マツオカ　カツヨシ   Matsuoka Katsuyoshi   松岡　克善    所属   東邦大学  医学部 医学科（佐倉病院）    職種   教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Certolizumab pegol for maintenance of medically induced remission in Crohn's disease.
掲載誌名	正式名：The Cochrane database of systematic reviews ISSNコード：1469493X/13616137
掲載区分	国外
巻・号・頁	6,pp.CD013747
著者・共著者	Okabayashi S, Yamazaki H, Yamamoto R, Anan K, Matsuoka K, Kobayashi T, Shinzaki S, Honzawa Y, Kataoka Y, Tsujimoto Y, Watanabe N
発行年月	2022/06
概要	BACKGROUND: Crohn's disease (CD) is a disease with an impaired immune response characterized by chronic, relapsing-remitting, and progressive inflammation mainly affecting the gastrointestinal tract. Certolizumab pegol (CZP) is a biological agent that regulates the impaired immune response by controlling tumour necrosis factor-α (TNFα). However, the efficacy and safety of long-term administration of CZP for people with CD with inflammation under control are not well understood. OBJECTIVES: To assess the efficacy and safety of CZP for maintenance of remission in people with CD. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, WHO ICTRP, and conference abstracts from inception to 23 March 2022. We contacted pharmaceutical companies involved with the production of CZP for further relevant information. SELECTION CRITERIA: We included randomized controlled trials (RCTs) comparing CZP with placebo in adults with CD. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies and extracted data. The main outcomes were failure to maintain clinical remission at week 26, failure to maintain clinical response at week 26, and serious adverse events. We planned to perform meta-analyses including all available studies if similar enough for pooling to be appropriate and calculated risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous outcomes and mean differences with 95% CIs for continuous outcomes. We analyzed the number needed to treat for an additional beneficial outcome (NNTB) and the number needed to treat for an additional harmful outcome (NNTH) to indicate the magnitude of treatment effects. The same two review authors independently evaluated the risk of bias by using the Cochrane RoB 2 tool and evaluated the certainty of evidence using the GRADE framework. MAIN RESULTS: We identified one study meeting our prespecified eligibility criteria. The included study enrolled 428 adults with CD who responded to induction