AND PRECAUTIONS (5.6)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Psoriasis
The safety data reflect exposure to STELARA® in 3117 psoriasis subjects, including 2414 exposed for at least 6 months, 1855 exposed for at least one year, 1653 exposed for at least two years, 1569 exposed for at least three years, 1482 exposed for at least four years and 838 exposed for at least five years.
Table 2 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the STELARA® groups than the placebo group during the placebo-controlled period of Ps STUDY 1 and Ps STUDY 2 [see CLINICAL STUDIES (14)].
Table 2: Adverse reactions reported by ≥1% of subjects through Week 12 in Ps STUDY 1 and Ps STUDY 2
STELARA®
Placebo 45 mg 90 mg
Subjects treated 665 664 666
Nasopharyngitis 51 (8%) 56 (8%) 49 (7%)
Upper respiratory tract infection 30 (5%) 36 (5%) 28 (4%)
Headache 23 (3%) 33 (5%) 32 (5%)
Fatigue 14 (2%) 18 (3%) 17 (3%)
Diarrhea 12 (2%) 13 (2%) 13 (2%)
Back pain 8 (1%) 9 (1%) 14 (2%)
Dizziness 8 (1%) 8 (1%) 14 (2%)
Pharyngolaryngeal pain 7 (1%) 9 (1%) 12 (2%)
Pruritus 9 (1%) 10 (2%) 9 (1%)
Injection site erythema 3 (<1%) 6 (1%) 13 (2%)
Myalgia 4 (1%) 7 (1%) 8 (1%)
Depression 3 (<1%) 8 (1%) 4 (1%)
Adverse reactions that occurred at rates less than 1% in the controlled period of Ps STUDIES 1 and 2 through week 12 included: cellulitis, herpes zoster, diverticulitis and certain injection site reactions (pain, swelling, pruritus, induration, hemorrhage, bruising, and irritation).
One case of RPLS occurred during clinical studies [see WARNINGS AND PRECAUTIONS (5.6)].
Infections
In the placebo-controlled period of clinical studies of psoriasis subjects (average follow-up of 12.6 weeks for placebo-treated subjects and 13.4 weeks for STELARA®-treated subjects), 27% of STELARA®-treated subjects reported infections (1.39 per subject-year of follow-up) compared with 24% of placebo-treated subjects (1.21 per subject-year of follow-up). Serious infections occurred in 0.3% of STELARA®-treated subjects (0.01 per subject-year of follow-up) and in 0.4% of placebo-treated subjects (0.02 per subject-year of follow-up) [see WARNINGS AND PRECAUTIONS (5.1)].
In the controlled and non-controlled portions of psoriasis clinical studies (median follow-up of 3.2 years), representing 8998 subject-years of exposure, 72.3% of STELARA®-treated subjects reported infections (0.87 per subject-years of follow-up). Serious infections were reported in 2.8% of subjects (0.01 per subject-years of follow-up).
Malignancies
In the controlled and non-controlled portions of psoriasis clinical studies (median follow-up of 3.2 years, representing 8998 subject-years of exposure), 1.7% of STELARA®-treated subjects reported malignancies excluding non-melanoma skin |
