Safety and Efficacy of Adalimumab in the Treatment of Refractory Behçet's Uveitis: A Prospective Cohort Study.

PURPOSE: Behçet's disease (BD) is a systemic vasculitis characterized by recurrent oral and genital ulcers, skin lesions, and ocular involvement. Uveitis is a major cause of disability and visual loss in BD. This study aimed to evaluate the safety and efficacy of adalimumab in refractory Behçet's uveitis.

METHODS

This prospective longitudinal cohort study included 25 patients with Behçet's disease and uveitis refractory to conventional immunosuppressive therapy. All patients received adalimumab 40 mg subcutaneously every other week and were followed for 1 year. Outcome measures included changes in best corrected visual acuity (BCVA), anterior chamber reaction, vitreous haze, retinal vasculitis, papillitis, retinitis, cystoid macular edema, corticosteroid use, and adverse events.

RESULTS

Mean BCVA improved from 0.14 ± 0.20 at baseline to 0.21 ± 0.23 at the final visit (p = 0.021). The proportion of eyes with absent anterior chamber reaction increased from 24% to 96% (p < 0.001), while vitreous haze improved in 92% of patients. Vasculitis, retinitis, and papillitis decreased from 92% at baseline to 20% at final follow-up (p < 0.001). Mean systemic corticosteroid dose decreased from 27.20 ± 11 mg/day to 15.20 ± 6 mg/day (p < 0.001). Oral and genital ulcers were controlled in 84% of patients. Two patients discontinued adalimumab because of systemic infection, and one patient was switched to infliximab due to inadequate response.

CONCLUSIONS

Adalimumab demonstrated significant efficacy in controlling ocular and systemic inflammation in refractory Behçet's uveitis with a meaningful steroid-sparing effect and acceptable safety profile over 1 year of follow-up.