Vedolizumab is a first-line treatment option for ulcerative colitis. There are differences in incidence of ulcerative colitis between males and females, but whether sex affects treatment outcomes is less clear. We examined sex-based differences in patients with ulcerative colitis initiated on vedolizumab from two major randomized controlled trials (RCTs). We conducted a post-hoc analysis on participants with ulcerative colitis from the VARSITY and GEMINI-1 RCTs who received vedolizumab. Outcomes of interest were rates of clinical improvement, clinical remission, and endoscopic improvement at weeks 6, 14, and 52 in male and female participants, as were differences in concentrations of trough vedolizumab and C-reactive protein; 1009 persons in GEMINI-1 and VARSITY trials were included. Male and female patients had similar disease characteristics aside from males being more likely to have Mayo 3 grade endoscopic severity at baseline (62.8 vs. 48.9%, P < 0.001). At week 6, females were more likely to have endoscopic improvement (47.4 vs. 35.2%, P = 0.001) and increased vedolizumab trough levels [34.0 (23.0-44.5) vs. 28.9 (19.0-34.6), P < 0.001]. The probability of achieving clinical remission (28.9 vs. 34.5%, P = 0.057) or endoscopic improvement (35.5 vs. 39.3%, P = 0.212) at week 52 was not different between males and females. Females with ulcerative colitis treated with vedolizumab appear more likely to achieve early endoscopic improvement than males, though longer-term outcomes demonstrated no difference. Further studies are required to better understand mechanisms through which sex or sex-associated factors could influence response to therapy in ulcerative colitis.

中文翻译：

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比较维多珠单抗在男性和女性之间的疗效：GEMINI-1 和 VARSITY 的事后分析。

维多珠单抗是溃疡性结肠炎的一线治疗选择。男性和女性之间溃疡性结肠炎的发病率存在差异，但性别是否影响治疗结果尚不清楚。我们通过两项主要随机对照试验 (RCT) 检查了开始使用维多珠单抗的溃疡性结肠炎患者的性别差异。我们对 VARSITY 和 GEMINI-1 RCT 中接受维多珠单抗治疗的溃疡性结肠炎参与者进行了事后分析。感兴趣的结果是男性和女性参与者在第 6、14 和 52 周时的临床改善率、临床缓解率和内镜改善率，以及维多珠单抗和 C 反应蛋白浓度的差异。 GEMINI-1 和 VARSITY 试验中纳入了 1009 人。男性和女性患者具有相似的疾病特征，除了男性更有可能在基线时出现 Mayo 3 级内镜严重程度（62.8% vs. 48.9%，P < 0.001）。第 6 周时，女性更有可能出现内镜检查改善（47.4% vs. 35.2%，P = 0.001），并且维多珠单抗谷水平升高 [34.0 (23.0-44.5) vs. 28.9 (19.0-34.6)，P < 0.001]。第 52 周时，男性和女性实现临床缓解（28.9 vs. 34.5%，P = 0.057）或内镜改善（35.5 vs. 39.3%，P = 0.212）的概率没有差异。接受维多珠单抗治疗的女性溃疡性结肠炎似乎比男性更有可能实现早期内窥镜改善，但长期结果显示没有差异。需要进一步的研究来更好地了解性别或性别相关因素可能影响溃疡性结肠炎治疗反应的机制。