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RA患者接受生物制剂治疗与肿瘤发生风险的荟萃分析

发布时间:2012-12-28 13:39:39

背景:关注类风湿关节炎(RA)患者接受生物制剂(BRMs)潜在的发生恶性肿瘤的风险。

研究目的:评价随机对照试验(RCTs)的RA患者使用BRMs后恶性肿瘤风险。

数据来源:通过电子数据库、会议文献资料和管理机构的网站搜索至2012年7月9日接受BRMs治疗的RCTs,BRMs包括:阿巴西普、阿达木单抗、阿那白滞素、赛妥珠单抗、依那西普、戈利木单抗、英夫利昔、利妥昔单抗和托珠单抗。

研究筛选:独立选择那些至少随访了24周,任何一种BRMs与安慰剂或传统的缓解病情的抗风湿药物相比较安全性的研究,包括RCTs。

数据提取:由独立的评审员选择研究并提取有关质量和结果的数据,计算每种BRM的综合估计和95%可信区间。

结果:总共分析了63项RCTs包含29423例患者,没有观察到恶性肿瘤发病风险在统计学上明显的增加。29423例患者中,211例患者试验期间发现一种恶性肿瘤(118例实体瘤,48例皮肤癌,14例淋巴瘤,5例血液系统非淋巴瘤和26例未明确的肿瘤),治疗第一年发生任意恶性肿瘤的风险在BRMs联合甲氨蝶呤组(0.77%; 95% CI, 0.65%-0.92%)、BRM单药治疗组(0.64%; 95% CI, 0.42%-0.95%)及对照组(0.66%; 95% CI, 0.52%-0.84%)都非常低。阿那白滞素联合甲氨蝶呤较单用甲氨蝶呤风险更低(Peto比值比为0.11;95% CI,0.03-0.45)。尽管接受肿瘤坏死因子抑制剂治疗者较对照组发生淋巴瘤的Peto比值比是2.1(95% CI,0.55-8.4),但特殊癌症位点的风险并未显示出明显统计学意义。

结论:在已有的RCTs中,与其他缓解病情的抗风湿药物或安慰剂相比,RA患者接受BRMs治疗至少6个月并未显著增加恶性肿瘤的发生风险。

【原文】

JAMA.2012 Sep 5;308(9):898-908.
Risk of malignancies in patients with rheumatoid arthritis treated with biologic therapy: a meta-analysis.
Lopez-Olivo MA, Tayar JH, Martinez-Lopez JA, Pollono EN, Cueto JP, Gonzales-Crespo MR, Fulton S, Suarez-Almazor ME.

Source:University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA.

Abstract

CONTEXT:
Concerns exist regarding the potential development of malignancies in patients with rheumatoid arthritis (RA) who are receiving biologic response modifiers (BRMs).

OBJECTIVE: To assess the risk of malignancy in patients with RA enrolled in randomized controlled trials (RCTs) of BRMs.

DATA SOURCES: Electronic databases, conference proceedings, and websites of regulatory agencies were searched for RCTs evaluating abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, and tocilizumab in RA from inception through July 9, 2012.

STUDY SELECTION: Independent selection of studies included RCTs that compared the safety of any BRMs used in RA patients with placebo and/or any traditional disease-modifying antirheumatic drugs with a minimum of 24 weeks of follow-up.

DATA EXTRACTION: Independent reviewers selected studies and extracted data on quality and outcomes. Pooled estimates and 95% confidence intervals were calculated for each BRM.

RESULTS: Sixty-three RCTs with 29,423 patients were analyzed. No statistically significant increased risk of developing malignancy was observed. Of the 29,423 patients, 211 developed a malignancy during the trial (118 solid tumors, 48 skin cancers, 14 lymphomas, 5 hematologic nonlymphomas, and 26 not specified). The incidence rate for any malignancy during the first year of therapy was very low in the BRM plus methotrexate group (0.77%; 95% CI, 0.65%-0.92%), the BRM monotherapy group (0.64%; 95% CI, 0.42%-0.95%), and the controls (0.66%; 95% CI, 0.52%-0.84%). Anakinra plus methotrexate showed lower odds compared with methotrexate alone (Peto odds ratio, 0.11; 95% CI, 0.03-0.45). No statistically significant risk was observed for specific cancer sites, although the Peto odds ratio for lymphoma was 2.1 (95% CI, 0.55-8.4) in patients receiving tumor necrosis factor inhibitors compared with controls.

CONCLUSION: The use of BRMs among patients with RA included in RCTs of at least 6 months| duration was not significantly associated with an increased risk of malignancy compared with other disease-modifying antirheumatic drugs or with placebo.

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