STELARA® clinical efficacy data in adult patients with moderately to severely active UC

INDUCTION STUDY: CLINICAL RESPONSE AND CLINICAL REMISSION AT WEEK 8

STELARA®DELIVERED RAPID RESPONSE AND REMISSION IN JUST 8 WEEKS1

CLINICAL RESPONSE*

Overall Population

Major Secondary Endpoint (P<0.001)

58%

of patients receiving STELARA®(n=186/322)

31%

of patients receiving placebo (n=99/319)

Bio-naïve Patients

Other Secondary Endpoint Prespecified Subgroup Analysis
Not Adjusted for Multiplicity

64%

of patients receiving STELARA®(n=94/147)

36%

of patients receiving placebo (n=55/151)

 

CLINICAL REMISSION

Overall Population

Primary Endpoint (P<0.001)

19%

of patients receiving STELARA®(n=62/322)

7%

of patients receiving placebo (n=22/319)

≈3X more patients

Bio-naïve Patients

Other Secondary Endpoint Prespecified Subgroup Analysis
Not Adjusted for Multiplicity

24%

of patients receiving STELARA®(n=36/147)

9%

of patients receiving placebo (n=14/151)

Bio-failure Patients

Other Secondary Endpoint Prespecified Subgroup Analysis
Not Adjusted for Multiplicity

14%

of patients receiving STELARA®(n=24/166)

4%

of patients receiving placebo (n=7/161)

View rapid response achieved at Week 6 with STELARA® in CD

Bio-failure=failed biologic treatment; Bio-naïve=naïve to biologic treatment; CD=Crohn's disease; UC=ulcerative colitis.

 

*Clinical response was defined as a decrease from baseline in the Mayo score by ≥30% and ≥2 points, with either a decrease from baseline in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1.

†An additional 7 patients receiving placebo and 9 patients receiving STELARA® (6 mg/kg) had been exposed to, but had not failed, biologics.

‡Clinical remission was defined as Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and Mayo endoscopy subscore of 0 or 1 (modified so that 1 does not include friability).

STELARA® clinical efficacy data in adult patients with moderately to severely active UC

MAINTENANCE STUDY: CLINICAL REMISSION AT 1 YEAR

STELARA® DELIVERED LASTING REMISSION AT 1 YEAR1

45% of the overall population receiving STELARA® were in clinical remission after 1 year of treatment

CLINICAL REMISSION*

Overall Population

Primary Endpoint (P≤0.001)

45%

of patients receiving STELARA® 90 mg subQ every 8 weeks (n=79/176)

26%

of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=46/175)

Among the patients in clinical remission at 1 year with STELARA®, 96% (n=76/79) were steroid free (post hoc analysis)

Bio-naïve Patients

Prespecified Subgroup Analysis of Primary Endpoint
Not Adjusted for Multiplicity

49%

of patients receiving STELARA® 90 mg subQ every 8 weeks (n=39/79)

36%

of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=30/84)

Bio-failure Patients

Prespecified Subgroup Analysis of Primary Endpoint
Not Adjusted for Multiplicity

41%

of patients receiving STELARA® 90 mg subQ every 8 weeks (n=37/91)

18%

of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=16/88)

article

STELARA® PIVOTAL STUDIES IN ULCERATIVE COLITIS

Get details about the pivotal trials of STELARA® as induction and maintenance therapy for the treatment of adults with moderately to severely active ulcerative colitis featured in The New England Journal of Medicine.

View lasting remission demonstrated at 1 year with STELARA® in CD

Bio-failure=failed biologic treatment; Bio-naïve=naïve to biologic treatment; CD=Crohn's disease; IV=intravenous; subQ=subcutaneous; UC=ulcerative colitis.

 

*Clinical remission was defined as Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and Mayo endoscopy subscore of 0 or 1 (modified so that 1 does not include friability).

†An additional 3 patients receiving placebo and 6 patients receiving STELARA® had been exposed to, but had not failed, biologics.

STELARA® clinical efficacy data in adult patients with moderately to severely active UC

MAINTENANCE STUDY: STEROID-FREE CLINICAL REMISSION

STELARA® PROVIDED STEROID-FREE REMISSION1*

43% of the overall population—and nearly half of bio-naïve patients—were in steroid-free clinical remission with STELARA® at 1 year

STEROID-FREE
CLINICAL REMISSION

Overall Population

Major Secondary Endpoint (P≤0.001)

43%

of patients receiving STELARA® 90 mg subQ every 8 weeks (n=76/176)

26%

of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=45/175)

Bio-naïve Patients

Prespecified Subgroup Analysis of Major Secondary Endpoint
Not Adjusted for Multiplicity

48%

of patients receiving STELARA® 90 mg subQ every 8 weeks (n=38/79)

36%

of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=30/84)

article

STELARA® PIVOTAL STUDIES IN ULCERATIVE COLITIS

Get details about the pivotal trials of STELARA® as induction and maintenance therapy for the treatment of adults with moderately to severely active ulcerative colitis featured in The New England Journal of Medicine.

