Data challenges migraine treatment pauses

Posted on 3 July, 2024 - Headache

New AJOVY® (fremanezumab) migraine prevention data presented at the EAN

  • 4th interim analysis of PEARL real world migraine prevention study presented at 10th European Association of Neurology (EAN) congress in Helsinki
  • New sub-analysis of PEARL data highlights potential negative impact of treatment pauses on patient outcomes1
  • Sub-analysis exploring impact of treatment cessation and reinitiation on migraine prevention suggests potential rise in migraine attacks and diminished treatment effectiveness upon reinitiation1

July 1, 2024: Teva Pharmaceutical Industries Ltd announced new data from the 4th interim analysis of the PEARL migraine prevention study with AJOVY® (fremanezumab) that may challenge the rationale for treatment pauses with calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) mandated or recommended by some reimbursement authorities after one year of continuous use.

The sub-analysis from the PEARL real world data explored the impact of fremanezumab treatment cessation and reinitiation on monthly migraine days (MMD) in adult patients with episodic or chronic migraine. The data1 show that pausing treatment of fremanezumab, a CGRP-pathway mAb, may result in a potential rise in monthly migraine days (MMD) following treatment cessation and reduced effectiveness upon reinitiation compared to the first treatment cycle, adding to the burden of the individual living with migraine:  

  • Over 40% of patients experienced a rapid worsening of their migraine (>=50% increase in MMD) at Months 1 and 2 post-cessation.
  • The proportion of patients achieving >=50% reduction in MMD at Month 1 and Month 3, respectively, was 49.0% and 58.9% in the first treatment period (before cessation) versus a lower effectiveness of 35.7% and 45.5% in the second treatment period (after treatment reinitiation).

Presenting the data, Dimos Mitsikostas, Professor of Neurology, Aeginition Hospital, Medical School of the National & Kapodistrian University of Athens said “The PEARL Study analysis is significant for clinicians treating people with episodic and chronic migraine as it shows that treatment cessation and reinitiation can disrupt the progress made in managing the condition in some of them. It is important that we are guided by the evidence and adopt a more personalised treatment approach and not a ‘one size fits all’ strategy in helping people with migraine long-term.”

It is important that we are guided by the evidence and adopt a more personalised treatment approach and not a ‘one size fits all’ strategy in helping people with migraine long-term

Dimos Mitsikostas, Professor of Neurology, Aeginition Hospital, Medical School of the National & Kapodistrian University of Athens

Although leading headache societies provide guidelines and consensus for beginning and escalating migraine prophylactic therapies, robust evidence to guide therapy discontinuation is currently lacking. The European Headache Federation (EHF) guidelines suggest considering a pause after 12-18 months of continuous treatment, but if deemed necessary, treatment should be continued as long as is necessary.2  A review of literature suggests stopping prophylaxis with CGRP-pathway mAbs when there appears to be a  lack of remaining need for migraine prevention, which would be less than four MMDs.3  Differing reimbursement conditions across Europe also contribute to these inconsistencies, with some  countries mandating one-year treatment pauses, despite limited supporting data.3

“This new sub-analysis may challenge the rationale for mandatory treatment pauses and highlights the potential for these breaks to diminish the benefits achieved in reducing migraine for some patients,” said Pinar Kokturk, M.D. Vice President & Head of Medical Affairs Europe at Teva. “The PEARL study demonstrates the long-term effectiveness and safety of fremanezumab in preventing both episodic and chronic migraine in a real-world setting and underscores the benefit of treatment continuity and individualised, uninterrupted patient management strategies.”

Dimos Mitsikostas, Professor of Neurology, Aeginition Hospital, Medical School of the National & Kapodistrian University of Athens, talks to ACNR about the PEARL study

References:

  1. Mitsikostas, D., et al. Impact of Fremanezumab Cessation and Reinitiation in Migraine Management: PEARL Study 4th Interim Analysis. Presented at European Academy of Neurology (EAN); 29 June-2 July 2024, Helsinki. EAN-EPR-196
  2. Sacco, S. et al. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention – 2022 update. The Journal of Headache and Pain. 2022 23:67
  3. Al-Hassany, L. et al. The sense of stopping migraine prophylaxis. The Journal of Headache and Pain. 2023 24:9