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I. Tugal–Tutkun, A. Gul, A. Mudun, M. Inanc, S. Kamali, M. Urgancioglu; Efficacy of Infliximab in the Treatment of Uveitis Resistant to the Combination of Azathioprine and Cyclosporin in Behçet's Disease: Preliminary Report of an Open Trial . Invest. Ophthalmol. Vis. Sci. 2004;45(13):2670.
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Purpose: This study was designed as an open trial to investigate the efficacy of infliximab on the frequency of uveitis attacks and visual prognosis in Behcet patients with uveitis resistant to the combined regimen of azathioprine, cyclosporin, and corticosteroid. Methods: We included male patients who had at least 2 attacks of posterior/panuveitis despite treatment with azathioprine, cyclosporin, and corticosteroid during the 6–month period prior to the enrollment. Infusions of 5 mg/kg infliximab were administered at weeks 0, 2, 6, and 14. Patients continued to receive 2 mg/kg azathioprine and corticosteroids. Cyclosporin was discontinued after the screening visit. The weeks 0–22 were defined as the infusion period and weeks 22–54 as the observation period. Complete response was the primary outcome measure and defined as the absence of posterior/panuveitis attacks during the infusion and observation periods. Other primary outcome measures included the changes in the frequency of uveitis attacks and the visual acuity during the infusion period. The number of attacks was compared by using the Wilcoxon test. Results: Ten patients completed the infusion period. Four of them remained attack free, 4 patients had one and 2 patients had 2 uveitis attacks. The mean number of uveitis attacks in the infusion period was significantly decreased compared to that in the previous 6–month period (0.80+0.79 vs 2.30+0.48) (p=0.006). All of the 8 attacks observed in weeks 0–22 were mild and did not cause visual deterioration. Four attacks occurred at week 14 and 2 attacks at week 22. During the completed part of the observation period, only 1 patient remained attack free until the last visit at week 34. Six patients had a total of 11 attacks between week 23 and 34. No serious adverse event was documented. Conclusions: The preliminary results of this trial indicate that infliximab is efficacious in the treatment of resistant uveitis in Behcet's disease, with 40% of the patients remaining in remission and 60% having a decreased number and severity of uveitis attacks. However, complete response could not be achieved with four infusions and patients should continue to receive infliximab to preserve this beneficial effect. Since the majority of uveitis attacks were observed at the end of the 8–week intervals, we also suggest that shorter infusion intervals could provide a higher rate of remission.
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