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Effectiveness and safety of clobetasol propionate 0.05% spray added on to regimens containing biologic agents for the treatment of moderate to severe plaque psoriasis
P3339
P3341
Once-daily clobetasol propionate 0.05% shampoo for scalp psoriasis improves quality of life and achieves high patient satisfaction levels Jerry Tan, MD, Windsor Clinical Research, Windsor, Ontario, Canada; Beatrice Wang, MD, Siena Medical Research, Westmount, QC, Canada; David Gratton, MHS, International Dermatology Research, Montreal, Quebec, Canada; Richard Thomas, Derm Research @ 888, Vancouver, British Columbia, Canada
Efficacy and safety of infliximab therapy in plaque psoriasis patients previously treated with etanercept: Analysis of PSUNRISE AB Gottlieb, MD, PhD, Tufts Medical Center, Boston, MA, United States; Jim Wang, PhD, Johnson & Johnson Pharmaceutical Research and Development, Horsham, PA, United States; Marc Chevrier, MD, PhD, Centocor Ortho Biotech Services, Horsham, PA, United States; Robert Kalb, MD, SUNY at Buffalo School of Medicine, Buffalo, New York, United States Introduction: PSUNRISE is a multicenter, open-label prospective study in psoriasis patients with an inadequate response to etanercept (ETN), which explores the efficacy and safety of transition to infliximab (IFX). This trial enrolled 217 ETNexposed patients with significant disease activity despite ETN alone or in combination with methotrexate (MTX) or cyclosporine (CYC). Methods: Patients who had a minimum of 4 months of therapy on US/Canada labelapproved doses of ETN (25 mg 23 weekly, 50 mg 13 weekly, or 50 mg 23 weekly) were transitioned to IFX 2 weeks after the last ETN dose. IFX was administered at 5 mg/kg at weeks 0, 2, and 6 before a primary efficacy endpoint at week 10. Later doses (weeks 14/22) support secondary durability and safety assessments. Patient eligibility criteria included 181 years of age, currently receiving ETN 1/- MTX or CYC and psoriasis disease activity defined by a static Physicians Global Assessment (PGA) score $ 2, combined with an inadequate response confirmed by the investigator. The primary endpoint is the proportion of patients with at least one dose of IFX and a PGA of # 1 at week 10. Safety analysis includes a summary of all adverse events. A protocol-stipulated interim analysis for safety/efficacy was performed when 50% of the target cohort completed week 10. Results: The overall modified intent-to-treat population (215 patients) exhibited a BMI of 30.6/weight 93.4 kg (medians) with 36.3% females. Static PGA assessments were: 2.7/3 (mean/median) at screening and 2.8/3 on the first day of IFX dosing. This reflects a lack of ETN withdrawal skin flares over the two week screening period. At the interim analysis of 105 patients, 64.4% of these patients achieved a week 10 response. A majority of patients entered the study with a PGA of 31. In interim responders, median improvement in PGA was 2 (beyond baseline after ETN therapy). There were no unexpected adverse events in this interim analysis. Conclusion: PSUNRISE explores incremental responses associated with transition from ETN to IFX. This analysis demonstrated improvements in the majority of the interim study population at week 10. Because IFX appeared to be safe, generally well tolerated, and effective in this cohort, a full analysis of efficacy, durability, and safety in the full cohort will continue through week 30.
While numerous treatments are currently available for scalp psoriasis, it remains a common problem associated with significant psychosocial burden and adverse impact on quality of life. The objective of this study was to assess the impact on quality of life and patient satisfaction with once daily clobetasol propionate (CP) 0.05% shampoo. Patients aged 18 years or older, with a clinical diagnosis of moderate to severe scalp psoriasis, defined as a Global Severity Score (GSS) equal to 3 or 4 (on a 0 to 5 scale), applied CP shampoo once daily for up to 4 weeks. The Dermatology Life Quality Index (DLQI) was administered at study baseline and at end of the 4-week treatment period. During the latter, a patient satisfaction questionnaire was also administered. A total of 288 patients were enrolled at 12 investigative sites in Canada. Patients were predominantly female (57.6%) and with a mean age of 50.4 years (range: 18-84). At end of the treatment, 78% had a GSS # 2. Significant improvement from baseline in DLQI was observed at the end of the 4week treatment, while at baseline, 54.4% of patients indicated that scalp psoriasis had a moderate, very large or extremely large effect on their life. This rate dropped to 18.3% at completion. The patient satisfaction questionnaire showed high satisfaction with regard to hair cosmetic aspect, product use, treatment side effects and effectiveness. In particular, about 92% found the treatment easy to incorporate into a daily routine, 69% were satisfied or very satisfied, 81% preferred CP shampoo over any previous therapy, and 86.5% stated they would use it again. Once-daily clobetasol propionate 0.05% shampoo for up to 4 weeks improved the quality of life of patients with scalp psoriasis and contributed to patient satisfaction. Commercial support: Study and poster support provided by Galderma Laboratories, L.P.
