Background Anti-CGRP monoclonal antibodies have represented a real revolution in the field of headaches, being the result of an extraordinary process of translation of new pathophysiological discoveries into successful therapies. Nonetheless, clinical practice is far more complex than pivotal trials setting, and real-world studies are blooming to deepen knowledge of these revolutionary medications.Objective To provide an updated guide for evidence-based clinical practice.Methods Pivotal phase 3 randomised clinical trials for each anti-CGRP(-R) monoclonal antibody were considered. We evaluated prospective real-world studies and summarised evidence on anti-CGRP mAbs use beyond episodic and chronic migraine.Results All phase 3 RCTs showed an unprecedented profile of efficacy and safety in migraine prevention for the four anti-CGRP mAbs. However, plenty of questions remained open after the approval process. Real-world studies filled the gap and effectiveness results equalled or unexpectedly outperformed RCTs figures in most cases; safety results showed a lower incidence of adverse events, but a higher frequency of reported constipation compared to RCTs. Almost all studies displayed a rapid and progressive headache worsening following treatment suspension. Several positive response predictors were suggested, such as unilateral pain, allodynia in episodic migraineurs, response to triptans, and a lower number of failed prophylaxes. Comparable effectiveness was observed in resistant/ refractory patients. In medication overuse headache patients, a clear clinical benefit was observed irrespective of any possible detoxification program.Conclusions Our narrative review restates the remarkable efficacy, effectiveness, and safety profile in both RCTs and realworld settings and provides scientific evidence for clinical practice.

Mascarella, D., Matteo, E., Favoni, V., Cevoli, S. (2022). The ultimate guide to the anti-CGRP monoclonal antibodies galaxy. NEUROLOGICAL SCIENCES, 43(9), 5673-5685 [10.1007/s10072-022-06199-1].

The ultimate guide to the anti-CGRP monoclonal antibodies galaxy

Mascarella, Davide
Writing – Original Draft Preparation
;
Matteo, Eleonora
Writing – Original Draft Preparation
;
Favoni, Valentina
Writing – Review & Editing
;
Cevoli, Sabina
Supervision
2022

Abstract

Background Anti-CGRP monoclonal antibodies have represented a real revolution in the field of headaches, being the result of an extraordinary process of translation of new pathophysiological discoveries into successful therapies. Nonetheless, clinical practice is far more complex than pivotal trials setting, and real-world studies are blooming to deepen knowledge of these revolutionary medications.Objective To provide an updated guide for evidence-based clinical practice.Methods Pivotal phase 3 randomised clinical trials for each anti-CGRP(-R) monoclonal antibody were considered. We evaluated prospective real-world studies and summarised evidence on anti-CGRP mAbs use beyond episodic and chronic migraine.Results All phase 3 RCTs showed an unprecedented profile of efficacy and safety in migraine prevention for the four anti-CGRP mAbs. However, plenty of questions remained open after the approval process. Real-world studies filled the gap and effectiveness results equalled or unexpectedly outperformed RCTs figures in most cases; safety results showed a lower incidence of adverse events, but a higher frequency of reported constipation compared to RCTs. Almost all studies displayed a rapid and progressive headache worsening following treatment suspension. Several positive response predictors were suggested, such as unilateral pain, allodynia in episodic migraineurs, response to triptans, and a lower number of failed prophylaxes. Comparable effectiveness was observed in resistant/ refractory patients. In medication overuse headache patients, a clear clinical benefit was observed irrespective of any possible detoxification program.Conclusions Our narrative review restates the remarkable efficacy, effectiveness, and safety profile in both RCTs and realworld settings and provides scientific evidence for clinical practice.
2022
Mascarella, D., Matteo, E., Favoni, V., Cevoli, S. (2022). The ultimate guide to the anti-CGRP monoclonal antibodies galaxy. NEUROLOGICAL SCIENCES, 43(9), 5673-5685 [10.1007/s10072-022-06199-1].
Mascarella, Davide; Matteo, Eleonora; Favoni, Valentina; Cevoli, Sabina
File in questo prodotto:
Eventuali allegati, non sono esposti

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/962382
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo

Citazioni
  • ???jsp.display-item.citation.pmc??? 4
  • Scopus 4
  • ???jsp.display-item.citation.isi??? 5
social impact