Effectiveness, and Safety of Eptinezumab in Episodic and Chronic Migraine Headache in the UAE: A retrospective study

doi:10.21203/rs.3.rs-2878810/v1

Download PDF

Research Article

Effectiveness, and Safety of Eptinezumab in Episodic and Chronic Migraine Headache in the UAE: A retrospective study

https://doi.org/10.21203/rs.3.rs-2878810/v1

This work is licensed under a CC BY 4.0 License

Version 1

posted

You are reading this latest preprint version

Background

Eptinezumab-jjmr is a humanized IgG1 immunoglobulin monoclonal antibody administered intravenously as a preventative migraine treatment. Previously conducted randomized, double-blind, placebo-controlled trials exhibited significant reduction in monthly migraine frequency among adults experiencing episodic and chronic migraine. The present study seeks to expand upon the current findings and evaluate Eptinezumab-jjmr’s efficacy as a preventative migraine treatment for chronic and episodic migraine patients in the United Arab Emirates. This study is intended to represent the first real-world evidence study and will hopefully serve as a valuable complement to the existing literature on the subject.

Methods

This was a retrospective, observational, and exploratory study. The participants included within the study were adult (≥ 18 years) patients diagnosed with either episodic or chronic migraine. Patients were categorized according to their history of previous preventative treatment failure. For the final assessment of treatment efficacy, we included only patients with a minimum of 6 months of clinical follow-up data. Patients were assessed at baseline for their monthly migraine frequency and assessed again at months 3 and 6. The primary objective was to evaluate the efficacy of Eptinezumab-jjmr in reducing migraine frequency among chronic and episodic migraine patients.

Results

100 participants were identified, of whom 53 patients completed the study protocol to month 6. 40 (75.5%) were female, 46 (86.8%) were Emirati locals, and 16 (30.2%) were pharmaceutically naïve, having never tried any prior preventative therapy. Additionally, 25 (47.2%) patients met the criteria for chronic migraine (CM), whereas the remaining 28 (52.8%) were diagnosed with episodic migraine (EM). The baseline monthly migraine frequency (MMD) was 12.2 (4.97) days across all participants, 15.6 (3.97) for CM patients, and 9.25 (3.76) for EM patients; by month 6, these frequencies reduced to 3.66 (4.21), 4.76 (5.32), and 2.68 (2.61), respectively. Overall, 58.5% of those enrolled experienced > 75% reduction in MMD frequency by month 6.

Conclusion

Patients enrolled in this trial experienced clinically significant reductions in MMD by month 6. Eptinezumab-jjmr was well tolerated with only one AE of note.

Eptinezumab

CGRP

Migraine

Onset

Effectiveness

Safety

UAE

Migraine is a neurological disorder that is experienced by an estimated 14.0% of the global population. It is a highly prevalent condition that can have a significant impact on an individual's quality of life. The impact of migraines on an individual's life can range from irritating to debilitating, depending on the severity of the attacks and the individual's ability to manage their symptoms.[1] Therefore, given the significant impact that migraines can have on individuals' quality of life, it is indeed imperative that adequate research is devoted to improving our understanding of the pathophysiology and treatment of this condition.[2] Prevailing belief regarding the onset of a migraine attributes the pain to neural vasodilation within intracranial tissue; this is caused, in part, by the release of calcitonin-gene related peptide (CGRP)[3]. CGRP is prevalent in the trigeminal ganglion and plays an active role in nociception[4]. The following literature review contains content sourced from peer reviewed academic journals. Articles were obtained through a search via Google Scholar. Included studies were published within the last 4 years and were searched for based on the following key terms: ‘Eptinezumab’, ‘migraine’, and ‘monoclonal antibody’.

Historically, attempts at mitigating migraine-like symptoms involved the use of vasoconstrictors[5]. However, this approach posed clear risks for cardiovascular adverse effects. Consequently, recent attempts at anti-migraine medication specifically target CGRP receptors; such is the case with Epitinezumab-jjmr, approved by the FDA in 2020[6]. Eptinezumab-jjmr is a humanized IgG1 immunoglobulin monoclonal antibody (-mAb) administered intravenously to prevent migraines[7]. Eptinezumab-jjmr acts by binding to ⍺-CGRP and β-CGRP. Monoclonal antibodies make for an effective and safe means of migraine treatment due to their ability to be metabolized to amino acids and their blood brain barrier impermeability[4].

