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Biologic disease-modifying anti-rheumatic drugs and patient-reported outcomes in axial SpA: a systematic review and a call for action

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Abstract

This paper is to assess the efficacy of different biologic DMARDs (bDMARDs) on several patient-reported outcomes (PROs) in randomized controlled trials (RCT) in axial spondyloarthritis (axSpA). A systematic literature review (SLR) was performed. MEDLINE (May 1, 2018) was used with the filters “published in the last 10 years” and “humans.” The PICO criteria used were Patients: adults with radiographic axSpA (r-axSpA) or non-radiographic axSpA (nr-axSpA); Intervention: any bDMARD; Compararator: placebo (PBO)/any different drug; Outcome: the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), the Ankylosing Spondylitis Quality of Life (ASQoL), the EuroQol-5D (EQ-5D), the Short Form 36 Health Survey physical component summary (SF36-PCS), the Short Form 36 Health Survey mental component summary (SF36-MCS), and the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F). After screening 84 initial references and manually selecting other 9, 24 publications, assessing TNF inhibitors (TNFi) or IL17A inhibitors (IL17Ai) were selected. Four RCTs quantified the minimal clinical important difference (MCID) between treatment arms. Most of the RCTs compared the mean difference of PROs between different timepoints. Overall, the treatment arm was superior to the comparator. PROs were often underreported or highly heterogeneously presented. MCID was seldom mentioned. There is a need to raise the standard of care on SpA by aiming at remission and PRO associated improvements. In order to achieve this goal, the target must be clearly defined, reported, and tested.

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Funding

This work was supported by Novartis Pharma Portugal. Funding was used to access all necessary scientific bibliography and cover meeting expenses. Novartis Pharma Portugal had no role in the collection, analysis, and interpretation of data, in the writing of the paper or in the decision to submit the paper for publication.

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Authors and Affiliations

  1. CEDOC, NOVA Medical School, Lisbon, Portugal

    Santiago Rodrigues-Manica & Fernando M. Pimentel-Santos

  2. Rheumatology Department, Centro Hospitalar de Lisboa Ocidental, Hospital Egas Moniz EPE, R. da Junqueira 126, 1349-019, Lisbon, Portugal

    Santiago Rodrigues-Manica & Fernando M. Pimentel-Santos

  3. Rheumatology Department, Unidade Local de Saúde do Alto Minho, Ponte de Lima, Portugal

    Joana Silva & José Tavares-Costa

  4. Rheumatology Department, Centro Hospitalar de Lisboa Norte EPE, Hospital de Santa Maria, R. da Junqueira 126, 1349-019, Lisbon, Portugal

    Rita Cruz-Machado & Elsa Vieira-Sousa

  5. Rheumatology Research Unit, Instituto de Medicina Molecular, Lisbon Academic Medical Centre, Lisbon, Portugal

    Rita Cruz-Machado & Elsa Vieira-Sousa

  6. Genetics Laboratory, Environmental Health Institute, Lisbon Medical School, University of Lisbon, Lisbon, Portugal

    Constança Coelho

  7. Medical Department, Novartis Pharma, Oeiras, Portugal

    Joana Duarte

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  1. Santiago Rodrigues-Manica
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All authors except CC and JD declare collaborating and receiving fees from Novartis and other pharmaceutical companies either through participation in advisory board or consultancy, congress symposia, clinical trial conduct, investigator-initiated trials or grants. CC has no conflicts of interest. JD is an employee of Novartis Pharma Portugal.

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Rodrigues-Manica, S., Silva, J., Cruz-Machado, R. et al. Biologic disease-modifying anti-rheumatic drugs and patient-reported outcomes in axial SpA: a systematic review and a call for action. Clin Rheumatol 40, 33–41 (2021). https://doi.org/10.1007/s10067-020-05209-x

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