Adalimumab versus Conventional Immunosuppression for Uveitis (ADVISE) Trial

Purpose Patients with noninfectious intermediate uveitis, posterior uveitis, or panuveitis typically are treated with oral corticosteroids and immunosuppressive agents, such as antimetabolites and calcineurin inhibitors. Goals of treatment include suppression of ocular inflammation (inactive disease) and reduction of oral corticosteroids to a prednisone dosage of ≤7.5 mg/day (corticosteroid sparing) or, if possible, discontinuation of prednisone. The anti–tumor necrosis factor monoclonal antibody adalimumab also is used to treat these diseases, but its comparative effectiveness versus conventional agents is unknown. The purpose of this trial was to compare the effectiveness of adalimumab treatment with that of conventional immunosuppressive drugs for uveitis. Design Randomized, unmasked, comparative effectiveness trial conducted at uveitis clinics at academic medical centers and private practices in the United States and internationally. Participants Patients with active or recently active noninfectious intermediate uveitis, posterior uveitis, or panuveitis needing immunosuppression. Methods Adalimumab versus conventional immunosuppressive drugs (antimetabolites, calcineurin inhibitors, or both). Main Outcome Measures The primary outcome was successful corticosteroid sparing, defined as inactive uveitis at a prednisone dosage of ≤7.5 mg/day (or its equivalent) for 2 consecutive study visits ≥28 days apart at 6 months. Other outcomes included successful corticosteroid sparing at 1 year and successful corticosteroid discontinuation, defined as inactive uveitis and no oral corticosteroid therapy for 2 consecutive study visits ≥28 days apart. Results Two hundred twenty-seven participants were randomized to either adalimumab (n = 114) or conventional immunosuppression (n = 113). By 6 months of follow-up, successful corticosteroid sparing occurred in 69% of participants assigned to adalimumab versus 54% assigned to conventional immunosuppression (odds ratio [OR], 1.86; 95% confidence interval [CI], 1.06–3.25; P = 0.029) and by 12 months in 86% of participants assigned to adalimumab versus 77% assigned to conventional immunosuppression (OR, 1.89; 95% CI, 0.93–3.83; P = 0.077). By 12 months, successful corticosteroid discontinuation occurred in 55% of participants assigned to adalimumab versus 40% assigned to conventional immunosuppression (OR, 1.85; 95% CI, 1.06–3.19; P = 0.028). Conclusions For patients with noninfectious intermediate uveitis, posterior uveitis, or panuveitis requiring immunosuppression, adalimumab treatment resulted in a greater proportion of participants with successful corticosteroid sparing at 6 months and successful corticosteroid discontinuation at 12 months compared with treatment with antimetabolites or calcineurin inhibitors. Financial Disclosure(s) Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.