XELJANZ® (tofacitinib citrate): Consistent Safety Profile in Patients With PsA1-5
*XELJANZ® (tofacitinib citrate) in combination with MTX is indicated for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD.
The below figure displays the incidence rates for serious infections associated with XELJANZ® (tofacitinib citrate) therapy in patients with PsA.8,10
Adapted from Arthritis Advisory committee 2017; Curtis J, et al. Presented at ACR 2017;poster 617; U.S Food and Drug Administration.
PsA: The ‘dose-comparison cohort’ included the same patients treated with tofacitinib at baseline as in the placebo-controlled cohort but the entire length of both studies, (OPAL Broaden, Months 0-12; OPAL Beyond, Months 0-6; patients randomised to tofacitinib 5 or 10 mg BID only), resulting in shared baseline demographics and characteristics for these cohorts; the ‘all-tofacitinib cohort’ comprised data from all patients receiving ≥1 dose of tofacitinib in Phase 3 or LTE studies (including placebo-controlled and dose-comparison cohorts and patients who advanced from placebo to tofacitinib after their first dose of tofacitinib)1,3,10; baseline demographics and characteristics were recorded separately for this cohort.
In 2 double-blind, randomised, Phase 3 clinical studies, OPAL Beyond and OPAL Broaden trials, conducted on patients with PsA, no case of TB was reported in either of the 3 treatment groups, that is, XELJANZ® (tofacitinib citrate), adalimumab and placebo (see the figure below).1,3
Adapted from Mease P, et al. 2017; Gladman D, et al. 2017.
The incidence rate of herpes zoster was higher with XELJANZ® (tofacitinib citrate) therapy versus adalimumab in patients with PsA.8,10
Adapted from Curtis J, et al. Presented at ACR 2017;poster 617; XELJANZ® (tofacitinib citrate) for the treatment of Psoriatic arthritis (PsA).
XELJANZ® (tofacitinib citrate) therapy was associated with no evidence of increased risk of pulmonary thromboembolic events in patients with PsA.11
Adapted from Mease P, et al. Presented at ACR 2017; poster 16
bDMARD, biologic disease-modifying antirheumatic drug; BID, twice daily; CI, confidence interval; JAK, Janus kinase; JAKi, Janus kinase inhibitor; LTE, long-term extension; MACE, major adverse cardiovascular event; MTX, methotrexate; NA, not applicable; OPAL, older persons’ assessment and liaison team; PE, pulmonary embolism; PsA, psoriatic arthritis; Pt, patient; PY, patient-years; Q2W, every 2 weeks; RA, rheumatoid arthritis; SC, subcutaneously; TB, tuberculosis.
XELJANZ® (tofacitinib citrate) is a small molecule that selectively targets the JAK pathway
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