Eptinezumab-jjmr’s status as the first intravenous CGRP-mab offers it potential advantages over similar pharmaceuticals; namely this allows for rapid effect, improved dosage precision, and high binding affinity. Through PREVAIL, a two-year, open-label, placebo-controlled study, 128 adults suffering from chronic migraine were administered 300 mg intravenously every three months for up to 8 doses and were followed for 5 months afterwards. One month following the first injection, 61.1% of patients reported perceived improvement of condition; this portion improved to 83.3% 5 months removed from the final injection[8].

A similar study, entitled PROMISE-2 was conducted in 2020. PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study designed to assess the viability of Eptinezumab-jjmr as a preventative migraine treatment strategy[9]. Participants in the study received intravenous administration of Eptinezumab-jjmr at either 100 mg or 300 mg doses 12 weeks apart and were observed over the course of 32 weeks beginning at screening. Both doses significantly decreased migraine frequency when compared to placebo. Furthermore, these benefits were heightened following administration of the second dose; possibly suggesting compounding effects. For this study, as well as its predecessor PROMISE-1, participants were excluded if experiencing confounding pain syndromes or untreated psychiatric disorder, had received recent monoclonal antibody treatment or botulinum toxin injection[10].

This current study offers insight into the potential use of Eptinezumab-jjmr in a real-world setting as a preventative migraine treatment; however, there remains gaps in our knowledge regarding the long-term safety implications, as well as how this treatment method may differentially impact diverse populations in the real-world setting. Furthermore, the focus on a primarily Arab population makes for unique evidence of pharmaceutical treatment on an underreported population in the pivotal trials. Despite possessing a prevalence falling within the global estimated range, there remains a lack of empirical research assessing migraine treatment strategies among Arab populations [11].

Study Design

For the purposes of this study, patients recruited were categorized according to their previous preventative treatment failure (PPTF), or the lack thereof. Patients without any PPTF were considered treatment naïve. Across participants, the most common PPFTs were Galcanezumab and Erenumab. All participating patients were prescribed an initial Eptinezumab-jjmr dose of 100mg following baseline assessment; however, this dose was subject to increase to 300 mg at the physician's discretion according to the individual needs of the patient. Such instances were documented and taken under consideration when interpreting findings. Included participants consented to begin or switch to Eptinezumab-jjmr as a migraine treatment strategy and agreed to returning every 3 months for each additional dose and follow-up assessment.

Demographic information, diagnosis, medication history, and baseline MMD was derived from clinical records. Participants’ perception of treatment effectiveness was similarly documented in clinical records, as well as in their ‘headache diaries’ where they were asked to document their symptoms post-treatment. Treatment efficacy was determined according to the change in MMD between assessments. Treatment safety was determined according to the presence or absence of adverse events (AE).

Patients were assessed on their baseline frequency of MMDs, and subsequently administered an initial 100mg dose of Eptinezumab-jjmr. Patients were reassessed and administered additional doses at both 3-months and 6-months following the initial assessment. Patients not completing study protocol through 6-months at the time of data analysis were not included in the final analysis. the occurrence of AEs was documented and considered when evaluating the safety and tolerability of Eptinezumab-jjmr.

All relevant ethical, health authority, data privacy and site-specific approvals were obtained prior to the start of the study. Informed consent was obtained from patients before data collection. Depending on each site’s local Institutional Review Board (IRB) regulations, a waiver of informed consent from the corresponding ethics committee was obtained. All authors were given access to the study data.

Objectives

The primary objective was to investigate the efficacy and safety of intravenous Eptinezumab-jjmr as a preventative migraine treatment. The aim was to examine possible differences in outcome for patients diagnosed with chronic and episodic migraine.

Furthermore, and as a secondary end point, it was sought to investigate the differences in treatment efficacy and safety for patients with at least one PPTF. Therefore, in addition to treatment-naïve patients, participants who had previously been prescribed Galcanezumab or Erenumab were included in the analysis of outcomes.

Statistical Analysis

Descriptive statistics include the following demographic and clinical information: sex, nationality, age, age of migraine onset, PPTF, and diagnosis (CM or EM). Treatment efficacy will be assessed according to patient testimonials, as per headache diaries, of MMD change from baseline since receiving treatment.

The following analysis is exploratory in nature and is not made in reference to any specific hypotheses. Numerical variables such as MMD will be reported as means and standard deviations (SD), whereas categorical variables will be reported using frequency and percentages. Paired, two-tailed t-tests were conducted to analyze differences in mean MMD between clinical assessments.

