Psoriasis

The prevalence of low back pain appears to be higher in people with psoriasis than in the general population, according to an analysis of national survey data.

The findings may change the way psoriasis patients are managed when they present to primary care or specialty clinics with sudden-onset back and buttock pain, said first author of the study, Dr. Nicole Thom of the division of rheumatology at Cedars-Sinai Medical Center, Los Angeles, and her colleagues (Arthritis Care Res. 2014 Dec. 2 [doi:10.1002/acr.22528]).

Using data from the 2009-2010 U.S. National Health and Nutrition Examination Survey of 6,684 adults, the researchers identified 5,103 people who had answered questions on back pain. A total of 148 had psoriasis and 5 had psoriatic arthritis (PsA).

People with psoriasis/PsA had a significantly higher prevalence of axial pain as measured using the 3-month duration criteria, compared with people without the disease (31.1% vs. 18.9%; P = .04). They were also more likely to have alternating buttock pain (7.2% vs. 2.4%; P = .03) and meet Berlin 7b and 8a criteria for inflammatory back pain (P = .04 and P = .02, respectively). The prevalence of spondyloarthritis was significantly higher in the psoriasis/PsA group when using Amor or European Spondyloarthritis Study Group criteria (14.3% vs. 1.5%; P = .001). Sudden onset of axial pain was also higher in the psoriasis/PsA group (23.3% vs. 13.0%; P = .01), the researchers reported.

“The internist or family medicine physician should include inflammatory back pain in their differential diagnosis,” the study authors suggest.

With more and more research continuing to support multiple comorbidities in psoriasis, it also raises the question as to whether rheumatologists, dermatologists, and other health care professionals should be screening for them, they said.

The work was supported in part by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and a National Center for Research Resources grant to the Clinical Translational Science Institute at the University of California, Los Angeles.

The prevalence of low back pain appears to be higher in people with psoriasis than in the general population, according to an analysis of national survey data.

The findings may change the way psoriasis patients are managed when they present to primary care or specialty clinics with sudden-onset back and buttock pain, said first author of the study, Dr. Nicole Thom of the division of rheumatology at Cedars-Sinai Medical Center, Los Angeles, and her colleagues (Arthritis Care Res. 2014 Dec. 2 [doi:10.1002/acr.22528]).

Using data from the 2009-2010 U.S. National Health and Nutrition Examination Survey of 6,684 adults, the researchers identified 5,103 people who had answered questions on back pain. A total of 148 had psoriasis and 5 had psoriatic arthritis (PsA).

People with psoriasis/PsA had a significantly higher prevalence of axial pain as measured using the 3-month duration criteria, compared with people without the disease (31.1% vs. 18.9%; P = .04). They were also more likely to have alternating buttock pain (7.2% vs. 2.4%; P = .03) and meet Berlin 7b and 8a criteria for inflammatory back pain (P = .04 and P = .02, respectively). The prevalence of spondyloarthritis was significantly higher in the psoriasis/PsA group when using Amor or European Spondyloarthritis Study Group criteria (14.3% vs. 1.5%; P = .001). Sudden onset of axial pain was also higher in the psoriasis/PsA group (23.3% vs. 13.0%; P = .01), the researchers reported.

“The internist or family medicine physician should include inflammatory back pain in their differential diagnosis,” the study authors suggest.

With more and more research continuing to support multiple comorbidities in psoriasis, it also raises the question as to whether rheumatologists, dermatologists, and other health care professionals should be screening for them, they said.

The work was supported in part by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and a National Center for Research Resources grant to the Clinical Translational Science Institute at the University of California, Los Angeles.

The prevalence of low back pain appears to be higher in people with psoriasis than in the general population, according to an analysis of national survey data.

The findings may change the way psoriasis patients are managed when they present to primary care or specialty clinics with sudden-onset back and buttock pain, said first author of the study, Dr. Nicole Thom of the division of rheumatology at Cedars-Sinai Medical Center, Los Angeles, and her colleagues (Arthritis Care Res. 2014 Dec. 2 [doi:10.1002/acr.22528]).

Using data from the 2009-2010 U.S. National Health and Nutrition Examination Survey of 6,684 adults, the researchers identified 5,103 people who had answered questions on back pain. A total of 148 had psoriasis and 5 had psoriatic arthritis (PsA).

People with psoriasis/PsA had a significantly higher prevalence of axial pain as measured using the 3-month duration criteria, compared with people without the disease (31.1% vs. 18.9%; P = .04). They were also more likely to have alternating buttock pain (7.2% vs. 2.4%; P = .03) and meet Berlin 7b and 8a criteria for inflammatory back pain (P = .04 and P = .02, respectively). The prevalence of spondyloarthritis was significantly higher in the psoriasis/PsA group when using Amor or European Spondyloarthritis Study Group criteria (14.3% vs. 1.5%; P = .001). Sudden onset of axial pain was also higher in the psoriasis/PsA group (23.3% vs. 13.0%; P = .01), the researchers reported.

“The internist or family medicine physician should include inflammatory back pain in their differential diagnosis,” the study authors suggest.

With more and more research continuing to support multiple comorbidities in psoriasis, it also raises the question as to whether rheumatologists, dermatologists, and other health care professionals should be screening for them, they said.

The work was supported in part by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and a National Center for Research Resources grant to the Clinical Translational Science Institute at the University of California, Los Angeles.

Psoriasis is a chronic relapsing inflammatory skin and joint disease that affects 1% to 3% of the US population.¹ In cases of mild to moderate disease, topical agents including corticosteroids, vitamin D analogues, and retinoids are the mainstay of therapy. The need for long-term treatment can be frustrating for patients and treatment adherence often is problematic, resulting in poor outcomes. Reported adherence rates to topical psoriasis treatments range from 27% to 73%.^2-6

Topical agents for treatment of psoriasis are available in various formulations, including creams, lotions, gels, ointments, solutions, and shampoos. For topical psoriasis therapies, vehicle formulation plays a major role in both delivery of the active drug and treatment adherence. Patients often cite poor cosmetic characteristics (eg, product feels too sticky or greasy, product feels unpleasant/has a bad texture, product is too messy, product application is too time consuming/takes too long to rub in) as reasons for poor treatment adherence.^2,6-9 Psoriasis patients tend to prefer formulations that are not as messy such as solutions and foams versus creams, gels, and ointments.¹⁰

Ointments have been favored by physicians for the treatment of psoriasis because of the belief that their occlusive properties result in greater potency; however, a systematic review of clinical trials of different formulations of clobetasol propionate did not find that ointments were more effective than other vehicles.¹¹ Furthermore, if a patient finds an ointment to be cosmetically unacceptable, he/she will be less inclined to use the medication as prescribed, regardless of its potency.

The objective of this study was to conduct a preliminary assessment of patient preference for ointment versus topical suspension formulations of calcipotriene 0.005%–betamethasone dipropionate 0.064% for treatment of plaque psoriasis. The specific attributes that were found to be appealing or unappealing by participants for each formulation also were evaluated.

Methods

Study Design and Participants

This open-label, investigator-blinded, crossover, prospective, single-center study evaluated patient preference for ointment versus topical suspension formulations of calcipo-triene 0.005%–betamethasone dipropionate 0.064% in the treatment of plaque psoriasis. The study protocol was approved by the Wake Forest School of Medicine (Winston-Salem, North Carolina) institutional review board.

Participants were recruited from the Wake Forest School of Medicine dermatology clinic. Inclusion criteria included men and women with mild to moderate plaque-type psoriasis who were 18 years of age or older; participants also were required to have an investigator global assessment (IGA) score of 2 (mild) or 3 (moderate) on a 5-point scale and 1% to 10% body surface involvement on the trunk or extremities.

Exclusion criteria included use of a topical or systemic psoriasis treatment within 2 or 4 weeks of baseline, respectively. Women who were pregnant, breastfeeding, planning to become pregnant, or could potentially become pregnant and were not using a medically accepted form of contraception also were excluded from the study. Patients with other serious skin conditions or any other chronic medical conditions that were not well controlled also were considered ineligible.

As a pilot study, a sample size of 20 participants was needed based on available funding.

Assessments

At baseline, the diagnosis of plaque-type psoriasis in each participant was confirmed by the investigator. Each participant’s medical history was obtained and all prior and current medications were reviewed to ensure eligibility criteria were met. Female participants of childbearing potential also underwent a urine pregnancy test. Consent was obtained from all enrolled participants. Investigators assessed the severity of psoriasis at baseline using the IGA.

All participants then were randomized (1:1 randomization) for treatment with either calcipotriene 0.005%–betamethasone dipropionate 0.064% ointment or calcipotriene 0.005%–betamethasone dipropionate 0.064% topical suspension. A simple random sampling chart was prepared and used by the study staff to determine treatment group allotment. Participants were instructed to apply the assigned study drug to affected areas of the body, excluding the scalp, face, and intertriginous areas, once daily for 3 days. Participants and study staff were aware of the study product being used, while investigators remained blinded. Participants also were asked to maintain a daily medication diary noting when the medication was applied.

Participants returned on day 3 for crossover treatment. Participants were asked to complete a subjective participant preference survey and study staff reviewed concomitant medications and adverse events. The packaging for the initial study drug was collected and weighed, and the crossover drug was dispensed to each participant to be applied once daily for 3 days.

Participants returned on day 6 or 7 for follow-up and were again asked to complete the subjective participant preference survey; study staff reviewed concomitant medications and adverse events. The packaging for the crossover study drug was collected and weighed, and the participant’s medication diary also was collected.

Subjective Participant Preference Survey

The subjective participant preference survey consisted of 15 questions relating to the participant’s experience with the study drug (eg, how the product felt to touch, amount of greasiness, time it took to apply). The final survey question asked participants to rate the overall appeal of the vehicle. Participants responded to the questions using a 7-point grading scale (1=extremely unappealing; 4=neutral; 7=extremely appealing). Total preference scores could range from 15 to 105.

End Points

The primary end point was the mean total preference score for each study drug obtained from the subjective participant preference surveys. Secondary end points included median values for individual survey questions and treatment adherence, which was measured from self-reported medication diary entries.

Statistical Analysis

Participant characteristics were reported with percentages for dichotomous data and median and ranges for other data. Subjective participant preference survey scores were calculated by taking the mean (standard deviation [SD]) sum of the scores for each individual survey item for both products. A generalized linear model that accounted for possible carryover and period effects was used to compare the difference of individual participant scores for the 2 products using SAS software. The mean (SD) amount of product used was reported and correlated to the preference score using a Spearman rank correlation. Total and individual survey scores were compared between sexes using Wilcoxon rank sum tests.

Results

Participants were enrolled in and completed the study from January 2013 to March 2013. The Figure presents a diagram of the Consolidated Standards of Reporting Trials. Thirty patients were screened; 10 patients did not meet eligibility criteria. Twenty patients were enrolled in the study with 10 patients randomized to each study arm. All 20 participants completed the study.

Consolidated Standards of Reporting Trials diagram of plaque psoriasis treatment with calcipotriene 0.005%–betamethasone dipropionate 0.064% ointment versus topical suspension.

Participant demographics are described in Table 1. The median age was 48 years (range 29–64 years). The majority of participants were male (13/20) and white (18/20). The median IGA score was 3 (range, 2–3).

The mean (SD) total preference score for the calcipotriene 0.005%–betamethasone dipropionate 0.064% ointment formulation was 73.5 (19.4) and 80 (20.2) for the topical suspension formulation. The difference between means was -6.5 (95% confidence interval, -19.7-6.8; P=.32 after adjusting for possible carryover and period effects). Participants used a mean (SD) of 11 (11.4) g of product per study arm for the ointment formulation and 8.8 (6.6) g for the topical suspension formulation. There was no correlation between the amount of product used and preference for product (Spearman r=-0.01; P=.94). No statistically significant difference in product preference among men versus women was noted when considering total preference score or median scores of individual survey questions. Median  overall appeal rating for the ointment formulation was 5 (slightly appealing) versus 6 (moderately appealing) for the topical suspension formulation, approaching statistical significance with P=.06 (Table 2). No significant carryover effects from one product to the other were noted (P=.64). The mean (SD) total preference scores were 81.1 (18.4) and 77.6 (21.2) in participants who used the topical suspension first followed by the ointment. In participants who used the ointment first followed by the topical suspension, the mean (SD) total preference scores were 69.4 (17.6) and 78.9 (22.8). Self-reported treatment adherence according to the participant’s daily medication diary was 100%.

