Adalimumab Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis of Results from Three Double-Blind, Placebo-Controlled Clinical Trials

Kim A Papp, April W Armstrong, Kristian Reich, Mahinda Karunaratne, Wendell Valdecantos, Kim A Papp, April W Armstrong, Kristian Reich, Mahinda Karunaratne, Wendell Valdecantos

Abstract

Introduction: There are limited data from randomized controlled clinical trials on the outcomes of biologics after discontinuation of a different systemic therapy. To determine the efficacy of adalimumab in patients who previously received systemic therapy (including failed therapy), we performed a pooled post hoc analysis of Psoriasis Area and Severity Index (PASI) response data from three double-blind, placebo-controlled clinical trials in patients with moderate to severe psoriasis.

Methods: Patients from the M02-528, REVEAL, and CHAMPION studies who were previously exposed to systemic treatment were categorized based on their response. The efficacy of adalimumab compared with placebo was analyzed at the end of the double-blind treatment period for the overall pooled intent-to-treat population (N = 1469) and subgroups that received (n = 780) or did not respond to (n = 229) previous systemic pretreatments.

Results: Rates for an improvement of ≥75% from baseline in the PASI score (PASI75 response) were significantly greater (p < 0.001) at week 16 in patients treated with adalimumab compared with patients who received placebo in the overall (72.1 vs. 8.0%, respectively), previously treated (72.7 vs. 8.5%), and previously failed treatment (70.4 vs. 8.1%) groups. PASI75 response rates were similar in the overall group and in patients who did not respond to methotrexate, cyclosporine, or psoralen plus ultraviolet A therapy. Improvements of ≥90 or ≥100 % from baseline PASI score were also higher with adalimumab vs. placebo in previously treated patients. Adverse events were similar among subgroups.

Conclusions: Adalimumab was efficacious for the treatment of moderate to severe psoriasis regardless of prior exposure to systemic therapies or failure of those prior therapies. CLINICALTRIALS.

Gov identifiers: NCT00645814, NCT00237887, NCT00235820.

Figures

Fig. 1
Fig. 1
PASI75, PASI90, and PASI100 response rates overall and by experience with prior systemic therapies at a 4 weeks and b 16 weeks. Patients from Study M02-528 were excluded from the analysis at 16 weeks because it was a 12-week study. PASI75, PASI90, and PASI100 improvement of ≥75, ≥90, and 100 % from baseline, respectively, in the Psoriasis Area and Severity Index score. *p < 0.001 compared with placebo
Fig. 2
Fig. 2
PASI75, PASI90, and PASI100 response rates at week 16 overall and by type of prior failed systemic therapy. Patients from Study M02-528 were excluded because it was a 12-week study. ADA adalimumab, PASI75, PASI90, and PASI100 improvement of ≥75, ≥90, and 100 % from baseline, respectively, in the Psoriasis Area and Severity Index score, PBO placebo, PUVA psoralen plus ultraviolet A. *p ≤ 0.001 compared with placebo

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Source: PubMed

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