Demographics and Baseline Characteristics

100 patients were identified; all except for one are still on treatment at the time of this submission. However, 53 patients only have met the inclusion criteria and are included in the final analysis. The descriptive statistics of which are shown in Table 1. Within the population pool, 25 (47.2%) patients met the criteria for a chronic migraine diagnosis, whereas the remaining 28 (52.8%) were diagnosed with episodic migraine. The mean (SD) age of participants was 36.4 (10.5) years, whereas the mean age of onset for migraine was 29.4 (8.74) years; these means did not differ significantly between CM and EM patients.

Table 1

Patient descriptive statistics and baseline data
	Overall (N = 53)	Chronic (N = 25)	Episodic (N = 28)	p-value
Age, years, mean (SD)	36.4 (10.5)	37.8 (9.88)	35.2 (11.2)	0.3824
Age of migraine onset, mean (SD)	29.4 (8.74)	31.1 (8.24)	27.9 (9.09)	0.2300
Sex, female, n (%)	40.0 (75.5)	16.0 (49.6)	24.0 (85.7)
Nationality, Emirati, n (%)	46.0 (86.8)	22.0 (88.0)	24.0 (85.7)
Migraine duration, years, mean (SD)	7.02 (7.94)	7.71 (9.58)	6.39 (6.24)	0.4431
Baseline MMD, days, mean (SD)	12.2 (4.97)	15.6 (3.97)	9.25 (3.76)	< 0.000001**
PPTF, naïve, n (%)	16.0 (30.2)	6.00 (24.0)	10.00 (35.7)
PPTF, Erenumab, n (%)	16.0 (30.2)	6.00 (24.0)	10.00 (35.7)
PPTF, Galcanezumab, n (%)	17.0 (32.1)	9.00 (36.0)	8.00 (28.6)
PPTF, other medication, n (%)	4.00 (7.55)	4.00 (16.0)	0.00
p-value listed is the result of unpaired, two-tailed t-tests comparing mean of CM and EM patients *p-value is statistically significant (p < 0.05)

A key feature of this study’s population was an overwhelming majority of female (75.5%) and Emirati participants (86.8%). Overall, distribution of PPTF history was relatively even, with naive, Erenumab, and Galcanezumab patients accounting for 30.2%, 30.2%, and 32.1%, respectively. The remaining 7.5% of participants expressed use of another medication. Among the 53 patients who had completed study protocol through month 6, 14 (26.4%) had undergone a dose increase, based on clinical discretion, from 100mg to 300mg at some point after initiation of treatment. Eight out of the 14 patients have met the criteria for a CM diagnosis.

The mean (SD) baseline frequency of MMD across all participants was 12.2 (4.97). When examining CM and EM data individually, MMD baseline frequency diverges to 15.6 (3.97) and 9.25 (3.76), respectively. The mean MMD frequencies of CM and EM patients differed significantly (p < 0.000001).

Chronic Migraine and Episodic Migraine

Across all patients, the mean (SD) MMD frequency decreased from 12.2 (4.97) to 5.21 (5.73) by month 3, and 3.66 (4.21) by month 6. For specifically CM patients, mean MMD decreased from 15.6 (3.97) at baseline (BL) to 7.76 (6.78) by month 3 (M3), and 4.76 (5.32) by month 6 (M6). For EM patients, mean BL MMD decreased from 9.25 (3.76) to 2.93 (3.30) by M3 and 2.68 (2.61) by M6. Across all patients, the decrease in MMD from BL to M3 (p < 0.000000001) and BL to M6 (p < 0.000000001) was statistically significant as was the decrease from M3 to M6 (p = 0.02). This trend holds when independently analyzing CM and EM patients as well. For CM patients a paired, two-tailed t-test yielded statistically significant difference for the change from BL to M3 (p < 0.000001) and BL to M6 (p < 0.0000001) and for M3 to M6 (P = 0.03). Similarly, for EM patients a t-test yielded a statistically significant difference for the change from BL to M3 (p < 0.000001) and BL to M6 (p < 0.00001) but not for M3 to M6 (P = 0.7449). These findings are visualized in Fig. 1.

As exhibited in Fig. 2, 58.5% of patients experienced at least 75% reduction in their MMD frequency by month 6. Furthermore, only 15.1% of patients experienced less than 50% reduction in MMD. A similar proportion of patients achieved > 75% reduction among CM (60.0%) and EM patients (57.1%). CM patients appeared to be less responsive initially (32.0% achieving > 75% reduction by month 3) when compared to EM patients (57.1%).

