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Efficacy

Safety & Tolerability

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Information on how to access XELJANZ®▼ (tofacitinib citrate) prescribing information and adverse event reporting can be found at the bottom of the page.

OCTAVE Study Design

The XELJANZ clinical development programme for ulcerative colitis includes one phase II and three phase III clinical trials of up to 12 months duration, and one ongoing long-term extension (LTE) study, OCTAVE Open.

The efficacy and safety of XELJANZ (tofacitinib citrate) for the treatment of adult patients with moderately to severely active ulcerative colitis was demonstrated in three Phase III randomised, double-blind, placebo- controlled trials (RCTs): OCTAVE Induction 1 and 2, and OCTAVE Sustain1:

  • OCTAVE Induction 1 and 2 were two identical studies of patients with moderately to severely active disease to assess the efficacy and safety of XELJANZ in inducing remission1
  • OCTAVE Sustain was a study of patients who had achieved clinical response in the two OCTAVE Induction studies to assess the efficacy and safety of XELJANZ in maintaining remission1
  • Patients in the OCTAVE Phase III trial programme were eligible to enter an ongoing open-label extension study, OCTAVE Open1

Study Designs1

OCTAVE Induction 1 and OCTAVE Induction 2 were identical replicate studies.¹
*Final complete efficacy assessment at week 8/52

In the OCTAVE Phase III studies, outcomes were measured for disease activity, health-related quality of life and health utility using multiple endpoints1,2

  • The primary and key secondary endpoints were clinical outcomes based on the Mayo score.
  • The Mayo endoscopic subscore, based on mucosal appearance during endoscopy, was assessed by central and local readings. Central assessment was by a central reader using video recorded during the procedure; local assessment was done by the study site investigator.
  • The central reading was used for eligibility and primary efficacy endpoint analysis. The OCTAVE programme was the first in ulcerative colitis to use central reads to assess primary efficacy endpoints. 
  • Local readings are more likely to reflect clinical practice where physicians use their own assessment of endoscopic findings to complement other data to make clinical decisions. 

The primary and key secondary endpoints for OCTAVE Induction 1 and 2 and OCTAVE Sustain are shown in the table below.

Clinical response is also defined as it was the criteria for entry into OCTAVE Open.

Primary and secondary endpoints in OCTAVE Induction and Maintenance studies1,2

Endpoint

Definition

Remission 
(primary endpoint: OCTAVE Induction and Maintenance)

Remission was defined as a Mayo score ≤2 with no individual subscore >1 and a rectal bleeding subscore of 0 at Week 8 for induction and Week 52 for maintenance.

Mucosal healing 
(key secondary endpoint: OCTAVE Induction and Maintenance) 
​​​​​​​

Improvement of endoscopic appearance of the mucosa (mucosal healing) was defined as a Mayo endoscopic subscore of ≤1 at Week 8 for induction and Week 52 for maintenance.

Sustained steroid-free remission
(key secondary endpoint: OCTAVE SUSTAIN only).


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

Clinical response
(secondary endpoint: OCTAVE Induction and Maintenance)

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.

Primary and secondary endpoints in OCTAVE Induction and Maintenance studies1,2

Endpoint​​​​​​​

Remission 
(primary endpoint: OCTAVE Induction and Maintenance)

Definition

Remission was defined as a Mayo score ≤2 with no individual subscore >1 and a rectal bleeding subscore of 0 at Week 8 for induction and Week 52 for maintenance.

Endpoint

Mucosal healing 
(key secondary endpoint: OCTAVE Induction and Maintenance)

Definition

Improvement of endoscopic appearance of the mucosa (mucosal healing) was defined as a Mayo endoscopic subscore of ≤1 at Week 8 for induction and Week 52 for maintenance.

Endpoint

Sustained steroid-free remission
(key secondary endpoint: OCTAVE SUSTAIN only)

Definition

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.

Endpoint

Clinical response
(secondary endpoint: OCTAVE Induction and Maintenance)

Definition

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.

In the OCTAVE UC trials, remission was defined more stringently than in previous clinical trials for UC, by including the requirement of a rectal bleeding subscore of 0.3

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Dosing in UC

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BID=twice daily; LTE=long-term extension.
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Prescribing Information:
​​​​​​​

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

References:
​​​​​​​
  1. Sandborn WJ et al. N Engl J Med 2017; 376(18): 1723–1736.
  2. XELJANZ (tofacitinib citrate) Summary of Product Characteristics.
  3. Pouillon L. Bossuyt P. Peyrin-Biroulet L. Gastroenterology 2017; 153(3): 862-864.
PP-XEL-GBR-3122. August 2021

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

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PP-PFE-GBR-2688. December 2020

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