Trial results for the ADVISE Trial (NCT03828019) investigating adalimumab versus conventional immunosuppression for uveitis were posted on ClinicalTrials.gov on 2025-05-16. The study demonstrated that adalimumab achieved a higher cumulative proportion of corticosteroid-sparing treatment success at 12 months, with 0.86 (86%) of participants compared to 0.77 (77%) for conventional immunosuppression.
Background
Adalimumab is a fully-human, anti-tumor necrosis (TNF)-α monoclonal antibody that is US FDA-approved for uveitis treatment. Non-infectious intermediate, posterior, and panuveitides are chronic, potentially-blinding diseases that often require long-term therapy with oral corticosteroids and immunosuppression.
Trial design
The ADVISE Trial (NCT03828019) was a Phase 3, multicenter, randomized, parallel-treatment, comparative effectiveness trial. It enrolled 227 participants with uveitis, specifically non-infectious intermediate, posterior, and panuveitides. The study compared adalimumab to conventional immunosuppression (small molecule) as a corticosteroid-sparing agent.
Key results
The trial evaluated several outcomes related to corticosteroid-sparing and visual acuity. For "Corticosteroid-sparing Treatment Success":
- Within the first 6 months, the cumulative proportion of participants was 0.69 for adalimumab and 0.54 for conventional immunosuppression.
- Within the first 12 months, the cumulative proportion was 0.86 for adalimumab and 0.77 for conventional immunosuppression.
A logistic regression analysis comparing corticosteroid-sparing between groups over time yielded an Odds Ratio (OR) of 1.86 (95% Confidence Interval [CI]: 1.06 to 3.25) with a p-value of 0.029, favoring adalimumab.
Regarding "Corticosteroid Discontinuation Success":
- By 6 months, the cumulative proportion was 0.15 for adalimumab and 0.11 for conventional immunosuppression.
- By 12 months, the cumulative proportion was 0.55 for adalimumab and 0.40 for conventional immunosuppression.
A logistic regression analysis for corticosteroid discontinuation over time showed an OR of 1.85 (95% CI: 1.06 to 3.19) with a p-value of 0.028, indicating greater success with adalimumab.
For "Corticosteroid Exposure Over 12 Months", the mean daily steroid use was 11.8 mg/day for adalimumab and 13.8 mg/day for conventional immunosuppression. A negative binomial model indicated a ratio of rate of steroid (ADA/CID) of 0.86 (95% CI: 0.73 to 1.01) with a p-value of 0.061.
For "Best Corrected Visual Acuity Change at 12 Months", the mean change was 3.6 standard letters ETDRS eye chart for adalimumab and 3.2 for conventional immunosuppression. A mixed models analysis showed a difference in mean change from baseline of 0.4 (95% CI: -2.3 to 3.1) with a p-value of 0.77.
What this means
The results suggest that adalimumab is more effective than conventional immunosuppression in achieving corticosteroid-sparing treatment success and corticosteroid discontinuation in patients with uveitis. The statistically significant odds ratios for both outcomes indicate that patients treated with adalimumab are more likely to reduce or discontinue corticosteroid use. While there was a trend towards lower overall corticosteroid exposure with adalimumab, this difference did not reach statistical significance. Visual acuity outcomes were comparable between the two treatment arms.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03828019, titled "Adalimumab vs. Conventional Immunosuppression for Uveitis Trial," were posted on 2025-05-16 on clinicaltrials.gov.