Abstract
OBJECTIVE: To assess the longer-term impact of bimekizumab to 1 year on patient-reported symptoms, health-related quality of life (HRQoL), and work productivity in patients with active PsA who were biologic disease-modifying antirheumatic drug (bDMARD)-naïve or had inadequate response/intolerance to tumor necrosis factor inhibitors (TNFi-IR) up to 1 year.
METHODS: BE OPTIMAL (NCT03895203; bDMARD-naïve) and BE COMPLETE (NCT03896581; TNFi-IR) are phase 3 studies of subcutaneous bimekizumab 160 mg every 4 weeks; both were double-blind and placebo-controlled to 16 weeks. Patients who completed Week 52 of BE OPTIMAL or Week 16 of BE COMPLETE were eligible for the open-label extension, BE VITAL (NCT04009499), during which all patients received bimekizumab. Patient-reported pain, fatigue, physical function, HRQoL, and work productivity are reported to Week 52/40 using individual study data for bimekizumab and placebo treatment arms.
RESULTS: Bimekizumab-randomized patients demonstrated sustained mean improvements from baseline in patient-reported outcomes to Week 52/40, including pain (Pain VAS [0-100]: bDMARD-naïve -30.5; TNFi-IR -31.8), fatigue (FACIT-Fatigue [0-52]: bDMARD-naïve 5.3; TNFi-IR 6.0), physical function (HAQ-DI [0-3]: bDMARD-naïve -0.34; TNFi-IR -0.39), and HRQoL (SF-36 PCS: bDMARD-naïve 8.1; TNFi-IR 8.4); placebo patients who switched to bimekizumab at Week 16 demonstrated comparable levels of improvement from Week 16 to 52/40. Improvements in overall work impairment were sustained among bimekizumab-randomized patients to Week 52. Similar trends were observed for absenteeism, presenteeism, and activity impairment.
CONCLUSION: Bimekizumab treatment resulted in sustained improvements in patient-reported symptoms, HRQoL, and work productivity up to 1 year in bDMARD-naïve and TNFi-IR patients with active PsA.
| Original language | English |
|---|---|
| Pages (from-to) | 466-478 |
| Journal | Journal of Rheumatology |
| Volume | 52 |
| Issue number | 5 |
| Early online date | 1 Mar 2025 |
| DOIs | |
| Publication status | Published - 1 May 2025 |
Data Availability Statement
Data from this manuscript may be requested by qualified researchers 6 monthsafter 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 raw datasets, analysis-ready datasets, study protocol, blank
case report form, annotated case report form, statistical analysis plan, dataset
specifications, and clinical study report. Prior to 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