Adverse effects during the study included 1 report of neck and back muscle pain and 1 report of sinusitis; neither was considered to be related to the study drugs.

Comment

Psoriasis is a chronic disease that can be difficult to treat, and treatment compliance often is poor. Multiple topical agents often are needed for adequate disease control, and adherence can be an even greater hurdle than with monotherapy. Combination products such as calcipotriene–betamethasone dipropionate offer the potential advantage of once-daily application. Adherence to once-daily application regimens for treatment of psoriasis has been shown to be greater than twice-daily application (82% vs 44%).⁴ However, the vehicle may be an adherence barrier for some patients.

Calcipotriene 0.005%–betamethasone dipropionate 0.064% topical suspension originally was indicated for the treatment of psoriasis of the scalp; however, it is now also indicated for treatment of psoriasis of the body.¹² This topical suspension formulation is less messy, which could potentially be more cosmetically appealing and useful for improving treatment adherence.

Overall, the participants in our small pilot study showed a preference for the topical suspension versus the ointment formulation. The difference was substantial but was not statistically significant. This result is consistent with a previous study in which patients were found to prefer solutions that were less greasy compared to messy sticky ointments.¹⁰ Although the topical suspension received a higher average rating from participants for how it felt to touch and how it felt under clothing than the ointment and the ointment was rated on average as more greasy (none of these individual items achieved statistical significance), the calcipotriene–betamethasone dipropionate ointment was still rated as slightly appealing overall (Table 2). This result supports the need for physicians to discuss individual patient preferences when choosing the most appropriate vehicle for topical psoriasis treatment.

In our study, participants were found to use less product during treatment with the topical suspension versus the ointment, likely because the topical suspension formulation is thinner and spreads easier; however, participants rated the ease of application of the 2 products equally (Table 2). Ease of application was rated moderately appealing and time to apply was rated slightly to moderately appealing, which is important because patients often cite these factors as barriers to treatment adherence.^2,6,13

The occlusive properties of ointment formulations provide moisturization by preventing water loss, a property that can be desirable when treating psoriatic plaques. Unlike the ointment, which was formulated with petrolatum and mineral oil, the calcipotriene–betamethasone dipropionate topical suspension was formulated with hydrogenated castor oil and mineral oil to provide moisturization. Nevertheless, participants found both the ointment and topical suspension to be moderately appealing (median score, 6; P=.94) for moisturization.

Limitations of this pilot study include the small sample size, which restricted the extent of subgroup analyses and the generalizability of our results. The small sample size also may or may not have contributed to the lack of statistical significance in the majority of the outcomes. This study provides pilot data that can be used to define a larger study; however, we do not think that a larger study is needed, as patients can be offered both vehicles in a practical clinical setting and can choose the product that is right for them. The short treatment duration of 3 days for each formulation also is a limitation, as a patient’s preference may change over time with longer use of the product. Treatment efficacy, which was not measured in this study, also could have an effect on patient preference, which could be assessed over a longer treatment period. Additionally, the study drugs may not be representative of all ointments or topical suspensions in their cosmetic appeal.

Conclusion

In this small cohort of plaque psoriasis patients, a calcipotriene–betamethasone dipropionate topical suspension was preferred over an ointment formulation, but in clinical practice it may be best to allow patients to choose the vehicle formulation that is most desirable on an individual basis. The topical suspension provides clinicians with an alternative that not only has the benefits of a combination product but also has been found to be appealing to patients.

Psoriasis is a chronic relapsing inflammatory skin and joint disease that affects 1% to 3% of the US population.¹ In cases of mild to moderate disease, topical agents including corticosteroids, vitamin D analogues, and retinoids are the mainstay of therapy. The need for long-term treatment can be frustrating for patients and treatment adherence often is problematic, resulting in poor outcomes. Reported adherence rates to topical psoriasis treatments range from 27% to 73%.^2-6

Topical agents for treatment of psoriasis are available in various formulations, including creams, lotions, gels, ointments, solutions, and shampoos. For topical psoriasis therapies, vehicle formulation plays a major role in both delivery of the active drug and treatment adherence. Patients often cite poor cosmetic characteristics (eg, product feels too sticky or greasy, product feels unpleasant/has a bad texture, product is too messy, product application is too time consuming/takes too long to rub in) as reasons for poor treatment adherence.^2,6-9 Psoriasis patients tend to prefer formulations that are not as messy such as solutions and foams versus creams, gels, and ointments.¹⁰

Ointments have been favored by physicians for the treatment of psoriasis because of the belief that their occlusive properties result in greater potency; however, a systematic review of clinical trials of different formulations of clobetasol propionate did not find that ointments were more effective than other vehicles.¹¹ Furthermore, if a patient finds an ointment to be cosmetically unacceptable, he/she will be less inclined to use the medication as prescribed, regardless of its potency.

The objective of this study was to conduct a preliminary assessment of patient preference for ointment versus topical suspension formulations of calcipotriene 0.005%–betamethasone dipropionate 0.064% for treatment of plaque psoriasis. The specific attributes that were found to be appealing or unappealing by participants for each formulation also were evaluated.

Methods

Study Design and Participants

This open-label, investigator-blinded, crossover, prospective, single-center study evaluated patient preference for ointment versus topical suspension formulations of calcipo-triene 0.005%–betamethasone dipropionate 0.064% in the treatment of plaque psoriasis. The study protocol was approved by the Wake Forest School of Medicine (Winston-Salem, North Carolina) institutional review board.

Participants were recruited from the Wake Forest School of Medicine dermatology clinic. Inclusion criteria included men and women with mild to moderate plaque-type psoriasis who were 18 years of age or older; participants also were required to have an investigator global assessment (IGA) score of 2 (mild) or 3 (moderate) on a 5-point scale and 1% to 10% body surface involvement on the trunk or extremities.

Exclusion criteria included use of a topical or systemic psoriasis treatment within 2 or 4 weeks of baseline, respectively. Women who were pregnant, breastfeeding, planning to become pregnant, or could potentially become pregnant and were not using a medically accepted form of contraception also were excluded from the study. Patients with other serious skin conditions or any other chronic medical conditions that were not well controlled also were considered ineligible.

As a pilot study, a sample size of 20 participants was needed based on available funding.

Assessments

At baseline, the diagnosis of plaque-type psoriasis in each participant was confirmed by the investigator. Each participant’s medical history was obtained and all prior and current medications were reviewed to ensure eligibility criteria were met. Female participants of childbearing potential also underwent a urine pregnancy test. Consent was obtained from all enrolled participants. Investigators assessed the severity of psoriasis at baseline using the IGA.

All participants then were randomized (1:1 randomization) for treatment with either calcipotriene 0.005%–betamethasone dipropionate 0.064% ointment or calcipotriene 0.005%–betamethasone dipropionate 0.064% topical suspension. A simple random sampling chart was prepared and used by the study staff to determine treatment group allotment. Participants were instructed to apply the assigned study drug to affected areas of the body, excluding the scalp, face, and intertriginous areas, once daily for 3 days. Participants and study staff were aware of the study product being used, while investigators remained blinded. Participants also were asked to maintain a daily medication diary noting when the medication was applied.

Participants returned on day 3 for crossover treatment. Participants were asked to complete a subjective participant preference survey and study staff reviewed concomitant medications and adverse events. The packaging for the initial study drug was collected and weighed, and the crossover drug was dispensed to each participant to be applied once daily for 3 days.

Participants returned on day 6 or 7 for follow-up and were again asked to complete the subjective participant preference survey; study staff reviewed concomitant medications and adverse events. The packaging for the crossover study drug was collected and weighed, and the participant’s medication diary also was collected.

Subjective Participant Preference Survey

The subjective participant preference survey consisted of 15 questions relating to the participant’s experience with the study drug (eg, how the product felt to touch, amount of greasiness, time it took to apply). The final survey question asked participants to rate the overall appeal of the vehicle. Participants responded to the questions using a 7-point grading scale (1=extremely unappealing; 4=neutral; 7=extremely appealing). Total preference scores could range from 15 to 105.

End Points

The primary end point was the mean total preference score for each study drug obtained from the subjective participant preference surveys. Secondary end points included median values for individual survey questions and treatment adherence, which was measured from self-reported medication diary entries.

Statistical Analysis

Participant characteristics were reported with percentages for dichotomous data and median and ranges for other data. Subjective participant preference survey scores were calculated by taking the mean (standard deviation [SD]) sum of the scores for each individual survey item for both products. A generalized linear model that accounted for possible carryover and period effects was used to compare the difference of individual participant scores for the 2 products using SAS software. The mean (SD) amount of product used was reported and correlated to the preference score using a Spearman rank correlation. Total and individual survey scores were compared between sexes using Wilcoxon rank sum tests.

Results

Participants were enrolled in and completed the study from January 2013 to March 2013. The Figure presents a diagram of the Consolidated Standards of Reporting Trials. Thirty patients were screened; 10 patients did not meet eligibility criteria. Twenty patients were enrolled in the study with 10 patients randomized to each study arm. All 20 participants completed the study.

Consolidated Standards of Reporting Trials diagram of plaque psoriasis treatment with calcipotriene 0.005%–betamethasone dipropionate 0.064% ointment versus topical suspension.

Participant demographics are described in Table 1. The median age was 48 years (range 29–64 years). The majority of participants were male (13/20) and white (18/20). The median IGA score was 3 (range, 2–3).

The mean (SD) total preference score for the calcipotriene 0.005%–betamethasone dipropionate 0.064% ointment formulation was 73.5 (19.4) and 80 (20.2) for the topical suspension formulation. The difference between means was -6.5 (95% confidence interval, -19.7-6.8; P=.32 after adjusting for possible carryover and period effects). Participants used a mean (SD) of 11 (11.4) g of product per study arm for the ointment formulation and 8.8 (6.6) g for the topical suspension formulation. There was no correlation between the amount of product used and preference for product (Spearman r=-0.01; P=.94). No statistically significant difference in product preference among men versus women was noted when considering total preference score or median scores of individual survey questions. Median  overall appeal rating for the ointment formulation was 5 (slightly appealing) versus 6 (moderately appealing) for the topical suspension formulation, approaching statistical significance with P=.06 (Table 2). No significant carryover effects from one product to the other were noted (P=.64). The mean (SD) total preference scores were 81.1 (18.4) and 77.6 (21.2) in participants who used the topical suspension first followed by the ointment. In participants who used the ointment first followed by the topical suspension, the mean (SD) total preference scores were 69.4 (17.6) and 78.9 (22.8). Self-reported treatment adherence according to the participant’s daily medication diary was 100%.

Adverse effects during the study included 1 report of neck and back muscle pain and 1 report of sinusitis; neither was considered to be related to the study drugs.

Comment

Psoriasis is a chronic disease that can be difficult to treat, and treatment compliance often is poor. Multiple topical agents often are needed for adequate disease control, and adherence can be an even greater hurdle than with monotherapy. Combination products such as calcipotriene–betamethasone dipropionate offer the potential advantage of once-daily application. Adherence to once-daily application regimens for treatment of psoriasis has been shown to be greater than twice-daily application (82% vs 44%).⁴ However, the vehicle may be an adherence barrier for some patients.

Calcipotriene 0.005%–betamethasone dipropionate 0.064% topical suspension originally was indicated for the treatment of psoriasis of the scalp; however, it is now also indicated for treatment of psoriasis of the body.¹² This topical suspension formulation is less messy, which could potentially be more cosmetically appealing and useful for improving treatment adherence.

Overall, the participants in our small pilot study showed a preference for the topical suspension versus the ointment formulation. The difference was substantial but was not statistically significant. This result is consistent with a previous study in which patients were found to prefer solutions that were less greasy compared to messy sticky ointments.¹⁰ Although the topical suspension received a higher average rating from participants for how it felt to touch and how it felt under clothing than the ointment and the ointment was rated on average as more greasy (none of these individual items achieved statistical significance), the calcipotriene–betamethasone dipropionate ointment was still rated as slightly appealing overall (Table 2). This result supports the need for physicians to discuss individual patient preferences when choosing the most appropriate vehicle for topical psoriasis treatment.

