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AboutAboutHow XELJANZ worksXELJANZ in ActionCytokinesSignalling PathwaysDosingDosingDosing in RADosing in UCDosing in PsADosing in pJIA and jPsADosing in ASSpecial Warnings & PrecautionsEfficacy & 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 OutcomesClinical Efficacy ASASAS20/40 DataASDAS(CRP) DataReal World EvidenceReal World EvidenceReal World Evidence
Why Real-World Data?Key Characteristics of RCTs & RWEKey Strengths & Limitations
STAR-RAMalignancy Study DesignMalignancy Risk OutcomesCV Risk Study DesignCV Risk OutcomesSCQM-RAStudy DesignStudy OutcomesCorEvitas RASafety Study DesignEfficacy Study DesignOutcomesUC RWETOUR Registry (US)Honap Study (UK)
Supporting ResourcesSupporting ResourcesMaterialsVideosGRAPPA GuidelinesExpert Opinions

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.

SCQM-RA Study DesignReal World Evidence for Rheumatoid ArthritisStudy Population  Loading
Baseline Characteristics 
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Study EndpointsLoadingStudy LimitationsLoading
Study Objective  The SCQM-RA Registry aimed to compare the drug maintenance and real-world effectiveness of three alternative treatment options for RA: XELJANZ (tofacitiinib citrate), TNFi, and bDMARD-OMA. It was also studied whether the effectiveness of these treatments was modiifed by concomitant csDMARD therapy. 

Observational cohort study nested within the Swiss RA registry (SCQM-RA) to
1:
  • 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

The majority of patients in the SCQM study received tofacitinib 5 mg BID1. XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK2.
Study Population 

Included patients with RA initiating a new therapy with XELJANZ, TNFi or bDMARD/OMA between August 2013 and September 20191:


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/OMA1

For XELJANZ, 96% of patients received XELJANZ ≤5 mg BID; a small minority (3.4%) received XELJANZ >5 mg BID1
 Baseline Characteristics 
  • 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
Characteristic XELJANZ TNFi OMA P-value
Mean age, years 59 54 58 <0.001
Mean duration of RA, years 12 9 11 <0.001
Mean CDAI 21 19 21 0.10
Mean DAS28 3.7 3.60 3.7 0.057
Scroll left to view table
Study Endpoints  Primary Outcomes

Overall drug maintenance (period between treatment, initiation and discontinuation)

Secondary Outcomes
Low disease activity (LDA) response rates based on CDAI at 12 months 
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

Explore MoreSCQM Registry Outcomes

Read next page to learn more about the SCQM-RA registry outcomes.

Next page Loading
XELJANZ in actionIf you are new to XELJANZ, then this short video contains useful information on it's mode of action.

bDMARD=biologic disease-modifying anti-rheumatic drug; CDAI=Clinical Disease Activity Index; csDMARD=conventional synthetic disease‑modifying anti-rheumatic drug; MTX=methotrexate; OMA=other modes of action; TNFi=tumour necrosis factor inhibitor; tsDMARD=targeted synthetic disease-modifying anti-rheumatic drug.

References

1. Finckh A, et al. RMD Open. 2020;6(1):e001174.
2. XELJANZ (tofacitinib citrate) Summary of Product Characteristics
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-4819. Dec 2023
Real-World Evidence: SCQM-RAExplore more Real-World Evidence in RARA Insights - Using Real-World Evidence (RWE) on JAK inhibitors for shared decision making 

In this video, 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.

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

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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