Psoriasis

While the availability of coupons can help defray out-of-pocket costs and improve access and adherence to high-cost specialty drugs, it may also result in higher costs to the health system.

Patients used drug coupons to pay for $21.2 million of $35.3 million in out-of-pocket costs, according to an analysis of 265,000 prescriptions worth $911 million in 2013. The coupons generally dropped a patient’s out-of-pocket costs to less than $250 per prescription, a point below which patients were “far less likely” to abandon prescriptions in cases of specialty anti-inflammatory drugs and treatments for multiple sclerosis (Health Affairs 2014;33:1761-9 [doi:10.1377/hlthaff.2014.0497]).

But while the use of coupons demonstrated that the lower cost led to lower prescription abandonment rates, it also allowed patients to circumvent cost-containment measures that pharmacy benefit managers employ.

© Photodisc / ThinkStockPhotos.com

“We found that drug coupons were extremely effective in lowering patients’ costs to less than $50 per prescription, thus eliminating the incentive to select a preferred drug,” wrote Catherine I. Starner, Pharm.D., senior health outcomes researcher at pharmacy benefit manager Prime Therapeutics, and her colleagues.

To control costs at the health system level, tighter controls could be placed on specialty drugs at the pharmacy benefit manager level, according to Dr. Starner and her colleagues. Such controls could include prior authorization or the use of step therapies,as well as excluding coverage of nonpreferred drugs. The latter strategy, however, could make drug access a problem, especially if physicians are not aware of an insurance plan taking these steps.

Excluding specialty drugs “makes the patient responsible for the entire cost of the drug,” the authors noted. “If prescribers are unaware of such exclusions, or if patients require specific therapies, such exclusions may impose considerable costs on patients” and potentially lead to access issues.

[email protected]

While the availability of coupons can help defray out-of-pocket costs and improve access and adherence to high-cost specialty drugs, it may also result in higher costs to the health system.

Patients used drug coupons to pay for $21.2 million of $35.3 million in out-of-pocket costs, according to an analysis of 265,000 prescriptions worth $911 million in 2013. The coupons generally dropped a patient’s out-of-pocket costs to less than $250 per prescription, a point below which patients were “far less likely” to abandon prescriptions in cases of specialty anti-inflammatory drugs and treatments for multiple sclerosis (Health Affairs 2014;33:1761-9 [doi:10.1377/hlthaff.2014.0497]).

But while the use of coupons demonstrated that the lower cost led to lower prescription abandonment rates, it also allowed patients to circumvent cost-containment measures that pharmacy benefit managers employ.

© Photodisc / ThinkStockPhotos.com

“We found that drug coupons were extremely effective in lowering patients’ costs to less than $50 per prescription, thus eliminating the incentive to select a preferred drug,” wrote Catherine I. Starner, Pharm.D., senior health outcomes researcher at pharmacy benefit manager Prime Therapeutics, and her colleagues.

To control costs at the health system level, tighter controls could be placed on specialty drugs at the pharmacy benefit manager level, according to Dr. Starner and her colleagues. Such controls could include prior authorization or the use of step therapies,as well as excluding coverage of nonpreferred drugs. The latter strategy, however, could make drug access a problem, especially if physicians are not aware of an insurance plan taking these steps.

Excluding specialty drugs “makes the patient responsible for the entire cost of the drug,” the authors noted. “If prescribers are unaware of such exclusions, or if patients require specific therapies, such exclusions may impose considerable costs on patients” and potentially lead to access issues.

[email protected]

While the availability of coupons can help defray out-of-pocket costs and improve access and adherence to high-cost specialty drugs, it may also result in higher costs to the health system.

Patients used drug coupons to pay for $21.2 million of $35.3 million in out-of-pocket costs, according to an analysis of 265,000 prescriptions worth $911 million in 2013. The coupons generally dropped a patient’s out-of-pocket costs to less than $250 per prescription, a point below which patients were “far less likely” to abandon prescriptions in cases of specialty anti-inflammatory drugs and treatments for multiple sclerosis (Health Affairs 2014;33:1761-9 [doi:10.1377/hlthaff.2014.0497]).

But while the use of coupons demonstrated that the lower cost led to lower prescription abandonment rates, it also allowed patients to circumvent cost-containment measures that pharmacy benefit managers employ.

© Photodisc / ThinkStockPhotos.com

“We found that drug coupons were extremely effective in lowering patients’ costs to less than $50 per prescription, thus eliminating the incentive to select a preferred drug,” wrote Catherine I. Starner, Pharm.D., senior health outcomes researcher at pharmacy benefit manager Prime Therapeutics, and her colleagues.

To control costs at the health system level, tighter controls could be placed on specialty drugs at the pharmacy benefit manager level, according to Dr. Starner and her colleagues. Such controls could include prior authorization or the use of step therapies,as well as excluding coverage of nonpreferred drugs. The latter strategy, however, could make drug access a problem, especially if physicians are not aware of an insurance plan taking these steps.

Excluding specialty drugs “makes the patient responsible for the entire cost of the drug,” the authors noted. “If prescribers are unaware of such exclusions, or if patients require specific therapies, such exclusions may impose considerable costs on patients” and potentially lead to access issues.

[email protected]

We are always conscious of the use of systemic medications in older patients, as they may have the potential for more toxicity. For dermatologists, use of systemic medications in psoriasis represents a large share of our total use. Theoretically, we are concerned that older patients may be more likely to develop serious infections and malignancies. Older psoriasis patients also represent a growing demographic, and they are underrepresented in clinical trials.

In an article published online on September 3, 2014, in the Journal of the European Academy of Dermatology and Venereology, Medina et al performed an analysis to evaluate the safety of systemic psoriasis therapy in patients older than 65 years compared to younger patients. Patients registered in Biobadaderm, a Spanish national registry of psoriasis patients treated with systemic therapy, were divided into 2 categories: elderly (≥65 years) and younger patients (<65 years). Rates of adverse events (AEs) were described by severity and type. The risks were compared in both groups, taking into account exposure to classic or biologic drugs using Cox regression.

In the overall study population, 175 (9.8%) of 1793 patients were elderly. The authors found that overall risk for AEs was not higher in elderly patients; the drug group–adjusted hazard ratio (HR) was 1.09 (95% confidence interval [CI], 0.93-1.3). However, serious AEs were more common in older patients, with a drug group–adjusted HR of 3.2 (95% CI, 2.0-5.1). Age-adjusted HR of all AEs was lower for patients exposed to biologics compared to classic drugs in the whole sample (HR, 0.7 [95% CI, 0.6-0.7]). Age did not seem to modify the effect of therapy (biologic vs classic) in the risk for AEs (likelihood ratio test for interaction: P=.12 for all AEs; P=.09 for serious AEs).

The authors concluded that serious AEs were more common in elderly patients. They argued, however, that these serious AEs might be related to other factors associated with this age group and not due to the treatment itself. Use of biologics was associated with lower risk for AEs in the whole group. There were no differences in this association between young and old. These results are reassuring, though uncontrolled confounding could not be excluded as an explanation for these findings. The power of the study to detect differences was low.

What’s the issue?

The results indicate that overall there is no increase in AEs in older patients. More data will need to be evaluated to see if the incidence of serious AEs is due to medication use or endogenous health factors. How do you approach the use of systemic medications in older patients?

We want to know your views! Tell us what you think.

We are always conscious of the use of systemic medications in older patients, as they may have the potential for more toxicity. For dermatologists, use of systemic medications in psoriasis represents a large share of our total use. Theoretically, we are concerned that older patients may be more likely to develop serious infections and malignancies. Older psoriasis patients also represent a growing demographic, and they are underrepresented in clinical trials.

In an article published online on September 3, 2014, in the Journal of the European Academy of Dermatology and Venereology, Medina et al performed an analysis to evaluate the safety of systemic psoriasis therapy in patients older than 65 years compared to younger patients. Patients registered in Biobadaderm, a Spanish national registry of psoriasis patients treated with systemic therapy, were divided into 2 categories: elderly (≥65 years) and younger patients (<65 years). Rates of adverse events (AEs) were described by severity and type. The risks were compared in both groups, taking into account exposure to classic or biologic drugs using Cox regression.

