Long-term efficacy and safety of brodalumab in psoriasis through 120 weeks and after withdrawal and retreatment: subgroup analysis of a randomised phase 3 trial (AMAGINE-1).

BACKGROUND: Brodalumab is efficacious for the treatment of moderate-to-severe plaque psoriasis through 52 weeks. OBJECTIVE: To evaluate the efficacy and safety of brodalumab through 120 weeks, including following withdrawal and retreatment. METHODS: At baseline, patients were randomized to brodalumab (n=222) or placebo (n=220). At week 12, patients achieving static physician's global assessment score of 0 or 1 (sPGA 0/1) with brodalumab were re-randomized to brodalumab (n=83) or placebo (n=84; later re-treated with brodalumab if sPGA >/=3 occurred), and patients receiving placebo switched to brodalumab (n=208). Safety was assessed by treatment-emergent adverse events. RESULTS: Among those who achieved sPGA 0/1 at week 12 and were re-randomized to brodalumab, 95.7% and 79.5% using observed data, respectively, and 73.9% and 61.4% using nonresponder imputation, respectively, achieved 75% improvement in psoriasis area and severity index (PASI 75) and PASI 100 at week 120. Following withdrawal from brodalumab, return of disease occurred after a mean (standard deviation) of 74.7 (50.5) days. Among those who switched from brodalumab to placebo at week 12, PASI 75 rates using observed data and nonresponder imputation were 55.1% and 51.2% at week 20, respectively, and 94.0% and 75.0% at week 120, respectively; PASI 100 rates at week 120 were 74.6% and 59.5%, respectively. Efficacy was maintained through week 120 in those receiving brodalumab after placebo. No new safety signals were observed. CONCLUSIONS: These findings indicate that brodalumab is efficacious and safe for continuous long-term treatment of psoriasis and support potential for response after discontinuation and retreatment.