1019), which Dr. Griffiths coauthored and which will be updated in late 2012, recommend avoiding giving live or attenuated virus vaccines within 2 weeks prior to starting a patient on biologic therapy, or while the patient is on a biologic, or for up to 6 months after the patient stops the biologic. Inactivated virus vaccines are safe for patients on biologic therapy, although the antibody response will be somewhat less robust in a patient on an anti-TNF agent than in other individuals.

"But we advise – as should you – that all patients on biologics should receive influenza and pneumococcal vaccines. It’s just good clinical practice because these patients are by definition in a high-risk category," he said.

Stopping and Restarting Biologics. It’s well established that etanercept can be used intermittently with good results. That is, a patient might use etanercept to good effect for 6 months, stop it, then restart when relapse occurs, and the agent will still remain effective. The same typically holds true for alefacept (Amevive).

In contrast, infliximab can realistically be used for only a single course of treatment. If a patient goes off the drug and later goes back on it, the chances of regaining a response are very low because of the formation of blocking antibodies.

The picture regarding the intermittent use of adalimumab is less clear. There are documented cases in which this agent hasn’t been effective any longer upon second usage.

There is good new evidence, presented by Dr. Griffiths elsewhere during the congress, that ustekinumab can be restarted after a hiatus with very good results.

Dr. Griffiths disclosed that he serves on the advisory boards for and has received research grants from numerous pharmaceutical companies.

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The vast majority of medical talks on biologic therapy for psoriasis focus on starting and maintaining the medications. Stopping biologics is a seldom-discussed topic, yet one that physicians often need to address.

"We’ve all got patients who are on biologic therapy who are completely clear of their psoriasis, and you’re constantly wondering, ‘Should I stop the biologic? Do they need to have that treatment anymore? Can I reduce the dosing frequency?’ The simplest answer is that in most cases, it’s probably not a good idea to stop unless there’s a good reason for doing so. It has been shown in most of the big clinical trials that if you stop therapy, the psoriasis will relapse at some point," Dr. Christopher Griffiths said at the annual congress of the European Academy of Dermatology and Venereology.

Dr. Christopher E. M. Griffiths

"With long-term therapy beyond 6-12 months, can biologics be stopped or produce remission? In most cases, no. And there’s no biomarker for disease activity as of yet to guide us," added Dr. Griffiths, professor of dermatology and associate dean for research at the University of Manchester (England).

Compelling reasons to stop biologic therapy include failure to achieve or maintain significant clinical improvement, serious adverse events, impending elective major surgery, certain vaccinations, and pregnancy. Dr. Griffiths highlighted the following points:

Lack of Effectiveness. Today’s biologics are not curative. In a recent French report, only 31 of 86 psoriasis patients (36%) who started on etanercept (Enbrel), infliximab (Remicade), or efalizumab were still on the same biologic agent 24 months later (J. Dermatol. Treat. 2011;22:151-2). Similarly, the Danish national psoriasis database experience has been that roughly 40% of patients started on etanercept or adalimumab (Humira) were still on the medication 4 years later, as were 70% of those who started on infliximab (Br. J. Dermatol. 2011;164:1091-6).

The good news, Dr. Griffiths continued, is that lack of effectiveness for anti–tumor necrosis factor agents is not a class effect. He and his coinvestigators have reported that 21 of 31 psoriasis patients who switched to adalimumab from another anti-TNF biologic for lack of efficacy met the NICE (U.K. National Institute for Health and Clinical Excellence) criteria for adalimumab treatment continuation at 16 weeks (Br. J. Dermatol. 2010;163:859-62).

"Each anti-TNF drug is different, so if you fail one it doesn’t mean you’re going to fail another. That’s a very important point, and a very strong argument in your favor when dealing with payers. And it’s an observation that can only come from real-life data from a cohort study; you’re not going to get that information from clinical trials," the dermatologist explained.

The NICE criteria for continuation of biologic therapy bring an element of strict objectivity to treatment decision making in a rationed health care system. For British psoriasis patients to continue on a given biologic agent, they have to demonstrate a PASI 75 response (that is, a 75% improvement over the baseline Psoriasis Area and Severity Index score) at 16 weeks, or a PASI 50 response plus a 5-point drop in the Dermatology Life Quality Index (DLQI).

When physicians switch biologics, Dr. Griffiths recommends that they skip a lengthy washout period because of the associated risk of a severe, hard-to-control flare. His practice is to stop one and start another.

Major Elective Surgery. There is a dearth of data on stopping biologics in psoriasis patients who plan to undergo elective surgery. The best practice for now, in Dr. Griffiths’ view, is to follow the British Society for Rheumatology guidance, which is based on an extensive biologics register the group maintains for rheumatoid arthritis.

The rheumatologists’ advice is to halt effective biologic therapy only for truly major surgery, and to stop anti-TNF drugs more than four half-lives before the operation. That’s 2-3 weeks beforehand for etanercept, 6-8 weeks for adalimumab, and 4-6 weeks for infliximab. There are no firm data for ustekinumab (Stelara) as yet, but experts advise halting it 12 weeks before surgery. Biologic therapy should be resumed as soon as possible postoperatively.

Pregnancy. Again, a paucity of data exists on biologics for psoriasis in pregnancy. But the data accumulating in the British Society for Rheumatology Biologics Register (BSRBR) is reassuring. Although the rheumatologists recommend that pregnancy be avoided in patients on biologics, the experience to date in pregnant rheumatoid arthritis patients suggests there is little to no risk to the fetus. Breastfeeding should be avoided by women on biologic therapy other than infliximab, which is not excreted in breast milk, Dr. Griffiths continued.

 

 

Vaccinations. British Association of Dermatologists guidelines on the use of biologics for psoriasis (Br. J. Dermatol. 2009;161:987-1019), which Dr. Griffiths coauthored and which will be updated in late 2012, recommend avoiding giving live or attenuated virus vaccines within 2 weeks prior to starting a patient on biologic therapy, or while the patient is on a biologic, or for up to 6 months after the patient stops the biologic. Inactivated virus vaccines are safe for patients on biologic therapy, although the antibody response will be somewhat less robust in a patient on an anti-TNF agent than in other individuals.

"But we advise – as should you – that all patients on biologics should receive influenza and pneumococcal vaccines. It’s just good clinical practice because these patients are by definition in a high-risk category," he said.

Stopping and Restarting Biologics. It’s well established that etanercept can be used intermittently with good results. That is, a patient might use etanercept to good effect for 6 months, stop it, then restart when relapse occurs, and the agent will still remain effective. The same typically holds true for alefacept (Amevive).

In contrast, infliximab can realistically be used for only a single course of treatment. If a patient goes off the drug and later goes back on it, the chances of regaining a response are very low because of the formation of blocking antibodies.

The picture regarding the intermittent use of adalimumab is less clear. There are documented cases in which this agent hasn’t been effective any longer upon second usage.

There is good new evidence, presented by Dr. Griffiths elsewhere during the congress, that ustekinumab can be restarted after a hiatus with very good results.

Dr. Griffiths disclosed that he serves on the advisory boards for and has received research grants from numerous pharmaceutical companies.

The vast majority of medical talks on biologic therapy for psoriasis focus on starting and maintaining the medications. Stopping biologics is a seldom-discussed topic, yet one that physicians often need to address.

"We’ve all got patients who are on biologic therapy who are completely clear of their psoriasis, and you’re constantly wondering, ‘Should I stop the biologic? Do they need to have that treatment anymore? Can I reduce the dosing frequency?’ The simplest answer is that in most cases, it’s probably not a good idea to stop unless there’s a good reason for doing so. It has been shown in most of the big clinical trials that if you stop therapy, the psoriasis will relapse at some point," Dr. Christopher Griffiths said at the annual congress of the European Academy of Dermatology and Venereology.

Dr. Christopher E. M. Griffiths

"With long-term therapy beyond 6-12 months, can biologics be stopped or produce remission? In most cases, no. And there’s no biomarker for disease activity as of yet to guide us," added Dr. Griffiths, professor of dermatology and associate dean for research at the University of Manchester (England).

Compelling reasons to stop biologic therapy include failure to achieve or maintain significant clinical improvement, serious adverse events, impending elective major surgery, certain vaccinations, and pregnancy. Dr. Griffiths highlighted the following points:

Lack of Effectiveness. Today’s biologics are not curative. In a recent French report, only 31 of 86 psoriasis patients (36%) who started on etanercept (Enbrel), infliximab (Remicade), or efalizumab were still on the same biologic agent 24 months later (J. Dermatol. Treat. 2011;22:151-2). Similarly, the Danish national psoriasis database experience has been that roughly 40% of patients started on etanercept or adalimumab (Humira) were still on the medication 4 years later, as were 70% of those who started on infliximab (Br. J. Dermatol. 2011;164:1091-6).

The good news, Dr. Griffiths continued, is that lack of effectiveness for anti–tumor necrosis factor agents is not a class effect. He and his coinvestigators have reported that 21 of 31 psoriasis patients who switched to adalimumab from another anti-TNF biologic for lack of efficacy met the NICE (U.K. National Institute for Health and Clinical Excellence) criteria for adalimumab treatment continuation at 16 weeks (Br. J. Dermatol. 2010;163:859-62).