Previous Preventative Treatment Failure

As part of this study’s exploratory objectives, patients were categorized according to their PPTF history, or lack thereof. As exhibited in Table 2, mean comparison tests were conducted between naïve patients, and those with PPTF history across the following variables: age, age of migraine onset, baseline MMD frequency, month 3 (M3) MMD frequency, and month 6 (M6) MMD frequency. Naïve and PPTF patients did not differ significantly in mean age (p = 0.1739) nor age of migraine onset (p = 0.7022). Additionally, naïve and PPTF patients did not differ significantly in baseline MMD frequency (p = 0.8808). However, at M3, naïve patients (mean = 2.13, SD = 1.86) had significantly lower mean MMD frequency (p = 0.0006) than PPTF patients (mean = 6.61, SD = 6.36). Full descriptive statistics and t-test results are presented in Table 2.

Table 2

PPTF group descriptive statistics and patient outcomes
mean	Overall* (N = 53)	Naïve (N = 16)	Erenumab (N = 16)	Galcanezumab (N = 17)	p-value**
Age, years, mean (SD)	36.4 (10.5)	33.3 (9.36)	38.6 (10.3)	36.2 (10.8)	0.1739
Age of migraine onset, mean (SD)	29.4 (8.74)	28.4 (6.42)	26.8 (7.79)	31.7 (9.80)	0.7023
Sex, female, n (%)	40 (75.5)	11 (68.8)	12.0 (75.0)	14.0 (82.4)
Nationality, Emirati, n (%)	46 (86.8)	16 (100.0)	14.0 (87.5)	14.0 (82.4)
Baseline MMD, days, mean (SD)	12.2 (4.97)	11.8 (4.34)	12.0 (5.13)	12.1 (5.92)	0.8808
Month 3 MMD, days, mean (SD)	5.21 (5.73)	2.13 (1.86)	5.69 (5.96)	7.47 (6.77)	0.0005687***
Month 6 MMD, days, mean (SD)	3.66 (4.21)	3.25 (4.27)	3.63 (4.86)	3.82 (2.67)	0.7072
Chronic Migraine, n (%)	25.0 (47.2)	6.00 (37.5)	6.00 (37.5)	9.00 (52.9)
Episodic Migraine, n (%)	28.0 (52.8)	10.0 (62.5)	10.0 (62.5)	8.00 (47.1)

*Study participants not fitting the criteria for any PPTF group are absent from the table despite factoring into the total study sample size.

**p-value listed is the result of unpaired, two-tailed t-tests comparing mean of naïve patients against the aggregate mean of Erenumab and Galcanezumab patients.

***p-value is statistically significant (p < 0.05)

Exposure and safety

Among the initial recruitment population (N = 100), only one patient reported an adverse event. This patient reported worsening headaches, increased photophobia, and a pimple-like rash. As a result, he/ she they were discontinued from the study. Eptinezumab-jjmr was well-tolerated across the remaining participants.

To our knowledge, this study represents the first real-world evidence study of intravenous migraine treatment and the first study examining the efficacy and tolerability of intravenous migraine medication among chronic and episodic migraine patients in the UAE. Similar to our study, other real-world data on other mAbs have validated our understanding of the effectiveness of these therapies[12, 13]. Furthermore, the current study included diverse pools of patients in terms of their prior preventive therapies’ exposure in their treatment; the inclusion of naïve patients, as well as those with PPTF for migraine headache allows for possible insights into how Eptinezumab-jjmr’s efficacy may be impacted by prior medication history. Our findings align strongly with those presented in PROMISE-1, PROMISE-2, and PREVAIL wherein administration of Eptinezumab-jjmr have significantly decreased migraine frequency with sustained effects over a 12-week period and was well-tolerated by most patients. Our results suggest that additional doses of treatment may result in further reduction in MMDs in a subset of patients and an increased proportion of patients experiencing a > 75% in MMDs from baseline by week 24 which mirrors the findings presented in PROMISE-2.

A major objective was to assess potential differences in response to Eptinezumab-jjmr for chronic and episodic migraine patients. In line with standard diagnostic criteria, CM patients expressed a significantly greater frequency of MMD at baseline assessment. Furthermore, it is worth noting that EM patients exhibited greater improvements by month 3 when compared to CM counterparts. By month 3, 57.1% of EM patients had experienced a > 75% reduction in MMD, whereas only 32.0% of CM patients achieved similar success. Nevertheless, this disparity approximately equalized by month 6. These findings, similar to other mAb, could indicate a greater treatment resistance to Eptinezumab-jjmr in CM patients. This outcome warrants further investigation into the safety and tolerability of 300mg doses as a treatment strategy for CM or otherwise treatment-resistant patients. In this present study, 14 participants, 8 of which were diagnosed with CM agreed to an increase in dosage from 100mg to 300mg and no AEs were documented as a result. Among patients agreeing to a dosage increase, 4 experienced < 25% reductions in MMD, 1 experienced 25% − 50% reduction, 6 patients showed a rate of 50% − 75% reduction, while the remaining 3 patients experienced > 75% reduction in MMD by month 6.

