Abstract text (incl. figure legends and references)

OBJECTIVE: To identify the proportions of patients shifting from higher to lower levels of headache frequency over Months 1-6 of treatment in the PROMISE studies.

METHODS: Headache frequency was categorized into 4 groups: chronic migraine (CM; ≥15 monthly headache days [MHDs]), high-frequency episodic migraine (HFEM; 10–14 MHDs), low-frequency episodic migraine (LFEM; 4–9 MHDs), and very-low-frequency episodic migraine (VLFEM; ≤3 MHDs). Outcomes included the percentage of patients within each MHD group and the percentage of patients improving by ≥1 diagnostic category.

RESULTS: At PROMISE-1 baseline, most patients were classified as having HFEM (100mg, 46.2% [102/221]; 300mg, 48.2% [107/222]; placebo, 51.4% [114/222]) or LFEM (100mg, 46.6% [103/221]; 300mg, 42.8% [95/222]; placebo, 42.3% [94/222]). In total, 35.7% (100mg, 79/221), 37.4% (300mg, 83/222), and 30.6% (placebo, 68/222) of patients had 6 months with reduction of ≥1 diagnostic category.

At PROMISE-2 baseline, all patients treated with eptinezumab 100mg (356/356) and placebo (366/366) groups experienced ≥15 MHDs, as did 99.4% (348/350) of patients treated with 300mg. In total, 43.0% (100mg, 153/356), 48.3% (300mg, 169/350), and 31.7% (placebo, 116/366) of patients had 6 months with reduction of ≥1 diagnostic category.

CONCLUSIONS: Patients treated with eptinezumab reported more downward shifts in diagnostic frequency category in Month 1 and sustained or improved this shift through Month 6 of treatment than placebo.