XELJANZ® (tofacitinib citrate)| Real-World Evidence

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Real-World Evidence

This resource considers 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. Please refer to the section 'Interpreting Real-World Evidence' at the bottom of this page for further information.

LDA/remission and mACR20

In the real-world setting,

Results comparing XELJANZ® and TNFi as third- and fourth-line therapies suggested similar effectiveness at 6 months¹

Analysis from the CorEvitas* Registry-a large, RA, real-world prospective cohort study in the US¹*

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 MTX. Included patients with RA initiating TNFi therapy (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) or XELJANZ with 6-month follow up:

6,241 TNFi initiators (1,889 [30%] monotherapy initiators)¹
402 XELJANZ initiators (238 [59%] monotherapy initiators)¹

XELJANZ ± MTX or TNFi + MTX was used as third- or fourth-line therapy at month 6

Previously known as the Corrona Registry.²

LDA was defined as CDAI > 2.8 to 10. Remission was defined as CDAI ≤ 2.8.¹

Limitations of this analysis from the US CorEvitas Registry¹

Non-randomised, retrospective comparison of effectiveness
Short duration of 6 months
No assessment of whether a response differed based on prior bDMARD response
Potential for unmeasured confounders despite propensity-score matching and controlling for measured differences
Specific geographical population may not be representative of the worldwide population (eg, patient characteristics, healthcare access)
Results from the CorEvltas Registry study do not necessarily apply to the entire RA patient population in the US

References:

Reed GW, Gerber RA. Shan Y, et al. Real-world comparative effectiveness of tofaclllnlb and tumor necrosis factor Inhibitors as monotherapy and combination therapy for treatment of rheumatoid arthritis. Rheumatol Ther. 2019;6(4):573-586.

Corrona announces name change to CorEvitas and expanded strategic direction [press release]. Waltham. Mass. and London: CorEvitas, LLC: Morch 9, 2021. Accessed September 16, 2021. https://www.corevitas.com/node/425

Real World Safety

Analysis from the CorEvitas* Registry—a large, RA, real-world prospective cohort study in the US^1,2

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

Incidence rates for selected AEs of interest in the PS-trimmed population receiving XELJANZ® or bDMARDs

US CorEvitas Registry data from a prospective, observational cohort recruited from 177 private/academic sites across 42 US states^1,
Incidence rates are number of first events/100 PY of outcomes in the PS-trimmed population; incidence rates were based on different definitions of the risk window for outcomes with acute onset (MACE, SIE, HZ) or latent onset (malignancies and death).
Patients initiated treatment as monotherapy or in combination with a csDMARD.¹

Previously known as the Corrona Registry.⁶

XELJANZ cohort primarily received 5 mg BID.¹

bDMARD cohort included patients initiating adalimumab, certolizumab pegol, golimumab, etanercept,
infliximab,abatacept, anakinra, rituximab, or tocilizumab.¹

MACE defined as myocardial infarction, stroke/transient ischemic attack, and cardiovascular death.¹

Includes nonserious and serious HZ events.¹

Hazard ratio for HZ was statistically significant. All other comparisons for selected AEs were not significant.¹

Active as of December 2018.¹

Baseline characteristics of patients from this analysis of the CorEvitas Registry¹

Data from CorEvitas Registry (N=1999, all XELJANZ doses)

Selected Comorbidities*

History of selected comorbidities occurring in ≥7% of patients.

Incidence Rates of Venous Thromboembolism (VTE) in the CorEvitas Registry^3,g

Drug exposure and unadjusted incidence rates (95% CI) for DVT, PE and VTE (DVT or PE) for RA patients with moderate to severe disease activity (CDAI >10) in the US Corrona RA registry subanalysis who were bDMARD or tofacitinib initiators; all patients, stratified by cardiovascular risk factors.

Final data as of December 2017.³

RA patients in the registry initiating tofacitinib for the first time.³

Included patients with moderate to severe RA (CDAI >10 at time of initiation) in the registry initiating a first or
subsequent bDMARD (each initiation was considered separately, such that there were multiple initiations per
patient) and who were XELJANZ-naïve.³

Baseline CV risk factors were defined as any patient aged ≥50 years and meeting ≥1 of the following criteria at
baseline: current smoker, diagnosis of hypertension, diagnosis of diabetes, history of coronary heart disease,
family history of premature coronary heart disease or current extra-articular RA disease.³

Baseline characteristics of patients from the VTE analysis of the CorEvitas Registry⁵

Data from CorEvitas Registry for VTE (N=1130, CDAI >10, all XELJANZ doses)

Selected comorbidities occurring in ≥7% of patients.