In the overall study population, 175 (9.8%) of 1793 patients were elderly. The authors found that overall risk for AEs was not higher in elderly patients; the drug group–adjusted hazard ratio (HR) was 1.09 (95% confidence interval [CI], 0.93-1.3). However, serious AEs were more common in older patients, with a drug group–adjusted HR of 3.2 (95% CI, 2.0-5.1). Age-adjusted HR of all AEs was lower for patients exposed to biologics compared to classic drugs in the whole sample (HR, 0.7 [95% CI, 0.6-0.7]). Age did not seem to modify the effect of therapy (biologic vs classic) in the risk for AEs (likelihood ratio test for interaction: P=.12 for all AEs; P=.09 for serious AEs).

The authors concluded that serious AEs were more common in elderly patients. They argued, however, that these serious AEs might be related to other factors associated with this age group and not due to the treatment itself. Use of biologics was associated with lower risk for AEs in the whole group. There were no differences in this association between young and old. These results are reassuring, though uncontrolled confounding could not be excluded as an explanation for these findings. The power of the study to detect differences was low.

What’s the issue?

The results indicate that overall there is no increase in AEs in older patients. More data will need to be evaluated to see if the incidence of serious AEs is due to medication use or endogenous health factors. How do you approach the use of systemic medications in older patients?

We want to know your views! Tell us what you think.

We are always conscious of the use of systemic medications in older patients, as they may have the potential for more toxicity. For dermatologists, use of systemic medications in psoriasis represents a large share of our total use. Theoretically, we are concerned that older patients may be more likely to develop serious infections and malignancies. Older psoriasis patients also represent a growing demographic, and they are underrepresented in clinical trials.

In an article published online on September 3, 2014, in the Journal of the European Academy of Dermatology and Venereology, Medina et al performed an analysis to evaluate the safety of systemic psoriasis therapy in patients older than 65 years compared to younger patients. Patients registered in Biobadaderm, a Spanish national registry of psoriasis patients treated with systemic therapy, were divided into 2 categories: elderly (≥65 years) and younger patients (<65 years). Rates of adverse events (AEs) were described by severity and type. The risks were compared in both groups, taking into account exposure to classic or biologic drugs using Cox regression.

In the overall study population, 175 (9.8%) of 1793 patients were elderly. The authors found that overall risk for AEs was not higher in elderly patients; the drug group–adjusted hazard ratio (HR) was 1.09 (95% confidence interval [CI], 0.93-1.3). However, serious AEs were more common in older patients, with a drug group–adjusted HR of 3.2 (95% CI, 2.0-5.1). Age-adjusted HR of all AEs was lower for patients exposed to biologics compared to classic drugs in the whole sample (HR, 0.7 [95% CI, 0.6-0.7]). Age did not seem to modify the effect of therapy (biologic vs classic) in the risk for AEs (likelihood ratio test for interaction: P=.12 for all AEs; P=.09 for serious AEs).

The authors concluded that serious AEs were more common in elderly patients. They argued, however, that these serious AEs might be related to other factors associated with this age group and not due to the treatment itself. Use of biologics was associated with lower risk for AEs in the whole group. There were no differences in this association between young and old. These results are reassuring, though uncontrolled confounding could not be excluded as an explanation for these findings. The power of the study to detect differences was low.

What’s the issue?

The results indicate that overall there is no increase in AEs in older patients. More data will need to be evaluated to see if the incidence of serious AEs is due to medication use or endogenous health factors. How do you approach the use of systemic medications in older patients?

We want to know your views! Tell us what you think.

For more information, access Dr. Weinberg's editorial from the September 2014 issue, "Under Pressure."

For more information, access Dr. Weinberg's editorial from the September 2014 issue, "Under Pressure."

For more information, access Dr. Weinberg's editorial from the September 2014 issue, "Under Pressure."

The oral phosphodiesterase-4 inhibitor apremilast is now indicated for the treatment of moderate to severe plaque psoriasis.

On Sept. 23, the manufacturer, Celgene, announced that the Food and Drug Administration had approved the expanded indication for apremilast, which was initially approved in March 2014 for treating psoriatic arthritis. The new indication is for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Approval was primarily based on the results of two multicenter, randomized, double-blind, placebo-controlled studies of adults with moderate to severe plaque psoriasis, according to Celgene. At 16 weeks, 33% and 29% of those randomized to the 30-mg, twice daily dose of apremilast had achieved at least a 75% reduction in the Psoriasis Area and Severity Index (PASI 75), compared with 5%-6% of those on placebo, according to the prescribing information.

The most common adverse events reported in studies, which affected at least 1% of treated patients and were more common than in patients on placebo, included diarrhea in 17% and nausea in 17%; other adverse events included upper respiratory infection, tension headache, and headache. The warnings and precautions section of the label includes the recommendation to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes in patients treated with the drug, and to monitor weight regularly for significant weight loss. In studies, treatment with apremilast has been associated with an increase in reports of depression and significant weight loss.

Celgene markets apremilast as Otezla.

Serious adverse events associated with treatment should be reported to the FDA at 800-332-1088 or www.fda.gov/medwatch.

Information about the pregnancy registry of women exposed to the drug during pregnancy can be obtained at 877-311-8972.

The updated prescribing information is available at http://www.celgene.com/content/uploads/2014/09/psoriasis-pi.pdf

[email protected]

The oral phosphodiesterase-4 inhibitor apremilast is now indicated for the treatment of moderate to severe plaque psoriasis.

On Sept. 23, the manufacturer, Celgene, announced that the Food and Drug Administration had approved the expanded indication for apremilast, which was initially approved in March 2014 for treating psoriatic arthritis. The new indication is for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Approval was primarily based on the results of two multicenter, randomized, double-blind, placebo-controlled studies of adults with moderate to severe plaque psoriasis, according to Celgene. At 16 weeks, 33% and 29% of those randomized to the 30-mg, twice daily dose of apremilast had achieved at least a 75% reduction in the Psoriasis Area and Severity Index (PASI 75), compared with 5%-6% of those on placebo, according to the prescribing information.

The most common adverse events reported in studies, which affected at least 1% of treated patients and were more common than in patients on placebo, included diarrhea in 17% and nausea in 17%; other adverse events included upper respiratory infection, tension headache, and headache. The warnings and precautions section of the label includes the recommendation to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes in patients treated with the drug, and to monitor weight regularly for significant weight loss. In studies, treatment with apremilast has been associated with an increase in reports of depression and significant weight loss.

Celgene markets apremilast as Otezla.

Serious adverse events associated with treatment should be reported to the FDA at 800-332-1088 or www.fda.gov/medwatch.

Information about the pregnancy registry of women exposed to the drug during pregnancy can be obtained at 877-311-8972.

The updated prescribing information is available at http://www.celgene.com/content/uploads/2014/09/psoriasis-pi.pdf

[email protected]

The oral phosphodiesterase-4 inhibitor apremilast is now indicated for the treatment of moderate to severe plaque psoriasis.

On Sept. 23, the manufacturer, Celgene, announced that the Food and Drug Administration had approved the expanded indication for apremilast, which was initially approved in March 2014 for treating psoriatic arthritis. The new indication is for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Approval was primarily based on the results of two multicenter, randomized, double-blind, placebo-controlled studies of adults with moderate to severe plaque psoriasis, according to Celgene. At 16 weeks, 33% and 29% of those randomized to the 30-mg, twice daily dose of apremilast had achieved at least a 75% reduction in the Psoriasis Area and Severity Index (PASI 75), compared with 5%-6% of those on placebo, according to the prescribing information.

The most common adverse events reported in studies, which affected at least 1% of treated patients and were more common than in patients on placebo, included diarrhea in 17% and nausea in 17%; other adverse events included upper respiratory infection, tension headache, and headache. The warnings and precautions section of the label includes the recommendation to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes in patients treated with the drug, and to monitor weight regularly for significant weight loss. In studies, treatment with apremilast has been associated with an increase in reports of depression and significant weight loss.

