Aimovig®: established safety profile in a broad range of patients1

Safety Across Pooled Pivotal Studies of Episodic and Chronic Migraine—at Month 31

Safety Across Pooled Pivotal Studies of Episodic and Chronic Migraine—at Month 31

Adverse reactions occurring with an incidence of at least 2% for either dose of Aimovig® and at least 2% greater than placebo through month 31
  • 90% of patients with episodic migraine completed the 6-month DBTP; <2% of patients receiving Aimovig® discontinued due to AEs1
  • 95% of patients completed the 3-month chronic migraine study; <2% of patients receiving Aimovig® discontinued due to AEs1

*Injection site reactions include multiple preferred terms, such as injection site pain and injection site erythema.1

The rate of injection site reactions reported is with the prefilled syringe.1

AE = adverse event; ATP = active treatment phase; DBTP = double-blind treatment phase; EM = episodic migraine; Ph = phase; QM = once a month.

*Injection site reactions include multiple preferred terms, such as injection site pain and injection site erythema.1

The rate of injection site reactions reported is with the prefilled syringe.1

Phase 3 episodic migraine active treatment phase (ATP) safety data and completion rates—6 months to 1 year

  • Treatment-emergent AEs were reported in 57.2% of patients in the 70 mg group (6.2% ≥Grade 3) and 55% in the 140 mg group (4.7% ≥Grade 3)1
  • Serious AEs were observed in 3.3% of patients in both the 70 mg and the 140 mg group1
  • Fatal AEs were reported in 1 patient (0.2%) treated in the 140 mg group1
  • Most frequent AEs were viral URI, URI, UTI, influenza, sinusitis, and arthralgia1
of patients with episodic migraine completed the STRIVE ATP (6 months to 1 year); 1.9% of patients discontinued due to AEs1,2,*

*The most frequently reported reasons (≥1.0% of total subjects) for discontinuation of Aimovig® were subject request (6.5%), lost to follow-up (2.0%), adverse event (1.9%), and protocol-specific criteria (1.2%).1,2

AE = adverse event; ATP = active treatment phase; EM = episodic migraine; Ph = phase; URI = upper respiratory tract infection; UTI = urinary tract infection.

*The most frequently reported reasons (≥1.0% of total subjects) for discontinuation of Aimovig® were subject request (6.5%), lost to follow-up (2.0%), adverse event (1.9%), and protocol-specific criteria (1.2%).1,2

Recently Released Data: Year 5

Safety demonstrated over 5 years in episodic migraine1,2

Phase 2 Episodic Migraine Open Label Treatment Phase (OLTP) Safety Data—Through 5 years1,2

Phase 2 Episodic Migraine Open Label Treatment Phase (OLTP) Safety Data—Through 5 years1,2

The safety profile observed in the OLTP was consistent with what was observed in the double-blind treatment phase (DBTP)2
  • Most frequent AEs in OLTP were nasopharyngitis, upper respiratory tract infection, influenza, and sinusitis2,3,†
  • 56.4% of patients completed the 5-year phase 2 EM open-label treatment phase; 5.0% of patients discontinued due to AEs2,‡

Patient-years of exposure was used in this calculation to account for different lengths of treatment periods experienced by each patient.

*One fatality, previously reported, due to arteriosclerosis occurred in patient with history of hypertension and left anterior hemiblock (ECG), who on autopsy showed evidence of severe coronary artery disease and presence of cardiac stimulants (liver tissue) -considered not related to investigational product by investigator. The other fatality was attributed to death unattended.1,2

Events with ≥4.2 patients per 100 patient years in the Aimovig® 70 mg/140 mg group.3

Phase 2 EM OLTP: The most frequently reported reasons (≥1.0% of total subjects) for discontinuation of Aimovig® were subject request (21.9%), other (7.8%), adverse event (5.0%), lost to follow-up (3.4%), lack of efficacy (3.1%), and non-compliance (1.8%).2

AE = adverse event; ATP = active treatment phase; ECG = electrocardiogram; EM = episodic migraine; n = number of patients reporting at least 1 occurrence of event; Ph = phase; QM = once a month; r = exposure-adjusted rate per 100 patient-years (n/e x 100).

Patient-years of exposure was used in this calculation to account for different lengths of treatment periods experienced by each patient.

*One fatality, previously reported, due to arteriosclerosis, occurred in patient with history of hypertension and left anterior hemiblock (ECG), who on autopsy showed evidence of severe coronary artery disease and presence of cardiac stimulants (liver tissue) -considered not related to investigational product by investigator.2 The other fatality was attributed to death unattended.1,2

Events with ≥4.2 patients per 100 patient years in the Aimovig® 70 mg/140 mg group.3

Phase 2 EM OLTP: The most frequently reported reasons (≥1.0% of total subjects) for discontinuation of Aimovig® were subject request (21.9%), other (7.8%), adverse event (5.0%), lost to follow-up (3.4%), lack of efficacy (3.1%), and non-compliance (1.8%).2