CorEvitas Safety 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.

CorEvitas Comparative Safety Study

Real World Evidence for Rheumatoid Arthritis

Study Population

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ORAL Surveillance Study

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 page

StudyObjective

Prospective, observational, 5-year post-authorisation safety study of data from the US CorEvitas RA Registry in patients initiating XELJANZ (5 mg BID^¶ or 11 mg prolonged release OD) or a bDMARD to¹:

compare 5-year IRs for AEs of special interest (MACE, SIE, HZ)
describe VTE IRs.

This study was not sponsored by Pfizer.

StudyPopulation¹

Included two cohorts of patients aged ≥18 years with RA initiating XELJANZ or a bDMARD from 6 November 2012 to 31 July 2018, with follow-up to 31 January 2019, covering 42 states¹:

All patients could receive XELJANZ/bDMARDs with concomitant RA therapy (MTX and/or non-MTX csDMARDs)
Unmatched population (MACE/SIEs/HZ): 1,999 XELJANZ initiators, 8,358 bDMARD initiators
PS-trimmed population (MACE): 1,866 XELJANZ initiators; 7,767 bDMARD initiators

Baseline Characteristics¹

Scroll left to view table

StudyEndpoints

5 year AE incidence rates of the following: MACE, SIEs, HZ, VTE (including DVT and PE)

StudyLimitations¹

Experience of patients in this cohort could vary from other geopolitical settings, where drug access and patient demographics differ
PS methods are intended to adjust for non-random prescribing patterns, but possibility of bias and endpoint misclassification remains
Despite use of PS methods and controlling for measured differences, there may be unmeasured confounders; however, the most clinically significant variables were taken into account

Explore More

Regulatory guidance on JAK inhibitors with James Galloway

Visit this page to hear Dr James Galloway give an expert perspective on the recent updates to JAK inhibitor guidance

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CorEvitas Efficacy Study Design

Read next page of CorEvitas Efficacy Study Design

Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.
The recommended dose of XELJANZ for the treatment of RA in the US is 5 mg BID or 11 mg prolonged-release OD. XELJANZ 5mg BID & 11mg prolonged-release OD are the only approved doses for the treatment of RA and PsA in the UK.
¶This study was initiated to evaluate the safety of XELJANZ after US approval of the 5 mg BID dose on 6 November 2012; therefore, the majority of patients initiating XELJANZ in this analysis were expected to be receiving 5 mg BID.
MACE was defined as any myocardial infarction, stroke/transient ischemic attack or cardiovascular death.

AE=adverse event; bDMARD=biologic disease-modifying anti-rheumatic drug; BID=twice daily; CDAI=Clinical Disease Activity Index; CI=confidence interval; csDMARD=conventional synthetic disease‑modifying anti‑rheumatic drug; DMARD=disease-modifying anti-rheumatic drug; HZ=herpes zoster; IQR=interquartile range; IR=incidence rate; LDA=low disease activity; MACE=major adverse cardiovascular event; mACR20=modified American College of Rheumatology criteria ≥20% improvement; MTX=methotrexate; OD=once daily; OMA=other modes of action; PS=propensity score; RA=rheumatoid arthritis; SAE=serious adverse event; SIE=serious infection event; TNF=tumour necrosis factor; TNFi=tumour necrosis factor inhibitor; USA/US=United States of America; VTE=venous thromboembolism

References

1. Kremer JM, et al. ACR Open Rheumatol. 2021;3(3):173-184.

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-4489. May 2023

Real-World Evidence: CorEvitas

Safety Study Design Efficacy Study design Study Outcomes

Explore more Real-World Evidence in RA

Understanding the clinical significance of Janus Kinase (JAK) selectivity in rheumatoid arthritis (RA)

Prof. Ernest Choy discusses the rationale for XELJANZ (tofacitinib citrate) in RA, the significance of the JAK pathway, JAK selectivity in clinical practice, and efficacy data and the safety profile for JAK inhibitors.

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

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