Real-life assessment of erenumab in refractory chronic migraine with medication overuse headache

Pensato, Umberto; Baraldi, Carlo; Favoni, Valentina; Cainazzo, Maria Michela; Torelli, Paola; Querzani, Pietro; Pascazio, Alessia; Mascarella, Davide; Matteo, Eleonora; Quintana, Simone; Asioli, Gian Maria; Cortelli, Pietro; Pierangeli, Giulia; Guerzoni, Simona; Cevoli, Sabina

doi:10.1007/s10072-021-05426-5

Cited by 36 publications

(66 citation statements)

References 37 publications

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“…Accordingly, a significant benefit was achieved in multiple efficacy and disability measures including MHDs, MPIM, MPI, HIT-6 and MIDAS. These results are in line with previous studies evaluating the efficacy of anti-CGRP mAbs in difficult-to-treat migraineurs, such as those suffering from MOH and refractory CM (8,9,14,(19)(20)(21)(22)(23)(24), yet nearly daily (!28 days per month) painkiller consumers were never selected before.…”

Section: Discussionsupporting

confidence: 91%

“…During the follow-up period no serious adverse event was observed, while a relatively high rate of mild adverse events, mostly constipation, was observed. Real-life studies investigating anti-CGRP monoclonal antibodies in refractory migraine patients revealed higher frequency of constipation (13.5-23.9%) compared to randomized clinical trial (19,20,22,24,25), yet this adverse event was even more common in our study (29%). While underlying mechanisms remain to be fully elucidated, a relationship between migraine treatment refractoriness and constipation frequency might exist.…”

Section: Discussioncontrasting

confidence: 61%

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Detoxification vs non-detoxification before starting an anti-CGRP monoclonal antibody in medication overuse headache

et al. 2022

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Background Medication overuse headache significantly contributes to the chronification process and treatment refractoriness of migraine. Currently, abrupt discontinuation of the overused medication still represents the best management strategy for these patients, challenging public health system resources. Methods In this prospective study, chronic migraine and medication overuse headache sufferers with at least 28 days of analgesic consumption per month were included. Assessment of efficacy outcomes at three months were compared among patients who underwent in-hospital abrupt discontinuation of overused acute medication (YES-DETOX group) and patients who did not (NO-DETOX group) before starting an anti-CGRP monoclonal antibody. Results Of 401 patients who received either erenumab or galcanezumab, 28% (n = 111) satisfied inclusion criteria (YES-DETOX n = 28; NO-DETOX n = 83). After three months of treatment, 59% (n = 65; 47/83 YES-DETOX; 18/28 NO-DETOX) patients reverted from medication overuse headache and 51% (n = 57; 42/83 YES-DETOX; 15/28 NO-DEOTX) achieved ≥50% reduction in monthly headache days; yet no statistical differences were observed between the two groups (p = 0.4788 and p = 0.8393, respectively). Monthly consumption of pain medication was the only baseline prognostic factor in multivariate analysis in the overall cohort (p = 0.016). Conclusion Our results support the emerging evidence that anti-CGRP monoclonal antibodies may be effective in medication overuse headache patients irrespective of detoxification, yet further studies are needed to draw definitive conclusions.

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Section: Discussionsupporting

confidence: 91%

Section: Discussioncontrasting

confidence: 61%

Detoxification vs non-detoxification before starting an anti-CGRP monoclonal antibody in medication overuse headache

et al. 2022

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“…Randomized controlled trials (RCTs) have consistently demonstrated that monoclonal antibodies (mAbs) specifically designed to target CGRP or its receptor are safe and effective in preventing CM [ 12 ]. These results have also been confirmed by real-life studies showing that clinical improvements can be even better in everyday clinical practice than in RCTs [ 13 – 16 ]. However, few studies focused on the efficacy of CGRP targeting mAbs in reverting CM to EM, mainly in the short term [ 16 – 18 ].…”

Section: Introductionmentioning

confidence: 58%

“…These results have also been confirmed by real-life studies showing that clinical improvements can be even better in everyday clinical practice than in RCTs [ 13 – 16 ]. However, few studies focused on the efficacy of CGRP targeting mAbs in reverting CM to EM, mainly in the short term [ 16 – 18 ]. Chronic migraine, indeed, is a fluctuating condition: nearly 75% of patients with CM can remit to EM for at least 3 months during 1 year [ 19 ].…”

