XELJANZ® (tofacitinib citrate)| Sub Groups

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Efficacy and Safety

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OCTAVE Study Design

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XELJANZ Mechanism of Action

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XELJANZ demonstrates efficacy in patients who have previously failed tumour necrosis factor inhibitor (TNFi) agents¹

Remission in patients with and without prior TNFi failure during induction¹

Regardless of prior TNFi use, XELJANZ was more effective than placebo at 10mg BID¹

Central reading of endoscopic findings was used for eligibility and primary and key secondary efficacy endpoint analyses.¹
In OCTAVE Induction 1, patients had a mean Total Mayo score of 9 at baseline (n=598). 51% had previously failed TNFi; 75% corticosteroids; 74% lmmunosuppressant therapy. Previous treatment failure was determined by the Investigator.
In OCTAVE Induction 2, patients had a mean Total Mayo score of 9 at baseline (n=541 ). 52% had previously failed TNFi; 71 % corticosteroids; 69% immunosuppressant therapy. Previous treatment failure was determined by the investigator.
BID=twice daily; TNFi=tumour necrosis factor inhibitor.

Remission of patients with and without prior TNFi failure during maintenance¹

Regardless of prior TNFi use, XELJANZ was more effective than placebo in maintaining remission.

Central reading of endoscopic findings was used for eligibility and primary and key secondary efficacy endpoint analyses.¹
Patients had a mean Total Mayo score of 3.3 at the baseline of OCTAVE Sustain (n=593). 45% of patients had previously failed TNFi; 75% corticosteroids; 70% immunosuppressant therapy.¹
BID=twice daily; TNFi=tumour necrosis factor inhibitor.

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

References:

Dubinsky MC et al. Poster presented at: World Congress of Gastroenterology at the American College of Gastroenterology Annual Scientific Meeting; October 13–18, 2017, Orlando, FL, USA.

XELJANZ Summary of Product Characteristics.

Clinical Efficacy in UC

SAFETY

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DOSING

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MECHANISM OF ACTION

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PP-XEL-IRL-0782 January 2023

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