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.