Efficacy and safety of tabalumab, an anti-BAFF monoclonal antibody, in patients with moderate-to-severe rheumatoid arthritis and inadequate response to TNF inhibitors: results of a randomised, double-blind, placebo-controlled, phase 3 study.

ABSTRACT:

Background

Tabalumab is a human monoclonal antibody that neutralises B-cell activating factor.

Objectives

To evaluate tabalumab efficacy and safety in patients with rheumatoid arthritis (RA).

Methods

This phase 3, randomised, double-blind, placebo-controlled study evaluated 456 patients with active RA after 24-week treatment with subcutaneous tabalumab (120 mg every 4 weeks (120/Q4W) or 90 mg every 2 weeks (90/Q2W)) versus placebo, with loading doses (240 or 180 mg) at week 0. Patients were allowed background disease-modifying antirheumatic drugs and previously discontinued ≥1 tumour necrosis factor α inhibitors for lack of efficacy/intolerance. Primary end point was American College of Rheumatology 20% (ACR20) response at 24 weeks. This study was terminated early due

SUBMITTER: Schiff M 

PROVIDER: S-EPMC4623366 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature