Background and Aims: Efficacy of adalimumab in Crohn’s disease (CD) has not been shown in China. The aim of this study was to evaluate the efficacy and safety of adalimumab in Chinese patients with CD. Methods: This 26-week, multicenter, phase III study evaluated patients with moderately to severely active CD and elevated high-sensitivity C-reactive protein (⩾3 mg/l) who were naïve to anti–tumor necrosis factor therapy. Patients were randomized to double-blind adalimumab 160/80 mg at weeks 0/2 and 40 mg at weeks 4/6 or placebo at weeks 0/2 followed by blinded adalimumab 160/80 mg at weeks 4/6. At week 8, all patients received open-label 40 mg adalimumab every other week through week 26. The primary endpoint was clinical remission [CD activity index (CDAI) <150] at week 4. Clinical remission at week 26 was assessed in week-8 responders (decrease in CDAI ⩾70 points at week 8 from baseline) and compared with a clinically meaningful threshold of 30%. Adverse events (AEs) were recorded throughout the study. Results: At baseline, 205 patients were enrolled, with mean [standard deviation (SD)] age of 32.9 (9.9) years and CD duration of 2.7 (3.0) years. At week 4, 38/102 patients (37%) receiving adalimumab and 7/103 (7%) receiving placebo ( p < 0.001) achieved clinical remission. Among week-8 responders, 93/144 (65%) achieved clinical remission at week 26 ( p < 0.001). No unexpected AEs and no malignancies, active tuberculosis, or deaths were reported. Conclusions: Adalimumab induced and maintained remission in Chinese patients with CD. Safety results were consistent with the known safety profile of adalimumab. identifier: NCT02499783
We consider high‐dimensional inference for potentially misspecified Cox proportional hazard models based on low‐dimensional results by Lin and Wei (1989). A desparsified Lasso estimator is proposed based on the log partial likelihood function and shown to converge to a pseudo‐true parameter vector. Interestingly, the sparsity of the true parameter can be inferred from that of the above limiting parameter. Moreover, each component of the above (nonsparse) estimator is shown to be asymptotically normal with a variance that can be consistently estimated even under model misspecifications. In some cases, this asymptotic distribution leads to valid statistical inference procedures, whose empirical performances are illustrated through numerical examples.
Objectives: This study aimed to describe a workplace intervention to sensitize employees to sleep problems, and to evaluate the medium-term impact of this intervention on participants' sleep status. Methods: Employees of different sites (China, France, Spain, United Kingdom) of a multinational company were offered a face-to-face session on sleep hygiene with a health professional using a tablet application providing feedback by email. Data on sleep status were collected through an interactive questionnaire at baseline (N=834 participants) and at six-month follow-up (n=291, 34.9% retention). Descriptive statistics, a three-way ANOVA and a logistic regression model were performed. Results: Sleep quality improved among followed-up participants. Statistically significant results concerned total sleep duration during weekend (P=0.046), sleep debt (P=0.019), sleep difficulties (P<0.001) and sleepiness (P=0.026). Conclusions: Interventions blending face-to-face and web-based approaches show promise for effective promotion of sleep awareness at the workplace.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.