Erenumab in highly therapy-refractory migraine patients: First German real-world evidence

DOI: https://doi.org/10.1186/s10194-020-01151-0

Abstract-Summary Clinical data regarding efficacy and tolerability of erenumab in highly therapy- refractory patients are not available, yet, although many patients treated with CGRP mAB under real world conditions can be considered as highly therapy-refractory.

4.2 Preventive Treatment

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Clinical routine data of highly therapy-refractory migraine patients treated with erenumab 70 mg for 3 months between November 2018 and December 2019 in the West German Headache Center, University Hospital Essen, Germany, were analysed.

Monthly migraine days (MMD), monthly headache days (MHD) and days of

acute medication intake (AMD) were assessed.

Complete clinical data were available for 26 episodic (EM) and 74 chronic (CM)

migraineurs.

Sixty-six % (n = 49) of CM patients had an additional medication overuse head-

ache (MOH).

After 3 months 57.7% of EM patients and 41.9% of CM patients had a 50% or

greater reduction of MMD.

Thirty-nine patients (52.7%) returned from chronic to episodic course of

migraine.

Erenumab seems to be a promising therapeutic option in highly therapy-refrac-

tory migraine patients.

Extended: Future applications will show whether our results can be confirmed

for larger numbers of patients and for CGRP mAB in general.

Background Clinical trials were only performed in migraine patients who had failed up to four prophylactic medications in the past [154, 250, 251].

Although there are indications of good effectiveness under real-world conditions [228, 252], data on highly therapy-refractory patients that had failed more than four prophylactic treatments are missing, yet.

Now clinical data on this highly therapy-refractory migraine population treated

with erenumab under real world conditions.

Methods We retrospectively analysed routine clinical data of EM and CM patients presented at the West German Headache Center, Department of Neurology, University Hospital Essen, Germany between November 2018 and December 2019.

Patients meeting the following criteria were included in the analysis: (a) EM/CM patients with at least 4 migraine days a month according to the current diagnostic criteria of the International headache classification (ICHD-3 [253]), (b) documented history of the last 90  days prior starting erenumab therapy regarding monthly migraine days (MMD), monthly headache days (MHD) and monthly intake of acute medication (AMD), (c) completion of a 90 days treatment interval with monthly 70 mg erenumab (d) available complete clinical data including headache diaries and side effects.

Due to reasons of reimbursement by the German statutory health insurance, all treated patients had tried at least 5 (when EM) and 6 (when CM) approved prophy- lactic drugs previously without sufficient treatment effects, had discontinued those due to side effects, or were not eligible for intake due to contraindication.

Results Sixty-six % (n = 49) of CM patients had an additional MOH.

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4 Treatment

Fifty-three % of CM patients (n = 39) returned from chronic to episodic course

of migraine.

Subjective improvement of migraine intensity and duration was reported by con- siderably more than half of the patients (n  =  67, 70.5% and n  =  53, 58.9%, respectively).

Out of 100 patients 42% (n = 42) reported side effects.

Discussion Efficacy of erenumab in highly therapy-refractory patients is comparable to results from clinical trials of patients that had failed fewer prophylactic medications prior treatment.

Results from the phase II erenumab CM trial reported a reduction of 6.6 days/ month and a 50% responder rate of 40% [226] which is comparable to our real world data showing a reduction of 4.72 days and a 50% responder rate of 41.9%.

The slightly better treatment effect under real-world conditions compared to pre- vious clinical study results may be explained by extraordinarily high patient expec- tations regarding the effectiveness of the drug and the lack of a placebo arm.

Many patients with highly therapy-refractory migraine suffer from additional

MOH, in our real-world population 49% of all analysed patients.

Our data show that erenumab could also be effective in patients with additional

MOH although medication overuse was not stopped prior therapy.

Conclusion Real-world efficacy and tolerability of erenumab seems to be comparable with results from clinical trials, even in more therapy- refractory patients than those treated in clinical studies.

Acknowledgement A machine generated summary based on the work of Scheffler, Armin; Messel, Olga; Wurthmann, Sebastian; Nsaka, Michael; Kleinschnitz, Christoph; Glas, Martin; Naegel, Steffen; Holle, Dagny. 2020 in The Journal of Headache and Pain.

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