infection prior to initiating treatment with SKYRIZI.
Across the Phase 3 psoriasis clinical studies, of the 72 subjects with latent TB who wereconcurrently treated with SKYRIZI and appropriate TB prophylaxis during thestudies, nonedeveloped active TB during the mean follow-up of 61 weeks on SKYRIZI.
Two subjects takingisoniazid for treatment of latent TB discontinued treatment due to liver injury. Of the 31 subjectsfrom the IMMHANCE study with latent TB who did not receive prophylaxis during the study,none developed active TB during the mean follow-up of 55 weeks on SKYRIZI. Consider antiTBtherapy prior to initiating SKYRIZI in patients with a past history of latent or active TB inwhom an adequate course of treatment cannot be confirmed. Monitor patients for signs andsymptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI topatients with active TB.
5.3 Immunizations
Prior to initiating therapy with SKYRIZI, consider completion of all age appropriateimmunizations according to current immunization guidelines. Avoid use of live vaccines inpatients treated with SKYRIZI. No data are available on the response to live or inactive vaccines.
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of labeling:
• Infections [see Warnings and Precautions (5.1)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse drug reactionrates observed in the clinical trials of a drug cannot be directly compared to rates in the clinicaltrials of another drug and may not reflect the rates observed in practice.
A total of 2234 subjects were treated with SKYRIZI in clinical development studies in plaquepsoriasis. Of these, 1208 subjects with psoriasis were exposed to SKYRIZI for at least one year.
Data from placebo- and active-controlled studies were pooled to eva luate the safety of SKYRIZIfor up to 16 weeks. In total, 1306 subjects were eva luated in the SKYRIZI 150 mg group.
Table 1 summarizes the adverse drug reactions that occurred at a rate of at least 1% and at ahigher rate in the SKYRIZI group than the placebo group during the 16-week controlled periodof pooled clinical studies.
Table 1. Adverse Drug Reactions Occurring in ≥ 1% of Subjects on SKYRIZI throughWeek 16
Adverse Drug Reactions
SKYRIZI
N = 1306
n (%)
Placebo
N = 300
n (%)
Upper respiratory infectionsa
170 (13.0) 29 (9.7)
Headacheb
46 (3.5) 6 (2.0)
Fatiguec
33 (2.5) 3 (1.0)
Injection site reactionsd
19 (1.5) 3 (1.0)
Tinea infectionse
14 (1.1) 1 (0.3)
a Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute),rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis
b Includes: headache, tension headache, sinus headache, cervicogenic headache
c Includes: fatigue, asthenia
d Includes: injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection,inflammation, irritation, pain, pruritus, reaction, swelling, warmth
e Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, tinea infection。
Adverse drug reactions that occurred in < 1% but > 0.1% of subjects in the SKYRIZI group andat a higher rate than in the placebo group through Week 16 were folliculitis and urticaria.
Specific Adverse Drug Reactions
Infections
In the first 16 weeks, infections occur |
