ORAL Strategy Efficacy Results

Completed head-to-head non-inferiority study comparing XELJANZ and adalimumab in patients with inadequate response to MTX¹

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 12.¹​​​​​​​

ORAL Strategy (MTX-IR RA population) – ACR50 responses over 12 months¹

Adapted from Fleischmann R et al. 2017.¹

Non-inferiority​​​​​​​

• ​​​​​​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

Statistical analysis

• ​​​​​​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 zero.¹

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