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
Explore more
Dosing in UC
Visit page
Xeljanz (tofacitinib citrate) Prescribing Information (Great Britain) - 5mg film-coated tablets
Xeljanz (tofacitinib citrate) Prescribing Information (Great Britain) - 10mg film-coated tablets
Xeljanz (tofacitinib citrate) Prescribing Information (Northern Ireland) - 5mg and 10mg film-coated tablets
- Sandborn WJ et al. N Engl J Med 2017; 376(18): 1723–1736
- XELJANZ (tofacitinib citrate) Summary of Product Characteristics.
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
- OCTAVE Study Design
- OCTAVE Sub Groups
- OCTAVE Induction
- OCTAVE Sustain
- Post-hoc Analyses
Register to receive tailored marketing information from Pfizer by email
Stay up to date with the latest relevant healthcare, medical and promotional information about medicines and vaccines promoted by Pfizer.
PP-PFE-GBR-2809. October 2020
Sign up now
For UK Healthcare Professionals*
These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.
I confirm that I am a healthcare professional* resident in the United Kingdom.
If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.
*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
PP-PFE-GBR-2688. December 2020
No