0%). Tabulated list of adverse reactions Adverse reactions observed from clinical trials and post-marketing experience are presented in Table 1 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, undesirable effects are presented in order of decreasing seriousness. The frequencies are based on the initial treatment period of up to 16 weeks in the pool of 5 studies in the atopic dermatitis population.
Table 1:
List of adverse reactions MedDRA System Organ Class Frequency Adverse reaction Infections and infestations Very common Common Upper respiratory tract infections Conjunctivitis Blood and lymphatic system disorders Common Eosinophilia Eye disorders Common Uncommon Conjunctivitis allergic Keratitis General disorders and administration site conditions Common Injection site reactions The long-term safety of tralokinumab was assessed in 2 monotherapy studies up to 52 weeks, and in a combination study with topical corticosteroids up to 32 weeks.
The long-term safety of tralokinumab is further assessed in an open-label extension study (ECZTEND) for up to 5 years of treatment in adults and up to 2 years in adolescents 12 years and older with moderate-to-severe AD (atopic dermatitis) receiving 300 mg of tralokinumab every two weeks (Q2W).
The long-term safety data were generally consistent with the safety profile observed up to week 16 in the pool of 5 adult studies. 9%) in the initial treatment period of up to 16 weeks in the pool of 5 studies. 8%; initial treatment period).
Most patients recovered or were recovering during the treatment period. 0 events/100 patient years of exposure. 93 events/100 patient years of exposure. 5% of subjects treated with tralokinumab during the initial treatment period. Of these, half were classified as keratoconjunctivitis, all were non-serious and mild or moderate in severity, and none led to treatment discontinuation.
7 events/100 patient years of exposure. 11 events/100 patient years of exposure. 3% of patients treated with placebo during the initial treatment period of up to 16 weeks in the pool of 5 studies. Tralokinumab-treated patients had a greater mean initial increase from baseline in eosinophil count compared to patients treated with placebo.
3% of placebo-treated patients in the initial treatment period. However, the increase in the tralokinumab-treated patients was transient, and mean eosinophil counts returned to baseline during continued treatment. The safety profile for subjects with eosinophilia was comparable to the safety profile for all subjects.
5% of subjects in the placebo group in the initial treatment period of up to 16 weeks in the pool of 5 studies in atopic dermatitis. 2 events/100 patient years of exposure. 67 events/100 patient years of exposure. Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity with tralokinumab.
Anti-drug-antibody (ADA) responses were not associated with any impact on tralokinumab exposure, safety, or efficacy in patients receiving tralokinumab for up to 6 years (in phase 2/phase 3 atopic dermatitis studies followed by the long-term extension study ECZTEND).
No immunogenicity-related adverse events such as immune-complex disease, serum sickness/serum sickness-like reactions, or anaphylaxis were observed. 2% of patients treated with placebo. 0% had neutralising antibodies. ADA incidences in patients who received tralokinumab for up to 6 years (in phase 2/phase 3 atopic dermatitis studies followed by the long-term extension study ECZTEND) were similar to those observed after 52 weeks in ECZTRA 1 and 2.
0%) in the initial treatment period of up to 16 weeks in the pool of 5 studies. Across all treatment […]