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Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study - 10/10/20

Doi : 10.1016/j.jaad.2020.05.105 
Andrew Blauvelt, MD, MBA a, , Kim A. Papp, MD, PhD b, Joseph F. Merola, MD c, Alice B. Gottlieb, MD, PhD d, Nancy Cross, MD e, Cynthia Madden, MD, MPH e, Maggie Wang, MS e, Christopher Cioffi, PhD f, Christopher E.M. Griffiths, MD g
a Oregon Medical Research Center, Portland, Oregon 
b Probity Medical Research and K. Papp Clinical Research, Waterloo, and University of Toronto, Toronto, Ontario 
c Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts 
d Icahn School of Medicine at Mount Sinai, New York, New York 
e UCB Biosciences Inc, Raleigh, North Carolina 
f UCB Pharma, Brussels, Belgium 
g Salford Royal Hospital, University of Manchester, Manchester NIHR Biomedical Research Centre, Manchester, United Kingdom 

Correspondence to: Andrew Blauvelt, MD, MBA, Oregon Medical Research Center, 9495 SW Locust St, Ste G, Portland, OR 97223.Oregon Medical Research Center9495 SW Locust StSte GPortlandOR97223

Abstract

Background

Dual neutralization of both interleukin 17A and 17F with the monoclonal antibody bimekizumab may have greater efficacy in psoriasis than neutralization of interleukin 17A alone.

Objective

To provide longer-term efficacy and safety data for bimekizumab from a phase 2b extension study in patients with moderate to severe psoriasis (BE ABLE 2).

Methods

After the 12-week initial study (BE ABLE 1), patients who had a 90% improvement in Psoriasis Area and Severity Index (PASI 90) at week 12 received bimekizumab 64, 160, or 320 mg for an additional 48 weeks (60 weeks in total). The primary objective was safety.

Results

Across all dose groups (N = 217), initial PASI 90 responders generally maintained high levels of efficacy through week 60: PASI 90, 80% to 100%; 100% improvement in PASI, 69% to 83%; Investigator's Global Assessment score 0 or 1, 78% to 100% (all nonresponder imputation). Incidence of serious treatment-emergent adverse events was 15/217 (6.9%). No cases of inflammatory bowel disease, major adverse cardiovascular events, or suicidal ideation or behavior were reported.

Limitations

Low numbers in the bimekizumab 64 mg group (n = 15). The majority of 60-week data reported here are primarily for the week 12 PASI 90 responders only.

Conclusion

Bimekizumab response rates were maintained through week 60. A substantial proportion of patients achieved complete skin clearance. Bimekizumab was generally well tolerated.

Le texte complet de cet article est disponible en PDF.

Key words : BE ABLE 2, bimekizumab, extension, IL-17A, IL-17F, PASI90, plaque psoriasis, randomized clinical trial

Abbreviations used : IL, PASI


Plan


 Funding sources: Supported by UCB Pharma.
 Conflicts of interest: Dr Blauvelt has received consultant and investigator fees from AbbVie, Aclaris, Allergan, Almira, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dermira Inc, Eli Lilly, FLX Bio, Forte, Galderma, Janssen, LEO, Novartis, Ortho, Pfizer, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, and UCB Pharma; and speaker fees from AbbVie. Dr Papp has received honoraria and grants from AbbVie, Akros, Amgen, Arcutis, Astellas, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, Canfite, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Forward Pharma, Galderma, Genentech, Gilead, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, LEO, MedImmune, Merck (MSD), Merck-Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi Aventis/Genzyme, Sun Pharma, Takeda, UCB Pharma, and Valeant/Bausch Health; and is a consultant (no compensation) for AstraZeneca and Meiji Seika Pharma. Dr Merola is a consultant or investigator for AbbVie, Aclaris, Almirall, Avotres, Biogen, Celgene, Dermavant, Eli Lilly, EMD Serono, Incyte, Janssen, Leo Pharma, Merck Research Laboratories, Novartis, Pfizer, Sanofi Regeneron, Sun Pharma, and UCB Pharma. Dr Gottlieb has received honoraria or grants from AbbVie, Avotres, Beiersdorf, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Incyte, Janssen, LEO, Novartis, Sun Pharma, UCB Pharma, and Xbiotech. Dr Cross is an employee of and holds stocks and stock options for UCB Pharma. Dr Madden is an employee of and holds stocks and stock options for UCB Pharma. Dr Cioffi is an employee of and holds stocks and stock options for UCB Pharma. Dr Griffiths has received honoraria or research grants from AbbVie, Almirall, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, Janssen, LEO, Pfizer, Novartis, Sandoz, Sanofi Regeneron, and UCB Pharma, and is supported in part by the Manchester NIHR Biomedical Research Centre. Author Wang is an employee and stockholder of UCB Pharma.
 IRB approval status: This study was approved by institutional review boards in the countries involved.


© 2020  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 83 - N° 5

P. 1367-1374 - novembre 2020 Retour au numéro
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