A double‐blind pilot study of oral baricitinib in adult patients with lupus erythematosus panniculitis

Author:

Chen Jingjing1ORCID,Luo Yijin2,Duan Yuanyuan1,Wang Liangchun2ORCID,Long Hai3,Liu Yi4,Yao Xu1,Lu Qianjin56ORCID

Affiliation:

1. Department of Allergy and Rheumatology, Hospital of Dermatology (Institute of Dermatology) Chinese Academy of Medical Sciences and Peking Union Medical College Nanjing Jiangsu China

2. Department of Dermatology, Sun Yat‐sen Memorial Hospital Sun Yat‐Sen University Guangzhou Guangdong China

3. Department of Dermatology, The Second Xiangya Hospital of Central South University, Institute of Dermatology and Venereology of Central South University Hunan Clinical Medicine Research Center for Major Skin Diseases and Skin Health Changsha Hunan China

4. Clinical Trials and Cosmetics Testing Center, Hospital for Skin Diseases (Institute of Dermatology) Chinese Academy of Medical Sciences and Peking Union Medical College Nanjing Jiangsu China

5. Hospital of Dermatology (Institute of Dermatology) Chinese Academy of Medical Sciences and Peking Union Medical College Nanjing Jiangsu China

6. Key Laboratory of Basic and Translational Research on Immune‐Mediated Skin Diseases Chinese Academy of Medical Sciences Nanjing Jiangsu China

Abstract

AbstractLupus erythematosus panniculitis (LEP) is a chronic inflammatory skin disease with a significant impact on the overall well‐being of patients. The safety and efficacy of oral baricitinib for the treatment of LEP have not been studied. This study aimed to explore the efficacy of oral baricitinib in patients with LEP who are recalcitrant or intolerant to conventional therapies. Patients (aged ≥18 years) with active LEP (with a revised cutaneous lupus erythematosus disease area and severity index [RCLASI]‐active score ≥4] were randomly assigned 2:1 to baricitinib (4 mg) or placebo (once daily for 20 weeks). The placebo group was switched to baricitinib (4 mg) at week 13, and the final evaluation was conducted at week 24. The primary endpoint was the proportion of patients with an RCLASI‐A score decreased by 20% at week 12. The secondary endpoints included the changes in the Cutaneous Lupus Erythematosus Disease Area and Severity Index active‐(CLASI‐A) score, the Dermatology Life Quality Index (DLQI), the Physician's Global Assessment (PGA) score, and safety. Five patients were enrolled. Three patients received baricitinib (4 mg), and two patients were treated with placebo. Two patients in the baricitinib treatment group showed a significant RCLASI‐A decrease at week 12 and week 24. Two patients in the placebo group had no change in RCLASI‐A at week 12 and a significant decrease at week 24. No new safety events were observed. Treatment with baricitinib was effective and well tolerated in patients with LEP.

Funder

National Natural Science Foundation of China

Publisher

Wiley

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