ArticleEClinicalMedicine2026
Adalimumab versus placebo as add-on to standard therapy for non-infectious uveitis in the United Kingdom: the ASTUTE randomised controlled trial with treatment run-in.
Article in EClinicalMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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.
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Authors and funding
18 authors.
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Abstract
Background: Immune-mediated non-infectious uveitis (NIU) is a leading cause of blindness in high-income countries. Adalimumab is the only licensed non-corticosteroid drug for non-infectious intermediate, posterior or panuveitis. We evaluated the efficacy, safety and cost-effectiveness of an adalimumab biosimilar as add-on therapy for a broad NIU population. Methods: This multicentre, placebo-controlled randomised trial recruited adults with sight-threatening or controlled NIU requiring oral prednisolone >5 mg/day from 18 UK NHS ophthalmology departments between 29 July 2021 and 7 June 2024. After a 16-week treatment run-in (TRI) with adalimumab, responders (prednisolone ≤5 mg/day, no active disease) were randomised 1:1 (parallel groups; concealed web-based allocation) to fortnightly subcutaneous 40 mg adalimumab (biosimilar) or placebo as add-on therapy; all but the trial statistician were masked. The primary outcome, time to treatment failure (TF; disease activity or prednisolone >5 mg/day), was analysed at 12 months by intention to treat. The health economic evaluation was pre-specified in the trial protocol; we estimated incremental cost per TF avoided, NHS perspective. Registered: ISRCTN31474800. Findings: 182 participants completed the TRI, 119 (65.4%) responded, and 115 were randomised (60 adalimumab, 55 placebo). At 12 months, 31.4% (adalimumab) and 59.0% (placebo) had experienced TF (hazard ratio 0.42, 95% CI 0.23-0.75, p = 0.003). Among patients ineligible for NHS treatment (85%), the effect was similar (hazard ratio 0.37, 95% CI 0.20-0.71, p = 0.003). Adverse events were similarly frequent; two were serious, one per group. Incremental cost was £2320 per TF avoided. Interpretation: Adalimumab added to standard care reduces treatment failure in NIU, including in patients with macular oedema, unilateral disease, and steroid-dependent inactive uveitis, and is affordable. Future work should identify complementary treatments for disease refractory to adalimumab. Funding: Health Technology Assessment Programme, National Institute for Health and Care Research (NIHR); Biogen International GmbH (Baar, Switzerland) provided the placebo for the trial.
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