Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL
Robert Landewé,
Joseph F Merola,
Laure Gossec,
Frank Behrens,
Ana-Maria Orbai,
Philip J Mease,
Iain B McInnes,
Dafna D Gladman,
Laura C Coates,
Alice B Gottlieb,
Vishvesh Shende,
Jason Coarse,
Christopher T Ritchlin,
Richard B Warren,
Akihiko Asahina,
Barbara Ink,
Rajan Bajracharya
Affiliations
Robert Landewé
Rheumatology, Atrium Medical Center, Heerlen, The Netherlands
Joseph F Merola
Dermatology and Medicine, Division of Rheumatology, UT Southwestern Medical Center, Dallas, Texas, USA
Laure Gossec
Rheumatology Department, AP-HP, Pitié-Salpêtrière Hospital, Paris, France
Frank Behrens
5Rheumatologie and Fraunhofer institut IME -TMP, Frankfurt, Germany
Ana-Maria Orbai
Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Philip J Mease
College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK
Iain B McInnes
5Glasgow Biomedical Research Centre, University of Glasgow, Glasgow, United Kingdom
Dafna D Gladman
Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada
Laura C Coates
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, UK
Alice B Gottlieb
Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA
Vishvesh Shende
UCB Pharma, Slough, UK
Jason Coarse
UCB Pharma, Morrisville, North Carolina, USA
Christopher T Ritchlin
Allergy, Immunology & Rheumatology Division, University of Rochester Medical School, Rochester, New York, USA
Richard B Warren
Dermatology Centre, Northern Care Alliance NHS Foundation Trust, Manchester, UK
Akihiko Asahina
Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan
Objectives To assess 52-week safety and efficacy of bimekizumab in patients with active psoriatic arthritis (PsA) and prior inadequate response/intolerance to tumour necrosis factor inhibitors.Methods Patients completing the 16-week phase III double-blind, placebo-controlled BE COMPLETE (NCT03896581) study entered the open-label extension, BE VITAL (NCT04009499). All patients in BE VITAL received 160 mg bimekizumab every 4 weeks. Safety and efficacy are reported to week 52.Results A total of 347/400 (86.8%) patients completed week 52. To week 52, the exposure-adjusted incidence rate/100 patient-years for ≥1 treatment-emergent adverse event (TEAE) was 126.0, and was 7.0 for serious TEAEs. The most frequent TEAEs were SARS-CoV-2 (COVID-19), oral candidiasis, nasopharyngitis and urinary tract infection. All fungal infections were mild or moderate in severity and localised; two patients discontinued the study due to oral candidiasis. No cases of active tuberculosis, uveitis or inflammatory bowel disease were reported. One sudden death occurred. Sustained efficacy was observed with bimekizumab from week 16 to 52 across clinical and patient-reported outcomes. At week 52, 51.7% bimekizumab-randomised and 40.6% placebo/bimekizumab patients (receiving bimekizumab from week 16 to 52) had ≥50% improvement in the American College of Rheumatology criteria. Complete skin clearance (Psoriasis Area and Severity Index 100) was achieved by 65.9% bimekizumab and 60.2% placebo/bimekizumab patients at week 52. Minimal disease activity was achieved by 47.2% bimekizumab and 33.1% placebo/bimekizumab patients at week 52.Conclusions Bimekizumab demonstrated a safety profile consistent with previous reports; no new safety signals were identified. Sustained efficacy was observed from week 16 to 52.