Celgene markets apremilast as Otezla.

Serious adverse events associated with treatment should be reported to the FDA at 800-332-1088 or www.fda.gov/medwatch.

Information about the pregnancy registry of women exposed to the drug during pregnancy can be obtained at 877-311-8972.

The updated prescribing information is available at http://www.celgene.com/content/uploads/2014/09/psoriasis-pi.pdf

[email protected]

Therapies for Palmoplantar Pustular Psoriasis

There is limited evidence on therapies for palmoplantar pustular psoriasis (PPPP) and maintaining long-term remission. Sevrain et al (J Eur Acad Dermatol Venereol. 2014;28[suppl 5]:13-16) conducted a systematic literature search to identify trials in patients with PPPP that assessed therapeutic interventions (not including systemic biotherapy). They found that oral retinoid therapy (acitretin), photochemotherapy, or a combination of both; low-dose cyclosporine; or topical corticosteroids under occlusion appeared to help relieve symptoms of PPPP. Newer studies have noted the benefits of psoralen plus UVA, with better efficacy compared to UVB therapy. A 308-nm excimer laser has been shown to improve PPPP.

Practice Point: Although phototherapy, cyclosporine, and topical corticosteroids seem to be able to control PPPP, more randomized controlled trials are needed to better define treatment strategies for PPPP.

>>Read more at Journal of the European Academy of Dermatology and Venereology

Pediatric Pustular Psoriasis Cleared With Systemic Medications

Treatment of pediatric pustular psoriasis is challenging. Posso-De Los Rios and colleagues (Pediatr Dermatol. 2014;31:430-439) conducted a systematic review of systemic interventions for pediatric pustular psoriasis with a focus on clinical response and treatment outcomes. The most common therapies used for generalized pustular psoriasis were acitretin, cyclosporine, and methotrexate.

Practice Point: Acitretin, methotrexate, and cyclosporine seem to control generalized pustular psoriasis in the pediatric population; however, long-term data are lacking and physicians may encounter disease regression after discontinuing or tapering the medications.

>>Read more at Pediatric Dermatology

Biologics for Erythrodermic and Pustular Psoriasis

Levin et al (J Drugs Dermatol. 2014;13:342-354) sought to evaluate the efficacy and safety of biologics in the treatment of erythrodermic and generalized pustular psoriasis by reviewing the literature. In both psoriasis subtypes, infliximab was used to treat more than half of the reported cases. Other biologics that were successfully used included etanercept, ustekinumab, adalimumab, and anakinra.

Practice Point: Patients with erythrodermic or generalized pustular psoriasis may experience disease improvement with biologics.

>>Read more at Journal of Drugs in Dermatology

Therapies for Palmoplantar Pustular Psoriasis

There is limited evidence on therapies for palmoplantar pustular psoriasis (PPPP) and maintaining long-term remission. Sevrain et al (J Eur Acad Dermatol Venereol. 2014;28[suppl 5]:13-16) conducted a systematic literature search to identify trials in patients with PPPP that assessed therapeutic interventions (not including systemic biotherapy). They found that oral retinoid therapy (acitretin), photochemotherapy, or a combination of both; low-dose cyclosporine; or topical corticosteroids under occlusion appeared to help relieve symptoms of PPPP. Newer studies have noted the benefits of psoralen plus UVA, with better efficacy compared to UVB therapy. A 308-nm excimer laser has been shown to improve PPPP.

Practice Point: Although phototherapy, cyclosporine, and topical corticosteroids seem to be able to control PPPP, more randomized controlled trials are needed to better define treatment strategies for PPPP.

>>Read more at Journal of the European Academy of Dermatology and Venereology

Pediatric Pustular Psoriasis Cleared With Systemic Medications

Treatment of pediatric pustular psoriasis is challenging. Posso-De Los Rios and colleagues (Pediatr Dermatol. 2014;31:430-439) conducted a systematic review of systemic interventions for pediatric pustular psoriasis with a focus on clinical response and treatment outcomes. The most common therapies used for generalized pustular psoriasis were acitretin, cyclosporine, and methotrexate.

Practice Point: Acitretin, methotrexate, and cyclosporine seem to control generalized pustular psoriasis in the pediatric population; however, long-term data are lacking and physicians may encounter disease regression after discontinuing or tapering the medications.

>>Read more at Pediatric Dermatology

Biologics for Erythrodermic and Pustular Psoriasis

Levin et al (J Drugs Dermatol. 2014;13:342-354) sought to evaluate the efficacy and safety of biologics in the treatment of erythrodermic and generalized pustular psoriasis by reviewing the literature. In both psoriasis subtypes, infliximab was used to treat more than half of the reported cases. Other biologics that were successfully used included etanercept, ustekinumab, adalimumab, and anakinra.

Practice Point: Patients with erythrodermic or generalized pustular psoriasis may experience disease improvement with biologics.

>>Read more at Journal of Drugs in Dermatology

Therapies for Palmoplantar Pustular Psoriasis

There is limited evidence on therapies for palmoplantar pustular psoriasis (PPPP) and maintaining long-term remission. Sevrain et al (J Eur Acad Dermatol Venereol. 2014;28[suppl 5]:13-16) conducted a systematic literature search to identify trials in patients with PPPP that assessed therapeutic interventions (not including systemic biotherapy). They found that oral retinoid therapy (acitretin), photochemotherapy, or a combination of both; low-dose cyclosporine; or topical corticosteroids under occlusion appeared to help relieve symptoms of PPPP. Newer studies have noted the benefits of psoralen plus UVA, with better efficacy compared to UVB therapy. A 308-nm excimer laser has been shown to improve PPPP.

Practice Point: Although phototherapy, cyclosporine, and topical corticosteroids seem to be able to control PPPP, more randomized controlled trials are needed to better define treatment strategies for PPPP.

>>Read more at Journal of the European Academy of Dermatology and Venereology

Pediatric Pustular Psoriasis Cleared With Systemic Medications

Treatment of pediatric pustular psoriasis is challenging. Posso-De Los Rios and colleagues (Pediatr Dermatol. 2014;31:430-439) conducted a systematic review of systemic interventions for pediatric pustular psoriasis with a focus on clinical response and treatment outcomes. The most common therapies used for generalized pustular psoriasis were acitretin, cyclosporine, and methotrexate.

Practice Point: Acitretin, methotrexate, and cyclosporine seem to control generalized pustular psoriasis in the pediatric population; however, long-term data are lacking and physicians may encounter disease regression after discontinuing or tapering the medications.

>>Read more at Pediatric Dermatology

Biologics for Erythrodermic and Pustular Psoriasis

Levin et al (J Drugs Dermatol. 2014;13:342-354) sought to evaluate the efficacy and safety of biologics in the treatment of erythrodermic and generalized pustular psoriasis by reviewing the literature. In both psoriasis subtypes, infliximab was used to treat more than half of the reported cases. Other biologics that were successfully used included etanercept, ustekinumab, adalimumab, and anakinra.

Practice Point: Patients with erythrodermic or generalized pustular psoriasis may experience disease improvement with biologics.

>>Read more at Journal of Drugs in Dermatology

LAS VEGAS – A number of drugs are showing promise for the treatment of psoriatic arthritis, but broader improvements are needed with respect to treatment strategies, according to Dr. Iain McInnes.

Earlier diagnosis, appropriate therapies, and treating to target are among the topics he covered in a presentation on maximizing patient outcomes at the annual Perspectives in Rheumatic Diseases.

A recent study demonstrated that even a 6-month delay in the diagnosis of psoriatic arthritis is associated with worse long-term outcomes on several measures. In that study of 283 patients (Ann. Rheum. Dis. 2014 Feb. 13 [doi: 10.1136/annrheumdis-2013-204858]), the median lag time from disease onset to first rheumatological assessment was 1 year, with only 30% of patients being seen by a rheumatologist within 6 months.

Multiple stepwise regression analysis showed that late consulters had a greater risk of developing peripheral joint erosions (odds ratio, 4.25) and had worse Health Assessment Questionnaire scores (odds ratio, 2.2).

