Adalimumab Tops Cyclosporine in Preventing Uveitis Relapse

TOPLINE:

Adalimumab combined with corticosteroids was more advantageous than cyclosporine combined with corticosteroids in preventing uveitis relapse while maintaining a favorable safety profile in patients with severe Behçet disease. In contrast, interferon alfa-2a is not superior to cyclosporine in terms of efficacy.

METHODOLOGY:

• Researchers compared the efficacy and safety of three immunomodulatory agents (cyclosporine, interferon alfa-2a, and adalimumab) in a randomized, open-label trial conducted at a specialized uveitis center in China.
• They included 270 patients (mean age, 38.1 years; 21% women) with severe Behçet disease who were naive to anti–tumor necrosis factor (anti-TNF) therapy and were randomly assigned to receive cyclosporine (2-5 mg/kg/d), interferon alfa-2a (3 million IU/d), or adalimumab (40 mg every 2 weeks), each combined with a tapering dose of corticosteroids.
• All patients maintained their entry dose of prednisone for 1-2 weeks, which was then tapered by 5 mg every 1 or 2 weeks to 20 mg, followed by 2.5-mg decrements every 1 or 2 weeks.
• Follow-up visits were scheduled for week 2 and months 2, 4, and 6, with a 14-day window for the week 2 visit and a 30-day window for all subsequent timepoints.
• The primary outcome was the annualized relapse rate of uveitis, defined as the average number of relapses during the treatment period standardized for 1 year.

TAKEAWAY:

• Patients who received adalimumab plus corticosteroids had a significantly lower annualized relapse rate of uveitis than those who received cyclosporine plus corticosteroids (least-squares mean difference, −0.90; P = .0054).
• Interferon alfa-2a was not superior to cyclosporine (least-squares mean difference, −0.40; P = .23 for superiority); it also did not meet criteria for noninferiority compared with adalimumab (least-squares mean difference, 0.50; P = .034 for noninferiority).
• Patients receiving cyclosporine (hazard ratio [HR], 2.00; 95% CI, 1.19-3.37) or interferon alfa-2a (HR, 1.73; 95% CI, 1.03-2.90) had an earlier occurrence of relapse than those receiving adalimumab.
• Serious adverse events were observed in 13% patients on cyclosporine, 9% on interferon alfa-2a, and 8% on adalimumab, with no treatment-related deaths reported.

IN PRACTICE:

“Given the data indicating adalimumab’s superior performance for the primary outcome, treatment protocols could prioritize adalimumab for patients with severe uveitis rate,” experts from the Division of Rheumatology and Immunology, Huadong Hospital Affiliated to Fudan University, Shanghai, China, wrote in an accompanying editorial.

SOURCE:

This study was led by Zhenyu Zhong, MD, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China, and was published online on September 2, 2024, in The Lancet Rheumatology.

LIMITATIONS:

The open-label design of this study may have introduced bias, as patients and treating clinicians were aware of what treatment they received. The findings of the study was not generalizable to patients previously treated with anti-TNF therapy or those on different corticosteroids. The travel restrictions due to the COVID-19 pandemic compromised follow-up procedures, leading to missing data that limited the interpretation of the results.

DISCLOSURES:

This study was funded by the National Natural Science Foundation of China Key Program, Major Program of Medical Science and Technology Project of Health Commission of Henan Province, Chongqing Key Laboratory of Ophthalmology, and grants from other sources. One author reported receiving research grants from OcuMension, Arctic Vision, and Roche.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.