Adalimumab and corticosteroids may reduce uveitis recurrence among patients with Behçet's disease: Lancet

A new study published in The Lancet Rheumatology showed that adalimumab and corticosteroids resulted in a noticeably decreased risk of recurrence in Behçet's disease uveitis when compared to ciclosporine with corticosteroids. There is a lack of information about head-to-head studies of immunomodulatory treatments for Behçet's disease. In order to avoid uveitis recurrence in patients with severe Behçet's disease, this study examined the safety and effectiveness of ciclosporin, interferon alfa-2a, and adalimumab when used in combination with corticosteroids. Thus, Zhong and colleagues carried out this study to evaluate the safety and effectiveness of ciclosporin, interferon alfa-2a, and adalimumab (Humira, AbbVie) when used in conjunction with corticosteroids.

This large, randomized study was conducted in specialized uveitis center in Chongqing, China. Eligible patients were the ones who were 18 years of age or older, using corticosteroids for severe Behçet's disease uveitis, and had never used anti-TNF medication. The patients received a tapering dosage of corticosteroids with subsequent dose modifications, and were randomly allocated in a 1:1:1 ratio to either ciclosporin, interferon alfa-2a, or adalimumab. The annualized recurrence rate of uveitis, as determined by the whole data set, was the main outcome. For the main endpoint, the non-inferiority margin of difference between the adalimumab and interferon alfa-2a groups was established at 1·0. Every patient who got at least one dosage of the trial medications had their safety evaluated. The conception and execution of the trial involved people who had firsthand experience with Behçet's illness uveitis.

A total of 270 individuals were randomized to receive interferon alfa-2a, ciclosporin, or adalimumab between May 12, 2020 and February 22, 2022; 261 patients made up the whole analysis set. The least-squares mean for the main outcome was 0·95 for adalimumab, 1·84 for ciclosporin and 1·44 for interferon alfa-2a. The patients on ciclosporin had a considerably greater annualized recurrence rate than those on adalimumab. Non-inferiority criterion were not met by the 0·50 least-squares mean difference between interferon alfa-2a and adalimumab. Ciclosporin and interferon alfa-2a did not significantly vary in the main result. 12 (13%) out of 90 patients receiving ciclosporin plus corticosteroids, 8 (9%) out of 90 patients receiving interferon alfa-2a plus corticosteroids, and 7 (8%) out of 90 patients receiving adalimumab plus corticosteroids experienced serious side effects. Overall, the combined protocol of adalimumab plus corticosteroids was better to that of ciclosporine plus corticosteroids for Behçet's disease uveitis on corticosteroid treatment.

Source:

Zhong, Z., Deng, D., Gao, Y., Bu, Q., Dai, L., Feng, X., Tang, C., Luo, X., Wang, Y., Zhou, C., Su, G., & Yang, P. (2024). Combinations of immunomodulatory agents for prevention of uveitis relapse in patients with severe Behçet’s disease already on corticosteroid therapy: a randomised, open-label, head-to-head trial. In The Lancet Rheumatology (Vol. 6, Issue 11, pp. e780–e790). Elsevier BV. https://doi.org/10.1016/s2665-9913(24)00194-2