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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.

Safety in RWEWhat is the association of SIEs with XELJANZ seen in real-world clinical practice? How do the incidence rates or risk of SIEs for XELJANZ compare with other advanced therapies in real-world clinical practice?
  • In an analysis of the CorEvitas Registry*, incidence rates of HZ‡ were significantly higher in patients taking XELJANZ compared with those taking bDMARDs1§¶:
    • PS-trimmed population incidence rates:
      • 3.12 vs 2.83 for XELJANZ and bDMARD groups, respectively
      • Adjusted HR for SIEs of 0.99 [95% CI 0.75–1.30], P=0.943).
    • 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
  • Incidence of SIEs in patients receiving XELJANZ or bDMARDs (PS-trimmed)1§¶

Example

Footnotes
*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 initiators primarily received XELJANZ 5 mg BID.1 XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK. Tofacitinib 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 antirheumatic drugs (DMARDs). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.3
†Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.
‡bDMARD initiators were the reference population for the calculation of HRs.
§The XELJANZ cohort included unique patients initiating tofacitinib as monotherapyǁ or in combination with a csDMARD. XELJANZ initiators could have previously used a csDMARD and/or a bDMARD but not XELJANZ (or other JAK inhibitors).
¶The bDMARD cohort included patients newly initiating a specific but not necessarily their first bDMARD. The bDMARD cohort included patients initiating a TNFi (adalimumab, certolizumab pegol, golimumab, etanercept or infliximab) or non-TNFi (abatacept, anakinra, rituximab or tocilizumab) as monotherapy or in combination with a csDMARD. bDMARD initiators could have previously used a csDMARD or different bDMARD but not XELJANZ (or other JAK inhibitors) or the bDMARD they were initiating.
ǁNICE 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 scheme.4

What is the association of HZ with XELJANZ seen in real-world clinical practice? How do the incidence rates or risks of HZ for XELJANZ compare with other advanced therapies in real-world clinical practice? 
  • In an analysis of the CorEvitas Registry*, incidence rates of HZ were significantly higher in patients taking XELJANZ compared with those taking bDMARDs1§¶:
    • PS-trimmed population incidence rates: 
      • 1.44 vs 0.65 for XELJANZ and bDMARD groups, respectively
      • Adjusted HRǁ for HZ‡ events of 2.32 [95% CI 1.43 –3.75], P=0.001).
    • 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
Incidence of HZ in patients receiving XELJANZ or bDMARDs (PS-trimmed)1§¶

Footnotes
*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 initiators primarily received XELJANZ 5 mg BID.1 XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK. Tofacitinib 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 antirheumatic drugs (DMARDs). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.3
†Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.
‡bDMARD initiators were the reference population for the calculation of HRs.
§The XELJANZ cohort included unique patients initiating tofacitinib as monotherapyǁ or in combination with a csDMARD. XELJANZ initiators could have previously used a csDMARD and/or a bDMARD but not XELJANZ (or other JAK inhibitors).
¶The bDMARD cohort included patients newly initiating a specific but not necessarily their first bDMARD. The bDMARD cohort included patients initiating a TNFi (adalimumab, certolizumab pegol, golimumab, etanercept or infliximab) or non-TNFi (abatacept, anakinra, rituximab or tocilizumab) as monotherapy or in combination with a csDMARD. bDMARD initiators could have previously used a csDMARD or different bDMARD but not XELJANZ (or other JAK inhibitors) or the bDMARD they were initiating.
ǁbDMARD initiators were the reference population for the calculation of HRs. 
ǂNICE 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 scheme.4

What is the association of VTE with XELJANZ seen in real-world clinical practice? How do the incidence rates or risks of VTE for XELJANZ compare with other advanced therapies in real-world clinical practice? 
  • In an analysis of the CorEvitas Registry,*† incidence rates of VTE overall, DVT and PE were numerically similar in patients treated with XELJANZ or bDMARDs1§¶
    • 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

Incidence of venous thromboembolic events in patients receiving XELJANZ or DMARDs1§¶

