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.

An observational study on monoclonal antibodies against calcitonin‐gene‐related peptide and its receptor

“…No significant response predictors could be found in the present studies. This finding is in contrast with previous studies reporting age at migraine onset, number of previously failed prophylaxes, unilateral pain localization, dopaminergic symptoms and triptan response to be positively associated to a significant clinical response, whereas negative predictors were found to be obesity and psychiatric comorbidities [7][8][9][10]18]. However, evidence remains in most cases weak and with mixed/inconsistent results.…”

Early and sustained efficacy of fremanezumab over 24-weeks in migraine patients with multiple preventive treatment failures: the multicenter, prospective, real-life FRIEND2 study

“…In fact, interictal CGRP levels in peripheral blood progressively increase from episodic migraine to CM, while elevated CGRP-like immunoreactivity in the cerebrospinal fluid had been suggested as a trait marker of major depressive disorder [18,19]. We also found a very low number of adverse events, in agreement with other real-life studies [3,4,[13][14][15][16][17]. Some additional issues should be considered.…”

“…Different real-life studies highlighted that the effectiveness of anti-CGRP mAbs is higher than efficacy. The comparison of ≥ 50% responders at week 12 for episodic and chronic migraine in RWE vs RCTs is 59.4% vs 30.0% and 55.5% vs 41.0% for erenumab, 66.7% vs 41.8% and 66.7% vs 32.8% for galcanezumab, and 76.5% vs 43.0% and 58.3% vs 29.0% for monthly fremanezumab [3,4,[13][14][15][16][17]. The reason is unclear and is still matter of speculation.…”

Nutrition and Calcitonin Gene Related Peptide (CGRP) in Migraine

“…Recent randomized controlled trials and real-life studies provided important information on GI homeostasis and anti-CGRP therapy. The multicenter prospective cohort GARLIT real-life study enrolled patients with high-frequency episodic migraine and chronic migraine [ 101 , 102 ]. It was shown that galcanezumab, a humanized monoclonal antibody against CGRP, was effective and well-tolerated in the 1-year term, but persistent responders were less likely to have a higher BMI.…”