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||1%||5%|
|Urinary tract infection||2%||4%|
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.
STELARA® (ustekinumab): Safety Profile in Crohn’s Disease
<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
<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
<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
<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
References: 1. STELARA [package insert]. Horsham, PA: Janssen Biotech, Inc; 2016. 2. Data on file. Janssen Biotech, Inc.