View efficacy data for STELARA® in CD

Bio-naïve=naïve to biologic treatment; CD=Crohn's disease; IV=intravenous; subQ=subcutaneous; UC=ulcerative colitis.

 

*Steroid-free clinical remission was defined as patients in clinical remission and not receiving corticosteroids at 1 year.

†An additional 3 patients receiving placebo and 6 patients receiving STELARA® had been exposed to, but had not failed, biologics.

STELARA® clinical efficacy data in adult patients with moderately to severely active UC

STELARA® IS THE FIRST AND ONLY FDA-APPROVED UC TREATMENT TO ACHIEVE HISTO-ENDOSCOPIC MUCOSAL IMPROVEMENT (HEMI)1*

Endoscopic Improvement

+

Histologic Improvement

=

Histo-Endoscopic 
Mucosal Improvement

HEMI is a combined measure that assesses improvement of the colon at the cellular level through histologic examination PLUS images observed during colonoscopy

STELARA®ACHIEVED HISTO-ENDOSCOPIC MUCOSAL IMPROVEMENT (HEMI)1*

HEMI RESULTS1

Overall Population

Multiplicity-controlled Other Secondary Endpoint (P<0.001)

17%

of patients receiving STELARA®(n=54/322)

8%

of patients receiving placebo (n=26/319)

Bio-naïve Patients

Prespecified Subgroup Analysis of Other Secondary Endpoint

20%

of patients receiving STELARA®(n=30/147)

13%

of patients receiving placebo (n=19/151)

HEMI RESULTS1,2

Overall Population

Prespecified Other Endpoint (P<0.001)‡

44%

of patients receiving STELARA® 90 mg subQ every 8 weeks (n=75/172)

23%

of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=40/172)

Bio-naïve Patients

Prespecified Subgroup Analysis of Other Endpoint

49%

of patients receiving STELARA® 90 mg subQ every 8 weeks (n=38/77)

31%

of patients receiving placebo (Note: STELARA® IV Induction Responders randomized to placebo) (n=25/81)

The relationship of HEMI to long-term outcomes was not studied in the clinical trials.

‡The P  value is nominal. It represents a summary statistic and cannot be used to conclude statistical significance.

View efficacy data for STELARA® in CD

Bio-naïve=naïve to biologic treatment; CD=Crohn's disease; IV=intravenous; subQ=subcutaneous; UC=ulcerative colitis.

 

*HEMI was defined as combined endoscopic improvement (Mayo endoscopy subscore of 0 or 1) and histologic improvement of the colon tissue (neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue).

†An additional 7 patients receiving placebo and 9 patients receiving STELARA® (6 mg/kg) had been exposed to, but had not failed, biologics.

 

References: 1. STELARA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.

STELARA® open-label LTE study design and background and analysis rules in adult patients with moderately to severely active UC

UNIFI CLINICAL TRIAL DESIGN

STUDY DESIGN WITH A UNIQUE ENDPOINT IN UC1

Designed to prospectively evaluate clinical remission, clinical response, steroid-free clinical remission, and, for the first time in Phase 3 clinical trials, Histo-Endoscopic Mucosal Improvement (HEMI)

STELARA® CLINICAL TRIAL DESIGN: PHASE 3 STUDIES AND OPEN-LABEL LTE IN UC1,2

INDUCTION STUDY

MAJOR SECONDARY ENDPOINTS INCLUDED:

  • Clinical response at Week 8
  • Endoscopic improvement at Week 8#

MAINTENANCE STUDY

MAJOR SECONDARY ENDPOINTS INCLUDED:

  • Maintenance of clinical response at 1 year after induction dose**
  • Endoscopic improvement at 1 year after induction dose#
  • Steroid-free clinical remission at 1 year after induction dose††
  • Maintenance of clinical remission at 1 year after induction dose‡‡

OPEN-LABEL LTE

All patients completing the Maintenance Study were eligible to enter the LTE. Placebo subQ patients were discontinued after unblinding at 1 year after induction dose. Efficacy measures were collected every 12 weeks thereafter. Safety was evaluated throughout.

OTHER SECONDARY ENDPOINTS IN THE INDUCTION AND MAINTENANCE STUDIES INCLUDED:

  • HEMI at Week 8 (other secondary endpoint) and at 1 year (other endpoint) after the induction dose§§

Adult patients with moderately to severely active UC who had an inadequate response to or failed to tolerate biologic (ie, TNF blocker and/or vedolizumab) or conventional (ie, corticosteroids and/or the immunomodulators 6-MP or AZA) therapy.

BACKGROUND AND ANALYSIS RULES FOR STELARA® UC OPEN-LABEL LTE2

Background

Objective: To evaluate the efficacy and safety data of STELARA® through 3 years of LTE after the maintenance treatment through Week 44. The final efficacy assessments will be performed at Week 200 and the final safety assessments at Week 220.

75% (588/783) of patients who started the maintenance phase entered the open-label LTE

  • All patients completing Week 44 were eligible to enter the open-label LTE

In the open-label LTE, if a patient's UC symptoms worsen per investigator judgment, the patient is allowed one dose adjustment. Patients randomized to the 90 mg every 8 weeks group received a sham escalation and stayed at 90 mg every 8 weeks.