It is possible that a previous prescription may impact the efficacy of Eptinezumab-jjmr. Our findings suggest that naïve patients are more responsive by month 3 than patients who had previously been prescribed Galcanezumab and Erenumab. Whether this means they are mAb resistant to CGRP based therapy or not, future trials may provide alternative and better pathophysiological based explanations.

Furthermore, developing resistance towards treatment could be another possible explanation, however this is not a common occurrence. A systematic review which was conducted to evaluate the treatment of resistant chronic migraine with anti- CGRP monoclonal antibodies mentions that developing tachyphylaxis is possible. This could be due to an increased development of antibodies in response to treatment [14].

On another hand, another study was conducted to investigate the development of anti-drug antibodies (ADAs). Based on their clinical immunogenicity evaluation, results showed that developing ADAs was rare however the presence of ADAs had no effect on the efficacy or safety[15]. Clinical studies with Eptinezumab reported the highest rates of ADAs and NAbs in comparison to other CGRP inhibitors.[16] This observation is worth noting, knowing that Eptinezumab is administered intravenously, while other CGRP mAbs are administered subcutaneously. Several factors influence immunogenicity and mitigation which include dosage, route of administration, protein structure as well as patient related factors such as concomitant medication use and comorbidities[17]. Future studies could help expand our knowledge to understand the long-term effects of immunogenicity of Eptinezumab.

MMD, the metric by which treatment efficacy is determined, is reliant on a patient's testimony. Therefore, the accuracy of MMD is subject to the patient’s ability to recall the frequency of migraine attacks over at least the last month; patients were asked to keep a regular diary of their symptoms. As a result, naïve patients may have their perception skewed towards greater improvement due to the lack of a previous reference point for medication effectiveness, or patients tend to neglect accurate documentation their daily headaches on a regular basis.

Our results demonstrated the promise of intravenous medication as an effective treatment strategy for migraine. Given that the means of administration necessitates a clinician, it encourages consistent follow-ups with a healthcare provider and minimizes risk of medication overuse/misuse. Most notably, most participants enrolled reported sustained improvements that spanned up to 3-month intervals, minimizing the burden of a daily prescription.

Regarding safety, administration of Eptinezumab-jjmr was well-tolerated and all but one participant proceeded without adverse effects. For the aforementioned patient, s/he reported worsening headaches, increased photophobia, and a pimple-like rash; s/he discontinued from the study.

Future follow-up studies would benefit from the inclusion of further surveys intended to quantify the physical and affective impact of Eptinezumab-jjmr on quality of lives in patients with migraines. Surveys assessing participants’ monthly migraine/headache days, as well as changes in their emotional wellbeing and productivity would allow for a more robust picture of Eptinezumab-jjmr’s impact on the lives of migraine patients.

This retrospective study examining the efficacy of Eptinezumab-jjmr among migraine patients in the UAE resulted in several valuable insights. Namely, early impressions suggest that intravenous migraine medication has potential to be an effective and well-tolerated treatment strategy; this appears to be especially true for naïve patients, and for those diagnosed with episodic migraine.

Across participants, administration of 100 mg Eptinezumab-jjmr appeared to result in at least moderate reduction in migraine frequency and severity with sustained effects over the course of three months. However, a small portion of participants did not experience meaningful reduction in migraine symptoms until dosage was increased to 300 mg. The relationship between dosage and efficacy remains a point of intrigue; the initial findings present serve as a necessary starting point into further explorations pertaining to this association.

Overall, the results provide compelling evidence towards the possible uses of a novel treatment strategy in a clinical context.

adverse events

baseline

CGRP

calcitonin-gene related peptide

chronic migraine

Episodic migraine

ICHD-3

International Classification of Headache Disorders

IRB

Institutional Review Board

mAb

monoclonal antibody

MMD

monthly migraine frequency

PPTF

previous preventative treatment failure

standard deviations

UAE

United Arab Emirates.

Acknowledgements

Not applicable.

