Abstract
Purpose: To evaluate and compare the efficacy and safety of interferon alpha-2a (IFN-α2a) and cyclosporine-A (CsA) in patients with refractory Behçet’s uveitis (BU). Methods: In this 12-month randomized, controlled, prospective trial, 26 participants (44 eyes) completed the study. Patients were randomly allocated to the IFN-α2a or CsA groups. All patients in both groups received a standardized prednisone burst and tapering schedule as per protocol. The primary outcome measures were response rate, complete remission rate, and tolerance rate. The secondary outcome measures included time to achieve complete remission, the logarithm of the minimum angle of resolution (logMAR) of best-corrected visual acuity (BCVA), and Behçet’s disease ocular attack score 24 (BOS24). T-tests and non-parametric tests were used to compare quantitative variables, and chi-square tests were performed to compare qualitative variables. Results: The response and complete remission rates were 85.7% (12/14 patients) and 50.0% (7/14 patients) in the IFN-α2a group, compared with 66.7% (8/12 patients) and 25.0% (3/12 patients) in the CsA group, respectively (p > 0.05). Complete remission was achieved at 3.3 and 7.0 months after initiation of IFN-α2a and CsA (p = 0.023). LogMAR BCVA significantly improved 1 month after IFN-α2a initiation (23 eyes) (p = 0.002), and this beneficial effect remained statistically significant during the entire follow-up period (p < 0.05); however, this improvement was not observed in the CsA group (21 eyes). At the endpoint, LogMAR BCVA in the IFN-α2a group was significantly better (0.22 vs. 0.31, p = 0.031) with a higher improvement rate (60.9 vs. 47.6%, p > 0.05). Moreover, compared to the CsA group, more eyes in the IFN-α2a group had a lower BOS24 score (87.0 vs. 57.1%, p = 0.042). None of the patients had any side effects that influenced the medication adherence. Conclusion: Compared to CsA plus corticosteroid, IFN-α2a plus corticosteroid appears to induce a better treatment response, a significantly greater improvement in visual acuity, and more stable remission of intraocular inflammation in a 12-month study period.
Highlights
Behçet’s disease (BD) is a multisystemic chronic inflammatory disease of unknown cause characterized by recurrent oral aphthous ulcers, ocular lesions, genital ulcers, gastrointestinal, and central nervous system manifestations (Greco et al, 2018)
logarithm of the minimum angle of resolution (LogMAR) best-corrected visual acuity (BCVA) significantly improved 1 month after IFN-α2a initiation (23 eyes) (p 0.002), and this beneficial effect remained statistically significant during the entire follow-up period (p < 0.05); this improvement was not observed in the CsA group (21 eyes)
Behçet’s uveitis (BU) classically manifests as recurrent non-granulomatous uveitis involving the posterior segment of the eye with or without anterior segment inflammation (Paovic et al, 2013), and visual loss is determined by accumulative damage to the intraocular structure caused by repeated episodes of acute uveitis attacks (Tugal-Tutkun et al, 2004; Takeuchi et al, 2005)
Summary
Behçet’s disease (BD) is a multisystemic chronic inflammatory disease of unknown cause characterized by recurrent oral aphthous ulcers, ocular lesions, genital ulcers, gastrointestinal, and central nervous system manifestations (Greco et al, 2018). Behçet’s uveitis (BU) classically manifests as recurrent non-granulomatous uveitis involving the posterior segment of the eye with or without anterior segment inflammation (Paovic et al, 2013), and visual loss is determined by accumulative damage to the intraocular structure caused by repeated episodes of acute uveitis attacks (Tugal-Tutkun et al, 2004; Takeuchi et al, 2005). While high-dose glucocorticoids are recommended as the mainstay treatment for acute ocular attacks, they are not suitable for long-term use because of their adverse effects (Hatemi et al, 2018). Up to 41.3% of refractory BU patients show inadequate responses to conventional immunosuppressives even at optimal therapeutic doses; switching to biologics could be considered (Celiker et al, 2018)
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