Comparative effectiveness and tolerability of calcitonin gene-related peptide (CGRP) monoclonal antibodies and onabotulinumtoxinA in chronic migraine: A multicenter, real-world study in Taiwan

Abstract

Objective: To compare the real-world effectiveness and tolerability of calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) and onabotulinumtoxinA in chronic migraine (CM) patients.

Methods: This multicenter study involved retrospective analysis of prospectively collected data of CM patients treated with CGRP mAbs or onabotulinumtoxinA, including difficult-to-treat (DTT) patients (i.e., ≥3 preventive failures). Treatment outcomes were determined at 6 months based on prospective headache diaries and Migraine Disability Assessment (MIDAS).

Results: The study included 316 (55 M/261F, mean age 44.4 ± 13.5 years) and 333 (61 M/272F, mean age 47.9 ± 13.4 years) CM patients treated with CGRP mAbs or onabotulinbumtoxinA, respectively. At 6 months, CGRP mAb treatment was associated with a greater decrease in monthly migraine days (MMDs) (-13.0 vs. -8.7 days/month, p < 0.001) and a higher ≥50% responder rate (RR) (74.7% vs. 50.7%, p < 0.001) compared with onabotulinumtoxinA injections. The findings were consistent in DTT patients (-13.0 vs. -9.1 MMDs, p < 0.001; ≥50% RR: 73.9% vs. 50.3%, p < 0.001) or those with medication-overuse headache (MOH) (-13.3 vs. -9.0 MMDs, p < 0.001; ≥50% RR: 79.0% vs. 51.6%, p < 0.001). Besides, patients receiving CGRP mAbs had greater improvement (-42.2 vs. -11.8, p < 0.001) and a higher ≥50% RR (62.0% vs. 40.0%, p = 0.001) in MIDAS scores and a lower rate of adverse events (AEs) (6.0% vs. 21.0%, p < 0.001). However, none of the patients discontinued treatment due to AEs.

Conclusions: In this multicenter, real-world study, CGRP mAbs were more effective than onabotulinumtoxinA in CM patients, even in DTT or MOH patients. All of these injectables were well tolerated. Further prospective studies are needed to verify these findings.

Keywords: CGRP; chronic migraine; fremanezumab; galcanezumab; onabotulinumtoxinA; outcome; refractory.

FIGURE 1

Patient selection. CGRP, calcitonin gene‐related peptide; CM, chronic migraine; mAb, monoclonal antibody; OnabotA, onabotulinumtoxinA.

FIGURE 2

Treatment outcomes of chronic migraine patients treated with calcitonin gene‐related peptide monoclonal antibodies or onabotulinumtoxinA at 6 months. Least‐squares mean change (standard error) from baseline in the number of monthly migraine days (MMDs) (a) and monthly moderate‐to‐severe migraine days (MMSMDs) (b) and proportions of patients with ≥50% (c) or ≥ 75% (d) reduction in MMDs and MMSMDs at 6 months. CGRP, calcitonin gene‐related peptide; DTT, difficult‐to‐treat; mAb, monoclonal antibody; MMD, monthly migraine day; MMSMD, monthly moderate‐to‐severe migraine day; MOH, medication‐overuse headache; onabotA, onabotulinumtoxinA. ***p ≤ 0.001, **p ≤ 0.01.

FIGURE 3

Subgroup analysis in difficult‐to‐treat (DTT) and medication‐overuse headache (MOH) patients. Least‐squares mean change (standard error) from baseline in the number of monthly migraine days (MMDs) (a) at 6 months and ≥ 50% and ≥ 75% responder rates for MMDs (b) in patients who were DTT and those with MOH (c, d). CGRP, calcitonin gene‐related peptide; DTT, difficult‐to‐treat; mAb, monoclonal antibody; MMD, monthly migraine day; MOH, medication‐overuse headache; onabotA, onabotulinumtoxinA. ***p ≤ 0.001, **p ≤ 0.01, *p < 0.05.

FIGURE 4

Patient‐reported outcomes in chronic migraine patients. (a) Least‐squares mean change from baseline in Migraine Disability Assessment (MIDAS) score, (b) proportions of patients with ≥50% and ≥ 75% response, and (c) patient's subjective ratings on overall effectiveness. ***p ≤ 0.001, ** p ≤ 0.01.