OCTAVE Induction | Xeljanz® (tofacitinib citrate)

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Adverse event reporting can be found at the bottom of the page

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XELJANZ® (tofacitinib citrate) Prescribing Information and Maxtrex (methotrexate) Prescribing Information. Adverse event reporting can be found at the bottom of the page.

Tofacitinib should only be used if no suitable treatment alternatives are available in patients:

65 years of age and older;
patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);
patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

These risks are considered class effects and relevant across all approved indications of JAKi in inflammatory and dermatologic diseases.

OCTAVE Induction

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.

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 XELJANZ^1,2

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

Dosing in UC

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References

Sandborn WJ et al. N Engl J Med 2017; 376(18): 1723–1736

XELJANZ (tofacitinib citrate) Summary of Product Characteristics.

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.

PP-XEL-GBR-3947. October 2022

Clinical Efficacy UC

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