Commercial support: Centocor Ortho Biotech Services.
P3342
P3340 Effectiveness and safety of clobetasol propionate 0.05% spray added on to regimens containing biologic agents for the treatment of moderate to severe plaque psoriasis Steven R. Feldman, MD, PhD, Wake Forest University School of Medicine, Winston Salem, NC, United States; John Y. M. Koo, MD, University of California, San Francisco Medical Center, San Francisco, CA, United States; Lori A. Johnson, PhD, Galderma Laboratories, Fort Worth, TX, United States; Luz E. Colon, MS, Galderma Laboratories, Fort Worth, TX, United States Moderate to severe psoriasis often requires systemic treatment, but even biologic medications do not induce complete clearing in the majority of patients. Topical treatments are often used as adjuncts to systemic treatment. A phase IV, multicenter, open-label trial was conducted to evaluate the effectiveness and safety of twice-daily clobetasol propionate 0.05% spray when added on to an existing stable regimen that included a biologic treatment ( $ 3 months duration) in 183 patients with moderate, severe, or very severe plaque psoriasis. By week 4, 78% of patients with moderate or severe disease and 66% of patients with very severe disease at baseline were clear or almost clear (P \.0001). Worst skin tolerability response was assessed postbaseline and included erythema (28% mild, 6% moderate, 1% severe), peeling (29% mild, 7% moderate, 1% severe), dryness (35% mild, 9% moderate, 2% severe), and stinging (24% mild, 4% moderate, 1% severe). Telangiectasias and skin atrophy were reported in 1% of patients each at some point during the study (postbaseline). Pruritus was reported in 10% of patients, and folliculitis was reported in 1% of patients. 10 patients experienced adverse events that were regarded as probably related to the study regimen, one of whom discontinued treatment. The addition of clobetasol propionate 0.05% spray to a stable regimen including a biologic resulted in clear or almost clear status in the majority of patients and provides an option for additional control of psoriasis plaques when biologic agents as monotherapy are not as effective as physicians and patients require. Commercial support: Study and poster support provided by Galderma Laboratories, L.P.
MARCH 2010
Adalimumab plus topical treatment (calcipotriol/betamethasone) in the treatment of moderate to severe psoriasis: Response across subgroups in BELIEVE ˚ rhus Sygehus, A ˚ rhus, Denmark; Diamant Thaci, MD, Knud Kragballe, MD, PhD, A Johann Wolfgang Goethe-University, Frankfurt, Hessen, Germany; Kristina Unnebrink, PhD, Abbott Laboratories, Ludwigshafen, Rhineland-Palatinate, Germany; Orin Goldblum, MD, Abbott Laboratories, Abbott Park, IL, United States Objectives: The phase IIIb, multicenter European study BELIEVE evaluated the efficacy of adjunctive topical therapy [calcipotriol/betamethasone (C/B)] for psoriasis patients (pts) receiving adalimumab (ADA). Subgroup analysis evaluated efficacy of ADA with or without C/B for pts grouped by baseline demographic and disease characteristics. Methods: BELIEVE was a 16-week study of pts with moderate to severe psoriasis who had failed, been intolerant of, or had contraindications for $ 2 systemic therapies. Pts received ADA (80 mg week 0; 40mg eow, weeks 1-15), and either (1) topical vehicle (V) or (2) topical C/B (daily for 4 weeks, then PRN; face, scalp, and nails excluded). (C/B provided by LEO Pharmaceutical Products Ltd. A/S, Ballerup, DE.) PASI 75 responses at week 16 were determined for pts grouped post-hoc by baseline demographic and disease parameters. Results: Seven hundred thirty patients (366, ADA 1 C/B; 364, ADA 1 V) were enrolled. Combination therapy was not superior to monotherapy at week 16 (PASI 75 ADA 1 C/B ¼ 64.8% vs ADA 1V ¼ 70.9%; P ¼.086). At week 16, PASI 75 response rates for subgroups of interest were as follows: pts \40/40-\65/ $ 65 years old for ADA 1 C/B (n ¼ 118/233/15) versus ADA 1 V (n ¼ 126/217/21): 74.6%/60.5%/53.3% and 73.8%/70.0%/61.9% (P \.05 ADA 1 V vs 1 C/B for 40\65 group); male/female pts for ADA 1 C/B (n ¼ 250/116) versus ADA 1 V (n ¼ 251/113): 65.6%/62.9% and 72.9%/66.4%; pts with