Tildrakizumab

No data are available on the response to live or inactivated vaccines. Live vaccines should not be given concurrently with tildrakizumab.

There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tildrakizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of tildrakizumab during pregnancy.

It is unknown whether tildrakizumab is excreted in human milk. Available toxicological data in cynomolgus monkey have shown negligible levels of tildrakizumab in milk on postnatal day 28. In humans, during the first few days after birth antibodies may be transferred to the newborns through milk. In this short period, a risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tildrakizumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Women of childbearing potential

Women of childbearing potential should use an effective method of contraception during treatment and for at least 17 weeks after treatment.

Fertility

The effect of tildrakizumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.

Tildrakizumab has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

The most common adverse reactions are upper respiratory tract infections, headache, gastroenteritis, nausea, diarrhoea, injection site pain and back pain.

List of adverse reactions

Three placebo-controlled studies (Phase 2b and two Phase 3) were integrated to evaluate the safety of tildrakizumab in comparison to placebo. A total of 1,768 patients were evaluated (705 patients on 100 mg, 708 patients on 200 mg and 355 patients on placebo). These 355 patients on placebo were subsequently crossed over to tildrakizumab.

Adverse reactions 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).

Infections and infestations

Very common: Upper respiratory tract infections^a

Nervous system disorders

Common: Headache

Gastrointestinal disorders

Common: Gastroenteritis, Nausea, Diarrhoea

General disorders and administration site conditions

Common: Injection site pain, Back pain

^a Including nasopharyngitis.

Description of selected adverse reaction

Immunogenicity

In pooled Phase 2b and Phase 3 analyses 7.3% of tildrakizumab-treated patients developed antibodies to tildrakizumab. No apparent association between the development of antibodies to tildrakizumab to lower efficacy and the development of treatment emergent adverse events was observed.