For the treatment of adult patients with moderately to severely active CD

INDUCTION STUDY

STELARA®DELIVERED RAPID RESPONSE AS EARLY AS WEEK 6 (CLINICAL RESPONSE) AND WEEK 3 (70-POINT RESPONSE)

Primary Endpoint

Clinical response was defined as reduction in CDAI score of ≥100 points or CDAI score of <150.1

SECONDARY ENDPOINT

Clinical response was defined as reduction in CDAI score of ≥100 points or CDAI score of <150.1

CD=Crohn's disease; CDAI=Crohn's Disease Activity Index; IV=intravenous; TNF=tumor necrosis factor.

 

*Weight-based induction dosage regimen: STELARA® 260 mg (weight ≤55 kg), STELARA® 390 mg (weight >55 kg  to 85 kg), STELARA® 520 mg (weight >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 of ≥70 points.1

 

For the treatment of adult patients with moderately to severely active CD

MAINTENANCE STUDY

STELARA® DELIVERED LASTING REMISSION AT 1 YEAR

A Majority of Patients in the Maintenance Study Were in Clinical Remission at 1 Year After Induction Dose1*

Primary Endpoint
Clinical remission at 1 year after induction dosePatient population: Combined TNF blocker naïve and TNF blocker failure

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

More Than Two-thirds of Patients in Clinical Remission at the Start of the Maintenance Study Were Still in Remission at 1 Year1*

Secondary Endpoint
Clinical remission at 1 year among patients in remission at the start of maintenance therapyPatient population: Combined TNF blocker naïve and TNF blocker failure

Clinical remission was defined as a CDAI score of <150 points.1 Patients in clinical remission at the end of maintenance therapy who were in remission at the start of maintenance therapy. This does not account for any other time point during maintenance therapy.

A Majority of TNF Blocker–naïve Patients in the Maintenance Study Were in Clinical Remission at 1 Year After Induction Dose1*

Other endpoint
Clinical remission in TNF blocker–naïve subgroup at 1 year after induction

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

CD=Crohn's disease; CDAI=Crohn's Disease Activity Index; IV=intravenous; subQ=subcutaneous; TNF=tumor necrosis factor.

*Data through 1 year of maintenance or 52 weeks after induction dose.2

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). Patients randomized in the maintenance study were those who had a clinical response to STELARA® IV at Week 8 during either induction study.1

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

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

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

For the treatment of adult patients with moderately to severely active CD

Maintenance Study and Open-label LTE
STELARA®: LASTING Remission Through 3 Years1,2,4*

Studies That Assessed Efficacy and Safety From Week 3 to Year 31,2,4*

STELARA® Clinical Trial Design: Phase 3 Studies (COMPLETED) and Open-label LTE (ONGOING)

 

BACKGROUND AND ANALYSIS RULES FOR STELARA® OPEN-LABEL LTE STUDY4

Background

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

 

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 was performed after the final patient completed the first and second years of the 4-year open-label LTE of the maintenance study (ie, Week 96 and Week 156 maintenance study visits)

  • This represents 3 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 open-label LTE efficacy analysis, any patient who met the criteria for treatment failure prior to Week 44 continued to be considered as a treatment failure through 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)

COMBINED TNF BLOCKER–NAÏVE AND TNF BLOCKER–FAILURE POPULATIONS


Among patients in clinical remission at 1 year in the overall population, 75% of patients were in clinical remission at 3 years2
  • SubQ placebo group (8 weeks to 1 year after induction dose) (n=131)4
  • STELARA® 90 mg every 8 weeks (8 weeks to 1 year after induction dose) and open-label LTE (1 year to 160 weeks after induction dose) (n=128)2,4
  • Efficacy analysis for the open-label LTE included patients who received STELARA® 90 mg every 8 weeks (n=128)2,4

TNF BLOCKER–NAÏVE SUBGROUP


Among TNF blocker–naïve patients in clinical remission at 1 year, 74% of patients were in clinical remission at 3 years2
  • SubQ placebo group (8 weeks to 1 year after induction dose) (n=51)4
  • STELARA® 90 mg every 8 weeks (8 weeks to 1 year after induction dose) and open-label LTE (1 year to 160 weeks after induction dose) (n=52)2,4
  • Efficacy analysis for the open-label LTE included TNF blocker–naïve patients who received STELARA® 90 mg every 8 weeks (n=52)2,4

CD=Crohn's disease; CDAI=Crohn's Disease Activity Index; IV=intravenous; LTE=long-term extension; subQ=subcutaneous; TNF=tumor necrosis factor.

*Data through 3 years of maintenance or 160 weeks after induction dose.2 Open-label LTE is ongoing.

Efficacy assessments done every 12 weeks until study unblinding (then at dosing visits). Clinical remission defined as CDAI score of <150.1,4

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 CDAI score of ≥100 points or CDAI score of <150.1

§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), STELARA® 390 mg (weight >55 kg to 85 kg), STELARA® 520 mg (weight >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 the 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 open-label LTE study included those from the nonapproved STELARA® 90 mg subQ every-12-week maintenance arm, which is not represented in the figure above.4

§§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). 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-weeks group.1

 

References: 1. STELARA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 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. 4. Sandborn WJ, Rutgeerts P, Gasink C, et al. Long-term efficacy and safety of ustekinumab for Crohn’s disease through the second year of therapy. Aliment Pharmacol Ther. 2018;48(1):65-77.

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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 antidiarrheal 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.”