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Real-world Reductions in Migraine and Headache Days for Patients With Chronic and Episodic Migraine Initiating Fremanezumab in the US (4171)
... The anti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP-mAb) represent one of the newest developments in the field of migraine therapies. Their benefit has been clearly demonstrated in placebo-controlled trials, [1][2][3][4][5][6][7][8] and multiple centres have reported benefit in patients with severe migraine phenotypes with prior failure of multiple conventional therapies including onabotulinum-toxinA. [9][10][11][12][13][14][15] As highly targeted therapies, modulating CGRP or its receptor, they also demonstrate good tolerability, especially when compared with standard preventive migraine therapies such as topiramate. [16][17][18] Despite this, those treated not infrequently fail to respond or derive limited benefit from an anti-CGRP-mAb drug or develop intolerable side effects necessitating discontinuation. ...
... The anti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP-mAb) represent one of the newest developments in the field of migraine therapies. Their benefit has been clearly demonstrated in placebo-controlled trials, [1][2][3][4][5][6][7][8] and multiple centres have reported benefit in patients with severe migraine phenotypes with prior failure of multiple conventional therapies including onabotulinum-toxinA. [9][10][11][12][13][14][15] As highly targeted therapies, modulating CGRP or its receptor, they also demonstrate good tolerability, especially when compared with standard preventive migraine therapies such as topiramate. [16][17][18] Despite this, those treated not infrequently fail to respond or derive limited benefit from an anti-CGRP-mAb drug or develop intolerable side effects necessitating discontinuation. ...
Objectives
The anti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP-mAb) are effective in migraine; however, few studies have examined the benefit of switching from one anti-CGRP-mAb to another. In order to better inform clinical practice in this situation, we present our real-world findings of switching anti-CGRP-mAb in chronic migraine.
Methods
Individuals with chronic migraine that switched anti-CGRP-mAb treatment (erenumab, fremanezumab or galcanezumab) due to ineffectiveness or adverse effects were retrospectively identified. Headache diary data before and up to 6 months after anti-CGRP-mAb switch were analysed. Main outcome measures were monthly red days (days with headaches limiting activity or requiring triptans), headache days (days with any kind of headache), triptan use, other analgesic use and headache disability (Headache Impact Test-6 (HIT-6) score) at 3 months.
Results
The analysis included 66 instances of switching among 54 individuals. There were non-significant reductions of −1.2 (−2.7, 0.3) red days from baseline at 3 months, with 10 individuals (15%) showing ≥50% improvement and 22 (33%) experiencing a ≥30% improvement. Improvements in headache days, triptan days, other painkiller use and HIT-6 score were non-significant. When individuals that switched due to side effects were excluded from the analysis, significant reductions in headache (Friedman p=0.044) and a trend for improvement in red days (Friedman p=0.083) were observed. With regard to side effects, on 12 occasions these improved or resolved on switching to a different anti-CGRP-mAb, while new symptoms were reported on eight occasions following a switch.
Conclusion
We recorded modest improvements in headache outcomes, although significant results were only observed in those that switched anti-CGRP-mAb due to ineffectiveness. Switching may therefore be a viable option for these individuals.
... Several phase II RCTs are underway assessing fremanezumab for treating patients with migraine and major depressive disorder, post-traumatic headache, and fibromyalgia [73]. RWD of fremanezumab after 6 months have revealed MMD reductions of − 7.7 and − 10.1 in patients with EM and CM, respectively [74]. A 24-month prospective, observational study of fremanezumab in EM and CM is currently ongoing in Europe [75]. ...
Calcitonin gene-related peptide (CGRP), a 37 amino-acid neuropeptide found mostly in peptidergic sensory C-fibers, has been suggested to be implicated in the pathogenesis of migraine, which is one of the most common neurological disorders seen in medical practice, affecting almost 16% of the US population. While previously thought to be a vascular condition, migraine attacks are the result of neurogenic inflammation and peripheral/central sensitization through dysfunctional activation of the trigeminovascular system. To date, two classes of therapeutic agents have been developed to interrupt the function of CGRP: CGRP-targeted monoclonal antibodies (mAbs) and small-molecule antagonists (gepants). There are currently four CGRP-targeted mAbs and three gepants that are US Food and Drug Administration (FDA) approved for the treatment of migraine. Multiple phase II and III studies have established the efficacies and tolerability of these treatments. Previously, we reviewed the fundamental role of CGRP in migraine pathogenesis. Here, we discuss in depth the clinical evidence (randomized controlled trials and real-world studies), safety, and tolerability of CGRP-targeted mAbs and gepants for treating migraine.