Footnotes
*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 initiators primarily received XELJANZ 5 mg BID.1 XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK. Tofacitinib 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 antirheumatic drugs (DMARDs). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.3
†Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.
‡VTE includes deep vein thrombosis and pulmonary embolism. Venous thromboembolism data did not have ≥80% power to detect a HR of 2.25 or less between cohorts.
§The XELJANZ cohort included unique patients initiating tofacitinib as monotherapyǁ or in combination with a csDMARD. XELJANZ initiators could have previously used a csDMARD and/or a bDMARD but not XELJANZ (or other JAK inhibitors).
¶The bDMARD cohort included patients newly initiating a specific but not necessarily their first bDMARD. The bDMARD cohort included patients initiating a TNFi (adalimumab, certolizumab pegol, golimumab, etanercept or infliximab) or non-TNFi (abatacept, anakinra, rituximab or tocilizumab) as monotherapy or in combination with a csDMARD. bDMARD initiators could have previously used a csDMARD or different bDMARD but not XELJANZ (or other JAK inhibitors) or the bDMARD they were initiating.
ǁNICE 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 scheme.4

What is the association of MACE with XELJANZ seen in real-world clinical practice? How do the incidence rates or risks of MACE for XELJANZ compare with other advanced therapies in real-world clinical practice? 
  • In an analysis of the CorEvitas Registry*, MACE incidence rates were numerically higher in patients taking XELJANZ compared with those taking bDMARDs1§¶:
    • PS-trimmed population incidence rates: 
      • 0.64 vs 0.91 for XELJANZ and bDMARD groups, respectively
      • adjusted HRǁ for MACE of 0.61 (95% CI 0.34–1.06) that was not significant (P=0.081)
    • 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

Incidence of MACE in patients receiving XELJANZ or bDMARDs (PS-trimmed)1§¶

​​​​​​​Footnotes
​​​​​​​
*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 initiators primarily received XELJANZ 5 mg BID.1XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK. Tofacitinib 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 antirheumatic drugs (DMARDs). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.3
†Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.
‡MACE was defined as myocardial infarction, stroke/transient ischaemic attack and cardiovascular death.
§The XELJANZ cohort included unique patients initiating tofacitinib as monotherapyǂ or in combination with a csDMARD. XELJANZ initiators could have previously used a csDMARD and/or a bDMARD but not XELJANZ (or other JAK inhibitors).
¶The bDMARD cohort included patients newly initiating a specific but not necessarily their first bDMARD. The bDMARD cohort included patients initiating a TNFi (adalimumab, certolizumab pegol, golimumab, etanercept or infliximab) or non-TNFi (abatacept, anakinra, rituximab or tocilizumab) as monotherapy or in combination with a csDMARD. bDMARD initiators could have previously used a csDMARD or different bDMARD but not XELJANZ (or other JAK inhibitors) or the bDMARD they were initiating.
ǁbDMARD initiators were the reference population for the calculation of HRs.
ǂNICE 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 scheme.4

What is the association of malignancies with XELJANZ seen in real-world clinical practice? How do the incidence rates or risks of malignancies for XELJANZ compare with other advanced therapies in real-world clinical practice? 
  • In an analysis of the CorEvitas Registry*, incidence rates for malignancies (excluding NMSC) were comparable in patients taking XELJANZ and those taking bDMARDs1‡§: 
    • PS-trimmed population incidence rates: 
      • 0.88 vs 0.81 for XELJANZ and bDMARD groups, respectively
      • adjusted HR for malignancies (excluding NMSC) was 1.04 (95% CI 0.68–1.61) (P=0.847)
    • 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

Incidence of malignancies (excluding NMSC) in patients receiving XELJANZ or bDMARDs (PS-trimmed)1‡§

Footnotes
*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 initiators primarily received XELJANZ 5 mg BID.1 XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK. Tofacitinib 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 antirheumatic drugs (DMARDs). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.3
†Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.
‡The XELJANZ cohort included unique patients initiating tofacitinib as monotherapyǁ or in combination with a csDMARD. XELJANZ initiators could have previously used a csDMARD and/or a bDMARD but not XELJANZ (or other JAK inhibitors). The bDMARD cohort included patients newly initiating a specific but not necessarily their first bDMARD.
§The bDMARD cohort included patients initiating a TNFi (adalimumab, certolizumab pegol, golimumab, etanercept or infliximab) or non-TNFi (abatacept, anakinra, rituximab or tocilizumab) as monotherapy or in combination with a csDMARD. bDMARD initiators could have previously used a csDMARD or different bDMARD but not XELJANZ (or other JAK inhibitors) or the bDMARD they were initiating.
¶bDMARD initiators were the reference population for the calculation of HRs.
ǁNICE 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 scheme.4

