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Infliximab safe, efficacious for refractory uveoretinitis in Behçet's disease
Infliximab demonstrated safe and effective results for patients with refractory uveoretinitis related to Behçet’s disease, according to data published in Arthritis Research & Therapy.
“Current treatments for [Behçet’s disease (BD)] uveoretinitis include glucocorticoids, cyclosporine and other immunosuppressants,” Shigeaki Ohno, MD, PhD, of the Hokkaido University Faculty School of Medicine, Japan, and colleagues wrote. “In particular, cyclosporine exerts potent immunosuppressive activity via the suppression of T-cell function, and various guidelines recommend its use for the treatment of BD uveoretinitis.”
However, the researchers noted that “given the adverse drug reactions associated with cyclosporine, including nephrotoxicity and central nervous system effects, and the existence of nonresponders to cyclosporine, a novel therapeutic agent is desirable.”
To analyze the long-term safety and efficacy of infliximab (Remicade, Janssen) in patients with refractory uveoretinitis related to Behçet’s disease in Japan, Ohno and colleagues initiated BRIGHT, a prospective, large-scale, long-term postmarketing surveillance study. Participants included all patients with Behçet’s-related refractory uveoretinitis who began treatment with infliximab — after failing to respond to conventional therapy, such as glucocorticoids, cyclosporine, colchicine and other immunosuppressants — across 215 Japanese medical facilities between January 2007 and January 2010.
The researchers evaluated all participants every 6 months, for up to 24 months. The drug’s tolerability was analyzed in 656 patients for whom safety data was available, of whom 555 completed the 24-month study period, while its efficacy was evaluated in 650 patients. Ohno and colleagues used chi-square or Fisher’s exact test to compare patient characteristics, as well as the Wilcoxon signed-rank test to analyze the frequency of ocular attacks before and after infliximab initiation. Multiple logistic regression analysis was used to determine independent associated factors for safety and efficacy.
According to the researchers, the incidence of adverse drug reactions was 32.32%, with serious adverse drug reactions occurring with an incidence rate of 6.1%. The most common reactions, serious or otherwise, were infections, with tuberculosis reported in two patients and Pneumocystis jirovecii in one. Independent associated risk factors for infections were comorbid respiratory disease, history of allergic disease, and concomitant use of glucocorticoids.
Meanwhile, the response rate for infliximab at 24 months — based on physician global assessment — was 80.7%, with decreases reported in the median frequency of ocular attacks per 6 months, from two prior to treatment initiation to zero. In addition, corrected visual acuity was maintained during the study.
“The safety profile of [infliximab] was similar to that observed in previous studies, and no new safety concerns were observed,” Ohno and colleagues wrote. “In addition, the efficacy of [infliximab] treatment was maintained for an extended period. These results suggest that [infliximab] is a suitable treatment option for [refractory uveoretinitis in Behçet’s disease] in real-world clinical settings.” – by Jason Laday
Disclosure: Ohno reports expert testimony fees from Mitsubishi Tanabe Pharma Corporation, AbbVie GK, Alcon Japan, Bosch & Lomb Japan and Santen Pharmaceutical Company; grants and research support from Mitsubishi Tanabe Pharma Corporation; lecture fees from Mitsubishi Tanabe Pharma Corporation, Alcon Japan, Otsuka Pharmaceutical Company and Santen Pharmaceutical Company; and patent fees from Mitsubishi Tanabe Pharma Corporation. Please see the study for all other authors’ relevant financial disclosures.