In our study, participants were found to use less product during treatment with the topical suspension versus the ointment, likely because the topical suspension formulation is thinner and spreads easier; however, participants rated the ease of application of the 2 products equally (Table 2). Ease of application was rated moderately appealing and time to apply was rated slightly to moderately appealing, which is important because patients often cite these factors as barriers to treatment adherence.^2,6,13

The occlusive properties of ointment formulations provide moisturization by preventing water loss, a property that can be desirable when treating psoriatic plaques. Unlike the ointment, which was formulated with petrolatum and mineral oil, the calcipotriene–betamethasone dipropionate topical suspension was formulated with hydrogenated castor oil and mineral oil to provide moisturization. Nevertheless, participants found both the ointment and topical suspension to be moderately appealing (median score, 6; P=.94) for moisturization.

Limitations of this pilot study include the small sample size, which restricted the extent of subgroup analyses and the generalizability of our results. The small sample size also may or may not have contributed to the lack of statistical significance in the majority of the outcomes. This study provides pilot data that can be used to define a larger study; however, we do not think that a larger study is needed, as patients can be offered both vehicles in a practical clinical setting and can choose the product that is right for them. The short treatment duration of 3 days for each formulation also is a limitation, as a patient’s preference may change over time with longer use of the product. Treatment efficacy, which was not measured in this study, also could have an effect on patient preference, which could be assessed over a longer treatment period. Additionally, the study drugs may not be representative of all ointments or topical suspensions in their cosmetic appeal.

Conclusion

In this small cohort of plaque psoriasis patients, a calcipotriene–betamethasone dipropionate topical suspension was preferred over an ointment formulation, but in clinical practice it may be best to allow patients to choose the vehicle formulation that is most desirable on an individual basis. The topical suspension provides clinicians with an alternative that not only has the benefits of a combination product but also has been found to be appealing to patients.

Psoriasis is a chronic relapsing inflammatory skin and joint disease that affects 1% to 3% of the US population.¹ In cases of mild to moderate disease, topical agents including corticosteroids, vitamin D analogues, and retinoids are the mainstay of therapy. The need for long-term treatment can be frustrating for patients and treatment adherence often is problematic, resulting in poor outcomes. Reported adherence rates to topical psoriasis treatments range from 27% to 73%.^2-6

Topical agents for treatment of psoriasis are available in various formulations, including creams, lotions, gels, ointments, solutions, and shampoos. For topical psoriasis therapies, vehicle formulation plays a major role in both delivery of the active drug and treatment adherence. Patients often cite poor cosmetic characteristics (eg, product feels too sticky or greasy, product feels unpleasant/has a bad texture, product is too messy, product application is too time consuming/takes too long to rub in) as reasons for poor treatment adherence.^2,6-9 Psoriasis patients tend to prefer formulations that are not as messy such as solutions and foams versus creams, gels, and ointments.¹⁰

Ointments have been favored by physicians for the treatment of psoriasis because of the belief that their occlusive properties result in greater potency; however, a systematic review of clinical trials of different formulations of clobetasol propionate did not find that ointments were more effective than other vehicles.¹¹ Furthermore, if a patient finds an ointment to be cosmetically unacceptable, he/she will be less inclined to use the medication as prescribed, regardless of its potency.

The objective of this study was to conduct a preliminary assessment of patient preference for ointment versus topical suspension formulations of calcipotriene 0.005%–betamethasone dipropionate 0.064% for treatment of plaque psoriasis. The specific attributes that were found to be appealing or unappealing by participants for each formulation also were evaluated.

Methods

Study Design and Participants

This open-label, investigator-blinded, crossover, prospective, single-center study evaluated patient preference for ointment versus topical suspension formulations of calcipo-triene 0.005%–betamethasone dipropionate 0.064% in the treatment of plaque psoriasis. The study protocol was approved by the Wake Forest School of Medicine (Winston-Salem, North Carolina) institutional review board.

Participants were recruited from the Wake Forest School of Medicine dermatology clinic. Inclusion criteria included men and women with mild to moderate plaque-type psoriasis who were 18 years of age or older; participants also were required to have an investigator global assessment (IGA) score of 2 (mild) or 3 (moderate) on a 5-point scale and 1% to 10% body surface involvement on the trunk or extremities.

Exclusion criteria included use of a topical or systemic psoriasis treatment within 2 or 4 weeks of baseline, respectively. Women who were pregnant, breastfeeding, planning to become pregnant, or could potentially become pregnant and were not using a medically accepted form of contraception also were excluded from the study. Patients with other serious skin conditions or any other chronic medical conditions that were not well controlled also were considered ineligible.

As a pilot study, a sample size of 20 participants was needed based on available funding.

Assessments

At baseline, the diagnosis of plaque-type psoriasis in each participant was confirmed by the investigator. Each participant’s medical history was obtained and all prior and current medications were reviewed to ensure eligibility criteria were met. Female participants of childbearing potential also underwent a urine pregnancy test. Consent was obtained from all enrolled participants. Investigators assessed the severity of psoriasis at baseline using the IGA.

All participants then were randomized (1:1 randomization) for treatment with either calcipotriene 0.005%–betamethasone dipropionate 0.064% ointment or calcipotriene 0.005%–betamethasone dipropionate 0.064% topical suspension. A simple random sampling chart was prepared and used by the study staff to determine treatment group allotment. Participants were instructed to apply the assigned study drug to affected areas of the body, excluding the scalp, face, and intertriginous areas, once daily for 3 days. Participants and study staff were aware of the study product being used, while investigators remained blinded. Participants also were asked to maintain a daily medication diary noting when the medication was applied.

Participants returned on day 3 for crossover treatment. Participants were asked to complete a subjective participant preference survey and study staff reviewed concomitant medications and adverse events. The packaging for the initial study drug was collected and weighed, and the crossover drug was dispensed to each participant to be applied once daily for 3 days.

Participants returned on day 6 or 7 for follow-up and were again asked to complete the subjective participant preference survey; study staff reviewed concomitant medications and adverse events. The packaging for the crossover study drug was collected and weighed, and the participant’s medication diary also was collected.

Subjective Participant Preference Survey

The subjective participant preference survey consisted of 15 questions relating to the participant’s experience with the study drug (eg, how the product felt to touch, amount of greasiness, time it took to apply). The final survey question asked participants to rate the overall appeal of the vehicle. Participants responded to the questions using a 7-point grading scale (1=extremely unappealing; 4=neutral; 7=extremely appealing). Total preference scores could range from 15 to 105.

End Points

The primary end point was the mean total preference score for each study drug obtained from the subjective participant preference surveys. Secondary end points included median values for individual survey questions and treatment adherence, which was measured from self-reported medication diary entries.

Statistical Analysis

Participant characteristics were reported with percentages for dichotomous data and median and ranges for other data. Subjective participant preference survey scores were calculated by taking the mean (standard deviation [SD]) sum of the scores for each individual survey item for both products. A generalized linear model that accounted for possible carryover and period effects was used to compare the difference of individual participant scores for the 2 products using SAS software. The mean (SD) amount of product used was reported and correlated to the preference score using a Spearman rank correlation. Total and individual survey scores were compared between sexes using Wilcoxon rank sum tests.

Results

Participants were enrolled in and completed the study from January 2013 to March 2013. The Figure presents a diagram of the Consolidated Standards of Reporting Trials. Thirty patients were screened; 10 patients did not meet eligibility criteria. Twenty patients were enrolled in the study with 10 patients randomized to each study arm. All 20 participants completed the study.

Consolidated Standards of Reporting Trials diagram of plaque psoriasis treatment with calcipotriene 0.005%–betamethasone dipropionate 0.064% ointment versus topical suspension.

Participant demographics are described in Table 1. The median age was 48 years (range 29–64 years). The majority of participants were male (13/20) and white (18/20). The median IGA score was 3 (range, 2–3).

The mean (SD) total preference score for the calcipotriene 0.005%–betamethasone dipropionate 0.064% ointment formulation was 73.5 (19.4) and 80 (20.2) for the topical suspension formulation. The difference between means was -6.5 (95% confidence interval, -19.7-6.8; P=.32 after adjusting for possible carryover and period effects). Participants used a mean (SD) of 11 (11.4) g of product per study arm for the ointment formulation and 8.8 (6.6) g for the topical suspension formulation. There was no correlation between the amount of product used and preference for product (Spearman r=-0.01; P=.94). No statistically significant difference in product preference among men versus women was noted when considering total preference score or median scores of individual survey questions. Median  overall appeal rating for the ointment formulation was 5 (slightly appealing) versus 6 (moderately appealing) for the topical suspension formulation, approaching statistical significance with P=.06 (Table 2). No significant carryover effects from one product to the other were noted (P=.64). The mean (SD) total preference scores were 81.1 (18.4) and 77.6 (21.2) in participants who used the topical suspension first followed by the ointment. In participants who used the ointment first followed by the topical suspension, the mean (SD) total preference scores were 69.4 (17.6) and 78.9 (22.8). Self-reported treatment adherence according to the participant’s daily medication diary was 100%.

Adverse effects during the study included 1 report of neck and back muscle pain and 1 report of sinusitis; neither was considered to be related to the study drugs.

Comment

Psoriasis is a chronic disease that can be difficult to treat, and treatment compliance often is poor. Multiple topical agents often are needed for adequate disease control, and adherence can be an even greater hurdle than with monotherapy. Combination products such as calcipotriene–betamethasone dipropionate offer the potential advantage of once-daily application. Adherence to once-daily application regimens for treatment of psoriasis has been shown to be greater than twice-daily application (82% vs 44%).⁴ However, the vehicle may be an adherence barrier for some patients.

Calcipotriene 0.005%–betamethasone dipropionate 0.064% topical suspension originally was indicated for the treatment of psoriasis of the scalp; however, it is now also indicated for treatment of psoriasis of the body.¹² This topical suspension formulation is less messy, which could potentially be more cosmetically appealing and useful for improving treatment adherence.

Overall, the participants in our small pilot study showed a preference for the topical suspension versus the ointment formulation. The difference was substantial but was not statistically significant. This result is consistent with a previous study in which patients were found to prefer solutions that were less greasy compared to messy sticky ointments.¹⁰ Although the topical suspension received a higher average rating from participants for how it felt to touch and how it felt under clothing than the ointment and the ointment was rated on average as more greasy (none of these individual items achieved statistical significance), the calcipotriene–betamethasone dipropionate ointment was still rated as slightly appealing overall (Table 2). This result supports the need for physicians to discuss individual patient preferences when choosing the most appropriate vehicle for topical psoriasis treatment.

In our study, participants were found to use less product during treatment with the topical suspension versus the ointment, likely because the topical suspension formulation is thinner and spreads easier; however, participants rated the ease of application of the 2 products equally (Table 2). Ease of application was rated moderately appealing and time to apply was rated slightly to moderately appealing, which is important because patients often cite these factors as barriers to treatment adherence.^2,6,13

The occlusive properties of ointment formulations provide moisturization by preventing water loss, a property that can be desirable when treating psoriatic plaques. Unlike the ointment, which was formulated with petrolatum and mineral oil, the calcipotriene–betamethasone dipropionate topical suspension was formulated with hydrogenated castor oil and mineral oil to provide moisturization. Nevertheless, participants found both the ointment and topical suspension to be moderately appealing (median score, 6; P=.94) for moisturization.

Limitations of this pilot study include the small sample size, which restricted the extent of subgroup analyses and the generalizability of our results. The small sample size also may or may not have contributed to the lack of statistical significance in the majority of the outcomes. This study provides pilot data that can be used to define a larger study; however, we do not think that a larger study is needed, as patients can be offered both vehicles in a practical clinical setting and can choose the product that is right for them. The short treatment duration of 3 days for each formulation also is a limitation, as a patient’s preference may change over time with longer use of the product. Treatment efficacy, which was not measured in this study, also could have an effect on patient preference, which could be assessed over a longer treatment period. Additionally, the study drugs may not be representative of all ointments or topical suspensions in their cosmetic appeal.

