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Effectiveness outcomes by proportion of patients with a ≥ 50% reduction from baseline in MMD: A) total population; B) dosing schedule subgroups; C) prior treatment failures subgroups. BL, baseline; MMD, monthly migraine days; Q, quarterly; M, monthly. aNumber of patients with available assessment at each time point
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Background
The efficacy and tolerability of fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP) and is approved for the preventive treatment of migraine in adults, have been demonstrated in randomized, double-blind, placebo-controlled trials. Real-world data can further suppor...
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Background
Erenumab is a fully human monoclonal antibody and a highly potent, first-in-class calcitonin gene-related peptide receptor inhibitor approved for migraine prevention in adults. Randomised, placebo-controlled trials show that erenumab treatment results in clinically meaningful responses, including significant reductions in monthly migrain...
Citations
... Fremanezumab, a humanized mAb that selectively targets both isoforms of CGRP, is US Food and Drug Administration (FDA)-approved for both quarterly and monthly subcutaneous dosing in adults [8]. Fremanezumab has demonstrated effectiveness over 6-12 months in the reduction of monthly migraine days (MMD) and monthly headache days (MHD) of at least moderate severity, along with improvements in disability outcomes, in Phase 3 extension studies and real-world studies in patients with migraine [6,[9][10][11][12][13]. These improvements in clinical symptoms have been observed with both monthly and quarterly fremanezumab dosing regimens in patients with episodic migraine (EM) and chronic migraine (CM), including those with multiple prior migraine preventive treatment failures, psychiatric comorbidities, and acute medication overuse in a real-world setting [10,11]. ...
... Fremanezumab has demonstrated effectiveness over 6-12 months in the reduction of monthly migraine days (MMD) and monthly headache days (MHD) of at least moderate severity, along with improvements in disability outcomes, in Phase 3 extension studies and real-world studies in patients with migraine [6,[9][10][11][12][13]. These improvements in clinical symptoms have been observed with both monthly and quarterly fremanezumab dosing regimens in patients with episodic migraine (EM) and chronic migraine (CM), including those with multiple prior migraine preventive treatment failures, psychiatric comorbidities, and acute medication overuse in a real-world setting [10,11]. ...
... In a 12-week multicenter, prospective cohort study, patients with highfrequency EM and CM who initiated fremanezumab demonstrated a significant reduction at Week 12 from the index date in MMD (− 4.6 days; p < 0.05) and MHD (− 9.4; p < 0.001); treatmentrelated AEs were uncommon (6%) and mild [39]. In a separate chart review study in patients with EM and CM, including those with multiple prior preventive treatment failures, acute medication overuse, and psychiatric comorbidities, fremanezumab treatment was associated with reductions from the index date of − 6.7 MMD and − 6.8 MHD at Month 3 and − 9.2 MMD and − 9.8 MHD at Month 6 [10]. Corresponding reductions in acute and preventive medication use and HCRU have been observed with fremanezumab treatment up to 12 months in patients with EM and CM, including those with multiple prior preventive treatment failures, acute medication overuse, and psychiatric comorbidities [28][29][30][31]. ...
Fremanezumab, a monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) pathway, and gepants, small molecule CGRP receptor antagonists, are both approved for the treatment of migraine or its symptoms. This study assessed effectiveness, tolerability, and migraine-related healthcare resource utilization (HCRU) after the addition of fremanezumab for preventive migraine treatment in patients using gepants for acute treatment.
Data were extracted during a retrospective chart review from electronic medical records from the Dent Neurologic Institute. Eligible patients were ≥ 18 years old, using gepants (rimegepant or ubrogepant), who initiated fremanezumab between January 1, 2020, and May 1, 2021 (index date: date of fremanezumab initiation) and continued concomitant use of gepants and fremanezumab for ≥ 1 month (post-index; between 7–9 months of follow-up). Outcomes included monthly migraine days (MMD), adverse events (AEs), reasons for discontinuation, and migraine-related HCRU.
A total of 55 patients [female, 93%; mean (SD) age, 43.5 (13.5) years] met the inclusion criteria. All patients were diagnosed with chronic migraine. Patients had an average (SD) MMD of 15.8 (7.4) at the index date. Average (SE) change in MMD from index date to post-index was − 6.5 (1.0) days (p < 0.0001). Five patients (9.1%) experienced AEs post-index; no serious AEs (SAEs) were reported. The number of migraine-related medications used decreased from the index date to post-index by a mean of 0.6 for preventive medications (p = 0.070), and 0.8 for acute medications (p = 0.050). The number of outpatient office-based visits also decreased [mean (SD): 6 months pre-index, 5.8 (4.4) vs. 6 months post-index, 4.1 (4.0); p < 0.0001].
