Pfizer Inc. has announced the publication of 2-year results from the Oral Start study in the 19 June 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 programme.
In the US, Xeljanz 5 mg tablets are indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Xeljanz may be used alone or in combination with methotrexate or other non-biologic, disease-modifying antirheumatic drugs (DMARDs). Use of Xeljanz in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended. The recommended dose is a 5 mg pill taken twice daily.
"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 2 years," said lead investigator Roy M. Fleischmann, MD, professor, Metroplex Clinical Research Center, Dallas, Texas. "These results also add to the information on the efficacy and safety of Xeljanz as monotherapy."
"The publication of the Oral Start data in The New England Journal of Medicine marks the sixth Phase III study in the Xeljanz clinical programme to be published in a major medical journal," said Dr Steven Romano, global medicines development lead for the Pfizer Global Innovative Pharmaceutical business. "The publication of all of the completed Xeljanz Phase III rheumatoid arthritis clinical studies in such respected publications speaks to the significance and clinical relevance of the data for Xeljanz."