Background: The present prospective, real-world study aims to assess anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) effectiveness across three consecutive one-year treatment cycles by means of a conservative intention-to-treat (ITT) analysis. Methods: We enrolled 179 subjects (75.4% females, 51.3 years 95% confidence interval [49.2–53.4] years), 87.2% with chronic migraine and medication overuse) who started mAbs between 2018 and 2020. We recorded clinical data supported by a prospectively filled headache diary up to three one-year treatment cycles. The ITT analysis was performed with a multivariate linear mixed model considering the entire population. Results: We observed a marked and consistent reduction in monthly migraine days (MMDs) across the three one-year cycles of treatment: −12.7 )[−11.4 – −14.1] at end of the first year of treatment (C1), −12.4 [−11.0 – −13.8] at the end of the second year (C2) and −12.9 [−11.4 – −14.3] at the end of the third year (C3). Baseline and residual MMDs progressively decreased across the three cycles (p = 0.008): from 21.1 [19.8–22.4] to 9.6 [8.3–11.0] in C1, from 19.0 [17.4–20.5] to 9.6 [8.1–11.1] in C2, and from 15.9 [14.3–17.5] to 8.5 [6.9–10.1] in C3. At the end of C3, the 50% response rate was 38.5% (69/179). Conclusions: In our cohort, mAbs induced a meaningful and sustained reduction in MMDs across three consecutive one-year cycles of treatment. The ITT analysis revealed a remaining high burden of disease. While confirming mAbs effectiveness in migraine prevention, these findings underscore the need for more treatment approaches and for exploring other non-CGRP dependent pathways.
Real world effectiveness of anti-CGRP monoclonal antibodies over three consecutive one-year treatment cycles: An intention-to-treat analysis
Vaghi, Gloria;Corrado, Michele;Pocora, Maria Magdalena;Bighiani, Federico;Cammarota, Francescantonio;Antoniazzi, Alessandro;Costantino, Luca;Martinelli, Daniele;Ghiotto, Natascia;Bottiroli, Sara;Montomoli, Cristina;Tassorelli, Cristina;De Icco, Roberto
2025-01-01
Abstract
Background: The present prospective, real-world study aims to assess anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) effectiveness across three consecutive one-year treatment cycles by means of a conservative intention-to-treat (ITT) analysis. Methods: We enrolled 179 subjects (75.4% females, 51.3 years 95% confidence interval [49.2–53.4] years), 87.2% with chronic migraine and medication overuse) who started mAbs between 2018 and 2020. We recorded clinical data supported by a prospectively filled headache diary up to three one-year treatment cycles. The ITT analysis was performed with a multivariate linear mixed model considering the entire population. Results: We observed a marked and consistent reduction in monthly migraine days (MMDs) across the three one-year cycles of treatment: −12.7 )[−11.4 – −14.1] at end of the first year of treatment (C1), −12.4 [−11.0 – −13.8] at the end of the second year (C2) and −12.9 [−11.4 – −14.3] at the end of the third year (C3). Baseline and residual MMDs progressively decreased across the three cycles (p = 0.008): from 21.1 [19.8–22.4] to 9.6 [8.3–11.0] in C1, from 19.0 [17.4–20.5] to 9.6 [8.1–11.1] in C2, and from 15.9 [14.3–17.5] to 8.5 [6.9–10.1] in C3. At the end of C3, the 50% response rate was 38.5% (69/179). Conclusions: In our cohort, mAbs induced a meaningful and sustained reduction in MMDs across three consecutive one-year cycles of treatment. The ITT analysis revealed a remaining high burden of disease. While confirming mAbs effectiveness in migraine prevention, these findings underscore the need for more treatment approaches and for exploring other non-CGRP dependent pathways.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
