STAR-RA Malignancy Risk Study Design | Xeljanz® (tofacitinib citrate)

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

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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.

STAR-RA Malignancy Study Design

Real World Evidence for Rheumatoid Arthritis

Study Population

Baseline Characteristics

Study Endpoints

Study Limitations

ORAL Surveillance

Please see the Oral Surveillance page (linked below) for more information on: study design, baseline characteristics, coprimary endpoints, and adverse events of special interest, before reading the real-world evidence content.

ORAL Surveillance

Study Objective

The STAR-RA study examines the risk of Malignancy with XELJANZ (tofacitinib citrate) vs TNFi‡ in patients with RA treated in routine clinical care settings.

3 adverse event reporting databases were used: Medicare, Optum, MarketScan

Considering the increased risk of serious infections, myocardial infarction, and malignancies with Xeljanz in patients 65 years of age and older, Xeljanz should only be used in these patients if no suitable treatment alternatives are available.

This study was not sponsored by Pfizer.

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StudyPopulation

New users of XELJANZ or TNFi‡ with ≥365 days continuous enrolment up to the cohort entry date

RWE Overall cohort¹

≥18 years old (≥65 years in Medicare)

Sample:

Optum: N=25,410 (13.0% of which are on XELJANZ)
MarketScan: N=29,511 (15.3% of which are on XELJANZ)
Medicare: N=28,374 (9.5% of which are on XELJANZ)

RWE 'RCT Duplicate' Cohort^1,2

RWE ‘RCT-duplicate’ cohort mimicks eligibility criteria of the ORAL Surveillance study¹ (Phase IIIb/IV randomized, open-label, non-inferiority, post-authorization, safety endpoint-driven study^2§)

≥50 years old (≥65 years in Medicare)
≥1 MTX dispensation in 6 months prior to cohort entry date
≥1 CV risk factor including history of smoking, hypertension, dyslipidemia, diabetes mellitus, IHD, or family history of IHD

Sample:

Optum: N=5899 (11.3% of which are on XELJANZ)
MarketScan: N=6588 (14.2% of which are on XELJANZ)
Medicare: N=14,548 (7.6% of which are on XELJANZ

Baseline Characteristics

RWE OVERALL COHORT

Demographics and RA treatment use¹

CV disease risk factors¹

Other comorbidities¹

RWE 'RCT DUPLICATE' COHORT

Demographics and RA treatment use ¹

CV disease risk factors¹

Other comorbidities¹

StudyEndpoints

Primary Outcome¹

Risk of any new malignancies excluding NMSC (composite)

Secondary Outcomes¹

Lung cancer
Prostate cancer
Breast cancer
Colorectal cancer
Lymphatic/hematopoietic cancer
NMSC

Positive control outcome:
HZ (used due to the known risk with XELJANZ)

StudyLimitations^1-3

US claims data on the risk of malignancy outcomes with XELJANZ: Study limitations

The specific geographic population may not be representative of the worldwide population (eg, patient characteristics,healthcare access)¹
Residual confounding is possible due to some unmeasured RA-related variables¹
Doses of MTX were not accounted for in the analyses
Other JAK inhibitors, eg, baricitinib or upadacitinib, were not assessed in this analysis and the results of this study cannot necessarily be extrapolated beyond XELJANZ¹
Relatively short follow-up time (mean follow-up <1 year) due to imposed as-treated definition where patients were censored at treatment discontinuation or switch¹
Outcome misclassification was possible¹
Administrative claims may contain missing data and/or coding errors because their primary use is to obtain payment for services and medications administered^1,3
Data may not be representative of patients without insurance¹
No analyses specific to dose¹
Comparisons between the RWE study and ORAL Surveillance study results should be interpreted with caution due to differences in trial design, populations, and methodology (eg, STAR-RA only looked at a US patient population, had a shorter length of follow-up, and not all the ORAL Surveillance inclusion and exclusion criteria can be adequately represented in claims data)^1,2
Some covariates in the matching model are co-linear, eg, use of glucocorticoids is included for those with prior use in the last 365 days or recent use in the last 60 days, which may limit the accuracy of propensity score weighting¹
As patients in the databases are de-identified, it is not possible to confirm that all patients across the three databases are completely independent of each other¹
Differences in demographics and study periods between databases mean they are not fully comparable¹

Explore More

Learn more about ORAL Surveillance

ORAL Surveillance

Learn more about outcomes of the STAR-RA study

STAR-RA Malignancy Outcomes

§ Eligibility criteria for ORAL Surveillance included: patients ≥50 years of age; taking MTX without adequate control of symptoms; moderate to severe RA, including ≥6 tender or painful joints and ≥6 swollen joints (28-joint count) ≥1 CV risk factor.2 See cited publication for full eligibility criteria and study design.
‡TNFi: Infliximab, adalimumab, certolizumab, pegol, etanercept, and golimumab.

CV=cardiovascular; JAK=Janus kinase; MTX=methotrexate; ORAL=Oral Rheumatoid Arthritis Trial; RA=rheumatoid arthritis; RCT=randomized controlled trial; RWE=real-world evidence; STAR-RA=Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis; US=United States; HR=hazard ratio; PS=propensity score; bDMARD=biologic disease-modifying antirheumatic drug; HZ=herpes zoster; IHD=ischemic heart disease; MI=myocardial infarction; MTX=methotrexate

Additional Prescribing Information:
Enbrel (etanercept): https://www.pfizerpiindex.co.uk/enbrel
Inflectra (infliximab): https://www.pfizerpiindex.co.uk/inflectra

References

1. Khosrow-Khavar F, et al. Arthritis Rheum. 2022; doi:10.1002/art.42250.
2. Ytterberg SR, et al. N Engl J Med. 2022;386(4):316-326.
3. Harnett J, et al. J Manag Care Spec Pharm. 2016;22(12):1457-1471.

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-4466. May 2023

Real-World Evidence: STAR-RA

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