"Each anti-TNF drug is different, so if you fail one it doesn’t mean you’re going to fail another. That’s a very important point, and a very strong argument in your favor when dealing with payers. And it’s an observation that can only come from real-life data from a cohort study; you’re not going to get that information from clinical trials," the dermatologist explained.

The NICE criteria for continuation of biologic therapy bring an element of strict objectivity to treatment decision making in a rationed health care system. For British psoriasis patients to continue on a given biologic agent, they have to demonstrate a PASI 75 response (that is, a 75% improvement over the baseline Psoriasis Area and Severity Index score) at 16 weeks, or a PASI 50 response plus a 5-point drop in the Dermatology Life Quality Index (DLQI).

When physicians switch biologics, Dr. Griffiths recommends that they skip a lengthy washout period because of the associated risk of a severe, hard-to-control flare. His practice is to stop one and start another.

Major Elective Surgery. There is a dearth of data on stopping biologics in psoriasis patients who plan to undergo elective surgery. The best practice for now, in Dr. Griffiths’ view, is to follow the British Society for Rheumatology guidance, which is based on an extensive biologics register the group maintains for rheumatoid arthritis.

The rheumatologists’ advice is to halt effective biologic therapy only for truly major surgery, and to stop anti-TNF drugs more than four half-lives before the operation. That’s 2-3 weeks beforehand for etanercept, 6-8 weeks for adalimumab, and 4-6 weeks for infliximab. There are no firm data for ustekinumab (Stelara) as yet, but experts advise halting it 12 weeks before surgery. Biologic therapy should be resumed as soon as possible postoperatively.

Pregnancy. Again, a paucity of data exists on biologics for psoriasis in pregnancy. But the data accumulating in the British Society for Rheumatology Biologics Register (BSRBR) is reassuring. Although the rheumatologists recommend that pregnancy be avoided in patients on biologics, the experience to date in pregnant rheumatoid arthritis patients suggests there is little to no risk to the fetus. Breastfeeding should be avoided by women on biologic therapy other than infliximab, which is not excreted in breast milk, Dr. Griffiths continued.

 

 

Vaccinations. British Association of Dermatologists guidelines on the use of biologics for psoriasis (Br. J. Dermatol. 2009;161:987-1019), which Dr. Griffiths coauthored and which will be updated in late 2012, recommend avoiding giving live or attenuated virus vaccines within 2 weeks prior to starting a patient on biologic therapy, or while the patient is on a biologic, or for up to 6 months after the patient stops the biologic. Inactivated virus vaccines are safe for patients on biologic therapy, although the antibody response will be somewhat less robust in a patient on an anti-TNF agent than in other individuals.

"But we advise – as should you – that all patients on biologics should receive influenza and pneumococcal vaccines. It’s just good clinical practice because these patients are by definition in a high-risk category," he said.

Stopping and Restarting Biologics. It’s well established that etanercept can be used intermittently with good results. That is, a patient might use etanercept to good effect for 6 months, stop it, then restart when relapse occurs, and the agent will still remain effective. The same typically holds true for alefacept (Amevive).

In contrast, infliximab can realistically be used for only a single course of treatment. If a patient goes off the drug and later goes back on it, the chances of regaining a response are very low because of the formation of blocking antibodies.

The picture regarding the intermittent use of adalimumab is less clear. There are documented cases in which this agent hasn’t been effective any longer upon second usage.

There is good new evidence, presented by Dr. Griffiths elsewhere during the congress, that ustekinumab can be restarted after a hiatus with very good results.

Dr. Griffiths disclosed that he serves on the advisory boards for and has received research grants from numerous pharmaceutical companies.

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For those of you who have had a busy year and haven't had the chance to regularly read the latest dermatology news on Skin and Allergy News Digital Network, we have you covered. As we ring in the new year, here's a rundown of last year's most-viewed stories:

10. Experts: Medical Dermatology Is Losing Ground, By Bruce Jancin: Experts in medical dermatology predicted the specialty will become narrower and less medically oriented by 2020. As we enter 2012, some experts said they were concerned about the emphasis on aesthetic dermatology and dermatologic surgery. 

Courtesy flickr user woodleywonderworks (Creative Commons)
    

9. Mohs Surgery in Medicare Patients Skyrocketing, By Sherry Boschert: Several Mohs surgery experts found that the rate of Mohs surgery per 1,000 Medicare beneficiaries increased by 236% between 1999 and 2009. Dr. Matthew Donaldson and his associates presented the data at the annual meeting of the American College of Mohs Surgery. 

8. Blog: New Isotretinoin Drug May Address Safety Concerns, By Amy Pfeiffer: This much-viewed blog post highlighted an investigational isotretinoin drug that may eliminate safety concerns associated with the drug, like IBD and depression. The gelatin capsules of CIP-iisotretinoin help reduce GI irritation and the drug is less food dependent.

7. Dosing Isotretinoin: Go Big to Avoid Second Course, By Jeffrey Eisenberg: In another isotretinoin study, investigators found that patients receiving a higher cumulative dose of the drug were no less likely to experience an acne relapse than those who received a lower cumulative dose. However, the investigators found that patients treated with a higher dose were less likely to need a second course of treatment. 

6. Knifelike Vulvar Ulcers May Signal Crohn's Disease, By Kate Johnson: Knifelike vulvar ulcers could be a sign of Crohn's disease in women, according to experts at a conference on vulvovaginal diseases. For some patients, ulcers may be the only manifestation of the disorder. 

5. Biologics Up Cardiovascular Risk, New Analysis Finds, By Sherry Boschert: Biologic therapies used to treat psoriasis have been linked to an increase in major cardiovascular events, according to researchers. One patient on placebo developed a major cardiovascular event in a study of etanercept. Five patients on ustekinumab, five on briakinumab, and one on adalimumab also developed major cardiovascular events.

4. Future Technologies Hold Promise for Hair Restoration, By Damian McNamara: At an annual meeting of dermatologic surgeons, Dr. Ricardo Mejia discussed technological advancements in hair restoration. He said the future for hair restoration could include technologies like robotic hair transfer, hair cloning, and technologies to optimize new growth. 

3. AAD: Potential Doxycycline, IBD Link Considered Worrisome, By Bruce Jancin: In more acne news, a retrospective cohort study linked tetracycline-class antibiotics with an increase in inflammatory bowel disease. The highly controversial findings were one of the hottest topics at the annual meeting of the American Academy of Dermatology and on this website.

2. Bimatoprost Repigments Vitiligo Patient Skin, By Bruce Jancin: A topical bimatoprost ophthalmic solution could serve as treatment for focal vitiligo, according to a pilot study presented at the World Congress of Dermatology. Researchers said 7 out of 10 patients exhibited pronounced repigmentation after 2 months of treatment. 

1. Marijuana Allergies "Fairly Common," Expert SaysBy M. Alexander Otto: A heads up to physicians: allergy experts said marijuana allergies are more common than most people think. Patients with with a marijuana allergy exhibit symptoms including wheezing, sinusitis, throat swelling, and inhalation issues. 

Best wishes for 2012!

-- Frances Correa (FMCReporting)

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For those of you who have had a busy year and haven't had the chance to regularly read the latest dermatology news on Skin and Allergy News Digital Network, we have you covered. As we ring in the new year, here's a rundown of last year's most-viewed stories:

10. Experts: Medical Dermatology Is Losing Ground, By Bruce Jancin: Experts in medical dermatology predicted the specialty will become narrower and less medically oriented by 2020. As we enter 2012, some experts said they were concerned about the emphasis on aesthetic dermatology and dermatologic surgery. 

Courtesy flickr user woodleywonderworks (Creative Commons)
    

9. Mohs Surgery in Medicare Patients Skyrocketing, By Sherry Boschert: Several Mohs surgery experts found that the rate of Mohs surgery per 1,000 Medicare beneficiaries increased by 236% between 1999 and 2009. Dr. Matthew Donaldson and his associates presented the data at the annual meeting of the American College of Mohs Surgery. 

8. Blog: New Isotretinoin Drug May Address Safety Concerns, By Amy Pfeiffer: This much-viewed blog post highlighted an investigational isotretinoin drug that may eliminate safety concerns associated with the drug, like IBD and depression. The gelatin capsules of CIP-iisotretinoin help reduce GI irritation and the drug is less food dependent.

7. Dosing Isotretinoin: Go Big to Avoid Second Course, By Jeffrey Eisenberg: In another isotretinoin study, investigators found that patients receiving a higher cumulative dose of the drug were no less likely to experience an acne relapse than those who received a lower cumulative dose. However, the investigators found that patients treated with a higher dose were less likely to need a second course of treatment. 

6. Knifelike Vulvar Ulcers May Signal Crohn's Disease, By Kate Johnson: Knifelike vulvar ulcers could be a sign of Crohn's disease in women, according to experts at a conference on vulvovaginal diseases. For some patients, ulcers may be the only manifestation of the disorder. 

