Minimal Impact of the COVID-19 Pandemic on Disease Activity and Health-Related Quality of Life in Patients With Ankylosing Spondylitis Receiving Bimekizumab: Exploratory Analyses From a Phase 2b Open-Label Extension Study

Philip C Robinson, Pedro M Machado, Nigil Haroon, Lianne S Gensler, John D Reveille, Vanessa Taieb, Thomas Vaux, Carmen Fleurinck, Marga Oortgiesen, Natasha de Peyrecave, Atul Deodhar, Philip C Robinson, Pedro M Machado, Nigil Haroon, Lianne S Gensler, John D Reveille, Vanessa Taieb, Thomas Vaux, Carmen Fleurinck, Marga Oortgiesen, Natasha de Peyrecave, Atul Deodhar

Abstract

Objective: The impact of the COVID-19 pandemic on patients with inflammatory rheumatic diseases, such as ankylosing spondylitis (AS), has been variable. Here, we assess disease activity and health-related quality of life (HRQoL) through the pandemic in patients with AS.

Methods: In the open-label extension (OLE) of the phase 2b BE AGILE study, patients with AS received 160 mg of subcutaneous bimekizumab every 4 weeks. We assessed Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Quality of Life (ASQoL) scores in the OLE immediately before and during the COVID-19 pandemic (September 2019 to April 2021).

Results: A total of 232 patients remained in the BE AGILE OLE and were included in this post hoc study at the start of the analysis period (September 1, 2019); 12 patients had a COVID-19 treatment-emergent adverse event, and no cases resulted in death. The number of missed bimekizumab doses due to COVID-19 (11 doses) was minimal, and missed assessments remained low (≤5%) compared with the prepandemic period. Mean ASDAS-CRP (1.8), BASDAI (2.4), and ASQoL scores (2.8) in the OLE were low at pre-pandemic baseline and remained stable at 1.7 to 1.8, 2.2 to 2.4, and 2.0 to 2.8, respectively, across successive 3-month periods immediately before and during the pandemic. ASDAS-CRP, BASDAI, and ASQoL stability was consistent across major study countries.

Conclusion: Disease activity and HRQoL remained stable during the COVID-19 pandemic in patients with AS receiving bimekizumab in the BE AGILE OLE, with no indication of negative effects on these outcomes.

© 2022 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.

Figures

Figure 1
Figure 1
Mean Ankylosing Spondylitis Disease Activity Score with C‐reactive protein (ASDAS‐CRP) (A), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (B) and Ankylosing Spondylitis Quality of Life (ASQoL) (C) scores during the prepandemic and pandemic periods in patients receiving 160 mg of bimekizumab every 4 weeks (observed data). Patients from the open‐label extension full analysis set who remained in the study on September 1, 2019, with a recorded outcome assessment. Error bars show SD. The mean score from each period of measurement was calculated using the last recorded measurement from each patient within the specified time period. Patient numbers appear lower for ASQoL than ASDAS‐CRP and BASDAI during the four pandemic periods because ASQoL assessments were conducted every 24 weeks from Week 156, whereas ASDAS‐CRP and BASDAI assessments were conducted every 12 weeks. Data for the period of March 1, 2021, to April 30, 2021, are not shown because data were only available for a limited number of patients at the time of the analyses.
Figure 2
Figure 2
Change in Ankylosing Spondylitis Disease Activity Score C‐reactive protein (ASDAS‐CRP) (A), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (B), and Ankylosing Spondylitis Quality of Life (ASQoL) (C) score since the start of the pandemic in patients receiving 160 mg of bimekizumab every 4 weeks (observed data). Patients from the open‐label extension full analysis set who remained in the study on September 1, 2019, with a recorded outcome assessment. Using the last data point collected before March 11, 2020, as prepandemic baseline, changes from this baseline in individual patients’ outcome scores are presented for each study visit. Each marker represents a single patient visit; linear trendlines for each of the countries/regions are shown. Patient numbers appear lower for ASQoL than ASDAS‐CRP and BASDAI during the pandemic period because ASQoL assessments were conducted every 24 weeks from Week 156, whereas ASDAS‐CRP and BASDAI assessments were conducted every 12 weeks. Lockdowns (national, unless otherwise indicated) for the major study countries are shown by dark‐colored bars. ASDAS‐CRP, Ankylosing Spondylitis Disease Activity Score C‐reactive protein; ASQoL, Ankylosing Spondylitis Quality of Life; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; OLE, open‐label extension; Q4W, every four weeks; SD, standard deviation.