Conclusion

In this small cohort of plaque psoriasis patients, a calcipotriene–betamethasone dipropionate topical suspension was preferred over an ointment formulation, but in clinical practice it may be best to allow patients to choose the vehicle formulation that is most desirable on an individual basis. The topical suspension provides clinicians with an alternative that not only has the benefits of a combination product but also has been found to be appealing to patients.

AMSTERDAM – Patient complaints of psoriasis-related sexual difficulties decreased significantly in response to treatment with the investigational biologic agent ixekizumab in a phase 2 dose-ranging study.

Sexual problems attributed by psoriasis patients to their skin condition are a common, underappreciated, and understudied problem. Most physicians simply don’t ask. But when they do, as was done formally in this study, it turned out that at baseline roughly one-third of the 142 participating subjects with moderate to severe chronic plaque psoriasis reported some degree of sexual problems they believed due specifically to their skin disease, Dr. Lyn Guenther reported at the annual congress of the European Academy of Dermatology and Venereology.

That rate dropped precipitously and in dose-dependent fashion in response to subcutaneous therapy with ixekizumab, a super-potent psoriasis medication directed against interleukin 17A, according to Dr. Guenther, professor of dermatology at the University of Western Ontario, London.

The study entailed double-blind randomization of the 142 participants to subcutaneous injections of ixekizumab at 10, 25, 75, or 150 mg or placebo at 0, 2, 4, 8, 12, and 16 weeks. The standard primary outcome -- the proportion of patients with a PASI 75 improvement at 12 weeks -- has previously been reported as highly positive (N. Engl. J. Med. 2012;366:1190-9).

For her secondary analysis of psoriasis-related sexual difficulties and their response to treatment, Dr. Guenther used as her metric the patients’ response to item 9 on the Dermatology Life Quality Index, which all subjects completed at weeks 0, 8, and 16. Item 9 asks the extent to which the responder’s skin “caused any sexual difficulties” during the past week. The options range from 0 (none at all) to 3 (very much). She categorized a response of 1 or more as evidence of sexual difficulties. And because of the relatively small sample size in this study, she lumped together as the low-dose therapy group those patients assigned to ixekizumab at 10 or 25 mg, with the high-dose group being comprised of patients on 75 or

After 8 weeks on low-dose ixekizumab, the proportion of patients reporting any skin disease-related sexual difficulties within the past week fell from a baseline of 30% to 16%. After 8 weeks of high-dose ixekizumab, the figure was just 7%. Those rates remained unchanged at 16 weeks. In contrast, the placebo group remained unchanged over time, with 32% of patients still reporting sexual difficulties caused by their skin disease at week 8.

The degree to which a patient’s psoriasis improved in response to therapy with the humanized monoclonal antibody was closely related to the reduction in skin-related sexual problems. Among the 76 ixekizumab-treated patients who achieved a PASI 75 response at week 16, the rate of self-reported sexual difficulties within the previous week was 7%. For those with less than a PASI 75 response, the rate was 24%.

An impressively high 38% percent of patients on high-dose ixekizumab achieved a PASI 100 response. Only 5% of them reported any skin-related sexual difficulties at week 8, as did 9% at week 16.

Dr. Guenther also looked at the data restricting the analysis to patients with more severe baseline sexual impairment as defined by a response of 2 or 3 on item 9 of the DLQI. Among patients on high-dose izekizumab, the rate dropped from 10.5% at baseline to 1.8% at week 8 to zero at week 16. For patients on low-dose izekizumab, the progression was 13.8% to 8.8% to 3.5% at week 16. Rates remained unchanged over time in the control group.

Although this phase 2 study was limited in size, Dr. Guenther found much the same thing earlier in the much larger phase 3 PHOENIX 1 and 2 trials of ustekinumab (Stelara), which together featured 1,334 psoriasis patients randomized to the human anti-interkelukin-12/23 monoclonal antibody. In that analysis, the proportion of ustekinumab-treated patients with impaired sexual function as assessed by DLQI item 9 plunged from 22.4% at baseline to 2.7% at week 12, compared with no change in placebo-treated controls. The bigger the PASI improvement, the greater the reduction in psoriasis-related sexual dysfunction (J. Eur. Acad. Dermatol. Venereol. 2011;25:851-7).

The phase 2 ixekizumab study was funded by Eli Lilly. Dr. Guenther is a consultant to the company. Positive primary outcomes in three pivotal phase 3 clinical trials of ixekizumab totalling nearly 3,900 randomized psoriasis patients have since been reported. The company plans to apply for marketing approval of the biologic in the first half of 2015.

[email protected]

AMSTERDAM – Patient complaints of psoriasis-related sexual difficulties decreased significantly in response to treatment with the investigational biologic agent ixekizumab in a phase 2 dose-ranging study.

Sexual problems attributed by psoriasis patients to their skin condition are a common, underappreciated, and understudied problem. Most physicians simply don’t ask. But when they do, as was done formally in this study, it turned out that at baseline roughly one-third of the 142 participating subjects with moderate to severe chronic plaque psoriasis reported some degree of sexual problems they believed due specifically to their skin disease, Dr. Lyn Guenther reported at the annual congress of the European Academy of Dermatology and Venereology.

That rate dropped precipitously and in dose-dependent fashion in response to subcutaneous therapy with ixekizumab, a super-potent psoriasis medication directed against interleukin 17A, according to Dr. Guenther, professor of dermatology at the University of Western Ontario, London.

The study entailed double-blind randomization of the 142 participants to subcutaneous injections of ixekizumab at 10, 25, 75, or 150 mg or placebo at 0, 2, 4, 8, 12, and 16 weeks. The standard primary outcome -- the proportion of patients with a PASI 75 improvement at 12 weeks -- has previously been reported as highly positive (N. Engl. J. Med. 2012;366:1190-9).

For her secondary analysis of psoriasis-related sexual difficulties and their response to treatment, Dr. Guenther used as her metric the patients’ response to item 9 on the Dermatology Life Quality Index, which all subjects completed at weeks 0, 8, and 16. Item 9 asks the extent to which the responder’s skin “caused any sexual difficulties” during the past week. The options range from 0 (none at all) to 3 (very much). She categorized a response of 1 or more as evidence of sexual difficulties. And because of the relatively small sample size in this study, she lumped together as the low-dose therapy group those patients assigned to ixekizumab at 10 or 25 mg, with the high-dose group being comprised of patients on 75 or

After 8 weeks on low-dose ixekizumab, the proportion of patients reporting any skin disease-related sexual difficulties within the past week fell from a baseline of 30% to 16%. After 8 weeks of high-dose ixekizumab, the figure was just 7%. Those rates remained unchanged at 16 weeks. In contrast, the placebo group remained unchanged over time, with 32% of patients still reporting sexual difficulties caused by their skin disease at week 8.

The degree to which a patient’s psoriasis improved in response to therapy with the humanized monoclonal antibody was closely related to the reduction in skin-related sexual problems. Among the 76 ixekizumab-treated patients who achieved a PASI 75 response at week 16, the rate of self-reported sexual difficulties within the previous week was 7%. For those with less than a PASI 75 response, the rate was 24%.

An impressively high 38% percent of patients on high-dose ixekizumab achieved a PASI 100 response. Only 5% of them reported any skin-related sexual difficulties at week 8, as did 9% at week 16.

Dr. Guenther also looked at the data restricting the analysis to patients with more severe baseline sexual impairment as defined by a response of 2 or 3 on item 9 of the DLQI. Among patients on high-dose izekizumab, the rate dropped from 10.5% at baseline to 1.8% at week 8 to zero at week 16. For patients on low-dose izekizumab, the progression was 13.8% to 8.8% to 3.5% at week 16. Rates remained unchanged over time in the control group.

Although this phase 2 study was limited in size, Dr. Guenther found much the same thing earlier in the much larger phase 3 PHOENIX 1 and 2 trials of ustekinumab (Stelara), which together featured 1,334 psoriasis patients randomized to the human anti-interkelukin-12/23 monoclonal antibody. In that analysis, the proportion of ustekinumab-treated patients with impaired sexual function as assessed by DLQI item 9 plunged from 22.4% at baseline to 2.7% at week 12, compared with no change in placebo-treated controls. The bigger the PASI improvement, the greater the reduction in psoriasis-related sexual dysfunction (J. Eur. Acad. Dermatol. Venereol. 2011;25:851-7).

The phase 2 ixekizumab study was funded by Eli Lilly. Dr. Guenther is a consultant to the company. Positive primary outcomes in three pivotal phase 3 clinical trials of ixekizumab totalling nearly 3,900 randomized psoriasis patients have since been reported. The company plans to apply for marketing approval of the biologic in the first half of 2015.

[email protected]

AMSTERDAM – Patient complaints of psoriasis-related sexual difficulties decreased significantly in response to treatment with the investigational biologic agent ixekizumab in a phase 2 dose-ranging study.

Sexual problems attributed by psoriasis patients to their skin condition are a common, underappreciated, and understudied problem. Most physicians simply don’t ask. But when they do, as was done formally in this study, it turned out that at baseline roughly one-third of the 142 participating subjects with moderate to severe chronic plaque psoriasis reported some degree of sexual problems they believed due specifically to their skin disease, Dr. Lyn Guenther reported at the annual congress of the European Academy of Dermatology and Venereology.

That rate dropped precipitously and in dose-dependent fashion in response to subcutaneous therapy with ixekizumab, a super-potent psoriasis medication directed against interleukin 17A, according to Dr. Guenther, professor of dermatology at the University of Western Ontario, London.

The study entailed double-blind randomization of the 142 participants to subcutaneous injections of ixekizumab at 10, 25, 75, or 150 mg or placebo at 0, 2, 4, 8, 12, and 16 weeks. The standard primary outcome -- the proportion of patients with a PASI 75 improvement at 12 weeks -- has previously been reported as highly positive (N. Engl. J. Med. 2012;366:1190-9).

For her secondary analysis of psoriasis-related sexual difficulties and their response to treatment, Dr. Guenther used as her metric the patients’ response to item 9 on the Dermatology Life Quality Index, which all subjects completed at weeks 0, 8, and 16. Item 9 asks the extent to which the responder’s skin “caused any sexual difficulties” during the past week. The options range from 0 (none at all) to 3 (very much). She categorized a response of 1 or more as evidence of sexual difficulties. And because of the relatively small sample size in this study, she lumped together as the low-dose therapy group those patients assigned to ixekizumab at 10 or 25 mg, with the high-dose group being comprised of patients on 75 or

After 8 weeks on low-dose ixekizumab, the proportion of patients reporting any skin disease-related sexual difficulties within the past week fell from a baseline of 30% to 16%. After 8 weeks of high-dose ixekizumab, the figure was just 7%. Those rates remained unchanged at 16 weeks. In contrast, the placebo group remained unchanged over time, with 32% of patients still reporting sexual difficulties caused by their skin disease at week 8.

The degree to which a patient’s psoriasis improved in response to therapy with the humanized monoclonal antibody was closely related to the reduction in skin-related sexual problems. Among the 76 ixekizumab-treated patients who achieved a PASI 75 response at week 16, the rate of self-reported sexual difficulties within the previous week was 7%. For those with less than a PASI 75 response, the rate was 24%.

An impressively high 38% percent of patients on high-dose ixekizumab achieved a PASI 100 response. Only 5% of them reported any skin-related sexual difficulties at week 8, as did 9% at week 16.

Dr. Guenther also looked at the data restricting the analysis to patients with more severe baseline sexual impairment as defined by a response of 2 or 3 on item 9 of the DLQI. Among patients on high-dose izekizumab, the rate dropped from 10.5% at baseline to 1.8% at week 8 to zero at week 16. For patients on low-dose izekizumab, the progression was 13.8% to 8.8% to 3.5% at week 16. Rates remained unchanged over time in the control group.

Although this phase 2 study was limited in size, Dr. Guenther found much the same thing earlier in the much larger phase 3 PHOENIX 1 and 2 trials of ustekinumab (Stelara), which together featured 1,334 psoriasis patients randomized to the human anti-interkelukin-12/23 monoclonal antibody. In that analysis, the proportion of ustekinumab-treated patients with impaired sexual function as assessed by DLQI item 9 plunged from 22.4% at baseline to 2.7% at week 12, compared with no change in placebo-treated controls. The bigger the PASI improvement, the greater the reduction in psoriasis-related sexual dysfunction (J. Eur. Acad. Dermatol. Venereol. 2011;25:851-7).

