Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials.

Abstract

BACKGROUND:

Data on treatment outcomes in patients with psoriasis who have skin of color are limited. Brodalumab has shown efficacy in patients with moderate-to-severe plaque psoriasis.

OBJECTIVE:

Our objective was to evaluate the efficacy, safety, and health-related quality of life associated with brodalumab in patients with skin of color participating in two phase III, multicenter, randomized, double-blind, placebo- and active comparator-controlled studies (AMAGINE-2/-3).

METHODS:

Patients were self-categorized into racial subgroups (black, Asian, or white) or the non-mutually exclusive ethnic subgroup Hispanic/Latino. Patients were randomized to receive brodalumab 210 mg every 2 weeks (Q2W) or ustekinumab (45 mg in patients weighing ≤ 100 kg and 90 mg in patients weighing > 100 kg) for 52 weeks. Skin clearance was monitored using the Psoriasis Area and Severity Index (PASI) and Static Physician's Global Assessment (sPGA). Treatment-emergent adverse events (TEAEs) were summarized by treatment and racial and ethnic subgroup. Health-related quality of life was assessed using the Dermatology Life Quality Index (DLQI).

RESULTS:

During the 12-week induction phase, 613 patients received ustekinumab (black, n = 20; Asian, n = 24; white, n = 551; Hispanic/Latino, n = 68) and 1236 patients received brodalumab 210 mg Q2W (black, n = 36; Asian, n = 39; white, n = 1116; Hispanic/Latino, n = 132). At week 52, a total of 590 patients received continuous ustekinumab (black, n = 19; Asian, n = 23; white, n = 532; Hispanic/Latino, n = 64) and 339 patients were re-randomized to continue receiving brodalumab 210 mg Q2W (black, n = 10; Asian, n = 7; white, n = 308; Hispanic/Latino, n = 40). Among patients who received brodalumab 210 mg Q2W, skin clearance response rates were similar across racial and ethnic subgroups at week 12 and week 52; rates of 75%, 90%, and 100% improvement in PASI from baseline were also higher, as was sPGA score ≤ 1, than in patients who received ustekinumab across all racial and ethnic subgroups. Rates of TEAEs and ≥ 5-point improvement in DLQI score were similar across racial and ethnic subgroups.

CONCLUSIONS:

Brodalumab 210 mg Q2W is well tolerated and efficacious across diverse racial and ethnic subgroups in patients with psoriasis, including black, Asian, white, and Hispanic/Latino patients.

TRIAL REGISTRY:

ClinicalTrials.gov identifier NCT01708603 (AMAGINE-2); NCT01708629 (AMAGINE-3).

• Authors: Amy McMichael, Seemal R Desai, Aamir Qureshi, Shipra Rastogi, Andrew F Alexis
• Journal: American journal of clinical dermatology (Am J Clin Dermatol) Vol. 20 Issue 2 Pg. 267-276 (Apr 2019) ISSN: 1179-1888 [Electronic] New Zealand
• PMID: 30471012 (Publication Type: Comparative Study, Journal Article, Meta-Analysis)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Dermatologic Agents
• brodalumab
• Ustekinumab

Topics

• Adult
• Antibodies, Monoclonal (administration & dosage, adverse effects)
• Antibodies, Monoclonal, Humanized
• Clinical Trials, Phase III as Topic
• Dermatologic Agents (administration & dosage, adverse effects)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Psoriasis (drug therapy, ethnology, pathology)
• Quality of Life
• Racial Groups (statistics & numerical data)
• Randomized Controlled Trials as Topic
• Severity of Illness Index
• Skin Pigmentation
• Treatment Outcome
• Ustekinumab (administration & dosage, adverse effects)