New evidence could expand access to sight-saving treatment for uveitis 

Adalimumab is already used in the NHS for arthritis and some forms of eye inflammation. It is funded by NICE for non-infectious uveitis for patients who meet a narrow set of conditions and is the only non-steroid treatment licensed for uveitis.

Uveitis is inflammation inside the eye. Non-infectious uveitis is a leading cause of blindness in high-income countries. It is considered rare but is mostly seen in people of working age.

The ASTUTE trial recruited patients with non-infectious uveitis at 18 hospitals across the UK, of which around 85% would not have met the eligibility criteria for the medication. 

Dr Srilakshmi Sharma, Consultant Medical Ophthalmologist at the Oxford Eye Hospital and the trial’s senior author

“We set out to answer a question that patients have been asking us in clinic for years, which is whether this drug would help them if only they were allowed to have it. The answer is yes, for many of them. These are people who come to our clinics with their sight at risk, and who we currently have to tell that the funding rules do not cover them. We now have UK trial evidence, from NHS clinics and patients, that the rules are drawn in the wrong place.”

Adalimumab was given for 16 weeks alongside standard care.  Those whose eyes settled then continued either on the drug or on a ‘dummy’ injection, with neither the patients nor their doctors knowing which. A year later, 31.4% of those still on adalimumab had experienced a relapse or needed more treatment, compared with 59% of those on the dummy. 

Side effects were no more common on adalimumab than on the dummy injection. Two serious adverse events occurred in the whole trial, one in each group. 

The trial also measured cost. Health economists at the University of Oxford found that the extra cost of treating a patient for a year was £662, and that the cost of preventing one episode of treatment failure was £2,320. The trial used a biosimilar version of adalimumab, the cheaper form the NHS now buys as standard, which is likely to matter when the economics are assessed. 

Patients helped design the trial before it opened, advising on what the study should measure and what could reasonably be asked of participants. 

Chief investigator for ASTUTE Professor Andrew Dick, University of Bristol and Dean of the Faculty of Brain Sciences at University College London

“This trial was designed to be difficult to argue with. We treated everyone first, so we knew who responded, and only then did we randomise. That design let us show, cleanly, that stopping the drug in people who are doing well on it leads to relapse in most of them. The implication for practice is straightforward: when it works, it needs to be continued, and in many more patients than are currently eligible.”

The researchers have already put the eligibility findings to NICE.

The ASTUTE trial was funded by the NIHR Health Technology Assessment Programme. The trial was led by Bristol and Oxford Universities and run from the Bristol Trials Centre, with Bristol Eye Hospital a major recruiting centre. It was also supported by Birdshot Uveitis Society and Oxford.