New AJOVY® (fremanezumab) Migraine Prevention Data Challenges Treatment Pauses
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4th interim analysis of PEARL real world migraine prevention study presented at 10th
European Association of Neurology (EAN) congress inHelsinki - 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
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,
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
“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
About AJOVY (fremanezumab-vfrm) injection
AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections. AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment. AJOVY European SmPC can be found here.
About Teva
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References:
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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 -
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 -
Al-Hassany, L. et al. The sense of stopping migraine prophylaxis.
The Journal of Headache and Pain . 2023 24:9
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