PsA/without PsA for ADA 1 C/B (n ¼ 106/260) versus ADA 1 V (n ¼ 99/265): 59.4%/66.9% and 65.7%/72.8%; pts with disease duration \12y/12e\20.1y/20.1e\27.9y/[27.9y for ADA 1 C/B (n ¼ 95/88/98/85) versus ADA 1 V (n ¼ 87/95/84/98): 69.5%/69.3%/63.3%/56.5% and 65.5%/71.6%/72.6%/73.5% (P \.05 ADA 1 V versus C/B for [27.9y group); pts with baseline weight \71 kg/71-\84 kg/84-\95 kg/ $ 95 kg for ADA 1 C/B (n ¼ 82/87/90/106) versus ADA 1 V (n ¼ 92/100/81/87): 79.3%/64.4%/62.2%/56.6% and 79.3%/71.0%/70.4%/60.9%; and pts with baseline BSA # 20%/[20% for ADA 1 C/B (n ¼ 126/239) versus ADA 1 V (n ¼ 133/231): 67.5%/63.2% and 69.2%/71.9% (P \.05 ADA 1 V vs C/B for BSA [20%). Conclusions: PASI 75 response rates at week 16 in BELIEVE, as assessed post-hoc in a variety of baseline subgroups, were generally similar to those obtained overall for pts treated with ADA 1 V versus ADA 1 C/B. Commercial support: 100% is sponsored by Abbott.
J AM ACAD DERMATOL
AB133
P3341
Once-daily clobetasol propionate 0.05% shampoo for scalp psoriasis improves quality of life and achieves high patient satisfaction levels Jerry Tan, MD, Windsor Clinical Research, Windsor, Ontario, Canada; Beatrice Wang, MD, Siena Medical Research, Westmount, QC, Canada; David Gratton, MHS, International Dermatology Research, Montreal, Quebec, Canada; Richard Thomas, Derm Research @ 888, Vancouver, British Columbia, Canada
Efficacy and safety of infliximab therapy in plaque psoriasis patients previously treated with etanercept: Analysis of PSUNRISE AB Gottlieb, MD, PhD, Tufts Medical Center, Boston, MA, United States; Jim Wang, PhD, Johnson & Johnson Pharmaceutical Research and Development, Horsham, PA, United States; Marc Chevrier, MD, PhD, Centocor Ortho Biotech Services, Horsham, PA, United States; Robert Kalb, MD, SUNY at Buffalo School of Medicine, Buffalo, New York, United States Introduction: PSUNRISE is a multicenter, open-label prospective study in psoriasis patients with an inadequate response to etanercept (ETN), which explores the efficacy and safety of transition to infliximab (IFX). This trial enrolled 217 ETNexposed patients with significant disease activity despite ETN alone or in combination with methotrexate (MTX) or cyclosporine (CYC). Methods: Patients who had a minimum of 4 months of therapy on US/Canada labelapproved doses of ETN (25 mg 23 weekly, 50 mg 13 weekly, or 50 mg 23 weekly) were transitioned to IFX 2 weeks after the last ETN dose. IFX was administered at 5 mg/kg at weeks 0, 2, and 6 before a primary efficacy endpoint at week 10. Later doses (weeks 14/22) support secondary durability and safety assessments. Patient eligibility criteria included 181 years of age, currently receiving ETN 1/- MTX or CYC and psoriasis disease activity defined by a static Physicians Global Assessment (PGA) score $ 2, combined with an inadequate response confirmed by the investigator. The primary endpoint is the proportion of patients with at least one dose of IFX and a PGA of # 1 at week 10. Safety analysis includes a summary of all adverse events. A protocol-stipulated interim analysis for safety/efficacy was performed when 50% of the target cohort completed week 10. Results: The overall modified intent-to-treat population (215 patients) exhibited a BMI of 30.6/weight 93.4 kg (medians) with 36.3% females. Static PGA assessments were: 2.7/3 (mean/median) at screening and 2.8/3 on the first day of IFX dosing. This reflects a lack of ETN withdrawal skin flares over the two week screening period. At the interim analysis of 105 patients, 64.4% of these patients achieved a week 10 response. A majority of patients entered the study with a PGA of 31. In interim responders, median improvement in PGA was 2 (beyond baseline after ETN therapy). There were no unexpected adverse events in this interim analysis. Conclusion: PSUNRISE explores incremental responses associated with transition from ETN to IFX. This analysis demonstrated improvements in the majority of the interim study population at week 10. Because IFX appeared to be safe, generally well tolerated, and effective in this cohort, a full analysis of efficacy, durability, and safety in the full cohort will continue through week 30.
