Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Oct 20:10:goac052.
doi: 10.1093/gastro/goac052. eCollection 2022.

The efficacy and safety of thalidomide in the treatment of refractory Crohn's disease in adults: a double-center, double-blind, randomized-controlled trial

Xiang Peng  1   2 , Zi-Wen Lin  3 , Min Zhang  1   2 , Jia-Yin Yao  1   2 , Jun-Zhang Zhao  1   2 , Pin-Jin Hu  1   2 , Qian Cao  3 , Min Zhi  1   2
Affiliations

The efficacy and safety of thalidomide in the treatment of refractory Crohn's disease in adults: a double-center, double-blind, randomized-controlled trial

Xiang Peng et al. Gastroenterol Rep (Oxf). .

Abstract

Background: Thalidomide is applied in therapy for refractory Crohn's disease (CD) in adults, but systematic and rigorous clinical evidence is scant. The aim was to provide theoretical references for the efficacy of thalidomide in the therapy for refractory CD in adults.

Methods: A double-center, double-blind, placebo-controlled, randomized clinical trial of refractory CD in adults in two inflammatory bowel disease centers in China. In the double-blind trial, patients were randomly assigned to 100 mg of thalidomide or placebo daily for 8 weeks. The primary outcome was considered as the clinical remission rate calculated based on the Crohn's disease activity index at the eighth week following thalidomide or placebo treatment. In open label, non-response to placebo was additionally treated with 8 weeks of thalidomide; all responders were continuously treated with thalidomide until the 48th week.

Results: Twenty-five patients were randomly assigned to each group. At the eighth week, the clinical remission rate in the thalidomide group was significantly higher than that in the placebo group (68.0% [17/25] vs 16.0% [4/25]; relative risk, 4.2; 95% confidence interval, 1.8-10.9, P < 0.001). After a 48-week follow-up, the continuous treatment rate of thalidomide was 46.3% (19/41). Adverse events during the whole process were reported in 58.5% of patients, mainly involving drowsiness, rash, and peripheral neuropathy that were mild and tolerable.

Conclusion: Thalidomide can be used in the induction and maintenance therapy of refractory CD in adults. And it could be one of the treatment options for refractory CD.

Keywords: Crohn’s disease; clinical remission; refractory; thalidomide.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
The follow-up diagram of the study
See this image and copyright information in PMC

References

    1. El-Matary W, Moroz SP, Bernstein CN.. Inflammatory bowel disease in children of Manitoba: 30 years' experience of a tertiary center. J Pediatr Gastroenterol Nutr 2014;59:763–6. - PubMed
    1. Rutgeerts P, Sandborn WJ, Feagan BG. et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005;353:2462–76. - PubMed
    1. Ye XQ, Cai J, Yu Q. et al. Nomogram to predict primary non-response to infliximab in patients with Crohn's disease: a multicenter study. Gastroenterol Rep (Oxf) 2021;9:329–38. - PMC - PubMed
    1. Gisbert JP, Panes J.. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol 2009;104:760–7. - PubMed
    1. Billioud V, Sandborn WJ, Peyrin-Biroulet L.. Loss of response and need for adalimumab dose intensification in Crohn's disease: a systematic review. Am J Gastroenterol 2011;106:674–84. - PubMed