of moderate to both studies severe active A3921069 Italy AIFA rheumatoid and arthritis (RA) in A3921044 are trial patients who included in have responded Section 5.1 of inadequately to, or the SmPC. who are intolerant to one or more diseasemodifying antirheumatic drugs. Xeljanz can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5). US 22 April Approved: Xeljanz Clinical data 2013 21 Feb (tofacitinib) is for 2014 indicated for the radiographic treatment of adult response: patients with Results from moderately to both studies severely active A3921069 rheumatoid and arthritis who have A3921044 are had an inadequate included in response or Section 14 of intolerance to the approved methotrexate. It USPI. may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). Limitations of Use: Use of Xeljanz in combination with biologic DMARDs or with potent such as azathioprine and cyclosporine is not recommended. Canada Planned for 2017
Italy AIFA of moderate to severe active rheumatoid arthritis (RA) in patients who have responded inadequately to, or who are intolerant to one or more diseasemodifying antirheumatic drugs. Xeljanz can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5). both studies A3921069 and A3921044 are included in Section 5.1 of the SmPC. US 22 April 2013 Approved: 21 Feb 2014 Xeljanz (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). Limitations of Use: Use of Xeljanz in combination with biologic DMARDs or with potent such as azathioprine and cyclosporine is not recommended. Clinical data for radiographic response: Results from both studies A3921069 and A3921044 are included in Section 14 of the approved USPI. Canada Planned for 2017 trial
auspar-tofacitinib-as-citrate-180525.docx