Multicenter double-blind randomized controlled trial to evaluate the effectiveness and safety of bortezomib as a treatment for refractory systemic lupus erythematosus.

Abstract:

OBJECTIVES:The objective of this study is to evaluate the efficacy and safety of bortezomib for treating systemic lupus erythematosus (SLE), in patients whose disease activity could not be controlled. METHODS:Fourteen SLE patients with persistent disease activity were selected, who required prednisolone doses of >10 mg/d despite concomitant immunosuppressive therapy. Patients were randomly administered either bortezomib or a placebo, eight times. The primary and secondary end-points were a change in anti-dsDNA antibody titer at week 24 and the SLE Responder Index (SRI), respectively. RESULTS:In the bortezomib group, four out of eight patients discontinued the trial; three others failed to complete the minimum protocol treatment due to adverse reactions. The changes in anti-dsDNA antibody titers at week 24 were 4.24% and -1.96%, for the bortezomib and placebo groups, respectively, disconfirming bortezomib's efficacy. In contrast, the corresponding SRI at week 12 was 75% and 40%. CONCLUSIONS:As bortezomib therapy for SLE is associated with many adverse reactions, treatment indications should be selected carefully, and protocols should aim to prevent these occurrences. Although the change in anti-dsDNA antibody titer did not support the efficacy of bortezomib as a treatment for SLE, high SRI in the treatment group suggests bortezomib may utilize mechanisms other than inhibition of anti-dsDNA antibody production.

journal_name

Mod Rheumatol

journal_title

Modern rheumatology

authors

Ishii T,Tanaka Y,Kawakami A,Saito K,Ichinose K,Fujii H,Shirota Y,Shirai T,Fujita Y,Watanabe R,Chiu SW,Yamaguchi T,Harigae H

doi

10.1080/14397595.2018.1432331

subject

Has Abstract

pub_date

2018-11-01 00:00:00

pages

986-992

issue

6

eissn

1439-7595

issn

1439-7609

journal_volume

28

pub_type

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