Infliximab for severe ocular inflammation in patients with Behcet's disease

A single infusion of the anti-tumour necrosis factor monoclonal antibody Infliximab, given in five patients with Behcet's disease (BD) and sight-threatening panuveitis relapse, resulted in rapid and effective suppression of ocular inflammation [1]. Until May 2003, a single Infliximab infusion (5 mg/kg) has been given in a total of 24 such patients (bilateral relapse or unilateral relapse in 18 and six patients, respectively). At day 1 post-treatment, a significant improvement of visual acuity, a striking decrease of anterior chamber cells, and a 50% decrease of vitreous haze was evident in all patients but one. Within 2 weeks, acute ocular inflammation, including retinal lesions and vasculitis, resolved completely in 26 eyes, and by 80–90% in six eyes. Visual acuity returned to the prerelapse levels (at least) in all.

We are currently looking at the safety and efficacy of continuous Infliximab infusions (at week 0, weeks 3–4, and every 6–8 weeks thereafter, at 5 mg/kg) in patients who do not respond, or in patients with an inadequate response to prednisolone (nine patients), combined either with cyclosporin A (six patients) and/or azathioprin (five patients), or cyclophosphamide (one patient). In the 17 affected eyes, visual acuity has improved by a mean of three lines in the Shnellen chart at 6 months compared with at baseline. This effect has been sustained during further follow-up (6 months-2 years). Concomitant immunosuppressive therapy has been significantly tapered in all. No patient has experienced an ocular relapse requiring other than topical treatment, or a major extra-ocular relapse of the disease. No possible side effects, including opportunistic infections or an exacerbation of previous neurological disease (present in three of nine patients), have been noted.

Similar results have been obtained in a parallel study looking at safety and efficacy of continuous Infliximab infusions as monotherapy in previously untreated patients, which is also underway.

Since conventional immunosuppressive treatment BD-associated acute ocular relapse is often unable to rapidly control ocular inflammation, which is critical to avoid development of chronic lesions, we suggest that a single infusion of Infliximab with observation for objective improvement is the treatment of choice in these patients, and that continuous treatment of Infliximab is a safe, effective and immunosuppressive therapy-sparing approach for patients with refractory, relapsing ocular disease.