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AboutAboutHow XELJANZ worksXELJANZ in ActionCytokinesSignalling PathwaysDosingDosingDosing in RADosingPractical ConsiderationsDosing in UCDosingPractical ConsiderationsDosing in PsADosingPractical ConsiderationsDosing in pJIA and jPsADosingPractical ConsiderationsEfficacy & SafetyEfficacy & SafetySafety & TolerabilityOral SurveillanceAdverse EventsClinical Efficacy RAORAL Strategy Study DesignORAL Strategy Efficacy ResultsORAL Strategy Safety OutcomesClinical Efficacy UCOCTAVE Study DesignOCTAVE Sub GroupsOCTAVE InductionOCTAVE SustainPost-hoc AnalysesClinical Efficacy PsAOPAL Broaden & BeyondClinical efficacy pJIA and jPsAJIA-1 study designJIA-1 Efficacy ResultsJIA-1 Safety OutcomesReal World EvidenceReal World EvidenceReal World ExperienceWhy Real-World Data?RWE available for XELJANZEffectiveness in RWESafety in RWEDrug Maintenance in RWESupporting ResourcesSupporting ResourcesGRAPPA GuidelinesMaterialsVideos

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

RWE available for XELJANZ

This resource considers three real-world datasets providing evidence for XELJANZ from selected registries/datasets to be consistent with the XELJANZ Summary of Product Characteristics and is not an exhaustive overview of all real-world data on XELJANZ globally.

Summary

This resource considers real-world datasets providing evidence for XELJZANZ from selected registries/datasets to be consistent with the XELJANZ Summary of Product Characteristics and is not an exhaustive overview of all real-world data on XELJANZ globally.

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Registry/database

Description Country (year XELJANZ approved for RA)
CorEvitas RA Registry1† • Largest RA real-world, prospective cohort study collecting data from more than 850 rheumatologists and 56,000 patients across the USA
• Data collected from physicians and patients with RA at the time of a clinical encounter and longitudinally thereafter
USA (2012)2
Swiss Clinical Quality Management in RA (SCQM-RA)3,4 • Prospective, longitudinal cohort of patients with RA in Switzerland (established in 1997)
• More than 300 (corresponding to 80%) of Swiss rheumatologists participate
• Patients come from diverse clinical settings: approximately 50% from private practice, 30% from non-academic centres and 20% from academic centres
• Patients are enrolled and followed up 1–4 times yearly by their rheumatologist
Switzerland (2013)5

Footnotes

†Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.6

CorEvitas RA Registry:‡† Comparative Safety Study
  • 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 to10:
    • compare 5-year IRs for AEs of special interest (MACE, SIE, HZ) 
    • describe VTE IRs.
  • 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 states10:
    • 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 characteristics10
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Characteristic (Unmatched population)

XELJANZ (n=1,999)
(Unmatched population)

DMARD initiators (n=8,358)
(PS trimmed population)

XELJANZ (n=1,866)
(PS trimmed population)

DMARD initiators (n=7,767)
Mean age, years 59.6 58.5 59.6 58.5
Female, n (%)
Content
1,610 (80.5) 6,716 (80.4) 1,505 (80.7) 6,223 (80.1) 
Mean duration of RA, years 13.8 10.6 14.0 10.6
Mean CDAI
Content
19.5 20.5 19.5 20.5
  • Outcomes were MACE, SIEs, HZ, VTE (including DVT and PE)10
    • SAEs and AEs of special interest were reported by participating physicians using targeted AE questionnaires, which were triggered by the initial reporting of an AE11
    • For MACE,** SIEs and HZ, the PS model included baseline variables with a standardised difference >[0.10] between XELJANZ and bDMARD initiators, and a priori-selected covariates (sex, age, number of prior DMARDs and history of AEs of interest) to derive PS-trimmed (primary) and PS-matched (sensitivity) populations
    •  For VTE: crude age- and gender-standardised IRs (95% CI) are presented descriptively for the unmatched population. At the time of the analyses, an insufficient number of VTE events had occurred in this study to permit an adequately powered comparative assessment of IRs between tofacitinib and bDMARD initiators; thus, PS modelling was not performed for assessment of VTE
  • Study limitations:
    • 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

Results of this study are discussed in the Safety in RWE section of this resource.

Footnotes

†Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.6
‡ The recommended dose of XELJANZ for the treatment of RA in the US is 5 mg BID or 11 mg prolonged-release OD.2 XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK.9
¶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.

SCQM-RA
  • Observational cohort study nested within the Swiss RA registry (SCQM-RA) to4:
    • Compare the drug maintenance and real-world effectiveness of three alternative treatment options for RA – XELJANZ, TNFi, bDMARD /other modes of action (abatacept or anti-IL-6 agents)
    • Examine whether the effectiveness of these treatments is modified by concomitant csDMARD therapy
  • Included patients with RA initiating a new therapy with XELJANZ, TNFi or bDMARD/OMA between August 2013 and September 20194:
    • 4,023 treatment courses were initiated during the study period in 2,600 patients: 806 treatment courses for XELJANZ, 1,862 for TNFi and 1,355 for bDMARD/OMA
    • For XELJANZ, 96% of patients received XELJANZ ≤5 mg BID; a small minority (3.4%) received XELJANZ >5 mg BID4‡
  • Outcomes4:
    • Primary outcome – drug maintenance (drug survival or drug retention rate, defined as the period between treatment initiation and discontinuation)
    • Secondary outcome – LDA response rates based on CDAI ≤10 at 1 year
  • Analysis of b/tsDMARDs started in a 6-year period (August 2013–September 2019)4
    • Only treatment courses that were followed up for at least 1 year were included in the analysis
  • Baseline characteristics4:
    • Differences in disease and treatment characteristics existed between groups
    • TNF is tended to be used more often as a first or second b/tsDMARD, resulting, on average, in younger patients with shorter disease duration
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Characteristic XELJANZ TNFi OMA P-value
Mean age, years 59 54 58 <0.001
Mean duration of RA, years 12 9 110.808 <0.001
Mean CDAI 21 19 21 0.1017.8 (10.0-28.5)
Mean DAS28 3.7 3.60 3.7 0.057
  • Study limitations:

    • Missing data and incomplete follow-up

    • Effectiveness analysis was limited by a reduced proportion of patients having an available CDAI around 1 year, and despite use of a mixed-effects model, response rates at 1 year should be interpreted with caution

    • Confounding by unmeasured factors, as with observational studies, may have affected study results

Results of this study are discussed in the Effectiveness in RWE section of this resource.

Footnotes

‡ The licensed dose of XELJANZ for the treatment of RA in Switzerland includes 10 mg BID. The majority of patients in the SCQM study received tofacitinib 5 mg BID.2 XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK.12

CorEvitas RA Registry:‡† Comparative Efficacy Study
  • Observational cohort study using data from the US CorEvitas RA Registry to compare the effectiveness of XELJANZ versus TNFi as monotherapy or in combination with MTX7
  • Included patients with RA initiating TNFi therapy (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) or XELJANZ with 6-month follow up7
    • 6,241 TNFi initiators (1,889 [30%] monotherapy initiators)7
    • 402 XELJANZ initiators (238 [59%] monotherapy initiators)7
  • Baseline characteristics8
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Characteristic XELJANZ

+MTX (n=106)
XELJANZ

Monotherapy
(n=106)
P-value TNFi

+MTX (n=1,590
TNFi

Monotherapy
(n=1,590)
P-value
Median (IQR) duration of RA, years 12 (6-19) 12 (7-21) 0.733 6 (2-13) 6 (2-14) 0.882
Mean age, years (IQR) 59 (53-67) 59.5 (52-67) 0.808 56 (47-63) 56 (47-64) 0.693
Female, n (%) 90 (84.9) 87 (82.1) 0.580 1259 (79.2) 1248 (78.5) 0.633
Median CDAI
score (IQR)
19.6 (9.0-31.0) 17.9 (10.3-30.5) 0.702 17.8 (10.0-28.5) 18.5 (9.5-29.0) 0.539
Biologic-naive, n (%) 0 0 - 600 (37.7) 600 (37.7) 1.000
  • Efficacy data collected at Month 67
    • CDAI (≤2.8 and >2.8-10)
    • mACR20 response§
    • Mean change in CDAI
    • Patient-reported pain (VAS)
  • Primary outcomes7:
    • Achievement of LDA (CDAI >2.8-10) or remission (CDAI ≤2.8) at Month 6
    • mACR20 response§ rate (no laboratory result) at Month 6
  • Study limitations:
    • Retrospective nature of study contributed to uncertainty with regard to treatment adherence
    • PS matching used to minimise bias from diverse population enrolled; however, additional unmeasured covariates may remain unbalanced
    • Non-randomised, retrospective comparison of effectiveness
    •  Short duration of follow-up (6 months)

Results of this study are discussed in the Effectiveness in RWE section of this resource.

Footnotes

†Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.6
‡ The recommended dose of XELJANZ for the treatment of RA in the US is 5 mg BID or 11 mg prolonged-release OD.2 XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK.9
§mACR20 response was defined as requiring at least 20% improvement in both tender and swollen joint counts and in two of the following endpoints: Patient’s Global Assessment of disease activity, Physician’s Global Assessment of disease activity, patient-reported pain (VAS), and Health Assessment Questionnaire Disability Index score.

Explore MoreDifferences in Randomised Controlled Trials and Real World Evidence | Professor Axel Finckh

Professor Axel Finckh covers important points such as the definitions of both Randomised Controlled Trials (RCTs) and Real World Evidence (RWE), the key differences in the patient populations, the data sources and how they are interpreted.

Prescribing Information

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Abbreviations

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. CorEvitas RA Registry Website. www.corevitas.com/registry/rheumatoid-arthritis. Accessed 22 February 2022.
2. XELJANZ (tofacitinib citrate). US Prescribing information.
3. Gabay C, et al. Rheumatology. 2015;54:1664–1672.
4. Finckh A, et al. RMD Open. 2020;6(1):e001174.
5. Approvals. Swiss Medic. www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/authorisations/new-medicines/xeljanz---filmtabletten--tofacitinibcitrat-.html. Accessed 22 February 2022.
6. CorEvitas Press Release, 9 March 2021. Corrona Announces Name Change to CorEvitas and Expanded Strategic Direction. www.corevitas.com/node/425. Accessed 22 February 2022
7. Reed GW, et al. Rheumatol Ther. 2019;6(4):573–586.
8. Reed GW, et al. Rheumatol Ther. 2019;6(4)(suppl):573–586.
9. XELJANZ (tofacitinib citrate) Summary of Product Characteristics.
10. Kremer JM, et al. ACR Open Rheumatol. 2021;3(3):173-184.
11. Kremer JM, et al. ACR Open Rheumatol. 2021;3(3)(suppl):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.
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In this episode, Dr Ai Lyn Tan and Dr Sarah Mackie highlight the recent real-world evidence on shared decision making, treatment persistence and second-line treatment strategies in the context of Rheumatoid Arthritis (RA) with Janus Kinase inhibitors.

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