Fracture in clinical studies of tofacitinib in rheumatoid arthritis.

ABSTRACT:

Background

Preclinical data suggest that tofacitinib would protect bone health in patients with rheumatoid arthritis (RA).

Objective

To assess fracture risk in tofacitinib RA clinical trials.

Design

Post hoc analysis.

Methods

We analyzed pooled data of phase I/II/III and long-term extension studies ('P123LTE cohort'), pooled data of placebo-controlled portions of phase III studies (phase III placebo-controlled cohort), and data from ORAL Surveillance [phase IIIb/IV randomized, open-label trial evaluating tofacitinib 5/10 mg twice daily (BID) vs tumor necrosis factor inhibitor (TNFi) in patients ⩾ 50 years with ⩾ 1 additional cardiovascular risk factor].

Results

In the phase III placebo-controlled cohort, incidence rates (IRs)

SUBMITTER: Hansen KE 

PROVIDER: S-EPMC9806361 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature