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A prospective phase III, randomized, double‐blind, placebo‐controlled study of brodalumab in patients with moderate‐to‐severe plaque psoriasis

Open access
Papp, K.A., Reich, K., Paul, C., Blauvelt, A., Baran, W., Bolduc, C., Toth, D., Langley, R.G., Cather, J., Gottlieb, A.B., Thaçi, D., Krueger, J.G., Russell, C.B., Milmont, C.E., Li, J., Klekotka, P.A., Kricorian, G., Nirula, A.·2016·British Journal of Dermatology
DOI 10.1111/bjd.14493
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Abstract

BACKGROUND: The interleukin-17 cytokine family plays a central role in psoriasis pathogenesis. OBJECTIVES: To evaluate the efficacy and safety of brodalumab, a human anti-interleukin-17 receptor antibody, in treating patients with moderate-to-severe plaque psoriasis. METHODS: In this phase III, double-blind, placebo-controlled study (NCT01708590; AMAGINE-1), adult patients in the U.S.A., Canada and Europe were randomized to brodalumab (140 or 210 mg) or placebo every 2 weeks (Q2W), with an additional dose at week 1, for a 12-week induction phase. At week 12, patients receiving brodalumab who achieved static Physician's Global Assessment 0 or 1 (sPGA success) were rerandomized to the placebo or induction dose. After week 16, patients with sPGA ≥ 3 were re-treated with the induction dose. After ≥ 12 weeks of retreatment, patients with sPGA 2 for ≥ 4 weeks or sPGA ≥ 3 were rescued with brodalumab 210 mg Q2W. At week 12, patients randomized to brodalumab with sPGA ≥ 2 or placebo received brodalumab 210 mg Q2W. Coprimary end points were the percentage of patients with ≥ 75% improvement in Psoriasis Area and Severity Index score (PASI 75) and sPGA success at week 12. RESULTS: There were 661 patients randomized: 220 placebo, 219 brodalumab 140 mg and 222 brodalumab 210 mg. At week 12, 60% (140 mg) and 83% (210 mg) vs. 3% (placebo) achieved PASI 75, and 54% (140 mg) and 76% (210 mg) vs. 1% (placebo) achieved sPGA success. The safety profile was considered acceptable. CONCLUSIONS: Brodalumab therapy resulted in significant clinical benefit and an acceptable safety profile in patients with moderate-to-severe plaque psoriasis.

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Metadata

Authors
Papp, K. A., Reich, K., Paul, C., Blauvelt, A., Baran, W., Bolduc, C., Toth, D., Langley, R. G., Cather, J., Gottlieb, A. B., Thaçi, D., Krueger, J. G., Russell, C. B., Milmont, C. E., Li, J., Klekotka, P. A., Kricorian, G., & Nirula, A.
Venue
British Journal of Dermatology
Publisher
Oxford University Press (OUP)
Published
2016-06-23
Volume
175
Issue
2
Pages
273-286
ISSN
  • 0007-0963 (ISSN-L)
  • 1365-2133
DOI
10.1111/bjd.14493
OpenAlex
W2276035339
Cited by
470
References
21
FWCI
28.94
Type
journal article
Language
en
Open access
hybrid

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The paper
Papp, K. A., Reich, K., Paul, C., Blauvelt, A., Baran, W., Bolduc, C., Toth, D., Langley, R. G., Cather, J., Gottlieb, A. B., Thaçi, D., Krueger, J. G., Russell, C. B., Milmont, C. E., Li, J., Klekotka, P. A., Kricorian, G., & Nirula, A. (2016). A prospective phase III, randomized, double‐blind, placebo‐controlled study of brodalumab in patients with moderate‐to‐severe plaque psoriasis. British Journal of Dermatology. https://doi.org/10.1111/bjd.14493

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.