One finding that could help with earlier diagnosis is detection of early entheseal involvement, said Dr. McInnes, professor of medicine and director of the Institute of Infection, Immunity and Immunology at the University of Glasgow (Scotland).

Subclinical entheseal involvement appears to predict psoriatic arthritis in patients presenting with psoriasis, he said at the conference.

In one study, the mean Glasgow Ultrasound Enthesitis Scoring System (GUESS) score was 7.9 in patients with psoriasis, compared with 2.9 in controls, and in another study, thickness of the quadriceps tendon was a significant predictor of the development of psoriatic arthritis in those with psoriasis.

A key challenge in maximizing outcomes in psoriatic arthritis is that rheumatoid arthritis and psoriatic arthritis are typically treated as homogeneous for the purposes of drug development, but the two diseases have distinct clinical phenotypes and time course, tissue distribution, tissue cell/molecular features, genetic susceptibility, and probably impact of immune senescence.

In fact, while disease-modifying antirheumatic drugs are included in European League Against Rheumatsm (EULAR) treatment guidelines for psoriatic arthritis, the Methotrexate in Psoriatic Arthritis (MIPA) trial, a 6-month, double-blind, randomized, placebo-controlled trial of methotrexate, showed no benefit for key psoriatic arthritis endpoints at 3 and 6 months (Rheumatology 2012;51:1368-77).

Data on methotrexate combination therapy is limited, but existing clinical trials and registry data show no clear evidence of benefit. Methotrexate also has long-term toxicity issues.

In studies of patients who received anti–tumor necrosis factor therapy, 59%-69% of patients achieved 20% improvement (ACR 20 response), 37%-50% achieved 50% improvement (ACR 50 response), and up to 52% of patients achieved minimal disease activity at various time points. Also, radiographic progression was improved with anti-TNF therapy vs. placebo. However, TNF inhibitors lose efficacy over time in some patients, and are associated with an increased risk of infection.

Other disappointments or unmet needs in psoriatic arthritis are dichotomous skin and joint responses to biologics, lack of established predictors of response to biologics, lack of a cure, and difficulties in achieving sustained remission, Dr. McInnes said.

Future therapeutic options, including several drugs in development, include drugs that target cytokines and their receptors, such as ustekinumab, which targets IL-12/23; secukinumab and ixekizumab, which target IL-17; and brodalumab, which targets IL-17 receptor A. Other potential targets include IL-6 and the IL-6 receptor and IL-23 and the IL-23 receptor.

Studies of ustekinumab, for example, demonstrate beneficial effects on enthesitis, dactylitis, and modified van der Heijde-Sharp score.

Drugs that target intracellular signaling pathways are also being studied in psoriatic arthritis, including JAK family agents such as tofacitinib and phosphodiesterase inhibitors like apremilast.

As for strategies to improve outcomes, the Tight Control in Psoriatic Arthritis (TICOPA) study provided a rationale for treating to target. Current recommendations call for a target of remission or low disease activity.

The availability of highly effective biologics makes minimal level of disease activity a realistic treatment target, Dr. McInnes said.

The conference was held by Global Academy for Medical Education. Global Academy for Medical Education and this news organization are owned by Frontline Medical Communications.

Dr. McInnes reported receiving research/grant support from Pfizer, Bristol-Myers Squibb, AstraZeneca, and Novo Nordisk, and serving as a consultant to Novartis, Bristol-Myers Squibb, Pfizer, and Galapagos. He is a member of scientific advisory boards for AstraZeneca, Crescendo Bioscience, and Janssen Biotech.

LAS VEGAS – A number of drugs are showing promise for the treatment of psoriatic arthritis, but broader improvements are needed with respect to treatment strategies, according to Dr. Iain McInnes.

Earlier diagnosis, appropriate therapies, and treating to target are among the topics he covered in a presentation on maximizing patient outcomes at the annual Perspectives in Rheumatic Diseases.

A recent study demonstrated that even a 6-month delay in the diagnosis of psoriatic arthritis is associated with worse long-term outcomes on several measures. In that study of 283 patients (Ann. Rheum. Dis. 2014 Feb. 13 [doi: 10.1136/annrheumdis-2013-204858]), the median lag time from disease onset to first rheumatological assessment was 1 year, with only 30% of patients being seen by a rheumatologist within 6 months.

Multiple stepwise regression analysis showed that late consulters had a greater risk of developing peripheral joint erosions (odds ratio, 4.25) and had worse Health Assessment Questionnaire scores (odds ratio, 2.2).

One finding that could help with earlier diagnosis is detection of early entheseal involvement, said Dr. McInnes, professor of medicine and director of the Institute of Infection, Immunity and Immunology at the University of Glasgow (Scotland).

Subclinical entheseal involvement appears to predict psoriatic arthritis in patients presenting with psoriasis, he said at the conference.

In one study, the mean Glasgow Ultrasound Enthesitis Scoring System (GUESS) score was 7.9 in patients with psoriasis, compared with 2.9 in controls, and in another study, thickness of the quadriceps tendon was a significant predictor of the development of psoriatic arthritis in those with psoriasis.

A key challenge in maximizing outcomes in psoriatic arthritis is that rheumatoid arthritis and psoriatic arthritis are typically treated as homogeneous for the purposes of drug development, but the two diseases have distinct clinical phenotypes and time course, tissue distribution, tissue cell/molecular features, genetic susceptibility, and probably impact of immune senescence.

In fact, while disease-modifying antirheumatic drugs are included in European League Against Rheumatsm (EULAR) treatment guidelines for psoriatic arthritis, the Methotrexate in Psoriatic Arthritis (MIPA) trial, a 6-month, double-blind, randomized, placebo-controlled trial of methotrexate, showed no benefit for key psoriatic arthritis endpoints at 3 and 6 months (Rheumatology 2012;51:1368-77).

Data on methotrexate combination therapy is limited, but existing clinical trials and registry data show no clear evidence of benefit. Methotrexate also has long-term toxicity issues.

In studies of patients who received anti–tumor necrosis factor therapy, 59%-69% of patients achieved 20% improvement (ACR 20 response), 37%-50% achieved 50% improvement (ACR 50 response), and up to 52% of patients achieved minimal disease activity at various time points. Also, radiographic progression was improved with anti-TNF therapy vs. placebo. However, TNF inhibitors lose efficacy over time in some patients, and are associated with an increased risk of infection.

Other disappointments or unmet needs in psoriatic arthritis are dichotomous skin and joint responses to biologics, lack of established predictors of response to biologics, lack of a cure, and difficulties in achieving sustained remission, Dr. McInnes said.

Future therapeutic options, including several drugs in development, include drugs that target cytokines and their receptors, such as ustekinumab, which targets IL-12/23; secukinumab and ixekizumab, which target IL-17; and brodalumab, which targets IL-17 receptor A. Other potential targets include IL-6 and the IL-6 receptor and IL-23 and the IL-23 receptor.

Studies of ustekinumab, for example, demonstrate beneficial effects on enthesitis, dactylitis, and modified van der Heijde-Sharp score.

Drugs that target intracellular signaling pathways are also being studied in psoriatic arthritis, including JAK family agents such as tofacitinib and phosphodiesterase inhibitors like apremilast.

As for strategies to improve outcomes, the Tight Control in Psoriatic Arthritis (TICOPA) study provided a rationale for treating to target. Current recommendations call for a target of remission or low disease activity.

The availability of highly effective biologics makes minimal level of disease activity a realistic treatment target, Dr. McInnes said.

The conference was held by Global Academy for Medical Education. Global Academy for Medical Education and this news organization are owned by Frontline Medical Communications.

Dr. McInnes reported receiving research/grant support from Pfizer, Bristol-Myers Squibb, AstraZeneca, and Novo Nordisk, and serving as a consultant to Novartis, Bristol-Myers Squibb, Pfizer, and Galapagos. He is a member of scientific advisory boards for AstraZeneca, Crescendo Bioscience, and Janssen Biotech.

