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Efficacy

Safety & Tolerability

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Information on how to access XELJANZ®▼ (tofacitinib citrate) prescribing information and adverse event reporting can be found at the bottom of the page.

OCTAVE Induction

XELJANZ demonstrates efficacy in achieving remission at 8 weeks1,2

The rates of remission at Week 8 were significantly higher with XELJANZ 10 mg BID vs. placebo, in both central and local reads1,2

Adapted from Sandborn WJ et al. 2017.1 Full analysis set - non-responder imputation.

Remission in OCTAVE Induction 1 and 2 was defined as a Total Mayo score of ≤2, with no subscore >1 and a rectal bleeding subscore of 0.

Central reading of endoscopic findings was used for eligibility and primary 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% immunosuppressant therapy. Previous treatment failure was determined by the investigator.1In 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.1BID=twice daily; TNFi=tumour necrosis factor inhibitor.

Mucosal healing after 8-week induction treatment with XELJANZ

Rates of clinical response at 8 weeks were significantly higher with XELJANZ 10 mg BID vs. placebo1

Adapted from Sandborn WJ et al. 2017.1 Full analysis set - non-responder imputation.​​​​​​​

Mucosal healing was defined as improvement in the endoscopic appearance of the mucosa to subscore 0 or 1.1

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% immunosuppressant therapy. Previous treatment failure was determined by the investigator.1In 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.1BID=twice daily

Clinical response after 8-week induction treatment with XELJANZ1,2

The rates of clinical response at 8 weeks were significantly higher with XELJANZ 10 mg BID vs. placebo1

Patients were eligible to enter the OCTAVE Sustain trial if they had a clinical response during OCTAVE Induction 1 or 2

Adapted from Sandborn WJ et al. 2017.1 Full analysis set - non-responder imputation.

Clinical response was defined as a decrease from baseline in the Total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1.1

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% immunosuppressant therapy. Previous treatment failure was determined by the investigator.1In 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.1BID=twice daily

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References:
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  1. Sandborn WJ et al. N Engl J Med 2017; 376(18): 1723–1736
  2. XELJANZ (tofacitinib citrate) Summary of Product Characteristics.
PP-XEL-GBR-2313. June 2021

Announcement Title

XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from https://www.medicines.org.uk/emc/. Patients treated with XELJANZ should be given the Patient Alert Card.

Clinical Efficacy UC

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