Background To evaluate the effect of infliximab (IFX), in comparison with cyclophosphamide (CP) on refractory uveitis of BD.

Methods Subjects with uveitis and retinal vasculitis (RV) resistant to conventional treatment were included. Ten patients were divided in the IFX and CP groups. Patients in the IFX group received four courses of 3 mg/kg of IFX, intravenously. Patients in the CP group received four courses of pulse CP of 1000 mg, by the monthly interval. All patients received weekly 25 mg of methotrexate, (or 5 mg/kg of cyclosporine daily), and 3 mg/kg and 1 mg/kg of daily azathioprine and prednisolone, respectively. To evaluate the treatment effects, visual acuity (VA), anterior uveitis (AU), posterior uveitis (PU), and RV were assessed, at the baseline and four months after treatment.

Results In ten patients included in this study there were no significant differences in the treatment effects of IFX, compared to the CP regarding VA, PU, AU and RV. RV became inactive after four months of treatment in all five patients in the IFX group versus four patients in the CP group.

Conclusion IFX and CP have the same efficacy in the short-term treatment of uveitis in BD. In future investigations, multi-center studies with larger sample sizes are required to investigate the cost-effectiveness of IFX in the treatment of uveitis of BD.

Highlights

A new anti-TNF biologic agent, infliximab and cyclophosphamide have the same efficacy in the treatment of uveitis in BD, and since it has less toxicity, it is a superior treatment option.

In areas where access to the contemporary treatment is limited and expensive, the use of traditional medication results in an increased quality-adjusted life year (QALY).

Multi-center studies with larger sample sizes are required to investigate the cost-effectiveness of infliximab in the treatment of uveitis of BD.

The authors have declared no competing interest.

IRCT20180110038297N1

This study was funded by Zanjan University of Medical Sciences.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This study was approved by The Regional Bioethics Committee of Zanjan University of Medical Sciences on March 28, 2016, with the Code of Ethics (ZUMS.REC.1395.233). The protocol was registered on National Registry of Clinical Trials Website (IRCT.IR) under the ID: IRCT20180110038297N1

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Data and analysis relevant to the findings of this study can be made available upon request.