What is the association of NMSC with XELJANZ seen in real-world clinical practice? How do the incidence rates or risks of NMSC for XELJANZ compare with other advanced therapies in real-world clinical practice?  
  • In an analysis of the CorEvitas Registry*, incidence rates for NMSC were comparable in patients taking XELJANZ and those taking bDMARDs1‡§ :
    • PS-trimmed population incidence rates:
      • 1.08 vs 1.10 for XELJANZ and bDMARD groups, respectively
      • adjusted HR for NMSC was 1.02 (95% CI 0.69–1.50 (P=0.917).
    • 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

Incidence of malignancies (excluding NMSC) in patients receiving XELJANZ or bDMARDs (PS-trimmed)1‡

Footnotes
*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 initiators primarily received XELJANZ 5 mg BID.1 XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK. Tofacitinib 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 antirheumatic drugs (DMARDs). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.3
†Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.
‡The XELJANZ cohort included unique patients initiating tofacitinib as monotherapyǁ or in combination with a csDMARD. XELJANZ initiators could have previously used a csDMARD and/or a bDMARD but not XELJANZ (or other JAK inhibitors). The bDMARD cohort included patients newly initiating a specific but not necessarily their first bDMARD.
§The bDMARD cohort included patients initiating a TNFi (adalimumab, certolizumab pegol, golimumab, etanercept or infliximab) or non-TNFi (abatacept, anakinra, rituximab or tocilizumab) as monotherapy or in combination with a csDMARD. bDMARD initiators could have previously used a csDMARD or different bDMARD but not XELJANZ (or other JAK inhibitors) or the bDMARD they were initiating.
¶bDMARD initiators were the reference population for the calculation of HRs.
ǁNICE 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 scheme.4

What does real-world evidence show with regard to the safety profile of XELJANZ vs other advanced therapies? 
  • In analysis of the CorEvitas Registry*, incidence rates and HRs for patients taking XELJANZ or bDMARDs were1§¶:
    • similar for SIEs in both treatment groups
    • significantly higher for HZǁ in patients taking XELJANZ than those taking bDMARDs
    •  numerically higher for MACEǂ in patients taking XELJANZ compared with those taking bDMARDs
    • comparable for malignancies (excluding NMSC) in both treatment groups
    • comparable for NMSC in both groups
    • numerically similar for VTE overall#, DVT and PE in both groups.
    • 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
​​​​​​​Incidence of selected AEs of interest patients receiving XELJANZ or bDMARDs (PS-trimmed)1‡§

Incidence of venous thromboembolic events in patients receiving XELJANZ or bDMARDs (PS-trimmed)1‡§

Footnotes
*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 initiators primarily received XELJANZ 5 mg BID.1 XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK. Tofacitinib 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 antirheumatic drugs (DMARDs). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.3
†Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.
‡bDMARD initiators were the reference population for the calculation of HRs.
§The XELJANZ cohort included unique patients initiating tofacitinib as monotherapyǀ or in combination with a csDMARD. XELJANZ initiators could have previously used a csDMARD and/or a bDMARD but not XELJANZ (or other JAK inhibitors).
¶The bDMARD cohort included patients newly initiating a specific but not necessarily their first bDMARD. The bDMARD cohort included patients initiating a TNFi (adalimumab, certolizumab pegol, golimumab, etanercept or infliximab) or non-TNFi (abatacept, anakinra, rituximab or tocilizumab) as monotherapy or in combination with a csDMARD. bDMARD initiators could have previously used a csDMARD or different bDMARD but not XELJANZ (or other JAK inhibitors) or the bDMARD they were initiating.
ǁIncludes non-serious and serious HZ events.
ǂMACE was defined as myocardial infarction, stroke/transient ischemic attack, and cardiovascular death.
#VTE includes deep vein thrombosis and pulmonary embolism. Venous thromboembolism data did not have ≥80% power to detect a HR of 2.25 or less between cohorts.
ǀNICE 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 scheme.4

What does evidence from the ORAL Surveillance study show about CV and cancer risk with XELJANZ in RA? 
  • ORAL Surveillance is a randomised, open-label, non-inferiority, post-authorisation, safety endpoint trial in patients aged ≥50 years with active RA despite MTX and at least one additional CV risk factor*5:
    • Patients were randomly assigned (1:1:1) to receive 5 mg XELJANZ twice daily (n=1,455), 10 mg XELJANZ twice daily (n=1,456) or subcutaneous TNFi (n=1,451)
    • Background MTX was continued unless modification was clinically indicated
    • Co-primary endpoints were adjudicated MACE and cancers, excluding NMSC
  • Non-inferiority of XELJANZ would be shown if the upper boundary of the two-sided 95% CI for the HRǁ was <1.8 for combined XELJANZ doses compared with a TNFi
  • During median follow-up of 4.0 years, non-inferiority of XELJANZ was not shown5:
  • ​​​​ The incidence of MACE was higher with the combined XELJANZ doses (n=98, 3.4%) than with a TNFiǂ (n=37, 2.5%): HRǁ 1.33 (95% CI 0.91–1.94)
​​​​​​​Incidence for MACE in patients receiving XELJANZ (5 or 10 mg) or TNFi5†‡

HRǁ for MACEin patients receiving XELJANZ (5 or 10 mg) or TNFi5†‡

  • The incidence of cancers was higher with the combined XELJANZ doses (n=122, 4.2%) than with a TNFiǂ (n=42, 2.9%): HRǁ 1.48 (95% CI 1.04–2.09)

Incidence for cancers (excluding NMSC) in patients receiving XELJANZ (5 or 10 mg) or TNFi5†‡

HRǁ for cancers (excluding NMSC) in patients receiving XELJANZ (5 or 10 mg) or TNFi5†‡

Footnotes
*Current cigarette smoker, hypertension, high-density lipoprotein cholesterol <40 mg/dL, diabetes mellitus, family history of premature coronary heart disease, extraarticular RA or history of coronary artery disease.
†XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK. Tofacitinib 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 antirheumatic drugs (DMARDs). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.3
‡Adalimumab at a dose of 40 mg every 2 weeks in North America, including the United States, Puerto Rico and Canada, or etanercept at a dose of 50 mg once weekly in the rest of the world.
§MACE defined as death from CV causes, non-fatal myocardial infarction or non-fatal stroke.
¶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 scheme.4
ǁHRs for each XELJANZ dose relative to a TNFi were estimated, with two-sided 95% confidence intervals, based on two Cox proportional-hazards models (for comparing the combined tofacitinib doses with a TNF inhibitor and for pairwise comparisons among treatment groups), with treatment as the covariate.

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 antirheumatic drug; BID=twice daily; CI=confidence interval; csDMARD=conventional synthetic disease-modifying antirheumatic drug; DAS28=Disease Activity Score – 28 diarthrodial joint count; DMARD=disease-modifying antirheumatic drug; DVT=deep vein thrombosis; HR=hazard ratio; HZ=hazard ratio; JAK=Janus kinase; MACE=major adverse cardiovascular event; NICE=National Institute for Health and Care Excellence; NMSC=non-melanoma skin cancer; OD=once daily; PE=pulmonary embolism; PS=propensity matched; RA=rheumatoid arthritis; RWE=real-world evidence; SIE=serious infection event; TNFi=tumour necrosis factor inhibitor; VTE=venous thromboembolism

References

1. Kremer JM, et al. ACR Open Rheumatol. 2021;3(3):173-184.
2. XELJANZ (tofacitinib citrate). US Prescribing Information.
3. XELJANZ (tofacitinib citrate) Summary of Product Characteristics.
4. National Institute for Health and Care Excellence (NICE), Tofacitinib for moderate to severe rheumatoid arthritis [TA480]. 2017. https://www.nice.org.uk/guidance/ta480. Accessed 23 February 2022.
5. Ytterberg SR, et al. N Engl J Med. 2022;386:316-26.

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-3487. 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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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


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