Erenumab (2) – Aimovig®

• Clinical trials
  • The HER-MES study is a randomised, double-blind, parallel-group RCT comparing erenumab with topiramate over a period of 24 weeks in adult patients experiencing at least 4 migraine days per month, comprising at least two different types of migraine attack.

a) Adults with at least 4 migraine days per month for whom conventional migraine prophylaxis is an option

• For migraine prophylaxis in adults with at least 4 migraine days per month who are eligible for conventional migraine prophylaxis, there is a hint of a considerable additional benefit of erenumab compared with the appropriate comparator therapy, topiramate.
• Overall, there is a hint of a considerable additional benefit of erenumab compared with the appropriate comparator therapy, topiramate.
• mortality
  • Overall mortality In the HER-MES study, no deaths occurred in either treatment arm.
• Morbidity – Symptoms (migraine days per month)
  • For the endpoint ‘migraine days per month’, responder analyses showing a reduction of ≥ 50% over the last three months and over the first month were considered relevant.
  • A statistically significant advantage in favour of erenumab over topiramate was observed for both the last three months and the first month.
• Health-related quality of life – General impairment due to headache (HIT-6) – Improvement of ≥ 5 or ≥ 6.3 points
  • For the endpoint ‘overall impairment due to headache’, a statistically significant advantage for erenumab over topiramate was observed for an improvement of ≥ 5 points on the HIT-6.
  • The responder analysis using a 15% scale range (improvement of ≥ 6.3 points on the HIT-6) also showed a statistically significant advantage in favour of erenumab over topiramate.
• Health-related quality of life – SF-36v2 – physical and mental health subscores (improvement in the SF-36 of ≥ 5 and ≥ 9.4 and 9.6 points, respectively)
  • For the endpoint ‘health-related quality of life’, a statistically significant advantage for erenumab over topiramate was observed for an improvement of ≥ 5 points in the SF-36, for both the physical and mental health subscores.
  • However, for the responder analysis at the 15% scale range (improvement of ≥ 9.4 points in the SF-36 PCS or improvement of ≥ 9.4 points in the SF-36 MCS), no statistically significant difference was observed between erenumab and topiramate.
• Side effects – SAE
  • For the SAE endpoint, there was no statistically significant difference between the erenumab and topiramate treatment groups at week 24.
• Side effects – discontinuation due to AEs
  • For the endpoint ‘discontinuation due to adverse events’, a statistically significant advantage in favour of erenumab over topiramate was observed at week 24.
• Side effects – Specific side effects
  • For the endpoint ‘nervous system disorders’ and the events it encompasses – paraesthesia, attention disorder and dizziness – as well as for the endpoints ‘nausea’, ‘fatigue’ and ‘decreased appetite’, a statistically significant advantage was observed in favour of erenumab compared with topiramate in each case.
  • For the endpoint ‘constipation’, however, a statistically significant disadvantage was observed with regard to erenumab.
• Overall assessment
  • In summary, within the morbidity endpoint categories, for the endpoints ‘migraine days per month’ and in health-related quality of life at week 24—both in the generic SF-36 and in the HIT-6—statistically significant advantages for erenumab over topiramate, the extent of which is considered considerable.
  • In the category of side effects, statistically significant advantages for erenumab compared with the appropriate comparator therapy, topiramate, can also be observed at week 24. For the endpoint of discontinuation due to adverse events, a statistically significant, considerable advantage in favour of erenumab over topiramate was observed, whilst no advantages or disadvantages could be identified for the overall rate of SAE.
  • Overall, in the endpoint categories of morbidity, health-related quality of life and side effects, erenumab demonstrated exclusively positive effects compared with the appropriate comparator therapy at week 24 within the study, with no relevant negative findings from other categories to offset these.
  • Based on these considerations, the information in the dossier and the results of the benefit assessment, the G-BA regards the additional benefit of erenumab compared with the appropriate comparator therapy, topiramate, in adults with at least 4 migraine days per month, for whom conventional migraine prophylaxis is an option, to be a significant improvement in treatment-related benefit not previously achieved, and classifies the extent of the additional benefit as considerable.

Courtesy translation only, please refer to the German original.