The 2025 British Society for Rheumatology guideline for the treatment of axial spondyloarthritis with biologic and targeted synthetic DMARDs

Le résumé fourni par la source

Axial spondyloarthritis (axSpA) is a chronic inflammatory condition that predominantly affects the spine and sacroiliac joints [1]. It can also involve peripheral joints and entheses, and extra-musculoskeletal manifestations (EMMs) such as acute anterior uveitis, psoriasis and IBD. Symptoms of axSpA typically begin in early adulthood but diagnosis can often take several years [2]. Chronic inflammatory pain and stiffness are well recognized as having adverse effects on quality of life, social participation and mental health [3–5]. Pharmacological management has advanced considerably since the previous BSR axSpA guideline [6] to incorporate new classes of biologic DMARDs (bDMARDs, including biosimilars), targeted synthetic DMARDs (tsDMARDs) and treatment strategies such as drug tapering. Therapeutic options for treating EMMs as index conditions have similarly evolved. The increasingly complex therapeutic landscape, with varying efficacy and safety of drugs for each disease manifestation, forms the context in which we aimed to update the BSR guideline for the treatment of axSpA with b/tsDMARDs. The key questions that the guideline sought to answer were published in the guideline scope [7], including the effectiveness and safety of targeted therapies; switching, combining, tapering or withdrawing targeted therapies; and treating to target. The guideline applies only to adults with axSpA. For brevity, we refer to b/tsDMARDs as “targeted therapies” throughout. This guideline is for health professionals in the UK who directly care for adults with axSpA (including but not limited to rheumatologists, rheumatology specialist nurses, allied health professionals, rheumatology specialty trainees, pharmacists), people living with axSpA and other stakeholders. NSAIDs, glucocorticoids and conventional synthetic DMARDs. Treatment of enthesitis/spondylitis-related juvenile idiopathic arthritis. Axial disease in psoriatic arthritis [8]. Safety of targeted therapies [9] or their use in pregnancy [10]. Health economic considerations. The guideline was developed by a multidisciplinary guideline working group (GWG), comprising and reflecting the views of individuals with lived experience of axSpA, rheumatologists, an ophthalmologist, a dermatologist, a gastroenterologist, a general practitioner, an epidemiologist, a specialist nurse, a consultant physiotherapist, a specialist pharmacist and the Chief Executive Office (CEO) of the patient-focused charity National Axial Spondyloarthritis Society (NASS). Drafting of the overarching principles was led by authors with lived experience of axSpA. Details of the GWG and their declared conflicts of interest are included at the end of this article and are available on the BSR website. The guideline was available for public consultation on the BSR website for a month prior to publication and was reviewed by the BSR Guideline Steering Group and external expert peer reviewers. This guideline was developed in accordance with the BSR Creating Guidelines Protocol (v5.4). The guideline and recommendations were underpinned by a systematic literature review. The full methodology and evidence tables are provided in Supplementary Data S1, available at Rheumatology online. The literature search was informed by the guideline scope [7] and registered in advance (PROSPERO: CRD42023437846). A literature review specialist (NC) performed searches across two databases (MEDLINE, EMBASE) and The Cochrane Library without language restriction, covering the period between 30th June 2014 (review date for the previous version of the guideline) and 17th April 2023. Full search details are provided in Supplementary Data S2. Eligibility criteria were agreed for randomized controlled trials (RCTs, for efficacy and safety) and observational designs (safety only). For observational evidence, only representative multi-site cohort studies or studies conducted using disease registries or electronic health record data were considered eligible. Other study designs, including cross-sectional studies, case-control designs, case series and other publication types (editorials, commentaries, trial protocols, letters, trials registry records and study protocols) were excluded, as well as full papers in any language other than English without an English translation. A detailed description of inclusion and exclusion criteria and a PRISMA flow diagram are provided in Supplementary Data S3 and S4, available at Rheumatology online, respectively. Two reviewers independently screened the first 10% of titles to ensure good agreement. For the remaining 90%, one reviewer screened titles, excluding studies that were clearly irrelevant. Abstracts, and then full texts were screened against eligibility criteria by one reviewer, with up to 20% double screened by a second reviewer to ensure accuracy. Any disagreements were resolved by a third reviewer. A standardized data extraction form was developed, piloted and used to collect data for analysis. Data were collected on country, study design, characteristics of the study population (including radiographic or non-radiographic axSpA and the presence of comorbidities and EMMs), intervention characteristics and efficacy and safety outcomes. Cochrane risk of bias tool [11] was used to assess risk of bias for RCTs and controlled clinical trials. For cohort designs, relevant bias domains were used from the ROBINS-I tool for assessing risk of bias in non-randomized intervention studies [12]. Data extraction and risk of bias assessment were undertaken by one reviewer and independently checked by a second for correctness and consistency. Disagreements were resolved by consulting a third reviewer if necessary. Evidence tables were prepared for each guideline question (Supplementary Data S1, available at Rheumatology online). GRADE [13] was used to summarize certainty in the evidence for each outcome across studies for each guideline question, separately for RCTs and observational studies, and separately for each drug category, and efficacy or safety outcome. As this was an update of an existing guideline, GRADE was applied to evidence identified from the update searches only (2014–2023), so does not reflect all evidence available for each intervention. Quality of evidence for each outcome was graded where A represents high, B moderate and C low/very low quality of evidence. “High quality” suggest that further research is very unlikely to change the confidence in the effect estimate (e.g. from well-performed RCTs or observational studies). Evidence was downgraded to moderate, low or very low based on concerns related to study design, risk of bias, inconsistency, indirectness (applicability) or imprecision. “Moderate quality” suggests that further research is likely to have an important impact on the confidence in the effect estimate and may change the estimate (e.g. from RCTs with important limitations, or from other study designs with special strength). “Low or very low quality” suggests that further research is very likely to have an important impact on confidence in the effect estimate and is likely to change the estimate (e.g. observational studies or RCTs with very serious limitations). Each recommendation was evaluated by all members of the GWG and subjected to a vote relating to strength of agreement (SoA) on a scale of 1 (total disagreement) to 100 (total agreement). The strength of agreement for each recommendation is presented as the mean of the GWG’s individual ratings, expressed as a percentage. Anonymized votes are shown in Supplementary Data S5, available at Rheumatology online. A rating of 1 (strong) is given where the GWG feels that benefits clearly outweigh the risks; 2 (conditional) when risks and benefits are more closely balanced or more uncertain. The recommendation statements are presented at the beginning of each section, accompanied by the strength of recommendation, quality of supporting evidence and strength of agreement in

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