title: Multicenter retrospective analysis of the effectiveness and safety of rituximab in korean patients with refractory systemic lupus erythematosus.
abstract: Objective. Although two recent randomized placebo-controlled trials of rituximab (RTX) failed to demonstrate efficacy in systemic lupus erythematosus (SLE), clinicians continue to use off-label RTX for cases refractory to current treatments. We evaluated the effectiveness and safety of rituximab for patients with refractory SLE in Korea. Methods. We retrospectively analyzed multicenter patients treated with RTX in Korea. Results. 39 SLE patients treated with RTX were included in the following manner: lupus nephritis 43.6%, hematologic 33.3%, arthritis 7.8%, myositis 7.8%, and others 7.7%. All patients had responded poorly to at least one conventional immunosuppressive agent (mean 2.5 ± 1.1, cyclophosphamide 43.6%, mycophenolate mofetil 48.7%, and other drugs) before RTX. Clinical improvements (complete or partial remission) occurred in patients with renal disease, hematologic disease, arthritis, myositis, and other manifestations at 6 months after RTX. The SLEDAI score was significantly decreased from 10.8 ± 7.1 at baseline to 6.7 ± 4.0 at 6 months, 6.2 ± 4.1 at 12 months, and 5.5 ± 3.6 at 24 months after RTX (P < 0.05). Among 28 clinical responders, 4 patients experienced a relapse of disease at 25 ± 4 months. Infections were noted in 3 patients (7.7%). Conclusion. RTX could be an effective and relatively safe therapeutic option in patients with severe refractory SLE until novel B-cell depletion therapy is available.
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, Hanyang University Guri Hospital, Gyeonggi-do, Guri-si 471-701, Republic of Korea.
authors.forename: So-Young
authors.initials: SY
authors.lastname: Bang
authors.forename: Chang Keun
authors.initials: CK
authors.lastname: Lee
authors.forename: Young Mo
authors.initials: YM
authors.lastname: Kang
authors.forename: Hyoun-Ah
authors.initials: HA
authors.lastname: Kim
authors.forename: Chang-Hee
authors.initials: CH
authors.lastname: Suh
authors.forename: Won Tae
authors.initials: WT
authors.lastname: Chung
authors.forename: Yong-Beom
authors.initials: YB
authors.lastname: Park
authors.forename: Jung-Yoon
authors.initials: JY
authors.lastname: Choe
authors.forename: Tae-Jong
authors.initials: TJ
authors.lastname: Kim
authors.forename: Yong-Wook
authors.initials: YW
authors.lastname: Park
authors.forename: Dae-Hyun
authors.initials: DH
authors.lastname: Yoo
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Bae
authors.forename: Hye-Soon
authors.initials: HS
authors.lastname: Lee