Bimekizumab maintenance of response through 3 years in patients with moderate-to-severe plaque psoriasis: results from the BE BRIGHT open-label extension trial

Author:

Strober Bruce12ORCID,Tada Yayoi3,Mrowietz Ulrich4,Lebwohl Mark5,Foley Peter67,Langley Richard G8,Warren Richard B9ORCID,Wang Maggie10,Vanvoorden Veerle11,Szilagyi Balint12,Ciaravino Valerie13,Paul Carle14ORCID

Affiliation:

1. Department of Dermatology, Yale University , New Haven, CT , USA

2. Central Connecticut Dermatology Research , Cromwell, CT , USA

3. Department of Dermatology, Teikyo University School of Medicine , Tokyo , Japan

4. Psoriasis Center, Department of Dermatology, University Medical Center Schleswig-Holstein , Campus Kiel , Germany

5. Department of Dermatology, Icahn School of Medicine at Mount Sinai , New York, NY , USA

6. The University of Melbourne, St Vincent’s Hospital Melbourne , Fitzroy, Victoria , Australia

7. Probity Medical Research Inc., Skin Health Institute , Carlton, Victoria , Australia

8. Dalhousie University , Halifax, NS , Canada

9. Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester , Manchester , UK

10. UCB Pharma , Morrisville, NC , USA

11. UCB Pharma , Brussels , Belgium

12. UCB Pharma , Monheim , Germany

13. UCB Pharma , Colombes , France

14. Toulouse University and CHU , Toulouse , France

Abstract

AbstractBackgroundGiven the chronic nature of psoriasis and the loss of response that can be observed with therapies over time, it is important to understand the long-term efficacy of new treatments.ObjectivesTo evaluate maintenance of Week 16 responses with bimekizumab (BKZ) treatment through Year 3, in patients with moderate-to-severe plaque psoriasis.MethodsData were pooled from BKZ-treated patients in the 52-week (BE VIVID) and 56-week (BE READY and BE SURE) phase III studies, and their ongoing open-label extension (OLE), BE BRIGHT. Efficacy outcomes are reported through 3 years of BKZ treatment in patients with an efficacy response at Week 16. Missing data were imputed primarily using modified nonresponder imputation (mNRI), with nonresponder imputation and observed case data also reported.ResultsA total of 989 patients were randomized to BKZ at baseline in BE VIVID, BE READY and BE SURE. At Week 16, 693 patients achieved ≥ 90% reduction from baseline in Psoriasis Area and Severity Index (PASI 90), 503 achieved 100% reduction from baseline in PASI (PASI 100), 694 achieved absolute PASI ≤ 2 and 597 achieved body surface area (BSA) ≤ 1%, and continued into the OLE. Of these, 93.0% maintained PASI 90, 80.8% maintained PASI 100, 94.0% maintained PASI ≤ 2 and 90.3% maintained BSA ≤ 1% responses through to 3 years of BKZ treatment (mNRI). Among Week 16 PASI 90 responders, 96.8% and 72.5% also achieved Investigator’s Global Assessment 0/1 and PASI 100 at Week 16, respectively, and 92.2% and 73.4% achieved these responses at Year 3 (mNRI). Among Week 16 PASI 100 responders, 76.3% also achieved Dermatology Life Quality Index (DLQI) 0/1 at Week 16, and DLQI 0/1 response increased with continuous BKZ treatment to 89.0% at Year 3 (mNRI).ConclusionsHigh levels of clinical response were maintained through to 3 years of BKZ treatment in the vast majority of Week 16 responders. Long-term treatment with BKZ was efficacious, with important benefits for health-related quality of life, in patients with moderate-to-severe plaque psoriasis.

Funder

UCB Pharma

Publisher

Oxford University Press (OUP)

Subject

Dermatology

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