Efficacy

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

Adapted from Sandborn WJ et al. 2017.1 Full analysis set - non-responder imputation.

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 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.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.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

 

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

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.
 

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.

XELJANZ Summary of Product Characteristics    XELJANZ Prescribing Information

1. Sandborn WJ et al. N Engl J Med 2017; 376(18): 1723–1736;
2. XELJANZ (tofacitinib citrate) Summary of Product Characteristics, Pfizer Inc.

PP-XEL-GBR-1957 October 2019

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 weeks1

https://pfizerprouk-dev3.pfizersite.io/sites/default/files/styles/panopoly_image_original/public/xeljanz_longterm_remission_maintenance_table_0.jpg?itok=S7d-dY2P

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
BID=twice daily.

 

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. placebo1

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 healing1

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.

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.1
BID=twice daily

 

Sustained steroid-free remission with XELJANZ maintenance treatment2

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 XELJ ANZ 10 mg BID2

https://pfizerprouk-dev3.pfizersite.io/sites/default/files/styles/panopoly_image_original/public/xeljanz_steroid_free_central_remission.jpg?itok=JLvLNxD8

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
BID=twice daily; TNFi=tumour necrosis factor inhibitor.

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.

1. Sandborn WJ et al. N Engl J Med 2017; 376(18): 1723–1736.
2. XELJANZ (tofacitinib citrate) Summary of Product Characteristics, Pfizer Inc.
3. 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.

XELJANZ Summary of Product Characteristics    XELJANZ Prescribing Information

PP-XEL-GBR-1958 October 2019

XELJANZ demonstrates efficacy in patients who have previously failed TNFi agents1

Remission in patients with and without prior TNFi failure during induction1

Regardless of prior TNFi use, XELJANZ was more effective than placebo at 10 mg BID1
 

Central reading of endoscopic findings was used for eligibility and primary and key secondary 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. 
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.
BID=twice daily; TNFi=tumour necrosis factor inhibitor.

 

Remission of patients with and without prior TNFi failure during maintenance1

Regardless of prior TNFi use, XELJANZ was more effective than placebo at both 5 mg and 10 mg BID1

Central reading of endoscopic findings was used for eligibility and primary and key secondary efficacy endpoint analyses.1
Patients had a mean Total Mayo score of 3.3 at the baseline of OCTAVE Sustain (n=593). 45% of patients had failed previously failed TNFi; 75% corticosteroids; 70% immunosuppressant therapy.1
BID=twice daily; TNFi=tumour necrosis factor inhibitor.

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.
 

1.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.

XELJANZ Summary of Product Characteristics    XELJANZ Prescribing Information

PP-XEL-GBR-1959 October 2019

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 tofacitinib 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 tofacitinib in maintaining remission1

  • Patients in the OCTAVE Phase III trial programme were eligible to enter an ongoing open-label extension study, OCTAVE Open1

In the OCTAVE Phase III studies, outcomes were measured for disease activity, health-related quality of life and health utility using multiple endpoints1,3:

  • 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.

 

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.

1. Sandborn WJ et al. N Engl J Med 2017; 376(18): 1723–1736.
2. Hanauer S 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.
3. 
XELJANZ (tofacitinib citrate) Summary of Product Characteristics, Pfizer Inc.
4. Pouillon L. Bossuyt P. Peyrin-Biroulet L. Gastroenterology 2017; 153(3): 862-864.

XELJANZ Summary of Product Characteristics    XELJANZ Prescribing Information

PP-XEL-GBR-1960 October 2019