5. Biologics Up Cardiovascular Risk, New Analysis Finds, By Sherry Boschert: Biologic therapies used to treat psoriasis have been linked to an increase in major cardiovascular events, according to researchers. One patient on placebo developed a major cardiovascular event in a study of etanercept. Five patients on ustekinumab, five on briakinumab, and one on adalimumab also developed major cardiovascular events.

4. Future Technologies Hold Promise for Hair Restoration, By Damian McNamara: At an annual meeting of dermatologic surgeons, Dr. Ricardo Mejia discussed technological advancements in hair restoration. He said the future for hair restoration could include technologies like robotic hair transfer, hair cloning, and technologies to optimize new growth. 

3. AAD: Potential Doxycycline, IBD Link Considered Worrisome, By Bruce Jancin: In more acne news, a retrospective cohort study linked tetracycline-class antibiotics with an increase in inflammatory bowel disease. The highly controversial findings were one of the hottest topics at the annual meeting of the American Academy of Dermatology and on this website.

2. Bimatoprost Repigments Vitiligo Patient Skin, By Bruce Jancin: A topical bimatoprost ophthalmic solution could serve as treatment for focal vitiligo, according to a pilot study presented at the World Congress of Dermatology. Researchers said 7 out of 10 patients exhibited pronounced repigmentation after 2 months of treatment. 

1. Marijuana Allergies "Fairly Common," Expert SaysBy M. Alexander Otto: A heads up to physicians: allergy experts said marijuana allergies are more common than most people think. Patients with with a marijuana allergy exhibit symptoms including wheezing, sinusitis, throat swelling, and inhalation issues. 

Best wishes for 2012!

-- Frances Correa (FMCReporting)

For those of you who have had a busy year and haven't had the chance to regularly read the latest dermatology news on Skin and Allergy News Digital Network, we have you covered. As we ring in the new year, here's a rundown of last year's most-viewed stories:

10. Experts: Medical Dermatology Is Losing Ground, By Bruce Jancin: Experts in medical dermatology predicted the specialty will become narrower and less medically oriented by 2020. As we enter 2012, some experts said they were concerned about the emphasis on aesthetic dermatology and dermatologic surgery. 

Courtesy flickr user woodleywonderworks (Creative Commons)
    

9. Mohs Surgery in Medicare Patients Skyrocketing, By Sherry Boschert: Several Mohs surgery experts found that the rate of Mohs surgery per 1,000 Medicare beneficiaries increased by 236% between 1999 and 2009. Dr. Matthew Donaldson and his associates presented the data at the annual meeting of the American College of Mohs Surgery. 

8. Blog: New Isotretinoin Drug May Address Safety Concerns, By Amy Pfeiffer: This much-viewed blog post highlighted an investigational isotretinoin drug that may eliminate safety concerns associated with the drug, like IBD and depression. The gelatin capsules of CIP-iisotretinoin help reduce GI irritation and the drug is less food dependent.

7. Dosing Isotretinoin: Go Big to Avoid Second Course, By Jeffrey Eisenberg: In another isotretinoin study, investigators found that patients receiving a higher cumulative dose of the drug were no less likely to experience an acne relapse than those who received a lower cumulative dose. However, the investigators found that patients treated with a higher dose were less likely to need a second course of treatment. 

6. Knifelike Vulvar Ulcers May Signal Crohn's Disease, By Kate Johnson: Knifelike vulvar ulcers could be a sign of Crohn's disease in women, according to experts at a conference on vulvovaginal diseases. For some patients, ulcers may be the only manifestation of the disorder. 

5. Biologics Up Cardiovascular Risk, New Analysis Finds, By Sherry Boschert: Biologic therapies used to treat psoriasis have been linked to an increase in major cardiovascular events, according to researchers. One patient on placebo developed a major cardiovascular event in a study of etanercept. Five patients on ustekinumab, five on briakinumab, and one on adalimumab also developed major cardiovascular events.

4. Future Technologies Hold Promise for Hair Restoration, By Damian McNamara: At an annual meeting of dermatologic surgeons, Dr. Ricardo Mejia discussed technological advancements in hair restoration. He said the future for hair restoration could include technologies like robotic hair transfer, hair cloning, and technologies to optimize new growth. 

3. AAD: Potential Doxycycline, IBD Link Considered Worrisome, By Bruce Jancin: In more acne news, a retrospective cohort study linked tetracycline-class antibiotics with an increase in inflammatory bowel disease. The highly controversial findings were one of the hottest topics at the annual meeting of the American Academy of Dermatology and on this website.

2. Bimatoprost Repigments Vitiligo Patient Skin, By Bruce Jancin: A topical bimatoprost ophthalmic solution could serve as treatment for focal vitiligo, according to a pilot study presented at the World Congress of Dermatology. Researchers said 7 out of 10 patients exhibited pronounced repigmentation after 2 months of treatment. 

1. Marijuana Allergies "Fairly Common," Expert SaysBy M. Alexander Otto: A heads up to physicians: allergy experts said marijuana allergies are more common than most people think. Patients with with a marijuana allergy exhibit symptoms including wheezing, sinusitis, throat swelling, and inhalation issues. 

Best wishes for 2012!

-- Frances Correa (FMCReporting)

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LAS VEGAS – Emerging data support the practice of switching biologic agents after an initial biologic therapy fails in psoriasis, and even the possibility of rotating back to a biologic that didn’t work previously, according to Dr. Francisco Kerdel, director of the dermatology inpatient service at the University of Miami Hospital.

In one recent series of 747 psoriasis patients on biologics, the 4-year drug response was in the range of 40% for etanercept or adalimumab and 70% for infliximab (Br. J. Dermatol. 2011;164:1091-6). "Thus, there is a logical need for ‘switching’ [biologic] therapy," he noted at the SDEF Las Vegas Dermatology Seminar.

The reasons for treatment failure are not known. Antibody production has been suspected of playing a role, but the presence of antibodies seldom correlates with clinical response, he said.

In a 16-week, open-label trial, a Physician Global Assessment (PGA) rating of "clear" or "minimal" was achieved in 52% of 152 patients who had chronic plaque psoriasis and were switched to adalimumab following suboptimal responses to etanercept, methotrexate, or phototherapy (J. Am. Acad. Dermatol. 2011;64:671-81).

In the PSUNRISE study (a prospective, multicenter, open-label study of infliximab treatment in 215 patients with plaque psoriasis who had had a prior inadequate response to etanercept), a PGA score of 0 (clear) or 1 was achieved by week 10 in 65% of the 179 completers, and 60% remained at PGA 0-1 in weeks 14-26. These data have been submitted for publication, according to Dr. Kerdel, who was one of the study authors.

Good to excellent responses were achieved with ustekinumab at doses of either 45 mg or 90 mg, depending on body weight, in 9 of 11 psoriasis patients who had experienced treatment failures on multiple biologics, including infliximab (11 patients), etanercept (10), efalizumab (9), adalimumab (7), and golimumab (3) (Int. J. Dermatol. 2011;50:478-82).

There is even some evidence that patients can return with success to a biologic therapy that they had previously failed.

Dr. Kerdel and his associates have conducted an open-label study of etanercept re-treatment in 20 patients with moderate to severe psoriasis (defined as a PGA score of 3 or greater) who had had prior therapy with etanercept for a minimum of 6 months but had discontinued it because of loss of efficacy. The 10 men and 10 women had an average age of 49 years, with an average of 3.5 years between stopping and restarting etanercept. Five patients withdrew and were classified as treatment failures, regardless of the reason for withdrawal.

The proportion of responders (defined as those achieving a PGA score of 0 or 1) was 5 of 20 (25%) at week 8, and 8 of 20 (40%) at week 12. Body weight appeared to play a role. Among the 14 patients who had a PGA score of 2 or less at week 12, the average weight was 198.4 pounds, compared with 217.6 pounds for the 6 who did not have that response.

These preliminary findings suggest that rotational therapy is possible, at least in cases of secondary failure with etanercept. Rotational therapy may be possible with other biologics as well, but further studies are necessary, Dr. Kerdel concluded.

It had been thought that this practice would be of limited value because of the development of circulating antibodies, which were found in one study to range in prevalence from 5% of rheumatoid arthritis patients on ustekinumab to 87% of those treated with adalimumab (Clin. Rev. Allergy Immunol. 2010;38:82-9). However, the therapeutic relevance of non-neutralizing vs. neutralizing antibodies is currently unknown, he said.

In a recent prospective cohort study of 272 RA patients treated with adalimumab, 28% had developed antiadalimumab antibodies, which appeared within the first 28 weeks of treatment in two-thirds of them. Over 3 years of follow-up, 38% of the patients with antibodies discontinued adalimumab therapy because of treatment failure, compared with 14% of those who did not develop antibodies. Minimal disease activity was achieved in 48% without antibodies, compared with 13% who had antibodies (JAMA 2011;305:1460-8).

