Conversion from chronic to episodic migraine in patients treated with galcanezumab in real life in Italy: the 12-month observational, longitudinal, cohort multicenter GARLIT experience

Claudia Altamura, Nicoletta Brunelli, Marilena Marcosano, Cinzia Aurilia, Gabriella Egeo, Carlo Lovati, Valentina Favoni, Armando Perrotta, Ilaria Maestrini, Francesca Schiano Di Cola, Florindo d'Onofrio, Cinzia Finocchi, Davide Bertuzzo, Francesco Bono, Angelo Ranieri, Maria Albanese, Roberta Messina, Alberto Doretti, Vittorio Di Piero, Sabina Cevoli, Piero Barbanti, Fabrizio Vernieri, GARLIT Study Group, Carmelina Maria Costa, Luisa Fofi, Renata Rao, Luigi d'Onofrio, Daniele Spitalieri, Marco Aguggia, Fabio Bombardieri, Bruno Colombo, Massimo Filippi, Stefano Messina, Gianluca Demirtzidis, Claudia Altamura, Nicoletta Brunelli, Marilena Marcosano, Cinzia Aurilia, Gabriella Egeo, Carlo Lovati, Valentina Favoni, Armando Perrotta, Ilaria Maestrini, Francesca Schiano Di Cola, Florindo d'Onofrio, Cinzia Finocchi, Davide Bertuzzo, Francesco Bono, Angelo Ranieri, Maria Albanese, Roberta Messina, Alberto Doretti, Vittorio Di Piero, Sabina Cevoli, Piero Barbanti, Fabrizio Vernieri, GARLIT Study Group, Carmelina Maria Costa, Luisa Fofi, Renata Rao, Luigi d'Onofrio, Daniele Spitalieri, Marco Aguggia, Fabio Bombardieri, Bruno Colombo, Massimo Filippi, Stefano Messina, Gianluca Demirtzidis

Abstract

Objective: To investigate in real-life the conversion from chronic migraine (CM) to episodic migraine (EM), specifically to EM with High-Frequency (HFEM: 8-14 monthly migraine days, MMDs), Medium-Frequency (MFEM, 4-7 MMDs), and Low-Frequency EM (LFEM, 0-3 MMDs), and its persistence during 1 year of treatment with galcanezumab.

Methods: Consecutive CM patients treated with galcanezumab completing 1 year of observation were enrolled. We collected data on MMDs, pain intensity (Numeric Rating Scale, NRS score), and monthly acute medication intake (MAMI) from baseline (V1) to the 12-month visit (V12).

Results: Of the 155 enrolled patients, 116 (around 75%) reverted to EM at every visit and 81 (52.3%) for the entire 1-year treatment. Patients with older onset age (p = 0.010) and fewer baseline MMDs (p = 0.005) reverted more frequently to EM. At V12, 83 participants (53.5%) presented MFEM or LFEM. Patients reverted to MFEM or LFEM for 7 months (25th 1, 75th 11). The medication overuse discontinuation rate at V12 was 82.8% and occurred for 11 months (25th 8, 75th 12). From baseline to V12, the MAMI decreased by 17 symptomatic drugs (p < 0.000001) while the NRS score reduced by almost 2 points (p < 0.000001). A consistent transition to EM for the entire treatment year was observed in 81 (52.3%) patients.

Discussion: The 1-year GARLIT experience suggests that more than half of CM patients treated with galcanezumab persistently reverted to EM in real life.

Trial registration: ClinicalTrials.gov NCT04803513.

Keywords: Calcitonin gene-related peptide; Chronic migraine; Conversion; Migraine treatment; Monoclonal antibodies; Real world.

Conflict of interest statement

Maria Albanese received honoraria or travel grants from Novartis, Teva, Merck Serono; Claudia Altamura received travel grants and honoraria from Novartis, Eli Lilly, Lusofarmaco, Laborest, Allergan, Almirall; Cinzia Aurilia received travel grants and honoraria from FB-Health, Lusofarmaco, Almirall, Eli-Lilly Novartis and Teva; Piero Barbanti received travel grants, honoraria for advisory boards, speaker panels or clinical investigation studies from Alder, Allergan, Angelini, Bayer, ElectroCore, Eli-Lilly, GSK, Lusofarmaco, MSD, Novartis, Stx-Med, Teva, Visufarma, Zambon; Francesco Bono received honoraria as a speaker or for participating in advisory boards from Teva, Novartis, Ipsen; Sabina Cevoli received travel grants, honoraria for advisory boards, speaker panels or clinical investigation studies from Novartis, Teva, Lilly, Allergan, Ibsa, Amgen and Lundbeck; Vittorio Di Piero received grants and honoraria by Bayer, Biogen, Lilly, TEVA and Novartis; Florindo d’Onofrio received grants and honoraria from Lilly, Teva, Novartis, Neopharmed; Alberto Doretti received grants and honoraria from Novartis, Eli Lilly; Gabriella Egeo received travel grants and honoraria from Eli-Lilly, Novartis, New Penta and Ecupharma; Valentina Favoni received honoraria as speaker or for participating in advisory boards from Ely-Lilly, Novartis and Teva; Cinzia Finocchi received grants and honoraria from Novartis, Eli Lilly, AIM group; Carlo Lovati received grants from Novartis and Lilly. Florindo d’Onofrio received grants and honoraria from Lilly, Teva, Novartis, Neopharmed; Ilaria Maestrini received honoraria from Eli Lilly. Roberta Messina received honoraria as speaker from Novartis, Eli Lilly, and Teva. Armando Perrotta travel grants, honoraria for advisory boards, speaker panels, or clinical investigation studies from Allergan, Eli-Lilly, Novartis, and Teva; Angelo Ranieri received speaker honoraria from Teva, Lilly; Fabrizio Vernieri received travel grants, honoraria for advisory boards, speaker panels, or clinical investigation studies from Allergan, Amgen, Angelini, Eli-Lilly, Lundbeck, Novartis, and Teva; Nicoletta Brunelli, Marilena Marcosano and Francesca Schiano Di Cola, Davide Bertuzzo have nothing to disclose.

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Figures

Fig. 1
Fig. 1
Study population and design
Fig. 2
Fig. 2
Percentage of patients reverting to EM (A) and to HFEM, MFEM, and LFEM (B) from V1 to V12
Fig. 3
Fig. 3
Percentage of patients with medication overuse (MO) from V1 to V12
Fig. 4
Fig. 4
Mean changes in the MAMI (panel A) and NRS score (panel B) from baseline to V12. SE standard error
Fig. 5
Fig. 5
Ratio between the mean MAMI and MMDs from baseline to V12. A ratio of 1 corresponds to the intake of one acute medication for each migraine day

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Source: PubMed

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