Adverse reactions : תופעות לוואי

4.8    Undesirable effects
Summary of the safety profile
The most frequently reported adverse reactions were upper respiratory infections.
Tabulated list of adverse reactions
Adverse reactions for risankizumab from clinical studies (Table 1) are listed by MedDRA system organ class and are based on 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); and very rare (< 1/10 000).


SKY 360-600 API FEB24_CL                                                         Page 4 of 16 Table 1: List of adverse reactions
System Organ Class             Frequency                       Adverse reactions Infections and                 Very common                     Upper respiratory infestations                                                   infectionsa Common                          Tinea infectionsb
Uncommon                        Folliculitis
Nervous system                 Common                          Headachec disorders
Skin and subcutaneous          Common                          Pruritus tissue disorders
Rash
Uncommon                        Urticaria
General disorders and          Common                          Fatigued administration site
Injection site reactionse conditions a
Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis, laryngitis, peritonsillar abscess b
Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, onychomycosis, tinea infection c
Includes: headache, tension headache, sinus headache d
Includes: fatigue, asthenia e
Includes: injection site bruising, erythema, haematoma, haemorrhage, irritation, pain, pruritus, reaction, swelling, induration, hypersensitivity, nodule, rash, urticaria, vesicles, warmth


Description of selected adverse reactions
Infections
Psoriasis
Over the entire psoriasis programme including long-term exposure to risankizumab, the rate of infections was 75.5 events per 100 subject-years. The majority of cases were non-serious and mild to moderate in severity and did not lead to discontinuation of risankizumab. The rate of serious infections was 1.7 events per 100 subject-years (see section 4.4).
Crohn’s disease
The adverse drug reaction profile observed in patients with Crohn’s disease treated with risankizumab was consistent with the adverse drug reaction profile observed in patients with plaque psoriasis. No new adverse reactions were identified in risankizumab Crohn’s disease studies.
The majority of infections were non-serious and mild to moderate in severity and did not lead to discontinuation of risankizumab.
The rate of infections in the pooled data from the 12-week induction studies was 83.3 events per 100 subject-years in subjects treated with risankizumab 600 mg IV compared to 117.7 events per 100 subject-years in placebo. The rate of serious infections was 3.4 events per 100 subject-years in subjects treated with risankizumab 600 mg IV compared to 16.7 events per 100 subject-years in placebo (see section 4.4).


SKY 360-600 API FEB24_CL                                                                    Page 5 of 16 The rate of infections in the 52-week maintenance study was 57.7 events per 100 subject-years in subjects treated with risankizumab 360 mg SC after risankizumab induction compared to 76.0 events per 100 subject-years in subjects who received placebo after risankizumab induction. The rate of serious infections was 6.0 events per 100 subject-years in subjects treated with risankizumab 360 mg SC after risankizumab induction compared to 5.0 events per 100 subject-years in subjects who received placebo after risankizumab induction (see section 4.4).
Immunogenicity
As with all therapeutic proteins, there is the potential for immunogenicity with risankizumab. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.
For subjects with Crohn’s disease treated with risankizumab at the recommended IV induction and SC maintenance doses for up to 64 weeks in CD clinical trials, treatment-emergent anti-drug antibodies and neutralizing antibodies were detected in 3.4% (2/58) and 0% (0/58) of evaluated subjects, respectively.
Antibodies to risankizumab including neutralizing antibodies were not associated with changes in clinical response or safety.
Elderly
There is limited safety information in subjects aged ≥65 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 events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il