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Safety Profile of Xeljanz® in PsA

  

XELJANZ® (tofacitinib citrate): Consistent Safety Profile in Patients With PsA1-5

XELJANZ® (tofacitinib citrate) is the first JAKi approved for PsA.6,9,*

   

*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.

  


Incidence of Serious Infections in Patients With PsA
 

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.

   


Incidence Rates for TB in Patients With PsA
​​​​​​​

   

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.


Incidence Rates for Herpes Zoster in Patients With PsA
 

   

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).


Incidence Rates for MACE in Patients With PsA
 

      

XELJANZ® (tofacitinib citrate) therapy was associated with no evidence of increased risk of pulmonary thromboembolic events in patients with PsA.11

   

The below figure displays the incidence rates for serious infections associated with XELJANZ® (tofacitinib citrate) therapy in patients with PsA.7
The below figure displays the incidence rates for serious infections associated with XELJANZ® (tofacitinib citrate) therapy in patients with PsA.7

Example

Example

Example

Example


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.

References:Mease P, FitzGerald HO, van der Heijde D, et al. Xeljanz or adalimumab versus placebo for psoriatic arthritis. N Engl J Med. 2017;377:1537-1550.Mease P, FitzGerald HO, van der Heijde D, et al. Xeljanz or adalimumab versus placebo for psoriatic arthritis. N Engl J Med. 2017;377:1537-1550 (Supplementary Appendix). Accessed June 2, 2022. https://www.nejm.org/doi/suppl/10.1056/NEJMoa1615975/suppl_file/nejmoa1615975_appendix.pdfGladman D, Rigby W, Azevedo VF, et al. Xeljanz for psoriatic arthritis in patients with an inadequate response to TNF inhibitors. N Engl J Med. 2017;377:1525-1536.Gladman D, Rigby W, Azevedo VF, et al. Xeljanz for psoriatic arthritis in patients with an inadequate response to TNF inhibitors. N Engl J Med. 2017;377:1525-1536 (Supplementary Appendix). 
Accessed June 2, 2022. https://www.nejm.org/doi/suppl/10.1056/NEJMoa1615977/suppl_file/nejmoa1615977_appendix.pdf
Nash P, Coates LC, Kivitz AJ, et al. Safety and efficacy of tofacitinib in patients with active psoriatic arthritis: interim analysis of OPAL Balance, an open-label, long-term. Rheumatol Ther. 2020;7:553-580.Xeljanz. Local product document. Pfizer; 2022. Version LPDTOFA012022.Pfizer statement on update to Xeljanz. Prescribing information in the United States. Pfizer. Accessed June 2, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-statement-update-xeljanzr-tofacitinib-prescribingCurtis J, Yun H, FitzGerald O, et al. Comparing Xeljanz safety profile in patients with psoriatic arthritis in clinical studies with real-world data. Paper presented at: 2017 ACR/ARHP Annual meeting; September 18, 2017.Multimedia: U.S. Food and Drug Administration approves Pfizer’s Xeljanz (tofacitinib citrate) for adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate. News release. Pfizer Inc. November 7, 2012. Accessed June 2, 2022. https://www.pfizer.com/news/press-release/press-release-detail/XELJANZ® (tofacitinib) for the Treatment of Psoriatic Arthritis (PsA). Arthritis Advisory Committee (AAC). Presented on August 3, 2017. FDA White Oak Campus. Silver Spring.Mease P, Kremer J, Cohen S, et al. Incidence of thromboembolic events in the Xeljanz rheumatoid arthritis, psoriasis, psoriatic arthritis and ulcerative colitis development programs. Paper presented at: 2017 ACR/ARHP Annual meeting; September 18, 2017.

   

Please click the Prescribing Information link to view the safety and adverse events information of Xeljanz®.
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XELJANZ® (tofacitinib citrate) is a small molecule that selectively targets the JAK pathway

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