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STELARA® safety and side effects data in adult patients with moderately to severely active UC
The safety of STELARA® was evaluated in 2 randomized, double-blind, placebo-controlled clinical studies in 960 adult patients with moderately to severely active UC.
≥3% of patients treated with STELARA® and higher than placebo |
STELARA® 6 mg/kg IV single dose (n=320) |
Placebo(n=319) |
---|---|---|
Nasopharyngitis | 7% | 4% |
≥3% of patients treated with STELARA® and higher than placebo |
STELARA® 90 mg subQ every 8 weeks(n=176) |
Placebo (STELARA® IV Induction Responders randomized to placebo)†(n=175) |
---|---|---|
Nasopharyngitis | 24% | 20% |
Headache | 10% | 4% |
Abdominal pain | 7% | 3% |
Influenza | 6% | 5% |
Fever | 5% | 4% |
Diarrhea | 4% | 1% |
Sinusitis | 4% | 1% |
Fatigue | 4% | 2% |
Nausea | 3% | 2% |
STELARA® 90 mg subQ every 8 weeks |
Placebo | |
---|---|---|
N (treated patients)‡ | 176 | 175 |
Average duration of follow-up (weeks) | 42.2 | 42.3 |
Deaths | 0 | 0 |
Percentage of Patients | ||
Adverse events | 77.3% | 78.9% |
Serious adverse events | 8.5% | 9.7% |
Infections | 48.9% | 46.3% |
Serious infections | 1.7% | 2.3% |
<1% Hypersensitivity reactions1
No cases of anaphylactic or delayed hypersensitivity reactions with STELARA® through 1 year in the UC trials. <1% of patients taking STELARA® in the CD trials experienced hypersensitivity reactions.
<1% Malignancy rate1§
STELARA® is an immunosuppressant and may increase the risk of malignancy.
<2% Serious infections2
1.7% 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.
<5% of patients developed antibodies1,2
4.6% of overall population treated with STELARA® and 3.4% of randomized patients treated with STELARA® 90 mg subQ every 8 weeks developed antibodies to the drug.
The limited number of patients positive for antibodies to STELARA® limits the ability to draw definitive conclusions regarding the relationship between antibodies to STELARA® and clinical efficacy and safety measures. The data above reflect the percentage of patients whose test results were positive for antibodies to STELARA® at any visit in the UC clinical program and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to STELARA® with the incidence of antibodies to other products may be misleading.
Patients treated with | STELARA® 90 mg subQ every 8 weeks during open-label LTEPlacebo | |
---|---|---|
N (randomized and nonrandomized patients who entered the open-label LTE) | 353 | 188 |
Average duration of follow-up (weeks) | 77.7 | 81.3 |
Deaths | 1|| | 0 |
Percentage of Patients | ||
Adverse events | 81.3% | 83.0% |
Serious adverse events | 7.9% | 11.2% |
Infections | 56.7% | 56.4% |
Serious infections | 2.5% | 3.2% |
<1% Malignancy rate
<3% Serious infections
CD=Crohn's disease; IV=intravenous; LTE=long-term extension; subQ=subcutaneous; UC=ulcerative colitis.
*Week 44 in the Maintenance Study was equivalent to 1 year after induction dose.
†Patients who were in clinical response to the STELARA® IV induction dosing and were randomized to placebo subQ on entry into this Maintenance Study.
‡Randomized patients in the Maintenance Study.
§Malignancy rates included here reflect a combined evaluation of patients treated with STELARA® including those randomized to either the q8w or q12w dosing regimen.
||After a prolonged hospitalization for a lumbar compression fracture secondary to osteoporosis and worsening of UC, a 73-year-old patient was transferred to a nursing facility for rehabilitation, where the patient ultimately died due to cardiac arrest.
References: 1. STELARA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc. 3. Food and Drug Administration. Guidance for Industry: lmmunogenicity Assessment for Therapeutic Protein Products. Silver Spring, MD: Food and Drug Administration, US Department of Health and Human Services; 2014. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/immunogenicity-assessment-therapeutic-protein-products. Accessed October 2, 2019.