For the treatment of adult patients with moderately to severely active CD
STELARA® HAS A PROVEN SAFETY PROFILE THROUGH
5 YEARS (FROM PHASE 3 STUDIES AND OPEN-LABEL LTE)1,2
The safety of STELARA® was evaluated in 1,407 patients with moderately to severely active CD (CDAI ≥220 and ≤450) in 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter studies through 1 year.
The overall safety profile of STELARA® in CD through 1 year was consistent with that seen in other approved indications.1
Common Adverse Reactions Through Week 8 in 2 Single IV Induction Studies
≥3% of patients treated with STELARA® and higher than placebo | STELARA® 6 mg/kg IV single dose (N=470) | Placebo (N=466) |
---|---|---|
Vomiting | 4% | 3% |
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*
≥3% of patients treated with STELARA® and higher than placebo | STELARA® 90 mg subQ every 8 weeks (N=131) | Placebo (N=133)† |
---|---|---|
Nasopharyngitis | 11% | 8% |
Injection-site erythema | 5% | 0 |
Vulvovaginal candidiasis/mycotic infection | 5% | 1% |
Bronchitis | 5% | 3% |
Pruritus | 4% | 2% |
Urinary tract infection | 4% | 2% |
Sinusitis | 3% | 2% |