ates of serious infections for the ILUMYA group and the placebo group were ≤0.3%.Treatment with ILUMYA should not be initiated in patients with any clinically important active infectionuntil the infection resolves or is adequately treated.In patients with a chronic infection or a history of recurrent infection, consider the risks and benefitsprior to prescribing ILUMYA. Instruct patients to seek medical help if signs or symptoms of clinicallyimportant chronic or acute infection occur. If a patient develops a clinically important or serious infectionor is not responding to standard therapy, monitor the patient closely and consider discontinuation of
ILUMYA until the infection resolves [see Adverse Reactions (6.1)].
5.3 Pretreatment eva luation for Tuberculosis
eva luate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Initiatetreatment of latent TB prior to administering ILUMYA. In clinical trials, of 55 subjects with latent TB whowere concurrently treated with ILUMYA and appropriate TB prophylaxis, no subjects developed active TB(during the mean follow-up of 56.5 weeks). One other subject developed TB while receiving ILUMYA.
Monitor patients for signs and symptoms of active TB during and after ILUMYA treatment. Consider antiTBtherapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom anadequate course of treatment cannot be confirmed. Do not administer ILUMYA to patients with active TBinfection.
5.4 Immunizations
Prior to initiating therapy with ILUMYA, consider completion of all age appropriate immunizationsaccording to current immunization guidelines. Avoid the use of live vaccines in patients treated withILUMYA. No data are available on the response to live or inactive vaccines.
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
Infections [see Warnings and Precautions (5.2)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction ratesobserved in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of anotherdrug and may not reflect the rates observed in practice.
In clinical trials, a total of 1994 subjects with plaque psoriasis were treated with ILUMYA, of which1083 subjects were treated with ILUMYA 100 mg. Of these, 672 subjects were exposed for at least 12months, 587 for 18 months, and 469 for 24 months.
Data from three placebo-controlled trials (Trials 1, 2, and 3) in 705 subjects (mean age 46 years,71% males, 81% white) were pooled to eva luate the safety of ILUMYA (100 mg administeredsubcutaneously at Weeks 0 and 4, followed by every 12 weeks [Q12W]) [see Clinical Studies (14)].
Placebo-Controlled Period (Weeks 0-16 of Trial 1 and Weeks 0-12 of Trials 2 and 3)In the placebo-controlled period of Trials 1, 2, and 3 in the 100 mg group, adverse events occurredin 48.2% of subjects in the ILUMYA group compared to 53.8% of subjects in the placebo group. The ratesof serious adverse events were 1.4% in the ILUMYA group and 1.7% in the placebo group.
Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higherrate in the ILUMYA group than in the placebo group.
Table 1: Adverse Reactions Occurring in ≥1% of Subjects in the ILUMYA Group and MoreFrequently than in the Placebo Group in the Plaque Psoriasis Trials 1, 2 |
