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J. Am. Acad. Dermatol. · Aug 2018
Randomized Controlled TrialDual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: Results from BE ABLE 1, a 12-week randomized, double-blinded, placebo-controlled phase 2b trial.
- Kim A Papp, Joseph F Merola, Alice B Gottlieb, Griffiths Christopher E M CEM Dermatology Centre, Salford Royal Hospital, University of Manchester, National Institute for Health Research Biomedical Research Centre, Man, Nancy Cross, Luke Peterson, Christopher Cioffi, and Andrew Blauvelt.
- Probity Medical Research and K Papp Clinical Research, Waterloo, Canada. Electronic address: kapapp@probitymedical.com.
- J. Am. Acad. Dermatol. 2018 Aug 1; 79 (2): 277-286.e10.
BackgroundNeutralizing interleukin (IL) 17F in addition to IL-17A might provide a more complete and specific approach to inhibiting inflammation.ObjectiveAssess the efficacy and safety of bimekizumab, a monoclonal antibody that potently and selectively neutralizes IL-17A and IL-17F, in patients with moderate-to-severe plaque psoriasis.MethodsDouble-blinded, placebo-controlled phase 2b study (NCT02905006). Patients (randomized 1:1:1:1:1:1) received subcutaneous bimekizumab every 4 weeks at doses of 64 mg, 160 mg, 160 mg with 320 mg loading dose, 320 mg, 480 mg, or placebo. Primary endpoint was ≥90% reduction in Psoriasis Area Severity Index (PASI90) at week 12.ResultsThere was a significant (P < .0001) dose-dependent response for PASI90 (week 12); more patients achieved PASI90 in the bimekizumab groups (46.2%-79.1%) than patients in the placebo group (0%; P < .0001 all doses). Across all doses, there were significant improvements from baseline for all secondary endpoints (PASI90 week 8, PASI75 week 12, PASI100 week 12, and Investigators Global Assessment clear or almost clear weeks 8 and 12; P ≤ .0003) compared with placebo. More bimekizumab-treated patients than placebo-treated patients achieved PASI100 (week 12) (27.9%-60.0% vs 0%; P ≤ .0002 all doses). Treatment-emergent adverse events were reported by 126 of 208 (61%) bimekizumab-treated patients and 15 of 42 (36%) placebo-treated patients.LimitationsNo active comparator.ConclusionDual neutralization of IL-17A and IL-17F with bimekizumab provided rapid and substantial clinical improvements in patients with psoriasis, with no unexpected or dose-related safety findings.Copyright © 2018 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
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