Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment.

ABSTRACT:

Objective

To report long-term safety and tolerability of olokizumab (OKZ) in combination with methotrexate (MTX) in subjects with active rheumatoid arthritis (RA), using pooled data from three randomised clinical trials (RCT) followed by open-label extension (OLE) study.

Methods

Cumulative data from three phase 3 core trials and their OLE were analysed. Safety variables assessed included treatment-emergent adverse events (AEs), serious AEs (SAEs), AEs of special interest and laboratory results. Efficacy assessments included ACR20/50/70 responses, Disease Activity Score 28 (C-reactive protein) <3.2, CDAI remission and low disease activity (LDA), SDAI remission and LDA, HAQ-DI decrease of 0.22 unit and Boolean 2.0 remission.

Results

A total of 2304 patients received OKZ

SUBMITTER: Feist E 

PROVIDER: S-EPMC11503126 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature