Real-world evidence data on the monoclonal antibody erenumab in migraine prevention: perspectives of treating physicians in Germany

Straube, Andreas; Stude, Philipp; Gaul, Charly; Schuh, Katrin; Koch, Mirja

doi:10.1186/s10194-021-01344-1

Cited by 20 publications

(7 citation statements)

References 39 publications

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“…Our observations also accord with other studies of erenumab in the real world across a range of regions and settings [21][22][23][24][25]. For example, The TELESCOPE study, a multicentre survey collecting real-world data from 45 German headache centres, reported a 7.5 days reduction (p < 0.0001) in MHD following 3 months treatment with erenumab [25]. In another multicentre study in Italy (EARLY2), erenumab treatment reduced MHD by 12.8 ± 8.9 from baseline through week 45 to 48 [21].…”

Section: Discussionsupporting

confidence: 92%

Real-world experience of erenumab in patients with chronic or episodic migraine in the UAE

Alsaadi¹,

Noori

Varakian³

et al. 2022

BMC Neurol

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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 migraine days. Real-world evidence of the effectiveness of erenumab in patients with migraine is accruing, but gaps remain, and findings may vary according to region. We evaluated the usage patterns and effectiveness of erenumab in real-world settings in patients with migraine in the United Arab Emirates (UAE). Methods This retrospective, observational real-world study enrolled patients ≥ 18 years with migraine who were prescribed erenumab in the UAE. Data were collected at baseline and Months 1, 3 and 6. The primary study objective was to characterise usage patterns of erenumab in patients with chronic migraine (CM) or episodic migraine (EM) in real-world settings in the UAE. Results Of the 166 patients, 124 (74.7%) were females. The mean (standard deviation) age at migraine onset was 29 (7.93) years. Seventy-one patients (42.8%) had CM and 95 (57.2%) had EM. In the overall population, the mean monthly headache/migraine days (MHD) at baseline was 15.7 (8.45) and mean change from baseline was − 8.2 (8.83) at Month 1, − 11.0 (9.15) at Month 3 and − 11.3 (8.90) at Month 6. The mean change from baseline in monthly acute migraine-specific medication days (MSMD) was − 9.0 (8.07) at Month 1, − 9.7 (8.73) at Month 3 and − 10.7 (8.95) at Month 6. At all time points, most patients achieved at least 50% reduction in MHD (80%–91%) and MSMD (84%–94%). Similar reductions in MHD and MSMD and clinical benefit in CM or EM were seen with erenumab monotherapy or erenumab add-on therapy, with or without dose escalation and for treatment naïve or ≥ 1 previous preventive treatment failures, with additional clinical benefit in the erenumab add-on therapy and dose escalation to 140 mg subgroups. Conclusion In this real-world study on erenumab use in the UAE, patients prescribed erenumab achieved clinically meaningful reductions in MHD and MSMD at all assessed time points. Erenumab was well tolerated with no new safety events.

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Section: Discussionsupporting

confidence: 92%

Real-world experience of erenumab in patients with chronic or episodic migraine in the UAE

Alsaadi¹,

Noori

Varakian³

et al. 2022

BMC Neurol

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“…To our knowledge, this study represents the rst real-world evidence study of intravenous migraine treatment and the rst study examining the e cacy 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 e cacy may be impacted by prior medication history.…”

Section: Discussionsupporting

confidence: 66%

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

Bader¹,

Suliman²,

Harb³

et al. 2023

Preprint

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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.

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“…After the publication of the previous guideline, CGRP-mAbs became available in Europe and real-world observational studies confirmed the effectiveness of those drugs outside RCTs [ 31 – 34 ]. Tolerability and safety profiles were confirmed to be excellent and the adherence to treatment was not reported as a critical issue as it was with oral treatments [ 35 – 37 ].…”

Section: Resultsmentioning

confidence: 99%

European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention – 2022 update

et al. 2022

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Background A previous European Headache Federation (EHF) guideline addressed the use of monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway to prevent migraine. Since then, randomized controlled trials (RCTs) and real-world evidence have expanded the evidence and knowledge for those treatments. Therefore, the EHF panel decided to provide an updated guideline on the use of those treatments. Methods The guideline was developed following the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach. The working group identified relevant questions, performed a systematic review and an analysis of the literature, assessed the quality of the available evidence, and wrote recommendations. Where the GRADE approach was not applicable, expert opinion was provided. Results We found moderate to high quality of evidence to recommend eptinezumab, erenumab, fremanezumab, and galcanezumab in individuals with episodic and chronic migraine. For several important clinical questions, we found not enough evidence to provide evidence-based recommendations and guidance relied on experts’ opinion. Nevertheless, we provided updated suggestions regarding the long-term management of those treatments and their place with respect to the other migraine preventatives. Conclusion Monoclonal antibodies targeting the CGRP pathway are recommended for migraine prevention as they are effective and safe also in the long-term.

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Real-world evidence data on the monoclonal antibody erenumab in migraine prevention: perspectives of treating physicians in Germany

Cited by 20 publications

References 39 publications

Real-world experience of erenumab in patients with chronic or episodic migraine in the UAE

Real-world experience of erenumab in patients with chronic or episodic migraine in the UAE

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

European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention – 2022 update

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