And in a retrospective observational study of 97 psoriasis patients who had been treated with anti–tumor necrosis factor–alpha therapy (60 on a first agent, 22 having failed one agent, 9 having failed two agents, and 6 having failed all three agents), antinuclear antibodies developed in 17%, 54%, 78% and 83%, respectively (Br. J. Dermatol. 2010;162:780-5). "So, antibodies do seem to play a role" in treatment failure, Dr. Kerdel commented.

Dr. Kerdel disclosed that he has been involved in clinical studies, has participated in advisory boards, and is a speaker for Amgen, Abbott, Janssen, Genentech, Astellas, Stiefel, Pfizer, Merck, Novartis, Eisai, and Celgene. SDEF and this news organization are owned by Elsevier.

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LAS VEGAS – Emerging data support the practice of switching biologic agents after an initial biologic therapy fails in psoriasis, and even the possibility of rotating back to a biologic that didn’t work previously, according to Dr. Francisco Kerdel, director of the dermatology inpatient service at the University of Miami Hospital.

In one recent series of 747 psoriasis patients on biologics, the 4-year drug response was in the range of 40% for etanercept or adalimumab and 70% for infliximab (Br. J. Dermatol. 2011;164:1091-6). "Thus, there is a logical need for ‘switching’ [biologic] therapy," he noted at the SDEF Las Vegas Dermatology Seminar.

The reasons for treatment failure are not known. Antibody production has been suspected of playing a role, but the presence of antibodies seldom correlates with clinical response, he said.

In a 16-week, open-label trial, a Physician Global Assessment (PGA) rating of "clear" or "minimal" was achieved in 52% of 152 patients who had chronic plaque psoriasis and were switched to adalimumab following suboptimal responses to etanercept, methotrexate, or phototherapy (J. Am. Acad. Dermatol. 2011;64:671-81).

In the PSUNRISE study (a prospective, multicenter, open-label study of infliximab treatment in 215 patients with plaque psoriasis who had had a prior inadequate response to etanercept), a PGA score of 0 (clear) or 1 was achieved by week 10 in 65% of the 179 completers, and 60% remained at PGA 0-1 in weeks 14-26. These data have been submitted for publication, according to Dr. Kerdel, who was one of the study authors.

Good to excellent responses were achieved with ustekinumab at doses of either 45 mg or 90 mg, depending on body weight, in 9 of 11 psoriasis patients who had experienced treatment failures on multiple biologics, including infliximab (11 patients), etanercept (10), efalizumab (9), adalimumab (7), and golimumab (3) (Int. J. Dermatol. 2011;50:478-82).

There is even some evidence that patients can return with success to a biologic therapy that they had previously failed.

Dr. Kerdel and his associates have conducted an open-label study of etanercept re-treatment in 20 patients with moderate to severe psoriasis (defined as a PGA score of 3 or greater) who had had prior therapy with etanercept for a minimum of 6 months but had discontinued it because of loss of efficacy. The 10 men and 10 women had an average age of 49 years, with an average of 3.5 years between stopping and restarting etanercept. Five patients withdrew and were classified as treatment failures, regardless of the reason for withdrawal.

The proportion of responders (defined as those achieving a PGA score of 0 or 1) was 5 of 20 (25%) at week 8, and 8 of 20 (40%) at week 12. Body weight appeared to play a role. Among the 14 patients who had a PGA score of 2 or less at week 12, the average weight was 198.4 pounds, compared with 217.6 pounds for the 6 who did not have that response.

These preliminary findings suggest that rotational therapy is possible, at least in cases of secondary failure with etanercept. Rotational therapy may be possible with other biologics as well, but further studies are necessary, Dr. Kerdel concluded.

It had been thought that this practice would be of limited value because of the development of circulating antibodies, which were found in one study to range in prevalence from 5% of rheumatoid arthritis patients on ustekinumab to 87% of those treated with adalimumab (Clin. Rev. Allergy Immunol. 2010;38:82-9). However, the therapeutic relevance of non-neutralizing vs. neutralizing antibodies is currently unknown, he said.

In a recent prospective cohort study of 272 RA patients treated with adalimumab, 28% had developed antiadalimumab antibodies, which appeared within the first 28 weeks of treatment in two-thirds of them. Over 3 years of follow-up, 38% of the patients with antibodies discontinued adalimumab therapy because of treatment failure, compared with 14% of those who did not develop antibodies. Minimal disease activity was achieved in 48% without antibodies, compared with 13% who had antibodies (JAMA 2011;305:1460-8).

And in a retrospective observational study of 97 psoriasis patients who had been treated with anti–tumor necrosis factor–alpha therapy (60 on a first agent, 22 having failed one agent, 9 having failed two agents, and 6 having failed all three agents), antinuclear antibodies developed in 17%, 54%, 78% and 83%, respectively (Br. J. Dermatol. 2010;162:780-5). "So, antibodies do seem to play a role" in treatment failure, Dr. Kerdel commented.

Dr. Kerdel disclosed that he has been involved in clinical studies, has participated in advisory boards, and is a speaker for Amgen, Abbott, Janssen, Genentech, Astellas, Stiefel, Pfizer, Merck, Novartis, Eisai, and Celgene. SDEF and this news organization are owned by Elsevier.

LAS VEGAS – Emerging data support the practice of switching biologic agents after an initial biologic therapy fails in psoriasis, and even the possibility of rotating back to a biologic that didn’t work previously, according to Dr. Francisco Kerdel, director of the dermatology inpatient service at the University of Miami Hospital.

In one recent series of 747 psoriasis patients on biologics, the 4-year drug response was in the range of 40% for etanercept or adalimumab and 70% for infliximab (Br. J. Dermatol. 2011;164:1091-6). "Thus, there is a logical need for ‘switching’ [biologic] therapy," he noted at the SDEF Las Vegas Dermatology Seminar.

The reasons for treatment failure are not known. Antibody production has been suspected of playing a role, but the presence of antibodies seldom correlates with clinical response, he said.

In a 16-week, open-label trial, a Physician Global Assessment (PGA) rating of "clear" or "minimal" was achieved in 52% of 152 patients who had chronic plaque psoriasis and were switched to adalimumab following suboptimal responses to etanercept, methotrexate, or phototherapy (J. Am. Acad. Dermatol. 2011;64:671-81).

In the PSUNRISE study (a prospective, multicenter, open-label study of infliximab treatment in 215 patients with plaque psoriasis who had had a prior inadequate response to etanercept), a PGA score of 0 (clear) or 1 was achieved by week 10 in 65% of the 179 completers, and 60% remained at PGA 0-1 in weeks 14-26. These data have been submitted for publication, according to Dr. Kerdel, who was one of the study authors.

Good to excellent responses were achieved with ustekinumab at doses of either 45 mg or 90 mg, depending on body weight, in 9 of 11 psoriasis patients who had experienced treatment failures on multiple biologics, including infliximab (11 patients), etanercept (10), efalizumab (9), adalimumab (7), and golimumab (3) (Int. J. Dermatol. 2011;50:478-82).

There is even some evidence that patients can return with success to a biologic therapy that they had previously failed.

Dr. Kerdel and his associates have conducted an open-label study of etanercept re-treatment in 20 patients with moderate to severe psoriasis (defined as a PGA score of 3 or greater) who had had prior therapy with etanercept for a minimum of 6 months but had discontinued it because of loss of efficacy. The 10 men and 10 women had an average age of 49 years, with an average of 3.5 years between stopping and restarting etanercept. Five patients withdrew and were classified as treatment failures, regardless of the reason for withdrawal.

The proportion of responders (defined as those achieving a PGA score of 0 or 1) was 5 of 20 (25%) at week 8, and 8 of 20 (40%) at week 12. Body weight appeared to play a role. Among the 14 patients who had a PGA score of 2 or less at week 12, the average weight was 198.4 pounds, compared with 217.6 pounds for the 6 who did not have that response.

These preliminary findings suggest that rotational therapy is possible, at least in cases of secondary failure with etanercept. Rotational therapy may be possible with other biologics as well, but further studies are necessary, Dr. Kerdel concluded.

It had been thought that this practice would be of limited value because of the development of circulating antibodies, which were found in one study to range in prevalence from 5% of rheumatoid arthritis patients on ustekinumab to 87% of those treated with adalimumab (Clin. Rev. Allergy Immunol. 2010;38:82-9). However, the therapeutic relevance of non-neutralizing vs. neutralizing antibodies is currently unknown, he said.

In a recent prospective cohort study of 272 RA patients treated with adalimumab, 28% had developed antiadalimumab antibodies, which appeared within the first 28 weeks of treatment in two-thirds of them. Over 3 years of follow-up, 38% of the patients with antibodies discontinued adalimumab therapy because of treatment failure, compared with 14% of those who did not develop antibodies. Minimal disease activity was achieved in 48% without antibodies, compared with 13% who had antibodies (JAMA 2011;305:1460-8).

