For the treatment of adults with moderately to severely active Crohn’s disease who have failed or were intolerant to conventional therapy (but never failed treatment with a TNF blocker) or have failed or were intolerant to treatment with one or more TNF blockers.

Start Strong With a Single IV Induction Dose for Crohn’s Disease1*

Primary Endpoint:
Clinical response at Week 6 (100-point reduction)

Clinical response was defined as reduction in Crohn’s Disease Activity Index (CDAI) score of ≥100 points or CDAI score of <150.1

Significant Response In Predominantly TNF Blocker–Naïve Patients at Week 3 (70-Point Reduction§)

Clinical response was defined as reduction in Crohn’s Disease Activity Index (CDAI) score of ≥100 points or CDAI score of <150.1

*Weight-based induction dosage regimen: STELARA® 260 mg (weight 55 kg or less), STELARA® 390 mg (weight more than 55 kg  to 85 kg), STELARA® 520 mg (weight more than 85 kg).1

69% of patients were TNF blocker naïve. Remaining population was patients previously exposed to, but who did not fail, treatment with TNF blockers. All patients in the study failed or were intolerant to conventional treatment (eg, azathioprine, 6-mercaptopurine, methotrexate, or corticosteroids).1,2

The induction studies each included a third randomized arm where patients received a single 130-mg IV administration dose of STELARA®. The 130-mg IV dose is not an approved induction dose.1,2

§70-point response was defined as reduction in CDAI score ≥70 points.1

 
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STELARA® PIVOTAL STUDIES

Get details about the 3 pivotal trials of STELARA® for the treatment of adults with moderately to severely active Crohn’s disease featured in The New England Journal of Medicine (NEJM).

The article may only be available to subscribers of The New England Journal of Medicine. To access this content, you may have to sign in using your personal or institutional credentials. If you are not registered or a member of NEJM, then you may need to purchase this article through their site.

The Maintenance Study

Staying the Course With STELARA®: A Majority of Patients in the Maintenance Study Were in Clinical Remission at 52 Weeks After Induction Dose1

Primary endpoint:
Clinical remission

Clinical remission was defined as a CDAI score of<150 points.1

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More Than Two-thirds of Patients in Clinical Remission at the Start of the Maintenance Study Were Still in Remission at Week 521

Secondary Endpoint:
Patients Who Entered the Maintenance Study in Remission Stayed in Remission 52 Weeks After Induction Dose1

Clinical remission was defined as a CDAI score<150 points.1

A Majority of TNF Blocker–naïve Patients in the Maintenance Study Were in Clinical Remission at 52 Weeks After Induction Dose1

Other endpoint:
Clinical Remission in TNF Blocker–naïve Subgroup

Clinical remission was defined as a CDAI score<150 points.1

Week 44 of the maintenance study or 52 weeks from initiation of the induction dose (8-week induction  + 44-week maintenance study=52 weeks).1

All patients randomized to placebo in the maintenance study had a single STELARA® IV induction dose.1

article icon
STELARA® PIVOTAL STUDIES

Get details about the 3 pivotal trials of STELARA® for the treatment of adults with moderately to severely active Crohn’s disease featured in The New England Journal of Medicine (NEJM).

The article may only be available to subscribers of The New England Journal of Medicine. To access this content, you may have to sign in using your personal or institutional credentials. If you are not registered or a member of NEJM, then you may need to purchase this article through their site.

References: 1. STELARA [package insert]. Horsham, PA: Janssen Biotech, Inc; 2016. 2. Data on file. Janssen Biotech, Inc. 3. Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn’s disease activity index. National cooperative Crohn’s disease study. Gastroenterology. 1976;70(3):439-443.

