Multidimensional assessment of the effects of erenumab in chronic migraine patients with previous unsuccessful preventive treatments: a comprehensive real-world experience

Abstract

Background: erenumab 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. Methods: Seventy 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. Results: 70% 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.

Conversion From Chronic to Episodic Migraine in Patients Treated With Erenumab: Real-life Data From an Italian Region

“…All converters withhold medication overuse. The high rate of conversion to EM in our population of di cult-to-treat patients with a long history of CM and multiple prior preventive treatment failures, including botulinum toxin in ≥ 40% of cases, supports the e cacy of erenumab for the preventive treatment of patients with CM, as shown in randomized controlled trials [13][14][15][16][17][18] and real-life studies [7][8][9][10]. We also found that at Months 4-6 16.5% of patients achieved a status of LFEM, while 28.6% achieved a status of MFEM, which indicates a high treatment bene t and a substantial improvement in the patients' quality of life.…”

“…Monoclonal antibodies directed against the calcitonin gene-related peptide (CGRP) or its receptor (CGRPr) are migraine-speci c treatments whose e cacy and safety were proven in both EM and CM [2][3][4][5]. However, the available real-life studies show that most patients treated in common clinical practice have CM [6][7][8][9][10]. In the present real-life, multicenter study, we assessed the rate and possible predictors of conversion from CM to EM in patients treated with erenumab.…”

Impact of Galcanezumab on Total Pain Burden: Findings From Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies in Patients with Episodic or Chronic Migraine (EVOLVE-1, EVOLVE-2, and REGAIN Trials)

“…In doing so, however, this may have inadvertently diminished the potential clinical value of assessing the impact of a treatment on the combination of frequency, severity, and duration of pain associated with migraine that may be more closely associated with the patient's overall pain experience [19,20]. Moreover, other "real-world" assessments of migraine include a variety of patient-reported outcomes (e.g., disability and quality of life) to fully assess the potential bene t of migraine treatment strategies [21,22]. Total pain burden may better re ect what clinicians and patients discuss regarding the individual's pain experience and could prove useful to further patient-centric discussions regarding treatment expectations when clinicians are evaluating options for migraine prevention.…”

Conversion From Chronic To Episodic Migraine In Patients Treated With Erenumab: Real-Life Data From An Italian Region

“…All converters withhold medication overuse. The high rate of conversion to EM in our population of di cult-to-treat patients with a long history of CM and multiple prior preventive treatment failures, including botulinum toxin in ≥40% of cases, supports the e cacy of erenumab for the preventive treatment of patients with CM, as shown in randomized controlled trials [17][18][19][20][21][22] and real-life studies [10][11][12][13]. We also found that at Months 4-6 16.5% of patients achieved a status of LFEM, while 28.6% achieved a status of MFEM, which indicates a high treatment bene t and a substantial improvement in the patients' quality of life.…”