And in a retrospective observational study of 97 psoriasis patients who had been treated with anti–tumor necrosis factor–alpha therapy (60 on a first agent, 22 having failed one agent, 9 having failed two agents, and 6 having failed all three agents), antinuclear antibodies developed in 17%, 54%, 78% and 83%, respectively (Br. J. Dermatol. 2010;162:780-5). "So, antibodies do seem to play a role" in treatment failure, Dr. Kerdel commented.

Dr. Kerdel disclosed that he has been involved in clinical studies, has participated in advisory boards, and is a speaker for Amgen, Abbott, Janssen, Genentech, Astellas, Stiefel, Pfizer, Merck, Novartis, Eisai, and Celgene. SDEF and this news organization are owned by Elsevier.

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Laser and Light Devices for Psoriasis, Part 1: Excimer Laser and Phototherapy

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Laser and Light Devices for Psoriasis, Part 1: Excimer Laser and Phototherapy
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For Etanercept Nonresponders, Switch or Escalate?

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LISBON – Switching to adalimumab in psoriasis patients who are not responding adequately to etanercept is significantly more cost effective than escalating the etanercept dose, an analysis has shown.

During the first 6 months following the decision to either switch or escalate, 372 etaner cept (Enbrel) dose escalators incurred an adjusted average of $2,451 more in incremental total health care costs than the $12,943 average in 728 patients who instead switched to adalimumab (Humira), Dr. Kim A. Papp reported at the annual congress of the European Academy of Dermatology and Venereology.

Dr. Kim Papp

Driving the markedly higher total costs in the etanercept dose escalation group was their significantly greater utilization of both inpatient and outpatient services, including urgent care. Also, psoriasis drug costs, which accounted for 75% of total health care costs, were significantly lower in the group that switched to adalimumab. The cost of adalimumab over the course of 6 months averaged an adjusted $1,573 less per patient than etanercept therapy, according to Dr. Papp, director of research at Probity Medical Research in Waterloo, Ont.

Subjects for this analysis were drawn from the MarketScan and Ingenix Impact National Managed Care databases. All participants were etanercept-treated psoriasis patients with full health care utilization and cost data accessible for the 6 months immediately before the escalate or switch decision and for 6 months afterward.

The two groups had nearly identical total health care costs during the baseline first 6 months: an average of $11,264 in patients prior to etanercept dose escalation, compared with $11,628 in those who went on to switch to adalimumab. The two groups were similar in age, sex, and comorbidities. However, the switchers appeared to have more severe psoriasis. They had a greater prevalence of psoriatic arthritis. Moreover, during the baseline period, they had significantly more outpatient visits, and 41% of them used antimicrobial medications, compared with 33% in the dose escalation group. These potential confounders were adjusted for in the analysis.

This switch or escalate decision point is a common but underappreciated aspect of etanercept therapy. Prior studies have established that 30%-50% of psoriasis patients placed on etanercept require a dosing increase during the first year of therapy, according to Dr. Papp.

This study was funded by Abbott Laboratories. Dr. Papp disclosed that he serves as an adviser to Abbott as well as numerous other pharmaceutical companies funding psoriasis research.

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LISBON – Switching to adalimumab in psoriasis patients who are not responding adequately to etanercept is significantly more cost effective than escalating the etanercept dose, an analysis has shown.

During the first 6 months following the decision to either switch or escalate, 372 etaner cept (Enbrel) dose escalators incurred an adjusted average of $2,451 more in incremental total health care costs than the $12,943 average in 728 patients who instead switched to adalimumab (Humira), Dr. Kim A. Papp reported at the annual congress of the European Academy of Dermatology and Venereology.

Dr. Kim Papp

Driving the markedly higher total costs in the etanercept dose escalation group was their significantly greater utilization of both inpatient and outpatient services, including urgent care. Also, psoriasis drug costs, which accounted for 75% of total health care costs, were significantly lower in the group that switched to adalimumab. The cost of adalimumab over the course of 6 months averaged an adjusted $1,573 less per patient than etanercept therapy, according to Dr. Papp, director of research at Probity Medical Research in Waterloo, Ont.

Subjects for this analysis were drawn from the MarketScan and Ingenix Impact National Managed Care databases. All participants were etanercept-treated psoriasis patients with full health care utilization and cost data accessible for the 6 months immediately before the escalate or switch decision and for 6 months afterward.

The two groups had nearly identical total health care costs during the baseline first 6 months: an average of $11,264 in patients prior to etanercept dose escalation, compared with $11,628 in those who went on to switch to adalimumab. The two groups were similar in age, sex, and comorbidities. However, the switchers appeared to have more severe psoriasis. They had a greater prevalence of psoriatic arthritis. Moreover, during the baseline period, they had significantly more outpatient visits, and 41% of them used antimicrobial medications, compared with 33% in the dose escalation group. These potential confounders were adjusted for in the analysis.

This switch or escalate decision point is a common but underappreciated aspect of etanercept therapy. Prior studies have established that 30%-50% of psoriasis patients placed on etanercept require a dosing increase during the first year of therapy, according to Dr. Papp.

This study was funded by Abbott Laboratories. Dr. Papp disclosed that he serves as an adviser to Abbott as well as numerous other pharmaceutical companies funding psoriasis research.

LISBON – Switching to adalimumab in psoriasis patients who are not responding adequately to etanercept is significantly more cost effective than escalating the etanercept dose, an analysis has shown.

During the first 6 months following the decision to either switch or escalate, 372 etaner cept (Enbrel) dose escalators incurred an adjusted average of $2,451 more in incremental total health care costs than the $12,943 average in 728 patients who instead switched to adalimumab (Humira), Dr. Kim A. Papp reported at the annual congress of the European Academy of Dermatology and Venereology.

Dr. Kim Papp

Driving the markedly higher total costs in the etanercept dose escalation group was their significantly greater utilization of both inpatient and outpatient services, including urgent care. Also, psoriasis drug costs, which accounted for 75% of total health care costs, were significantly lower in the group that switched to adalimumab. The cost of adalimumab over the course of 6 months averaged an adjusted $1,573 less per patient than etanercept therapy, according to Dr. Papp, director of research at Probity Medical Research in Waterloo, Ont.

Subjects for this analysis were drawn from the MarketScan and Ingenix Impact National Managed Care databases. All participants were etanercept-treated psoriasis patients with full health care utilization and cost data accessible for the 6 months immediately before the escalate or switch decision and for 6 months afterward.

The two groups had nearly identical total health care costs during the baseline first 6 months: an average of $11,264 in patients prior to etanercept dose escalation, compared with $11,628 in those who went on to switch to adalimumab. The two groups were similar in age, sex, and comorbidities. However, the switchers appeared to have more severe psoriasis. They had a greater prevalence of psoriatic arthritis. Moreover, during the baseline period, they had significantly more outpatient visits, and 41% of them used antimicrobial medications, compared with 33% in the dose escalation group. These potential confounders were adjusted for in the analysis.

This switch or escalate decision point is a common but underappreciated aspect of etanercept therapy. Prior studies have established that 30%-50% of psoriasis patients placed on etanercept require a dosing increase during the first year of therapy, according to Dr. Papp.

This study was funded by Abbott Laboratories. Dr. Papp disclosed that he serves as an adviser to Abbott as well as numerous other pharmaceutical companies funding psoriasis research.

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Major Finding: During the first 6 months after psoriasis patients were switched from etanercept to adalimumab because of an inadequate response to etanercept, total health care costs averaged $2,451 less than in nonresponders whose etanercept dose was escalated.

Data Source: Analysis of administrative databases containing complete data on health care costs and resource utilization for 728 switchers and 372 dose escalators.

Disclosures: The study was sponsored by Abbott Laboratories. Dr. Papp disclosed that he serves as an adviser to Abbott as well as numerous other pharmaceutical companies funding psoriasis research.

FDA Advises Caution When IV Methotrexate-PPI Used Together

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Administration of a proton pump inhibitor with intravenous methotrexate may result in elevated serum levels of methotrexate, with toxic consequences, according to a statement issued on Dec. 21 by the Food and Drug Administration.

Case reports and published pharmacokinetic studies "suggest" that concomitant use of proton pump inhibitors (PPIs) with methotrexate, primarily high dose methotrexate, "may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities," the statement says.

In two cases, elimination of methotrexate was delayed when it was administered with a PPI but not when it was administered with ranitidine, the statement says. However, no formal drug interaction studies of methotrexate and ranitidine have been conducted, the statement adds. Ranitidine, a histamine H2-receptor antagonist used for similar indications as PPIs, is marketed as Zantac and is available in generic formulations.

The FDA is recommending that clinicians "use caution when administering high-dose methotrexate to patients receiving proton pump inhibitor therapy," and this information has been added to the warnings section of the label for methotrexate.

Methotrexate, classified as an antimetabolite, is approved to treat neoplastic diseases, severe psoriasis, and rheumatoid arthritis. PPIs are widely used drugs used to treat several conditions, including gastroesophageal reflux disease. The PPIs available in the United States include omeprazole (Prilosec), esomeprazole (Nexium), lansoprazole (Prevacid), and pantoprazole (Protonix), as well as several generic and over-the-counter formulations. The FDA statement did not say that the warning is being added to the PPI labels.

