ArticleAdvances in rheumatology (London, England)2024
Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis.
Article in Advances in rheumatology (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (as)
A phase 3, randomized, double-blind, placebo-controlled, study of the efficacy and safety of tofacitinib in subjects with active ankylosing spondylitis (as)
Who cites it
4 citing papers in PubMed.
- Korean College of Rheumatology treatment recommendations for patients with axial spondyloarthritis: 2026 update.Journal of rheumatic diseases · 2026Article
- Clinical efficacy of tofacitinib in active ankylosing spondylitis and dynamic changes in gut microbiota: an exploratory descriptive four-case series with 16S rRNA sequencing analysis.Frontiers in immunology · 2026Article
- Cardiovascular involvement in ankylosing spondylitis and axial spondyloarthritis: epidemiology, mechanisms, and clinical management.Frontiers in medicine · 2026Review
- Article
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Authors and funding
15 authors.
Funding
Abstract
objectivesDescribe tofacitinib safety from an integrated analysis of randomized controlled trials (RCTs) in patients with ankylosing spondylitis (AS).
methodPooled data from Phase 2 (NCT01786668; 04/2013-03/2015)/Phase 3 (NCT03502616; 06/2018-08/2020) RCTs in AS patients were analyzed (3 overlapping cohorts): 16-week placebo-controlled (tofacitinib 5 mg twice daily [BID] [n = 185]; placebo [n = 187]); 48-week only-tofacitinib 5 mg BID (n = 316); 48-week all-tofacitinib (≥ 1 dose of tofacitinib 2, 5, or 10 mg BID; n = 420). Baseline 10-year atherosclerotic cardiovascular disease (ASCVD) risk was determined in patients without history of ASCVD (48-week cohorts). Adverse events (AEs)/AEs of special interest were evaluated/compared with findings from other tofacitinib programs (16 Phase 2/Phase 3 rheumatoid arthritis [RA]; 2 Phase 3 psoriatic arthritis [PsA] RCTs) and a real-world cohort of AS patients initiating biologic disease-modifying antirheumatic drugs (US MarketScan).
resultsMost patients (> 75%; 48-week cohorts) without history of ASCVD had low baseline 10-year ASCVD risk. One patient (tofacitinib 5 mg BID; in all 3 cohorts) had a serious infection (aseptic meningitis). Herpes zoster (non-serious) occurred in the 48-week only-tofacitinib 5 mg BID (n = 5 [1.6%]) and all-tofacitinib (n = 7 [1.7%]; one multi-dermatomal [tofacitinib 10 mg BID]) cohorts. No deaths, opportunistic infections, tuberculosis, malignancies, major adverse cardiovascular events, thromboembolic events, gastrointestinal perforations occurred. LIMITATIONS: short RCT durations/low patient numbers within cohorts.
conclusionTofacitinib 5 mg BID was well tolerated to 48 weeks in AS patients; safety profile was consistent with RA/PsA clinical programs and a cohort of AS patients from US routine clinical practice. CLINICAL TRIAL REGISTRATION NUMBERS: NCT01786668 (2013-02-06); NCT03502616 (2018-04-11).
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Registered trials
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