ABSTRACT
BACKGROUND: Anti-CGRP monoclonal antibodies (anti-CGRP MAbs) are approved and available treatments for migraine prevention. Patients do not respond alike and many countries have reimbursement policies, which hinder treatments to those who might respond. This study aimed to investigate clinical factors associated with good and excellent response to anti-CGRP MAbs at 6 months. METHODS: European multicentre, prospective, real-world study, including high-frequency episodic or chronic migraine (CM) patients treated since March 2018 with anti-CGRP MAbs. We defined good and excellent responses as ≥50% and ≥75% reduction in monthly headache days (MHD) at 6 months, respectively. Generalised mixed-effect regression models (GLMMs) were used to identify variables independently associated with treatment response. RESULTS: Of the 5818 included patients, 82.3% were females and the median age was 48.0 (40.0-55.0) years. At baseline, the median of MHD was 20.0 (14.0-28.0) days/months and 72.2% had a diagnosis of CM. At 6 months (n=4963), 56.5% (2804/4963) were good responders and 26.7% (1324/4963) were excellent responders. In the GLMM model, older age (1.08 (95% CI 1.02 to 1.15), p=0.016), the presence of unilateral pain (1.39 (95% CI 1.21 to 1.60), p<0.001), the absence of depression (0.840 (95% CI 0.731 to 0.966), p=0.014), less monthly migraine days (0.923 (95% CI 0.862 to 0.989), p=0.023) and lower Migraine Disability Assessment at baseline (0.874 (95% CI 0.819 to 0.932), p<0.001) were predictors of good response (AUC of 0.648 (95% CI 0.616 to 0.680)). These variables were also significant predictors of excellent response (AUC of 0.691 (95% CI 0.651 to 0.731)). Sex was not significant in the GLMM models. CONCLUSIONS: This is the largest real-world study of migraine patients treated with anti-CGRP MAbs. It provides evidence that higher migraine frequency and greater disability at baseline reduce the likelihood of responding to anti-CGRP MAbs, informing physicians and policy-makers on the need for an earlier treatment in order to offer the best chance of treatment success.
ABSTRACT
WHAT IS KNOWN AND OBJECTIVE?: Erenumab and galcanezumab have shown great results for migraine prevention. However, strict inclusion criteria, absence of concomitant medication and selective outcome report of clinical trials may sometimes be barely representative of the real-world daily practice. Therefore, this study was designed to evaluate effectiveness and safety of these two monoclonal antibodies targeting calcitonin gene-related peptide in real-world patients. METHODS: This observational, retrospective study evaluated the effectiveness and safety of erenumab 140 mg and galcanezumab 120 mg in 142 real-world patients who had previously not responded to three well-established pharmacological alternatives for migraine prevention. To do so, a combination of objective parameters (monthly headache days and acute migraine-specific medication days) and subjective measurements (Migraine Disability Assessment questionnaire, Headache Impact Test and Visual Analogue Scale), validated for clinical research in migraine, were assessed during clinical interview. RESULTS AND DISCUSSION: Findings here reported show that erenumab and galcanezumab reduced monthly headache days, acute migraine specific medication days per month, Headache Impact Test score, Migraine Disability Assessment Test score and Visual Analogue Scale score after 3 and 6 doses (p < 0.01). Additionally, more than 25% of the patients enrolled in the study experienced a reduction by a half in monthly headache days, and more than 50% of the patients also reported a reduction by a half in the number of migraine specific medication days. Both treatments exhibited a great safety profile, rarely leading to discontinuation because of poor tolerance. WHAT IS NEW AND CONCLUSIONS?: Altogether, these results support previous real-life studies regarding effectiveness and safety and provide an interesting insight in how these preventive therapies are also effective in patients diagnosed with difficult to treat migraine who have previously failed, at least, three different drug classes stablished by current neurology guidelines for migraine prevention. Moreover, these data may suggest that erenumab and galcanezumab are able to not only diminish frequency, but also migraine intensity, and that it should be also considered as an effectiveness measure in line with other authors suggestion.
Subject(s)
Graft vs Host Disease , Migraine Disorders , Antibodies, Monoclonal, Humanized , Double-Blind Method , Headache , Humans , Migraine Disorders/drug therapy , Migraine Disorders/prevention & control , Retrospective Studies , Treatment OutcomeABSTRACT
INTRODUCTION: Up to 60% of women relate their episodes of headache to menstrual cycle. Menstrual migraine has been included in the second edition of the International Classification of Headache disorders. Menstrual tension-type headache has not yet been recognised by the International Headache Society. AIMS: To evaluate the prevalence of different subtypes of menstrual headache and to analyze their clinical features and the treatment prescribed. PATIENTS AND METHODS: We prospectively included women attending several neurology outpatient clinics, from January to November 2008 whose headache appeared during the menstrual period. RESULTS: A total of 108 patients were included during the study period. Mean age was 34.8 ± 8.9 years-old. 29.3% suffered from pure menstrual migraine, 58.7% from menstrual related migraine, 4.5% from pure menstrual tension-type headache and 7.5% from menstrual related tension type headache. CONCLUSIONS: Our data suggest that menstrual related tension-type headaches exist with a prevalence found about 12%, in our neurology outpatient clinics.