LAS VEGAS – A number of drugs are showing promise for the treatment of psoriatic arthritis, but broader improvements are needed with respect to treatment strategies, according to Dr. Iain McInnes.

Earlier diagnosis, appropriate therapies, and treating to target are among the topics he covered in a presentation on maximizing patient outcomes at the annual Perspectives in Rheumatic Diseases.

A recent study demonstrated that even a 6-month delay in the diagnosis of psoriatic arthritis is associated with worse long-term outcomes on several measures. In that study of 283 patients (Ann. Rheum. Dis. 2014 Feb. 13 [doi: 10.1136/annrheumdis-2013-204858]), the median lag time from disease onset to first rheumatological assessment was 1 year, with only 30% of patients being seen by a rheumatologist within 6 months.

Multiple stepwise regression analysis showed that late consulters had a greater risk of developing peripheral joint erosions (odds ratio, 4.25) and had worse Health Assessment Questionnaire scores (odds ratio, 2.2).

One finding that could help with earlier diagnosis is detection of early entheseal involvement, said Dr. McInnes, professor of medicine and director of the Institute of Infection, Immunity and Immunology at the University of Glasgow (Scotland).

Subclinical entheseal involvement appears to predict psoriatic arthritis in patients presenting with psoriasis, he said at the conference.

In one study, the mean Glasgow Ultrasound Enthesitis Scoring System (GUESS) score was 7.9 in patients with psoriasis, compared with 2.9 in controls, and in another study, thickness of the quadriceps tendon was a significant predictor of the development of psoriatic arthritis in those with psoriasis.

A key challenge in maximizing outcomes in psoriatic arthritis is that rheumatoid arthritis and psoriatic arthritis are typically treated as homogeneous for the purposes of drug development, but the two diseases have distinct clinical phenotypes and time course, tissue distribution, tissue cell/molecular features, genetic susceptibility, and probably impact of immune senescence.

In fact, while disease-modifying antirheumatic drugs are included in European League Against Rheumatsm (EULAR) treatment guidelines for psoriatic arthritis, the Methotrexate in Psoriatic Arthritis (MIPA) trial, a 6-month, double-blind, randomized, placebo-controlled trial of methotrexate, showed no benefit for key psoriatic arthritis endpoints at 3 and 6 months (Rheumatology 2012;51:1368-77).

Data on methotrexate combination therapy is limited, but existing clinical trials and registry data show no clear evidence of benefit. Methotrexate also has long-term toxicity issues.

In studies of patients who received anti–tumor necrosis factor therapy, 59%-69% of patients achieved 20% improvement (ACR 20 response), 37%-50% achieved 50% improvement (ACR 50 response), and up to 52% of patients achieved minimal disease activity at various time points. Also, radiographic progression was improved with anti-TNF therapy vs. placebo. However, TNF inhibitors lose efficacy over time in some patients, and are associated with an increased risk of infection.

Other disappointments or unmet needs in psoriatic arthritis are dichotomous skin and joint responses to biologics, lack of established predictors of response to biologics, lack of a cure, and difficulties in achieving sustained remission, Dr. McInnes said.

Future therapeutic options, including several drugs in development, include drugs that target cytokines and their receptors, such as ustekinumab, which targets IL-12/23; secukinumab and ixekizumab, which target IL-17; and brodalumab, which targets IL-17 receptor A. Other potential targets include IL-6 and the IL-6 receptor and IL-23 and the IL-23 receptor.

Studies of ustekinumab, for example, demonstrate beneficial effects on enthesitis, dactylitis, and modified van der Heijde-Sharp score.

Drugs that target intracellular signaling pathways are also being studied in psoriatic arthritis, including JAK family agents such as tofacitinib and phosphodiesterase inhibitors like apremilast.

As for strategies to improve outcomes, the Tight Control in Psoriatic Arthritis (TICOPA) study provided a rationale for treating to target. Current recommendations call for a target of remission or low disease activity.

The availability of highly effective biologics makes minimal level of disease activity a realistic treatment target, Dr. McInnes said.

The conference was held by Global Academy for Medical Education. Global Academy for Medical Education and this news organization are owned by Frontline Medical Communications.

Dr. McInnes reported receiving research/grant support from Pfizer, Bristol-Myers Squibb, AstraZeneca, and Novo Nordisk, and serving as a consultant to Novartis, Bristol-Myers Squibb, Pfizer, and Galapagos. He is a member of scientific advisory boards for AstraZeneca, Crescendo Bioscience, and Janssen Biotech.

Patients with psoriatic arthritis who began taking disease-modifying antirheumatic drugs often changed regimens soon afterward, especially if they had started with nonbiologic treatments, researchers reported online in Arthritis Research and Therapy.

Only 31% of patients who started methotrexate or another nonbiologic disease-modifying antirheumatic drug (DMARD) for psoriatic arthritis stayed with their initial treatment for the next year, compared with 54% of patients who started on a biologic DMARD such as etanercept, infliximab, or golimumab, said Dr. Huabin F. Zhang at Celgene in Summit, N.J., and his associates.

The researchers analyzed U. S. health care claims data for 1,698 adults with psoriatic arthritis who were started on oral nonbiologic DMARDs and for 3,263 patients started on biologic DMARDs. In all, 69% of patients who started nonbiologic DMARDs and 46% of those who started biologic DMARDs discontinued, switched, or added on to their treatment within a year of starting therapy, they found. Patients most often switched to or added a biologic as opposed to a nonbiologic DMARD, the investigators said. Those who started on nonbiologics primarily took methotrexate, and "patient persistence with treatment was generally low and relatively brief," they said. Other studies have shown that use of nonbiologic DMARDs "erodes rapidly and progressively over time," they said (Arthritis Res. Ther. 2014 Aug. 22 [doi:10.1186/s13075-014-0420-5]).

Health insurance companies often require patients to take one or two nonbiologics before they will reimburse for a biologic DMARD, which could partially explain these findings, the researchers said. But the retrospective observational study did not capture data on side effects, safety concerns, or other reasons for treatment changes, they noted.

Celgene funded the study and employs Dr. Zhang. The other three coauthors reported receiving consultancy fees from Celgene.

Patients with psoriatic arthritis who began taking disease-modifying antirheumatic drugs often changed regimens soon afterward, especially if they had started with nonbiologic treatments, researchers reported online in Arthritis Research and Therapy.

Only 31% of patients who started methotrexate or another nonbiologic disease-modifying antirheumatic drug (DMARD) for psoriatic arthritis stayed with their initial treatment for the next year, compared with 54% of patients who started on a biologic DMARD such as etanercept, infliximab, or golimumab, said Dr. Huabin F. Zhang at Celgene in Summit, N.J., and his associates.

The researchers analyzed U. S. health care claims data for 1,698 adults with psoriatic arthritis who were started on oral nonbiologic DMARDs and for 3,263 patients started on biologic DMARDs. In all, 69% of patients who started nonbiologic DMARDs and 46% of those who started biologic DMARDs discontinued, switched, or added on to their treatment within a year of starting therapy, they found. Patients most often switched to or added a biologic as opposed to a nonbiologic DMARD, the investigators said. Those who started on nonbiologics primarily took methotrexate, and "patient persistence with treatment was generally low and relatively brief," they said. Other studies have shown that use of nonbiologic DMARDs "erodes rapidly and progressively over time," they said (Arthritis Res. Ther. 2014 Aug. 22 [doi:10.1186/s13075-014-0420-5]).

Health insurance companies often require patients to take one or two nonbiologics before they will reimburse for a biologic DMARD, which could partially explain these findings, the researchers said. But the retrospective observational study did not capture data on side effects, safety concerns, or other reasons for treatment changes, they noted.

Celgene funded the study and employs Dr. Zhang. The other three coauthors reported receiving consultancy fees from Celgene.

Patients with psoriatic arthritis who began taking disease-modifying antirheumatic drugs often changed regimens soon afterward, especially if they had started with nonbiologic treatments, researchers reported online in Arthritis Research and Therapy.

