XELJANZ® (tofacitinib citrate): Consistent Safety Profile in Patients With RA1,2
*Tofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) 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).
The below figure displays the incidence rates for serious infections associated with XELJANZ® (tofacitinib citrate) therapy in patients with RA.2,6
Adapted from Cohen S, et al. 2014; 2017
RA: Bars indicate 95% confidence limits; incidence rate of patients per 100 PY. Phase 3 data as of 19 April 2012. LTE data as of January 2016.
An integrated safety summary of XELJANZ® (tofacitinib citrate), comprised of two Phase 1, nine Phase 2, six Phase 3 and 2 LTE studies in adult patients with active RA, demonstrated the incidence rate of TB as 0.1 and 0.08 with average XELJANZ® (tofacitinib citrate) 5 mg BID and constant XELJANZ® (tofacitinib citrate) 5 mg BID therapy, respectively.2
Adapted from Winthrop K, et al. 2016; Cohen S, et al. 2017.
Incidence Rates for Herpes Zoster in Patients With RA
The IR of herpes zoster was higher with XELJANZ® (tofacitinib citrate) therapy versus adalimumab in patients with RA.2,7
Adapted from Winthrop K, et al. 2016; Cohen S, et al. 2017.
Incidence rates for MACE were similar for XELJANZ® (tofacitinib citrate), placebo and adalimumab in patients with RA8
Adapted from Charles-Schoeman C, et al. 2016.
XELJANZ® (tofacitinib citrate) therapy was associated with no evidence of increased risk of pulmonary thromboembolic events in patients with RA9
Adapted from Mease P, et al. 2017.
ADA, adalimumab; bDMARD, biologic disease-modifying antirheumatic drug; BID, twice daily; CI, confidence interval; JAKi, Janus kinase inhibitor; LTE, long-term extension; MACE, major adverse cardiovascular event; MTX, methotrexate; OCTAVE, Operationally Critical Threat, Asset and Vulnerability Evaluation; OPAL, older persons’ assessment and liaison team; PBO, placebo; PE, pulmonary embolism; PsA, psoriatic arthritis; PY, patient-years; Q2W, every 2 weeks; RA, rheumatoid arthritis; SC, subcutaneously.
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