Efficacy and safety of anti-CD20 antibody rituximab for patients with refractory systemic lupus erythematosus. (April 2018)

• Record Type: Journal Article
• Authors: Iwata, S; Saito, K; Hirata, S; Ohkubo, N; Nakayamada, S; Nakano, K; Hanami, K; Kubo, S; Miyagawa, I; Yoshikawa, M; Miyazaki, Y; Yoshinari, H; Tanaka, Y
• Is Part Of: Lupus. Volume 27:Number 5(2018)
• Page Start: 802
• Page End: 811
• Publication Date: 2018-04
• Subjects: Renal lupus -- systemic lupus erythematosus -- neuropsychiatric lupus; Systemic lupus erythematosus -- Periodicals; 616.772005
• DOI: 10.1177/0961203317749047
• Languages: English
• ISSNs: 0961-2033

Abstract

Objective: We examined the efficacy and safety of rituximab in patients with refractory systemic lupus erythematosus (SLE). Methods: The study enrolled 63 SLE patients who were treated with rituximab between 2002 and 2015. The participants underwent a battery of tests before treatment and at one year. Treatment ranged from two to four times at 500 or 1000 mg. Results: Baseline characteristics were males:females = 6:57, age 33.9 years, and disease duration 87.2 months. The primary endpoint: The rate of major clinical response (MCR) was 60% while the partial clinical response (PCR) was 25%. Thirty of 36 (83%) patients with lupus nephritis (WHO II: 2, III: 5, IV: 22, V: 4, IV+V: 2, not assessed: 1) and 22 of 24 patients (92%) with neuropsychiatric SLE, who could be followed at one year, showed changes from BILAG A or B score to C or D score at one year. Multivariate analysis identified high anti-dsDNA antibody and shorter disease duration as significant determinants of MCR at one year. Repeat examination was conducted at five years. Primary failure was recorded in 8.8% and secondary failure in 32.4% (time to relapse: 24.4 months). Rituximab was well tolerated although 65 adverse events, mostly infections, were recorded within one year. Conclusion: Rituximab is potentially efficacious for the treatment of patients with refractory SLE.