 

STELARA® FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE RESULTS FROM PHASE 3 STUDIES AND NEARLY 2 YEARS OF MAINTENANCE DATA FROM THE OPEN-LABEL LONG-TERM EXTENSION

 

STELARA® Clinical Trial Design: Phase 3 Studies and the Open-label Long-term Extension (LTE)1-3*†

 

 

* In both induction studies, patients were randomized to receive STELARA® weight-based dosage regimen (approximately 6 mg/kg), STELARA® 130-mg IV, or placebo. The 130-mg IV dose is not an approved induction dose and therefore is not shown. Clinical response was defined as reduction in Crohn’s Disease Activity Index (CDAI) score of ≥100 points or CDAI score of <150.1,2

69% of patients were TNF blocker naïve. Remaining population were patients previously exposed to, but who did not fail, treatment with TNF blockers. All patients in the study failed or were intolerant to conventional treatment (eg, azathioprine, 6-mercaptopurine, methotrexate, or corticosteroids).1

Weight-based induction dosage regimen: STELARA® 260 mg (weight 55 kg or less), STELARA® 390 mg (weight more than 55 kg to 85 kg), STELARA® 520 mg (weight more than 85 kg).1

§ Patients were intolerant to or failed TNF blocker therapy.1

|| 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 either induction study. 1,2

Clinical remission was defined as a CDAI score of <150. Week 44 of the maintenance study was defined as 1 year from initiation of the induction dose (8-week induction + 44-week maintenance study=1 year).1

# All patients randomized to placebo in the maintenance study had a single STELARA®  IV induction dose.1

**Subjects in the LTE study included those from the nonapproved STELARA® 90 mg subQ every-12-week maintenance arm not represented in the figure above.3

 

STELARA® Open-label LTE Study3

Background

Objective: To evaluate the efficacy and safety data of STELARA® through approximately 2 years of maintenance treatment. The final efficacy and safety assessments will be performed at Week 252 (5 years of maintenance treatment).

 

75% (298/397) of randomized subjects who started maintenance phase entered open-label LTE

  • All patients completing Week 44 (1 year after induction dose) were eligible to enter the open-label LTE

 

Database lock performed after the final patient completed the first year of the 4-year open-label LTE of the maintenance study (ie, Week 96 maintenance study visit)

  • This represents approximately 2 years of treatment with STELARA®

 

Study was unblinded after final Week 44 maintenance analysis was completed (August 2015)

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

Analysis Rules

Analyses shown are intent-to-treat

 

For the 2-year open-label LTE efficacy analyses, any patient who met the criteria for treatment failure prior to Week 44 continued to be considered as a treatment failure throughout the open-label LTE

 

Patients who discontinued or had missing data were assumed not to be in response or remission. Patients undergoing CD-related surgeries or initiating prohibited medications were considered treatment failures

 

In the open-label LTE, patients were not allowed to dose adjust upon loss of response, but could make changes in steroids or immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate) if medically appropriate. Otherwise, all treatment failure rules were the same as they had been prior to Week 44 (during maintenance trial)

 

Rate of Remission in Patients Responding to STELARA® Through Nearly 2 Years1-3*†

 

 

 

  • SubQ placebo group (8 weeks to 1 year after induction dose) (n=131)3
  • STELARA® 90 mg every 8 weeks (8 weeks to 1 year after induction dose) and open-label LTE (1 year to 100 weeks after induction dose) (n=128)3
  • Efficacy analysis for the open-label LTE included patients who received STELARA® 90 mg every 8 weeks (n=128)3

 

*Data through nearly 2 years of maintenance or 100 weeks after induction dose.3

Efficacy assessments done every 12 weeks until study unblinding (then at dosing visits). Clinical remission defined as Crohn’s Disease Activity Index (CDAI) score <150.1,3

Week 44 of the maintenance study or 1 year from initiation of the induction dose (8-week induction study + 44-week maintenance study = 1 year). Patients randomized in the maintenance study were those who had a clinical response to STELARA®  IV at Week 8 during either induction study.1

§Patients randomized to the STELARA® 90 mg every-8-week group.1

||All patients randomized to placebo in the maintenance study had a single STELARA®  IV induction dose.1

 

 

Rate of Remission in TNF Blocker–Naïve Subgroup of Patients Responding to STELARA® Through Nearly 2 Years1-3*†

 

 

 

