ORAL start study confirms Xeljanz as monotherapy in RA- Pfizer

Pfizer Inc.has announced the publication of two-year results from the ORAL Start study in the June 19 issue of The New England Journal of Medicine. ORAL Start is a 24-month Phase III study in patients with moderately to severely active Rheumatoid Arthritis who had not previously received methotrexate. The study showed that Xeljanz (tofacitinib citrate) 5 mg and 10 mg twice daily, as monotherapy (e.g., taken without methotrexate), inhibited the progression of structural damage and reduced the signs and symptoms of Rheumatoid Arthritis, and was statistically significantly superior to methotrexate on these measures at Month 6 (primary endpoint) and at all measured time points up to 24 months. Xeljanz is not indicated in patients who had not previously received methotrexate. The safety profile of Xeljanz in the ORAL Start study was consistent with that seen previously in the clinical development program.

�This study showed that Xeljanz taken by itself was statistically significantly superior to methotrexate in measures of clinical, radiographic and functional efficacy rheumatoid arthritis outcomes, and these results were sustained over two years,� said lead investigator Roy M. Fleischmann, MD, professor, Metroplex Clinical Research Center, Dallas, Texas.

See-"Tofacitinib versus Methotrexate in Rheumatoid Arthritis"- Eun Bong Lee, M.D., Roy Fleischmann, M.D., Stephen Hall, M.D., et.al., for the ORAL Start Investigators- N Engl J Med 2014; 370:2377-2386June 19, 2014DOI: 10.1056/NEJMoa1310476.