The addition of fremanezumab preventively to gepants for acute migraine treatment was effective, resulted in fewer outpatient office visits, and yielded no SAEs or AEs that were novel to these migraine medication classes.
... Real-life studies confirmed the effectiveness and safety of monthly and quarterly fremanezumab in both chronic and episodic migraine patients, and also in patients with multiple previous failures and diverse comorbidities [11][12][13][14][15]. The real-life FRIEND study suggested a potential clinical advantage for the monthly regimen, although only few patients received quarterly fremanezumab and no statistical analyses were conducted [13,14]. ...
... Previous RCTs and real-life studies demonstrated that fremanezumab is effective for migraine prevention [4][5][6][7][8][9][10][11][12][13][14][15]. A network meta-analysis of RCTs focusing on migraine preventive treatments targeting the CGRP found both fremanezumab 225 and 675 mg to be effective in reducing MMD, MHD, and AMD compared to placebo. ...
... A recent meta-analysis showed that the most frequent AEs associated with fremanezumab were injection site erythema, induration, and pruritus [24]. Transient injection-site reactions were found to be the most common AE also in real-life studies [11][12][13][14]. Similar to previous RCTs and real-life data, we found that the most common AEs were injection-site reactions, both for monthly and quarterly fremanezumab, without significant difference between the two regimens. ...
Background and Purpose
Fremanezumab, a monoclonal antibody targeting the calcitonin gene‐related peptide for migraine prevention, is available in monthly (225 mg) and quarterly (675 mg) doses. Previous studies showed efficacy and safety for both regimens, but a real‐life comparison is lacking. This study aimed to compare the effectiveness and safety of monthly and quarterly fremanezumab in a real‐life setting.
Methods
This Italian, prospective, multicenter study enrolled 95 migraine patients. During a 3‐month treatment period, patients received either monthly or quarterly fremanezumab (49 monthly, 46 quarterly). A 6‐month treatment period involved 79 patients (43 monthly, 36 quarterly). Monthly headache (MHD) and migraine days (MMD), number of days (AMD) and pills (AMP) of acute medication intake, and Headache Impact Test (HIT‐6), Migraine Disability Assessment (MIDAS) test, and Numeric Rating Scale (NRS) scores were recorded at baseline and after 3 and 6 months of treatment. Adverse events (AEs), responder rates, and medication overuse were also investigated.
Results
Both monthly and quarterly treatments led to significant reductions in MMD, MHD, AMP, AMD, HIT‐6, MIDAS, and NRS scores after 3 and 6 months. The monthly regimen exhibited a slightly greater reduction in MMD and MHD after the first quarter, with no significant difference observed after 6 months. The most common AE was transient injection‐site reaction, without between‐group differences. Responder rates and resolution of medication overuse did not significantly differ between the groups.
Conclusions
Both monthly and quarterly regimens were effective and safe, with a tendency for an advantage of the monthly regimen only in the first quarter of treatment.
... Масштабное исследование фреманезумаба в реальной практике было выполнено в США M.T. Driessen и соавт. [13,14]. В него вошли 1003 пациента с ЭМ и ХМ, получавших терапию у 421 врача. ...
... Данное исследование -одно из первых в российской популяции пациентов с ЭМ и ХМ, в котором представлены данные об эффективности и безопасности фреманезумаба (Аджови) в условиях рутинной клинической практики. Большинство полученных нами данных находятся в соответствии с результатами исследований, проведен- ных в других странах [13][14][15][16][17][23][24][25][26]. Вместе с тем следует отметить ряд особенностей. ...
... Доля респондеров со снижением частоты дней с мигренью в месяц более чем наполовину составила 75,7%. В странах Европы [13][14][15], в США [16] и особенно в Великобритании, где для назначения фреманезумаба на момент проведения исследований требовался предыдущий неуспех использования более чем двух-трех классов антимигренозных препаратов [17], доля респондеров на фоне применения анти-CGRP мАТ была ниже. ...
Anti-CGRP monoclonal antibodies (mAb) have been approved and successfully used in Russia since 2020.
