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. 2021 Sep 20;22(1):111.
doi: 10.1186/s10194-021-01323-6.

CGRP antibody therapy in patients with drug resistant migraine and chronic daily headache: a real-world experience

Armin Scheffler  1 , Hannah Schenk  2 , Sebastian Wurthmann  2 , Michael Nsaka  2 , Christoph Kleinschnitz  2   3 , Martin Glas  3 , Dagny Holle  2
Affiliations

CGRP antibody therapy in patients with drug resistant migraine and chronic daily headache: a real-world experience

Armin Scheffler et al. J Headache Pain. .

Abstract

Background: Calcitonin gene-related peptide (CGRP) (receptor) antibodies (erenumab, fremanezumab and galcanezumab) are increasingly used in prophylactic treatment of migraine. In the approval studies, severely affected patients with migraine and chronic daily headache without any headache free days were excluded. Thus, less is known about the effectiveness of CGRP antibody treatment in this cohort.

Methods: Clinical routine data of 32 patients with migraine and daily headache were analysed after three months of treatment with a CGRP antibody (16 erenumab, 7 galcanezumab, 9 fremanezumab), including changes of monthly headache days (MHD) monthly migraine days (MMD) and monthly acute medication intake (AMD) as well as migraine characteristics. Statistical analysis was performed with the Wilcoxon-Test. Migraine characteristics were analysed descriptively.

Results: The number of MHD was significantly reduced (mean reduction (standard error), p-value): (-4.2 (1.3), p = 0.009) as well as MMD (-4.3 (1.6), p = 0.033). Four patients (13 %) reached a 50 % reduction regarding MHD and 8 patients (25 %) regarding MMD, migraine duration and intensity improved under therapy.

Conclusions: Despite the low responder rate, CGRP antibodies can be effective at least in a few cases of severely affected patients with drug resistant migraine and chronic daily headache.

Trial registration: Retrospective registered.

Keywords: CGRP antibody; Chronic daily headache; Migraine; Real-world; Therapy.

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Conflict of interest statement

Martin Glas received honoraria from Novartis, UCB, Teva, Bayer, Novocure, Medac, Merck, Kyowa Kirin, has a consulting or advisory role to declare for Roche, Novartis, AbbVie, Novocure, and Daiichi Synkyo, and received travel fees from Novocure and Medac.

Dagny Holle has received scientific support and/or honoraria from Biogen, Novartis, Lilly, Sanofi-Aventis, Teva, Allergan, Hormosan.

Christoph Kleinschnitz has received honoraria, a consulting or advisory role to declare for Alexion, Almirall, Amgen, Amicus, Bayer, Biogen, Biotronik, Boehringer Ingelheim, Bristol Myers-Squibb, Celgene, CSL Behring, Daiichi Sankyo, Desitin, Eisai, Ever Pharma, GE Healthcare, MedDay Pharmaceuticals, Merck Serono, Mylan, Novartis, Pfizer, Roche, Sanofi-Genzyme, Siemens, Stago, Teva.

Michael Nsaka received travel fees from Licher MT.

Armin Scheffler received travel fees from Teva, honoraria for participation on an advisory board of Novartis.

Sebastian Wurthmann reports personal fees from Allergan, personal fees from Teva, personal fees from Novartis, outside the submitted work.

Hannah Schenk declares that there is no conflict of interest.

Figures

Fig. 1
Fig. 1
Treatment response. Boxplot of monthly headache days (MHD), monthly migraine days (MMD) and monthly acute medication intake (AMD) (y-axis) before treatment (0 Mo) and after 3 months (3Mo) of treatment (x-axis). Median, first and third qantile as well as minimum and maximum are shown. MHD and MMD were significant reduced, AMD alterations were not significant (*** p = 0.009; ** p = 0.033; * p = 0.123)
Fig. 2
Fig. 2
Migraine characteristics. Changes of migraine characteristics after three months of treatment. The relative proportion and the absolute number of patients who noticed the respective change are noted. All non-existent, non-applicable and non-occurring events are summarised under not existing
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