Efficacy 
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
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
>
References
  1.  
  2. Sandborn WJ et al. N Engl J Med 2017; 376(18): 1723–1736
  3. XELJANZ (tofacitinib citrate) Summary of Product Characteristics.
  4.  
PP-XEL-GBR-3120. August 2021
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.

© 2021 Pfizer Pte Ltd. All rights reserved.


The information provided in this site is intended only for Healthcare Professionals in Singapore. The products discussed herein may have different product labelling in different countries. Pfizer Pte Ltd, Singapore is a subsidiary of Pfizer Inc, a pharmaceutical company committed to helping people improve their health by discovering and developing medicines.