Trial suggests more people should receive sight-saving uveitis treatment

A UK clinical trial has shown that the drug adalimumab protects the sight of a far wider group of patients with the eye inflammation condition uveitis than previously thought.

The research team say that their findings, published in eClinical Medicine, suggest that the National Institute for Health and Care Excellence (NICE) criteria for who should be eligible to receive the drug should be widened.

Uveitis is inflammation inside the eye. Although considered rare, non-infectious uveitis is a leading cause of blindness in high-income countries.

Adalimumab is already used in the NHS for arthritis and some forms of eye inflammation and is the only non-steroid treatment licensed for uveitis.

The ASTUTE trial, co-led by Oxford University Hospitals and Bristol NHS Foundation Trust, recruited patients with non-infectious uveitis at 18 hospitals across the UK.

Initially, everyone in the trial was given adalimumab for 16 weeks alongside standard care. Those whose eyes settled continued either on the drug or 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 placebo.

NICE currently only funds adalimumab for non-infectious uveitis for patients who meet a narrow set of conditions, set out in guidance published in 2017, before trials in this group had been done. Around 85% of the patients randomised in the ASTUTE trial would not have met those conditions. For these ‘excluded’ patients, continuing the drug reduced the risk of treatment failure by 63%, and the benefits for this group were the same for all patients in the trial.

Dr Srilakshmi Sharma, Consultant Medical Ophthalmologist at the Oxford Eye Hospital and the trial’s senior author, said: “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.”

Side effects were no more common on adalimumab than on the placebo injection.

As part of the trial, University of Oxford health economists assessed the cost to the NHS. They 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 cheaper biosimilar version of adalimumab, of the kind routinely used by the NHS.

Chief investigator for study, Professor Andrew Dick, of the University of Bristol and University College London, said: “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.”

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

The ASTUTE trial was supported by Birdshot Uveitis Society and the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme and by the NIHR Biomedical Research Centres at Moorfields and Oxford.

Annie Folkard, co-founder of the Birdshot Uveitis Society, which supported the trial, said: “Living with uveitis means living with the fear that your sight will go. Patients helped shape this study from the start, and more than a hundred people gave up years of appointments and tests to see it through. They deserve to know that it has produced an answer that could change who gets treated.”

The research team has put the eligibility findings to NICE.