While numerous treatments are currently available for scalp psoriasis, it remains a common problem associated with significant psychosocial burden and adverse impact on quality of life. The objective of this study was to assess the impact on quality of life and patient satisfaction with once daily clobetasol propionate (CP) 0.05% shampoo. Patients aged 18 years or older, with a clinical diagnosis of moderate to severe scalp psoriasis, defined as a Global Severity Score (GSS) equal to 3 or 4 (on a 0 to 5 scale), applied CP shampoo once daily for up to 4 weeks. The Dermatology Life Quality Index (DLQI) was administered at study baseline and at end of the 4-week treatment period. During the latter, a patient satisfaction questionnaire was also administered. A total of 288 patients were enrolled at 12 investigative sites in Canada. Patients were predominantly female (57.6%) and with a mean age of 50.4 years (range: 18-84). At end of the treatment, 78% had a GSS # 2. Significant improvement from baseline in DLQI was observed at the end of the 4week treatment, while at baseline, 54.4% of patients indicated that scalp psoriasis had a moderate, very large or extremely large effect on their life. This rate dropped to 18.3% at completion. The patient satisfaction questionnaire showed high satisfaction with regard to hair cosmetic aspect, product use, treatment side effects and effectiveness. In particular, about 92% found the treatment easy to incorporate into a daily routine, 69% were satisfied or very satisfied, 81% preferred CP shampoo over any previous therapy, and 86.5% stated they would use it again. Once-daily clobetasol propionate 0.05% shampoo for up to 4 weeks improved the quality of life of patients with scalp psoriasis and contributed to patient satisfaction. Commercial support: Study and poster support provided by Galderma Laboratories, L.P.
Commercial support: Centocor Ortho Biotech Services.
P3342
P3340 Effectiveness and safety of clobetasol propionate 0.05% spray added on to regimens containing biologic agents for the treatment of moderate to severe plaque psoriasis Steven R. Feldman, MD, PhD, Wake Forest University School of Medicine, Winston Salem, NC, United States; John Y. M. Koo, MD, University of California, San Francisco Medical Center, San Francisco, CA, United States; Lori A. Johnson, PhD, Galderma Laboratories, Fort Worth, TX, United States; Luz E. Colon, MS, Galderma Laboratories, Fort Worth, TX, United States Moderate to severe psoriasis often requires systemic treatment, but even biologic medications do not induce complete clearing in the majority of patients. Topical treatments are often used as adjuncts to systemic treatment. A phase IV, multicenter, open-label trial was conducted to evaluate the effectiveness and safety of twice-daily clobetasol propionate 0.05% spray when added on to an existing stable regimen that included a biologic treatment ( $ 3 months duration) in 183 patients with moderate, severe, or very severe plaque psoriasis. By week 4, 78% of patients with moderate or severe disease and 66% of patients with very severe disease at baseline were clear or almost clear (P \.0001). Worst skin tolerability response was assessed postbaseline and included erythema (28% mild, 6% moderate, 1% severe), peeling (29% mild, 7% moderate, 1% severe), dryness (35% mild, 9% moderate, 2% severe), and stinging (24% mild, 4% moderate, 1% severe). Telangiectasias and skin atrophy were reported in 1% of patients each at some point during the study (postbaseline). Pruritus was reported in 10% of patients, and folliculitis was reported in 1% of patients. 10 patients experienced adverse events that were regarded as probably related to the study regimen, one of whom discontinued treatment. The addition of clobetasol propionate 0.05% spray to a stable regimen including a biologic resulted in clear or almost clear status in the majority of patients and provides an option for additional control of psoriasis plaques when biologic agents as monotherapy are not as effective as physicians and patients require. Commercial support: Study and poster support provided by Galderma Laboratories, L.P.
