| Abstract: |
Monthly headache frequency directly correlates with personal/societal burden and impacts severity and preventive treatment decisions. This post hoc analysis identified shifts from higher to lower frequency headache categories over 6 months in patients with migraine participating in the PROMISE clinical trials receiving two eptinezumab doses. Headache frequency at baseline and over study months 1-6 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 ≤ 3 MHDs. Outcomes included the percentage of patients within each MHD category, the percentage of patients improving by ≥ 1 MHD category, and the number of months with reduction of ≥ 1 MHD category. Data from patients who received approved eptinezumab doses (100 mg or 300 mg) or placebo were included. Mean headache frequency at baseline in PROMISE-1 was 10 MHDs; most patients were classified as having HFEM (48. 6%) or LFEM (43. 9%). At Month 1, 62/221 (28. 1%), 75/222 (33. 8%), and 45/222 (20. 3%) patients who received eptinezumab 100 mg, 300 mg, and placebo had ≤ 3 MHDs, with 97/221 (43. 9%), 108/222 (48. 6%), and 84/222 (37. 8%), respectively, falling below the diagnostic EM threshold at Month 6. More than one-third (79/221 [35. 7%], 83/222 [37. 4%], and 68/222 [30. 6%] of patients in the eptinezumab 100 mg, 300 mg, and placebo groups, respectively), had 6 months of reduction of ≥ 1 frequency category. At baseline in PROMISE-2, mean headache frequency was 20. 5 MHDs. All patients (100%) in the eptinezumab 100 mg and placebo groups had CM, as did 99. 4% of patients receiving eptinezumab 300 mg. At Month 1, 209/356 (58. 7%), 216/350 (61. 7%), and 167/366 (45. 6%) patients treated with eptinezumab 100 mg, 300 mg, and placebo had ≤ 14 MHDs, with 240/356 (67. 4%), 249/350 (71. 1%), and 221/366 (60. 4%), respectively, falling below CM threshold at Month 6. Additionally, 153/356 (43. 0%), 169/350 (48. 3%), and 116/366 (31. 7%) patients in the eptinezumab 100 mg, 300 mg, and placebo groups, respectively, had 6 months of reduction of ≥ 1 frequency category. In the PROMISE studies, episodic and chronic migraine patients treated with eptinezumab were more likely to reduce their headache frequency versus placebo, which directly and in a sustained way improved their diagnostic category classification. ClinicalTrials. gov Identifier: NCT02559895, NCT02974153. |
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(Hospital Universitari Vall d'Hebron)