Serious adverse events associated with these and other drugs should be reported to the FDA’s MedWatch program at 800-332-1088.

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Administration of a proton pump inhibitor with intravenous methotrexate may result in elevated serum levels of methotrexate, with toxic consequences, according to a statement issued on Dec. 21 by the Food and Drug Administration.

Case reports and published pharmacokinetic studies "suggest" that concomitant use of proton pump inhibitors (PPIs) with methotrexate, primarily high dose methotrexate, "may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities," the statement says.

In two cases, elimination of methotrexate was delayed when it was administered with a PPI but not when it was administered with ranitidine, the statement says. However, no formal drug interaction studies of methotrexate and ranitidine have been conducted, the statement adds. Ranitidine, a histamine H2-receptor antagonist used for similar indications as PPIs, is marketed as Zantac and is available in generic formulations.

The FDA is recommending that clinicians "use caution when administering high-dose methotrexate to patients receiving proton pump inhibitor therapy," and this information has been added to the warnings section of the label for methotrexate.

Methotrexate, classified as an antimetabolite, is approved to treat neoplastic diseases, severe psoriasis, and rheumatoid arthritis. PPIs are widely used drugs used to treat several conditions, including gastroesophageal reflux disease. The PPIs available in the United States include omeprazole (Prilosec), esomeprazole (Nexium), lansoprazole (Prevacid), and pantoprazole (Protonix), as well as several generic and over-the-counter formulations. The FDA statement did not say that the warning is being added to the PPI labels.

Serious adverse events associated with these and other drugs should be reported to the FDA’s MedWatch program at 800-332-1088.

Administration of a proton pump inhibitor with intravenous methotrexate may result in elevated serum levels of methotrexate, with toxic consequences, according to a statement issued on Dec. 21 by the Food and Drug Administration.

Case reports and published pharmacokinetic studies "suggest" that concomitant use of proton pump inhibitors (PPIs) with methotrexate, primarily high dose methotrexate, "may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities," the statement says.

In two cases, elimination of methotrexate was delayed when it was administered with a PPI but not when it was administered with ranitidine, the statement says. However, no formal drug interaction studies of methotrexate and ranitidine have been conducted, the statement adds. Ranitidine, a histamine H2-receptor antagonist used for similar indications as PPIs, is marketed as Zantac and is available in generic formulations.

The FDA is recommending that clinicians "use caution when administering high-dose methotrexate to patients receiving proton pump inhibitor therapy," and this information has been added to the warnings section of the label for methotrexate.

Methotrexate, classified as an antimetabolite, is approved to treat neoplastic diseases, severe psoriasis, and rheumatoid arthritis. PPIs are widely used drugs used to treat several conditions, including gastroesophageal reflux disease. The PPIs available in the United States include omeprazole (Prilosec), esomeprazole (Nexium), lansoprazole (Prevacid), and pantoprazole (Protonix), as well as several generic and over-the-counter formulations. The FDA statement did not say that the warning is being added to the PPI labels.

Serious adverse events associated with these and other drugs should be reported to the FDA’s MedWatch program at 800-332-1088.

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Metabolic Syndrome Strikes Hard in Psoriatic Patients

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CHICAGO – Metabolic syndrome is significantly more common in patients with psoriatic arthritis than in those with rheumatoid arthritis, based on data from nearly 2,000 adults.

Previous studies have suggested that metabolic syndrome is associated with "a state of chronic, low-grade inflammation," said Dr. Asena Bahce-Altuntas of Albert Einstein College of Medicine in New York.

"Since psoriatic arthritis [PsA] is characterized by inflammation of both skin and joints, we may be underestimating this cardiovascular risk in PsA," she said at the annual meeting of the American College of Rheumatology.

To compare the prevalence of metabolic syndrome in patients with PsA versus rheumatoid arthritis (RA), Dr. Bahce-Altuntas and her colleagues used data from the Consortium of Rheumatology Researchers of North America (CORRONA) registry, a prospective, observational cohort including 4,014 patients with PsA and 25,976 patients with RA in academic and private practices throughout the United States. Lipid profile data were available for 1,956 patients from the CORRONA registry: 294 with PsA and 1,662 with RA.

Overall, 27% of PsA patients met criteria for metabolic syndrome, compared with 19% of RA patients. In addition, several specific components of metabolic syndrome were significantly more common in PsA patients.

In particular, significantly more PsA patients than RA patients had triglycerides greater than 150 mg/dL (38% vs. 28%).

Significantly more PsA patients than RA patients were male (54% vs. 23%, respectively), and the mean age was significantly greater in RA patients than in PsA patients (62 years vs. 56 years, respectively). However, after age, sex, and ethnicity were controlled for, the odds of metabolic syndrome remained significantly higher for PsA patients (odds ratio, 1.44).

Metabolic syndrome was defined as a body mass index greater than 30 kg/m2 and any two of the following criteria: triglycerides greater than 150 mg/dL, HDL less than 40 mg/dL for men or less than 50 mg/dL for women, a diagnosis of hypertension, or a diagnosis of diabetes.

In a subanalysis of obese patients (133 PsA patients and 654 RA patients with a BMI greater than 30), the prevalence of metabolic syndrome remained significantly higher in PsA patients (60%) than in RA patients (49%), as did the prevalence of patients with triglycerides greater than 150 mg/dL (51% vs. 39%).

The study was limited by the relatively small sample of PsA patients, and by the modified metabolic syndrome criteria that may have underestimated the prevalence of metabolic syndrome in both groups, said Dr. Bahce-Altuntas.

However, the results suggest that metabolic syndrome and its components are significantly more common in PsA than in RA. "High triglycerides appear to drive the estimated increase in risk of metabolic syndrome in PsA vs. RA," she noted.

The combination of skin and joint inflammation in PsA may contribute to the increased frequency of metabolic syndrome in these patients, but more research is needed, Dr. Bahce-Altuntas said.

Meanwhile, "more intensive interventions to modify these risk factors are warranted in PsA patients in order to reduce cardiovascular morbidity and mortality," she said.

The following companies have supported CORRONA through contracted subscriptions over the past 2 years: Abbott, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, Genentech, Lilly, Pfizer, and Roche. Dr. Bahce-Altuntas had no financial conflicts to disclose.

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CHICAGO – Metabolic syndrome is significantly more common in patients with psoriatic arthritis than in those with rheumatoid arthritis, based on data from nearly 2,000 adults.

Previous studies have suggested that metabolic syndrome is associated with "a state of chronic, low-grade inflammation," said Dr. Asena Bahce-Altuntas of Albert Einstein College of Medicine in New York.

"Since psoriatic arthritis [PsA] is characterized by inflammation of both skin and joints, we may be underestimating this cardiovascular risk in PsA," she said at the annual meeting of the American College of Rheumatology.

To compare the prevalence of metabolic syndrome in patients with PsA versus rheumatoid arthritis (RA), Dr. Bahce-Altuntas and her colleagues used data from the Consortium of Rheumatology Researchers of North America (CORRONA) registry, a prospective, observational cohort including 4,014 patients with PsA and 25,976 patients with RA in academic and private practices throughout the United States. Lipid profile data were available for 1,956 patients from the CORRONA registry: 294 with PsA and 1,662 with RA.

Overall, 27% of PsA patients met criteria for metabolic syndrome, compared with 19% of RA patients. In addition, several specific components of metabolic syndrome were significantly more common in PsA patients.

In particular, significantly more PsA patients than RA patients had triglycerides greater than 150 mg/dL (38% vs. 28%).

Significantly more PsA patients than RA patients were male (54% vs. 23%, respectively), and the mean age was significantly greater in RA patients than in PsA patients (62 years vs. 56 years, respectively). However, after age, sex, and ethnicity were controlled for, the odds of metabolic syndrome remained significantly higher for PsA patients (odds ratio, 1.44).

Metabolic syndrome was defined as a body mass index greater than 30 kg/m2 and any two of the following criteria: triglycerides greater than 150 mg/dL, HDL less than 40 mg/dL for men or less than 50 mg/dL for women, a diagnosis of hypertension, or a diagnosis of diabetes.

In a subanalysis of obese patients (133 PsA patients and 654 RA patients with a BMI greater than 30), the prevalence of metabolic syndrome remained significantly higher in PsA patients (60%) than in RA patients (49%), as did the prevalence of patients with triglycerides greater than 150 mg/dL (51% vs. 39%).

The study was limited by the relatively small sample of PsA patients, and by the modified metabolic syndrome criteria that may have underestimated the prevalence of metabolic syndrome in both groups, said Dr. Bahce-Altuntas.

However, the results suggest that metabolic syndrome and its components are significantly more common in PsA than in RA. "High triglycerides appear to drive the estimated increase in risk of metabolic syndrome in PsA vs. RA," she noted.

The combination of skin and joint inflammation in PsA may contribute to the increased frequency of metabolic syndrome in these patients, but more research is needed, Dr. Bahce-Altuntas said.