Section: Introductionmentioning

confidence: 58%

Conversion from chronic to episodic migraine in patients treated with galcanezumab in real life in Italy: the 12-month observational, longitudinal, cohort multicenter GARLIT experience

et al. 2022

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Objective To investigate in real-life the conversion from chronic migraine (CM) to episodic migraine (EM), specifically to EM with High-Frequency (HFEM: 8–14 monthly migraine days, MMDs), Medium-Frequency (MFEM, 4–7 MMDs), and Low-Frequency EM (LFEM, 0–3 MMDs), and its persistence during 1 year of treatment with galcanezumab. Methods Consecutive CM patients treated with galcanezumab completing 1 year of observation were enrolled. We collected data on MMDs, pain intensity (Numeric Rating Scale, NRS score), and monthly acute medication intake (MAMI) from baseline (V1) to the 12-month visit (V12). Results Of the 155 enrolled patients, 116 (around 75%) reverted to EM at every visit and 81 (52.3%) for the entire 1-year treatment. Patients with older onset age ( p = 0.010) and fewer baseline MMDs ( p = 0.005) reverted more frequently to EM. At V12, 83 participants (53.5%) presented MFEM or LFEM. Patients reverted to MFEM or LFEM for 7 months (25th 1, 75th 11). The medication overuse discontinuation rate at V12 was 82.8% and occurred for 11 months (25th 8, 75th 12). From baseline to V12, the MAMI decreased by 17 symptomatic drugs ( p < 0.000001) while the NRS score reduced by almost 2 points ( p < 0.000001). A consistent transition to EM for the entire treatment year was observed in 81 (52.3%) patients. Discussion The 1-year GARLIT experience suggests that more than half of CM patients treated with galcanezumab persistently reverted to EM in real life. Trial registration ClinicalTrials.gov NCT04803513. Supplementary Information The online version contains supplementary material available at 10.1007/s00415-022-11226-4.

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“…Predictors of treatment response might help patient selection and advising clinical decision on when to start or discontinue the treatment with an anti-CGRP mAb. Most studies focused on predictors of negative or incomplete response to the treatment such as medication overuse, higher acute medications intake, higher number of prior preventive treatment failures, 39 , 40 , 79 allodynia 48 and psychiatric comorbidities. 46 Few other studies identified predictors of positive response to the treatment such as triptans, 80 unilateral localization of pain, allodynia, osmophobia, unilateral autonomic symptoms, and dopaminergic symptoms (ie yawning, somnolence, nausea, vomiting, mood changes, which are epiphenomena of a reduced inhibition of neuronal discharge in trigemino-cervical complex exerted by A11 dopaminergic cells).…”

Section: Predictors Of Treatment Responsementioning

confidence: 99%

Migraine Prevention with Erenumab: Focus on Patient Selection, Perspectives and Outcomes

Sacco¹,

Ornello²

2022

TCRM

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Erenumab is a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor suitable for episodic and chronic migraine prevention. Randomized clinical trials proved the superiority of erenumab to placebo in a strictly selected population, while real-world studies confirmed treatment efficacy in more severe forms of disease – most patients suffered from chronic migraine with medication overuse headache, had prior treatment failures, and long disease duration. According to guidelines, anti-CGRP pathway monoclonal antibodies should be reserved to patients who failed or have contraindication to several classes of preventive treatments. However, their ease of use, tolerability and efficacy make these monoclonal antibodies ideally suitable for most patients with migraine; cost-effectiveness needs to be considered when looking at expanding current prescription criteria. Also, data from open label extensions of randomized control trials confirmed sustained benefits of prolonged treatment up to 5 consecutive years without significant risk of adverse events. Further studies will provide insights on optimal treatment duration to achieve migraine remission and predictors of treatment response. In the present work, we aimed at reviewing design and results of the main studies on erenumab and discussing treatment use in the current migraine prevention scenario; we also summarized the main ongoing research projects and provided clinical perspectives for the future.

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Real-life assessment of erenumab in refractory chronic migraine with medication overuse headache

Cited by 36 publications

References 37 publications

Detoxification vs non-detoxification before starting an anti-CGRP monoclonal antibody in medication overuse headache

Detoxification vs non-detoxification before starting an anti-CGRP monoclonal antibody in medication overuse headache

Conversion from chronic to episodic migraine in patients treated with galcanezumab in real life in Italy: the 12-month observational, longitudinal, cohort multicenter GARLIT experience

Migraine Prevention with Erenumab: Focus on Patient Selection, Perspectives and Outcomes

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