The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naive early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression.
The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naive early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression.
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DOI：
10.1136/annrheumdis-2015-207511
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发表时间：
2016-01
影响因子：
27.4
通讯作者：
Koike T
中科院分区：
文献类型：
--
作者：
Atsumi T;Yamamoto K;Takeuchi T;Yamanaka H;Ishiguro N;Tanaka Y;Eguchi K;Watanabe A;Origasa H;Yasuda S;Yamanishi Y;Kita Y;Matsubara T;Iwamoto M;Shoji T;Okada T;van der Heijde D;Miyasaka N;Koike T
评价certolizumab pegol（CZP）和甲氨蝶呤（MTX）联合治疗作为MTX初治的早期类风湿关节炎（RA）的一线治疗与MTX单药相比的疗效和安全性。这项多中心、双盲、随机、安慰剂（PBO）对照研究入组了MTX初治的早期RA患者，这些患者的疾病持续时间≤12个月，抗环瓜氨酸肽水平高，类风湿因子阳性和/或存在骨侵蚀。患者按1：1随机分配至CZP+MTX或PBO+MTX治疗52周。 主要终点是第52周时放射学进展的抑制（改良的Sharp总评分（mTSS CFB）较基线的变化）。次要终点为第24周时的mTSS CFB以及第24周和第52周时的临床缓解率。316例随机分配至CZP+MTX组（n=159）或PBO+MTX组（n=157）的患者具有反映早期RA特征的相似基线特征（平均病程：4.0 vs 4.3个月;疾病活动性评分28-关节评估（DAS 28））（红细胞沉降率（ESR）：5.4 vs 5.5; mTSS：5.2 vs 6.0）。 CZP+MTX组在第52周（mTSS CFB=0.36 vs 1.58; p<0.001）和第24周（mTSS CFB=0.26 vs 0.86; p=0.003）显示出相对于PBO+MTX显著更大的放射学进展抑制。在第24周和第52周，CZP+MTX组的临床缓解率（简单疾病活动指数、布尔和DAS 28（ESR））显著高于PBO+MTX组。两组的安全性结果相似，在MTX中加入CZP后未观察到新的安全性信号。在具有不良预后因素的MTX初治早期RA患者中，CZP+MTX显著抑制结构损伤并减少RA体征和症状，证明CZP在这些患者中的疗效。（NCT01451203）。
To evaluate efficacy and safety of combination therapy using certolizumab pegol (CZP) and methotrexate (MTX) as first-line treatment for MTX-naive, early rheumatoid arthritis (RA) with poor prognostic factors, compared with MTX alone. MTX-naive, early RA patients with ≤12 months persistent disease, high anti-cyclic citrullinated peptide, and either rheumatoid factor positive and/or presence of bone erosions were enrolled in this multicentre, double-blind, randomised placebo (PBO)-controlled study. Patients were randomised 1:1 to CZP+MTX or PBO+MTX for 52 weeks. Primary endpoint was inhibition of radiographic progression (change from baseline in modified Total Sharp Score (mTSS CFB)) at week 52. Secondary endpoints were mTSS CFB at week 24, and clinical remission rates at weeks 24 and 52. 316 patients randomised to CZP+MTX (n=159) or PBO+MTX (n=157) had comparable baseline characteristics reflecting features of early RA (mean disease duration: 4.0 vs 4.3 months; Disease Activity Score 28-joint assessment (DAS28)) (erythrocyte sedimentation rate (ESR)): 5.4 vs 5.5; mTSS: 5.2 vs 6.0). CZP+MTX group showed significantly greater inhibition of radiographic progression relative to PBO+MTX at week 52 (mTSS CFB=0.36 vs 1.58; p<0.001) and week 24 (mTSS CFB=0.26 vs 0.86; p=0.003). Clinical remission rates (Simple Disease Activity Index, Boolean and DAS28 (ESR)) of the CZP+MTX group were significantly higher compared with those of the PBO+MTX group, at weeks 24 and 52. Safety results in both groups were similar, with no new safety signals observed with addition of CZP to MTX. In MTX-naive early RA patients with poor prognostic factors, CZP+MTX significantly inhibited structural damage and reduced RA signs and symptoms, demonstrating the efficacy of CZP in these patients. (NCT01451203).