First real-world effectiveness data of erenumab is promising

SQUARE was the first study that prospectively collected real-world data on erenumab treatment under routine medical care in Switzerland [1]. In both sexes with either episodic or chronic migraine and in patients with different prior prophylactic treatment failures (PPTFs), erenumab significantly improved quality of life and migraine-related disability and decreased the need for acute migraine therapy.

In 2018, erenumab received marketing authorisation in Switzerland for the prevention of migraine in adults. Real-world data evaluating the effect of erenumab in a setting of routine medical care in Switzerland is limited. The observational SQUARE study (CAMG334ACH01) aimed to address this data gap.

SQUARE is a prospective, non-interventional study evaluating erenumab in a post-marketing setting in Switzerland [1]. Patients with prior treatment with erenumab or any calcitonin gene-related peptide (CGRP)-based therapy or recent use of investigational drugs were excluded. Patients were observed over a period of 24 months. Prof. Andreas R. Gantenbein (Zurzach Care, Switzerland) shared results on the real-world effectiveness of erenumab at month 6 compared to baseline.

A total of 172 adult patients were enrolled from 19 centres, both migraine care specialist centres and general neurologist centres. Most participants were women (84.9%). At baseline, patients had an average of 16.6 monthly migraine days (MMDs) and 11.6 monthly acute migraine-specific medication (AMSM) days. Almost 54% of patients fulfilled the criteria for episodic migraine versus 46% for chronic migraine.

Erenumab significantly reduced the Headache Impact Test (HIT)-6 score from baseline to month 3 and month 6 (both P<0.001) in both men and women and in patients with either episodic or chronic migraine (see Figure). Erenumab also significantly reduced the HIT-6 score in all groups with PPTFs from baseline to month 3 and month 6 (all P≤0.001). These results suggest improved quality of life. In line with these results, erenumab significantly reduced modified (monthly) migraine disability assessment test (mMIDAS) during this treatment period in both sexes (both P<0.001), indicating improvement in migraine-related disability. Comparable results were found for Impact of Migraine on Partners and Adolescent Children (IMPAC), which shows a decreased impact on spouses and children of patients.

Figure: Effect of erenumab on HIT-6 score by sex or by migraine type [1]



No difference was observed in treatment satisfaction between sexes, as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)-9. There was a significant difference between the episodic and chronic migraine groups in TSQM-9 scores for effectiveness (P=0.011), but not for convenience or global satisfaction. PPTF had no significant impact on any TSQM-9 score.

Erenumab significantly reduced mean MMDs from baseline to months 3 and 6, irrespective of sex or migraine subtype (all P<0.001) and in all PPTF groups from baseline to month 3 (P=0.013) and month 6 (P=0.014). MMD response rates were not significantly different between sexes except 100% response rate for month 6 (P=0.015). MMD response rates were not significantly different between migraine types. Finally, erenumab significantly reduced the mean AMSM days (triptans and/or ergot derivates) from baseline to month 3 and month 6 (both P<0.001).

SQUARE was the first study that prospectively collected real-world data on erenumab under routine medical care in Switzerland. In addition to meaningful clinical improvements, patients reported consistent treatment satisfaction with erenumab across sexes, migraine type, and PPTF group.

1. Gantenbein A, et al. Real-world effectiveness data of erenumab-treated migraine patients in Switzerland: The SQUARE study. AL078, IHC 2021, 8–12 September.

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Posted on 8 November, 20211 February, 2024