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Efficacy and SafetyClinical Efficacy RAORAL StrategyReal-World EvidenceORAL Surveillance and Integrated Safety SummaryClinical Efficacy PsAOPAL Clinical ProgrammeClinical Efficacy UCOCTAVE Study DesignOCTAVE Clinical ProgrammeSub GroupsPost-hoc AnalysesSafety and TolerabilitySafety Profile SummarySpecial Warnings & Precautions for UseAboutXELJANZ Mechanism of ActionDosing and AdministrationDosing in RA & PsADosingDosing in UCDosingSupport & ResourcesSupport & ResourcesMaterials
OCTAVE Clinical ProgrammeThe OCTAVE clinical programme included the following studies: OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain.

In OCTAVE Induction 1 and 2, patients with moderately to severely active UC were randomised to receive XELJANZ 10 mg twice daily or placebo for 8 weeks. Patients who had a clinical response in the induction trials were enrolled into OCTAVE Sustain, and further randomised to receive either XELJANZ 5 mg twice daily maintenance therapy, XELJANZ 10 mg twice daily maintenance therapy or placebo for another 52 weeks.

Learn more about OCTAVE Induction and OCTAVE Sustain below.

OCTAVE InductionXELJANZ demonstrates efficacy in achieving remission at 8 weeksThe 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.1
In 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.1
BID=twice daily; TNFi=tumour necrosis factor inhibitor.Mucosal healing after 8-week induction treatment with XELJANZRates of improvement in endoscopic appearance of the mucosa at 8 weeks were significantly higher with XELJANZ 10 mg BID vs. placebo1
  • 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.1
In 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.1
BID=twice dailyClinical response after 8-week induction treatment with XELJANZThe 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
  • 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.1
In 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.1
BID=twice daily.OCTAVE SustainXELJANZ demonstrates long-term efficacy at 52 weeksMaintenance therapy with XELJANZ at a dose of either 5 mg or 10 mg BID was significantly more effective than placebo in leading to remission at 52 weeks1
  • 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=593). 45% of patients had  previously failed TNFi; 75% corticosteroids; 70% immunosuppressant therapy.1
BID=twice daily; TNFi= tumour necrosis factor inhibitor.Mucosal healing after 52-week maintenance treatment with XELJANZMaintenance 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 healing1
  • Mucosal healing was defined as improvement in the endoscopic appearance of the mucosa to subscore 0 or 1.1
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=593). 45% of patients had previously failed TNFi; 75% corticosteroids; 70% inmunosuppressant therapy.1Sustained steroid-free remission with XELJANZ maintenance treatmentThe goal of maintenance therapy in UC is to maintain steroid free remission.4

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
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

XELJANZ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.2
The recommended dose is 10 mg given orally twice daily for induction for 8 weeks. The recommended dose for maintenance treatment is 5 mg given orally twice daily.2

For further information on the recommended dosages for induction and maintenance treatment in UC patients, please refer to the Dosing page of this site and the XELJANZ Summary of Product Characteristics.

Explore more Interested in reading more about the OCTAVE clinical programme? Learn more

Please refer to the XELJANZ Summary of Product Characteristics for full prescribing information

References:Sandborn WJ et al. N Engl J Med 2017; 376(18): 1723–1736XELJANZ Summary of Product CharacteristicsDubinsky 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.Harbord M et al. J Crohns Colitis 2017; 11(7): 769–784
Clinical Efficacy in UC SAFETY

Learn more about the XELJANZ safety profile

 See safety profile summaryLoading DOSING

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MECHANISM OF ACTION

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