Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: the multicenter prospective cohort RE-DO study.
CGRP
Discontinuation
Migraine
Monoclonal antibodies
Real life
Retreatment
Journal
Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161
Informations de publication
Date de publication:
Nov 2023
Nov 2023
Historique:
received:
07
05
2023
accepted:
10
07
2023
revised:
10
07
2023
pubmed:
20
7
2023
medline:
20
7
2023
entrez:
19
7
2023
Statut:
ppublish
Résumé
The outcome of migraine patients retreated with monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (anti-CGRP) or its receptor (anti-CGRPr) is not completely known. This multicentric prospective observational cohort study assessed monthly migraine days (MMDs), migraine acute medication intake (MAMI), and HIT-6 at baseline, after 90-112 days (Rev-1), after 84-90 days since Rev-1 (Rev-2) and 30 days after the last injection of anti-CGRP/CGRPr mAbs (Year-end), in the first and the second year after a discontinuation period. We enrolled 226 patients (79.6% with chronic migraine; 55.3% on erenumab and 44.7% on galcanezumab or fremanezumab). MMDs, MAMI, and HIT-6-did not differ at the respective first and second-year evaluations in the entire cohort, and comparing anti-CGRP with anti-CGRPr Abs. MMDs (18.1 ± 7.8 vs. 3.4 ± 7.8), MAMI (26.7 ± 28.3 vs.17.7 ± 17.2), and HIT-6 scores (63.1 ± 5.9 vs. 67.1 ± 10.3) were lower in the second year than in the pre-treatment baseline (consistently, p < 0.0001). Second-year baseline MMDs were lower in patients on anti-CGRP mAbs (p = 0.001) and with lower pre-treatment baseline MMDs (p ≤ 0.001). Anti-CGRP/CGRPr mAbs are effective in the second as in the first year. The use of anti-CGRP or CGRPr mAbs influenced the second-year baseline MMDs, but their effectiveness did not differ during the two treatment years.
Sections du résumé
BACKGROUND
BACKGROUND
The outcome of migraine patients retreated with monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (anti-CGRP) or its receptor (anti-CGRPr) is not completely known.
METHODS
METHODS
This multicentric prospective observational cohort study assessed monthly migraine days (MMDs), migraine acute medication intake (MAMI), and HIT-6 at baseline, after 90-112 days (Rev-1), after 84-90 days since Rev-1 (Rev-2) and 30 days after the last injection of anti-CGRP/CGRPr mAbs (Year-end), in the first and the second year after a discontinuation period.
RESULTS
RESULTS
We enrolled 226 patients (79.6% with chronic migraine; 55.3% on erenumab and 44.7% on galcanezumab or fremanezumab). MMDs, MAMI, and HIT-6-did not differ at the respective first and second-year evaluations in the entire cohort, and comparing anti-CGRP with anti-CGRPr Abs. MMDs (18.1 ± 7.8 vs. 3.4 ± 7.8), MAMI (26.7 ± 28.3 vs.17.7 ± 17.2), and HIT-6 scores (63.1 ± 5.9 vs. 67.1 ± 10.3) were lower in the second year than in the pre-treatment baseline (consistently, p < 0.0001). Second-year baseline MMDs were lower in patients on anti-CGRP mAbs (p = 0.001) and with lower pre-treatment baseline MMDs (p ≤ 0.001).
CONCLUSION
CONCLUSIONS
Anti-CGRP/CGRPr mAbs are effective in the second as in the first year. The use of anti-CGRP or CGRPr mAbs influenced the second-year baseline MMDs, but their effectiveness did not differ during the two treatment years.
Identifiants
pubmed: 37468621
doi: 10.1007/s00415-023-11872-2
pii: 10.1007/s00415-023-11872-2
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
5436-5448Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.
