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*
|STELARA® 6 mg/kg IV single dose (N=470)||
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*
|STELARA® 90 mg subQ every 8 weeks (N=131)||
|Vulvovaginal candidiasis/mycotic infection||5%||1%|
|Urinary tract infection||4%||2%|
Adverse Events of Interest and Additional Safety Information at 1 Year1,2
|Patients treated with STELARA®§||Placebo|||
|N (treated patients)||1,157||242|
|Average duration of follow-up (weeks)||30.9||34.0|
|Percentage of patients|
|Serious adverse events||14.7%||15.3%|
Additional Safety Information
<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.
<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.
<4% of patients reported serious infections2
3.2% of patients in the STELARA® group reported serious infections vs 2.1% in the placebo group during the phase 3 maintenance study.
<3% of patients developed antibodies1,2
2.3% (27/1,154) of patients treated with STELARA® in Crohn’s disease studies developed antibodies to the drug. Among randomized patients in the maintenance study, 2.4% (3/127) of patients treated with STELARA® 90 mg subQ every 8 weeks developed antibodies to STELARA®.
CD=Crohn's disease; IV=intravenous; subQ=subcutaneous; TNF=tumor necrosis factor.
*≥3% of patients and higher than placebo.1
†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
§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
Summary of Adverse Events of Interest in All Patients in the Open-label LTE at 3 Years2,3*
Safety Analysis: Included All Patients Treated With STELARA® Who Entered the Open-label LTE (n=567)
|All patients treated with STELARA® who entered the open-label LTE||Placebo†|
|N (randomized and nonrandomized patients who entered the open-label LTE)||567||151|
|Average duration of follow-up (weeks)||141.7||104.0|
|Percentage of patients|
|Serious adverse events||27.3%||26.5%|
Additional STELARA® Safety Information During Open-label LTE
STELARA® 90 mg every 8 weeks: 1.1% (4/354)
STELARA® 90 mg every 12 weeks: 1.9% (4/213)
Placebo: 2.0% (3/151)
Percentage of treatment-emergent malignancies per treatment group from Weeks 44 to 156
STELARA®: 7.4% (42/567)
Placebo: 4.0% (6/151)
Rates of treatment-emergent serious infections from Weeks 44 to 156
ANTIBODIES TO STELARA® (OPEN-LABEL LTE)2
Randomized patients treated with STELARA® who entered the open-label LTE: 4.6% (11/237)
- Randomized patients treated with STELARA® 90-mg subQ dose every 8 weeks: 2.4% (2/82)
Randomized patients receiving placebo who entered the open-label LTE and were treated with only the STELARA® induction dose: 8.2% (5/61)
All patients treated with STELARA® in the induction or maintenance trials who entered the open-label LTE: 4.8% (27/567)
IV=intravenous; LTE=long-term extension; subQ=subcutaneous.
*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
‡Three 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 arrhythmia, 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 1 month after withdrawal of consent (previously receiving STELARA® 90 mg every 12 weeks). Three deaths occurred between Weeks 96 and 156 of the open-label LTE; 1 due to end-stage renal disease, 1 due to an acute myocardial infarction, and 1 due to sepsis.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.