Ilumetri Adverse Reactions

Summary of the safety profile: The most common adverse reactions are upper respiratory tract infections (12.6%), headache (4.0%), diarrhoea (1.6%), gastroenteritis (1.5%), back pain (1.5%), nausea (1.3%) and injection site pain (1.3%).
Tabulated list of adverse reactions: Adverse reactions from clinical studies (see Table 3) are listed by MedDRA system organ class (SOC) and frequency, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); and not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

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Description of selected adverse reaction: Immunogenicity: In pooled Phase 2b and Phase 3 analyses 7.3% of tildrakizumab-treated patients developed antibodies to tildrakizumab up to week 64. Of the subjects who developed antibodies to tildrakizumab, 38% (22/57 patients) had neutralizing antibodies. This represents 2.8% of all subjects receiving tildrakizumab.
In pooled phase 3 analyses, 8.3% of tildrakizumab-treated patients developed antibodies to tildrakizumab up to 420 weeks of treatment. Of the tildrakizumab-treated patients who developed antibodies to tildrakizumab, 35% (36/102 patients) had antibodies that were classified as neutralizing, which represents 2.9% of all tildrakizumab-treated patients.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.