Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL

Abstract

Background: REVEAL was a 52-week phase III trial of adalimumab therapy for moderate to severe chronic plaque psoriasis. Patients from REVEAL could enter an open-label extension trial to receive adalimumab for approximately 3 years of total therapy.

Objective: We sought to determine long-term efficacy and safety of continuous adalimumab therapy for patients from REVEAL.

Methods: Efficacy and safety over greater than 3 years of treatment were analyzed for 4 groups of patients from REVEAL. Patients who received adalimumab continuously from baseline were grouped by their responses in REVEAL: (1) greater than or equal to 75% improvement in Psoriasis Area and Severity Index (PASI) score (PASI 75) at weeks 16 and 33 (sustained responders); (2) less than PASI 75 at week 16; and (3) greater than or equal to PASI 75 at week 16 with 50% to less than 75% improvement in PASI score at week 33. Results were also analyzed for patients who began adalimumab after 16 weeks of placebo therapy.

Results: For patients with sustained PASI 75 responses during REVEAL, efficacy was generally well maintained over 3 years, with 75%/90%/100% improvement in PASI score response rates (last observation carried forward) of 83%/59%/33% after 100 weeks and 76%/50%/31% after 160 weeks of continuous therapy. Some patients with less than PASI 75 responses in REVEAL also achieved long-term PASI 75 responses. Efficacy in the placebo/adalimumab group was consistent with the ensemble of results from the other 3 groups. Adverse event rates were consistent with those during REVEAL.

Limitations: The REVEAL study design prevented analyzing all patients from the adalimumab arm as one long-term cohort.

Conclusion: Adalimumab efficacy was well maintained over more than 3 years of continuous therapy for patients with sustained initial PASI 75 responses. Maintenance was best at the PASI 100 level.

Trial registration: ClinicalTrials.gov NCT00195676 NCT00237887.