The phase 2 ixekizumab study was funded by Eli Lilly. Dr. Guenther is a consultant to the company. Positive primary outcomes in three pivotal phase 3 clinical trials of ixekizumab totalling nearly 3,900 randomized psoriasis patients have since been reported. The company plans to apply for marketing approval of the biologic in the first half of 2015.

[email protected]

LAS VEGAS – Psoriasis patients who are unresponsive to topical therapy, do not have psoriatic arthritis, and can make regular office visits may be candidates for successful treatment with phototherapy.

A patient with type II skin and extensive plaque psoriasis could be treated with a targeted NB-UVB laser, Dr. Kenneth B. Gordon said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

However, it’s important to evaluate each patient individually on phototherapy decisions, rather than relying on published protocols, noted Dr. Gordon of Northwestern University Feinberg School of Medicine in Chicago.

The advantages of the NB-UVB laser for psoriasis include a high rate of response (data show more than 75% of patients achieve PASI 75), the ability to avoid treating uninvolved skin, and potential long-term clearing of lesions, he said.

For someone with extensive plaque psoriasis, Dr. Gordon said he would start with 3 treatments per week, at 200 mJ, and increase the fluence by 25 mJ if necessary. “A good response can be expected in 4-6 weeks,” he said.

As for long-term treatment, “I leave it up to the patient but offer long-term maintenance,” said Dr. Gordon. Long-term efficacy of NB-UVB for plaque psoriasis has not been well studied, and safety data are unknown. “It is unclear whether there is a skin cancer risk,” he said. Reducing the number of exposures for a patient on maintenance therapy may be an option, he added.

Short-term treatment with NB-UVB can be effective in some psoriasis patients, such as in cases of an acute flare of guttate psoriasis, Dr. Gordon noted. Psoralen and UV light therapy (PUVA) is another option, he said.

Phototherapy also has a role in managing psoriasis in conjunction with retinoids, Dr. Gordon said. He cited an example of a 59-year-old woman with palmar psoriasis. For this patient, he said he would recommend starting with acitretin for approximately 1 month, if the patient tolerates it. “If the acitretin works by itself, no need to add phototherapy,” he said. However, if UVB is added, account for the photosensitizing agent, he emphasized. “Decrease the starting dose by 25-50 mJ or decrease the skin type by one,” he said.

Some psoriasis patients will not benefit from phototherapy, particularly those with erythroderma, said Dr. Gordon. “If skin is highly inflamed, phototherapy could induce easy burning, Koebnerization,” or other complications, he noted.

Dr. Gordon disclosed that his department at Northwestern derives income from phototherapy, but he personally does not. He also disclosed receiving research grants from and/or serving as a consultant to multiple companies including AbbVie, Amgen, Celgene, Eli Lilly, and Janssen.

[email protected]

LAS VEGAS – Psoriasis patients who are unresponsive to topical therapy, do not have psoriatic arthritis, and can make regular office visits may be candidates for successful treatment with phototherapy.

A patient with type II skin and extensive plaque psoriasis could be treated with a targeted NB-UVB laser, Dr. Kenneth B. Gordon said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

However, it’s important to evaluate each patient individually on phototherapy decisions, rather than relying on published protocols, noted Dr. Gordon of Northwestern University Feinberg School of Medicine in Chicago.

The advantages of the NB-UVB laser for psoriasis include a high rate of response (data show more than 75% of patients achieve PASI 75), the ability to avoid treating uninvolved skin, and potential long-term clearing of lesions, he said.

For someone with extensive plaque psoriasis, Dr. Gordon said he would start with 3 treatments per week, at 200 mJ, and increase the fluence by 25 mJ if necessary. “A good response can be expected in 4-6 weeks,” he said.

As for long-term treatment, “I leave it up to the patient but offer long-term maintenance,” said Dr. Gordon. Long-term efficacy of NB-UVB for plaque psoriasis has not been well studied, and safety data are unknown. “It is unclear whether there is a skin cancer risk,” he said. Reducing the number of exposures for a patient on maintenance therapy may be an option, he added.

Short-term treatment with NB-UVB can be effective in some psoriasis patients, such as in cases of an acute flare of guttate psoriasis, Dr. Gordon noted. Psoralen and UV light therapy (PUVA) is another option, he said.

Phototherapy also has a role in managing psoriasis in conjunction with retinoids, Dr. Gordon said. He cited an example of a 59-year-old woman with palmar psoriasis. For this patient, he said he would recommend starting with acitretin for approximately 1 month, if the patient tolerates it. “If the acitretin works by itself, no need to add phototherapy,” he said. However, if UVB is added, account for the photosensitizing agent, he emphasized. “Decrease the starting dose by 25-50 mJ or decrease the skin type by one,” he said.

Some psoriasis patients will not benefit from phototherapy, particularly those with erythroderma, said Dr. Gordon. “If skin is highly inflamed, phototherapy could induce easy burning, Koebnerization,” or other complications, he noted.

Dr. Gordon disclosed that his department at Northwestern derives income from phototherapy, but he personally does not. He also disclosed receiving research grants from and/or serving as a consultant to multiple companies including AbbVie, Amgen, Celgene, Eli Lilly, and Janssen.

[email protected]

LAS VEGAS – Psoriasis patients who are unresponsive to topical therapy, do not have psoriatic arthritis, and can make regular office visits may be candidates for successful treatment with phototherapy.

A patient with type II skin and extensive plaque psoriasis could be treated with a targeted NB-UVB laser, Dr. Kenneth B. Gordon said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

However, it’s important to evaluate each patient individually on phototherapy decisions, rather than relying on published protocols, noted Dr. Gordon of Northwestern University Feinberg School of Medicine in Chicago.

The advantages of the NB-UVB laser for psoriasis include a high rate of response (data show more than 75% of patients achieve PASI 75), the ability to avoid treating uninvolved skin, and potential long-term clearing of lesions, he said.

For someone with extensive plaque psoriasis, Dr. Gordon said he would start with 3 treatments per week, at 200 mJ, and increase the fluence by 25 mJ if necessary. “A good response can be expected in 4-6 weeks,” he said.

As for long-term treatment, “I leave it up to the patient but offer long-term maintenance,” said Dr. Gordon. Long-term efficacy of NB-UVB for plaque psoriasis has not been well studied, and safety data are unknown. “It is unclear whether there is a skin cancer risk,” he said. Reducing the number of exposures for a patient on maintenance therapy may be an option, he added.

Short-term treatment with NB-UVB can be effective in some psoriasis patients, such as in cases of an acute flare of guttate psoriasis, Dr. Gordon noted. Psoralen and UV light therapy (PUVA) is another option, he said.

Phototherapy also has a role in managing psoriasis in conjunction with retinoids, Dr. Gordon said. He cited an example of a 59-year-old woman with palmar psoriasis. For this patient, he said he would recommend starting with acitretin for approximately 1 month, if the patient tolerates it. “If the acitretin works by itself, no need to add phototherapy,” he said. However, if UVB is added, account for the photosensitizing agent, he emphasized. “Decrease the starting dose by 25-50 mJ or decrease the skin type by one,” he said.

Some psoriasis patients will not benefit from phototherapy, particularly those with erythroderma, said Dr. Gordon. “If skin is highly inflamed, phototherapy could induce easy burning, Koebnerization,” or other complications, he noted.

Dr. Gordon disclosed that his department at Northwestern derives income from phototherapy, but he personally does not. He also disclosed receiving research grants from and/or serving as a consultant to multiple companies including AbbVie, Amgen, Celgene, Eli Lilly, and Janssen.

[email protected]

Over the last several years, we have come to understand that patients with inflammatory diseases may be at higher risk for major adverse cardiovascular events (MACEs) and cardiovascular death. In an article published online on October 28 in the Annals of the Rheumatic Diseases, Ogdie et al reported on a study of the risk for MACEs among patients with psoriatic arthritis (PsA), rheumatoid arthritis (RA), and psoriasis without known PsA compared with the general population after adjusting for traditional cardiovascular risk factors.

The authors performed a population-based longitudinal cohort study (1994-2010) in The Health Improvement Network (THIN), a primary care medical record database in the United Kingdom. Patients aged 18 to 89 years with the applicable diagnoses were included. Up to 10 unexposed controls were selected for each patient with PsA, matched on practice and index date.

The study outcomes included the following: cardiovascular death, myocardial infarction, cerebrovascular accidents, and the composite outcome (MACE). Cox proportional hazards models were utilized to calculate the hazard ratios (HRs) for each of the outcomes after adjusting for traditional risk factors. The authors’ preliminary hypothesis was that there was an interaction between disease status and disease-modifying antirheumatic drug (DMARD) use.

In the analysis, the authors identified individuals with PsA (N=8706), RA (N=41,752), psoriasis (N=138,424), and unexposed controls (N=81,573). After adjusting for traditional risk factors, the risk for MACE was higher in the following populations: patients with PsA not prescribed a DMARD (HR, 1.24; 95% confidence interval [CI], 1.03-1.49), patients with RA (no DMARD: HR, 1.39; 95% CI, 1.28-1.50; DMARD: HR, 1.58; 95% CI, 1.46-1.70), patients with psoriasis not prescribed a DMARD (HR, 1.08; 95% CI, 1.02-1.15), and patients with severe psoriasis (DMARD: HR, 1.42; 95% CI, 1.17-1.73).

The authors concluded that cardiovascular risk should be addressed with all patients affected by psoriasis, PsA, or RA. These results suggest the need for improved screening and management of traditional cardiovascular risk factors in patients with inflammatory diseases.

What’s the issue?

Although there has been literature on MACE in these diseases, existing studies have not examined the risk for incident MACE including myocardial infarction, cerebrovascular accidents, and cardiovascular death in PsA compared with matched internal controls from a population-based perspective after accounting for the presence of traditional cardiovascular risk factors. This study is an additional piece of evidence that supports the need for comprehensive management of these patients. How do you currently address the concern for MACE?

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

Over the last several years, we have come to understand that patients with inflammatory diseases may be at higher risk for major adverse cardiovascular events (MACEs) and cardiovascular death. In an article published online on October 28 in the Annals of the Rheumatic Diseases, Ogdie et al reported on a study of the risk for MACEs among patients with psoriatic arthritis (PsA), rheumatoid arthritis (RA), and psoriasis without known PsA compared with the general population after adjusting for traditional cardiovascular risk factors.

The authors performed a population-based longitudinal cohort study (1994-2010) in The Health Improvement Network (THIN), a primary care medical record database in the United Kingdom. Patients aged 18 to 89 years with the applicable diagnoses were included. Up to 10 unexposed controls were selected for each patient with PsA, matched on practice and index date.

The study outcomes included the following: cardiovascular death, myocardial infarction, cerebrovascular accidents, and the composite outcome (MACE). Cox proportional hazards models were utilized to calculate the hazard ratios (HRs) for each of the outcomes after adjusting for traditional risk factors. The authors’ preliminary hypothesis was that there was an interaction between disease status and disease-modifying antirheumatic drug (DMARD) use.

In the analysis, the authors identified individuals with PsA (N=8706), RA (N=41,752), psoriasis (N=138,424), and unexposed controls (N=81,573). After adjusting for traditional risk factors, the risk for MACE was higher in the following populations: patients with PsA not prescribed a DMARD (HR, 1.24; 95% confidence interval [CI], 1.03-1.49), patients with RA (no DMARD: HR, 1.39; 95% CI, 1.28-1.50; DMARD: HR, 1.58; 95% CI, 1.46-1.70), patients with psoriasis not prescribed a DMARD (HR, 1.08; 95% CI, 1.02-1.15), and patients with severe psoriasis (DMARD: HR, 1.42; 95% CI, 1.17-1.73).

The authors concluded that cardiovascular risk should be addressed with all patients affected by psoriasis, PsA, or RA. These results suggest the need for improved screening and management of traditional cardiovascular risk factors in patients with inflammatory diseases.

What’s the issue?

