Effect of Bimekizumab on Patient-reported Disease Impact in Patients with Psoriatic Arthritis: 1-year Results from Two Phase 3 Studies

Overview

Journal Rheumatology (Oxford)

Publisher Oxford University Press

Specialty Rheumatology

Date 2024 May 16

PMID 38754125

Authors

Laure Gossec

Ana-Maria Orbai

Maarten de Wit

Laura C Coates

Alexis Ogdie

Barbara Ink

Jason Coarse

Jeremy Lambert

Vanessa Taieb

Dafna D Gladman

Affiliations

Soon will be listed here.

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).

Citing Articles

Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: pooled 16-week results from two phase 3 studies.

Husni M, Mease P, Merola J, Tillett W, Goldammer N, Ink B RMD Open. 2024; 10(3).

PMID: 39313302 PMC: 11418537. DOI: 10.1136/rmdopen-2024-004464.

References

Hojgaard P, Ballegaard C, Cordtz R, Zobbe K, Clausen M, Glintborg B . Gender differences in biologic treatment outcomes-a study of 1750 patients with psoriatic arthritis using Danish Health Care Registers. Rheumatology (Oxford). 2018; 57(9):1651-1660. DOI: 10.1093/rheumatology/key140. View

Ogdie A, Michaud K, Nowak M, Bruce R, Cantor S, Hintzen C . Patient's experience of psoriatic arthritis: a conceptual model based on qualitative interviews. RMD Open. 2020; 6(3). PMC: 7722387. DOI: 10.1136/rmdopen-2020-001321. View

Mease P, Armstrong A . Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014; 74(4):423-41. PMC: 3958815. DOI: 10.1007/s40265-014-0191-y. View

Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A . Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005; 8(2):94-104. DOI: 10.1111/j.1524-4733.2005.04054.x. View

Gossec L, Theander E, Chakravarty S, Bergmans P, Lavie F, Noel W . Response to treatment in psoriatic arthritis, the effect of age: analysis of patients receiving ustekinumab in the PsABio real-world study. Arthritis Res Ther. 2023; 25(1):100. PMC: 10251537. DOI: 10.1186/s13075-023-03078-8. View

Gladman D, Antoni C, Mease P, Clegg D, Nash P . Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005; 64 Suppl 2:ii14-7. PMC: 1766874. DOI: 10.1136/ard.2004.032482. View

Husni M, Merola J, Davin S . The psychosocial burden of psoriatic arthritis. Semin Arthritis Rheum. 2017; 47(3):351-360. DOI: 10.1016/j.semarthrit.2017.05.010. View

Ritchlin C, Colbert R, Gladman D . Psoriatic Arthritis. N Engl J Med. 2017; 376(10):957-970. DOI: 10.1056/NEJMra1505557. View

Gudu T, Gossec L . Quality of life in psoriatic arthritis. Expert Rev Clin Immunol. 2018; 14(5):405-417. DOI: 10.1080/1744666X.2018.1468252. View

10.

McInnes I, Asahina A, Coates L, Landewe R, Merola J, Ritchlin C . Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2022; 401(10370):25-37. DOI: 10.1016/S0140-6736(22)02302-9. View

11.

Veale D, Fearon U . The pathogenesis of psoriatic arthritis. Lancet. 2018; 391(10136):2273-2284. DOI: 10.1016/S0140-6736(18)30830-4. View

12.

Husted J, Gladman D, Farewell V, Cook R . Health-related quality of life of patients with psoriatic arthritis: a comparison with patients with rheumatoid arthritis. Arthritis Rheum. 2001; 45(2):151-8. DOI: 10.1002/1529-0131(200104)45:2<151::AID-ANR168>3.0.CO;2-T. View

13.

Leung Y, Orbai A, Hojgaard P, Holland R, Mathew A, Goel N . OMERACT Filter 2.1 instrument selection for physical function domain in psoriatic arthritis: Provisional endorsement for HAQ-DI and SF-36 PF. Semin Arthritis Rheum. 2021; 51(5):1117-1124. PMC: 8453108. DOI: 10.1016/j.semarthrit.2021.07.014. View

14.

Husted J, Tom B, Schentag C, Farewell V, Gladman D . Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis. 2008; 68(10):1553-8. DOI: 10.1136/ard.2008.098202. View

15.

Karmacharya P, Stull C, Stephens-Shields A, Husni M, Scher J, Craig E . Responsiveness and Minimum Clinically Important Difference in Patient-Reported Outcome Measures Among Patients With Psoriatic Arthritis: A Prospective Cohort Study. Arthritis Care Res (Hoboken). 2023; 75(10):2182-2189. PMC: 11229093. DOI: 10.1002/acr.25111. View

16.

Gossec L, de Wit M, Kiltz U, Braun J, Kalyoncu U, Scrivo R . A patient-derived and patient-reported outcome measure for assessing psoriatic arthritis: elaboration and preliminary validation of the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire, a 13-country EULAR initiative. Ann Rheum Dis. 2014; 73(6):1012-9. DOI: 10.1136/annrheumdis-2014-205207. View

17.

de Wit M, Kvien T, Gossec L . Patient participation as an integral part of patient-reported outcomes development ensures the representation of the patient voice: a case study from the field of rheumatology. RMD Open. 2015; 1(1):e000129. PMC: 4613173. DOI: 10.1136/rmdopen-2015-000129. View

18.

Orbai A, Holland R, Leung Y, Tillett W, Goel N, Christensen R . PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials. J Rheumatol. 2018; 46(8):990-995. PMC: 6571063. DOI: 10.3899/jrheum.181077. View

19.

Walsh J, Ogdie A, Michaud K, Peterson S, Holdsworth E, Karyekar C . Impact of key manifestations of psoriatic arthritis on patient quality of life, functional status, and work productivity: Findings from a real-world study in the United States and Europe. Joint Bone Spine. 2023; 90(3):105534. DOI: 10.1016/j.jbspin.2023.105534. View

20.

Merola J, Landewe R, McInnes I, Mease P, Ritchlin C, Tanaka Y . Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2022; 401(10370):38-48. DOI: 10.1016/S0140-6736(22)02303-0. View