Objective : to investigate the efficacy and safety of fremanezumab (FRE) therapy (225 mg monthly or 675 mg quarterly) in real-life clinical practice in patients with migraine who referred to a specialized Russian headache center.
Material and methods . This open-label, retrospective study involved 202 patients (mean age 39.4±12.2 years) with frequent episodic (EM) or chronic migraine (CM) who received at least three injections of FRE 225 mg or three injections with a total dose of 675 mg and regularly completed the Migrebot headache diary one month before starting therapy and throughout the course of treatment.
Results . The mean number of migraine days per month decreased in the whole group from 20.1±8.2 (before treatment) to 8.5±7.9 after 12 weeks (p<0.0001), in the EM group from 10.9±4.1 to 3.6±3.7 (p<0.0001) and in the CM group - from 24.4±5.7 to 10.8±8.3 (p<0.0001). Adverse events were observed in 13 (6.4%) patients (most frequently local reactions: itching, rash, redness, induration at the injection site).
Conclusion . The study showed a favourable efficacy and safety profile of FRE in the Russian population, where anti-CGRP mAbs are considered the first-line treatment for migraine.
... RWS of fremanezumab have demonstrated its efficacy and tolerability regardless of migraine type or prior exposure to a different CGRP monoclonal antibody (55)(56)(57). RWS have also disclosed greater efficacy than randomized controlled trials (RCT), with rare treatment emergent adverse events, which were mostly mild conditions such as pain, rash or pruritus, flu-like symptoms, and hair loss (56,58,59). Additionally, significant reductions in antidepressant and anxiolytic medication use have been observed (60). ...
Migraine, a prevalent neurological disorder, affects approximately 14.1% of the global population and disproportionately impacts females. This debilitating condition significantly compromises quality of life, productivity, and incurs high healthcare costs, presenting a challenge not only to individuals but to societal structures as a whole. Despite advances in our understanding of migraine pathophysiology, treatment options remain limited, necessitating ongoing research into effective therapies. This review delves into the complexity of migraine management, examining the roles of genetic predisposition, environmental influences, personalized treatment approaches, comorbidities, efficacy and safety of existing acute and preventive treatments. It further explores the continuum between migraine and tension-type headaches and discusses the intricacies of treating various migraine subtypes, including those with and without aura. We emphasize the recent paradigm shift toward trigeminovascular activation and the release of vasoactive substances, such as calcitonin gene-related peptide (CGRP), which offer novel therapeutic targets. We assess groundbreaking clinical trials, pharmacokinetic and pharmacodynamic perspectives, safety, tolerability, and the real-world application of CGRP monoclonal antibodies and gepants. In the face of persisting treatment barriers such as misdiagnosis, medication overuse headaches, and limited access to specialist care, we discuss innovative CGRP-targeted strategies, the high cost and scarcity of long-term efficacy data, and suggest comprehensive solutions tailored to Turkiye and developing countries. The review offers strategic recommendations including the formulation of primary care guidelines, establishment of specialized outpatient clinics, updating physicians on novel treatments, enhancing global accessibility to advanced therapies, and fostering patient education. Emphasizing the importance of lifestyle modifications and holistic approaches, the review underscores the potential of mass media and patient groups in disseminating critical health information and shaping the future of migraine management.
... Recent retrospective chart reviews have demonstrated substantial clinical benefit of fremanezumab for patients with migraine and AMO, major depressive disorder (MDD), generalized anxiety disorder (GAD), or prior migraine preventive treatment failures [29,30]. Such chart review studies are limited by the data available in the electronic medical record (i.e., HCRU and costs cannot be analyzed). ...
... Prior studies have demonstrated the realworld clinical benefit of fremanezumab for patients within this patient population. Driessen et al. found that fremanezumab treatment demonstrated sustained reductions in monthly migraine days over 6 months in a subgroup of patients with MDD or GAD, a subgroup with AMO, and subgroups with an unsatisfactory response to multiple migraine preventive treatments in a retrospective online, clinician panelbased chart review [29,30]. The current study expands upon those findings to demonstrate reductions in migraine-related acute and preventive migraine medication use and migrainerelated inpatient and outpatient office visits, as would be expected to follow with reductions in migraine symptoms. ...
Fremanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide, is indicated for preventive treatment of migraine in adults. Real-world evidence assessing the effect of fremanezumab on migraine-related medication use, health care resource utilization (HCRU), and costs in patient populations with comorbidities, acute medication overuse (AMO), and/or unsatisfactory prior migraine preventive response (UPMPR) is needed.
