Rudwaleit M, Rødevand E, Holck P, Vanhoof J, Kron M, Kary S, Kupper H
Charité University Medicine Berlin, Benjamin Franklin Campus, Berlin, Germany.
Ann Rheum Dis. 2009 May;68(5):696-701. doi: 10.1136/ard.2008.092585. Epub 2008 Jul 28.
To evaluate the effect of adalimumab on the frequency of anterior uveitis (AU) flares in patients with active ankylosing spondylitis (AS).
We determined the history of ophthalmologist-diagnosed AU in 1250 patients with active AS who were enrolled in a multinational, open-label, uncontrolled clinical study of treatment with adalimumab, 40 mg every other week for up to 20 weeks. All AU flares were documented throughout the adalimumab treatment period plus 70 days. We compared the rates of AU flares per 100 patient years (PYs) reported during the year before adalimumab treatment with rates during adalimumab treatment, in total and by patient subgroups.
The AU flare rates before adalimumab treatment were 15/100 PYs in all patients (n = 1250), 68.4/100 PYs in 274 patients with a history of AU flares, 176.9/100 PYs in 106 patients with a recent history of AU flares, 192.9/100 PYs in 28 patients with symptomatic AU at baseline and 129.1/100 PYs in 43 patients with a history of chronic uveitis. During adalimumab treatment, the rate of AU flares was reduced by 51% in all patients, by 58% in 274 patients with a history of AU, by 68% in 106 patients with a recent history of AU, by 50% in 28 patients with symptomatic AU at baseline and by 45% in 43 patients with chronic uveitis. AU flares during adalimumab treatment were predominantly mild. Two patients with periods of high AS disease activity had new-onset AU during the treatment period.
Results of this prospective open-label study suggest that adalimumab had a substantial preventive effect on AU flares in patients with active AS, including patients with a recent history of AU flares. Clinical trials: ClinicalTrials.gov Identifier: NCT00478660.
评估阿达木单抗对活动性强直性脊柱炎(AS)患者前葡萄膜炎(AU)发作频率的影响。
我们确定了1250例活动性AS患者的眼科医生诊断的AU病史,这些患者参加了一项多国、开放标签、非对照的阿达木单抗治疗临床研究,每两周注射40mg,持续长达20周。在阿达木单抗治疗期间加70天内记录所有AU发作情况。我们比较了阿达木单抗治疗前一年每100患者年(PYs)报告的AU发作率与阿达木单抗治疗期间的发作率,总体及按患者亚组进行比较。
所有患者(n = 1250)在阿达木单抗治疗前的AU发作率为15/100 PYs,274例有AU发作史的患者为68.4/100 PYs,106例近期有AU发作史的患者为176.9/100 PYs,28例基线时有症状性AU的患者为192.9/100 PYs,43例有慢性葡萄膜炎病史的患者为129.1/100 PYs。在阿达木单抗治疗期间,所有患者的AU发作率降低了51%,274例有AU病史的患者降低了58%,106例近期有AU病史的患者降低了68%,28例基线时有症状性AU的患者降低了50%,43例有慢性葡萄膜炎的患者降低了45%。阿达木单抗治疗期间的AU发作主要为轻度。两名AS疾病活动度高的患者在治疗期间出现了新发AU。
这项前瞻性开放标签研究的结果表明,阿达木单抗对活动性AS患者的AU发作有显著预防作用,包括近期有AU发作史的患者。临床试验:ClinicalTrials.gov标识符:NCT00478660。