Deucravacitinib

Prior to initiating therapy with deucravacitinib, consider completion of all age-appropriate immunisations according to current immunisation guidelines. Use of live vaccines in patients being treated with deucravacitinib should be avoided. The response to live or non-live vaccines has not been evaluated.

Caution should be exercised when considering the use of deucravacitinib in patients with a chronic infection or a history of recurrent infection.

There is a limited amount of data on the use of deucravacitinib in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of deucravacitinib during pregnancy.

It is unknown whether deucravacitinib/metabolites are excreted in human milk. Available data in animals have shown excretion of deucravacitinib in milk.

A risk to the newborns/infants by breast-feeding cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from deucravacitinib therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

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

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

Summary of the safety profile

The most commonly reported adverse reaction was upper respiratory infections (18.9% in plaque psoriasis studies and 15.1% in psoriatic arthritis studies). Overall, the safety profile observed in psoriatic arthritis patients treated with deucravacitinib was consistent with the safety profile observed in patients with plaque psoriasis. The longer-term safety profile of deucravacitinib was similar and consistent with previous experience.

Tabulated list of adverse reactions

Adverse reactions for deucravacitinib from clinical studies are listed by MedDRA System Organ Class and are based on the following conventions: 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 the available data).

List of adverse reactions:

^a Upper respiratory infections include nasopharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, pharyngitis, sinusitis, acute sinusitis, rhinitis, tonsillitis, peritonsillar abscess, laryngitis, tracheitis, pharyngotonsillitis, and rhinotracheitis.
^b Herpes simplex infections include oral herpes, herpes simplex, genital herpes, herpes ophthalmic, and herpes viral infection.
^c Oral ulcers include aphthous ulcer, mouth ulceration, tongue ulceration, and stomatitis.
^d Acneiform rash includes acne, dermatitis acneiform, rash, rosacea, pustule, rash pustular, rash papular, and papule.

Description of selected adverse reactions

Infections

In POETYK PSO-1 and POETYK PSO-2, infections occurred in 29.1% of patients in the deucravacitinib group (116.0 events per 100 person-years) compared to 21.5% of patients in the placebo group (83.7 events per 100 person-years) during the first 16 weeks. The majority of infections were non-serious and mild to moderate in severity and did not lead to discontinuation of deucravacitinib. The incidence of serious infections in the deucravacitinib group was 0.6% (2.0 events per 100 person-years) and in the placebo group was 0.5% (1.6 events per 100 person-years).

The rate of infections in the deucravacitinib group did not increase through week 52 (95.4 events per 100 person-years). The rate of serious infections in the deucravacitinib group did not increase through week 52 (1.7 events per 100 person-years).

Overall, the rate of infections including serious infections observed in psoriatic arthritis patients treated with deucravacitinib was consistent with that observed in patients with plaque psoriasis.