Kim A Papp1, Min Yang2, Murali Sundaram3, John Jarvis4, Keith A Betts4, Yanjun Bao3, James E Signorovitch4. 1. Probity Medical Research, and K. Papp Clinical Research, Waterloo, Ontario, Canada. 2. Analysis Group Inc., Boston, MA, USA. Electronic address: Min.Yang@analysisgroup.com. 3. AbbVie Inc., North Chicago, IL, USA. 4. Analysis Group Inc., Boston, MA, USA.
Abstract
OBJECTIVES: To compare outcomes between adalimumab and etanercept in the treatment of moderate to severe plaque psoriasis. METHODS: Study groups included patients randomized to adalimumab or placebo (REVEAL and CHAMPION trials) and those randomized to etanercept or placebo (M10-114 and M10-315 trials). Week 12 outcomes were compared between patients receiving adalimumab and those receiving etanercept after adjusting for cross-trial differences in patient characteristics using propensity score weighting and after subtracting effects of placebo. Outcomes included proportion of patients achieving 75% or more, 90% or more, and 100% reductions from baseline in the Psoriasis Area and Severity Index (PASI75, PASI90, PASI100, respectively), symptom resolution (pruritus = 0; psoriatic pain = 0), lesion resolution (minimal scores for plaque signs erythema, desquamation, and induration, and by body regions head, upper limbs, trunk, and lower limbs), absence of skin-related quality-of-life impact (Dermatology Life Quality Index [DLQI] = 0), "complete disease control" (patient's global assessment [PtGA] = 0), and adverse events. RESULTS: After adjustment, baseline characteristics were balanced among study groups (adalimumab = 875 vs. placebo = 427; etanercept = 260 vs. placebo = 130). Compared with etanercept, adalimumab was associated with significantly better placebo-adjusted outcomes (PASI75: 62.3% vs. 42.6%; PASI90: 35.9% vs. 12.1%; PASI100: 13.1% vs. 4.9%; pruritus: 24.7% vs. 13.0%; psoriatic pain: 27.4% vs. 8.7%; DLQI: 27.7% vs. 11.7%; and PtGA: 16.4% vs. 10.6%; all P < 0.05), except for similar rates of adverse events and head-specific lesion resolution. CONCLUSIONS: Compared with etanercept, adalimumab treatment for moderate to severe plaque psoriasis was associated with greater PASI reduction, higher rates of resolution of skin signs and symptoms, and greater improvements in dermatological life quality.
RCT Entities:
OBJECTIVES: To compare outcomes between adalimumab and etanercept in the treatment of moderate to severe plaque psoriasis. METHODS: Study groups included patients randomized to adalimumab or placebo (REVEAL and CHAMPION trials) and those randomized to etanercept or placebo (M10-114 and M10-315 trials). Week 12 outcomes were compared between patients receiving adalimumab and those receiving etanercept after adjusting for cross-trial differences in patient characteristics using propensity score weighting and after subtracting effects of placebo. Outcomes included proportion of patients achieving 75% or more, 90% or more, and 100% reductions from baseline in the Psoriasis Area and Severity Index (PASI75, PASI90, PASI100, respectively), symptom resolution (pruritus = 0; psoriatic pain = 0), lesion resolution (minimal scores for plaque signs erythema, desquamation, and induration, and by body regions head, upper limbs, trunk, and lower limbs), absence of skin-related quality-of-life impact (Dermatology Life Quality Index [DLQI] = 0), "complete disease control" (patient's global assessment [PtGA] = 0), and adverse events. RESULTS: After adjustment, baseline characteristics were balanced among study groups (adalimumab = 875 vs. placebo = 427; etanercept = 260 vs. placebo = 130). Compared with etanercept, adalimumab was associated with significantly better placebo-adjusted outcomes (PASI75: 62.3% vs. 42.6%; PASI90: 35.9% vs. 12.1%; PASI100: 13.1% vs. 4.9%; pruritus: 24.7% vs. 13.0%; psoriatic pain: 27.4% vs. 8.7%; DLQI: 27.7% vs. 11.7%; and PtGA: 16.4% vs. 10.6%; all P < 0.05), except for similar rates of adverse events and head-specific lesion resolution. CONCLUSIONS: Compared with etanercept, adalimumab treatment for moderate to severe plaque psoriasis was associated with greater PASI reduction, higher rates of resolution of skin signs and symptoms, and greater improvements in dermatological life quality.