ABSTRACT
@#The international, multicenter Chronic Migraine OnabotulinumtoxinA Prolonged Efficacy Open Label (COMPEL) study evaluated long-term safety and efficacy of onabotulinumtoxinA in individuals with chronic migraine (CM). This post hoc analysis evaluates the safety and efficacy of onabotulinumtoxinA in South Korean patients for up to 108 weeks of treatment. OnabotulinumtoxinA 155 U was administered every 12 weeks for 9 treatment cycles (108 weeks). The primary efficacy measure was change from baseline in heads he-day frequency for the 28-day period ending at week 108. Additional outcome measures included change in 6-item Headache Impact Test (HIT-6) scores and measures of migrainerelated disability and quality of life. Safety and tolerability were assessed from the frequency of adverse events (AEs). Of 716 patients in the United States, South Korea, and Australia, 80 were from South Korean study sites; 58 (72.5%) South Koreans and 315 (49.5%) non-Koreans completed the study. Within-group improvements in all efficacy measures from baseline to week 108 were statistically significant (P<0.05). Mean change in headache-day frequency (SD) at week 108 was similar for South Koreans and non-Koreans (–11.8 [7.8] vs –10.6 [6.2]; P=0.115). However, at week 108, the South Korean subgroup showed significantly greater reductions in moderate to severe headache days (–10.8[7.0] vs –9.3 [5.9]; P=0.040) and in HIT-6 scores (–9.8 [8.6] vs –6.7 [7.0]; P<0.001). Treatment related AEs occurred less frequently in South Koreans than non-Koreans (7.5% vs 19.7%). In the COMPEL study, onabotulinumtoxinA was an effective and well-tolerated preventive treatment for South Koreans with CM.