Only 31% of patients who started methotrexate or another nonbiologic disease-modifying antirheumatic drug (DMARD) for psoriatic arthritis stayed with their initial treatment for the next year, compared with 54% of patients who started on a biologic DMARD such as etanercept, infliximab, or golimumab, said Dr. Huabin F. Zhang at Celgene in Summit, N.J., and his associates.

The researchers analyzed U. S. health care claims data for 1,698 adults with psoriatic arthritis who were started on oral nonbiologic DMARDs and for 3,263 patients started on biologic DMARDs. In all, 69% of patients who started nonbiologic DMARDs and 46% of those who started biologic DMARDs discontinued, switched, or added on to their treatment within a year of starting therapy, they found. Patients most often switched to or added a biologic as opposed to a nonbiologic DMARD, the investigators said. Those who started on nonbiologics primarily took methotrexate, and "patient persistence with treatment was generally low and relatively brief," they said. Other studies have shown that use of nonbiologic DMARDs "erodes rapidly and progressively over time," they said (Arthritis Res. Ther. 2014 Aug. 22 [doi:10.1186/s13075-014-0420-5]).

Health insurance companies often require patients to take one or two nonbiologics before they will reimburse for a biologic DMARD, which could partially explain these findings, the researchers said. But the retrospective observational study did not capture data on side effects, safety concerns, or other reasons for treatment changes, they noted.

Celgene funded the study and employs Dr. Zhang. The other three coauthors reported receiving consultancy fees from Celgene.

VANCOUVER, B.C. – Results from some studies have concluded that treatment with conventional systemic or biologic therapy improves the elevated risk of cardiovascular disease in patients with psoriasis, but the association is not yet definitive, according to Dr. Robert Kalb.

"Current evidence is suggestive, but certainly our patients with psoriasis need intensive management of cardiovascular risk factors and appropriate psoriasis therapy, which may also produce benefits from a cardiovascular standpoint," Dr. Kalb said at the annual meeting of the Pacific Dermatologic Association.

Researchers who conducted the earliest study to explore the association between psoriasis and increased risk for cardiovascular death found that when they controlled for risk factors including age, sex, smoking, diabetes, hypertension, and hyperlipidemia, having psoriasis led to a hazard ratio of 1.57 for cardiovascular death (Eur. Heart J. 2010;31:1000-6). Since that time, six meta-analyses have appeared in the medical literature showing that psoriasis is linked to an increased risk of cardiovascular disease. Most of these studies defined severe psoriasis as patients who had received a systemic agent. Body surface area or other objective measures of psoriasis were not part of the definition, said Dr. Kalb, a dermatologist in group practice in Buffalo.

Emerging evidence supports the idea that increased risk factors are associated with the severity of psoriasis. As part of the landmark Incident Health Outcomes and Psoriasis Events (iHope) study, investigators found that patients with disease affecting 10% or more body surface area had an increased risk of myocardial infarction. One study defined psoriasis severity by body surface area (JAMA Dermatol. 2013;149:1173-9). The investigators found that the burdens of MI and other comorbid diseases increase with increasing disease severity, particularly in those with 10% body surface area or more affected.

Investigators are also working to determine if systemic therapy reduces the risk of MI in psoriasis patients. The Consortium of Rheumatology Researchers of North America (CORRONA) registry database found that in patients with rheumatoid arthritis, anti–tumor necrosis factor (TNF) agents reduced the risk of cardiovascular events (HR, 0.39), compared with nonbiologic disease-modifying antirheumatic drugs. Methotrexate did not reduce the risk of cardiovascular events, while the use of prednisone increased the risk (Ann. Rheum. Dis. 2011;70:576-82). Another review showed that anti-TNF therapy decreased the risk, but the use of methotrexate decreased the risk slightly more (Rheumatology 2011;50:518-31). "Reassuringly, there was no increased risk of congestive heart failure, which has always been [included] in the label of [anti-]TNF agents," Dr. Kalb said.

A cohort study of 25,554 patients with moderate to severe psoriasis used U.S. administrative and pharmacy claims data to examine the risk of acute myocardial infarction in those who underwent systemic therapy, compared with those who underwent phototherapy. The investigators found a trend toward an increased risk of MI in those who received systemic therapy, but there were no significant differences in risk between the two treatment groups (Br. J. Dermatol. 2011;165:1066-73). On the other hand, a retrospective, longitudinal cohort study of 2,400 patients with severe psoriasis in Denmark showed that the use of biologic agents and methotrexate was associated with fewer cardiovascular events (hazard ratios, 0.48 and 0.50, respectively), but the use of other antipsoriatic therapies – including cyclosporine, retinoids, phototherapy, and topicals – were not (J. Intern Med. 2013;273:197-204).

A retrospective cohort study of 8,845 Kaiser Permanente psoriasis patients set out to determine whether treatment with TNF inhibitors was associated with a decreased risk of MI, compared with those who did not receive TNF inhibitors (Arch. Dermatol. 2012;148:1244-50) . After adjusting for MI risk factors, the researchers found that those who received TNF inhibitors had a significantly lower risk of MI, compared with those who received topical therapy (adjusted HR, 0.50).

"Why do different studies reach different conclusions?" Dr. Kalb asked. "Different populations were studied, and there were differences in terms of how reference groups were defined and in the methods for categorizing therapy and severity of disease. Data from population studies are not yet sufficient to determine whether [anti-]TNF agents will reduce the incidence of MI."

One conundrum for researchers is how to measure this decreased risk. "What surrogate markers should we use?" Dr. Kalb asked. "One study showed a significant decrease in CRP [C-reactive protein] and ESR [erythrocyte sedimentation rate] in patients receiving therapy. The gold standard of decrease in mortality in this type of study will not be done because it requires thousands of patients studied over at least 10 years." However, in cardiology, 18-fluorodeoxyglucose PET scanning shows decreased inflammation in patients taking statins. Whether the same effect can be shown in psoriasis patients taking systemic medications for their disease remains unknown, but prospective studies are ongoing.

Dr. Kalb disclosed that he is an investigator and/or consultant for AbbVie, Amgen, Celgene, Dermira, Janssen, Leo, Merck, Pfizer, and Taro. He is also on the dermatology safety monitoring board for ApoPharma and Eli Lilly.

[email protected]

On Twitter @dougbrunk

VANCOUVER, B.C. – Results from some studies have concluded that treatment with conventional systemic or biologic therapy improves the elevated risk of cardiovascular disease in patients with psoriasis, but the association is not yet definitive, according to Dr. Robert Kalb.

"Current evidence is suggestive, but certainly our patients with psoriasis need intensive management of cardiovascular risk factors and appropriate psoriasis therapy, which may also produce benefits from a cardiovascular standpoint," Dr. Kalb said at the annual meeting of the Pacific Dermatologic Association.

Researchers who conducted the earliest study to explore the association between psoriasis and increased risk for cardiovascular death found that when they controlled for risk factors including age, sex, smoking, diabetes, hypertension, and hyperlipidemia, having psoriasis led to a hazard ratio of 1.57 for cardiovascular death (Eur. Heart J. 2010;31:1000-6). Since that time, six meta-analyses have appeared in the medical literature showing that psoriasis is linked to an increased risk of cardiovascular disease. Most of these studies defined severe psoriasis as patients who had received a systemic agent. Body surface area or other objective measures of psoriasis were not part of the definition, said Dr. Kalb, a dermatologist in group practice in Buffalo.

Emerging evidence supports the idea that increased risk factors are associated with the severity of psoriasis. As part of the landmark Incident Health Outcomes and Psoriasis Events (iHope) study, investigators found that patients with disease affecting 10% or more body surface area had an increased risk of myocardial infarction. One study defined psoriasis severity by body surface area (JAMA Dermatol. 2013;149:1173-9). The investigators found that the burdens of MI and other comorbid diseases increase with increasing disease severity, particularly in those with 10% body surface area or more affected.

