Uveitis Patients Reduced Prednisone with Adalimumab in New Trial | AAO 2025

The use of adalimumab (sold as Humira by AbbVie) to treat patients with uveitis was successful in controlling ocular inflammation and allowed patients to taper the use of corticosteroids, according to findings of a study discussed during a session today at the annual American Academy of Ophthalmology meeting and published online in Ophthalmology.

Uveitis is an inflammatory condition that can have serious complications, including a rapid loss of vision. Other complications include glaucoma, macular edema, and cataracts. Current treatment focuses on lowering the inflammation with immunosuppressive therapies and the use of the corticosteroid prednisone.

The monoclonal antibody adalimumab can also be used because it works to block the inflammatory cytokine tumor necrosis factor-alpha, which plays a key role in inflammation associated with uveitis.

But the efficacy of adalimumab compared with other immunosuppressive treatments has not been studied, Douglas A. Jabs, M.D., MBA, director of the Center for Clinical Trials and Evidence Synthesis and professor at Johns Hopkins Bloomberg School of Public Health, said during the session.

The ADVISE trial, he said, aimed to do just that. The unmasked study enrolled patients with noninfectious intermediate, posterior, or panuveitis, which affects the middle or back of the eye. The trial enrolled 227 patients who were randomized to either adalimumab or conventional immunosuppression, which included azathioprine, methotrexate, mycophenolate, cyclosporine, and tacrolimus.

The primary outcome was reduction or discontinuation of prednisone, which would indicate inactive disease, for two consecutive visits at least 28 days apart at six months. Researchers also studied as a secondary endpoint reduction or discontinuation of prednisone at 12 months.

Researchers found that at six months, more patients in the adalimumab group were able to reduce the use of prednisone, 69% compared with 54% for conventional immunosuppression. By 12 months, 86% of patients in the adalimumab arm were able to reduce the use of prednisone compared with 77% using conventional immunosuppressives.

By 12 months, 55% of patients assigned to adalimumab were able to successfully discontinue corticosteroids compared with 40% assigned to conventional immunosuppression.

“Ocular outcomes did show a slight advantage for adalimumab in visual acuity at the three- and six-month visits that was returned to normal,” Jabs said. “There was a greater rate of cataract surgery in the conventional immunosuppression group.”

But he said there was more use of a second immunosuppressive drug in the adalimumab group among patients who did not come into the trial on any immunosuppressive drug.

Adverse events were similar between the two groups, except for the increased cataract surgery in the group using conventional immunosuppression. Drug intolerance was also significantly greater in the conventional treatment group.

“We only have one year of follow-up, and we don’t know what would happen with longer follow-up,” he said. “Conventional immunosuppression appeared to be catching up with corticosteroid sparing by 12 months. And the question arises, is adalimumab just faster, and do we really have no data on anti-adalimumab antibodies in this trial? There are data that have now come out suggesting that this may be a problem and that it may be treatable by the use of a second agent. The long-term consequences of adalimumab monotherapy remain unknown.”

A panelist during the session, Philip J. Rosenfeld, M.D., Ph.D., with the Bascom Palmer Eye Institute at the University of Miami Health System, said the use of adalimumab appears to be a safe strategy with fewer complications. But he cautioned that payers want patients to start on the conventional immunosuppressive agents because of the higher costs associated with adalimumab.

The study was funded by the National Institutes of Health, and AbbVie donated adalimumab for the trial.