ArticleTherapeutic advances in musculoskeletal disease2020
Disease activity guided stepwise tapering or discontinuation of rhTNFR:Fc, an etanercept biosimilar, in patients with ankylosing spondylitis: a prospective, randomized, open-label, multicentric study.
Article in Therapeutic advances in musculoskeletal disease, 2020. 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 8 papers.
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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.
Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis: a Prospective, Randomized Multicentric Study on Disease Activity Guided Etanercept Tapering or Discontinuation
A Prospective, Randomized Biologic Tapering Study of TNF Inhibitors in Axial Spondyloarthritis
Who cites it
8 citing papers in PubMed.
- Exploring TNFi drug-levels and anti-drug antibodies during tapering among patients with inflammatory arthritis: secondary analyses from the randomised BIODOPT trial.Rheumatology international · 2024Trial
- Biological tapering is cost-effective in patients with inflammatory arthritis in the biosimilar era: secondary analyses on the randomised BIODOPT trial.EULAR rheumatology open · 2025Article
- Dose Tapering of Advanced Therapies in Psoriatic Arthritis: Clinical Predictors and Outcomes in a Biosimilar-Dominant Real-Life Cohort.Journal of clinical medicine · 2025Article
- The 2025 British Society for Rheumatology guideline for the treatment of axial spondyloarthritis with biologic and targeted synthetic DMARDs.Rheumatology (Oxford, England) · 2025Article
- Dose Tapering and Discontinuation of Biologic DMARDs in Axial Spondyloarthritis: A Narrative Review (2023 SPARTAN Annual Meeting Proceedings).Current rheumatology reports · 2024Review
- Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study.Frontiers in pediatrics · 2022Article
- [Relapse of ankylosing spondylitis and its predictors after withdrawal of tumor necrosis factor-α inhibitors: a 52-week follow-up study].Nan fang yi ke da xue xue bao = Journal of Southern Medical University · 2021Article
- Understanding flare in axial spondyloarthritis: novel insights from daily self-reported flare experience.Rheumatology advances in practice · 2021Article
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12 authors.
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Abstract
backgroundThe aim of this study was to evaluate disease-activity-guided stepwise tapering or discontinuation of rhTNFR:Fc, an etanercept biosimilar, in patients with ankylosing spondylitis (AS) in a prospective, randomized, open-label, multicentric study.
methodsActive AS patients with AS disease activity score (ASDAS) ⩾2.1 recruited from 10 hospitals were treated with rhTNFR:Fc 50 mg weekly for 12 weeks, and further randomized into different tapering or discontinuation groups according to ASDAS at week 12. Patients who achieved clinical remission (ASDAS < 1.3) were assigned randomly to stepwise tapering group or discontinuation group. Patients who achieved low disease activity (LDA, 1.3⩽ASDAS < 2.1) were assigned randomly to stepwise tapering, delayed tapering, or discontinuation group. All patients were evaluated every 12 weeks until week 48. The primary endpoint was cumulative flare rates in different groups at week 48.
resultsA total of 311 patients were enrolled with an average ASDAS of 3.6 ± 1.0, and 259 completed 12 weeks of rhTNFR:Fc induction therapy, with 148 patients (57.1%) achieved clinical remission, 100 (38.6%) achieved LDA, and 11 (4.3%) remained as high disease activity (ASDAS⩾2.1). In patients who achieved clinical remission at week 12, stepwise tapering of rhTNFR:Fc demonstrated significantly lower flare rates at each evaluation compared with discontinuation. In patients who achieved LDA, there was no significant difference of flare rates between stepwise tapering, delayed tapering, and discontinuation. With stepwise tapering of rhTNFR:Fc, flare rates were comparable in AS patients, irrespective of initial ASDAS before tapering.
conclusionStepwise tapering of rhTNFR:Fc when patients achieved clinical remission was able to maintain favorable low flare rates in 48 weeks. LDA was an alternative therapeutic target, as well as an viable timing for initiation of rhTNFR:Fc tapering. rhTNFR:Fc 25 mg monthly maintained flare-free status in a considerable number of patients. However, abrupt discontinuation of rhTNFR:Fc even if patients achieved clinical remission should be avoided.
trial registrationClinicalTrials.gov: NCT03880968,URL: https://clinicaltrials.gov/ct2/show/NCT03880968.
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