Rudwaleit M, Rosenbaum J T, Landewé R, Marzo-Ortega H, Sieper J, van der Heijde D, Davies O, Bartz H, Hoepken B, Nurminen T, Deodhar A
Klinikum Bielefeld, Bielefeld, Germany.
Devers Eye Institute, Legacy Health System, Portland, Oregon, and Oregon Health & Science University, Portland.
Arthritis Care Res (Hoboken). 2016 Jun;68(6):838-44. doi: 10.1002/acr.22848.
Axial spondyloarthritis (axial SpA) is characterized by inflammation of the spine and sacroiliac joints and can also affect extraarticular sites, with the most common manifestation being uveitis. Here we report the incidence of uveitis flares in axial SpA patients from the RAPID-axSpA trial, including ankylosing spondylitis (AS) and nonradiographic (nr) axial SpA.
The RAPID-axSpA (NCT01087762) trial is double-blind and placebo-controlled to week 24, dose-blind to week 48, and open-label to week 204. Patients were randomized to certolizumab pegol (CZP) or placebo. Placebo patients entering the dose-blind phase were re-randomized to CZP. Uveitis events were recorded on extraarticular manifestation or adverse event forms. Events were analyzed in patients with/without history of uveitis, and rates reported per 100 patient-years.
At baseline, 38 of 218 CZP-randomized patients (17.4%) and 31 of 107 placebo-randomized patients (29.0%) had past uveitis history. During the 24-week double-blind phase, the rate of uveitis flares was lower in CZP (3.0 [95% confidence interval (95% CI) 0.6-8.8] per 100 patient-years) than in placebo (10.3 [95% CI 2.8-26.3] per 100 patient-years). All cases observed during the 24-week double-blind phase were in patients with a history of uveitis; in these patients, rates were similarly lower for CZP (17.1 [95% CI 3.5-50.1] per 100 patient-years) than placebo (38.5 [95% CI 10.5-98.5] per 100 patient-years). Rates of uveitis flares remained low up to week 96 (4.9 [95% CI 3.2-7.4] per 100 patient-years) and were similar between AS (4.4 [95% CI 2.3-7.7] per 100 patient-years) and nr-axial SpA (5.6 [95% CI 2.9-9.8] per 100 patient-years).
The rate of uveitis flares was lower for axial SpA patients treated with CZP than placebo during the randomized controlled phase. Incidence of uveitis flares remained low to week 96 and was comparable to rates reported for AS patients receiving other anti-tumor necrosis factor antibodies.
中轴型脊柱关节炎（axial SpA）的特征是脊柱和骶髂关节炎症，也可累及关节外部位，最常见的表现是葡萄膜炎。在此，我们报告了来自RAPID-axSpA试验的中轴型脊柱关节炎患者葡萄膜炎发作的发生率，该试验包括强直性脊柱炎（AS）和非放射学（nr）中轴型脊柱关节炎。
RAPID-axSpA（NCT01087762）试验在第24周为双盲和安慰剂对照，在第48周为剂量盲法，在第204周为开放标签。患者被随机分为赛妥珠单抗聚乙二醇（CZP）或安慰剂组。进入剂量盲法阶段的安慰剂组患者重新随机分为CZP组。葡萄膜炎事件记录在关节外表现或不良事件表格上。对有/无葡萄膜炎病史的患者的事件进行分析，并报告每100患者年的发生率。
基线时，218例随机接受CZP治疗的患者中有38例（17.4%）和107例随机接受安慰剂治疗的患者中有31例（29.0%）有既往葡萄膜炎病史。在24周的双盲阶段，CZP组葡萄膜炎发作的发生率（每100患者年3.0 [95%置信区间（95%CI）0.6 - 8.8]）低于安慰剂组（每100患者年10.3 [95%CI 2.8 - 26.3]）。在24周双盲阶段观察到的所有病例均为有葡萄膜炎病史的患者；在这些患者中，CZP组的发生率（每100患者年17.1 [95%CI 3.5 - 50.1]）同样低于安慰剂组（每100患者年38.5 [95%CI 10.5 - 98.5]）。直到第96周，葡萄膜炎发作的发生率仍然很低（每100患者年4.9 [95%CI 3.2 - 7.4]），AS组（每100患者年4.4 [95%CI 2.3 - 7.7]）和nr-中轴型脊柱关节炎组（每100患者年5.6 [95%CI 2.9 - 9.8]）相似。
在随机对照阶段，接受CZP治疗的中轴型脊柱关节炎患者葡萄膜炎发作的发生率低于安慰剂组。到第96周时，葡萄膜炎发作的发生率仍然很低，与接受其他抗肿瘤坏死因子抗体治疗的AS患者报告的发生率相当。
