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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.

Effectiveness in RWEWhat do real-world data show with respect to achieving LDA/remission with XELJANZ? How does this compare for effectiveness between XELJANZ and other advanced therapies for RA?
  • In the CorEvitas Registry*, XELJANZ monotherapy and combination therapy had similar effectiveness in terms of CDAI LDA/remission§ and mACR20 to TNFis as third- and fourth-line therapy at Month 6.1
    • 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)​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​

CorEvitas Registry: LDA/remission and mACR20 for TNFi + MTX or XELJANZ ± MTX (Month 6)1

  • In the SCQM-RA Registry, LDAǁ at Month 12 was achieved in 40% of those receiving TNFi, 46% receiving bDMARD-OMAǂ and 40% receiving XELJANZ.2 The likelihood of reaching LDAǁ at Month 12 was not significantly different between the three treatments.2
    • 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

Footnotes

*The recommended dose of XELJANZ for the treatment of RA in the US is 5 mg BID or 11 mg prolonged-release OD.3 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.4

†Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.

‡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.5

§LDA defined as CDAI >2.8 to 10; remission defined as CDAI ≤2.8. 

¶ 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 UK.4

ǁLDA defined as CDAI ≤10.

Is XELJANZ effective in treatment-refractory patients? Is XELJANZ effective as a third- or fourth-line treatment option?
  • In the CorEvitas Registry*, XELJANZ monotherapy and combination therapy both showed similar effectiveness to TNFis as third- and fourth-line therapy at Month 6.1
    • TNFi + MTX (n=990) vs XELJANZ monotherapy (n=106):
      • CDAI-defined LDA/remission§ rates: 33.8% vs 29.9%; OR (95% CI): 1.21 (0.74, 1.97) 
      • mACR20 response: 18.4% vs 20.7%; OR (95% CI): 0.87 (0.49, 1.53)
    • TNFi + MTX (n=111) vs XELJANZ + MTX (n=111):
      • CDAI-defined LDA/remission§ rates: 38.7% vs 36.0%; OR (95% CI): 1.12 (0.65, 1.93) 
      • mACR20 response: 21.7% vs 17.8%; OR (95% CI): 1.28 (0.65, 2.53)

LDA/remission with XELJANZ ± MTX or TNFi + MTX used as third- or fourth-line therapy at Month 61

Footnotes

*The recommended dose of XELJANZ for the treatment of RA in the USA is 5 mg BID or 11 mg prolonged-release OD.3 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.4

†Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.

‡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.5

§LDA defined as CDAI >2.8 to 10; remission defined as CDAI ≤2.8.

Is there any difference in effectiveness when XELJANZ is used as combination therapy vs monotherapy?
  • In the CorEvitas Registry*, there was no significant difference in effectiveness between XELJANZ monotherapy and combination therapy as measured by CDAI-defined LDA/remission§ rates (32.1% vs 30.2%; OR [95% CI]: 1.09 [0.61, 1.95]) and mACR20 response (17.9% vs 19.4%; OR [95% CI]: 0.87 [0.39, 1.93]).

LDA/remission with XELJANZ ± MTX or TNFi + MTX used as third- or fourth-line therapy at Month 61

  • In the SCQM-RA Registry, LDAǁ at Month 12 was achieved in 40% of those receiving TNFi, 46% receiving bDMARD-OMAǂ and 40% receiving XELJANZ.2 The likelihood of reaching LDAǁ at Month 12 was not significantly different between the three treatments.2

Footnotes

*The recommended dose of XELJANZ for the treatment of RA in the US is 5 mg BID or 11 mg prolonged-release OD.3 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.4

†Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.

‡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.5

§LDA defined as CDAI >2.8 to 10; remission defined as CDAI ≤2.8.

¶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 UK.4

ǁLDA defined as CDAI ≤10.

ǂOMA agents were abatacept and tocilizumab or sarilumab.

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

Watch NowLoading
Abbreviations

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; LDA=low disease activity; mACR20=modified American College of Rheumatology criteria – ≥20% improvement; MTX=methotrexate; NICE=National Institute for Health and Care Excellence; OD=once daily; OMA=other modes of action; OR=odds ratio; PS=propensity-score; RA=rheumatoid arthritis; SDAI=Simplified Disease Activity Index; TNFi=tumour necrosis factor inhibitor; USA=United States of America

ReferencesReed GW, et al. Rheumatol Ther. 2019;6(4):573–586.Finckh A, et al. RMD Open. 2020;6(1):e001174.XELJANZ (tofacitinib citrate). US Prescribing Information.XELJANZ (tofacitinib citrate) Summary of Product Characteristics.National Institute for Health and Care Excellence (NICE), Tofacitinib for moderate to severe rheumatoid arthritis [TA480]. 2017. www.nice.org.uk/guidance/ta480. Accessed 23 February 2022.
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-3486. 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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