Spevigo Adverse Reactions

Summary of the safety profile: The most frequent adverse reactions are infections (17.1%) with urinary tract infection reported as serious in 1 patient (2.9%).
Tabulated list of adverse reactions: Table 3 provides a list of the adverse reactions reported from clinical trials. The adverse reactions are listed by MedDRA System Organ Class (SOC) and frequency category using 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), very rare (< 1/10 000), not known (frequency cannot be estimated from the available data). (See Table 3.)

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Description of selected adverse reactions: Infections: During the 1-week placebo-controlled period in Effisayil 1, infections were reported in 17.1% of patients treated with spesolimab compared with 5.6% of patients treated with placebo. Serious infection (urinary tract infection) was reported in 1 patient (2.9%) in the spesolimab group and no patients in the placebo group. Infections observed in clinical trials with spesolimab were generally mild to moderate with no distinct pattern regarding pathogen or type of infection.
Injection site reactions: Injection site reactions include injection site erythema, injection site swelling, injection site pain, injection site induration, and injection site warmth. Injection site reactions were typically mild-to-moderate in severity.
Immunogenicity: In patients with GPP treated with spesolimab in Effisayil 1, anti-drug antibodies (ADA) formed with a median onset of 2.3 weeks. Following intravenous administration of spesolimab 900 mg, 24% of patients had a maximum ADA titer greater than 4,000 and were Neutralising antibody-positive by end of the trial (weeks 12 to 17). Females appeared to have higher immunogenicity response; the percentage of patients with ADA titer greater than 4,000 was 30% in females, and 12% in males, respectively.
In some patients with ADA titer values > 4,000, plasma spesolimab concentrations were reduced, with no apparent impact on pharmacokinetics at ADA titers below 4,000.
As the majority of patients did not experience a subsequent new flare in Effisayil 1, the data on re-treatment of patients with ADA (n = 4) is limited. It is currently unknown if there is a correlation between the presence of ADA to spesolimab and maintenance of efficacy or hypersensitivity reactions upon re-treatment.
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.