4). 2%) were reported in prurigo nodularis. Tabulated list of adverse reactions Table 1 includes all adverse reactions observed in clinical studies presented by system organ class and frequency, using the following categories: 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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1:
List of adverse reactions MedDRA System Organ Class Frequency Adverse reactions Infections and infestations Common Superficial fungal infections*# Blood and lymphatic system disorders Uncommon Eosinophilia† Immune system disorders Common Type I hypersensitivity (incl.
urticaria† and angioedema*) Nervous system disorders Common Headache* (incl. tension headache) Respiratory, thoracic and mediastinal disorders Common Worsening of asthma* (incl. asthma, wheezing, peak expiratory flow rate decreased) Skin and subcutaneous tissue disorders Common Uncommon Atopic dermatitis* Eczema* Eczema nummular* Bullous pemphigoid§ General disorders and administration site conditions Common Injection site reactions (incl.
erythema, pruritus, haematoma†, pain†, irritation†, bruising*, and injection site oedema†) †Occurred in atopic dermatitis studies *Occurred in prurigo nodularis studies #Superficial fungal infections include: body tinea, tinea pedis, onychomycosis, fungal infection, tinea versicolor, tinea cruris, fungal skin infection and fungal foot infection §From post-marketing reporting Description of selected adverse reactions Hypersensitivity Type 1 hypersensitivity reactions (Ig-E mediated reactions), including mild urticaria and mild facial (peri-ocular) angioedema, were commonly observed in subjects treated with nemolizumab during the clinical studies.
4). 0%) compared to patients treated with placebo. Headache was more frequently observed in female patients in both groups. In the nemolizumab group, headache was mostly mild or moderate in severity and did not lead to discontinuation of treatment.
7%) patients experienced a worsening of asthma (WOA) after initiation of nemolizumab, 5 of whom had a body weight > 90 kg and received 60 mg nemolizumab every 4 weeks. In the population of PN patients with pre-existing asthma, WOA was 3 times more frequent in patients with a body weight > 90 kg who received 60 mg nemolizumab every 4 weeks than in patients with a body weight < 90 kg who received 30 mg nemolizumab every 4 weeks.
The majority of WOA events occurred within the first two months of treatment initiation and all were reported as mild or moderate in severity. Most patients experienced a single event of WOA during treatment and the event resolved with standard of care asthma medications (inhalers) without the use of systemic steroids.
None led to permanent discontinuation of treatment. The incidence of WOA did not increase with longer term exposure to nemolizumab (up to Week 52) in the PN open-label long- term extension study. 5%). These eczematous reactions were mild or moderate in severity.
5%) patients. Patients > 65 years of age had a higher rate of eczematous reactions. Eosinophilia Proportion of patients with clinically significant elevated eosinophils (> 700 cells/mcL) was 10,2% in the AD population (in the initial period) and 5,5% in the PN population.
Severe eosinophilia (> 5000 cells/mcL) was not observed in AD nemolizumab-treated patients in the initial treatment period. 2% of AD patients treated with nemolizumab during the initial treatment period up to Week 16. All events in AD subjects were mild in intensity and not associated with clinical symptoms.
No TEAE of eosinophilia led to discontinuation of treatment. Apart from one case of eosinophilic colitis in an AD subject with other atopic comorbidities, there were no other reports of eosinophilic disorders. Paediatric population Atopic dermatitis Adolescents (12 to 17 years of age) The safety of nemolizumab was assessed in 176 paediatric subjects 12 to 17 years of age with moderate- to-severe atopic dermatitis enrolled in the ARCADIA 1 and ARCADIA 2 studies.
The safety profile of nemolizumab in these subjects through Week 16 was similar to the safety profile seen in adults with atopic dermatitis. 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.