皮下golimumab维护严重溃疡性结肠炎患者的临床反应。

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Sandborn WJ, Feagan BG, Marano C, H,施特劳斯R,约翰斯J, Adedokun橙汁,Guzzo C, Colombel摩根富林明,钟情W,吉布森公关,柯林斯J, Jarnerot G, Rutgeerts P

皮下golimumab维护严重溃疡性结肠炎患者的临床反应。

胃肠病学。2014年1月,146 (1):96 - 109. - e1。doi: 10.1053 / j.gastro.2013.06.010。Epub 2013年6月14日。

PubMed ID

23770005 (在PubMed

]

文摘

背景与目的:皮下golimumab,一个完整的人单克隆抗体对肿瘤坏死因子-α(TNFalpha),被评价为维持疗法在TNFalpha antagonist-naive成人溃疡性结肠炎严重,尽管传统疗法,回应golimumab诱导治疗。方法:我们进行了三期,双盲试验的患者完成golimumab诱导试验(溃疡性结肠炎的研究利用试验性治疗,如追求)。患者反应诱导治疗golimumab (n = 464)被随机分配给组安慰剂或注射50或100毫克每四周golimumab通过52周。归纳研究,对安慰剂反应的患者继续接受安慰剂。Nonresponders感应研究获得100毫克golimumab。主要终点是临床反应通过54周维护;次要终点包括临床缓解期和粘膜愈合两周30和54。结果:临床反应是通过周保持在47.0%的病人接受50毫克golimumab 54, 49.7%的患者接受100毫克golimumab,台端面应接受安慰剂的患者和31.2% (P = P <措施分别)。在30周和54,更高比例的患者接受100毫克golimumab在临床缓解,粘膜愈合(27.8%和42.4%)患者给予安慰剂(15.6%和26.6%;分别为P = 04和P = .002)或50毫克golimumab(分别为23.2%和41.7%)。 Percentages of serious adverse events were 7.7%, 8.4%, and 14.3% among patients given placebo, 50 mg, or 100 mg golimumab, respectively; percentages of serious infections were 1.9%, 3.2%, and 3.2%, respectively. Among all patients given golimumab in the study, 3 died (from sepsis, tuberculosis, and cardiac failure, all in patients who received 100 mg golimumab) and 4 developed active tuberculosis. CONCLUSIONS: Golimumab (50 mg or 100 mg) maintained clinical response through week 54 in patients who responded to induction therapy with golimumab and had moderate-to-severe active ulcerative colitis; patients who received 100 mg golimumab had clinical remission and mucosal healing at weeks 30 and 54. Safety was consistent with that reported for other TNFalpha antagonists and golimumab in other approved indications. ClinicalTrials.gov number: NCT00488631.

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药物

Golimumab