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

Research output: Contribution to journalArticle

12 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)79-86
Number of pages8
JournalAmerican Journal of Clinical Dermatology
Volume17
Issue number1
DOIs
StatePublished - Feb 1 2016
Externally publishedYes

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Controlled Clinical Trials
Psoriasis
Placebos
Therapeutics
PUVA Therapy
Adalimumab
Biological Products
Methotrexate
Cyclosporine
Randomized Controlled Trials

ASJC Scopus subject areas

  • Dermatology

Cite this

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

In: American Journal of Clinical Dermatology, Vol. 17, No. 1, 01.02.2016, p. 79-86.

Research output: Contribution to journalArticle

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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.",
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