Adalimumab vs placebo as add-on to Standard Therapy for autoimmune Uveitis: Tolerability, Effectiveness and cost-effectiveness (ASTUTE) Trial
- Genomics and economics
Autoimmune non‑infectious uveitis (ANIU) is an immune‑mediated ocular inflammatory condition affecting people across all age groups. It is responsible for 10–15% of preventable blindness in high‑income countries, representing a significant and under‑addressed public health burden.
Current standard care relies heavily on corticosteroids to manage inflammation, yet prolonged use carries serious systemic and ocular risks, including cardiovascular events and vision‑threatening complications. Immunomodulatory therapies (IMTs), particularly TNF‑α inhibitors such as adalimumab, offer a corticosteroid‑sparing alternative and have shown efficacy in reducing uveitis flares and preserving visual acuity in clinical trials. However, approximately 40% of patients with sight‑threatening ANIU fail to respond to IMTs, and critical questions around optimal treatment duration and the management of complications such as cystoid macular oedema (CME) remain unanswered by existing evidence.
This project evaluates the clinical effectiveness and cost‑effectiveness of extended adalimumab therapy in ANIU patients who have already demonstrated an initial response to treatment. By addressing gaps in current trial evidence — including the exclusion of CME and the absence of data on adalimumab as an add‑on strategy — the study aims to generate robust, real‑world‑applicable evidence to inform treatment guidelines and expand access to effective care for patients currently left without suitable options.
Funder: National Institute for Health Research (NIHR) Health Technology Assessment programme