Abstract
Backgrounderenumab was safe and effective in clinical trials for the prevention of migraine. However, real-life data are still lacking. Here we report the clinical experience from an Italian real-world setting using erenumab in patients with chronic migraine experiencing previous unsuccessful preventive treatments.MethodsSeventy patients with chronic migraine and failure to ≥4 migraine preventive medication classes initially received monthly erenumab 70 mg s.c. Patients without a clinically meaningful improvement, considered as a > 30% reduction in headache days per month, after ≥3 months of therapy switched to monthly erenumab 140 mg. At the first administration and after 3 and 6 months, patients underwent extensive interviews to assess clinical parameters of disease severity and migraine-related disability and impact, and validated questionnaires to explore depression/anxiety, sleep, and quality of life (QoL). Finally, the Pain Catastrophizing Scale, Allodynia Symptom Checklist-12 and MIGraine attacks-Subjective COGnitive impairments scale (MIG-SCOG) were administered.Results70% of patients were “responders” after the third administration of erenumab 70 mg, whereas 30% switched to erenumab 140 mg; 29% (6 pts) responded after the sixth administration. The headache-day frequency was reduced from 21.1 ± 0.7 to 11.4 ± 0.9 days after the third administration (p < 0.001) and to 8.9 ± 0.7 days after the sixth administration (p < 0.001). 53% and 70% of patients, respectively, showed a reduction of ≥50% of headache days/month after the third and the sixth administrations.Also improved were headache pain severity, migraine-related disability, and impact on daily living, QoL, pain catastrophizing and allodynia (all p < 0.001), quality of sleep, symptoms of depression or anxiety (p < 0.05) but not MIG-SCOG. There were no new adverse event signals.ConclusionThese real-world data support monthly erenumab 70 or 140 mg s.c. as a safe and effective preventive treatment to reduce headache frequency and severity in chronic migraine patients experiencing previous unsuccessful preventive treatments.
Highlights
The International Classification of Headache Disorders stratifies migraine into episodic or chronic, when patients experience less than or more than 15 days, respectively, of headache per month for at least 3 months, with the migraine features present at least eight days per month [1].It is of note that chronic migraine, accompanied by functional and microstructural brain abnormalities [2], is associated with a substantially greater personal and societal burden and higher frequency of comorbidities [3]
Eptinezumab, fremanezumab, and galcanezumab bind to the calcitonin gene-related peptide (CGRP) molecule, whereas erenumab binds to the CGRP receptor [7, 8, 12,13,14]
After the sixth administration of monthly erenumab (70 mg s.c. or 140 mg s.c.) 70% (49 pts) and 26% (18 pts) of patients reported respectively a ≥ 50% or a ≥ 75% reduction in the monthly number of headache days when compared to baseline
Summary
The International Classification of Headache Disorders stratifies migraine into episodic or chronic, when patients experience less than or more than 15 days, respectively, of headache per month for at least 3 months, with the migraine features present at least eight days per month [1].It is of note that chronic migraine, accompanied by functional and microstructural brain abnormalities [2], is associated with a substantially greater personal and societal burden and higher frequency of comorbidities [3]. The standard preventive care based on repositioning drugs discovered by “serendipity” still seems to be a challenging issue, with regard to the therapeutic approach to chronic migraine, for which Onabotulinumtoxin type A (onabotulinumtoxinA) is the only guidelineslicensed treatment is [6]. In this context, monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) or its receptor represent the first selective therapeutic approach specific for migraine prevention [7,8,9,10,11,12]. Erenumab [15, 16] is a fully human monoclonal antibody shown to be effective and well-tolerated in the preventive therapy of episodic and chronic migraine, with and without medication overuse, even when previous preventive approaches have failed [17]
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