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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

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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).

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Acknowledgements

Editorial assistance was provided under the direction of the authors by MedThink SciCom with support from Brittany Eldridge, PhD and David Boffa, ELS.

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Authors and Affiliations

  1. Department of Dermatology, Wake Forest Baptist Medical Center, Medical Center Boulevard, Winston-Salem, NC, 27104, USA

    Amy McMichael

  2. Innovative Dermatology, Plano, TX, USA

    Seemal R. Desai

  3. University of Texas Southwestern Medical Center, Dallas, TX, USA

    Seemal R. Desai

  4. Ortho Dermatologics, Bridgewater, NJ, USA

    Aamir Qureshi & Shipra Rastogi

  5. Mount Sinai St. Luke’s and Mount Sinai West, New York, NY, USA

    Andrew F. Alexis

Authors
  1. Amy McMichael
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  2. Seemal R. Desai
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  5. Andrew F. Alexis
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Corresponding author

Correspondence to Amy McMichael.

Ethics declarations

Funding

The AMAGINE-2/-3 studies were supported by Amgen. This analysis was supported by Ortho Dermatologics.

Ethical approval

Study protocols were consistent with the 2008 Declaration of Helsinki and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guidelines for Good Clinical Practice and were approved by individual institutional review boards at each participating study center. All participants signed and personally dated the informed consent form approved by the independent ethics committees and institutional review boards before any study-specific procedures were performed. Additional informed consent was obtained from all individual participants whose photographs appear in this article.

Conflict of interest

Amy McMichael has been an investigator for Allergan, Casseopea, Concert, Incyte, and Samumed and a consultant to Aclaris, Galderma, IntraDerm, Johnson & Johnson, Merz, Pfizer, PharmaDerm, Procter & Gamble, and Samumed. Seemal R. Desai has been a consultant to Bausch Health Companies. Andrew F. Alexis has received grants from Dermira, Novartis, and LEO Pharma; consulting fees or honorarium from Novartis, LEO Pharma, and Bausch Health Companies; and speaking fees from LEO Pharma; and has provided writing assistance, medicines, equipment, or administrative support to Bausch Health Companies. Aamir Qureshi is an employee of Ortho Dermatologics and may hold stocks and/or stock options in Bausch Health Companies Pharmaceuticals. Shipra Rastogi may hold stocks and/or stock options in Bausch Health Companies Pharmaceuticals.

Data availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

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McMichael, A., Desai, S.R., Qureshi, A. et al. 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. Am J Clin Dermatol 20, 267–276 (2019). https://doi.org/10.1007/s40257-018-0408-z

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  • DOI: https://doi.org/10.1007/s40257-018-0408-z

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