1. Medicines
  2. Neuroscience
  3. AIMOVIG® (erenumab)
  4. Efficacy

Efficacy

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Prescribing Information

Aimovig® is a potent and selective CGRP receptor antagonist being studied in both episodic and chronic migraine patients.1

Expand each section below to learn more about the Aimovig® efficacy data across the migraine spectrum.

Reference

  1. Aimovig SmPC available at www.medicines.ie [accessed July 2021]

Efficacy of Aimovig® in Episodic Migraine Patients

  • In a phase 3 pivotal study of episodic migraine patients, 50% of patients achieved a ≥50% reduction in mean monthly migraine days (MMD) from baseline with Aimovig 140mg.1,2
  • Overall 43% of patients receiving 70mg achieved a ≥50% reduction in mean monthly migraine days from baseline.1,2

 

These patients achieved a reduction of 3.2 and 3.7 mean monthly migraine days at 6 months, for the 70mg and 140mg respectively.2

 

Aimovig® has been evaluated in a 5-year long-term extension study.5 The data suggests that benefits with Aimovig® can improve over time among responders.3-5 Of the patients that continued treatment with Aimovig over a 5-year period, 71% achieved a           ≥50% reduction, 47.1% achieved a ≥75% reduction and 35.5% achieved a 100% reduction in MMD during the last 4 weeks of treatment compared to baseline.5

 

 

 

Reference

  1. Aimovig SmPC available at www.medicines.ie [accessed July 2021]
  2. Goadsby PJ, et al. N Engl J Med 2017; 377: 2123-2132.
  3. Ashina M, et al. Neurology 2017; 89(12): 1237-1243.
  4. Ashina M, et al. Headache 2019; 59 (Suppl 1): 25.
  5. Ashina M, et al. Eur J Neurol. 2021 28(5):1716-1725
  6. Sun H, et al. Lancet Neurol 2016; 15: 382-390.

Efficacy of Aimovig® in Chronic Migraine Patients

Aimovig® has also been shown to reduce monthly migraine days for chronic migraine patients.1,2

 

During a phase 2 pivotal study, patients receiving Aimovig 70 mg and 140 mg experienced significant reductions in MMD of 6.6 days from baseline at week 12 compared to a 4.2 day reduction in the placebo arm.2

For the  sub-group of patients with a response at a 100% threshold, an even greater reduction in MMD was observed than in the overall Aimovig® treated population. This sub-group analysis shows that patients who respond to treatment with Aimovig® can achieve a reduction of up to 15 monthly migraine days compared to the overall treated population.3

This reduction was sustained for up to 1 year in the open-label extension of the study.4 Pooled across the two doses, patients achieved a mean reduction of 9.3 monthly migraine days.4

 

Dashed lines indicate transition from end of parent study to Week 4 of OLTP. *Patients completing 52 weeks of IP. Of the 609 patients enrolled in the OLTP phase, 469 patients completed 52 weeks of IP (70mg N=266, 140mg N=203). Of these patients, 379 patients (70mg n=214, 140mg n=165) were available for analysis at the corresponding visit at Week 52. Baseline mean MMD for DTBP: placebo 18.2, Aimovig® 70mg 17.9, Aimovig® 140mg 17.8.3 Baseline mean MMD for OLTP: 18.1. CI, confidence interval; DBTP, double-blind treatment phase; IP, investigational product; MMD, monthly migraine days; OLTP, open-label treatment phase.

 

Aimovig has also been shown to reduce monthly migraine days in patients who have failed ≥3 prior prophylactic treatments.5

In a subgroup analysis of patients in the open label treatment phase, Aimovig® led to a sustained reduction in monthly migraine days in this difficult to treat patient cohort.5 Almost one in two chronic migraine patients with ≥3 prior treatment failures achieved a ≥50% reduction in MMD with Aimovig® at 52 weeks.5

References

  1. Aimovig SmPC available at www.medicines.ie [accessed July 2021]
  2. Tepper S, et al. Lancet Neurol 2017; 16: 425-434.
  3. Brandes JL, et al. Cephalalgia 2019. DOI: 10.1177/0333102419894559.
  4. Tepper SJ, et al. Poster PF115LB. AHS, San Francisco; June 28-July 1, 2018.
  5. Weatherall, M. et al. Poster IHC-PO-175. IHC, Dublin, Ireland, 5–8 September, 2019
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IE 154241 September 2021
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*AIMOVIG® IS PCRS REIMBURSABLE FOR CHRONIC MIGRAINE PATIENTS WITH THREE OR MORE PREVIOUS PROPHYLACTIC TREATMENT FAILURES.
ABBREVIATED PRESCRIBING INFORMATION

▼ Aimovig® (erenumab) 70 mg and 140 mg solution for injection in pre-filled pen

Important note: Before prescribing, consult full prescribing information.