  • SubQ placebo group (8 weeks to 1 year after induction dose) (n=51)3
  • STELARA® 90 mg every 8 weeks (8 weeks to 1 year after induction dose) and open-label LTE (1 year to 100 weeks after induction dose) (n=52)3
  • Efficacy analysis for the open-label LTE included TNF blocker-naïve patients who received STELARA® 90 mg every 8 weeks (n=52)3

 

* Data through nearly 2 years of maintenance or 100 weeks after induction dose.3

Efficacy assessments done every 12 weeks until study unblinding (then at dosing visits). Clinical remission defined as CDAI score <150.1,3

Week 44 of the maintenance study or 1 year from initiation of the induction dose (8-week induction study + 44-week maintenance study = 1 year). Patients randomized in the maintenance study were those who had a clinical response to STELARA® IV at Week 8 during either induction study.1

§ Patients randomized to the STELARA® 90 mg every-8-week group.1

||All patients randomized to placebo in the maintenance study had a single STELARA®  IV induction dose.1

Summary of Adverse Events of Interest in All Patients in the Open-label LTE Study at Nearly 2 Years2,3*

Safety analysis: included all STELARA®-treated patients who entered the open-label LTE (n=567)

 

 

Additional Safety Information During Open-label LTE

Malignancies2

STELARA® 90 mg every 8 weeks: 0.3% (1/354)

STELARA® 90 mg every 12 weeks: 0.5% (1/213)

Placebo: 2.0% (3/151)

 

Percentage of treatment-emergent malignancies per treatment group from Weeks 44 to 96.

Serious infections3

STELARA®: 3.5%  

Placebo: 3.3%

 

Rates of serious infections from Weeks 44 to 96.

Antibody formation (open-label LTE)3

Among randomized patients who entered LTE:

-All patients randomized to STELARA®: 4.2% (10/237)

-Patients randomized to STELARA® 90 mg subQ every 8 weeks: 2.4% (2/82)

-Placebo (received STELARA® induction): 8.2% (5/61)

 

Among all patients treated with STELARA® in induction or maintenance and entered LTE: 4.2% (24/567)

 

 

*100-week data include randomized and nonrandomized patients who entered the open-label LTE.3

Patients who were in clinical response to STELARA® IV induction dosing and received placebo subQ on entry into the maintenance study and did not meet loss of response criteria from Week 8 through Week 32. Patients who were in clinical response to placebo IV induction dosing and received placebo subQ on entry into the maintenance study.2

3 deaths occurred from Weeks 44 to 96 of the open-label LTE study; a sudden death in a 61-year-old patient receiving STELARA® 90 mg every 8 weeks due to presumed arrythmia, asphyxia due to a hanging (suicide) in a 24-year-old patient receiving STELARA® 90 mg every 8 weeks and cardiopulmonary arrest in a 56-year-old patient one month after withdrawal of consent (previously receiving STELARA® 90 mg every 12 weeks).3

 

References: 1. STELARA® [prescribing information]. Horsham, PA: Janssen Biotech, Inc; 2018. 2. Data on file. Janssen Biotech, Inc. 3. Sandborn WJ, Rutgeerts P, Gasink C, et al. Long-term efficacy and safety of ustekinumab for Crohn’s Disease: results from IM-UNITI long-term extension through 2 years. Poster presented at: Digestive Disease Week (DDW) 2017.

 

 

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CROHN’S DISEASE ACTIVITY INDEX (CDAI) CONSISTS OF THE WEIGHTED SUM TOTAL OF THE FOLLOWING3:
  1. Number of liquid or soft stools each day for 7 days;
  2. Abdominal pain;
  3. General well-being;
  4. Presence of complications;
  5. Taking anti-diarrheal medications;
  6. Presence of abdominal mass;
  7. Hematocrit <0.47 in men and <0.42 in women;
  8. Percentage deviation from standard weight.
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Important Context About the Placebo Arm1

All patients randomized to placebo in the maintenance study had previously received a single STELARA® IV induction dose and achieved clinical response at Week 8 of induction prior to entering the maintenance study. Therefore, the placebo arm in the maintenance study is referred to as “placebo-induction responders.”