Satoshi Yamashita

Background/Objectives: Although calcitonin gene-related peptide monoclonal antibodies (CGRP-mAbs) have improved migraine prevention, some patients continue to experience inadequate response or re-worsening during treatment. This study evaluated the effectiveness of add-on Kampo therapy in migraine patients receiving CGRP-mAb treatment. Methods: This retrospective observational study included 39 migraine patients who received add-on Kampo therapy during ongoing CGRP-mAb treatment, contributing 55 treatment episodes. The primary endpoint was the change in monthly headache days (MHD) from baseline to 1 month after Kampo initiation. Secondary outcomes included migraine frequency, headache-related disability, quality of life, acute medication use, and work productivity. A responder was defined as achieving a ≥30% reduction in MHD at 1 month. Results: The study population was highly refractory, with chronic migraine present in 79.5% of patients and medication-overuse headache in 56.4%. Among treatment episodes, 72.7% experienced re-worsening after an initial response to CGRP-mAb treatment. Median MHD was 14.0 days after CGRP-mAb treatment and subsequently increased to 16.0 days before Kampo initiation. After Kampo initiation, median MHD decreased to 10.0 days at 1 month. Significant improvements were also observed at 1 month in headache-related disability, quality of life, acute medication use, and presenteeism. The ≥30% and ≥50% responder rates at 1 month were 41.8% and 12.7%, respectively. Re-worsening after an initial CGRP-mAb response showed an exploratory association with treatment response in the Firth penalized logistic regression model. Conclusions: Add-on Kampo therapy was associated with improvements in headache burden, quality of life, acute medication use, and work productivity in patients with inadequate response or re-worsening during CGRP-mAb treatment. These hypothesis-generating findings suggest a potential role for add-on Kampo therapy as a treatment optimization strategy and warrant confirmation in prospective controlled studies.

Background/Objectives: Anti-calcitonin gene-related peptide monoclonal antibodies (CGRP-mAbs) are effective injectable medications for the treatment of migraine. This study aimed to evaluate continuation, resumption, and withdrawal rates of CGRP-mAb treatment under real-world clinical conditions. Methods: Treatment-naïve patients with at least 3 months of follow-up after starting CGRP-mAb treatment were included. The decision to continue, discontinue, or resume CGRP-mAb treatment was made freely by the patients. Headache Impact Test-6 (HIT-6) and the Migraine-Specific Quality of Life Questionnaire (MSQ) were administered before starting treatment and one month after each CGRP-mAb injection. The endpoints were as follows: continuation rates of CGRP-mAb treatment after treatment initiation; resumption rate; withdrawal rate; changes in HIT-6 and MSQ scores; and differences in background factors between the resumption and withdrawal groups. Results: Of the 1162 migraine patients, 146 were included in the analysis. Continuation rates of CGRP-mAb treatment at 3, 6, 9, 12, 18, and 24 months were 93.2%, 80.2%, 68.9%, 58.8%, 55.4%, and 51.7%, respectively. For the patients who discontinued, the resumption rate was 76.8%, and the withdrawal rate was 20.7%. HIT-6 and MSQ scores were significantly decreased at all assessment points compared with before CGRP-mAb treatment. There were no significant differences in factors between the resumption and withdrawal groups. Conclusions: Under real-world clinical conditions in which patients were free to choose their own treatment, the continuation rate of CGRP-mAb treatment 12 months after treatment initiation was 58.8%, and more than half of patients remained on treatment after 24 months. The resumption rate was 76.8% and the withdrawal rate was 20.7%.