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Abstract Number: 0496

Safety and Efficacy of Rituximab for Systemic Sclerosis: A Double-Blind, Parallel-Group Comparison, Investigators Initiated Confirmatory Randomized Clinical Trial (DESIRES Study)

Satoshi Ebata1, Ayumi Yoshizaki1, Koji Oba2, Kosuke Kashiwabara3, Keiko Ueda3, Yukari Umemura4, Takeyuki Watadani5, Takemichi Fukasawa1, Shunsuke Miura1, Asako Yoshizaki-Ogawa1, Yoshihide Asano1, Naoko Okiyama6, Masanari Kodera7, Minoru Hasegawa8 and Shinichi Sato1, 1Department of Dermatology, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan, 2Department of Biostatistics, School of Public Health, Graduate School of Medicine, and Interfaculty Initiative in Information Studies, The University of Tokyo, Tokyo, Japan, 3Clinical Research Support Center, The Tokyo University Hospital, Tokyo, Japan, 4Biostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan, 5Department of Diagnostic Radiology, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan., Tokyo, Japan, 6Department of Dermatology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan., Ibaraki, Japan, 7Department of Dermatology, Japan Community Health Care Organization Chukyo Hospital, Aichi, Japan., Aichi, Japan, 8Department of Dermatology, Division of Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan., Fukui, Japan

Meeting: ACR Convergence 2021

Keywords: B-Cell Targets, clinical trial, interstitial lung disease, Randomized Trial, Systemic sclerosis

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Session Information

Date: Saturday, November 6, 2021

Session Title: Abstracts: Systemic Sclerosis & Related Disorders – Clinical (0496–0501)

Session Type: Abstract Session

Session Time: 3:30PM-3:45PM

Background/Purpose: Systemic sclerosis (SSc) is a systemic autoimmune disease belonging to collagen diseases, characterized by fibrosis of various organs including the skin and lungs, and vascular damage. SSc is considered to have a high unmet medical need because of its poor prognosis in severe cases and the lack of satisfactory and effective treatments. Previous studies have shown that B cells play a major role in the development of SSc. In fact, several clinical studies have suggested that B cell depletion therapy with rituximab, anti-CD20 antibody, is effective. However, no randomized, placebo-controlled trial has been able to confirm the efficacy of rituximab in SSc, which implies that there has been no high-quality evidence to date.

Methods: In this study, a multicenter, double-blind, placebo-controlled, parallel-group comparison, investigator-initiated clinical trial was conducted to evaluate the safety and efficacy of rituximab for SSc. Patients were randomized 1:1 to rituximab (375 mg/m2) or placebo and received the study drug intravenously once a week for 4 weeks. The primary endpoint was the change in the modified Rodnan total skin thickness score, a semiquantitative measure of the degree of skin sclerosis, 24 weeks after the start of the intervention. The main secondary endpoint was the change in %forced vital capacity (%FVC) at 24 weeks. This trial had been registered with ClinicalTrials.gov (NCT04274257) and UMIN-CTR (UMIN000030139).

Results: A total of 56 patients participated in the study, 54 of whom received rituximab or placebo. Twenty-four weeks after the start of the intervention, the modified Rodnan total skin thickness score was significantly improved in the rituximab group compared to the placebo group (6.30 decrease in the rituximab group vs. 2.14 increase in the placebo group; difference 8.44 [95% confidence interval -11.00 to -5.88]; P < 0.0001). In addition, the %FVC of 48 patients with interstitial lung disease was significantly improved in the rituximab group than in the placebo group at 24 weeks (0.09% improvement in the rituximab group vs. 2.87% deterioration in the placebo group; difference 2.96% [95% confidence interval 0.08 to 5.84]; P = 0.04). The incidence of adverse events was comparable between the two groups, and there were no significantly increased adverse events in either group. There were no deaths during the trial.

Conclusion: This study was the first to validate the efficacy and safety of rituximab for skin sclerosis in SSc. Moreover, this clinical trial suggested the efficacy of rituximab for SSc-associated interstitial lung disease. Therefore, it is promising that rituximab becomes a new standard therapy for SSc.


Disclosures: S. Ebata, None; A. Yoshizaki, None; K. Oba, None; K. Kashiwabara, None; K. Ueda, None; Y. Umemura, None; T. Watadani, None; T. Fukasawa, None; S. Miura, None; A. Yoshizaki-Ogawa, None; Y. Asano, None; N. Okiyama, None; M. Kodera, None; M. Hasegawa, None; S. Sato, None.

To cite this abstract in AMA style:

Ebata S, Yoshizaki A, Oba K, Kashiwabara K, Ueda K, Umemura Y, Watadani T, Fukasawa T, Miura S, Yoshizaki-Ogawa A, Asano Y, Okiyama N, Kodera M, Hasegawa M, Sato S. Safety and Efficacy of Rituximab for Systemic Sclerosis: A Double-Blind, Parallel-Group Comparison, Investigators Initiated Confirmatory Randomized Clinical Trial (DESIRES Study) [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/safety-and-efficacy-of-rituximab-for-systemic-sclerosis-a-double-blind-parallel-group-comparison-investigators-initiated-confirmatory-randomized-clinical-trial-desires-study/. Accessed January 27, 2023.
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