Long-term efficacy and safety of brodalumab in the treatment of psoriasis: 120-week results from the randomized, double-blind, placebo- and active comparator-controlled phase 3 AMAGINE-2 trial
BACKGROUND Randomized controlled trials have demonstrated efficacy and safety of brodalumab in patients with moderate-to-severe plaque psoriasis.
OBJECTIVE To evaluate the efficacy and safety of brodalumab through 120 weeks of treatment in the AMAGINE-2 trial.
METHODS Patients received ustekinumab through week 52 followed by brodalumab 210 mg every 2 weeks (Q2W), continuous brodalumab 210 mg Q2W, or any dose of brodalumab. Efficacy data were reported through 120 weeks using observed data, last observation carried forward, and nonresponder imputation (NRI) analyses.
RESULTS Of patients who received brodalumab 210 mg Q2W, 84.4%, 75.6%, and 61.1% achieved 75%, 90%, and 100% improvement from baseline in psoriasis area and severity index at 120 weeks (observed data analysis), respectively. Patients who received brodalumab 210 mg Q2W after receiving ustekinumab through 52 weeks achieved similar skin clearance responses as patients who received continuous brodalumab 210 mg Q2W. Safety through 120 weeks was comparable to that of the blinded study periods.
LIMITATIONS A large number of discontinuations toward the end of the study (31% in the final 6 months) were due to early termination and led to differences between observed data and NRI results.
CONCLUSION Brodalumab is well tolerated and demonstrated robust efficacy for>2 years.