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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.

Drug Maintenance in RWE
  • How long do patients stay on XELJANZ?
  • Are there any differences in the rates of persistence with XELJANZ between different patient populations?
  • How does persistence compare with other treatments?

SCQM-RA1*:

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

Overall drug discontinuation

  • Of the 4023 treatment courses, 2103 treatment discontinuations were reporting during the median follow-up time of 3 years. The crude overall drug retention differed between the three treatment groups (p=0.012, log-rank test) and the media drug maintenance was 17 months for TNFi (IQR 15 - 18), 19 months for bDMARDs-OMA(IQR 17 - 22) and 25 months for XELJANZ (IQR 19 - 30)
  • Adjusted analyses demonstrated a higher risk of drug discontinuation with TNFis than with XELJANZ: HR 1.29 (95% CI 1.14–1.47) 
  • No significant difference in drug discontinuation was observed between bDMARDs-OMA† and XELJANZ: HR 1.09 (95% CI 0.96–1.24)
  • LDA‡ at Month 12 was achieved in 40% of those receiving TNFi, 46% receiving bDMARD-OMA† and 40% receiving XELJANZ
    • Likelihood of reaching LDA‡ at Month 12 was not significantly different between the three groups

Drug maintenance and likelihood of reaching LDA‡ with and without concomitant csDMARDs

  • Drug maintenance with XELJANZ§ or bDMARD-OMA was not significantly different with or without csDMARDs, whereas TNFi drug maintenance significantly improved with concomitant csDMARD therapy
  • The likelihood of reaching LDA‡ with XELJANZ§, bDMARD-OMA or TNFi with or without csDMARDs was similar
Scroll left to view table

Treatment

HRmonotherapy
(95% CI)

ORmonotherapy
(95% CI)

XELJANZ monotherapy§ versus combination therapy

1.11 (0.91–1.35)

1.04 (0.69–1.57)

OMA† monotherapy versus combination therapy†

1.03 (0.89–1.20)

1.12 (0.80–1.57)

TNFi monotherapy versus combination therapy

1.27 (1.08–1.49)

1.04 (0.76–1.40)

Adjusted survival curve of overall drug discontinuation for any reason¶1

Overall drug maintenance with or without concomitant csDMARDs¶1

Footnotes
*The licensed dose of XELJANZ for the treatment of RA in Switzerland includes 10 mg BID. XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK2.
OMA agents were abatacept, tocilizumab or sarilumab.
LDA defined as CDAI ≤10.
§NICE recommends XELJANZ as monotherapy to treat active RA only in adults who cannot take methotrexate because it is contraindicated or because of intolerance, when patients have responded inadequately to intensive therapy with a combination of csDMARDs, disease is severe (DAS28 >5.1) and with the discount agreed in the patient access scheme and in adults whose disease has responded inadequately to or who cannot have other DMARDs, including at least one bDMARD, only if disease is severe (DAS28 >5.1), they cannot have rituximab and with the discount agreed in the patient access scheme3.
The adjusted survival curves are based on 4023 treatment courses with 2103 events, representing the average patient in the SCQM population: female, seropositive, non-smoking patients with one prior bDMARD, mean age of 57 years, disease duration of 10.5 years, baseline DAS28 of 3.7, BMI of 26, who initiated treatment before the launch of a second JAKi.

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

bDMARD=biologic disease-modifying anti-rheumatic drug; BMI=body mass index; CDAI=Clinical Disease Activity Index; CI=confidence interval; DAS28= Disease Activity Score – 28 diarthrodial joint count; DMARD=disease-modifying antirheumatic drug; HR=hazard ratio; IQR=Inter-Quartile Range; JAKi=Janus kinase inhibitor; OMA=other modes of action; OR=odds ratio; RA=rheumatoid arthritis; TNFi=tumour necrosis factor inhibitor

References

1.Finckh A, et al. RMD Open. 2020;6(1):e001174.
2.XELJANZ (tofacitinib citrate) Summary of Product Characteristics.
3.Bird P, et al. Clin Rheumatol. 2020;39(9):2545−2551.

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-3488. July 2022
Real World Evidence Using Real-World Evidence (RWE) on JAK inhibitors for shared decision making

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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