Authors contribution

YB helped collecting data and analyzing results, and Medline search. IQ, MH, VS helped collecting data. RS, TA helped interpreting data, write up and overseeing the project. All authors read and approved the final manuscript.

Funding

Not Applicable

Availability of data and materials

All data that has been analyzed and relevant to this study has been included within the manuscript.

Ethics approval and consent to participate

The study was approved by the American Center for Psychiatry and Neurology (ACPN) Institutional Review Board. The research was conducted in accordance with the Declaration of Helsinki and consistent with GCP and the applicable regulatory requirements. The ethics committee of the ACPN has waived the need for informed consent for this study as it involved a retrospective analysis.

Consent for Publication

Not Applicable

Competing interests

The authors declare that they have no competing interest.

Stovner LJ, Hagen K, Linde M, Steiner TJ. The global prevalence of headache: an update, with analysis of the influences of methodological factors on prevalence estimates. J Headache Pain. 2022;23:34.
Mungoven TJ, Henderson LA, Meylakh N. Chronic Migraine Pathophysiology and Treatment: A Review of Current Perspectives. Front Pain Res. 2021;2.
Schoenen J, Manise M, Nonis R, Gérard P, Timmermans G. Monoclonal antibodies blocking CGRP transmission: An update on their added value in migraine prevention. Rev Neurol (Paris). 2020;176:788–803.
Bo Y, Li J, Wang Y. The Mechanism of Eptinezumab-Jjmr Targeting CGRP In the Treatment of Migraine. 2022 International Conference on Biotechnology, Life Science and Medical Engineering (BLSME 2022). Clausius Scientific Press; 2022.
Edvinsson L. CGRP and migraine: from bench to bedside. Rev Neurol (Paris). 2021;177:785–90.
Dhillon S, Eptinezumab. First Approval Drugs. 2020;80:733–9.
Vijayanandh M. VYEPTI (eptinezumab-jjmr) Intravenous Drug as a Preventive Treatment of Migraine. Pondicherry J Nurs. 2020;12:56–7.
Kudrow D, Cady RK, Allan B, Pederson SM, Hirman J, Mehta LR, et al. Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial. BMC Neurol. 2021;21:126.
Yuan H, Silberstein SD, Eptinezumab. 2021. p. 109–19.
Ashina M, McAllister P, Cady R, Hirman J, Ettrup A. Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2. Cephalalgia. 2022;42:696–704.
El-Metwally A, Toivola P, AlAhmary K, Bahkali S, AlKhathaami A, Al Ammar SA, et al. The Epidemiology of Migraine Headache in Arab Countries: A Systematic Review. Sci World J. 2020;2020:1–11.
Alsaadi T, Noori S, Varakian R, Youssef S, Almadani A. Real-world experience of erenumab in patients with chronic or episodic migraine in the UAE. BMC Neurol. 2022;22:221.
Straube A, Stude P, Gaul C, Schuh K, Koch M. Real-world evidence data on the monoclonal antibody erenumab in migraine prevention: perspectives of treating physicians in Germany. J Headache Pain. 2021;22:133.
Sevivas H, Fresco P. Treatment of resistant chronic migraine with anti-CGRP monoclonal antibodies: a systematic review. Eur J Med Res. 2022;27:86.
Pederson S, Biondi DM, Allan B, Cady R, Schaeffler B, Baker B et al. Clinical Immunogenicity Evaluation of Eptinezumab, a Therapeutic Humanized Monoclonal Antibody Targeting Calcitonin Gene-Related Peptide (CGRP) for the Preventive Treatment of Migraine. Front Immunol. 2021;12.
Cohen JM, Ning X, Kessler Y, Rasamoelisolo M, Campos VR, Seminerio MJ, et al. Immunogenicity of biologic therapies for migraine: a review of current evidence. J Headache Pain. 2021;22:3.
Chirmule N, Jawa V, Meibohm B. Immunogenicity to Therapeutic Proteins: Impact on PK/PD and Efficacy. AAPS J. 2012;14:296–302.

No competing interests reported.

Download PDF

Version 1

posted

You are reading this latest preprint version

Effectiveness, and Safety of Eptinezumab in Episodic and Chronic Migraine Headache in the UAE: A retrospective study

Status:

Version 1

Abstract

Figures

Background

Methods

Study Design

Objectives

Statistical Analysis

Results

Demographics and Baseline Characteristics

Chronic Migraine and Episodic Migraine

Previous Preventative Treatment Failure

Exposure and safety

Discussion

Conclusions

Abbreviations

Declarations

References

Additional Declarations

Status:

Version 1