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Background

Behçet’s syndrome (BS) is a multifactorial, polygenic, autoinflammatory vasculitis characterized by recurrent oral and genital ulcers, uveitis, skin lesions, and arthritis. Azathioprine has been well established as an effective therapy among other immunosuppressive drugs; however, concerns remain about its safety. This study was conducted to determine the types and prevalence of adverse events related with azathioprine in patients with ocular BS.

Methods

We carried out a cross-sectional study of 165 patients with a confirmed diagnosis of BS who had ocular involvement. Data were collected retrospectively on disease-related characteristics and events including severity, recurrence, relapse, recovery and flare-up, as well as on azathioprine dosage and the duration of use.

Results

Of 165 enrolled patients, 103 (62.43%) were male and 62 (37.57%) were female. Adverse events of treatment with azathioprine occurred in 11 patients (6.67%). These side effects included elevation of liver enzymes in 4 patients (2.43%), hypersensitivity reaction in 2 patients (1.21%), leukopenia in 2 patients (1.21%), nausea in 1 patient (0.61%), skin tumor in 1 patient (0.61%), and concomitant pancreatitis and hepatitis in 1 patient (0.61%). Six of these patients discontinued treatment, and 5 of them tapered the dose. In addition, we observed severe leukopenia in 2 patients.

Conclusion

Administration of azathioprine with due attention to the signs, symptoms, and severity of the disease, results in a reduced rate of adverse events and resolution of the ocular involvement in patients with BS.