Gender Differences in 3-Month Outcomes of Erenumab Treatment—Study on Efficacy and Safety of Treatment With Erenumab in Men

Ornello, Raffaele; Baraldi, Carlo; Guerzoni, Simona; Lambru, Giorgio; Fuccaro, Matteo; Raffaelli, Bianca; Gendolla, Astrid; Barbanti, Piero; Aurilia, Cinzia; Cevoli, Sabina; Favoni, Valentina; Vernieri, Fabrizio; Altamura, Claudia; Russo, Antonio; Silvestro, Marcello; Valle, Elisabetta Dalla; Mancioli, Andrea; Ranieri, Angelo; Alfieri, G; Latysheva, N. V.; Филатова, Е. Г.; Talbot, Jamie; Cheng, Sheue-yann; Holle, Dagny; Scheffler, Armin; Nežádal, Tomáš; Čtrnáctá, Dana; Šípková, Jitka; Matoušová, Zuzana; Sette, Lucia; Casalena, Alfonsina; Maddestra, Maurizio; Viola, Stefano; Affaitati, Giannapia; Giamberardino, Maria Adele; Pistoia, Francesca; Reuter, Uwe; Sacco, Simona

doi:10.3389/fneur.2021.774341

Cited by 18 publications

(11 citation statements)

References 27 publications

(19 reference statements)

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“…At variance, psychological and psychiatric comorbidities as well as previously failed preventive therapies seem to play an important role as negative predictors of outcome [7][8][9][10][34][35][36][37][38]. No concordance was found on gender and erenumab responsiveness in CM, as both an association to male sex and no difference among gender were detected [10,40].…”

Section: Discussionmentioning

confidence: 99%

Does MIDAS reduction at 3 months predict the outcome of erenumab treatment? A real-world, open-label trial

et al. 2022

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Background In Italy, monoclonal antibodies targeting the CGRP pathway are subsidized for the preventive treatment of high frequency and chronic migraine (CM) in patients with a MIgraine Disability ASsessment (MIDAS) score ≥ 11. Eligibility to treatment continuation requires a ≥ 50% MIDAS score reduction at three months (T3). In this study, we evaluate whether a ≥ 50% MIDAS score reduction at T3 is a reliable predictor of response to one-year erenumab treatment. Methods In this prospective, open-label, real-world study, 77 CM patients were treated with erenumab 70–140 mg s.c. every 28 days for one year (T13). We collected the following variables: monthly migraine days (MMDs), monthly headache days (MHDs), days of acute medication intake, MIDAS, HIT-6, anxiety, depression, quality of life and allodynia. Response to erenumab was evaluated as: i) average reduction in MMDs during the 1-year treatment period; and ii) percentage of patients with ≥ 50% reduction in MMDs during the last 4 weeks after the 13 th injection (Responders T13 ). Results Erenumab induced a sustained reduction in MMDs, MHDs and intake of acute medications across the 12-month treatment period, with 64.9% of patients qualifying as Responders T13 . At T3, 55.8% of patients reported a ≥ 50% reduction in MIDAS score (MIDAS Res ) and 55.4% of patients reported a ≥ 50% reduction in MMDs (MMD Res ). MIDAS Res and MMD Res patients showed a more pronounced reduction in MMDs during the 1-year treatment as compared to NON-MIDAS Res (MIDAS Res : T0: 23.5 ± 4.9 vs. T13: 7.7 ± 6.2; NON- MIDAS Res : T0: 21.6 ± 5.4 vs. T13: 11.3 ± 8.8, p = 0.045) and NON-MMD Res (MMD Res : T0: 23.0 ± 4.5 vs. T13: 6.6 ± 4.8; NON-MMD Res : T0: 22.3 ± 6.0 vs. T13: 12.7 ± 9.2, p < 0.001) groups. The percentage of Responders T13 did not differ between MIDAS Res (74.4%) and NON-MIDAS Res (52.9%) patients ( p = 0.058), while the percentage of Responders T13 was higher in the MMD Res group (83.3%) when compared to NON-MMD Res (42.9%) ( p = 0.001). MMD Res predicted the long-term outcome according to a multivariate analysis (Exp(B) = 7.128; p = 0.001), while MIDAS Res did not. Treatment discontinuation based on MIDAS Res would have early excluded 36.0% of Responders T13 . ...

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Section: Discussionmentioning

confidence: 99%

Does MIDAS reduction at 3 months predict the outcome of erenumab treatment? A real-world, open-label trial

et al. 2022

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“…Some studies have suggested that responsiveness to antiCGRP mAbs could be related to several demographic and clinical features -including age, sex, body mass index, basal migraine frequency and disability, pain side and severity, allodynia, dopaminergic symptoms, response to triptans and psychiatric comorbidities and personality trait. The heterogeneity of these findings could depend on differences on populations studied, sample sizes, study designs and clinical endpoints investigated [7][8][9][10][11][12][13][14][15][16][17][18].…”

Section: Introductionmentioning

confidence: 99%

Predictors of response to anti-CGRP monoclonal antibodies: a 24-week, multicenter, prospective study on 864 migraine patients

