PT  - JOURNAL ARTICLE
AU  - Shigeaki Ohno
AU  - Satoshi Nakamura
AU  - Sadao Hori
AU  - Machiko Shimakawa
AU  - Hidetoshi Kawashima
AU  - Manabu Mochizuki
AU  - Sunao Sugita
AU  - Satoki Ueno
AU  - Kazuyuki Yoshizaki
AU  - Goro Inaba
TI  - Efficacy, safety, and pharmacokinetics of multiple administration of infliximab in Behçet's disease with refractory uveoretinitis.
DP  - 2004 Jul 01
TA  - The Journal of Rheumatology
PG  - 1362--1368
VI  - 31
IP  - 7
4099  - http://www.jrheum.org/content/31/7/1362.short
4100  - http://www.jrheum.org/content/31/7/1362.full
SO  - J Rheumatol2004 Jul 01; 31
AB  - OBJECTIVE: Behçet's disease (BD) with uveoretinitis is a chronic refractory disease accompanied by ocular attacks. As the decrease in visual acuity due to ocular attack is seriously life-threatening, development of a new drug is anticipated. Since tumor necrosis factor-a (TNF-a) is involved in the symptoms of BD, particularly the activity of ocular symptoms, suppression of TNF-a might be effective in treating BD with uveoretinitis. We conducted a clinical trial of infliximab, an anti-TNF-a chimeric monoclonal antibody, in patients with BD. METHODS: In this open label trial, the efficacy, safety, and pharmacokinetics of repeated administration of infliximab were evaluated in 13 patients with BD accompanied by refractory uveoretinitis. Infliximab was administered 4 times at Weeks 0, 2, 6, and 10 at doses of either 5 or 10 mg/kg by intravenous drip infusion. Frequency of ocular attacks was used as the primary index for evaluation of efficacy, with visual acuity and extraocular symptoms as secondary indices. RESULTS: The mean numbers of ocular attacks, converted to frequency per 14 weeks, were 3.96 times for the 5 mg/kg group and 3.79 times for the 10 mg/kg group during the observation period. Following treatment with infliximab, they decreased to 0.98 times and 0.16 times, respectively. A serious adverse event, tuberculosis, was observed in one case in the 10 mg/kg group. Serum infliximab concentration increased with dosage. CONCLUSION: Administration of infliximab in patients with BD with refractory uveoretinitis suppressed the frequency of ocular attacks, and multiple administration was well tolerated, suggesting that infliximab is effective for this condition.