RA ℞: Tofacitinib

An Integrated Analysis of Tofacitinib Safety

Whether you’re impressed with its efficacy, or distressed with its side effects, its track record is…

No New Safety Signals for JAK Inhibitor in RA After Almost a Decade

Adverse events that did occur were stable over time

Pfizer Inc. (NYSE:PFE) announced today top-line results from ORAL Strategy, a Phase 3B/4 study of XELJANZ® (tofacitinib citrate) 5mg twice daily (

“XELJANZ 5mg plus MTX met its primary endpoint in demonstrating non-inferiority versus Humira plus MTX.
XELJANZ 5mg monotherapy did not meet its primary endpoint of non-inferiority versus Humira plus MTX or versus XELJANZ plus MTX”

Reading the second statement carefully, Xeljanz as monotherapy is INFERIOR to its combination with MTX, and INFERIOR to Humira combined with MTX.

While Xeljanz may be adequate as standalone for milder RA, especially in patients intolerant of, or prefer not to take a csDMARD like MTX, it works better in combination with MTX.

Tofacitinib combined with conventional disease-modifying antirheumatic drug therapy led to…

In the ORAL SYNC trial, patient reported outcomes (PROs) were in focus. Measures examined include function, fatigue, sleep and quality of life.

Tofacitinib at standard (5mg twice daily) and higher dose (10mg bd) were given to RA patients with inadequate response to a csDMARD, with continuation of the csDMARD.

All PROs improved with either dose by 3 months, except for emotional well-being, which required the higher dose for meaningful response.