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Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis.
N Engl J Med. 2012 Mar 29; 366(13):1181-9.NEJM

Abstract

BACKGROUND

In this phase 2, randomized, double-blind, placebo-controlled, dose-ranging study, we assessed the efficacy and safety of brodalumab (AMG 827), a human anti-interleukin-17-receptor monoclonal antibody, for the treatment of moderate-to-severe plaque psoriasis.

METHODS

We randomly assigned patients with a score of 12 or higher on the psoriasis area-and-severity index (PASI, on which scores range from 0 to 72, with higher scores indicating more severe disease) and with 10% or more of their body-surface area affected by psoriasis to receive brodalumab (70 mg, 140 mg, or 210 mg at day 1 and weeks 1, 2, 4, 6, 8, and 10 or 280 mg monthly) or placebo. The primary end point was the percentage improvement from baseline in the PASI score at week 12. Secondary end points included improvement of at least 75% and at least 90% in the PASI score and the score on the static physician's global assessment at week 12.

RESULTS

A total of 198 patients underwent randomization. At week 12, the mean percentage improvements in the PASI score were 45.0% among patients receiving 70 mg of brodalumab, 85.9% among those receiving 140 mg, 86.3% among those receiving 210 mg, 76.0% among those receiving 280 mg, and 16.0% among those receiving placebo (P<0.001 for all comparisons with placebo). An improvement of at least 75% and at least 90% in the PASI score at week 12 was seen in 77% and 72%, respectively, of the patients in the 140-mg brodalumab group and in 82% and 75%, respectively, of the patients in the 210-mg group, as compared with 0% in the placebo group (P<0.001 for all comparisons). The percentage of patients with a static physician's global assessment of clear or minimal disease was 26%, 85%, 80%, and 69% with the 70-mg, 140-mg, 210-mg, and 280-mg doses, respectively, of brodalumab, as compared with 3% with placebo (P<0.01 for all comparisons with placebo). Two cases of grade 3 neutropenia were reported in the 210-mg brodalumab group. The most commonly reported adverse events in the combined brodalumab groups were nasopharyngitis (8%), upper respiratory tract infection (8%), and injection-site erythema (6%).

CONCLUSIONS

Brodalumab significantly improved plaque psoriasis in this 12-week, phase 2 study. (Funded by Amgen; ClinicalTrials.gov number, NCT00975637.).

Links

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Authors+Show Affiliations

Papp KA
Probity Medical Research, Waterloo, ON, Canada. kapapp@probitymedical.com
Leonardi C
No affiliation info available
Menter A
No affiliation info available
Ortonne JP
No affiliation info available
Krueger JG
No affiliation info available
Kricorian G
No affiliation info available
Aras G
No affiliation info available
Li J
No affiliation info available
Russell CB
No affiliation info available
Thompson EH
No affiliation info available
Baumgartner S
No affiliation info available

MeSH

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansInjections, SubcutaneousMaleMiddle AgedPsoriasisReceptors, Interleukin-17Severity of Illness IndexTreatment Outcome

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22455412

Clinical Trial Links

Clinical trial which this article describes

Citation

Papp, Kim A., et al. "Brodalumab, an Anti-interleukin-17-receptor Antibody for Psoriasis." The New England Journal of Medicine, vol. 366, no. 13, 2012, pp. 1181-9.
Papp KA, Leonardi C, Menter A, et al. Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. N Engl J Med. 2012;366(13):1181-9.
Papp, K. A., Leonardi, C., Menter, A., Ortonne, J. P., Krueger, J. G., Kricorian, G., Aras, G., Li, J., Russell, C. B., Thompson, E. H., & Baumgartner, S. (2012). Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. The New England Journal of Medicine, 366(13), 1181-9. https://doi.org/10.1056/NEJMoa1109017
Papp KA, et al. Brodalumab, an Anti-interleukin-17-receptor Antibody for Psoriasis. N Engl J Med. 2012 Mar 29;366(13):1181-9. PubMed PMID: 22455412.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. AU - Papp,Kim A, AU - Leonardi,Craig, AU - Menter,Alan, AU - Ortonne,Jean-Paul, AU - Krueger,James G, AU - Kricorian,Gregory, AU - Aras,Girish, AU - Li,Juan, AU - Russell,Chris B, AU - Thompson,Elizabeth H Z, AU - Baumgartner,Scott, PY - 2012/3/30/entrez PY - 2012/3/30/pubmed PY - 2012/4/11/medline SP - 1181 EP - 9 JF - The New England journal of medicine JO - N Engl J Med VL - 366 IS - 13 N2 - BACKGROUND: In this phase 2, randomized, double-blind, placebo-controlled, dose-ranging study, we assessed the efficacy and safety of brodalumab (AMG 827), a human anti-interleukin-17-receptor monoclonal antibody, for the treatment of moderate-to-severe plaque psoriasis. METHODS: We randomly assigned patients with a score of 12 or higher on the psoriasis area-and-severity index (PASI, on which scores range from 0 to 72, with higher scores indicating more severe disease) and with 10% or more of their body-surface area affected by psoriasis to receive brodalumab (70 mg, 140 mg, or 210 mg at day 1 and weeks 1, 2, 4, 6, 8, and 10 or 280 mg monthly) or placebo. The primary end point was the percentage improvement from baseline in the PASI score at week 12. Secondary end points included improvement of at least 75% and at least 90% in the PASI score and the score on the static physician's global assessment at week 12. RESULTS: A total of 198 patients underwent randomization. At week 12, the mean percentage improvements in the PASI score were 45.0% among patients receiving 70 mg of brodalumab, 85.9% among those receiving 140 mg, 86.3% among those receiving 210 mg, 76.0% among those receiving 280 mg, and 16.0% among those receiving placebo (P<0.001 for all comparisons with placebo). An improvement of at least 75% and at least 90% in the PASI score at week 12 was seen in 77% and 72%, respectively, of the patients in the 140-mg brodalumab group and in 82% and 75%, respectively, of the patients in the 210-mg group, as compared with 0% in the placebo group (P<0.001 for all comparisons). The percentage of patients with a static physician's global assessment of clear or minimal disease was 26%, 85%, 80%, and 69% with the 70-mg, 140-mg, 210-mg, and 280-mg doses, respectively, of brodalumab, as compared with 3% with placebo (P<0.01 for all comparisons with placebo). Two cases of grade 3 neutropenia were reported in the 210-mg brodalumab group. The most commonly reported adverse events in the combined brodalumab groups were nasopharyngitis (8%), upper respiratory tract infection (8%), and injection-site erythema (6%). CONCLUSIONS: Brodalumab significantly improved plaque psoriasis in this 12-week, phase 2 study. (Funded by Amgen; ClinicalTrials.gov number, NCT00975637.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/22455412/Brodalumab_an_anti_interleukin_17_receptor_antibody_for_psoriasis_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa1109017?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -