• 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,^¶ LDA^ǁ at Month 12 was achieved in 40% of those receiving TNFi, 46% receiving bDMARD-OMA^ǂ 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.

• 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.

• 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]).¹ 

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.

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