Data for this US, retrospective claims analysis were obtained from the Merative® MarketScan® Commercial and supplemental databases. Eligible adults with migraine initiated fremanezumab between 1 September 2018 and 30 June 2019 (date of earliest fremanezumab claim is the index date), had ≥ 12 months of continuous enrollment prior to initiation (preindex period) and ≥ 6 months of data following initiation (postindex period; variable follow-up after 6 months), and had certain preindex migraine comorbidities (depression, anxiety, and cardiovascular disease), potential AMO, or UPMPR. Changes in migraine-related concomitant acute and preventive medication use, HCRU, and costs were assessed pre- versus postindex.
In total, 3193 patients met the eligibility criteria. From pre- to postindex, mean (SD) per patient per month (PPPM) number of migraine-related acute medication and preventive medication claims (excluding fremanezumab), respectively, decreased from 0.97 (0.90) to 0.86 (0.87) (P < 0.001) and 0.94 (0.74) to 0.81 (0.75) (P < 0.001). Migraine-related outpatient and neurologist office visits, emergency department visits, and other outpatient services PPPM decreased pre- versus postindex (P < 0.001 for all), resulting in a reduction in mean (SD) total health care costs PPPM from US858) to US974) (P = 0.003). Patients showed high adherence and persistence rates, with mean (SD) proportion of days covered of 0.71 (0.29), medication possession ratio of 0.74 (0.31), and persistence duration of 160.3 (33.2) days 6 months postindex.
Patients with certain migraine comorbidities, potential AMO, and/or UPMPR in a real-world setting had reduced migraine-related medication use, HCRU, and costs following initiation of fremanezumab.
Graphical abstract available for this article.
... These results are consistent with this PEARL analysis, indicating that fremanezumab effectiveness remains high in RWE studies in patients for whom multiple migraine preventive treatments have failed. No new safety findings compared with RCTs have been identified in these studies [26,[44][45][46]. ...
In 2020, the Italian Medicines Agency (AIFA) approved the reimbursement of calcitonin gene-related peptide (CGRP) pathway monoclonal antibodies (mAbs), including fremanezumab, in patients with a Migraine Disability Assessment Scale (MIDAS) score ≥ 11, with prescription renewals for up to 12 months in patients with ≥ 50% reduction in MIDAS score at Months 3 and 6. In this sub-analysis of the Pan-European Real Life (PEARL) study, we provide real-world data on fremanezumab use in Italian routine clinical practice (EUPAS35111).
This first interim analysis for Italy was conducted when 300 enrolled adult patients with episodic or chronic migraine (EM, CM) completed 6 months of treatment with fremanezumab. The primary endpoint is the proportion of patients achieving ≥ 50% reduction in monthly migraine days (MMD) across the 6 months post-fremanezumab initiation. Secondary endpoints include: proportion of patients achieving ≥ 50% reduction in MIDAS score at Months 3 and 6, and mean change from baseline across Months 1–6 in MMD and headache-related disability. Safety was assessed through adverse events (AEs) reported.
Of 354 patients enrolled at Italian centers, 318 (EM, 35.5%, CM, 64.5%) were included in the effectiveness analysis. Of patients with available data, 109 (61.2%) achieved the primary endpoint. 61.0% and 65.1% achieved ≥ 50% reduction in MMDs at Months 3 and 6, respectively; 79.9% and 81.0% experienced ≥ 50% reduction in MIDAS at the same timepoints.
Fremanezumab was effective and well-tolerated over the first 6 months of treatment, with approximately 80% of patients meeting Italian criteria for treatment continuation at Months 3 and 6.
... Despite the rising number of real-world studies on other available mAbs against CGRP (ligand) or its receptor (calcitonin-like receptor/receptor-activating modifying protein 1), such as erenumab and galcanezumab [6], research on fremanezumab is sparse. So far, only three real-world studies with short follow-up periods (up to 12 or 24 weeks) [7][8][9] and a retrospective chart review in the USA [10] have been conducted. Two large studies are underway, including the pan-European PEARL study [11] involving more than 11 countries, and the multicenter FINESSE study, which is being conducted in Austria and Germany [12]. ...