Références
Sacco S, Amin FM, Ashina M et al (2022) European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention—2022 update. J Headache Pain 23:67. https://doi.org/10.1186/s10194-022-01431-x
doi: 10.1186/s10194-022-01431-x
pubmed: 35690723
pmcid: 9188162
Ashina M, Goadsby PJ, Reuter U et al (2019) Long-term safety and tolerability of erenumab: three-plus year results from a 5-year open-label extension study in episodic migraine. Cephalalgia 39:1455–1464. https://doi.org/10.1177/0333102419854082
doi: 10.1177/0333102419854082
pubmed: 31146544
pmcid: 6779015
Pozo-Rosich P, Detke HC, Wang S et al (2022) Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. https://doi.org/10.1080/03007995.2022.2059975
doi: 10.1080/03007995.2022.2059975
pubmed: 35392739
Ashina M, Goadsby PJ, Reuter U et al (2021) Long-term efficacy and safety of erenumab in migraine prevention: results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol 28:1716–1725. https://doi.org/10.1111/ENE.14715
doi: 10.1111/ENE.14715
pubmed: 33400330
pmcid: 8248354
Drellia K, Kokoti L, Deligianni CI et al (2021) Anti-CGRP monoclonal antibodies for migraine prevention: a systematic review and likelihood to help or harm analysis. Cephalalgia 41:851–864. https://doi.org/10.1177/0333102421989601
doi: 10.1177/0333102421989601
pubmed: 33567891
Vandervorst F, Van Deun L, Van Dycke A et al (2021) CGRP monoclonal antibodies in migraine: an efficacy and tolerability comparison with standard prophylactic drugs. J Headache Pain. https://doi.org/10.1186/s10194-021-01335-2
doi: 10.1186/s10194-021-01335-2
pubmed: 34696711
pmcid: 8547103
Reuter U, Ehrlich M, Gendolla A et al (2022) Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial. Cephalalgia 42:108–118. https://doi.org/10.1177/03331024211053571
doi: 10.1177/03331024211053571
pubmed: 34743579
Hepp Z, Dodick DW, Varon SF et al (2015) Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia 35:478–488. https://doi.org/10.1177/0333102414547138
doi: 10.1177/0333102414547138
pubmed: 25164920
Förderreuther S, Zhang Q, Stauffer VL et al (2018) Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent: data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. J Headache Pain. https://doi.org/10.1186/s10194-018-0951-2
doi: 10.1186/s10194-018-0951-2
pubmed: 30594122
pmcid: 6755564
Vernieri F, Altamura C, Brunelli N et al (2021) Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study). J Headache Pain 22:35. https://doi.org/10.1186/s10194-021-01247-1
doi: 10.1186/s10194-021-01247-1
pubmed: 33941080
pmcid: 8091153
Barbanti P, Aurilia C, Cevoli S et al (2021) Long-term (48 weeks) effectiveness, safety, and tolerability of erenumab in the prevention of high-frequency episodic and chronic migraine in a real world: results of the EARLY 2 study. Headache 61:1351–1363. https://doi.org/10.1111/head.14194
doi: 10.1111/head.14194
pubmed: 34309862
Vernieri F, Brunelli N, Marcosano M et al (2023) Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: the multicenter prospective cohort GARLIT study. Eur J Neurol 30:224–234. https://doi.org/10.1111/ENE.15563
doi: 10.1111/ENE.15563
pubmed: 36097739
Serrano D, Lipton RB, Scher AI et al (2017) Fluctuations in episodic and chronic migraine status over the course of 1 year: implications for diagnosis, treatment and clinical trial design. J Headache Pain 18:101. https://doi.org/10.1186/s10194-017-0787-1
doi: 10.1186/s10194-017-0787-1
pubmed: 28980171
pmcid: 5628086
Gantenbein AR, Agosti R, Gobbi C et al (2021) Impact on monthly migraine days of discontinuing anti-CGRP antibodies after one year of treatment—a real-life cohort study. Cephalalgia. https://doi.org/10.1177/03331024211014616
doi: 10.1177/03331024211014616
pubmed: 34000847
pmcid: 8504406
De Matteis E, Affaitati G, Frattale I et al (2021) Early outcomes of migraine after erenumab discontinuation: data from a real-life setting. Neurol Sci 42:3297–3303. https://doi.org/10.1007/s10072-020-05022-z
doi: 10.1007/s10072-020-05022-z
pubmed: 33389227
Raffaelli B, Terhart M, Overeem LH et al (2021) Migraine evolution after the cessation of CGRP(-receptor) antibody prophylaxis: a prospective, longitudinal cohort study. Cephalalgia. https://doi.org/10.1177/03331024211046617
doi: 10.1177/03331024211046617
pubmed: 34644203
pmcid: 8988456
Vernieri F, Brunelli N, Messina R et al (2021) Discontinuing monoclonal antibodies targeting CGRP pathway after one-year treatment: an observational longitudinal cohort study. J Headache Pain 22:154. https://doi.org/10.1186/s10194-021-01363-y
doi: 10.1186/s10194-021-01363-y
pubmed: 34922444
pmcid: 8903705
Iannone LF, Fattori D, Benemei S et al (2022) Predictors of sustained response and effects of the discontinuation of anti-calcitonin gene related peptide antibodies and reinitiation in resistant chronic migraine. Eur J Neurol 29:1505–1513. https://doi.org/10.1111/ENE.15260
