Early Erenumab in Episodic Migraine Improves Long-Term Efficacy, Tolerability, and Adherence Compared to Oral Prophylactics | Top Vip News

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Patricia Pozo-Rosich, MD, PhD

Recently published data from the phase 4 APPRIASE study (NCT03927144) showed that earlier use of erenumab (Aimovig; Amgen) in patients with episodic migraine (EM) who failed 1 or 2 preventive treatments resulted in better efficacy, tolerability and long-term adherence. than the use of oral prophylactics. Overall, patients treated with the drug calcitonin gene-related peptide (CGRP) were 6 times more likely to achieve a 50% or greater reduction in monthly migraine days, further underscoring the importance of starting early in treatment.

The pragmatic study spanning 17 countries randomized 621 eligible participants with MS 2:1 to erenumab (n = 413) or non-specific oral migraine prevention medications (OMPM; n = 208) over a 12-month period . OMPMs, which include beta-blockers, calcium channel blockers, antiepileptics, and antidepressants, have been a standard of care for migraine prevention; However, OMPMs were not developed specifically for migraine and most of them have insufficient or limited evidence of efficacy or safety.

Led by Patricia Pozo-Rosich, MD, PhD, director of the Headache and Craniofacial Pain Clinical Unit and the Adaptive Brain Center for Migraine at Vall d’Hebron University Hospital, 532 patients (84.2%) completed the treatment phase and 98 (15.8%) discontinued the study. After 12 months of treatment, the primary endpoint, achieving a 50% or greater reduction in monthly migraine days (MMD), was achieved by 86.9% of those initially treated with erenumab versus 37.9%. 5% of those in the OMPM group (OR, 11.27; 95% CI, 7.53-16.87; P <.001). Erenumab continued to outperform OMPM on the primary endpoint regardless of whether patients switched treatments from week 12 to week 52.

“Earlier initiation of erenumab may ultimately lead to fewer patients discontinuing or switching medications in real-world clinical practice,” the study authors concluded. “In addition, these findings may help reduce healthcare resource utilization, decrease disability, and increase better quality of life. These findings further support the recent guideline update published by the European Headache Federation, in mAbs targeting CGRP are considered a first-line treatment option for migraine patients requiring preventive treatment.”

APPRAISE is unique in that it tested erenumab in MS patients who have failed 1 to 2 prior preventive treatments for migraine when traditionally access to monoclonal antibodies targeting CGRP is often limited to those with 3 to 5 prior preventive failures. The study also encompassed a practical methodology, granting clinicians the autonomy to determine the treatment trajectory after randomization, in both treatment arms and within local protocols, reflecting real-world clinical practice.

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Overall, 13% (n = 81) of the cohort switched from the initially assigned treatment. Among switching patients, 8 of 9 (88.9%; erenumab) and 31 of 72 (43.1%; OMPM) reported a lack of efficacy, while 1 of 9 (11.1; erenumab) and 36 of 72 (50.0%; OMPM) reported a lack of tolerability as the main reason. At month 12, using the full cohort, the change in adjusted mean MMDs was –4.32 days for erenumab and –2.65 days for OMPM (treatment difference, –1.67 [SE, 0.35] days; P <.001).

In terms of safety, treatment-emergent adverse events (TEAEs) were recorded in 74.8% of those taking erenumab and 76.2% of those taking OMPM; however, after adjusting for treatment exposure, the exposure-adjusted rate was approximately 30% lower in those treated with the CGRP monoclonal antibody. Patients treated with erenumab had fewer AEs suspected to be related to the study drug (32.1% vs. 56.3%), and these mostly included constipation (12.3%) and pain at the injection site. injection (4.7%). For OMPM, the most related AEs were fatigue (14.1%) and weight gain (9.7%).

Between the 2 groups, the incidence of AEs leading to treatment discontinuation was approximately 8-fold lower in patients treated with erenumeb (2.9% of the initial dose) versus OMPM (23.3%, including 9 others who switched from the erenumab group). Furthermore, the incidence of AEs leading to dose adjustment was approximately 15 times lower in the erenumab group (1.0%; n = 4) than in the OMPM group (15.5%; n = 32). Of note, constipation was observed more frequently in the erenumab group compared to the OMPM group (13.0% vs. 1.0%). One patient taking the medication CGRP reported severe constipation, which resolved after treatment with a laxative.

At 12 months, 76.0% of those taking erenumab and 18.8% of those taking OMPM were identified as responders on the PGIC scale (OR, 13.75; 95% CI, 9.08- 20.83; P <.001). Of patients who switched treatment, 24.7% (20 of 81) were identified as responders at month 12. In the OMPM group, most patients initially received beta-blockers (31.3%), topiramate ( Topamax; 22.1%) and tricyclic antidepressants. (15.9%).

REFERENCE
1. Pozo-Rosich P, Dolezil D, Paemeleire K, et al. Early use of erenumab versus nonspecific oral migraine preventives: the APPRAISE randomized clinical trial. JAMA Neurol. Published online March 25, 2024. doi:10.1001/jamaneurol.2024.0368

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