Although there has been literature on MACE in these diseases, existing studies have not examined the risk for incident MACE including myocardial infarction, cerebrovascular accidents, and cardiovascular death in PsA compared with matched internal controls from a population-based perspective after accounting for the presence of traditional cardiovascular risk factors. This study is an additional piece of evidence that supports the need for comprehensive management of these patients. How do you currently address the concern for MACE?

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

Over the last several years, we have come to understand that patients with inflammatory diseases may be at higher risk for major adverse cardiovascular events (MACEs) and cardiovascular death. In an article published online on October 28 in the Annals of the Rheumatic Diseases, Ogdie et al reported on a study of the risk for MACEs among patients with psoriatic arthritis (PsA), rheumatoid arthritis (RA), and psoriasis without known PsA compared with the general population after adjusting for traditional cardiovascular risk factors.

The authors performed a population-based longitudinal cohort study (1994-2010) in The Health Improvement Network (THIN), a primary care medical record database in the United Kingdom. Patients aged 18 to 89 years with the applicable diagnoses were included. Up to 10 unexposed controls were selected for each patient with PsA, matched on practice and index date.

The study outcomes included the following: cardiovascular death, myocardial infarction, cerebrovascular accidents, and the composite outcome (MACE). Cox proportional hazards models were utilized to calculate the hazard ratios (HRs) for each of the outcomes after adjusting for traditional risk factors. The authors’ preliminary hypothesis was that there was an interaction between disease status and disease-modifying antirheumatic drug (DMARD) use.

In the analysis, the authors identified individuals with PsA (N=8706), RA (N=41,752), psoriasis (N=138,424), and unexposed controls (N=81,573). After adjusting for traditional risk factors, the risk for MACE was higher in the following populations: patients with PsA not prescribed a DMARD (HR, 1.24; 95% confidence interval [CI], 1.03-1.49), patients with RA (no DMARD: HR, 1.39; 95% CI, 1.28-1.50; DMARD: HR, 1.58; 95% CI, 1.46-1.70), patients with psoriasis not prescribed a DMARD (HR, 1.08; 95% CI, 1.02-1.15), and patients with severe psoriasis (DMARD: HR, 1.42; 95% CI, 1.17-1.73).

The authors concluded that cardiovascular risk should be addressed with all patients affected by psoriasis, PsA, or RA. These results suggest the need for improved screening and management of traditional cardiovascular risk factors in patients with inflammatory diseases.

What’s the issue?

Although there has been literature on MACE in these diseases, existing studies have not examined the risk for incident MACE including myocardial infarction, cerebrovascular accidents, and cardiovascular death in PsA compared with matched internal controls from a population-based perspective after accounting for the presence of traditional cardiovascular risk factors. This study is an additional piece of evidence that supports the need for comprehensive management of these patients. How do you currently address the concern for MACE?

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

AMSTERDAM – Oral tofacitinib for psoriasis proved as effective as – and in certain domains better than – subcutaneous etanercept in improving patient-reported quality of life endpoints in a phase III clinical trial.

The double-blind study included 1,101 patients with moderate to severe chronic plaque psoriasis who were randomized to 12 weeks of the oral Janus kinase inhibitor tofacitinib at 5 mg twice daily, 10 mg twice daily, subcutaneous etanercept (Enbrel) at 50 mg twice weekly, or placebo. The findings were presented by Dr. Fernando Valenzuela at the annual congress of the European Academy of Dermatology and Venereology.

Courtesy of the Centers for Disease Control and Prevention (CDC)

Earlier in 2014, at the annual meeting of the American Academy of Dermatology in Denver, Dr. Valenzuela presented the phase III study’s primary results, in which the oral small molecule proved noninferior to the tumor necrosis factor inhibitor in improving PASI scores. At the EADV Congress in Amsterdam, he focused on the secondary outcomes, which arguably matter more to patients than do changes in PASI scores, namely, measures of quality of life and itchiness.

From a baseline Itch Severity Item score of 5, indicative of moderate to severe itching, week 12 scores fell by a mean of 3.2, 4.0, 3.5, and 0.4 points, respectively, in patients on low- or high-dose tofacitinib, etanercept, and placebo. The improvement in itch in patients randomized to tofacitinib at 10 mg twice daily was not only greater than with etanercept, it occurred faster as well, with significant reduction in itch scores documented on day 2 of therapy, reported Dr. Valenzuela, a dermatologist at the University of Chile in Santiago.

The median baseline Dermatology Life Quality Index (DLQI) score was 12. Significant improvement was seen from week 4 in all three active treatment study arms. By week 12, DLQI scores had dropped by an average of 7.3 points in patients on tofacitinib at 5 mg twice daily, 9.7 points in those on 10 mg twice daily, 9.0 points in etanercept-treated patients, and 1.9 points with placebo. Seventy-eight percent of patients on tofacitinib at 10 mg twice daily experienced a 5-point or larger drop in the DLQI by week 12, as did 75% of those on etanercept, 66% of those on low-dose tofacitinib, and 32% of those on placebo.

At baseline, 30% of patients rated their psoriasis as moderate and 70% rated their psoriasis as severe based on Patient Global Assessment. By week 12, more than 50% of patients on tofacitinib at 10 mg twice daily or etanercept rated their skin as clear or almost clear.

More than 70% of patients in all three active treatment arms indicated at week 12 that they were satisfied with their medication. Satisfaction scores were highest, and equally so, in those on high-dose tofacitinib and etanercept.

“Patients using tofacitinib at the low dose had not that good an improvement. It was better improvement than with placebo, but it doesn’t look like etanercept,” Dr. Valenzuela concluded.

Tofacitinib is approved as Xeljanz for the treatment of rheumatoid arthritis, but remains investigational for psoriasis. According to a company statement, Pfizer intends to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration by early 2015.

The study was funded by Pfizer. Dr. Valenzuela is an adviser to Pfizer, AbbVie, Eli Lilly, Janssen, Merck, and Novartis.

[email protected]

AMSTERDAM – Oral tofacitinib for psoriasis proved as effective as – and in certain domains better than – subcutaneous etanercept in improving patient-reported quality of life endpoints in a phase III clinical trial.

The double-blind study included 1,101 patients with moderate to severe chronic plaque psoriasis who were randomized to 12 weeks of the oral Janus kinase inhibitor tofacitinib at 5 mg twice daily, 10 mg twice daily, subcutaneous etanercept (Enbrel) at 50 mg twice weekly, or placebo. The findings were presented by Dr. Fernando Valenzuela at the annual congress of the European Academy of Dermatology and Venereology.

Courtesy of the Centers for Disease Control and Prevention (CDC)

Earlier in 2014, at the annual meeting of the American Academy of Dermatology in Denver, Dr. Valenzuela presented the phase III study’s primary results, in which the oral small molecule proved noninferior to the tumor necrosis factor inhibitor in improving PASI scores. At the EADV Congress in Amsterdam, he focused on the secondary outcomes, which arguably matter more to patients than do changes in PASI scores, namely, measures of quality of life and itchiness.

From a baseline Itch Severity Item score of 5, indicative of moderate to severe itching, week 12 scores fell by a mean of 3.2, 4.0, 3.5, and 0.4 points, respectively, in patients on low- or high-dose tofacitinib, etanercept, and placebo. The improvement in itch in patients randomized to tofacitinib at 10 mg twice daily was not only greater than with etanercept, it occurred faster as well, with significant reduction in itch scores documented on day 2 of therapy, reported Dr. Valenzuela, a dermatologist at the University of Chile in Santiago.

The median baseline Dermatology Life Quality Index (DLQI) score was 12. Significant improvement was seen from week 4 in all three active treatment study arms. By week 12, DLQI scores had dropped by an average of 7.3 points in patients on tofacitinib at 5 mg twice daily, 9.7 points in those on 10 mg twice daily, 9.0 points in etanercept-treated patients, and 1.9 points with placebo. Seventy-eight percent of patients on tofacitinib at 10 mg twice daily experienced a 5-point or larger drop in the DLQI by week 12, as did 75% of those on etanercept, 66% of those on low-dose tofacitinib, and 32% of those on placebo.

At baseline, 30% of patients rated their psoriasis as moderate and 70% rated their psoriasis as severe based on Patient Global Assessment. By week 12, more than 50% of patients on tofacitinib at 10 mg twice daily or etanercept rated their skin as clear or almost clear.

More than 70% of patients in all three active treatment arms indicated at week 12 that they were satisfied with their medication. Satisfaction scores were highest, and equally so, in those on high-dose tofacitinib and etanercept.

“Patients using tofacitinib at the low dose had not that good an improvement. It was better improvement than with placebo, but it doesn’t look like etanercept,” Dr. Valenzuela concluded.

Tofacitinib is approved as Xeljanz for the treatment of rheumatoid arthritis, but remains investigational for psoriasis. According to a company statement, Pfizer intends to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration by early 2015.

The study was funded by Pfizer. Dr. Valenzuela is an adviser to Pfizer, AbbVie, Eli Lilly, Janssen, Merck, and Novartis.

[email protected]

AMSTERDAM – Oral tofacitinib for psoriasis proved as effective as – and in certain domains better than – subcutaneous etanercept in improving patient-reported quality of life endpoints in a phase III clinical trial.

The double-blind study included 1,101 patients with moderate to severe chronic plaque psoriasis who were randomized to 12 weeks of the oral Janus kinase inhibitor tofacitinib at 5 mg twice daily, 10 mg twice daily, subcutaneous etanercept (Enbrel) at 50 mg twice weekly, or placebo. The findings were presented by Dr. Fernando Valenzuela at the annual congress of the European Academy of Dermatology and Venereology.

Courtesy of the Centers for Disease Control and Prevention (CDC)

Earlier in 2014, at the annual meeting of the American Academy of Dermatology in Denver, Dr. Valenzuela presented the phase III study’s primary results, in which the oral small molecule proved noninferior to the tumor necrosis factor inhibitor in improving PASI scores. At the EADV Congress in Amsterdam, he focused on the secondary outcomes, which arguably matter more to patients than do changes in PASI scores, namely, measures of quality of life and itchiness.

From a baseline Itch Severity Item score of 5, indicative of moderate to severe itching, week 12 scores fell by a mean of 3.2, 4.0, 3.5, and 0.4 points, respectively, in patients on low- or high-dose tofacitinib, etanercept, and placebo. The improvement in itch in patients randomized to tofacitinib at 10 mg twice daily was not only greater than with etanercept, it occurred faster as well, with significant reduction in itch scores documented on day 2 of therapy, reported Dr. Valenzuela, a dermatologist at the University of Chile in Santiago.

The median baseline Dermatology Life Quality Index (DLQI) score was 12. Significant improvement was seen from week 4 in all three active treatment study arms. By week 12, DLQI scores had dropped by an average of 7.3 points in patients on tofacitinib at 5 mg twice daily, 9.7 points in those on 10 mg twice daily, 9.0 points in etanercept-treated patients, and 1.9 points with placebo. Seventy-eight percent of patients on tofacitinib at 10 mg twice daily experienced a 5-point or larger drop in the DLQI by week 12, as did 75% of those on etanercept, 66% of those on low-dose tofacitinib, and 32% of those on placebo.

At baseline, 30% of patients rated their psoriasis as moderate and 70% rated their psoriasis as severe based on Patient Global Assessment. By week 12, more than 50% of patients on tofacitinib at 10 mg twice daily or etanercept rated their skin as clear or almost clear.

More than 70% of patients in all three active treatment arms indicated at week 12 that they were satisfied with their medication. Satisfaction scores were highest, and equally so, in those on high-dose tofacitinib and etanercept.

“Patients using tofacitinib at the low dose had not that good an improvement. It was better improvement than with placebo, but it doesn’t look like etanercept,” Dr. Valenzuela concluded.

Tofacitinib is approved as Xeljanz for the treatment of rheumatoid arthritis, but remains investigational for psoriasis. According to a company statement, Pfizer intends to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration by early 2015.

The study was funded by Pfizer. Dr. Valenzuela is an adviser to Pfizer, AbbVie, Eli Lilly, Janssen, Merck, and Novartis.