MARCH 2010
Adalimumab plus topical treatment (calcipotriol/betamethasone) in the treatment of moderate to severe psoriasis: Response across subgroups in BELIEVE ˚ rhus Sygehus, A ˚ rhus, Denmark; Diamant Thaci, MD, Knud Kragballe, MD, PhD, A Johann Wolfgang Goethe-University, Frankfurt, Hessen, Germany; Kristina Unnebrink, PhD, Abbott Laboratories, Ludwigshafen, Rhineland-Palatinate, Germany; Orin Goldblum, MD, Abbott Laboratories, Abbott Park, IL, United States Objectives: The phase IIIb, multicenter European study BELIEVE evaluated the efficacy of adjunctive topical therapy [calcipotriol/betamethasone (C/B)] for psoriasis patients (pts) receiving adalimumab (ADA). Subgroup analysis evaluated efficacy of ADA with or without C/B for pts grouped by baseline demographic and disease characteristics. Methods: BELIEVE was a 16-week study of pts with moderate to severe psoriasis who had failed, been intolerant of, or had contraindications for $ 2 systemic therapies. Pts received ADA (80 mg week 0; 40mg eow, weeks 1-15), and either (1) topical vehicle (V) or (2) topical C/B (daily for 4 weeks, then PRN; face, scalp, and nails excluded). (C/B provided by LEO Pharmaceutical Products Ltd. A/S, Ballerup, DE.) PASI 75 responses at week 16 were determined for pts grouped post-hoc by baseline demographic and disease parameters. Results: Seven hundred thirty patients (366, ADA 1 C/B; 364, ADA 1 V) were enrolled. Combination therapy was not superior to monotherapy at week 16 (PASI 75 ADA 1 C/B ¼ 64.8% vs ADA 1V ¼ 70.9%; P ¼.086). At week 16, PASI 75 response rates for subgroups of interest were as follows: pts \40/40-\65/ $ 65 years old for ADA 1 C/B (n ¼ 118/233/15) versus ADA 1 V (n ¼ 126/217/21): 74.6%/60.5%/53.3% and 73.8%/70.0%/61.9% (P \.05 ADA 1 V vs 1 C/B for 40\65 group); male/female pts for ADA 1 C/B (n ¼ 250/116) versus ADA 1 V (n ¼ 251/113): 65.6%/62.9% and 72.9%/66.4%; pts with PsA/without PsA for ADA 1 C/B (n ¼ 106/260) versus ADA 1 V (n ¼ 99/265): 59.4%/66.9% and 65.7%/72.8%; pts with disease duration \12y/12e\20.1y/20.1e\27.9y/[27.9y for ADA 1 C/B (n ¼ 95/88/98/85) versus ADA 1 V (n ¼ 87/95/84/98): 69.5%/69.3%/63.3%/56.5% and 65.5%/71.6%/72.6%/73.5% (P \.05 ADA 1 V versus C/B for [27.9y group); pts with baseline weight \71 kg/71-\84 kg/84-\95 kg/ $ 95 kg for ADA 1 C/B (n ¼ 82/87/90/106) versus ADA 1 V (n ¼ 92/100/81/87): 79.3%/64.4%/62.2%/56.6% and 79.3%/71.0%/70.4%/60.9%; and pts with baseline BSA # 20%/[20% for ADA 1 C/B (n ¼ 126/239) versus ADA 1 V (n ¼ 133/231): 67.5%/63.2% and 69.2%/71.9% (P \.05 ADA 1 V vs C/B for BSA [20%). Conclusions: PASI 75 response rates at week 16 in BELIEVE, as assessed post-hoc in a variety of baseline subgroups, were generally similar to those obtained overall for pts treated with ADA 1 V versus ADA 1 C/B. Commercial support: 100% is sponsored by Abbott.
J AM ACAD DERMATOL
AB133