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STELARA® has an established safety profile that remained generally consistent throughout the 152-week safety analysis
STELARA® adverse event profile
The most common adverse reaction (>5%) in controlled periods of the UC clinical study UNIFI-I with STELARA® I.V.
UNIFI-I*
|
| |
STELARA® I.V.
~6 mg/kg |
Placebo |
| Nasopharyngitis |
5.6% |
2.8% |
Adapted from the Product Monograph.
The most common adverse reactions (>5%) in controlled periods of the UC clinical study UNIFI-M with STELARA®
UNIFI-M‡
|
| |
STELARA®
90 mg Q8W |
Placebo |
| Nasopharyngitis |
14.8% |
16.0% |
| Headache |
10.2% |
4.0% |
| Upper respiratory tract infection |
9.1% |
4.6% |
Adapted from the Product Monograph.
In the placebo-controlled periods of PsO, PsA, CD and UC clinical trials
| |
STELARA®/STELARA® I.V. |
Placebo |
Infection rate
(per patient-year) |
1.36 |
1.34 |
Serious infection rate
(per patient-year) |
0.03 |
0.03 |
Malignancy rate: Non-melanoma skin cancer
(per 100 patient-years) |
0.43 |
0.46 |
Malignancy rate: Malignancies excluding non-melanoma skin cancer
(per 100 patient-years) |
0.11 |
0.23 |
| In CD and UC studies |
|
STELARA® I.V. |
Placebo |
| Infusion-related adverse events during or within 1 hour of infusion**(% of patients) |
1.9% |
2.2% |
Adapted from the Product Monograph.
** In post-marketing experience, serious allergic reactions, including anaphylaxis and angioedema, have been reported. If an anaphylactic or other serious allergic reaction occurs, institute appropriate therapy, and administration of STELARA®/STELARA® I.V. should be discontinued.