Presentation: Aimovig 70 mg solution for injection in pre-filled pen. Each pre-filled pen contains 70 mg erenumab. Aimovig 140 mg solution for injection in pre-filled pen. Each pre-filled pen contains 140 mg erenumab.

Indications: Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

Dosage and administration: Adults: The recommended dose of Aimovig is 70 mg administered subcutaneously every 4 weeks. Some patients may benefit from a dosage of 140 mg once every 4 weeks. Each 140 mg dose is given either as one subcutaneous injection of 140 mg or as two subcutaneous injections of
70 mg. Aimovig is intended for patient self-administration in the abdomen, thigh, or, if someone else is giving the injection, also into the outer area of the upper arm. Administration should be performed by an individual who has been trained to administer the product. The needle cover of Aimovig prefilled pen contains dry natural rubber, which may cause allergic reactions in individuals sensitive to latex.

Special populations: Paediatric patients: The safety and effectiveness of Aimovig has not been studied in paediatric patients.

Elderly (aged 65 years and over): The safety and effectiveness of Aimovig has not been studied in elderly patients. No dose adjustment is necessary as the pharmacokinetics of erenumab are not affected by age.

Renal impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment.

Hepatic impairment: No studies have been performed in patients with hepatic impairment. Hepatic clearance is not a major clearance pathway for erenumab.

Contraindications: Hypersensitivity to the active substance or to any of the excipients.

Warnings and precautions: Hypersensitivity reactions: Serious hypersensitivity reactions, including rash, angioedema, and anaphylactic reactions, have been reported with erenumab in post-marketing experience. These reactions may occur within minutes, although some may occur more than one week after treatment. In that context, patients should be warned about the symptoms associated with hypersensitivity reactions. If a serious or severe hypersensitivity reaction occurs, initiate appropriate therapy and do not continue treatment with erenumab. Constipation: Constipation is a common undesirable effect of Aimovig and is usually mild or moderate in intensity. In a majority of the cases, the onset was reported after the first dose of Aimovig; however patients have also experienced constipation later on in the treatment. In most cases constipation resolved within three months. In the post marketing setting, constipation with serious complications has been reported with erenumab. In some of these cases hospitalisation was required, including cases where surgery was necessary. History of constipation or the concurrent use of medicinal products associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation related complications. Patients should be warned about the risk of constipation and advised to seek medical attention in case constipation does not resolve or worsens. Patients should seek medical attention immediately if they develop severe constipation. Constipation should be managed promptly as clinically appropriate. For severe constipation, discontinuation of treatment should be considered. Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Latex sensitive individuals: The removable cap of the Aimovig pre-filled pen contains dry natural rubber latex, which may cause Allergic reactions in individuals sensitive to latex Pregnancy, lactation, fertility: Pregnancy: There are a limited amount of data from the use of erenumab in pregnant women. As a precautionary measure it is preferable to avoid the use of Aimovig during pregnancy. Lactation: It is not known whether erenumab is present in human milk. The use of Aimovig could be considered during breastfeeding only if clinically needed. Fertility: There is no data available on the impact of Aimovig on male and female fertility. Animal studies showed no impact on female and male fertility.

Adverse drug reactions: Common (≥1/100 to <1/10): Hypersensitivity reactions including anaphylaxis, angioedema, rash, swelling/oedema and urticaria. Injection site reactions, constipation, muscle spasm, pruritus.

Interactions: No effect on exposure of co-administered medicinal products is expected based on the metabolic pathway of monoclonal antibodies. No interactions with oral contraceptives (ethinyl estradiol and norgestimate) or sumatriptan were observed in studies with healthy volunteers.

Legal Category: POM.

Marketing Authorisation Holder: Novartis Europharm Ltd, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland.

Marketing Authorisation Numbers: EU/1/18/1293/001 006.

Date of last revision of Abbreviated Prescribing Information: September 2020.

Full prescribing information is available upon request from: Novartis Ireland Limited, Vista Building, Elm Park Business Campus, Merrion
Road, Dublin 4, Ireland, Tel: + 353 1 220 4100 or at
www.medicines.ie. Detailed information on this product is also available on the website of the European Medicines Agency http://www.ema.europa.eu.

 

▼ This medicinal product is subject to additional monitoring. Reporting suspected adverse reactions of the medicinal product is important to Novartis and the HPRA. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Adverse events could also be reported to Novartis preferably via www.report.novartis.com or by email: [email protected] or by calling
01 2080 612.