单克隆抗体erenumab在偏头痛预防中的真实世界数据:德国治疗医师的视角
Real-world evidence data on the monoclonal antibody erenumab
Real-world evidence data on the monoclonal antibody erenumab in migraine prevention: perspectives of treating physicians in Germany
DOI: https://doi.org/10.1186/s10194-021-01344-1
Abstract-Summary Erenumab patient profiles outside clinical trials and physicians’ treatment patterns, as well as data from patients treated in Germany, a severely impacted population, are not published yet.
Treating physicians shared their experiences on current erenumab treatment with
regard to patient profiles, treatment patterns and treatment responses.
A retrospective chart review was conducted of 542 migraine patients treated with
erenumab for at least three months.
The analysis of 542 patients’ charts revealed that three-month treatment with erenumab significantly reduced monthly headaches, migraine and acute medica- tion days.
According to the treating physicians’ professional judgement, 83 % of patients
responded to erenumab and 80 % were satisfied with the treatment.
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Physicians evaluated restricted quality of life, the number of monthly migraine days and previous, prophylactic treatments as the main components of the current patient profile for monoclonal antibody recipients.
Based on the assessment of physicians, erenumab reduced migraine symptoms in
65 % and increased quality of life in more than 75 % of their patients.
TELESCOPE confirms positive treatment responses with erenumab shown in
clinical trials in a real-world multi-centre setting.
The results show consistently positive experiences of physicians utilizing ere- numab in clinical practice and underline that therapy with this monoclonal antibody is effective in migraine patients, particular in those, who have failed several prophy- lactic therapies.
Extended: Treating physicians reported experiences on treating patients with
erenumab.
Physicians consecutively documented at least 10 but not more than 30 of their patients that had received erenumab for ≥3 month via a retrospective chart review. Of TELESCOPE, medical chart data of 542 consecutively selected erenumab
patients were gathered anonymously.
According to the experience of treating physicians, erenumab treatment had led to a relevant reduction in headache intensity in 77% of the population and patient- relevant improvement of QoL in 76%.
According to the retrospective analysis of the medical records, 85% of the
patients were female, 50% were suffering from EM and 50 % from CM.
Background Erenumab, the first-in-class fully human monoclonal antibody targeting the CGRP receptor, showed efficacy and safety in large randomized clinical trials for preven- tive treatment of migraine patients with and without prior treatment failures [154, 183, 225, 226].
Published real-world data have further confirmed the efficacy and tolerability profile of erenumab in patients suffering from migraine who failed prior prophylac- tic treatments [227–245].
Direct experience from the treating physicians on patient profiles and treatment
patterns of erenumab in daily routines have not been reported so far.
An online survey was conducted to document physicians’ experiences regarding current patient profiles for CGRP antibody recipients, therapy approach and treat- ment responses with erenumab.
A retrospective chart review was conducted to analyse data of migraine patients being treated with erenumab for at least three months, focusing on treatment effects and various aspects of patients’ quality of life (QoL).
Methods Physicians consecutively documented at least 10 but not more than 30 of their patients that had received erenumab for ≥3 month via a retrospective chart review. The first four questions reflected the characteristics of the participating centres
(e.g. number of headache and migraine patients treated).
The following four questions evaluated physicians’ experiences in treating migraine patients; i.e. the current patient profile for the initiation of monoclonal
4.2 Preventive Treatment
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antibody treatment, treatment management and general outcome of the treatment with erenumab.
The survey also inquired the physicians’ opinion on patients’ satisfaction and
treatment success.
For the latter, physicians were asked how many patients they consider as “responders” according to their professional judgement, which was based on the reduction of headache days and the overall impression of their patients in order to reflect current treatment routine in Germany.
Results Physicians’ file research of the total population, who have been treated for at least three months with erenumab revealed that the majority of patients (84%) initiated treatment with 70 mg, whereas for 16% the higher dose of 140 mg was chosen.
According to the experience of treating physicians, erenumab treatment had led to a relevant reduction in headache intensity in 77% of the population and patient- relevant improvement of QoL in 76%.
75.3% of all patients had reduced headache intensity, 85.4% reduced frequency of headaches and 35.2% accompanying aura after three months of erenumab treatment.
Regarding migraine-related symptoms, physicians reported that nausea and eme- sis were reduced in 46.7% of all patients and sensitivity for light and noise in 42.4% of patients three months after initial treatment with erenumab.
Discussion Three-month treatment with erenumab significantly decreased MMD, MHD and acute medication days, reduced headache frequency, intensity and frequency of accompanying aura, improved the patients’ clinical global impression scale and QoL in a patient population with several treatment failures.
Data investigating erenumab treatment in large numbers of both CM and EM
patients in real-world multi-centre settings are limited.
Based on physicians’ clinical experience, erenumab treatment mediated a rele- vant reduction in headache intensity and patient-relevant improvement of QoL in more than three quarters of the treated population.
This is in line with findings of another German real-life cohort in which the majority of patients (82%) also reported to be satisfied with erenumab treat- ment [232].
Another relevant therapeutic effect of erenumab treatment was evaluated by the reduction of attack intensity and frequency in over 80% of EM and the majority of CM patients.
Conclusions In TELESCOPE, we provide comprehensive retrospective real-world evidence in a large migraine cohort in Germany and in addition first real-life insights on physi- cians’ overall experiences with erenumab treatment in migraine patients.
Based on the assessment of physicians, erenumab reduced migraine symptoms in
65% and increased quality of life in more than 75% of their treated population.
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The retrospective analysis revealed that three months of erenumab treatment sig- nificantly reduced migraine- specific headache parameter and increased QoL in this severely impacted patient population.
According to the treating physicians’ professional judgement, the vast majority
of their patients did benefit from and were satisfied with the treatment.
Acknowledgement A machine generated summary based on the work of Straube, Andreas; Stude, Philipp; Gaul, Charly; Schuh, Katrin; Koch, Mirja. 2021 in The Journal of Headache and Pain.
Real-World Trends in Characteristics of Patients with Migraine Newly Initiated on Erenumab in the USA: A Retrospective Analysis