Limitations of these analyses from the US CorEvitas Registry¹

Non-randomised, prospective comparison of effectiveness

Potential for unmeasured confounders despite propensity-score matching and controlling for measured differences

Results from the CorEvitas Registry study do not necessarily apply to the entire RA patient population in the US or in other countries

References:

Kremer JM, Bingham CO III, Cappelli LC, et al. Post approval comparative safety study of tofacitinib and biological disease-modifying antirheumatic drugs: 5-year results from a United States–based rheumatoid arthritis registry. ACR Open Rheumatol. 2021;3(3):173-184.

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

Mease P, Charles-Schoeman C, Cohen S, et al. Incidence of venous and arterial thromboembolic events reported in the tofacitinib rheumatoid arthritis, psoriasis and psoriatic arthritis development programmes and from real-world data. Ann Rheum Dis. 2020;79(11):1400-1413.

XELJANZ Summary of Product Characteristics.

Mease P, Charles-Schoeman C, Cohen S, et al. Incidence of venous and arterial thromboembolic events reported in the tofacitinib rheumatoid arthritis, psoriasis and psoriatic arthritis development programmes and from real-world data. [online supplementary material] Ann Rheum Dis. 2020;79(11):1400-1413.

Corrona announces name change to CorEvitas and expanded strategic direction [press release]. Waltham, Mass. and London:CorEvitas, LLC; March 9, 2021. Accessed September 16, 2021. https://www.corevitas.com/node/425

Drug Maintenance

In the real-world setting,

XELJANZ® demonstrated significantly higher drug maintenance compared to TNFis^1,a-c

SCQM Registry—a prospective, longitudinal registry of Swiss RA patients¹

Observational cohort study nested within the Swiss RA registry (SCQM-RA) to:

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 2019:
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

SCQM Registry-a prospective, longitudinal registry of Swiss RA patients¹

Adjusted survival curve of overall drug discontinuation for any reason

In the real-world setting,

XELJANZ demonstrated similar drug maintenance with and without csDMARDs^1,d-e

Drug maintenance with and without csDMARDs ^1,

csDMARDs did not improve adjusted drug maintenance in patients with RA receiving XELJANZ or bDMARD-OMA, whereas TNFis required csDMARDs for improved drug maintenance¹. XELJANZ in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatlc drugs (DMARDs). XELJANZ can be given as monotherapy in case of Intolerance to MTX or when treatment with MTX is inappropriate.²

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Overall Drug Maintenance ^1,f	Hazard Ratio (95% Cl)
XELJANZ monotherapy vs XELJANZ combination therapy	1.11 (0.91, 1.35)
bDMARD-OMA monotherapy vs bDMARD-OMA combination therapy^a	1.03 (0.89, 1.20)
TNFi combination therapy vs TNFi monotherapy	1.27 (1.08, 1.49)

Results for XELJANZ were similar to bDMARD-OMAs.¹

The adjusted survival curves represent female, seropositive, nonsmoking patients with one prior bDMARD/tsDMARD, an average age of 57, an average disease duration of 10.5 years, an average baseline DAS28 of 3.7, and an average BMI of 26. The curves are calculated using the mean predicted estimates obtained by the 75 completed datasets after multiple imputation.¹

In this analysis, patients took XELJANZ ≤ 5 mg BID (n=761) or XELJANZ >5 to ≤ 10 mg BID (n=27). XELJANZ 5 mg BID is the only approved dosage for the treatment of RA.^1,2

bDMARD-OMA agents were abatacept and sarilumab or tocilizumab.¹

The adjusted survival curves represent female, seropositive, nonsmoking patients with one prior bDMARD/tsDMARD, an average age of 57, an average disease duration of 10.5 years, an average baseline DAS28 of 3.7, and an average BMI of 26, who had started the respective treatment as monotherapy (solid lines) or in combination with a csDMARD (dotted lines). The curves are calculated using the mean predicted estimates obtained by the 75 completed datasets after multiple imputation.¹

The crude overall drug maintenance differed between the 3 drug groups (P=0.012, log-rank test).¹

