Abstract
Background: Psoriatic arthritis (PsA) is a chronic inflammatory disease that causes pain and fatigue, reduces physical function, and negatively impacts health-related quality of life (HRQoL). In the phase III BE OPTIMAL and BE COMPLETE studies, bimekizumab demonstrated clinical efficacy and meaningful improvements in patient-reported outcome (PRO) measures in biologic disease-modifying antirheumatic drug (bDMARD)-naïve patients, and those who had prior inadequate response/intolerance to tumor necrosis factor inhibitors (TNFi-IR).
Objectives: To examine the association between achieving increasingly stringent clinical disease control criteria and improvements in PRO measures in patients with active PsA receiving bimekizumab.
Design: Post hoc analysis of two phase III studies.
Methods: BE OPTIMAL and BE COMPLETE assessed subcutaneous bimekizumab 160 mg every 4 weeks in bDMARD-naïve and TNFi-IR patients with active PsA. Disease control was assessed using American College of Rheumatology (ACR) response criteria, Minimal Disease Activity, Disease Activity Index for Psoriatic Arthritis, and the composite outcome of ACR50 and 100% improvement in Psoriasis Area and Severity Index. Associations between clinical disease control criteria and PRO measures of pain, fatigue, physical function, and HRQoL were assessed at week 16 and week 52/40 (BE OPTIMAL/BE COMPLETE).
Results: Achievement of increasingly stringent clinical disease control criteria was generally associated with sequentially greater improvements in all PRO measures, including pain. At week 52/40, 94.7% of bDMARD-naïve and 97.6% of TNFi-IR patients achieving ACR70 reported ⩾50% improvements in pain from baseline, and the greatest numerical improvements (−48.5 bDMARD-naïve; −54.7 TNFi-IR). This pattern was evident as early as week 16 and sustained when assessed at week 52/40 across the majority of clinical disease control criteria and PRO measures reported.
Conclusion: The achievement of increasingly stringent thresholds of disease control was associated with corresponding greater improvements in PROs, for patients receiving bimekizumab treatment, irrespective of prior TNFi use. Trial registration ClinicalTrials.gov: NCT03895203, NCT03896581, and NCT04009499.
| Original language | English |
|---|---|
| Journal | Therapeutic Advances in Musculoskeletal Disease |
| Volume | 16 |
| Early online date | 11 Nov 2024 |
| DOIs | |
| Publication status | Published - 31 Dec 2024 |
Data Availability Statement
Data from this manuscript may be requested by qualified researchers 6 months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient data and redacted study documents which may include the following: raw datasets, analysis-ready datasets, study protocols, blank case report forms, annotated case report forms, statistical analysis plans, dataset specifications, and clinical study reports. Prior to the use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data-sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password-protected portal.Acknowledgements
The authors thank the patients, the investigators, and their teams who took part in this study. The authors also acknowledge Heather Edens, PhD, UCB, Smyrna, GA, USA, for publication coordination and editorial assistance, Nadine Goldammer for their work as clinical program delivery lead for the bimekizumab PsA program, and David Morgan, PhD, Costello Medical, Manchester, UK, for medical writing and editorial assistance based on the authors’ input and direction.Keywords
- bDMARD-naïve
- bimekizumab
- disease control
- IL-17
- patient-reported outcomes
- psoriatic arthritis
- TNF inhibitor inadequate response or intolerance
ASJC Scopus subject areas
- Rheumatology
- Orthopedics and Sports Medicine