Meanwhile, "more intensive interventions to modify these risk factors are warranted in PsA patients in order to reduce cardiovascular morbidity and mortality," she said.

The following companies have supported CORRONA through contracted subscriptions over the past 2 years: Abbott, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, Genentech, Lilly, Pfizer, and Roche. Dr. Bahce-Altuntas had no financial conflicts to disclose.

CHICAGO – Metabolic syndrome is significantly more common in patients with psoriatic arthritis than in those with rheumatoid arthritis, based on data from nearly 2,000 adults.

Previous studies have suggested that metabolic syndrome is associated with "a state of chronic, low-grade inflammation," said Dr. Asena Bahce-Altuntas of Albert Einstein College of Medicine in New York.

"Since psoriatic arthritis [PsA] is characterized by inflammation of both skin and joints, we may be underestimating this cardiovascular risk in PsA," she said at the annual meeting of the American College of Rheumatology.

To compare the prevalence of metabolic syndrome in patients with PsA versus rheumatoid arthritis (RA), Dr. Bahce-Altuntas and her colleagues used data from the Consortium of Rheumatology Researchers of North America (CORRONA) registry, a prospective, observational cohort including 4,014 patients with PsA and 25,976 patients with RA in academic and private practices throughout the United States. Lipid profile data were available for 1,956 patients from the CORRONA registry: 294 with PsA and 1,662 with RA.

Overall, 27% of PsA patients met criteria for metabolic syndrome, compared with 19% of RA patients. In addition, several specific components of metabolic syndrome were significantly more common in PsA patients.

In particular, significantly more PsA patients than RA patients had triglycerides greater than 150 mg/dL (38% vs. 28%).

Significantly more PsA patients than RA patients were male (54% vs. 23%, respectively), and the mean age was significantly greater in RA patients than in PsA patients (62 years vs. 56 years, respectively). However, after age, sex, and ethnicity were controlled for, the odds of metabolic syndrome remained significantly higher for PsA patients (odds ratio, 1.44).

Metabolic syndrome was defined as a body mass index greater than 30 kg/m2 and any two of the following criteria: triglycerides greater than 150 mg/dL, HDL less than 40 mg/dL for men or less than 50 mg/dL for women, a diagnosis of hypertension, or a diagnosis of diabetes.

In a subanalysis of obese patients (133 PsA patients and 654 RA patients with a BMI greater than 30), the prevalence of metabolic syndrome remained significantly higher in PsA patients (60%) than in RA patients (49%), as did the prevalence of patients with triglycerides greater than 150 mg/dL (51% vs. 39%).

The study was limited by the relatively small sample of PsA patients, and by the modified metabolic syndrome criteria that may have underestimated the prevalence of metabolic syndrome in both groups, said Dr. Bahce-Altuntas.

However, the results suggest that metabolic syndrome and its components are significantly more common in PsA than in RA. "High triglycerides appear to drive the estimated increase in risk of metabolic syndrome in PsA vs. RA," she noted.

The combination of skin and joint inflammation in PsA may contribute to the increased frequency of metabolic syndrome in these patients, but more research is needed, Dr. Bahce-Altuntas said.

Meanwhile, "more intensive interventions to modify these risk factors are warranted in PsA patients in order to reduce cardiovascular morbidity and mortality," she said.

The following companies have supported CORRONA through contracted subscriptions over the past 2 years: Abbott, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, Genentech, Lilly, Pfizer, and Roche. Dr. Bahce-Altuntas had no financial conflicts to disclose.

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Major Finding: Metabolic syndrome is significantly more common in psoriatic arthritis patients than in rheumatoid arthritis patients (27% vs. 19%).

Data Source: Data from 1,956 adults in the CORRONA registry: 294 with PsA and 1,662 with RA.

Disclosures: The following companies have supported CORRONA through contracted subscriptions over the past 2 years: Abbott, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, Genentech, Lilly, Pfizer, and Roche. Dr. Bahce-Altuntas had no financial conflicts to disclose.

Pulsed Dye Laser Zaps Nail Psoriasis in Small Study

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LISBON – Pulsed dye laser therapy may be an attractive new option for treating nail psoriasis, according to Dr. Veronique Blatiere.

Nail psoriasis is challenging to treat because the psoriatic disease process damages the nails while they are still being formed. But Turkish investigators have reported positive results with three once-monthly pulsed dye laser (PDL) treatment sessions in a small uncontrolled patient series, Dr. Blatiere reported at the annual congress of the European Academy of Dermatology and Venereology.

Dr. Yasemin Oram and coworkers at the American Hospital in Istanbul, Turkey, reported on five patients with nail psoriasis treated using PDL. The laser therapy was applied at 595 nm with a pulse duration of 1.5 milliseconds, a beam diameter of 7 mm, and an energy fluence of 8-10 J/cm2. A treatment session was continued until a purple discoloration appeared.

The hypothesized mechanism of action involves destruction of the abnormal vasculature, according to the investigators (Dermatol. Surg. 2010;36:377-81).

Nail bed lesions, particularly onycholysis and subungual hyperkeratosis, responded to PDL better than did nail matrix lesions. After three treatment sessions, the average Nail Psoriasis Severity Index (NAPSI) score for nail bed lesions dropped from 14.8 to 8.

While the Turkish report is certainly encouraging, it should be viewed as a proof of concept pilot study, said Dr. Blatiere of Saint Eloi University Hospital in Montpellier, France. It needs confirmation with larger numbers of patients, a control arm, and blinded investigator assessment.

Dr. Blatiere noted that interest has been mounting in evaluating biologic agents for nail psoriasis. Favorable clinical experiences, albeit all of them open label, have recently been reported for the use of infliximab (J. Eur. Acad. Dermatol. Venereol. 2011;25:549-53); adalimumab (J. Eur. Acad. Dermatol. Venereol. 2010;24:530-4); ustekinumab (Arch. Dermatol. 2010;146:1315-6); and etanercept for nail psoriasis (J. Eur. Acad. Dermatol. Venereol. 2009;23:896-904).

But important questions remain about biologics for nail psoriasis, such as the appropriate duration of treatment, length of response, and whether they will help prevent psoriatic arthritis. And then there are the still incompletely answered questions regarding the long-term safety of the agents, as well as the issue of their considerable expense, Dr. Blatiere said.

She reported having no relevant financial disclosures.

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LISBON – Pulsed dye laser therapy may be an attractive new option for treating nail psoriasis, according to Dr. Veronique Blatiere.

Nail psoriasis is challenging to treat because the psoriatic disease process damages the nails while they are still being formed. But Turkish investigators have reported positive results with three once-monthly pulsed dye laser (PDL) treatment sessions in a small uncontrolled patient series, Dr. Blatiere reported at the annual congress of the European Academy of Dermatology and Venereology.

Dr. Yasemin Oram and coworkers at the American Hospital in Istanbul, Turkey, reported on five patients with nail psoriasis treated using PDL. The laser therapy was applied at 595 nm with a pulse duration of 1.5 milliseconds, a beam diameter of 7 mm, and an energy fluence of 8-10 J/cm2. A treatment session was continued until a purple discoloration appeared.

The hypothesized mechanism of action involves destruction of the abnormal vasculature, according to the investigators (Dermatol. Surg. 2010;36:377-81).

Nail bed lesions, particularly onycholysis and subungual hyperkeratosis, responded to PDL better than did nail matrix lesions. After three treatment sessions, the average Nail Psoriasis Severity Index (NAPSI) score for nail bed lesions dropped from 14.8 to 8.

While the Turkish report is certainly encouraging, it should be viewed as a proof of concept pilot study, said Dr. Blatiere of Saint Eloi University Hospital in Montpellier, France. It needs confirmation with larger numbers of patients, a control arm, and blinded investigator assessment.

Dr. Blatiere noted that interest has been mounting in evaluating biologic agents for nail psoriasis. Favorable clinical experiences, albeit all of them open label, have recently been reported for the use of infliximab (J. Eur. Acad. Dermatol. Venereol. 2011;25:549-53); adalimumab (J. Eur. Acad. Dermatol. Venereol. 2010;24:530-4); ustekinumab (Arch. Dermatol. 2010;146:1315-6); and etanercept for nail psoriasis (J. Eur. Acad. Dermatol. Venereol. 2009;23:896-904).

But important questions remain about biologics for nail psoriasis, such as the appropriate duration of treatment, length of response, and whether they will help prevent psoriatic arthritis. And then there are the still incompletely answered questions regarding the long-term safety of the agents, as well as the issue of their considerable expense, Dr. Blatiere said.

She reported having no relevant financial disclosures.

LISBON – Pulsed dye laser therapy may be an attractive new option for treating nail psoriasis, according to Dr. Veronique Blatiere.

Nail psoriasis is challenging to treat because the psoriatic disease process damages the nails while they are still being formed. But Turkish investigators have reported positive results with three once-monthly pulsed dye laser (PDL) treatment sessions in a small uncontrolled patient series, Dr. Blatiere reported at the annual congress of the European Academy of Dermatology and Venereology.

