Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile

The most commonly reported adverse reaction is upper respiratory infections (18.9%), most frequently nasopharyngitis. The longer-term safety profile of deucravacitinib was similar and consistent with previous experience.

Tabulated list of adverse reactions

The following list of adverse reactions for deucravacitinib is from clinical trials in plaque psoriasis (Table 1). These reactions are presented by MedDRA System Organ Class and by frequency.

Frequencies are defined as: 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); not known (cannot be estimated from the available data).



Table 1: List of adverse reactions

System Organ Class                       Frequency                           Adverse reaction Infections and infestations                      Very common             Upper respiratory infectionsa Common                  Herpes simplex infectionsb
Uncommon                Herpes zoster
Gastrointestinal disorders                       Common                  Oral ulcersc Skin and subcutaneous tissue disorders           Common                  Acneiform rashd Folliculitis
Investigations                                    Common                 Blood creatine phosphokinase increased 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, and rhinotracheitis.
b
Herpes simplex infections include oral herpes, herpes simplex, genital herpes, 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, and papule.

Description of selected adverse reactions

Infections
In POETYK PSO-1 and POETYK PSO-2 (see section 5.1), 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).

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. Any suspected adverse event should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/.