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Safety Profile of Xeljanz® in RA

XELJANZ® (tofacitinib citrate): Consistent Safety Profile in Patients With RA1,2

  

  

XELJANZ® (tofacitinib citrate) is the first JAKi approved for RA.3,4*

  

*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).

  

Incidence Rates of Serious Infections in Patients With RA

The below figure displays the incidence rates for serious infections associated with XELJANZ® (tofacitinib citrate) therapy in patients with RA.2,6

  

Incidence Rates of Serious Infections in Patients With RA

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.

  

Incidence Rates for TB in Patients With RA

   

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 in Patients With RA

   

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.

   

Incidence Rates for PE in Patients With RA

    

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.

   

References:

Wollenhaupt J, Silverfield J, Lee EB, et al. Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study. Arthritis Res Ther. 2019;21:89.Cohen S, Tanaka Y, Mariette X, et al. Long-term safety of Xeljanz for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017;76:1253-1262.Xeljanz. Local product document. Pfizer; 2022. Version LPDTOFA012022.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/Pfizer statement on update to Xeljanz. Prescribing information in the United States. Accessed June 2, 2022. https://www.pfizer.com/news/press-release/press-release-detail/fda-issues-update-xeljanzr-prescribing-information-unitedCohen S, Radominski SC, Gomez-Reino JJ, et al. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of Xeljanz in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014;66:2924-2937.Winthrop KL, Yamanaka H, Valdez H, et al. Herpes zoster and Xeljanz therapy in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014;66(10):2675-2684.Charles-Schoeman C, Wicker P, Gonzalez-Gay MA, et al. Cardiovascular safety findings in patients with rheumatoid arthritis treated with Xeljanz, an oral Janus kinase inhibitor. Semin Arthritis Rheum. 2016;46:261-271.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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