Dr. Yasemin Oram and coworkers at the American Hospital in Istanbul, Turkey, reported on five patients with nail psoriasis treated using PDL. The laser therapy was applied at 595 nm with a pulse duration of 1.5 milliseconds, a beam diameter of 7 mm, and an energy fluence of 8-10 J/cm2. A treatment session was continued until a purple discoloration appeared.

The hypothesized mechanism of action involves destruction of the abnormal vasculature, according to the investigators (Dermatol. Surg. 2010;36:377-81).

Nail bed lesions, particularly onycholysis and subungual hyperkeratosis, responded to PDL better than did nail matrix lesions. After three treatment sessions, the average Nail Psoriasis Severity Index (NAPSI) score for nail bed lesions dropped from 14.8 to 8.

While the Turkish report is certainly encouraging, it should be viewed as a proof of concept pilot study, said Dr. Blatiere of Saint Eloi University Hospital in Montpellier, France. It needs confirmation with larger numbers of patients, a control arm, and blinded investigator assessment.

Dr. Blatiere noted that interest has been mounting in evaluating biologic agents for nail psoriasis. Favorable clinical experiences, albeit all of them open label, have recently been reported for the use of infliximab (J. Eur. Acad. Dermatol. Venereol. 2011;25:549-53); adalimumab (J. Eur. Acad. Dermatol. Venereol. 2010;24:530-4); ustekinumab (Arch. Dermatol. 2010;146:1315-6); and etanercept for nail psoriasis (J. Eur. Acad. Dermatol. Venereol. 2009;23:896-904).

But important questions remain about biologics for nail psoriasis, such as the appropriate duration of treatment, length of response, and whether they will help prevent psoriatic arthritis. And then there are the still incompletely answered questions regarding the long-term safety of the agents, as well as the issue of their considerable expense, Dr. Blatiere said.

She reported having no relevant financial disclosures.

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Pulsed Dye Laser Zaps Nail Psoriasis in Small Study
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Pulsed Dye Laser Zaps Nail Psoriasis in Small Study
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Pulsed dye laser therapy, nail psoriasis, Dr. Veronique Blatiere,
psoriatic disease, nail damage, PDL, the European Academy of Dermatology and Venereology, Dr. Yasemin Oram Nail Psoriasis Severity Index, NAPSI, nail bed lesions
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psoriatic disease, nail damage, PDL, the European Academy of Dermatology and Venereology, Dr. Yasemin Oram Nail Psoriasis Severity Index, NAPSI, nail bed lesions
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EXPERT ANALYSIS FROM THE ANNUAL CONGRESS OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

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Comorbid Psoriasis/Diabetes Carries Hefty Economic Burden

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Comorbid Psoriasis/Diabetes Carries Hefty Economic Burden

LISBON – Psoriasis and diabetes are expensive diseases, and patients with both conditions experience a synergistic increase in health care utilization and costs that is significantly greater than the incremental economic burden imposed by each disease individually.

In other words, patients with comorbid psoriasis and diabetes have more hospitalizations and outpatient visits over the course of a year than would be expected simply from adding together the increased use typical of patients with psoriasis to that of patients with diabetes, compared with health care use by individuals with neither condition, Dr. Frank Zhang reported at the annual congress of the European Academy of Dermatology and Venereology.

This is an observation with important implications for health economics. These are two common diseases. Psoriasis affects 2%-3% of the world’s population, with 260,000 new cases arising per year in the United States alone. Psoriasis predisposes to insulin resistance, and psoriasis patients have a one-third greater risk of diabetes than the general population, noted Dr. Zhang of Celgene Corporation, Summit, N.J.

Because the economic impact of having both diseases had not been addressed, he and his colleagues conducted a retrospective study of 106,128 patient pairs matched for age and gender, one member of each pair having psoriasis and the other free of the disease. The patients were drawn from the Thomson Reuters MarketScan Research Databases for 2004 through June 2009.

Sixteen percent of the psoriasis patients had diabetes, significantly greater than the 13% with diabetes in the control group.

Psoriasis patients with diabetes averaged 17 more hospitalizations per 100 patient-years and 5.8 more outpatient visits per year than did psoriasis patients without diabetes. And patients with diabetes with psoriasis averaged five more hospitalizations per 100 patient-years and 6.3 additional outpatient visits per year, compared with non–psoriatic patients with diabetes.

The most likely explanation for this synergistic health care burden in the dual-diagnosis patient lies in the complexity entailed in managing the two diseases simultaneously, said Dr. Zhang.

Total annual health care costs in patients with both psoriasis and diabetes averaged $19,536, compared with $13,589 for psoriasis-free patients with diabetes and $5,539 in those who had psoriasis but not diabetes.

The study was funded by Celgene, where Dr. Zhang is employed.

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LISBON – Psoriasis and diabetes are expensive diseases, and patients with both conditions experience a synergistic increase in health care utilization and costs that is significantly greater than the incremental economic burden imposed by each disease individually.

In other words, patients with comorbid psoriasis and diabetes have more hospitalizations and outpatient visits over the course of a year than would be expected simply from adding together the increased use typical of patients with psoriasis to that of patients with diabetes, compared with health care use by individuals with neither condition, Dr. Frank Zhang reported at the annual congress of the European Academy of Dermatology and Venereology.

This is an observation with important implications for health economics. These are two common diseases. Psoriasis affects 2%-3% of the world’s population, with 260,000 new cases arising per year in the United States alone. Psoriasis predisposes to insulin resistance, and psoriasis patients have a one-third greater risk of diabetes than the general population, noted Dr. Zhang of Celgene Corporation, Summit, N.J.

Because the economic impact of having both diseases had not been addressed, he and his colleagues conducted a retrospective study of 106,128 patient pairs matched for age and gender, one member of each pair having psoriasis and the other free of the disease. The patients were drawn from the Thomson Reuters MarketScan Research Databases for 2004 through June 2009.

Sixteen percent of the psoriasis patients had diabetes, significantly greater than the 13% with diabetes in the control group.

Psoriasis patients with diabetes averaged 17 more hospitalizations per 100 patient-years and 5.8 more outpatient visits per year than did psoriasis patients without diabetes. And patients with diabetes with psoriasis averaged five more hospitalizations per 100 patient-years and 6.3 additional outpatient visits per year, compared with non–psoriatic patients with diabetes.

The most likely explanation for this synergistic health care burden in the dual-diagnosis patient lies in the complexity entailed in managing the two diseases simultaneously, said Dr. Zhang.

Total annual health care costs in patients with both psoriasis and diabetes averaged $19,536, compared with $13,589 for psoriasis-free patients with diabetes and $5,539 in those who had psoriasis but not diabetes.

The study was funded by Celgene, where Dr. Zhang is employed.

LISBON – Psoriasis and diabetes are expensive diseases, and patients with both conditions experience a synergistic increase in health care utilization and costs that is significantly greater than the incremental economic burden imposed by each disease individually.

In other words, patients with comorbid psoriasis and diabetes have more hospitalizations and outpatient visits over the course of a year than would be expected simply from adding together the increased use typical of patients with psoriasis to that of patients with diabetes, compared with health care use by individuals with neither condition, Dr. Frank Zhang reported at the annual congress of the European Academy of Dermatology and Venereology.

This is an observation with important implications for health economics. These are two common diseases. Psoriasis affects 2%-3% of the world’s population, with 260,000 new cases arising per year in the United States alone. Psoriasis predisposes to insulin resistance, and psoriasis patients have a one-third greater risk of diabetes than the general population, noted Dr. Zhang of Celgene Corporation, Summit, N.J.

Because the economic impact of having both diseases had not been addressed, he and his colleagues conducted a retrospective study of 106,128 patient pairs matched for age and gender, one member of each pair having psoriasis and the other free of the disease. The patients were drawn from the Thomson Reuters MarketScan Research Databases for 2004 through June 2009.

Sixteen percent of the psoriasis patients had diabetes, significantly greater than the 13% with diabetes in the control group.

Psoriasis patients with diabetes averaged 17 more hospitalizations per 100 patient-years and 5.8 more outpatient visits per year than did psoriasis patients without diabetes. And patients with diabetes with psoriasis averaged five more hospitalizations per 100 patient-years and 6.3 additional outpatient visits per year, compared with non–psoriatic patients with diabetes.

The most likely explanation for this synergistic health care burden in the dual-diagnosis patient lies in the complexity entailed in managing the two diseases simultaneously, said Dr. Zhang.

Total annual health care costs in patients with both psoriasis and diabetes averaged $19,536, compared with $13,589 for psoriasis-free patients with diabetes and $5,539 in those who had psoriasis but not diabetes.

The study was funded by Celgene, where Dr. Zhang is employed.

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FROM THE ANNUAL CONGRESS OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

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Major Finding: Psoriasis patients with diabetes averaged 17 more hospitalizations per 100 patient-years and 5.8 more outpatient visits per patient-year than psoriasis patients without diabetes.

Data Source: A retrospective study of 106,128 matched patient pairs, one with psoriasis and the other without.

Disclosures: The study was funded by Celgene, where Dr. Zhang is employed.