Efficacy and Safety of Brodalumab in Participants With Moderate-to-Severe Plaque Psoriasis: The Patient Journey

Abstract

Introduction Brodalumab is the only human interleukin-17 (IL-17) receptor A blocker approved for moderate-to-severe plaque psoriasis; it is indicated in adults who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. This broad inhibition of IL-17 signaling could enhance the likelihood of rapid, deep, and durable disease control. Efficacy and safety of brodalumab were demonstrated in three pivotal, phase 3, multicenter, randomized trials of patients with moderate-to-severe plaque psoriasis (AMAGINE-1, AMAGINE-2, and AMAGINE-3). Here we present efficacy and safety data from 4 clinical study participants to document their brodalumab treatment journey.

Methods In AMAGINE-1, -2, and -3 (NCT01708590, NCT01708603, NCT01708629), participants were initially randomized to receive brodalumab (140 or 210 mg) or placebo via subcutaneous injection every 2 weeks (Q2W) during a 12-week induction period; AMAGINE-2 and -3 also included a randomized active comparator arm with the IL-12/23 inhibitor ustekinumab. At week 12, brodalumab-treated patients were rerandomized to receive placebo or the same brodalumab dose (AMAGINE-1) or various brodalumab regimens (AMAGINE-2 and -3) through week 52. Descriptive data are only summarized for selected cases who completed 52 weeks of brodalumab 210 mg Q2W treatment. Outcomes included Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and treatment-emergent adverse events.

Results At baseline, patients (n=4) were 34-56 years of age and PASI scores ranged from 15-30; 1 patient received prior biologic therapy. With brodalumab treatment, PASI score ranges decreased to 0-21 by week 12 and 0-5 by week 52; 1 patient achieved PASI score of 0 by week 12. Skin clearance was accompanied by improvements in quality of life, with DLQI total score ranges decreasing (ie, improving) from 18-27 at baseline to 0-11 at week 52. Most adverse events across patients were deemed not related to treatment.

Conclusions Across three pivotal phase 3 clinical trials, brodalumab was found to be an efficacious and safe option for participants with moderate-to-severe plaque psoriasis. All 4 cases presented here achieved substantial reductions in PASI scores and improvements in quality of life, with the majority of adverse events being unrelated to treatment. These clinical study cases reinforce that brodalumab is an important, well-tolerated therapeutic option for achieving high levels of disease control in patients with moderate-to-severe plaque psoriasis.