Maintenance of response and predictive factors of 1‐year GalcanezumAb treatment in real‐life migraine patients in Italy: The multicenter prospective cohort GARLIT study

Abstract Background and Purpose To evaluate the 1‐year effectiveness and tolerability of galcanezumab in real life and the prognostic indicators of persistent response. Methods High‐frequency episodic migraine (HFEM) and chronic migraine (CM) patients treated with galcanezumab who completed a 1‐year observation were enrolled. The primary outcomes assessed during the 12 months (V1–V12) were the change in monthly migraine days (MMDs) from baseline and the response rates ≥50% in MMDs (MMD ≥50% RR). The secondary outcomes were changes in pain intensity (numerical rating scale [NRS]) and in monthly acute medication intake (MAMI). Results We enrolled 191 patients (77.5% CM). Twenty‐three patients (12%) dropped out, two for nonserious adverse events. At least 40% of patients took add‐on standard preventives from baseline to V12. At V12, MMDs were reduced by 6.0 days in HFEM and by 11.9 days in CM patients (both p < 0.00001); NRS and MAMI were also decreased in both groups ( p < 0.00001). One‐hundred eight (56.5%) patients presented MMD ≥50% RR for 9 cumulative months (interquartile range=8): we defined this value as the cutoff for a persistent response. Persistent responders were less likely to have a higher body mass index (BMI) ( p = 0.007) but more frequently had a good response to triptans ( p = 0.005) and MMD ≥50% RR at V1 ( p < 0.0000001). Patients without a persistent response were on add‐on therapy for longer periods of time ( p < 0.001). Conclusions Galcanezumab was effective and well‐tolerated in the 1‐year term, with most patients presenting MMD ≥50% RR for at least 9 months. Triptan response, lower BMI, and MMD ≥50% RR in the first month emerged as predictive factors for a persistent response.