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Efficacy and SafetyClinical Efficacy RAORAL StrategyReal-World EvidenceORAL Surveillance and Integrated Safety SummaryClinical Efficacy PsAOPAL Clinical ProgrammeClinical Efficacy UCOCTAVE Study DesignOCTAVE Clinical ProgrammeSub GroupsPost-hoc AnalysesSafety and TolerabilitySafety Profile SummarySpecial Warnings & Precautions for UseAboutXELJANZ Mechanism of ActionDosing and AdministrationDosing in RA & PsADosingDosing in UCDosingSupport & ResourcesSupport & ResourcesMaterials
ORAL StrategyA head to head study comparing tofacitinib and adalimumab in rheumatoid arthritis patients with inadequate response to MTX1ORAL Strategy Summary
  • XELJANZ is non-inferior compared with adalimumab when both are administered with MTX as measured by ACR50 at Month 61
  • Non-inferiority was not demonstrated for XELJANZ monotherapy vs. adalimumab + MTX or XELJANZ + MTX1 
  • ACR50 response rates were maintained at Month 12 in all treatment groups1
Study Design12-month Phase IIIb/IV non-inferiority study in 1,146 patients with moderate to severe active RA with an inadequate response to MTX1Adapted from Fleischmann R et al. 2017.1 

Patient population1
  • Moderate to severe RA
  • MTX-IR
  • N=1,146 randomised patients
  • Global study
  • Randomised, controlled clinical trial

Primary efficacy endpoint1
  • The primary efficacy endpoint of the study was ACR50 at Month 6 (non-inferiority was assessed between treatment groups)*1
XELJANZ + MTX was compared with adalimumab + MTX; and XELJANZ monotherapy was compared with both adalimumab + MTX and with XELJANZ + MTX.Non-inferiority
  • Non-inferiority for the primary endpoint was demonstrated for XELJANZ + MTX vs. adalimumab + MTX*1 
  • Non-inferiority was not demonstrated for XELJANZ monotherapy vs. adalimumab + MTX or XELJANZ + MTX*1
Adapted from Fleischmann R et al. 2017.1 
  • The non-inferiority margin was assessed using a 13% difference and non-inferiority was declared if the lower boundary of the 98.34% CI for the difference was larger than -13%1 
  • For any comparison between primary endpoints, if non-inferiority was demonstrated, superiority could be declared if the lower boundary of the 98.34% CI of the difference was greater than zero1 
ACR50 at Month 6 (primary endpoint of the study) was based on the full analysis set (all patients who were randomly assigned to a group and received at least one dose of the study treatment).1 ACR50
  • XELJANZ + MTX was non-inferior compared with adalimumab + MTX as measured by ACR50 at Month 6*1
  • XELJANZ monotherapy was not non-inferior compared with adalimumab + MTX or XELJANZ + MTX as measured by ACR50 at Month 6*1 
ORAL Strategy (MTX-IR RA population) – Primary endpoint: ACR50 at Month 6*1

Adapted from Fleischmann R et al 2017.1

  • ACR50 response rates were maintained at Month 121
ORAL Strategy (MTX-IR RA population) – ACR50 responses over 12 months1 Adapted from Fleischmann R et al. 20171ACR50 at Month 6 (primary endpoint of the study) was based on the full analysis set.1ORAL Strategy Safety XELJANZ Adverse Events (AE's)
  • AE rates, including rates of the most common AE's, were comparable between treatment arms1 
  • The majority of AE's were mild or moderate in severity1 
Adapted from Fleischmann R et al. 20171Safety analysis set was identical to the full analysis set. Two (1%) of patients receiving XELJANZ monotherapy died during the first year of therapy.1Patients could have experienced more than one AE.1 

XELJANZ in combination with methotrexate 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. XELJANZ can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.2

XELJANZ 5 mg BID and XELJANZ 11 mg prolonged-release once daily tablets are the only approved dosages for the treatment of RA, which should not be exceeded.2

Explore more Have you seen the real-world clinical evidence for XELJANZ? Learn more Loading

Please refer to the XELJANZ Summary of Product Characteristics for full prescribing information

ACR = American College of Rheumatology; AE= Adverse Event; BID = Twice Daily; CI = Confidence interval;  IR = Inadequate Response; MTX = Methotrexate; Q2W = Once every 2 weeks; RA = Rheumatoid Arthritis; SAE = Serious Adverse Event; SC = Subcutaneously

References:Fleischmann R et al. Lancet 2017; 390:457–468XELJANZ Summary of Product Characteristics
Clinical Efficacy RA
SAFETY

Learn more about the XELJANZ safety profile

 See safety data
DOSING

Learn about dosing in RA

 See recommended dosing Loading
MECHANISM OF ACTION

Find out more about how XELJANZ works

 See how XELJANZ works

Legal Category: S1A
Further information is available upon request

PP-XEL-IRL-0777 January 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

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