About - JAKi Market Experience | Xeljanz®

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Summary of Prescribing Information

A Mark of Powerful Efficacy

A mark of experience¹

The first and only oral JAKi approved for the treatment of RA, UC and PsA^1-3

XELJANZ® has been prescribed to >260,000 patients across indications globally and has up to 9.5 years of long-term safety data in RA, up to 6.8 years in UC and up to 3 years in PsA^4-8

JAKis are recommended as a treatment option for RA in the EULAR recommendations 2019 update and in the 2015 ACR guidelines^9,10

They are recommended as a treatment option for PsA in the EULAR recommendations 2019 update¹¹

ACR, American College of Rheumatology; EULAR, European Alliance of Associations for Rheumatology; JAKi, Janus kinase inhibitor; PsA, psoriatic arthritis; RA, rheumatoid arthritis; UC, ulcerative colitis.

References:

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/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

FDA Advisory Committee votes in favor of Xeljanz (tofacitinib citrate) for the treatment of active psoriatic arthritis. News release. Pfizer Inc. August 3, 2017. Accessed June 2, 2022. https://www.pfizer.com/news/press-release/press-release-detail/fda_advisory_committee_votes_in_favor_of_xeljanz_tofacitinib_citrate_for_the_treatment_of_active_psoriatic _arthritis

Xeljanz (tofacitinib citrate) receives marketing authorization in the European Union for moderately to severely active ulcerative colitis. News release. Pfizer Inc. August 1, 2018. Accessed June 2, 2022. https://www.pfizer.com/news/press-release/pressreleasedetail/xeljanz_tofacitinib_citrate_receives_marketing_authorization_in_the_european_union_for_moderately_to_severely_active_ulcerative_colitis-0

Wollenhaupt J, Silverfield J, Lee EB, et al. Tofacitinib, an oral janus kinase inhibitor, in the treatment of rheumatoid arthritis: safety and efficacy in open-label, long-term extension studies over 9 years. Paper presented at: American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting; November 3-8, 2017; San Diego, CA. Abstract 522.

Wollenhaupt J, Lee EB, Curtis JR, 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(1):89.

Data on file. Pfizer Inc., New York, NY.

Nash P, Coates LC, Kivitz AJ, et al. Safety and efficacy of tofacitinib, an oral Janus kinase inhibitor, up to 36 months in patients with active psoriatic arthritis: data from the third interim analysis of OPAL Balance, an open-label, long-term extension study. Paper presented at: American College of Rheumatology Annual Scientific Meeting; October 19-24, 2018; Chicago, IL. Poster 2565.

Sandborn WJ, Panés J, Sands BE, et al. Incidence of venous thromboembolic events in patients with ulcerative colitis treated with tofacitinib in the ulcerative colitis clinical development programme: an update as of May 2019. Paper presented at: 15th Congress of the European Crohn’s and Colitis (ECCO); February 12-15, 2020; Vienna, Austria. Presentation P598.

Singh JA, Saag KG, Bridges SL Jr, et al; American College of Rheumatology. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2016;68(1):1-25.

Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79(6):685-699.

Gossec L, Baraliakos X, Kerschbaumer A, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020;79(6):700-712.

Please click the Prescribing Information link to view the safety and adverse events information of Xeljanz^®.
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PP-XEL-IND-0843 22/07/22

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These pages are not intended for patients or for members of the general public. The web pages contain promotional content. For the use only of Registered Medical Practitioners or a Hospital or a Laboratory. Full prescribing information available on request. For more details on, Who is a Registered Medical Practitioner, please visit "https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf", Page No. 39, Rule 2 part (ee), last accessed on 26th April2021.

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