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

STELARA®: Safety Profile in CD1

The safety of STELARA® was evaluated in 1,407 patients with moderately to severely active CD (CDAI ≥220 and ≤450) in 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter studies through 1 year.

The overall safety profile of STELARA® in CD through 1 year was consistent with that seen in other approved indications.1

Common Adverse Reactions Through Week 8 in 2 Single IV Induction Studies

≥3% of patients treated with STELARA® and higher than placebo STELARA® 6 mg/kg IV single dose (N=470) Placebo (N=466)
Vomiting 4% 3%

Other less common adverse reactions reported in patients in the 2 single IV induction studies included asthenia (1% vs 0.4%), acne (1% vs 0.4%), and pruritus (2% vs 0.4%).

Common Adverse Reactions Through Week 44 in SubQ Maintenance Study*

≥3% of patients treated with STELARA® and higher than placebo STELARA® 90 mg subQ every 8 weeks (N=131) Placebo (N=133)
Nasopharyngitis 11% 8%
Injection-site erythema 5% 0
Vulvovaginal candidiasis/mycotic infection 5% 1%
Bronchitis 5% 3%
Pruritus 4% 2%
Urinary tract infection 4% 2%
Sinusitis 3% 2%

Adverse Events THROUGH 1 Year1,2

  Patients treated with STELARA®§
90 mg subQ every 8 weeks
Placebo||
N (treated patients) 131 133
Average duration of follow-up (weeks) 35.2 32.0
Deaths 0 0
  Percentage of patients  
Adverse events 81.7% 83.5%
Serious adverse events 9.9% 15.0%
Infections 48.1% 49.6%
Serious infections 2.3% 2.3%

Additional Safety at 1 Year

STELARA®: infusion reactions

<1% hypersensitivity reactions1

One patient (0.08%) experienced signs and symptoms consistent with or related to a hypersensitivity reaction after receiving the initial STELARA® IV dose. One patient (0.1%) experienced signs and symptoms consistent with anaphylaxis# after receiving a single subQ STELARA® dose. In both cases, patients were treated with oral antihistamines or corticosteroids and symptoms were resolved within an hour.

STELARA®: malignancy rate

<1% malignancy rate1**

With up to 1 year of treatment, nonmelanoma skin cancer developed in 0.2% of both the STELARA® group and the placebo group. Other malignancies occurred in 0.2% of patients receiving STELARA® and in none of the patients receiving placebo. STELARA® is an immunosuppressant and may increase the risk of malignancy.

STELARA®: serious infections

<3% serious infections2

2.3% of patients in the STELARA® 90 mg subQ every-8-weeks group reported serious infections vs 2.3% in the placebo group during the phase 3 Maintenance Study.

STELARA®: antibodies

<3% of patients developed antibodies1,2

2.9% of patients treated with STELARA® in Crohn’s disease studies developed antibodies to the drug. Among randomized patients in the Maintenance Study, 2.4% of patients treated with STELARA® 90 mg subQ every 8 weeks developed antibodies to STELARA®.

CD=Crohn's disease; CDAI=Crohn's Disease Activity Index; IV=intravenous; LTE=long-term extension; q8w=every 8 weeks; q12w=every 12 weeks; subQ=subcutaneous; UC=ulcerative colitis.

*Week 44 was equivalent to 1 year after induction dose.1

Patients who were in clinical response to the STELARA® IV induction dosing and were randomized to placebo subQ on entry into this Maintenance Study.1

Randomized patients in the Maintenance Study.1

§Included responders and nonresponders to STELARA® IV induction dosing.2

||Includes: 1) All data for patients who were in clinical response to placebo IV induction dosing and received placebo subQ in the Maintenance Study. 2) The data from Week 8 onward for patients who were in clinical response to STELARA® IV induction dosing and received placebo subQ in this Maintenance Study.2

Symptoms included chest discomfort, flushing, urticaria, and increased body temperature.1

#Symptoms included tightness of the throat, shortness of breath, and flushing.1

**Malignancy rates included here reflect a combined evaluation of patients treated with STELARA® including those randomized to either the q8w or q12w dosing regimens.1,2

STELARA® SAFETY IN CD at 3 Years2,3*

ADVERSE EVENTS IN THE OPEN-LABEL LTE STUDY THROUGH 3 YEARS

  Patients treated with STELARA® 90 mg subQ every 8 weeks who entered the open-label LTE Placebo
N (randomized and nonrandomized patients who entered the open-label LTE) 354 151
Average duration of follow-up (weeks) 140.9 104.0
Deaths 4ǂ 0
  Percentage of patients  
Adverse events 95.5% 92.7%
Serious adverse events 26.8% 26.5%
Infections 78.5% 74.8%
Serious infections 8.5% 6.6%

ADDITIONAL SAFETY DURING OPEN-LABEL LTE (WEEK 0 OF MAINTENANCE STUDY TO WEEK 156)

MALIGNANCIES2

STELARA® 90 mg every 8 weeks: 1.7% (6/354)

Placebo: 2.0% (3/151)

SERIOUS INFECTIONS2

STELARA® 90 mg subQ every 8 weeks: 8.5% (30/354)

Placebo: 6.6% (10/151)

ANTIBODIES TO STELARA® (OPEN-LABEL LTE)2

Antibody formation—among randomized patients who entered open-label LTE:

  • 4.6% (11/237) of all patients receiving STELARA® developed antibodies
  • 2.4% (2/82) of patients receiving STELARA® 90 mg subQ every 8 weeks developed antibodies
  • 8.2% (5/61) of patients receiving placebo developed antibodies (induction STELARA® only)

CD=Crohn's disease; CDAI=Crohn's Disease Activity Index; IV=intravenous; LTE=long-term extension; q8w=every 8 weeks; q12w=every 12 weeks; subQ=subcutaneous; UC=ulcerative colitis.

*156-week data (164 weeks after induction dose) included randomized and nonrandomized patients who entered the open-label LTE.2

Includes: 1) 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. 2) Patients who were in clinical response to placebo IV induction dosing and received placebo subQ on entry into the Maintenance Study.2

Four deaths occurred during the open-label LTE study in patients receiving STELARA® 90 mg every 8 weeks: a sudden death in a 61-year-old patient due to presumed arrhythmia, asphyxia due to hanging (suicide) in a 24-year-old patient, end-stage renal disease in a 72-year-old patient, and sepsis in a 33-year-old patient. Two deaths occurred during the open-label LTE in patients receiving STELARA® 90 mg every 12 weeks: cardiopulmonary arrest in a 56-year-old patient (with a known history of coronary heart disease and 2 additional cardiovascular risk factors) 1 month after withdrawal of consent and an acute myocardial infarction in a 46-year-old patient with 3 known cardiovascular risk factors.2,3

 

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 through the second year of therapy. Aliment Pharmacol Ther. 2018;48(1):65-77.