[email protected]

Less than half of dermatologists screen or counsel psoriasis patients about alcohol or tobacco use, compared with all patients, but approximately 60% screen or counsel psoriasis patients about obesity, based on data from an online survey of 171 dermatologists and dermatology residents.

The findings were published in a letter to the editor in the November issue of the Journal of the American Academy of Dermatology (2014;71:1028-9).

© javi_indy/ Thinkstock.com

However, among patients with psoriasis, more than two-thirds of the respondents said they were more likely to both screen and counsel patients with moderate to severe psoriasis about alcohol, tobacco, and obesity, compared with psoriasis patients overall.

Previous research suggests that if psoriasis patients’ issues with alcohol, tobacco, and obesity are addressed, “patients may experience disease improvement, emphasizing the importance of screening and counseling,” wrote Brandon L. Adler and Aimee E. Krausz, medical students at Albert Einstein College of Medicine, Bronx, N.Y., and their colleagues.

Overall, 87% of respondents believed themselves responsible for screening for the three risk factors, but 56% believed themselves responsible for counseling.

Although the results were limited by the focus on academic dermatologists, the findings suggest a need to improve dermatologists’ confidence in counseling patients, the researchers noted. “Systematic training and effective counseling instruments would empower practitioners to translate this knowledge into clinical practice.”

The study was supported by the Dermatology Foundation Career Development Awards Program.

The researchers had no financial conflicts to disclose.

hsplet[email protected]

Less than half of dermatologists screen or counsel psoriasis patients about alcohol or tobacco use, compared with all patients, but approximately 60% screen or counsel psoriasis patients about obesity, based on data from an online survey of 171 dermatologists and dermatology residents.

The findings were published in a letter to the editor in the November issue of the Journal of the American Academy of Dermatology (2014;71:1028-9).

© javi_indy/ Thinkstock.com

However, among patients with psoriasis, more than two-thirds of the respondents said they were more likely to both screen and counsel patients with moderate to severe psoriasis about alcohol, tobacco, and obesity, compared with psoriasis patients overall.

Previous research suggests that if psoriasis patients’ issues with alcohol, tobacco, and obesity are addressed, “patients may experience disease improvement, emphasizing the importance of screening and counseling,” wrote Brandon L. Adler and Aimee E. Krausz, medical students at Albert Einstein College of Medicine, Bronx, N.Y., and their colleagues.

Overall, 87% of respondents believed themselves responsible for screening for the three risk factors, but 56% believed themselves responsible for counseling.

Although the results were limited by the focus on academic dermatologists, the findings suggest a need to improve dermatologists’ confidence in counseling patients, the researchers noted. “Systematic training and effective counseling instruments would empower practitioners to translate this knowledge into clinical practice.”

The study was supported by the Dermatology Foundation Career Development Awards Program.

The researchers had no financial conflicts to disclose.

hsplet[email protected]

Less than half of dermatologists screen or counsel psoriasis patients about alcohol or tobacco use, compared with all patients, but approximately 60% screen or counsel psoriasis patients about obesity, based on data from an online survey of 171 dermatologists and dermatology residents.

The findings were published in a letter to the editor in the November issue of the Journal of the American Academy of Dermatology (2014;71:1028-9).

© javi_indy/ Thinkstock.com

However, among patients with psoriasis, more than two-thirds of the respondents said they were more likely to both screen and counsel patients with moderate to severe psoriasis about alcohol, tobacco, and obesity, compared with psoriasis patients overall.

Previous research suggests that if psoriasis patients’ issues with alcohol, tobacco, and obesity are addressed, “patients may experience disease improvement, emphasizing the importance of screening and counseling,” wrote Brandon L. Adler and Aimee E. Krausz, medical students at Albert Einstein College of Medicine, Bronx, N.Y., and their colleagues.

Overall, 87% of respondents believed themselves responsible for screening for the three risk factors, but 56% believed themselves responsible for counseling.

Although the results were limited by the focus on academic dermatologists, the findings suggest a need to improve dermatologists’ confidence in counseling patients, the researchers noted. “Systematic training and effective counseling instruments would empower practitioners to translate this knowledge into clinical practice.”

The study was supported by the Dermatology Foundation Career Development Awards Program.

The researchers had no financial conflicts to disclose.

hsplet[email protected]

BOSTON – Secukinumab improved quality of life and symptoms in patients with psoriatic arthritis, regardless of whether they had received prior anti-tumor-necrosis factor therapy or were concurrently receiving methotrexate, Dr. Ian B. McInnes reported at the annual meeting of the American College of Rheumatology.

A 300-mg dose of the investigational drug, which is given subcutaneously, proved to be the most effective dose, Dr. McInnes, of the University of Glasgow, Scotland, said in his presentation of the 24-week results of the FUTURE 2 study. The primary endpoint, a response of at least ACR20, was achieved by 54% of 100 patients given the 300-mg dose and by 51% of 100 patients given the 150-mg dose. The 75-mg dose was far less effective, with a 29% response in 99 patients; the 98 patients given placebo had a 15% response.

At the 150-mg and 300-mg doses, the rates of ACR20 responses were comparable whether or not patients were also taking concomitant methotrexate. Further, the drug’s safety profile was comparable to placebo, Dr. McInnes said.

Mary Jo Dales/Frontline Medical News

An ACR50 was achieved by 35% of patients given secukinumab at either 300 mg or 150 mg, and by 18% of those given 75 mg and 7% of those given placebo. About 20% of patients given the higher doses had an ACR70 response, as did 6% of those given 75 mg and 1% of those given placebo.

At the 300-mg dose, secukinumab also resolved dactylitis and enthesitis in approximately half of the affected patients.

Mean improvements in quality of life based on patients’ SF 36 PCS score (Short Form-36 Physical Component Summary) at 24 weeks from baseline were 7.25 in those on the 300-mg dose and 6.39 in those on the 150-mg dose. Those on the 75-mg dose had a 4.38-point mean improvement, whereas patients on placebo had a 1.34-point mean improvement in SF 36 PCS.

No safety signals were noted; adverse events were few and comparable to placebo. Five subjects on the active drug had mild to moderate candidal infections that responded to oral therapy. Neutropenia occurred in one patient in the 300-mg dose group and in one patient in the placebo group, but was transient and patients continued on therapy.

Secukinumab is a fully-human IgG1k monoclonal antibody that selectively targets IL-17A. The drug, manufactured by Novartis, was unanimously recommended for approval by an advisory committee to the Food and Drug Administration. It was administered weekly as a subcutaneous injection for the first 4 weeks of the study, then given again at week 8 and once every 4 weeks thereafter in patients assigned to one of the secukinumab arms of the double-blind, randomized study. Patient assigned to the placebo group were either responders and assigned to receive secukinumab at week 24 and every 4 weeks thereafter or were nonresponders assigned to receive secukinumab at week 16 and every 4 weeks thereafter. Only patients with at least 20% reductions in the number of tender joints or swollen joints continue to receive the drug beyond 1 year.

To be eligible for the study, patients needed to have a diagnosis of active psoriatic arthritis classified by CASPAR criteria and tenderness in at least 3 of 78 joints and swelling of at least 3 of 76 joints. They additionally needed to have an inadequate response to nonsteroidal anti-inflammatory drugs, methotrexate, or anti-TNF therapy

The primary endpoint of the study was ACR20 response at 24 weeks. Secondary endpoints included PASI 75 and PASI 90 responses, change in DAS28-CRP (28-joint Disease Activity Score using C-reactive protein) from baseline, change in SF-36 PCS and HAQ-DI (Health Assessment Questionnaire-Disability Index) from baseline, ACR50 response, the proportion of subjects with dactylitis and enthesitis, and overall safety and tolerability.

As of press time, the FDA was expected to take additional action in January 2015, according to Novartis.

The study was sponsored by Novartis, the maker of secukinumab. Dr. McInnes receives consulting fees from Novartis as well as multiple other pharmaceutical companies.

[email protected]

BOSTON – Secukinumab improved quality of life and symptoms in patients with psoriatic arthritis, regardless of whether they had received prior anti-tumor-necrosis factor therapy or were concurrently receiving methotrexate, Dr. Ian B. McInnes reported at the annual meeting of the American College of Rheumatology.

A 300-mg dose of the investigational drug, which is given subcutaneously, proved to be the most effective dose, Dr. McInnes, of the University of Glasgow, Scotland, said in his presentation of the 24-week results of the FUTURE 2 study. The primary endpoint, a response of at least ACR20, was achieved by 54% of 100 patients given the 300-mg dose and by 51% of 100 patients given the 150-mg dose. The 75-mg dose was far less effective, with a 29% response in 99 patients; the 98 patients given placebo had a 15% response.

At the 150-mg and 300-mg doses, the rates of ACR20 responses were comparable whether or not patients were also taking concomitant methotrexate. Further, the drug’s safety profile was comparable to placebo, Dr. McInnes said.

Mary Jo Dales/Frontline Medical News

An ACR50 was achieved by 35% of patients given secukinumab at either 300 mg or 150 mg, and by 18% of those given 75 mg and 7% of those given placebo. About 20% of patients given the higher doses had an ACR70 response, as did 6% of those given 75 mg and 1% of those given placebo.

At the 300-mg dose, secukinumab also resolved dactylitis and enthesitis in approximately half of the affected patients.

Mean improvements in quality of life based on patients’ SF 36 PCS score (Short Form-36 Physical Component Summary) at 24 weeks from baseline were 7.25 in those on the 300-mg dose and 6.39 in those on the 150-mg dose. Those on the 75-mg dose had a 4.38-point mean improvement, whereas patients on placebo had a 1.34-point mean improvement in SF 36 PCS.

No safety signals were noted; adverse events were few and comparable to placebo. Five subjects on the active drug had mild to moderate candidal infections that responded to oral therapy. Neutropenia occurred in one patient in the 300-mg dose group and in one patient in the placebo group, but was transient and patients continued on therapy.

Secukinumab is a fully-human IgG1k monoclonal antibody that selectively targets IL-17A. The drug, manufactured by Novartis, was unanimously recommended for approval by an advisory committee to the Food and Drug Administration. It was administered weekly as a subcutaneous injection for the first 4 weeks of the study, then given again at week 8 and once every 4 weeks thereafter in patients assigned to one of the secukinumab arms of the double-blind, randomized study. Patient assigned to the placebo group were either responders and assigned to receive secukinumab at week 24 and every 4 weeks thereafter or were nonresponders assigned to receive secukinumab at week 16 and every 4 weeks thereafter. Only patients with at least 20% reductions in the number of tender joints or swollen joints continue to receive the drug beyond 1 year.

To be eligible for the study, patients needed to have a diagnosis of active psoriatic arthritis classified by CASPAR criteria and tenderness in at least 3 of 78 joints and swelling of at least 3 of 76 joints. They additionally needed to have an inadequate response to nonsteroidal anti-inflammatory drugs, methotrexate, or anti-TNF therapy

The primary endpoint of the study was ACR20 response at 24 weeks. Secondary endpoints included PASI 75 and PASI 90 responses, change in DAS28-CRP (28-joint Disease Activity Score using C-reactive protein) from baseline, change in SF-36 PCS and HAQ-DI (Health Assessment Questionnaire-Disability Index) from baseline, ACR50 response, the proportion of subjects with dactylitis and enthesitis, and overall safety and tolerability.

As of press time, the FDA was expected to take additional action in January 2015, according to Novartis.

The study was sponsored by Novartis, the maker of secukinumab. Dr. McInnes receives consulting fees from Novartis as well as multiple other pharmaceutical companies.

[email protected]

BOSTON – Secukinumab improved quality of life and symptoms in patients with psoriatic arthritis, regardless of whether they had received prior anti-tumor-necrosis factor therapy or were concurrently receiving methotrexate, Dr. Ian B. McInnes reported at the annual meeting of the American College of Rheumatology.

A 300-mg dose of the investigational drug, which is given subcutaneously, proved to be the most effective dose, Dr. McInnes, of the University of Glasgow, Scotland, said in his presentation of the 24-week results of the FUTURE 2 study. The primary endpoint, a response of at least ACR20, was achieved by 54% of 100 patients given the 300-mg dose and by 51% of 100 patients given the 150-mg dose. The 75-mg dose was far less effective, with a 29% response in 99 patients; the 98 patients given placebo had a 15% response.

