Real-world effectiveness of fremanezumab in patients with migraine switching from another mAb targeting the CGRP pathway: a subgroup analysis of the Finesse Study.

Calcitonin gene-related peptide Fremanezumab Migraine Non-responder

Journal

The journal of headache and pain
ISSN: 1129-2377
Titre abrégé: J Headache Pain
Pays: England
ID NLM: 100940562

Informations de publication

Date de publication:
23 May 2023
Historique:
received: 23 03 2023
accepted: 07 05 2023
medline: 25 5 2023
pubmed: 24 5 2023
entrez: 23 5 2023
Statut: epublish

Résumé

Monoclonal antibodies targeting the CGRP pathway are effective and safe for prophylactic treatment of episodic (EM) and chronic migraine (CM). In case of treatment failure of a CGRP pathway targeting mAb, physician has to decide whether using another anti-CGRP pathway mAb is useful. This interim analysis of Finesse Study evaluates effectiveness of the anti-CGRP mAb fremanezumab in patients with a history of other prior anti-CGRP pathway mAb treatments (switch patients). FINESSE, a non-interventional, prospective, multicentre, two-country (Germany-Austria) study observing migraine patients receiving fremanezumab in clinical routine. This subgroup analysis presents data on documented effectiveness over 3 months after the first dose of fremanezumab in switch patients. Effectiveness was evaluated based on reduction in average number of migraine days per month (MMDs), MIDAS and HIT-6 scores changes as well as in number of monthly days with acute migraine medication use. One hundred fifty-three out of 867 patients with a history of anti-CGRP pathway mAb treatment prior to initiation of fremanezumab were analysed. Switch to fremanezumab led to ≥ 50% MMD reduction in 42.8% of migraine patients, with higher response rate in EM (48.0%) than in CM patients (36.5%). A ≥ 30% MMD reduction was achieved by 58.7% in CM patients. After three months, monthly number of migraine days decreased by 6.4 ± 5.87 (baseline: 13.6 ± 6.5; p < 0.0001) in all patients, 5.2 ± 4.04 in EM and 7.7 ± 7.45 in CM patients. MIDAS scores decreased from 73.3 ± 56.8 (baseline) to 50.3 ± 52.9 (after 3 months; p = 0.0014), HIT-6 scores decreased from 65.9 ± 5.0 to 60.9 ± 7.2 (p < 0.0001). Concomitant use of acute migraine medication had decreased from 9.7 ± 4.98 (baseline) to 4.9 ± 3.66 (3 months) (p < 0.0001). Our results show that about 42.8% of anti-CGRP pathway mAb-non-responder benefit from switching to fremanezumab. These results suggest that switching to fremanezumab may be a promising option for patients experiencing poor tolerability or inadequate efficacy with prior other anti-CGRP pathway mAb use. FINESSE Study is registered on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (EUPAS44606).

Sections du résumé

BACKGROUND BACKGROUND
Monoclonal antibodies targeting the CGRP pathway are effective and safe for prophylactic treatment of episodic (EM) and chronic migraine (CM). In case of treatment failure of a CGRP pathway targeting mAb, physician has to decide whether using another anti-CGRP pathway mAb is useful. This interim analysis of Finesse Study evaluates effectiveness of the anti-CGRP mAb fremanezumab in patients with a history of other prior anti-CGRP pathway mAb treatments (switch patients).
METHODS METHODS
FINESSE, a non-interventional, prospective, multicentre, two-country (Germany-Austria) study observing migraine patients receiving fremanezumab in clinical routine. This subgroup analysis presents data on documented effectiveness over 3 months after the first dose of fremanezumab in switch patients. Effectiveness was evaluated based on reduction in average number of migraine days per month (MMDs), MIDAS and HIT-6 scores changes as well as in number of monthly days with acute migraine medication use.
RESULTS RESULTS
One hundred fifty-three out of 867 patients with a history of anti-CGRP pathway mAb treatment prior to initiation of fremanezumab were analysed. Switch to fremanezumab led to ≥ 50% MMD reduction in 42.8% of migraine patients, with higher response rate in EM (48.0%) than in CM patients (36.5%). A ≥ 30% MMD reduction was achieved by 58.7% in CM patients. After three months, monthly number of migraine days decreased by 6.4 ± 5.87 (baseline: 13.6 ± 6.5; p < 0.0001) in all patients, 5.2 ± 4.04 in EM and 7.7 ± 7.45 in CM patients. MIDAS scores decreased from 73.3 ± 56.8 (baseline) to 50.3 ± 52.9 (after 3 months; p = 0.0014), HIT-6 scores decreased from 65.9 ± 5.0 to 60.9 ± 7.2 (p < 0.0001). Concomitant use of acute migraine medication had decreased from 9.7 ± 4.98 (baseline) to 4.9 ± 3.66 (3 months) (p < 0.0001).
CONCLUSIONS CONCLUSIONS
Our results show that about 42.8% of anti-CGRP pathway mAb-non-responder benefit from switching to fremanezumab. These results suggest that switching to fremanezumab may be a promising option for patients experiencing poor tolerability or inadequate efficacy with prior other anti-CGRP pathway mAb use.
TRIAL REGISTRATION BACKGROUND
FINESSE Study is registered on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (EUPAS44606).

