opharyngeal pain
Gastrointestinal disorders
Common
Diarrhoea
Nausea
Musculoskeletal and connective tissue disorders
Common
Arthralgia
Myalgia
General disorders and administration site conditions
Common
Fatigue
Injection site reactions (including injection site erythema, pain, pruritus, bruising, haemorrhage)
Description of selected adverse reactions
Infections
During the 12-week placebo-controlled trial period in plaque psoriasis, infections were reported in 25.4% of patients treated with Kyntheum compared with 23.4% of patients treated with placebo. The majority of infections consisted of nasopharyngitis, upper respiratory tract infection, pharyngitis, urinary tract infections, bronchitis, and influenza, which did not necessitate treatment discontinuation. Serious infections occurred in 0.5% of patients treated with Kyntheum and in 0.2% of patients treated with placebo. Higher rates of fungal infections, primarily non-serious skin and mucosal candida infections, were observed in Kyntheum patients compared to placebo patients, 1.8% vs 0.9%, respectively. One serious case of cryptococcal meningitis and one serious case of coccidioidies infection were observed in clinical trials (see section 4.4).
Through Week 52, the exposure-adjusted event rates (per 100 patient-years) for infections were 114.6 for patients treated with Kyntheum and 118.1 for patients treated with ustekinumab. The exposure-adjusted event rates (per 100 patient-years) for serious infections were 1.3 for patients treated with Kyntheum and 1.0 for patients treated with ustekinumab.
Neutropenia
During the 12-week placebo-controlled period of clinical trials, neutropenia was reported in 0.8% of patients treated with Kyntheum compared with 0.5% of patients treated with placebo. Most adverse reactions of Kyntheum-associated neutropenia observed were mild, transient and reversible.
Neutropenia Grade 3 and 4 were reported in 0.4% of patients receiving Kyntheum compared to 0.2% of patients who received ustekinumab and none in patients receiving placebo. No serious infections were associated with neutropenia.
Immunogenicity
Antibodies to brodalumab developed in 2.7% (122/4461) of patients treated with Kyntheum for up to 52 weeks in psoriasis clinical trials (0.3% of these patients had anti-brodalumab antibodies at baseline). Of these patients, none had neutralising antibodies.
No evidence of altered pharmacokinetic profile, clinical response, or safety profile was associated with anti-brodalumab antibody development.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Doses up to 700 mg intravenously have been administered in clinical trials with no evidence of dose limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors, ATC code: L04AC12
Mechanism of action
Brodalumab is a recom |
