Reversion from MO to no MO
Among CM patients with baseline MO, significantly greater proportions of patients treated with fremanezumab quarterly or monthly reverted to no MO during the 12-week treatment period (quarterly 111/201 [55.2%], P = 0.0389; monthly 120/198 [60.6%], P = 0.0024) than those who received placebo (87/188 [46.3%]) (Fig. 3). This effect was present by week 4 (quarterly 102/201 [50.7%], monthly 107/198 [54.0%] vs placebo 73/188 [38.8%]).
Fig. 3 Proportion of patients with CM who reverted from MO to no MO during the 12-week treatment period. CM, chronic migraine; MO, medication overuse
Similar baseline mean (standard deviation) monthly average number of days of acute headache medication use were observed across treatment arms within the subgroup of patients who reverted from MO (quarterly 16.6 [3.4], monthly 16.7 [3.6], placebo 16.6 [3.3]) and the subgroup of patients who continued MO (quarterly 19.9 [3.9], monthly 21.0 [4.5], placebo 19.5 [4.8]), though numerically greater numbers were observed among patients who continued MO. Among patients who reverted from MO at baseline, the reduction from baseline in the monthly average number of days of acute headache medication use was − 9.0 (0.4) with fremanezumab quarterly, − 8.9 (0.4) with fremanezumab monthly, and − 7.1 (0.5) with placebo (Fig. 4a). In comparison, patients with continued MO experienced numerically smaller reductions in the monthly average number of days of acute medication use in both the fremanezumab-treated groups (quarterly − 1.7 [0.4], monthly: − 2.2 [0.4]) and the placebo group (− 1.1 [0.4]; Fig. 4a).
Fig. 4 (a) Reduction in medication use and (b) ≥ 50% response in patients with CM by reversion to no MO. Values shown in part A are mean (SE) change from baseline over 12 weeks in the monthly average number of days of acute medication use in patients who reverted from MO to no MO (blue bars) and in those who did not revert from MO to no MO (green bars). Values shown in part B are the proportions of patients with a ≥ 50% response, defined as a ≥ 50% reduction in the monthly average number of headache days of at least moderate severity from baseline over 12 weeks, in patients who reverted from MO to no MO (blue bars) and in those who did not revert from MO to no MO (green bars). CM = chronic migraine; MO = medication overuse; SE = standard error
Furthermore, more than half of the patients who reverted from MO achieved a ≥ 50% reduction in the monthly average number of headache days of at least moderate severity after treatment with fremanezumab quarterly (66/111 [59.5%]) or monthly (67/120 [55.8%]); of those treated with placebo, 27.6% (24/87) achieved a ≥ 50% reduction (Fig. 4b). Among patients who continued to experience MO, the proportion of patients with a ≥ 50% reduction in the monthly average number of headache days of at least moderate severity was 4.4% (4/90) with fremanezumab quarterly, 14.1% (11/78) with fremanezumab monthly, and 2.0% (2/101) with placebo (Fig. 4b).