Long term efficacy and safety analysis of thalidomide monotherapy in the maintenance treatment of intestinal Behcet's disease
10.3760/cma.j.cn101480-20221123-00187
- VernacularTitle:沙利度胺单药维持治疗肠白塞病的长期疗效及安全性分析
- Author:
Zhaopeng HUANG
1
;
Kang CHAO
;
Ruibin WU
;
Xiang GAO
;
Qingfan YANG
Author Information
1. 中山大学附属第六医院消化内科，广州 510655
- Publication Type:Journal Article
- Keywords:
Intestinal Behcet′s disease;
Thalidomide;
Long term efficacy;
Safety
- From:
Chinese Journal of Inflammatory Bowel Diseases
2023;07(4):313-318
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy, predictive factors, and safety of thalidomide monotherapy in the maintenance treatment of intestinal Behcet's disease.Methods:From January 2013 to March 2022, patients with intestinal Behcet's disease received thalidomide in the Sixth Affiliated Hospital of Sun Yat-sen University were retrospectively enrolled for analysis. The primary end points were the maintained steroid-free remission at 6 and 12 months. The secondary end points were the mucosal healing at 6 and 12 months, the long-term maintained steroid-free remission, predictive factors and adverse events.Results:A total of 28 patients with active intestinal Behcet's disease were enrolled. The maintained steroid-free remission at month 6, 12, 24 and 36 were 85.7%, 74.0%, 63.5% and 50.4% respectively. The median duration of maintained steroid-free remission was 49.5 (35.4, 63.6) months. Mucosal healing was 40.0% and 35.0% at month 6 and 12 respectively. Multivariate Cox regression analysis indicated that high disease activity index for intestinal Behcet's disease at baseline ( P = 0.014, HR = 1.057, 95% CI 1.011-1.104) was independently associated with lower likelihoods of maintaining steroid-free remission. During follow-up, 14 patients (50.0%) got adverse reactions and the incidence of limb numbness was 28.6%, with a median duration of 9.5 (5.5, 22.5) months. The drug dosage reduction rate was 14.3%, and the drug discontinuation rate was 17.9% due to side effects respectively. The median duration of drug discontinuation was 10.5 (23.5, 40.3) months. Conclusion:Thalidomide shows good effectiveness in maintaining long term steroid-free remission in intestinal Behcet′s disease, but the high incidence of limb numbness deserves attention.