Investigators are also working to determine if systemic therapy reduces the risk of MI in psoriasis patients. The Consortium of Rheumatology Researchers of North America (CORRONA) registry database found that in patients with rheumatoid arthritis, anti–tumor necrosis factor (TNF) agents reduced the risk of cardiovascular events (HR, 0.39), compared with nonbiologic disease-modifying antirheumatic drugs. Methotrexate did not reduce the risk of cardiovascular events, while the use of prednisone increased the risk (Ann. Rheum. Dis. 2011;70:576-82). Another review showed that anti-TNF therapy decreased the risk, but the use of methotrexate decreased the risk slightly more (Rheumatology 2011;50:518-31). "Reassuringly, there was no increased risk of congestive heart failure, which has always been [included] in the label of [anti-]TNF agents," Dr. Kalb said.

A cohort study of 25,554 patients with moderate to severe psoriasis used U.S. administrative and pharmacy claims data to examine the risk of acute myocardial infarction in those who underwent systemic therapy, compared with those who underwent phototherapy. The investigators found a trend toward an increased risk of MI in those who received systemic therapy, but there were no significant differences in risk between the two treatment groups (Br. J. Dermatol. 2011;165:1066-73). On the other hand, a retrospective, longitudinal cohort study of 2,400 patients with severe psoriasis in Denmark showed that the use of biologic agents and methotrexate was associated with fewer cardiovascular events (hazard ratios, 0.48 and 0.50, respectively), but the use of other antipsoriatic therapies – including cyclosporine, retinoids, phototherapy, and topicals – were not (J. Intern Med. 2013;273:197-204).

A retrospective cohort study of 8,845 Kaiser Permanente psoriasis patients set out to determine whether treatment with TNF inhibitors was associated with a decreased risk of MI, compared with those who did not receive TNF inhibitors (Arch. Dermatol. 2012;148:1244-50) . After adjusting for MI risk factors, the researchers found that those who received TNF inhibitors had a significantly lower risk of MI, compared with those who received topical therapy (adjusted HR, 0.50).

"Why do different studies reach different conclusions?" Dr. Kalb asked. "Different populations were studied, and there were differences in terms of how reference groups were defined and in the methods for categorizing therapy and severity of disease. Data from population studies are not yet sufficient to determine whether [anti-]TNF agents will reduce the incidence of MI."

One conundrum for researchers is how to measure this decreased risk. "What surrogate markers should we use?" Dr. Kalb asked. "One study showed a significant decrease in CRP [C-reactive protein] and ESR [erythrocyte sedimentation rate] in patients receiving therapy. The gold standard of decrease in mortality in this type of study will not be done because it requires thousands of patients studied over at least 10 years." However, in cardiology, 18-fluorodeoxyglucose PET scanning shows decreased inflammation in patients taking statins. Whether the same effect can be shown in psoriasis patients taking systemic medications for their disease remains unknown, but prospective studies are ongoing.

Dr. Kalb disclosed that he is an investigator and/or consultant for AbbVie, Amgen, Celgene, Dermira, Janssen, Leo, Merck, Pfizer, and Taro. He is also on the dermatology safety monitoring board for ApoPharma and Eli Lilly.

[email protected]

On Twitter @dougbrunk

VANCOUVER, B.C. – Results from some studies have concluded that treatment with conventional systemic or biologic therapy improves the elevated risk of cardiovascular disease in patients with psoriasis, but the association is not yet definitive, according to Dr. Robert Kalb.

"Current evidence is suggestive, but certainly our patients with psoriasis need intensive management of cardiovascular risk factors and appropriate psoriasis therapy, which may also produce benefits from a cardiovascular standpoint," Dr. Kalb said at the annual meeting of the Pacific Dermatologic Association.

Researchers who conducted the earliest study to explore the association between psoriasis and increased risk for cardiovascular death found that when they controlled for risk factors including age, sex, smoking, diabetes, hypertension, and hyperlipidemia, having psoriasis led to a hazard ratio of 1.57 for cardiovascular death (Eur. Heart J. 2010;31:1000-6). Since that time, six meta-analyses have appeared in the medical literature showing that psoriasis is linked to an increased risk of cardiovascular disease. Most of these studies defined severe psoriasis as patients who had received a systemic agent. Body surface area or other objective measures of psoriasis were not part of the definition, said Dr. Kalb, a dermatologist in group practice in Buffalo.

Emerging evidence supports the idea that increased risk factors are associated with the severity of psoriasis. As part of the landmark Incident Health Outcomes and Psoriasis Events (iHope) study, investigators found that patients with disease affecting 10% or more body surface area had an increased risk of myocardial infarction. One study defined psoriasis severity by body surface area (JAMA Dermatol. 2013;149:1173-9). The investigators found that the burdens of MI and other comorbid diseases increase with increasing disease severity, particularly in those with 10% body surface area or more affected.

Investigators are also working to determine if systemic therapy reduces the risk of MI in psoriasis patients. The Consortium of Rheumatology Researchers of North America (CORRONA) registry database found that in patients with rheumatoid arthritis, anti–tumor necrosis factor (TNF) agents reduced the risk of cardiovascular events (HR, 0.39), compared with nonbiologic disease-modifying antirheumatic drugs. Methotrexate did not reduce the risk of cardiovascular events, while the use of prednisone increased the risk (Ann. Rheum. Dis. 2011;70:576-82). Another review showed that anti-TNF therapy decreased the risk, but the use of methotrexate decreased the risk slightly more (Rheumatology 2011;50:518-31). "Reassuringly, there was no increased risk of congestive heart failure, which has always been [included] in the label of [anti-]TNF agents," Dr. Kalb said.

A cohort study of 25,554 patients with moderate to severe psoriasis used U.S. administrative and pharmacy claims data to examine the risk of acute myocardial infarction in those who underwent systemic therapy, compared with those who underwent phototherapy. The investigators found a trend toward an increased risk of MI in those who received systemic therapy, but there were no significant differences in risk between the two treatment groups (Br. J. Dermatol. 2011;165:1066-73). On the other hand, a retrospective, longitudinal cohort study of 2,400 patients with severe psoriasis in Denmark showed that the use of biologic agents and methotrexate was associated with fewer cardiovascular events (hazard ratios, 0.48 and 0.50, respectively), but the use of other antipsoriatic therapies – including cyclosporine, retinoids, phototherapy, and topicals – were not (J. Intern Med. 2013;273:197-204).

A retrospective cohort study of 8,845 Kaiser Permanente psoriasis patients set out to determine whether treatment with TNF inhibitors was associated with a decreased risk of MI, compared with those who did not receive TNF inhibitors (Arch. Dermatol. 2012;148:1244-50) . After adjusting for MI risk factors, the researchers found that those who received TNF inhibitors had a significantly lower risk of MI, compared with those who received topical therapy (adjusted HR, 0.50).

"Why do different studies reach different conclusions?" Dr. Kalb asked. "Different populations were studied, and there were differences in terms of how reference groups were defined and in the methods for categorizing therapy and severity of disease. Data from population studies are not yet sufficient to determine whether [anti-]TNF agents will reduce the incidence of MI."

One conundrum for researchers is how to measure this decreased risk. "What surrogate markers should we use?" Dr. Kalb asked. "One study showed a significant decrease in CRP [C-reactive protein] and ESR [erythrocyte sedimentation rate] in patients receiving therapy. The gold standard of decrease in mortality in this type of study will not be done because it requires thousands of patients studied over at least 10 years." However, in cardiology, 18-fluorodeoxyglucose PET scanning shows decreased inflammation in patients taking statins. Whether the same effect can be shown in psoriasis patients taking systemic medications for their disease remains unknown, but prospective studies are ongoing.

Dr. Kalb disclosed that he is an investigator and/or consultant for AbbVie, Amgen, Celgene, Dermira, Janssen, Leo, Merck, Pfizer, and Taro. He is also on the dermatology safety monitoring board for ApoPharma and Eli Lilly.

[email protected]

On Twitter @dougbrunk

One of the most important elements of a psoriasis patient’s medical history is the medication list. We are aware of the possible association between induction or exacerbation of psoriasis and intake of drugs including beta-blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, lithium, and nonsteroidal anti-inflammatory drugs. However, we are lacking comprehensive data on these putative relationships.