... To the best of our knowledge, this is the first real-world study assessing the effectiveness of fremanezumab up to 12 months in patients with drug-resistant migraine. We are aware of a previous Italian study that evaluated the efficacy of fremanezumab with a 3-or 6-month follow-up (FRIEND study) [7,8], as well as a Greek registry with an up to 3-month follow-up [9], and a retrospective US chart review study reporting data up to 6 months [10]. The characteristics of our cohort are comparable to those described in previous studies, both in terms of sex and distribution of other clinical variables, including prior preventive failures. ...
... In line with previous real-world studies [8][9][10], we confirmed the effectiveness and tolerability of monthly fremanezumab in difficult-to-treat patients with HFEM and CM, with several preventive failures, including onabotulinumtoxin A. At variance with previous investigations, in our present study, most patients completed the 12 months of treatment, before the mandatory interruption according to the Italian regulations, with a low discontinuation rate (18.0%). This highlights a favorable clinical response to fremanezumab as an effective migraine preventive treatment, confirming the remarkable persistence in anti-CGRP mAb treatment, which substantially differs from persistence reported for standard oral preventive therapies [19]. ...
Real-world studies on fremanezumab, an anti-calcitonin gene-related peptide monoclonal antibody for migraine prevention, are few and with limited follow-up.
We aimed to evaluate the long-term (up to 52 weeks) effectiveness and tolerability of fremanezumab in high-frequency episodic migraine and chronic migraine.
This s an independent, prospective, multicenter cohort study enrolling outpatients in 17 Italian Headache Centers with high-frequency episodic migraine or chronic migraine and multiple preventive treatment failures. Patients were treated with fremanezumab 225 mg monthly. The primary outcomes included changes from baseline (1 month before treatment) in monthly headache days, response rates (reduction in monthly headache days from baseline), and persistence in medication overuse at months 3, 6, and 12 (all outcome timeframes refer to the stated month). Secondary outcomes included changes from baseline in acute medication intake and disability questionnaires scores at the same timepoints. A last observation carried forward analysis was also performed.
A total of 90 patients who received at least one dose of fremanezumab and with a potential 12-month follow-up were included. Among them, 15 (18.0%) patients discontinued treatment for the entire population, a reduction in monthly headache days compared with baseline was reported at month 3, with a significant median [interquartile range] reduction in monthly headache days (− 9.0 [11.5], p < 0.001). A statistically different reduction was also reported at month 6 compared with baseline (− 10.0 [12.0]; p < 0.001) and at 12 months of treatment (− 10.0 [14.0]; p < 0.001). The percentage of patients with medication overuse was significantly reduced compared with baseline from 68.7% (57/83) to 29.6% (24/81), 25.3% (19/75), and 14.7% (10/68) at 3, 6, and 12 months of treatment, respectively (p < 0.001). Acute medication use (days and total number) and disability scores were also significantly reduced (p < 0.001). A ≥ 50% response rate was achieved for 51.9, 67.9, and 76.5% of all patients at 3, 6, and 12 months, respectively. Last observation carried forward analyses confirmed these findings. Fremanezumab was well tolerated, with just one patient discontinuing treatment because of adverse events.
This study provides evidence for the real-world effectiveness of fremanezumab in treating both high-frequency episodic migraine and chronic migraine, with meaningful and sustained improvements in multiple migraine-related variables. No new safety issue was identified.
... Although prior studies have evaluated real-world treatment patterns for patients initiating mAbs targeting the CGRP pathway [7][8][9][10][11][12][13][14][15], there are limited real-world data on the use of nAMSMs in the context of anti-CGRP pathway mAbs. The safety and tolerability of nAMSMs in combination with mAbs has been explored in the literature. ...
Background
New acute and preventive migraine medications are available, but data on current treatment patterns are limited. This study describes migraine treatment patterns among patients initiating novel acute migraine specific medications (nAMSMs), overall and by prior use of anti-calcitonin gene-related peptide (CGRP) pathway monoclonal antibodies (mAbs).
Methods
In this retrospective cohort study using IQVIA open-source pharmacy and medical claims data, we identified patients with ≥ 1 claim for a nAMSM (ubrogepant, rimegepant, lasmiditan) between 01/01/2020 and 09/30/2020 (index period). Patients were indexed on their first nAMSM claim and stratified into 2 cohorts: patients with prior mAb use (≥ 1 claim for erenumab, fremanezumab, galcanezumab in the 6-month pre-index period) or patients without prior mAb use. Treatment patterns were assessed during the 6-month post-index period.