... While pharmacological RCTs test drugs under ideal conditions, real-life studies explore their effectiveness, safety, and tolerability in unselected patients in routine circumstances, detecting rare or late-onset adverse events, assessing adherence and patterns of use, providing higher generalizability results, and testing new hypotheses [11]. In addition to the growing real-life evidence on erenumab [12,13] and galcanezumab [14,15], preliminary results from non-peer reviewed publications on retrospective, real-world studies are available for fremanezumab, documenting a reduction ranging from 68.7% to 77% in monthly migraine days (MMDs) and from 65.9% to 74.8% in monthly headache days (MHDs) in EM or CM, lower acute medication use and emergency department, and outpatient physician costs [16]. ...
Background:
Fremanezumab has demonstrated to be effective, safe, and tolerated in the prevention of episodic or chronic migraine (CM) in randomized, placebo-controlled trials (RCTs). Real-life studies are needed to explore drug effects in unselected patients in routine circumstances and to provide higher generalizability results. This study explores the effectiveness, safety, and tolerability of fremanezumab in a real-life population of individuals affected by high-frequency episodic (HFEM: 8-14 days/month) or CM.
Methods:
This is a 12-week multicenter, prospective, cohort, real-life study. We considered all consecutive patients affected by HFEM or CM visited at 9 Italian headache centers from 28/07/2020 to 11/11/2020. Eligible patients were given subcutaneous fremanezumab at the doses of 225 mg monthly or 675 mg quarterly, according to their preference. Primary study endpoints were the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM patients at weeks 9-12 compared to baseline. Secondary endpoints encompassed variation in monthly analgesic intake (MAI), Numerical Rating Scale (NRS), HIT-6 and MIDAS scores, and ≥ 50%, ≥ 75% and 100% responder rates at the same time intervals.
Results:
Sixty-seventh number migraine patients had received ≥ 1 subcutaneous fremanezumab dose and were considered for safety analysis, while 53 patients completed 12 weeks of treatment and were included also in the effectiveness analysis. Fremanezumab was effective in both HFEM and CM, inducing at week 12 a significant reduction in MMDs (-4.6, p < 0.05), MHDs (-9.4, p < 0.001), MAI (-5.7, p < 0.05; -11.1, p < 0.001), NRS (-3.1, p < 0.001; -2.5, p < 0.001), and MIDAS scores (-58.3, p < 0.05; -43.7; p < 0.001). HIT-6 was significantly reduced only in HFEM patients (-18.1, p < 0.001). Remission from CM to episodic migraine and from MO to no-MO occurred in 75% and 67.7% of the patients. The ≥ 50%, ≥ 75% and 100% responder rates at week 12 were 76.5%, 29.4% and 9.9% in HFEM and 58.3%, 25% and 0% in CM. Younger age emerged as a positive response predictor (OR = 0.91; 95% CI 0.85-0.98, p = 0.013). Treatment-emergent adverse events were uncommon (5.7%) and mild. No patient discontinued fremanezumab for any reason.
Conclusions:
Fremanezumab seems more effective in real-life than in RCTs. Younger age emerges as a potential response predictor.
El fremanezumab es un anticuerpo monoclonal subcutáneo contra el péptido relacionado con el gen de la calcitonina (CGRP) indicado en la migraña episódica y crónica que ha demostrado eficacia, efectividad, seguridad y buena tolerabilidad en ensayos clínicos, estudios abiertos y análisis ad hoc. Desde su comercialización se han realizado diversos estudios que confirman su eficacia y seguridad en la vida real y analizan otras características no presentes en los ensayos clínicos, como su utilidad en pacientes más refractarios, con comorbilidades o polimedicados.
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