Efficacy

Recently completed head-to-head study comparing XELJANZ and adalimumab in patients with inadequate response to MTX1

  • 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 vs. adalimumab + MTX or XELJANZ + MTX1
  • ACR50 response rates were maintained at Month 121

 ACR, American College of Rheumatology; MTX, methotrexate.

  1. Fleischmann R et al. Lancet 2017; 390:457–468.

 

PP-XEL-GBR-1948 October 2019

12-month Phase IIIb/IV non-inferiority study in 1,146 patients with moderate to severe active RA with an inadequate response to MTX1

Adapted 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.

ACR, American College of Rheumatology; BID, twice-daily; IR, inadequate response; MTX, methotrexate; Q2W, once every 2 weeks; RA, rheumatoid arthritis; SC, subcutaneously.

1. Fleischmann R et al. Lancet 2017; 390:457–468.

 

PP-XEL-GBR-1949 October 2019

  • Non-inferiority for the primary endpoint was demonstrated for XELJANZ + MTX vs. adalimumab + MTX*1
  • Non-inferiority was not demonstrated for XELJANZ 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.1

ACR, American College of Rheumatology; BID, twice-daily; CI, confidence interval; MTX, methotrexate.

1. Fleischmann R et al. Lancet 2017; 390:457–468.

 

PP-XEL-GBR-1950 October 2019

  • 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. 2017.1

*ACR50 at Month 6 (primary endpoint of the study) was based on the full analysis set.1

ACR, American College of Rheumatology; BID, twice-daily; IR, inadequate response; LOCF, last observation carried forward; MTX, methotrexate; NRI, non-responder imputation; Q2W, once every 2 weeks; RA, rheumatoid arthritis; SC, subcutaneously.

1. Fleischmann R et al. Lancet 2017; 390:457–468.

 

PP-XEL-GBR-1951 October 2019

 XELJANZ Adverse Events

  • AE rates, including rates of the most common AEs, were comparable between treatment arms1
  • The majority of AEs were mild or moderate in severity1

Adapted from Fleischmann R et al. 2017.1

Safety analysis set was identical to the full analysis set. Two (1%) of patients receiving XELJANZ monotherapy died during the first year of therapy.1

*Patients could have experienced more than one AE.1

AE, adverse event; BID, twice-daily; MTX, methotrexate; Q2W, once every 2 weeks; SAE, serious adverse event. 

1. Fleischmann R et al. Lancet 2017; 390:457–468.

 

PP-XEL-GBR-1952 October 2019