OCTAVE Study Design | Xeljanz® (tofacitinib citrate)

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XELJANZ® (tofacitinib citrate) Prescribing Information and Maxtrex (methotrexate) Prescribing Information. Adverse event reporting can be found at the bottom of the page.

Tofacitinib should only be used if no suitable treatment alternatives are available in patients:

65 years of age and older;
patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);
patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

These risks are considered class effects and relevant across all approved indications of JAKi in inflammatory and dermatologic diseases.

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 endpoints^1,2

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 studies^1,2
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.

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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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BID=twice daily; LTE=long-term extension.

References

Sandborn WJ et al. N Engl J Med 2017; 376(18): 1723–1736.

XELJANZ (tofacitinib citrate) Summary of Product Characteristics.

Pouillon L. Bossuyt P. Peyrin-Biroulet L. Gastroenterology 2017; 153(3): 862-864.

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.

PP-XEL-GBR-3945. October 2022

Clinical Efficacy UC

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