Long-term efficacy of brodalumab for the treatment of moderate-to-severe psoriasis: data from a pivotal Phase III clinical trial
Presenters: Menter A1, Sobell J2, Silverberg JI3, Lebwohl M4, Rastogi S5, Pillai R6, Israel RJ5
Affiliations: 1Baylor University Medical Center, Dallas, TX; 2SkinCare Physicians, Chestnut Hill, MA; 3Northwestern University Feinberg School of Medicine, Chicago, IL; 4Icahn School of Medicine at Mount Sinai, New York, NY; 5Valeant Pharmaceuticals North America LLC, Bridgewater, NJ; 6Dow Pharmaceutical Sciences, Petaluma, CA
Background/Objective: Brodalumab is a fully human anti-interleukin-17 receptor A (IL-17RA) monoclonal antibody that antagonizes the action of specific inflammatory cytokines involved in psoriasis. Pivotal Phase III clinical trials demonstrated the efficacy and safety of brodalumab through 52 weeks of treatment in patients with moderate-to-severe psoriasis. We evaluated the efficacy of brodalumab in psoriasis from Week 52 through Week 120. Data were derived from the long-term, open-label extension study of a 52-week, randomized, double-blind, placebo- and active comparator-controlled clinical trial (AMAGINE-2).
Methods: Patients received brodalumab 210mg or 140mg every two weeks (Q2W), ustekinumab, or placebo during a 12-week induction phase, followed by a maintenance phase through Week 52. During the maintenance phase, patients receiving brodalumab were rerandomized to a different dose and interval of brodalumab (210mg or 140mg Q2W, Q4W, or Q8W), patients receiving placebo were switched to brodalumab 210mg Q2W, and patients receiving ustekinumab continued on ustekinumab. At Week 52, patients who received brodalumab during the maintenance phase continued receiving their maintenance dose of brodalumab, and patients who were taking ustekinumab switched to brodalumab 210mg Q2W. Data are presented for patients who received brodalumab 210mg Q2W (the FDA-approved dose) through Week 120 of the long-term extension phase.
Results: A total of 1,392 patients received brodalumab 210mg Q2W in the long-term extension phase. At Week 52, rates (95% confidence interval [CI]) of these patients for Psoriasis Area and Severity Index (PASI) 75-percent improvement (PASI 75), PASI 90, and PASI 100 were 90.6 percent (88.9%-92.2%), 77.6 percent (75.2%-79.9%), and 53.3 percent (50.5%-56.0%), respectively. Similarly, at Week 120, corresponding responder rates (95% CI) were 88.4 percent (86.0%-90.6%), 76.8 percent (73.6%-79.7%), and 56.2 percent (52.7%-59.7%), respectively. Success rates (95% CI), based on static physician’s global assessment score of 0 or 1, were 79.2 percent (76.8%-81.4%) and 76.6 percent (73.5%-79.6%) at Weeks 52 and 120, respectively. The patients who received continuous brodalumab 210mg Q2W (n=334) achieved Static Physician’s Global Assessment Score of 0 or 1, PASI 75, PASI 90, and PASI 100 response of 79.2, 86.5, 76.4, and 59.0 percent, respectively, through Week 120.
Conclusion: Treatment with brodalumab resulted in substantial psoriatic lesion clearing for more than two years in most patients with moderate-to-severe psoriasis.
Funding: This study was sponsored by Amgen Inc.