Why Real World Data | Xeljanz® (tofacitinib citrate)

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Adverse event reporting can be found at the bottom of the page

About

How XELJANZ works

XELJANZ in Action

Cytokines

Signalling Pathways

Dosing

Dosing in RA

Dosing in UC

Dosing in PsA

Dosing in pJIA and jPsA

Dosing in AS

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Oral Surveillance

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Clinical Efficacy RA

ORAL Strategy Study Design

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ORAL Strategy Safety Outcomes

Clinical Efficacy UC

OCTAVE Study Design

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Clinical Efficacy pJIA and jPsA

JIA-1 Study Design

JIA-1 Efficacy Results

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Real World Evidence

Why Real-World Data?

Key Characteristics of RCTs & RWE

Key Strengths & Limitations

STAR-RA

Malignancy Study Design

Malignancy Risk Outcomes

CV Risk Study Design

CV Risk Outcomes

SCQM-RA

Study Design

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CorEvitas RA

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Honap Study (UK)

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XELJANZ® (tofacitinib citrate) Prescribing Information and Maxtrex (methotrexate) Prescribing Information. Adverse event reporting can be found at the bottom of the page.

Tofacitinib should only be used if no suitable treatment alternatives are available in patients:

65 years of age and older;
patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);
patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

These risks are considered class effects and relevant across all approved indications of JAKi in inflammatory and dermatologic diseases.

Why Real-World Data?

XELJANZ has extensive RCT data and real-world exposure in RA^1–3
Real-world data can be used to complement the knowledge gained from RCTs, by investigating larger heterogeneous populations of patients that reﬂect actual medical practice^4,5
RWE demonstrates whether results observed in RCTs are also observed in routine clinical practice^4,5

†Data as of April 2019. ‡Data as of March 2017. §Estimate as of October 2020. ‖Data as of March 2021
‡XELJANZ is not indicated in MTX-naïve patients. §Eligible patients had previously completed a Phase I, II or III qualifying index study of XELJANZ and received open-label XELJANZ 5 mg or 10 mg BID.

Explore More

Learn more about the ORAL Surveillance trial.

ORAL Surveillance

*Data cut-off March 2017.†Included all doses of XELJANZ studied in the RA clinical trial programme of XELJANZ film-coated tablets. The
licensed dose of XELJANZ for the treatment of RA in the UK is 5 mg BID or 11 mg prolonged-release OD, which should not be exceeded.⁷‡Data cut-off April 2019.
LTE=long-term extension; PY=patient-years; RA=rheumatoid arthritis; RCT=randomised controlled trial; RWE=real-world evidence

References:
1. Cohen S, et al. RMD Open. 2020;6(3):e001395.
2. Cohen S, et al. Lancet Rheumatol. 2019;1:e23–e34.
3. Data on file. Pfizer UK [REF-XEL24268]. June 2022
4. Sherman RE, et al. N Engl J Med. 2016;375(23):2293–2297.
5. Berger ML, et al. Pharmacoepidemiol Drug Saf. 2017;26(9):1033−1039.
6. Blonde L, et al. Adv Ther. 2018;35(11):1763-1774.
7. XELJANZ (tofacitinib citrate) Summary of Product Characteristics.

XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from https://www.medicines.org.uk/emc/. Patients treated with XELJANZ should be given the Patient Alert Card.

PP-XEL-GBR-4470. May 2023

Real World Evidence

Why Real World Data?Key Characteristics of RCTs and Real-World AnalysesStrengths and limitations of RCTs and RWE Data Sources

Explore more Real World Evidence in RA

CorEvitas

ORAL Surveillance study in Rheumatoid Arthritis | Dr James Galloway

In this video, Dr James Galloway, respected rheumatologist and researcher talks about the ORAL Surveillance study and its implications for the use of tofacitinib in the treatment of RA. He offers an overview of the study design and a summary of the results, before offering his own clinical interpretation and how this affects his prescribing decisions.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search

for MHRA Yellow Card in Google Play or Apple App Store

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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