doi: 10.1111/ENE.15260
pubmed: 35098620
Raffaelli B, Terhart M, Mecklenburg J et al (2022) Resumption of migraine preventive treatment with CGRP(-receptor) antibodies after a 3-month drug holiday: a real-world experience. J Headache Pain. https://doi.org/10.1186/S10194-022-01417-9
doi: 10.1186/S10194-022-01417-9
pubmed: 36224519
pmcid: 9555163
Headache Classification Committee of the International Headache Society (IHS) (2018) The International classification of headache disorders, 3rd edition. Cephalalgia 38:1–211. https://doi.org/10.1177/0333102417738202
doi: 10.1177/0333102417738202
Sacco S, Bendtsen L, Ashina M et al (2019) European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. J Headache Pain 20:6. https://doi.org/10.1186/s10194-018-0955-y
doi: 10.1186/s10194-018-0955-y
pubmed: 30651064
pmcid: 6734227
Ornello R, Baraldi C, Guerzoni S et al (2022) Comparing the relative and absolute effect of erenumab: is a 50% response enough? Results from the ESTEEMen study. J Headache Pain 23:38. https://doi.org/10.1186/S10194-022-01408-W
doi: 10.1186/S10194-022-01408-W
pubmed: 35305579
pmcid: 8933935
Do TP, Hougaard A, Dussor G et al (2023) Migraine attacks are of peripheral origin: the debate goes on. J Headache Pain 24:3. https://doi.org/10.1186/s10194-022-01538-1
doi: 10.1186/s10194-022-01538-1
pubmed: 36627561
pmcid: 9830833
Edvinsson L, Haanes KA, Warfvinge K, DiN K (2018) CGRP as the target of new migraine therapies—successful translation from bench to clinic. Nat Rev Neurol 14:338–350. https://doi.org/10.1038/s41582-018-0003-1
doi: 10.1038/s41582-018-0003-1
pubmed: 29691490
Pellesi L, Do TP, Ashina H et al (2020) Review articles dual therapy with anti-CGRP monoclonal antibodies and botulinum toxin for migraine prevention: Is there a rationale? Headache. Headache 60:1056–1065. https://doi.org/10.1111/head.13843
doi: 10.1111/head.13843
pubmed: 32437038
Blumenfeld AM, Frishberg BM, Schim JD et al (2021) Real-world evidence for control of chronic migraine patients receiving CGRP monoclonal antibody therapy added to OnabotulinumtoxinA: a retrospective chart review. Pain Ther 10:809–826. https://doi.org/10.1007/s40122-021-00264-x
doi: 10.1007/s40122-021-00264-x
pubmed: 33880725
pmcid: 8586140
De Logu F, Nassini R, Hegron A et al (2022) Schwann cell endosome CGRP signals elicit periorbital mechanical allodynia in mice. Nat Commun. https://doi.org/10.1038/S41467-022-28204-Z
doi: 10.1038/S41467-022-28204-Z
pubmed: 35115501
pmcid: 8813987
Mullin K, Kudrow D, Croop R et al (2020) Potential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy. Neurology 94:e2121–e2125. https://doi.org/10.1212/WNL.0000000000008944
doi: 10.1212/WNL.0000000000008944
pubmed: 31932515
pmcid: 7526667
Barbanti P, Egeo G, Mitsikostas DD (2019) Trigeminal-targeted treatments in migraine: Is 60% the magic number? Headache 59:1659–1661. https://doi.org/10.1111/head.13635
doi: 10.1111/head.13635
pubmed: 31508812
Sebastianelli G, Casillo F, Di Renzo A et al (2023) Effects of botulinum toxin Type A on the nociceptive and lemniscal somatosensory systems in chronic migraine: an electrophysiological study. Toxins (Basel) 15:76. https://doi.org/10.3390/TOXINS15010076
doi: 10.3390/TOXINS15010076
pubmed: 36668895
Casillo F, Sebastianelli G, Di Renzo A et al (2022) The monoclonal CGRP-receptor blocking antibody erenumab has different effects on brainstem and cortical sensory-evoked responses. Cephalalgia 42:1236–1245. https://doi.org/10.1177/03331024221103811
doi: 10.1177/03331024221103811
pubmed: 35637558
Grazzi L, Andrasik F, Rizzoli P et al (2021) Acceptance and commitment therapy for high frequency episodic migraine without aura: Findings from a randomized pilot investigation. Headache 61:895–905. https://doi.org/10.1111/HEAD.14139
doi: 10.1111/HEAD.14139
pubmed: 34115399
Fiedler-Kelly JB, Cohen-Barak O, Morris DN et al (2019) Population pharmacokinetic modelling and simulation of fremanezumab in healthy subjects and patients with migraine. Br J Clin Pharmacol 85:2721–2733. https://doi.org/10.1111/BCP.14096
doi: 10.1111/BCP.14096
pubmed: 31418911
pmcid: 6955415
Kielbasa W, Quinlan T (2020) Population pharmacokinetics of galcanezumab, an anti-CGRP antibody, following subcutaneous dosing to healthy individuals and patients with migraine. J Clin Pharmacol 60:229–239. https://doi.org/10.1002/jcph.1511
doi: 10.1002/jcph.1511
pubmed: 31482569
de Hoon J, Van Hecken A, Vandermeulen C et al (2018) Phase I, randomized, double-blind, placebo-controlled, single-dose, and multiple-dose studies of erenumab in healthy subjects and patients with migraine. Clin Pharmacol Ther 103:815–825. https://doi.org/10.1002/CPT.799
doi: 10.1002/CPT.799
pubmed: 28736918