In the MTX group of ORAL Start (Study VI), 55 percent of patients experienced no radiographic progression at Month 6 compared to 73 percent of patients treated with XELJANZ 5 mg BID.
It is important to note that the U.S. label specifies that use of live vaccines should be avoided concurrently with XELJANZ. Update immunizations in agreement with current immunization guidelines prior to initiating XELJANZ therapy.
The ORAL Start study showed that XELJANZ 5 mg BID, as a single agent, was statistically significantly superior to MTX, providing a greater inhibition of progression of structural joint damage, as measured by mean change from baseline in mTSS at Month 6 (primary endpoint), and sustained at 12 months (refer to table above). The study was conducted in MTX-naïve patients with moderately to severely active RA who were randomized to receive XELJANZ 5 or 10 mg BID or to MTX dose-titrated over 8 weeks to 20 mg weekly. XELJANZ is not indicated for use in MTX-naïve patients. The safety experience of the patients in ORAL Start was consistent with the results of the five Phase 3 pivotal trials.
The risks and benefits of treatment should be considered prior to initiating XELJANZ in patients with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The ORAL Scan study demonstrated that XELJANZ 10 mg BID provided statistically significantly greater reduction of progression of structural joint damage as measured by mean change from baseline in mTSS compared to placebo at 6 months (primary endpoint – refer to table above). Results for the 5 mg BID dose exhibited similar effects on mean progression of structural damage but were not statistically significant (refer to table above). The ORAL Scan study was conducted in patients with moderately to severely active RA who had an inadequate response to MTX. Patients were randomized to receive XELJANZ 5 or 10 mg BID or placebo, and all treatments were added to background MTX. The controlled period for the study ended at 6 months. The 10 mg BID dose is not approved.