Wu et al¹ evaluated the association of hypertension and antihypertensive medications with risk for psoriasis. The authors pointed out that psoriasis patients have an increased risk for hypertension, and medications for hypertension, especially beta-blockers, have been associated with the development of psoriasis. They noted, however, that there has been no prospective assessment of the association of existing hypertension and antihypertensive medications with risk for incident psoriasis.¹

The authors performed a prospective cohort study (June 1996 to June 1998) of 77,728 women from the Nurses’ Health Study who provided biennially updated data on hypertension and antihypertensive medications.¹ They documented 843 incidents of psoriasis during 1,066,339 person-years of follow-up. Women with hypertension tended to be older and had a higher body mass index. In addition, they had proportionately higher prevalence rates of cardiovascular disease, type 2 diabetes mellitus, and hypercholesterolemia. They also were less physically active than subjects without hypertension. Compared with those with normal blood pressure, women with hypertension lasting 6 years or more were at higher risk for development of psoriasis (hazard ratio [HR], 1.27; 95% confidence interval [CI], 1.03-1.57). In stratified analysis, the risk for psoriasis was higher among hypertensive women without medication use (HR, 1.49; 95% CI, 1.15-1.92) and among hypertensive women with current medication use (HR, 1.31; 95% CI, 1.10-1.55) when compared with those without hypertension and without medication use.¹

Among the individual antihypertensive drugs, only beta-blockers were associated with an increased risk for psoriasis.¹ Of interest, this association persisted in a duration-dependent manner, with a higher risk for psoriasis found among women who regularly used beta-blockers with a duration of use of 6 years or more (HR, 1.39; 95% CI, 1.11-1.73; P for trend=.009). No association was found between any other individual hypertension medication and the development of psoriasis.¹

The authors concluded that their study provided evidence that a history of long-term hypertension was associated with an increased risk for psoriasis.¹ Among the individual medications analyzed in the study, only beta-blockers were linked to an increased risk for psoriasis after long-term regular use (≥6 years). They noted that these findings provided insights into the relationship between hypertension, medications for the condition, and psoriasis. However, further work is necessary to confirm these findings and clarify the biological mechanisms that may explain these links.¹

As we further evaluate the associations between psoriasis and systemic comorbidities, we are learning more about the complex interrelationship between these conditions. The findings reported by Wu et al¹ serve as another reminder that clinicians should be proactive in having psoriasis patients actively monitor their blood pressure, either with the dermatologist or with the primary care physician. This type of novel prospective information serves as another piece of the puzzle in our comprehensive management of psoriasis.

One of the most important elements of a psoriasis patient’s medical history is the medication list. We are aware of the possible association between induction or exacerbation of psoriasis and intake of drugs including beta-blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, lithium, and nonsteroidal anti-inflammatory drugs. However, we are lacking comprehensive data on these putative relationships.

Wu et al¹ evaluated the association of hypertension and antihypertensive medications with risk for psoriasis. The authors pointed out that psoriasis patients have an increased risk for hypertension, and medications for hypertension, especially beta-blockers, have been associated with the development of psoriasis. They noted, however, that there has been no prospective assessment of the association of existing hypertension and antihypertensive medications with risk for incident psoriasis.¹

The authors performed a prospective cohort study (June 1996 to June 1998) of 77,728 women from the Nurses’ Health Study who provided biennially updated data on hypertension and antihypertensive medications.¹ They documented 843 incidents of psoriasis during 1,066,339 person-years of follow-up. Women with hypertension tended to be older and had a higher body mass index. In addition, they had proportionately higher prevalence rates of cardiovascular disease, type 2 diabetes mellitus, and hypercholesterolemia. They also were less physically active than subjects without hypertension. Compared with those with normal blood pressure, women with hypertension lasting 6 years or more were at higher risk for development of psoriasis (hazard ratio [HR], 1.27; 95% confidence interval [CI], 1.03-1.57). In stratified analysis, the risk for psoriasis was higher among hypertensive women without medication use (HR, 1.49; 95% CI, 1.15-1.92) and among hypertensive women with current medication use (HR, 1.31; 95% CI, 1.10-1.55) when compared with those without hypertension and without medication use.¹

Among the individual antihypertensive drugs, only beta-blockers were associated with an increased risk for psoriasis.¹ Of interest, this association persisted in a duration-dependent manner, with a higher risk for psoriasis found among women who regularly used beta-blockers with a duration of use of 6 years or more (HR, 1.39; 95% CI, 1.11-1.73; P for trend=.009). No association was found between any other individual hypertension medication and the development of psoriasis.¹

The authors concluded that their study provided evidence that a history of long-term hypertension was associated with an increased risk for psoriasis.¹ Among the individual medications analyzed in the study, only beta-blockers were linked to an increased risk for psoriasis after long-term regular use (≥6 years). They noted that these findings provided insights into the relationship between hypertension, medications for the condition, and psoriasis. However, further work is necessary to confirm these findings and clarify the biological mechanisms that may explain these links.¹

As we further evaluate the associations between psoriasis and systemic comorbidities, we are learning more about the complex interrelationship between these conditions. The findings reported by Wu et al¹ serve as another reminder that clinicians should be proactive in having psoriasis patients actively monitor their blood pressure, either with the dermatologist or with the primary care physician. This type of novel prospective information serves as another piece of the puzzle in our comprehensive management of psoriasis.

One of the most important elements of a psoriasis patient’s medical history is the medication list. We are aware of the possible association between induction or exacerbation of psoriasis and intake of drugs including beta-blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, lithium, and nonsteroidal anti-inflammatory drugs. However, we are lacking comprehensive data on these putative relationships.

Wu et al¹ evaluated the association of hypertension and antihypertensive medications with risk for psoriasis. The authors pointed out that psoriasis patients have an increased risk for hypertension, and medications for hypertension, especially beta-blockers, have been associated with the development of psoriasis. They noted, however, that there has been no prospective assessment of the association of existing hypertension and antihypertensive medications with risk for incident psoriasis.¹

The authors performed a prospective cohort study (June 1996 to June 1998) of 77,728 women from the Nurses’ Health Study who provided biennially updated data on hypertension and antihypertensive medications.¹ They documented 843 incidents of psoriasis during 1,066,339 person-years of follow-up. Women with hypertension tended to be older and had a higher body mass index. In addition, they had proportionately higher prevalence rates of cardiovascular disease, type 2 diabetes mellitus, and hypercholesterolemia. They also were less physically active than subjects without hypertension. Compared with those with normal blood pressure, women with hypertension lasting 6 years or more were at higher risk for development of psoriasis (hazard ratio [HR], 1.27; 95% confidence interval [CI], 1.03-1.57). In stratified analysis, the risk for psoriasis was higher among hypertensive women without medication use (HR, 1.49; 95% CI, 1.15-1.92) and among hypertensive women with current medication use (HR, 1.31; 95% CI, 1.10-1.55) when compared with those without hypertension and without medication use.¹

Among the individual antihypertensive drugs, only beta-blockers were associated with an increased risk for psoriasis.¹ Of interest, this association persisted in a duration-dependent manner, with a higher risk for psoriasis found among women who regularly used beta-blockers with a duration of use of 6 years or more (HR, 1.39; 95% CI, 1.11-1.73; P for trend=.009). No association was found between any other individual hypertension medication and the development of psoriasis.¹

The authors concluded that their study provided evidence that a history of long-term hypertension was associated with an increased risk for psoriasis.¹ Among the individual medications analyzed in the study, only beta-blockers were linked to an increased risk for psoriasis after long-term regular use (≥6 years). They noted that these findings provided insights into the relationship between hypertension, medications for the condition, and psoriasis. However, further work is necessary to confirm these findings and clarify the biological mechanisms that may explain these links.¹

As we further evaluate the associations between psoriasis and systemic comorbidities, we are learning more about the complex interrelationship between these conditions. The findings reported by Wu et al¹ serve as another reminder that clinicians should be proactive in having psoriasis patients actively monitor their blood pressure, either with the dermatologist or with the primary care physician. This type of novel prospective information serves as another piece of the puzzle in our comprehensive management of psoriasis.