At the 150-mg and 300-mg doses, the rates of ACR20 responses were comparable whether or not patients were also taking concomitant methotrexate. Further, the drug’s safety profile was comparable to placebo, Dr. McInnes said.

Mary Jo Dales/Frontline Medical News

An ACR50 was achieved by 35% of patients given secukinumab at either 300 mg or 150 mg, and by 18% of those given 75 mg and 7% of those given placebo. About 20% of patients given the higher doses had an ACR70 response, as did 6% of those given 75 mg and 1% of those given placebo.

At the 300-mg dose, secukinumab also resolved dactylitis and enthesitis in approximately half of the affected patients.

Mean improvements in quality of life based on patients’ SF 36 PCS score (Short Form-36 Physical Component Summary) at 24 weeks from baseline were 7.25 in those on the 300-mg dose and 6.39 in those on the 150-mg dose. Those on the 75-mg dose had a 4.38-point mean improvement, whereas patients on placebo had a 1.34-point mean improvement in SF 36 PCS.

No safety signals were noted; adverse events were few and comparable to placebo. Five subjects on the active drug had mild to moderate candidal infections that responded to oral therapy. Neutropenia occurred in one patient in the 300-mg dose group and in one patient in the placebo group, but was transient and patients continued on therapy.

Secukinumab is a fully-human IgG1k monoclonal antibody that selectively targets IL-17A. The drug, manufactured by Novartis, was unanimously recommended for approval by an advisory committee to the Food and Drug Administration. It was administered weekly as a subcutaneous injection for the first 4 weeks of the study, then given again at week 8 and once every 4 weeks thereafter in patients assigned to one of the secukinumab arms of the double-blind, randomized study. Patient assigned to the placebo group were either responders and assigned to receive secukinumab at week 24 and every 4 weeks thereafter or were nonresponders assigned to receive secukinumab at week 16 and every 4 weeks thereafter. Only patients with at least 20% reductions in the number of tender joints or swollen joints continue to receive the drug beyond 1 year.

To be eligible for the study, patients needed to have a diagnosis of active psoriatic arthritis classified by CASPAR criteria and tenderness in at least 3 of 78 joints and swelling of at least 3 of 76 joints. They additionally needed to have an inadequate response to nonsteroidal anti-inflammatory drugs, methotrexate, or anti-TNF therapy

The primary endpoint of the study was ACR20 response at 24 weeks. Secondary endpoints included PASI 75 and PASI 90 responses, change in DAS28-CRP (28-joint Disease Activity Score using C-reactive protein) from baseline, change in SF-36 PCS and HAQ-DI (Health Assessment Questionnaire-Disability Index) from baseline, ACR50 response, the proportion of subjects with dactylitis and enthesitis, and overall safety and tolerability.

As of press time, the FDA was expected to take additional action in January 2015, according to Novartis.

The study was sponsored by Novartis, the maker of secukinumab. Dr. McInnes receives consulting fees from Novartis as well as multiple other pharmaceutical companies.

[email protected]

BOSTON – It’s time to test whether methotrexate is really up to snuff as a first-line therapy for psoriatic arthritis, Canadian investigators say.

They base that recommendation on findings from a retrospective study showing that fewer than 18% of patients with psoriatic arthritis treated with methotrexate achieved minimal disease activity (MDA) after 6 months.

They also found evidence to suggest that physicians may overestimate the benefits of methotrexate for psoriatic arthritis.

“Physician-dependent measures reveal good response to methotrexate at 6 months, but patient-reported measures are less responsive, possibly due to side effects, back pain, disease, [and/or] disability,” said Dr. Barry J. Sheane of the division of rheumatology in the department of medicine at the University of Toronto.

The data on the effects of methotrexate in psoriatic arthritis are considerably less impressive than are those seen with tumor necrosis factor–alpha inhibitors (TNFi), Dr. Sheane said. For example, at 24 weeks, 39% of patients treated with adalimumab (Humira) and 52% treated with infliximab (Remicade) had achieved MDA, he noted.

“We suggest that a randomized controlled trial of methotrexate compared to a TNF inhibitor is warranted,” Dr. Sheane said at the annual meeting of the American College of Rheumatology.

He and his colleagues reviewed records on 204 consecutive patients treated for psoriatic arthritis with methotrexate from January 2004 through April 2014. The patients, who had a mean duration of psoriatic arthritis of 6.2 years, were all naive to biological antirheumatic drugs and were initiating methotrexate therapy.

Of the 204 patients, 167 had data sufficient for a 6-month analysis.

The investigators defined MDA after 6 months on methotrexate, the primary endpoint, as the presence of at least five out of the following seven domains: 0-1 tender joints, 0-1 swollen joints, Psoriasis Area Severity Index (PASI) 1 or less or body surface area involved 3% or less, 0-1 tender entheseal points, Health Assessment Questionnaire (HAQ) score of 0.5 or less, patient global disease activity Visual Analog Scale score of 20 or lower, and patient pain Visual Analog Scale score of 15 or lower.

They found that 17.4% of patients (29 of 167) met the physician-rated criteria for MDA at 6 months, even though 82.6% of the patients (138) had a PASI score of 1 or lower, and 58.1% (97) had a swollen joint count of 1 or fewer.

When the patients were asked for their assessment of global disease activity, 13.2% (22) rated disease activity with a prespecified score of 20 or lower. Only 12% of patients (20) reported an HAQ score of 0.5 or less.

The mean methotrexate dose was similar between patients who achieved MDA (17.8 mg/week) and those who did not (17.3 mg/week). The median dose was 17.5 mg/week in each group.

After controlling for sex, baseline sacroiliitis, and duration of psoriasis and psoriatic arthritis at the start of methotrexate in a multivariate model, the authors found that only dactylitis, inflammatory back pain, and mechanical back pain were significantly associated with a lower probability of patients reaching MDA. The variables that did not prove to be associated with achieving MDA after 6 months on methotrexate included erythrocyte sedimentation rate, presence of nail disease, number of clinically damaged joints, and body mass index.

The study was internally funded. Dr. Sheane reported having no relevant disclosures.

BOSTON – It’s time to test whether methotrexate is really up to snuff as a first-line therapy for psoriatic arthritis, Canadian investigators say.

They base that recommendation on findings from a retrospective study showing that fewer than 18% of patients with psoriatic arthritis treated with methotrexate achieved minimal disease activity (MDA) after 6 months.

They also found evidence to suggest that physicians may overestimate the benefits of methotrexate for psoriatic arthritis.

“Physician-dependent measures reveal good response to methotrexate at 6 months, but patient-reported measures are less responsive, possibly due to side effects, back pain, disease, [and/or] disability,” said Dr. Barry J. Sheane of the division of rheumatology in the department of medicine at the University of Toronto.

The data on the effects of methotrexate in psoriatic arthritis are considerably less impressive than are those seen with tumor necrosis factor–alpha inhibitors (TNFi), Dr. Sheane said. For example, at 24 weeks, 39% of patients treated with adalimumab (Humira) and 52% treated with infliximab (Remicade) had achieved MDA, he noted.

“We suggest that a randomized controlled trial of methotrexate compared to a TNF inhibitor is warranted,” Dr. Sheane said at the annual meeting of the American College of Rheumatology.

He and his colleagues reviewed records on 204 consecutive patients treated for psoriatic arthritis with methotrexate from January 2004 through April 2014. The patients, who had a mean duration of psoriatic arthritis of 6.2 years, were all naive to biological antirheumatic drugs and were initiating methotrexate therapy.

Of the 204 patients, 167 had data sufficient for a 6-month analysis.

The investigators defined MDA after 6 months on methotrexate, the primary endpoint, as the presence of at least five out of the following seven domains: 0-1 tender joints, 0-1 swollen joints, Psoriasis Area Severity Index (PASI) 1 or less or body surface area involved 3% or less, 0-1 tender entheseal points, Health Assessment Questionnaire (HAQ) score of 0.5 or less, patient global disease activity Visual Analog Scale score of 20 or lower, and patient pain Visual Analog Scale score of 15 or lower.

They found that 17.4% of patients (29 of 167) met the physician-rated criteria for MDA at 6 months, even though 82.6% of the patients (138) had a PASI score of 1 or lower, and 58.1% (97) had a swollen joint count of 1 or fewer.

When the patients were asked for their assessment of global disease activity, 13.2% (22) rated disease activity with a prespecified score of 20 or lower. Only 12% of patients (20) reported an HAQ score of 0.5 or less.

The mean methotrexate dose was similar between patients who achieved MDA (17.8 mg/week) and those who did not (17.3 mg/week). The median dose was 17.5 mg/week in each group.

After controlling for sex, baseline sacroiliitis, and duration of psoriasis and psoriatic arthritis at the start of methotrexate in a multivariate model, the authors found that only dactylitis, inflammatory back pain, and mechanical back pain were significantly associated with a lower probability of patients reaching MDA. The variables that did not prove to be associated with achieving MDA after 6 months on methotrexate included erythrocyte sedimentation rate, presence of nail disease, number of clinically damaged joints, and body mass index.

The study was internally funded. Dr. Sheane reported having no relevant disclosures.

BOSTON – It’s time to test whether methotrexate is really up to snuff as a first-line therapy for psoriatic arthritis, Canadian investigators say.

They base that recommendation on findings from a retrospective study showing that fewer than 18% of patients with psoriatic arthritis treated with methotrexate achieved minimal disease activity (MDA) after 6 months.

They also found evidence to suggest that physicians may overestimate the benefits of methotrexate for psoriatic arthritis.

“Physician-dependent measures reveal good response to methotrexate at 6 months, but patient-reported measures are less responsive, possibly due to side effects, back pain, disease, [and/or] disability,” said Dr. Barry J. Sheane of the division of rheumatology in the department of medicine at the University of Toronto.

The data on the effects of methotrexate in psoriatic arthritis are considerably less impressive than are those seen with tumor necrosis factor–alpha inhibitors (TNFi), Dr. Sheane said. For example, at 24 weeks, 39% of patients treated with adalimumab (Humira) and 52% treated with infliximab (Remicade) had achieved MDA, he noted.

“We suggest that a randomized controlled trial of methotrexate compared to a TNF inhibitor is warranted,” Dr. Sheane said at the annual meeting of the American College of Rheumatology.

He and his colleagues reviewed records on 204 consecutive patients treated for psoriatic arthritis with methotrexate from January 2004 through April 2014. The patients, who had a mean duration of psoriatic arthritis of 6.2 years, were all naive to biological antirheumatic drugs and were initiating methotrexate therapy.

Of the 204 patients, 167 had data sufficient for a 6-month analysis.

The investigators defined MDA after 6 months on methotrexate, the primary endpoint, as the presence of at least five out of the following seven domains: 0-1 tender joints, 0-1 swollen joints, Psoriasis Area Severity Index (PASI) 1 or less or body surface area involved 3% or less, 0-1 tender entheseal points, Health Assessment Questionnaire (HAQ) score of 0.5 or less, patient global disease activity Visual Analog Scale score of 20 or lower, and patient pain Visual Analog Scale score of 15 or lower.

They found that 17.4% of patients (29 of 167) met the physician-rated criteria for MDA at 6 months, even though 82.6% of the patients (138) had a PASI score of 1 or lower, and 58.1% (97) had a swollen joint count of 1 or fewer.

When the patients were asked for their assessment of global disease activity, 13.2% (22) rated disease activity with a prespecified score of 20 or lower. Only 12% of patients (20) reported an HAQ score of 0.5 or less.

The mean methotrexate dose was similar between patients who achieved MDA (17.8 mg/week) and those who did not (17.3 mg/week). The median dose was 17.5 mg/week in each group.

After controlling for sex, baseline sacroiliitis, and duration of psoriasis and psoriatic arthritis at the start of methotrexate in a multivariate model, the authors found that only dactylitis, inflammatory back pain, and mechanical back pain were significantly associated with a lower probability of patients reaching MDA. The variables that did not prove to be associated with achieving MDA after 6 months on methotrexate included erythrocyte sedimentation rate, presence of nail disease, number of clinically damaged joints, and body mass index.

The study was internally funded. Dr. Sheane reported having no relevant disclosures.