Limitations of this analysis from the SCQM Registry¹

Missing baseline covariates; however, multiple imputations were performed and confirmed that there was no bias to the results
As expected with observational studies, the data may be confounded by unmeasured factors
Reduced proportion of patients having CDAI assessment at 1 year, to assess effectiveness
Long-term efficacy and safety of XELJANZ not explored
Specific geographical population may not be representative of the worldwide population (eg, patient characteristics, healthcare access)

References:

Finckh A, Tellenbach C, Herzog L, et al. Comparative effectiveness of antitumour necrosis factor agents, biologics with an alternative mode of action and tofacitinib In an observational cohort of patients with rheumatoid arthritis in Switzerland. RMD Open. 2020;6(1):e001174. doi:10.1136/rmdopen-2020-00117 4

XELJANZ Summary of Product Characteristics

Interpreting Real World Evidence

What are the benefits/limitations of looking at XELJANZ real-world evidence?

Real-world data can be used to complement the knowledge gained from randomised clinical trials, by investigating larger heterogenous populations of patients that reflect actual medical practice. Some considerations when looking into real-world data are listed below.

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Randomised Controlled Trials (RCTs)^1-3vsReal-World Data Sources ^1-3
lnterventional design	Observational design
Always prospective	Often retrospective
Data from prespecified assessment of relatively homogenous patient population selected using well-defined eligibility criteria	Data from routine clinical practice and relevant point-of-care assessments of relatively heterogeneous patient population
Patient treatment based on randomised assignment to treatment or control/ comparator groups	Patient treatment based on prescriber decision (not randomised)
Bias is controlled by random treatment assignment	A variety of statistical approaches are used to minimize bias

Findings from real-world analyses should not be directly compared with those from RCTs^1-3

Patient population: Unlike RCTs, real-world analyses often assess a blended population of patients with different types of comorbidities, durations of disease, levels of disease activity, and treatment histories
Prescribed therapy: Real-world analyses may assess one specific treatment regimen or multiple regimens to capture relevant treatment patterns and outcomes In a population that is treated with a range of on-label options
Methods: Real-world analyses use designs, measures, and analysis approaches that may differ from those typically prespeclfied In RCTs

Limitations of real-world analyses^1,2

It Is difficult to Infer causality from observational data
- Non-randomised design and may lack a control group
Potential for reduced data quality (missing data, data entry/coding errors)
- May lack standardised approach across settings
- Visit schedules may not be required/data may not be collected at fixed intervals
Often subject to bias and confounding factors that require statistical adjustments (eg,propensity-score matching)
- Risk factors may change during follow-up

References:

Katkade VB, Sanders KN, Zou KH. Real world data: an opportunity to supplement existing evidence for the use of longestablished medicines In health care decision making. J Multidiscip Healthc. 2018;11 :295-304.

Blonde L, Khunti K, Harris SB, Meizinger C, Skolnik NS. Interpretation and impact of real world clinical data for the practicing cllnlclan. Adv Ther. 2018;35(11 ):1763-1774.

Garrison LP Jr, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for coverage and payment decisions: the ISPOR real-world data task force report. Value Health. 2007;10(5):326-335.

Explore more

In addition to real-world data, see complementary clinical trial data for XELJANZ

See data

Please see the XELJANZ Summary of Product Characteristics for more information

AE=adverse event; bDMARD=biologic disease-modifying antirheumatic drug; BID=twice daily; BMI=body mass index; CDAI=clinical disease activity index; CI= confidence interval; csDMARD=conventional synthetic disease-modifying antirheumatic drug; CV=cardiovascular; DAS28=Disease Activity Score for 28-joint counts; HR=hazard ratio; HZ=herpes zoster; JAK= Janus kinase; LDA=low disease activity; MACE=major adverse cardiovascular event; mACR20=modified American College of Rheumatology 20; MTX=methotrexate; NMSC=nonmelanoma skin cancer; OMA=other mode of action; PS=propensity score; PY=patient-year; QD=once daily; RA=rheumatoid arthritis; SIE=serious infection event; SCQM=Swiss Clinical Quality Management in rheumatic diseases; TNFi=tumor necrosis factor inhibitor; tsDMARD=targeted synthetic disease-modifying antirheumatic drug;

Clinical Efficacy RA

SAFETY

Learn more about the XELJANZ safety profile

See safety data

DOSING

Learn about dosing in RA

See recommended dosing

MECHANISM OF ACTION

Find out more about how XELJANZ works

See how XELJANZ works

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