Efficacy
OCTAVE Sustain
XELJANZ demonstrates long-term efficacy at 52 weeks1,2
Maintenance therapy wth XELJANZ at a dose of either 5 mg or 10 mg BID was significantly more effective than placebo in leading to remission at 52 weeks.1

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 and key secondary efficacy endpoint analyses. Eligible patients were randomised to XELJANZ 10 mg BID, 5 mg BID, or placebo during maintenance.1
Patients were eligible to enter the OCTAVE Sustain trial if they had a clinical response during OCTAVE Induction 1 or 2.
Patients had a mean Total Mayo score of 3.3 at the baseline of OCTAVE Sustain (n=59 3). 45% of patients had failed previously failed TNFi; 75% corticosteroids; 70% immunosuppressant therapy.1
Mucosal healing after 52-week maintenance treatment with XELJANZ1
The rates of mucosal healing at Week 8 were significantly higher with XELJANZ 10 mg BID vs. placebo.1
Maintenance therapy with XELJANZ at a dose of either 5 mg or 10 mg BID was significantly more effective at Week 52 than placebo in leading to mucosal healing.1
Mucosal healing was defined as improvement in the endoscopic appearance of the mucosa to subscore 0 or 1.1
Adapted from Sandborn WJ et al. 2017.1 Patients who were eligible to enter OCTAVE Sustain were randomised to receive XELJANZ 5 mg BID, 10 mg BID, or placebo for maintenance.

​​​​​​​Patients were eligible to enter the OCTAVE Sustain trial if they had a clinical response during OCTAVE induction 1 or 2.
​​​​​​​
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% inmunosuppressant therapy.1
Sustained steroid-free remission with XELJANZ maintenance treatment.2
Corticosteroid tapering and withdrawal while maintaining remission is a core goal of treatment in UC. Almost 40% of patients who had failed on TNFi achieved sustained steroid-free remission with XELJANZ 10 mg BID.2

Sustained steroid-free remission was defined as being in remission and using no corticosteroids for at least 4 weeks prior to the visit at both Week 24 and Week 52.2
Central Read data from the OCTAVE Sustain Study. The majority (88%) of patients in the OCTAVE Sustain trial had received XELJ ANZ during the induction trial, and 30% were in remission at maintenance-trial entry.1
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BID=twice daily; TNFi=tumour necrosis factor inhibitor.​​​​​​​
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. 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.
  5.  
PP-XEL-GBR-3119. 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.

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