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

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. Supplementary Information The online version contains supplementary material available at 10.1007/s00415-022-11226-4.

Efficacy and safety of fremanezumab for migraine prophylaxis in patients with at least three previous preventive failures: Prospective, multicenter, real‐world data from a Greek registry

“…Nonetheless, although our findings are overall in agreement with the results reported in the FRIEND study, a direct comparison cannot be done because of significant differences in the number of patients studied (67 vs. 204 in our study) and different medical histories and comorbidities. Moreover, we report similar findings to those recently published for erenumab [19][20][21] and galcanezumab [22,23] in real-world studies in both the EM and CM settings, although again methodological differences exist between studies, including the evaluation of changes in monthly migraine days (MMD) rather than MHD and the definition of the cut-off for treatment response at the level of 30% rather than 50% reduction in MHD. TA B L E 3 Changes in efficacy, disability, and quality of life outcomes at baseline (T0-trimester before initiation of therapy) and after fremanezumab treatment in patients with chronic migraine (n = 107).…”

Galcanezumab in the Treatment of Migraine: A Narrative Review of Real-World Studies

“…Patients who converted from CM to EM in GARLIT achieved significantly lower MIDAS scores than those not converting to EM (50 vs 74; P = 0.005) 20 . However, even patients with no response at 3 months had clinically meaningful reductions in HIT-6 scores, pain severity, and the number of acute medications by month 6 38 . Also, in the study by Vaghi et al 24 evaluating 12 months of therapy with galcanezumab in patients with refractory CM, MIDAS scores declined from 82.8 at baseline to 27, whereas HIT-6 scores declined from 68.1 to 59.4 (both P < 0.01 vs baseline).…”

Chronic Migraine as a Primary Chronic Pain Syndrome and Recommended Prophylactic Therapeutic Options: A Literature Review

“…The GARLIT trial (a 12-month, observational, longitudinal, cohort multi-center study), which evaluated the conversion from CM to EM, revealed that 52.3% of the CM patients showed consistent conversion to EM for the entire 12 month period [ 100 ].…”