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Dataset Information

Long-term safety and efficacy of sarilumab with or without background csDMARDs in rheumatoid arthritis.


ABSTRACT:

Objective

To evaluate the long-term safety and efficacy of sarilumab with/without conventional synthetic (cs)DMARDs in RA.

Methods

The analyses evaluated two open-label extensions (OLEs): EXTEND and MONARCH OLE, which included patients from six randomized trials. Patients received sarilumab 200 mg once every 2 weeks (q2w) for at least 264 weeks up to 516 weeks (EXTEND: Sarilumab Monotherapy and Sarilumab + csDMARD groups) or for 276 weeks (MONARCH OLE: Continuation and Switch groups). Primary endpoints included safety, immunogenicity and changes in laboratory parameters. Secondary endpoints included clinical signs and symptoms along with health-related quality-of-life (HRQOL) questionnaires.

Results

The Sarilumab Monotherapy (n = 111), Continuation (n = 165) and Switc

SUBMITTER: Burmester GR 

PROVIDER: S-EPMC10547516 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature