Efficacy and Safety of a Second Adalimumab Treatment Cycle in Psoriasis Patients who Relapsed after Adalimumab Discontinuation or Dosage Reduction: A Double-Blind, Randomized, Placebo-Controlled Trial

Abstract

Objective To evaluate re-treatment with weekly adalimumab in patients with moderate to severe psoriasis who had been successfully treated with weekly adalimumab but relapsed following randomization to either dosage reduction or discontinuation. Methods Patients who had achieved a Psoriasis Area and Severity Index (PASI) response of 50 or greater after 12 weeks on adalimumab 40 mg weekly in a previous study (M02-538), but then fell below a PASI 50 response within 12 weeks following reduction of dosage frequency to adalimumab 40 mg every other week or treatment discontinuation, could enter study M03-596 and receive open-label re-treatment with 12 weeks of weekly adalimumab. Results Thirty-two patients relapsed on or before week 24 of M02-538 and entered study M03-596. Overall, 81.3% (26 of 32) again achieved a PASI 50 response after 12 weeks of re-treatment. Of the 19 M03-596 patients who had a PASI 75 response at week 12 of M02-538, 12 (63.1%) again achieved a PASI 75 response at week 12 of M03-596. Conclusion Most patients who had initially responded to weekly adalimumab and who relapsed after randomization to a lower dosage or discontinuation regained response upon re-treatment with weekly adalimumab.

Comprehensive long‐term safety of adalimumab from 18 clinical trials in adult patients with moderate‐to‐severe plaque psoriasis

“…The main inclusion and exclusion criteria for most of the studies have been previously published . Briefly, included patients were aged ≥ 18 years with a diagnosis of moderate‐to‐severe psoriasis for ≥ 6 months.…”

Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis

“…Patients completing the extension and patients from other phase II/III studies of adalimumab [ 14 – 18 ] were eligible for enrollment in another study (NCT00195676) [ 19 ], in which adults with moderate to severe chronic plaque psoriasis received open-label adalimumab EOW or EW for up to 252 weeks (Fig. 1 c).…”

Efficacy, safety and medication cost implications of adalimumab 40 mg weekly dosing in patients with psoriasis with suboptimal response to 40 mg every other week dosing: results from an open-label study

“…This multicentre, open‐label continuation study enrolled adult patients with moderate‐to‐severe chronic plaque psoriasis who had participated in a prior adalimumab psoriasis study and either prematurely terminated from one of those studies owing to failure to achieve PASI 75 response at the primary endpoint, relapse, or loss of adequate response (studies REVEAL, M02‐538 and M03‐596) and/or had completed the antecedent study (M02‐528, M02‐529, M02‐538, M03‐596, REVEAL and CHAMPION) and remained eligible to enrol in the OLE (Table 1). Details from the preceding adalimumab studies, including inclusion and exclusion criteria, baseline demographics, and efficacy and safety outcomes, have been published 2,6–10 …”