Results
Overall, 78,574 patients were identified (63% indexed on ubrogepant, 34% on rimegepant, and 3% on lasmiditan) with 26,656 patients (34%) having had prior mAb use. In the pre-index period, 79% of patients used non-mAb preventive medications and 75% of patients used acute medications. Following the index nAMSM claim, 65% of patients had ≥ 1 refill and 21% had ≥ 4 refills of their index nAMSM; 10% of patients switched to another nAMSM. Post-index mAb use was observed in 82% of patients with a prior mAb and 15% of patients without. Among patients with pre- and post-index use of acute medications, 38% discontinued ≥ 1 acute medication class in the post-index period. Among patients with concomitant use of traditional preventive medications at index, 30% discontinued ≥ 1 concomitant preventive anti-migraine medication in the post-index period.
Conclusions
Most patients initiating nAMSMs had prior treatment with acute and preventive medications. Approximately one-third of patients had prior treatment with anti-CGRP pathway mAbs. After starting nAMSMs, more than one-third of patients discontinued at least one traditional acute medication and one-third of patients discontinued at least one traditional preventive medication.
Despite nAMSM initiation, most patients with prior anti-CGRP pathway mAb use continued mAb use. Around 15% of patients without a prior mAb newly started a mAb. These results provide insight into how nAMSMs and mAbs have been integrated into clinical management of migraine in the real-world.
... The real-world evidence for other antibodies targeting the CGRP pathway, including Fremanezumab and Galcanezumab, is limited. While the existing studies suggest a greater reduction in MMD with these CGRP ligand antibodies, population differences make a direct comparison with our results impossible [26,27]. Most importantly, a high number of prior preventive treatments is a known predictor of poor treatment response, which might explain the lower response rates in this treatment-refractory population [28]. ...
Migraine preventive treatment with the CGRP-receptor monoclonal antibody Erenumab can positively impact health-related quality of life (HRQoL) and disease-associated disability. Patient-reported outcome measures (PROMs) are a valuable additional datapoint to real-world evidence covering how treatment affects physical, mental, and social domains of patients’ lives. In this real-world, single-center retrospective observational cohort study, we analyzed clinical performance indicators and PROMs for migraine patients who failed at least four other preventive medications and received Erenumab over the course of one year. Endpoints were the average monthly migraine days as well as PROMs including the MIDAS, EQ-5D-VAS and PROMIS-29. Data were collected digitally via the software heartbeat ONE in an ambulatory care setting as part of the clinical routine. A total of 145 patients treated with Erenumab provided data for 12 months. After 12 months, the median number of monthly migraine days decreased from 9 to 7 days. A clinically relevant reduction in migraine days by ≥30% was reported by 40% of the patients. The migraine-specific MIDAS score, the EQ-5D-VAS measuring the overall health status and all PROMIS domains, except sleep disturbance, changed significantly, reflecting a positive disease progression. This study highlights how patients with a treatment-resistant migraine in an outpatient setting benefit from a preventive treatment with Erenumab. A decrease in migraine days and an increase in HRQoL was maintained over one year. It also underscores the significance of collecting real-world evidence, including PROMs, as an integral component of the healthcare cycle, as such data can reveal additional factors relevant to treatment.
... Lovati et al. [46] found non-responders (<30% reduction in MHD) scored higher on disinhibition, anhedonia, depressivity, and distractibility on the Personality Inventory for DSM-5 (PID-5) questionnaire than full-responders (>50% reduction in MHD) [46]. In Driessen et al., however, the response rate to fremanezumab was not significantly different in subgroups with major depressive disorder or generalized anxiety disorder [47]. preventive medication failures and response rate to CGRP(-R) mAbs (pooled OR: 0.83, 95% CI: 0.73-0.93, Figure 8). ...
... Lovati et al. [46] found non-responders (<30% reduction in MHD) scored higher on disinhibition, anhedonia, depressivity, and distractibility on the Personality Inventory for DSM-5 (PID-5) questionnaire than full-responders (>50% reduction in MHD) [46]. In Driessen et al., however, the response rate to fremanezumab was not significantly different in subgroups with major depressive disorder or generalized anxiety disorder [47]. There was significant variability in the methods used to determine comorbid psychiatric conditions. ...
... There was significant variability in the methods used to determine comorbid psychiatric conditions. Most studies used the data collected at baseline on medical history and comorbidities, either through electronic chart review [47,55,56,66,68] or baseline in-person Figure 9. Effect of comorbid psychiatric disorders or measures of psychological vulnerability at baseline on treatment response. ...
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.
