Summary of the safety profile: A total of over 2,500 patients (more than 2,600 patient years) have been treated with Aimovig in registration studies. Of these, more than 1,300 patients were exposed for at least 12 months.
The reported adverse drug reactions for 70 mg and 140 mg were injection site reactions (5.6%/4.5%), constipation (1.3%/3.2%), muscle spasms (0.1%/2.0%) and pruritus (0.7%/1.8%). Most of the reactions were mild or moderate in severity. Less than 2% of patients in these studies discontinued due to adverse events.
Tabulated list of adverse reactions: Table 3 lists all adverse drug reactions that occurred in Aimovig-treated patients during the 12-week placebo-controlled periods of the studies. Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is 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); very rare (<1/10,000). (See Table 3.)
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Description of selected adverse reactions: Injection site reactions: In the integrated 12-week placebo-controlled phase of the studies, injection site reactions were mild and mostly transient. There was one case of discontinuation in a patient receiving the 70 mg dose due to injection site rash. The most frequent injection site reactions were localised pain, erythema and pruritus. Injection site pain typically subsided within 1 hour after administration.
Cutaneous and hypersensitivity reactions: In the integrated 12-week placebo-controlled phase of studies, non-serious cases of rash, pruritus, swelling/oedema and urticaria were observed, which in the majority of cases were mild and did not lead to treatment discontinuation.
Cases of anaphylactoid reactions and angiodoema were also observed in the post-marketing setting.
Constipation: In the integrated 12-week placebo-controlled phase of the studies, 28 cases of constipation were reported out of 1,400 Aimovig-treated patients. All were mild or moderate in severity. A majority of the cases (23) had onset within one month after the first dose; however, some patients also presented with constipation later on in the treatment. In most cases (18), constipation resolved within three months. All but one patient continued treatment.
Constipation with serious complications has been reported in the post-marketing setting. In a majority of these cases, the onset was reported after the first dose of Aimovig; however patients have also experienced these events later on in the treatment. Many of the cases of constipation with serious complications were reported in patients with a history of constipation or concurrently using medicinal products associated with decreased gastrointestinal motility. In some severe cases hospitalisation was required.
Immunogenicity: In the clinical studies, the incidence of anti-erenumab antibody development during the double-blind treatment phase was 6.3% (56/884) among subjects receiving a 70 mg dose of erenumab (3 of whom had in vitro neutralising activity) and 2.6% (13/504) among subjects receiving a 140 mg dose of erenumab (none of whom had in vitro neutralising activity). There was no impact of anti-erenumab antibody development on efficacy or safety.