Barbanti

Egeo²,

Aurilia³

et al. 2022

J Headache Pain

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Background and objectives The identification of predictors of response to antiCGRP mAbs could favor tailored therapies and personalized treatment plans. This study is aimed at investigating predictors of ≥ 50%, ≥ 75% and 100% response at 24 weeks in patients with high-frequency episodic (HFEM: 8–14 days/month) or chronic migraine (CM). Methods This is a large, multicenter, cohort, real-life study. We considered all consecutive adult patients affected by HFEM or CM who were prescribed antiCGRP mAbs for ≥ 24 weeks in 20 headache centers. Patients were interviewed face-to-face using a shared semi-structured questionnaire carefully exploring socio-demographic and clinical characteristics. Patients received subcutaneous erenumab (70 mg or140 mg, monthly), galcanezumab (120 mg monthly, following a 240 mg loading dose), or fremanezumab (225 mg, monthly or 675 mg, quarterly) according to drug market availability, physician’s choice, or patient’s preference. The primary endpoint of the study was the assessment of ≥ 50% response predictors at 24 weeks. Secondary endpoints included ≥ 75% and 100% response predictors at 24 weeks. Results Eight hundred sixty-four migraine patients had been treated with antiCGRP mAbs for ≥ 24 weeks (erenumab: 639 pts; galcanezumab: 173 pts; fremanezumab: 55 pts). The ≥50% response (primary endpoint) in HFEM was positively associated with unilateral pain (UP) + unilateral cranial autonomic symptoms (UAs) (OR:4.23, 95%CI:1.57–11.4; p = 0.004), while in CM was positively associated with UAs (OR:1.49, 95%CI:1.05–2.11; p = 0.026), UP + UAs (OR:1.90, 95%CI:1.15–3.16; p = 0.012), UP + allodynia (OR:1.71, 95%CI:1.04–2.83; p = 0.034), and negatively associated with obesity (OR:0.21, 95%CI:0.07–0.64; p = 0.006). The 75% response (secondary endpoint) was positively associated with UP + UAs in HFEM (OR:3.44, 95%CI:1.42–8.31; p = 0.006) and with UP + UAs (OR:1.78, 95%CI:1.14–2.80; p = 0.012) and UP + allodynia (OR:1.92, 95%CI:1.22–3.06; p = 0.005) in CM. No predictor of 100% response emerged in patients with HFEM or CM. Conclusions A critical evaluation of headache characteristics indicating peripheral or central sensitization may help in predicting responsiveness to antiCGRP mAbs in HFEM and CM. A more precise pain profiling may represent a steppingstone for a mechanism-based approach and personalized treatment of migraine with compounds targeting specific molecular mechanisms.

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“…A negative family history of migraine was associated with a decreased likelihood of response to CGRP(-R) mAbs (OR: 0.4, 95% CI: 0.16-0.97) in one study [42]. We found three studies [70][71][72] specifically designed to determine if specific demographic factors predict response to CGRP(-R) mAbs. Cetta et al showed that similar reductions in monthly headache days (MHD) were seen in patients under and over the age of 65 [71].…”

Section: Demographic Characteristicsmentioning

confidence: 95%

A Scoping Review and Meta-Analysis of Anti-CGRP Monoclonal Antibodies: Predicting Response

et al. 2023

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Calcitonin gene-related peptide-targeted monoclonal antibodies (CGRP mAbs) are increasingly being used as preventive treatments for migraine. Their effectiveness and safety were established through numerous randomized placebo-controlled trials and real-world studies, yet a significant proportion of patients do not respond to this treatment, and currently, there is a lack of accepted predictors of response to guide expectations, as data from studies so far are lacking and inconsistent. We searched Embase and MEDLINE databases for studies reporting on predictors of response to CGRP and/or CGRP-receptor (CGRP-R) mAbs, defined as a 30% or 50% reduction in monthly headache or migraine days at varying durations of follow-up. Quantitative synthesis was performed where applicable. We found 38 real-world studies that investigated the association between various predictors and response rates. Based on these studies, good response to triptans and unilateral pain with or without unilateral autonomic symptoms are predictors of a good response to CGRP(-R) mAbs. Conversely, obesity, interictal allodynia, the presence of daily headaches, a higher number of non-successful previous prophylactic medications, and psychiatric comorbidities including depression are predictive of a poor response to CGRP(-R) mAbs. Future studies should confirm these results and help to generate more tailored treatment strategies in patients with migraine.

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Gender Differences in 3-Month Outcomes of Erenumab Treatment—Study on Efficacy and Safety of Treatment With Erenumab in Men

Cited by 18 publications

References 27 publications

Does MIDAS reduction at 3 months predict the outcome of erenumab treatment? A real-world, open-label trial

Does MIDAS reduction at 3 months predict the outcome of erenumab treatment? A real-world, open-label trial

Predictors of response to anti-CGRP monoclonal antibodies: a 24-week, multicenter, prospective study on 864 migraine patients

A Scoping Review and Meta-Analysis of Anti-CGRP Monoclonal Antibodies: Predicting Response

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