, and 3Adverse Reaction ILUMYA100mg
(N=705)
N (%)
Placebo
(N=355)
N (%)
Upper respiratory infections* 98 (14) 41 (12)
Injection site reactions† 24 (3) 7 (2)
Diarrhea 13 (2) 5 (1)
* Upper respiratory infections include nasopharyngitis, upper respiratory tract infection, viral upperrespiratory tract infection, and pharyngitis.
† Injection site reactions include injection site urticaria, pruritus, pain, reaction, erythema, inflammation,edema, swelling, bruising, hematoma, and hemorrhage.
During the placebo-controlled period of Trials 1, 2, and 3, adverse reactions that occurred at ratesless than 1% but greater than 0.1% in the ILUMYA group and at a higher rate than in the placebo groupincluded dizziness and pain in extremity.
Specific Adverse Reactions
Hypersensitivity Reactions
Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials [seeWarnings and Precautions (5.1)].
Infections
Infections were slightly more common in the ILUMYA group. The difference in frequency ofinfections between the ILUMYA group (23%) and the placebo group was less than 1% during theplacebo-controlled period. The most common (≥1%) infections were upper respiratory infections. Therates of severe infections for the ILUMYA group and the placebo group were ≤0.3%.
Safety Through Week 52/64
Through Week 52 (Trials 1 and 3) and Week 64 (Trial 2), no new adverse reactions were identifiedwith ILUMYA use and the frequency of the adverse reactions was similar to that observed during theplacebo-controlled period.
6.2 Immunogenicity
As with all therapeutic proteins there is the potential for immunogenicity. The detection of antibodyformation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observedincidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several
factors including assay methodology, sample handling, timing of sample collection, concomitantmedications, and underlying disease. For these reasons, comparison of incidence of antibodies totildrakizumab in the studies described below with the incidences of antibodies in other studies or to otherproducts may be misleading.
Up to Week 64, approximately 6.5% of subjects treated with ILUMYA 100 mg developed antibodiesto tildrakizumab. Of the subjects who developed antibodies to tildrakizumab, approximately 40% (2.5% ofall subjects receiving ILUMYA) had antibodies that were classified as neutralizing. Development ofneutralizing antibodies to tildrakizumab was associated with lower serum tildrakizumab concentrationsand reduced efficacy.
7 DRUG INTERACTIONS
7.1 Live Vaccinations
Avoid use of live vaccines in patients treated with ILUMYA [see Warnings and Precautions (5.4)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Limited available data with ILUMYA use in pregnant women are insufficient to inform a drugassociated risk of adverse developmental outcomes. Human IgG is known to cross the placental barrier;therefore, ILUMYA may be transferred from the mother to the fetus. An embryofetal developmental studyconducted with tildrakizumab in pregnant monkeys revealed no treatment-related effects to thedeveloping fetus when tildrakizumab was administered subcutaneously during organogenesis to near
parturition at doses up to 159 times the maximum recommended human dose (MRHD). When dosing wascontinued u |
