STELARA® SAFETY

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

  Placebo (N=466) STELARA® 6 mg/kg IV single dose (N=470)
Vomiting 3% 4%

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*

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

The overall safety profile of STELARA® was consistent with that seen in the psoriasis and psoriatic arthritis studies.

*≥3% of patients and higher than placebo.

 

View the summary of adverse events of interest in all patients in the open-label LTE study at nearly 2 years

STELARA® (ustekinumab): Safety Profile in Crohn’s Disease

STELARA®: infusion reactions

<1% hypersensitivity reactions

1 patient (0.08%) experienced signs and symptoms consistent with or related to a hypersensitivity reaction† after receiving the initial STELARA® IV dose. 1 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

STELARA®: malignancy rate

<1% malignancy rate

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.1

STELARA®: serious infections

<4% of patients reported serious infections

3.2% of patients in the STELARA® group reported serious infections vs 2.1% in the placebo group during the phase 3 maintenance study.2

STELARA®: antibodies

<3% of patients developed antibodies

<3% of patients treated with STELARA® in Crohn’s disease studies developed antibodies to the drug.1

The safety of STELARA® was evaluated in 1407 patients with moderately to severely active Crohn’s disease (CDAI ≥220 and ≤450) in 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter studies.

 

Symptoms included chest discomfort, flushing, urticaria, and increased body temperature.1
Symptoms included tightness of the throat, shortness of breath, and flushing.1

 

View the summary of adverse events of interest in all patients in the open-label LTE study at nearly 2 years

References: 1. STELARA [package insert]. Horsham, PA: Janssen Biotech, Inc; 2016. 2. Data on file. Janssen Biotech, Inc.