Identifiants

pubmed: 37221478
doi: 10.1186/s10194-023-01593-2
pii: 10.1186/s10194-023-01593-2
pmc: PMC10207758
doi:

Substances chimiques

Antibodies, Monoclonal 0
fremanezumab 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

59

Informations de copyright

© 2023. The Author(s).

Références

Pain Manag. 2021 Mar;11(2):101-112
pubmed: 33291980
Ann Neurol. 1993 Jan;33(1):48-56
pubmed: 8388188
Headache. 2020 Feb;60(2):469-470
pubmed: 31872439
Cephalalgia. 2022 Apr;42(4-5):291-301
pubmed: 34644203
Nervenarzt. 2023 Apr;94(4):306-317
pubmed: 36287216
CNS Drugs. 2021 Aug;35(8):805-820
pubmed: 34272688
Cephalalgia. 2021 Apr;41(5):499-514
pubmed: 33626922
Headache. 2017 May;57 Suppl 2:47-55
pubmed: 28485848
Nature. 1983 Jul 14-20;304(5922):129-35
pubmed: 6346105
J Headache Pain. 2021 Sep 20;22(1):111
pubmed: 34544359
N Engl J Med. 2017 Nov 30;377(22):2113-2122
pubmed: 29171818
Cephalalgia. 2018 Jan;38(1):1-211
pubmed: 29368949
Cephalalgia. 2021 Oct;41(11-12):1222-1239
pubmed: 34130525
J Headache Pain. 2022 Jun 11;23(1):67
pubmed: 35690723
Elife. 2022 May 23;11:
pubmed: 35604755
J Headache Pain. 2022 May 16;23(1):56
pubmed: 35578182
Clin Exp Pharmacol Physiol. 2022 Nov;49(11):1156-1168
pubmed: 35781694
Eur Neurol. 2022;85(2):132-135
pubmed: 34510038
Medicine (Baltimore). 2019 Dec;98(52):e18483
pubmed: 31876735
J Headache Pain. 2022 Nov 1;23(1):138
pubmed: 36316648
Lancet. 2004 Jan 31;363(9406):381-91
pubmed: 15070571
Cephalalgia. 2011 Feb;31(3):357-67
pubmed: 20819842
Curr Opin Neurol. 2017 Jun;30(3):272-280
pubmed: 28240610
Neurology. 2020 Nov 17;95(20):e2794-e2802
pubmed: 32917805
Pain. 2000 Oct;88(1):41-52
pubmed: 11098098
Eur J Hosp Pharm. 2021 Sep 14;:
pubmed: 34521726

Auteurs

Andreas Straube (A)

Department of Neurology, University Hospital, LMU Munich, Munich, Germany. Andreas.Straube@med.uni-muenchen.de.

Gregor Broessner (G)

Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.

Charly Gaul (C)

Headache Center Frankfurt, Frankfurt, Germany.

Xenia Hamann (X)

Teva GmbH, Ulm, Germany.

Joachim Hipp (J)

Teva GmbH, Ulm, Germany.

Torsten Kraya (T)

Department of Neurology, Hospital Sankt Georg Leipzig gGmbH, Leipzig, Germany.
Department of Neurology, Headache Center Halle, University Hospital Halle, Halle (Saale), Germany.

Lars Neeb (L)

Helios Global Health, Berlin, Germany.
Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany.

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Classifications MeSH