STELARA® safety and side effects data in adult patients with moderately to severely active UC
STELARA®: SAFETY PROFILE IN UC
The overall safety profile of STELARA® in UC was consistent with that seen in other approved indications1
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.
COMMON ADVERSE REACTIONS THROUGH WEEK 8 IN SINGLE IV INDUCTION STUDY1,2
| ≥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% |
COMMON ADVERSE REACTIONS THROUGH WEEK 44 IN SINGLE SUBQ MAINTENANCE STUDY1,2*
| ≥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% |
Adverse Events THROUGH 1 Year1,2
|
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% |
ADDITIONAL SAFETY AT 1 YEAR
<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§
- Nonmelanoma skin cancer: STELARA®: 0.4%; Placebo: 0.0%
- Other malignancies: STELARA®: 0.5%; Placebo: 0.2%
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.
Antidrug antibodies can bind to therapeutic protein products, thereby reducing or inhibiting their efficacy3
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.
STELARA® safety in UC at 3 years2
Number of Events per 100 patient-years of follow-up (95% CI) FROM THE MAINTENANCE WEEK 0II
| STELARA® 90 mg subQ every 8 weeks during the open-label LTE¶ | Placebo# | |
|---|---|---|
| N (randomized and nonrandomized patients who were treated in the open-label LTE) | 376 | 188 |
| Average duration of follow-up (weeks) | 124.5 | 84.1 |
| Total patient-years of follow-up | 900.3 | 304.0 |
| Deaths |
0.11 (0.00, 0.62) |
0.00 (0.00, 0.99) |
| Adverse events |
251.90 (241.64, 262.49) |
285.81 (267.12, 305.46) |
| Serious adverse events |
8.44 (6.65, 10.57) |
10.52 (7.20, 14.86) |
| Infections** |
76.53 (70.92, 82.46) |
85.51 (75.43, 96.56) |
| Serious infections** |
2.22 (1.36, 3.43) |
3.29 (1.58, 6.05) |
Data are presented by event rates adjusted by 100 patient-years to normalize differences in follow-up between STELARA® and placebo treatment groups.
ADDITIONAL SAFETY AT 3 YEARS
Additional safety during open-label LTE (week 0 or maintenance study to week 156)
0.67 Malignancy per 100 patient-years (95% CI)II¶#
- STELARA® 90 mg every 8 weeks: 0.67 (0.24, 1.45)
- Placebo: 0.66 (0.08, 2.38)
< 3 Serious infections per 100 patient-years (95% CI)II¶#**
- STELARA® 90 mg every 8 weeks: 2.22 (1.36, 3.43)
- Placebo: 3.29 (1.58, 6.05)
<5% of patients developed antibodies to STELARA®††‡‡
Antibody formation among randomized patients who were treated in the open-label LTE:
- 4.9% (5/103) of patients randomized to STELARA® 90 mg subQ every 8 weeks developed antibodies to the drug
View safety profile of STELARA® in CD
CD=Crohn's disease; IV=intravenous; LTE=long-term extension; q8w=every 8 weeks; 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.
||Confidence intervals based on an exact method assuming that the observed number of events follows a Poisson distribution.
¶Includes 1) patients who were in clinical response to ustekinumab IV induction dosing and were randomized to receive ustekinumab 90 mg subQ q8w on entry into the maintenance study, with data from maintenance Week 0 through Week 156; 2) patients who were in clinical response to ustekinumab IV induction dosing, randomized to receive placebo subQ or ustekinumab 90 mg subQ q12w on entry into the maintenance study, and had a dose adjustment to ustekinumab subQ 90 mg q8w, with data from the time of adjustment onward; and 3) patients who were not in clinical response to ustekinumab at induction Week 8 but were in clinical response at induction Week 16 after a subQ administration of ustekinumab at induction Week 8 and received ustekinumab 90 mg subQ q8w on entry into the maintenance study with data from maintenance Week 0 through Week 156.
#Includes 1) data from maintenance Week 8 onward for patients who were in clinical response to ustekinumab IV induction dosing and were randomized to placebo subQ on entry into the maintenance study, up to the dose adjustment for patients who had dose adjustment during LTE; and 2) data for Week 0 of maintenance for patients who were in clinical response to placebo IV induction dosing and received placebo subQ on entry into the maintenance study.
**Infection as assessed by the investigator.
††Patients who had at least 1 positive sample at any time after their study agent administration of the induction study through the evaluation visit.
‡‡Denominator is patients with appropriate samples.
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. fda.gov/regulatory-information/search-fda-guidance-documents/immunogenicity-assessment-therapeutic-protein-products. Accessed October 2, 2019.