The final database lock will occur when all patients have completed or terminated before Week 220 the open-label LTE of the Maintenance Study

  • This represents 4 years of treatment with STELARA®

Study was unblinded after final Week 44 maintenance analysis was completed

  • Patients randomized to placebo were discontinued after study unblinding and are not included in the open-label LTE efficacy analysis

ANALYSIS RULES

Analyses shown are intent-to-treat:

Patients who had a prohibited change in UC medication, an ostomy or colectomy, used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an adverse event of worsening of UC prior to the Week 44 visit were considered not to be in symptomatic remission. Additionally, patients who had an ostomy or colectomy, or discontinued study agent due to lack of therapeutic effect or due to an adverse event of worsening of UC after Week 44 and prior to the designated visit, were considered not to be in symptomatic remission.

Patients who are receiving any of the UC-specific medical therapies (oral 5-ASA, AZA, 6-MP, or MTX) at the time of entry into the Maintenance Study and do not lose response must keep their prescribed dosage stable through completion of the Week 44 assessment. During the LTE, discontinuation of immunomodulators was allowed as determined by the investigator.

6-MP=6-mercaptopurine; AZA=azathioprine; IV=intravenous; LTE=long-term extension; subQ=subcutaneous; TNF=tumor necrosis factor; UC=ulcerative colitis.

*In the Induction Study, patients were randomized to receive STELARA® weight-based dosage regimen (approximately 6 mg/kg), STELARA® 130-mg IV dose, or IV placebo. The 130-mg IV dose is not an approved induction dose and therefore is not shown.

Clinical remission was defined as Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and Mayo endoscopy subscore of 0 or 1 (modified so that 1 does not include friability).

Weight-based induction dosage regimen: STELARA® 260 mg (weight ≤55 kg), STELARA® 390 mg (weight >55 kg to 85 kg), and STELARA® 520 mg (weight >85 kg).

§The Maintenance Study included a third randomized arm where patients received STELARA® 90 mg subQ every 12 weeks. STELARA® 90 mg subQ every 12 weeks is not an approved maintenance dose and therefore is not shown. Patients randomized in the Maintenance Study were those who had a clinical response to STELARA® IV at Week 8 during the Induction Study.

IISymptomatic remission was defined as no rectal bleeding (Mayo rectal bleeding subscore of 0) and normal to near-normal stool frequency (Mayo stool frequency subscore of 0 or 1); no endoscopic assessment was performed.

Clinical response was defined as a decrease from baseline in Mayo score by ≥30% and ≥2 points, with either a decrease from baseline in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1.

#Endoscopic improvement was defined as Mayo endoscopy subscore of 0 or 1 (modified so that 1 does not include friability).

**Patients who achieved clinical response to STELARA® at the end of the Induction Study.

††Steroid-free clinical remission was defined as patients in clinical remission and not receiving steroids at 1 year.

‡‡Maintenance of clinical remission at 1 year was defined as remission at Week 44 in patients who achieved clinical remission 8 weeks after induction.

§§HEMI was defined as combined endoscopic improvement (Mayo endoscopy subscore of 0 or 1) and histologic improvement of the colon tissue (neutrophil infiltration <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue).

IIIIWeek 44 of the Maintenance Study was defined as 1 year from initiation of the induction (8-week Induction Study + 44-week Maintenance Study=1 year).

 

References: 1. STELARA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.

STELARA® clinical efficacy data in adult patients with moderately to severely active UC

OPEN-LABEL LTE: 2-YEAR SYMPTOMATIC REMISSION

STELARA®: LASTING SYMPTOMATIC REMISSION* THROUGH ≈2 YEARS1

Symptomatic remission was defined as no rectal bleeding and normal to near-normal stool frequency; no endoscopic assessment was performed

SYMPTOMATIC REMISSION (WEEKS 0 TO 92—POST HOC ANALYSIS AT YEAR 2)

Overall Population

Other Endpoint
of Maintenance Study
Not Adjusted for Multiplicity

68%

of patients receiving
STELARA® 90 mg subQ
every 8 weeks
(n=119/176)

45%

of patients
receiving placebo
(Note: STELARA® IV
Induction Responders
randomized to placebo)
(n=79/175)

Includes efficacy data from 26/176 patients who experienced UC worsening per investigator’s judgment during Weeks 56 to 92 but remained on STELARA® 90 mg every 8 weeks.

SYMPTOMATIC REMISSION (WEEKS 0 TO 92—POST HOC ANALYSIS AT YEAR 2)

Overall Population

68%

of patients receiving
STELARA® 90 mg subQ
every 8 weeks
(n=119/176)

Among patients in symptomatic remission at ≈Year 2 with STELARA®, 97% (n=116/119) were steroid free

Includes efficacy data from 26/176 patients who experienced UC worsening per investigator’s judgment during Weeks 44 to 92 but remained on STELARA® 90 mg every 8 weeks.

View efficacy data for STELARA® in CD

*Symptomatic remission was defined as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0.

Reference: 1. Data on file. Janssen Biotech, Inc.