References

    1. Landewe R, Dougados M, Mielants H, van der Tempel H, van der Heijde D. Physical function in ankylosing spondylitis is independently determined by both disease activity and radiographic damage of the spine. Ann Rheum Dis 2009;68:863–7.
    1. Law L, Beckman Rehnman J, Deminger A, Klingberg E, Jacobsson LT, Forsblad‐d'Elia H. Factors related to health‐related quality of life in ankylosing spondylitis, overall and stratified by sex. Arthritis Res Ther 2018;20:284.
    1. Li Y, Zhang S, Zhu J, Du X, Huang F. Sleep disturbances are associated with increased pain, disease activity, depression, and anxiety in ankylosing spondylitis: a case‐control study. Arthritis Res Ther 2012;14:R215.
    1. Liew JW, Castillo M, Zaccagnino E, Katz P, Haroon N, Gensler LS. Patient‐reported disease activity in an axial spondyloarthritis cohort during the COVID‐19 pandemic. ACR Open Rheumatol 2020;2:533–9.
    1. Ciurea A, Papagiannoulis E, Burki K, von Loga I, Micheroli R, Moller B, et al. Impact of the COVID‐19 pandemic on the disease course of patients with inflammatory rheumatic diseases: results from the Swiss Clinical Quality Management cohort. Ann Rheum Dis 2021;80:238–41.
    1. Garrido‐Cumbrera M, Marzo‐Ortega H, Christen L, Plazuelo‐Ramos P, Webb D, Jacklin C, et al. Assessment of impact of the COVID‐19 pandemic from the perspective of patients with rheumatic and musculoskeletal diseases in Europe: results from the REUMAVID study (phase 1). RMD Open 2021;7:e001546.
    1. Reuter K, Deodhar A, Makri S, Zimmer M, Berenbaum F, Nikiphorou E. The impact of the COVID‐19 pandemic on people with rheumatic and musculoskeletal diseases: insights from patient‐generated data on social media. Rheumatology (Oxford) 2021;60:SI77–84.
    1. Chevallard M, Belloli L, Ughi N, Adinolfi A, Casu C, Di Cicco M, et al. Use of telemedicine during the COVID‐19 pandemic in patients with inflammatory arthritis: a retrospective study on feasibility and impact on patient‐reported outcomes in a real‐life setting. Rheumatol Int 2021;41:1253–61.
    1. De Mits S, de Craemer AS, Deroo L, Renson T, van den Bosch FE, Carron P, et al. Unexpected impact of COVID‐19 lockdown on spinal mobility and health perception in spondyloarthritis. Ann Rheum Dis 2021;80:1638–40.
    1. Johnstone G, Treharne GJ, Fletcher BD, Lamar RS, White D, Harrison A, et al. Mental health and quality of life for people with rheumatoid arthritis or ankylosing spondylitis in Aotearoa New Zealand following the COVID‐19 national lockdown. Rheumatol Int 2021;41:1763–72.
    1. van der Heijde D, Gensler LS, Deodhar A, Baraliakos X, Poddubnyy D, Kivitz A, et al. Dual neutralisation of interleukin‐17A and interleukin‐17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48‐week phase IIb, randomised, double‐blind, placebo‐controlled, dose‐ranging study. Ann Rheum Dis 2020;79:595–604.
    1. Baraliakos X, Deodhar A, Dougados M, Oortgiesen M, de Peyrecave N, Bauer M, et al. Bimekizumab long‐term efficacy and safety over 96 weeks in patients with ankylosing spondylitis: interim results from a phase 2b open‐label extension study [abstract]. Arthritis Rheumatol 2020;72 Suppl 10. URL: .
    1. van der Heijde D, Deodhar A, Gensler LS, Poddubnyy D, Kivitz A, Dougados M, et al. Bimekizumab long‐term safety and efficacy in patients with ankylosing spondylitis: 3‐year results from a phase 2b study [abstract]. Ann Rheum Dis 2021;80 Suppl 1:332–3.
    1. World Health Organization . WHO Director‐General's opening remarks at the media briefing on COVID‐19 – 11 March 2020. URL: .
    1. Gensler LS, Deodhar A, van der Heijde D, Poddubnyy D, Kivitz A, Dougados M, et al. Bimekizumab long‐term safety and efficacy in patients with ankylosing spondylitis: interim results after 3 years of treatment in an ongoing phase 2b study [abstract]. Arthritis Rheumatol 2021;73 Suppl 10. URL: .
    1. Hausmann JS, Kennedy K, Simard JF, Liew JW, Sparks JA, Moni TT, et al. Immediate effect of the COVID‐19 pandemic on patient health, health‐care use, and behaviours: results from an international survey of people with rheumatic diseases. Lancet Rheumatol 2021;3:e707–14.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren