Effect of bimekizumab on symptoms and impact of disease in patients with psoriatic arthritis over 3 years: results from BE ACTIVE

Philip J Mease, Akihiko Asahina, Dafna D Gladman, Yoshiya Tanaka, William Tillett, Barbara Ink, Deepak Assudani, Christine de la Loge, Jason Coarse, Jason Eells, Laure Gossec, Philip J Mease, Akihiko Asahina, Dafna D Gladman, Yoshiya Tanaka, William Tillett, Barbara Ink, Deepak Assudani, Christine de la Loge, Jason Coarse, Jason Eells, Laure Gossec

Abstract

Objectives: Evaluate effects of long-term bimekizumab treatment on patient-reported outcome (PRO) measures, symptoms and the impact of PsA on patients.

Methods: Patients with active PsA were enrolled into BE ACTIVE, a 48-week randomised controlled trial (NCT02969525). After Week 48, patients could enter a 104-week open-label extension (NCT03347110), receiving bimekizumab 160 mg every four weeks. PRO measures assessed included arthritis pain visual analogue scale (VAS), PsA Impact of Disease (PsAID)-9, 36-Item Short Form Survey (SF-36) and HAQ-Disability Index (HAQ-DI). Results were analysed as mean (S.E.M.) changes from baseline (CfB) from Week 0 to the end of the open-label extension (3 years) and as percentage of patients reaching patient-acceptable symptom state (PASS) for global impact (PsAID-9 total score ≤4) and normal function (HAQ-DI total score <0.5). Non-responder imputation was applied to missing binary outcomes.

Results: In 206 patients (mean age 49.3 years, 51.0% male), completion rate was high; 161 (78.2%) patients completed Week 152. Bimekizumab treatment was associated with long-term sustained improvements in pain [arthritis pain VAS CfB; Week 48: -29.9 (1.9); Week 152: -32.0 (1.9)] and fatigue [PsAID-9 fatigue CfB; -2.4 (0.2); -2.7 (0.2)]. High percentages of patients achieved acceptable symptom state (PsAID-9 PASS: 75.2%; 65.0%) and normalised function (HAQ-DI <0.5: 49.0%; 46.1%). Improvements in patient global assessment and SF-36 Physical Component Summary were also sustained.

Conclusions: Bimekizumab treatment was associated with long-term sustained improvements in pain and fatigue, reducing overall impact of PsA on patients. Physical function and quality of life improved up to 3 years.

Trial registration: ClinicalTrials.gov, https://ichgcp.net/clinical-trials-registry/NCT02969525" title="See in ClinicalTrials.gov">NCT02969525, NCT03347110.

Keywords: bimekizumab; fatigue; pain; patient-reported outcome measures; physical function; psoriatic arthritis.

© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Figures

Graphical abstract
Graphical abstract
Fig . 1
Fig. 1
Sustained improvements in pain for patients treated with bimekizumab Full analysis set. Patient-reported pain was measured by the CfB in arthritis pain VAS score (A) and PsAID-9 pain NRS (B) as well as the percentage of patients achieving ≥30% (C) and ≥50% (D) improvement in the arthritis pain VAS. Week 48 and Week 152 values shown. BKZ: bimekizumab; CfB: change from baseline; MI: multiple imputation; NRI: non-responder imputation; NRS: numerical rating scale; PsAID-9: PsA Impact of Disease-9; VAS: visual analogue scale.
Fig . 2
Fig. 2
Sustained improvements in fatigue for patients treated with bimekizumab Full analysis set. Patient-reported fatigue was measured by the PsAID-9 fatigue NRS (A) and SF-36 vitality dimension (B). Scores obtained using MI with Week 48 and Week 152 values shown. BKZ: bimekizumab; CfB: change from baseline; MI: multiple imputation; NRS: numerical rating scale; PsAID-9: PsA Impact of Disease-9; SF-36: 36-Item Short Form Survey.
Fig . 3
Fig. 3
Improvements in PsAID-9 and HAQ-DI thresholds and CfB in total scores for bimekizumab-treated patients The percentage of patients achieving PsAID-9 PASS (PsAID-9 total score ≤4) (A) and HAQ-DI <0.5 (B), clinically meaningful thresholds (PsAID-9 MCII (C) and HAQ-DI MID (D) and CfB in PsAID-9 (E) and HAQ-DI (F) score; full analysis set. aPatients with a PsAID-9 total score ≥3 at baseline (n = 162); bPatients with HAQ-DI ≥0.35 at baseline (n = 174). BKZ: bimekizumab; CfB: change from baseline; HAQ-DI: HAQ-Disability Index; MCII: minimal clinically important improvement; MI: multiple imputation; MID: minimally important difference; NRI: non-responder imputation; OC: observed case; PASS: Patient Acceptable Symptom State; PsAID-9: PsA Impact of Disease-9.
Fig . 4
Fig. 4
Association of PsAID-9 total score with disease activity at Weeks 48 and 152 Full analysis set. MI was used for PsAID-9 total scores. This analysis is based on observed disease status at Weeks 48 (A) and 152 (B). Disease activity was categorised by VLDA, MDA and DAPSA disease states. BKZ: bimekizumab; DAPSA: Disease Activity Index for PsA; HDA: high disease activity; LDA: low disease activity; MDA: minimal disease activity; MI: multiple imputation; MoDA: moderate disease activity; PsAID-9: PsA Impact of Disease-9; REM: remission; VLDA: very low disease activity.
Fig . 5
Fig. 5
Box and whisker plots of PsAID-9 and SF-36 measures at Weeks 0 and 152 Full analysis set. PsAID-9 total (A) and individual dimension (B) scores and SF-36 PCS, MCS (C) and individual dimension (D) scores reported using MI. aQ3 and maximum values were equal (57.3); bMedian and Q3, values were equal (57.3); cMedian, Q3 and maximum values were equal (56.2); dMedian and Q3 values were equal (56.2). BKZ: bimekizumab; CfB: change from baseline; MCS: Mental Component Summary; MI: multiple imputation; PASS: patient acceptable symptom state; PCS: Physical Component Summary; PsAID-9: PsA Impact of Disease-9; Q1: lower quartile; Q3: upper quartile; SF-36: 36-Item Short Form Survey.

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