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Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies.
Gossec, Laure; Orbai, Ana-Maria; de Wit, Maarten; Coates, Laura C; Ogdie, Alexis; Ink, Barbara; Coarse, Jason; Lambert, Jérémy; Taieb, Vanessa; Gladman, Dafna D.
Afiliación
  • Gossec L; Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.
  • Orbai AM; AP-HP, Pitié Salpêtrière Hospital, Rheumatology Department, Paris, France.
  • de Wit M; Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Coates LC; Patient Research Partner, Stichting Tools, Amsterdam, The Netherlands.
  • Ogdie A; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, UK.
  • Ink B; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
  • Coarse J; UCB Pharma, Slough, UK.
  • Lambert J; UCB Pharma, Morrisville, NC, USA.
  • Taieb V; UCB Pharma, Colombes, France.
  • Gladman DD; UCB Pharma, Colombes, France.
Rheumatology (Oxford) ; 63(9): 2399-2410, 2024 Sep 01.
Article en En | MEDLINE | ID: mdl-38754125
ABSTRACT

OBJECTIVES:

To evaluate 1-year bimekizumab efficacy in PsA from the patient perspective using the 12-item PsA Impact of Disease (PsAID-12) questionnaire.

METHODS:

BE OPTIMAL (NCT03895203; biologic DMARD [bDMARD]-naïve), BE COMPLETE (NCT03896581; inadequate response/intolerance to TNF inhibitors [TNFi-IR]) and BE VITAL (NCT04009499; open-label extension) assessed bimekizumab 160 mg every 4 weeks in patients with PsA. Post hoc analyses of patient-reported disease impact, assessed by the PsAID-12 questionnaire, are reported to 1 year (collected to Week 40 in BE COMPLETE).

RESULTS:

Overall, 1,112 total patients were included (698 bimekizumab, 414 placebo). Rapid improvements observed with bimekizumab treatment at Week 4 continued to Week 16 and were sustained to 1 year. At 1 year, mean (SE) change from baseline in PsAID-12 total score was comparable between bimekizumab-randomized patients and patients who switched to bimekizumab at Week 16 (bDMARD-naïve bimekizumab -2.3 [0.1], placebo/bimekizumab -2.2 [0.1]; TNFi-IR bimekizumab -2.5 [0.1], placebo/bimekizumab -2.2 [0.2]). Proportions of bimekizumab-randomized patients achieving clinically meaningful within-patient improvement (≥3-point decrease from baseline) at Week 16 were sustained to 1 year (bDMARD-naïve 49.0%; TNFi-IR 48.5%) and were similar for placebo/bimekizumab patients (bDMARD-naïve 44.4%; TNFi-IR 40.6%). Across studies and arms, 35.3% to 47.8% of patients had minimal or no symptom impact at 1 year. Improvements were observed to 1 year across all single-item domains, including pain, fatigue and skin problems.

CONCLUSION:

Bimekizumab treatment resulted in rapid and sustained clinically meaningful improvements in disease impact up to 1 year in bDMARD-naïve and TNFi-IR patients with PsA. TRIAL REGISTRATION BE OPTIMAL NCT03895203; BE COMPLETE NCT03896581; BE VITAL NCT04009499 (ClinicalTrials.gov).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Artritis Psoriásica / Anticuerpos Monoclonales Humanizados / Medición de Resultados Informados por el Paciente Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Rheumatology (Oxford) Asunto de la revista: REUMATOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Artritis Psoriásica / Anticuerpos Monoclonales Humanizados / Medición de Resultados Informados por el Paciente Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Rheumatology (Oxford) Asunto de la revista: REUMATOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Reino Unido