PMC:7507645 / 9697-13601
Annnotations
{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/7507645","sourcedb":"PMC","sourceid":"7507645","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7507645","text":"A total of 1130 patients with CM were randomized to receive fremanezumab quarterly (n = 376), fremanezumab monthly (n = 379), or placebo (n = 375). The criteria for CM with MO at baseline were met by 201 (53.6%), 198 (52.8%), and 188 (50.7%) of the evaluable patients in the fremanezumab quarterly, fremanezumab monthly, and placebo groups, respectively. The demographics and clinical characteristics of patients in each subgroup (with MO and without MO) differed from each other in several ways, most notably age, years since initial diagnosis, current preventive medication use, current use of triptans or ergots, prior topiramate use, prior onabotulinumtoxinA use, headache days of at least moderate severity, migraine days, and days of acute headache medication use, although statistical significance of differences between subgroups in individual characteristics was not tested (Table 1).\nTable 1 Demographics and baseline characteristics with and without MOa\nCM With MO CM Without MO\nFremanezumab Fremanezumab\nQuarterly (n = 201) Monthly (n = 198) Placebo (n = 188) Quarterly (n = 174) Monthly(n = 177) Placebo(n = 183)\nAge, mean (SD), y 44.6 (11.6) 44.8 (10.9) 45.0 (10.8) 39.0 (12.6) 36.2 (11.5) 37.7 (12.1)\nSex, female, n (%) 183 (91) 173 (87) 168 (89) 147 (84) 154 (87) 158 (86)\nBMI, mean (SD), kg/m2 26.4 (5.3) 26.4 (5.0) 26.0 (5.0) 26.9 (5.5) 26.7 (5.3) 26.9 (5.1)\nDisease history\n Years since initial migraine diagnosis, mean (SD) 21.0 (12.7) 22.8 (12.3) 23.2 (13.8) 18.3 (12.9) 17.1 (11.0) 16.7 (11.0)\n Current preventive medication use, n (%) 47 (23.4) 54 (27.3) 38 (20.2) 30 (17.2) 31 (17.5) 39 (21.3)\n Current use of triptans or ergots, n (%) 141 (70.1) 138 (69.7) 128 (68.1) 67 (38.5) 49 (27.7) 64 (35.0)\n Prior topiramate use, n (%) 65 (32.3) 72 (36.4) 77 (41.0) 41 (23.6) 43 (24.3) 40 (21.9)\n Prior onabotulinumtoxinA use, n (%) 38 (18.9) 34 (17.2) 32 (17.0) 28 (16.1) 16 (9.0) 17 (9.3)\nDisease characteristics during the 28-day pretreatment period\n Number of headache days of at least moderate severity,b mean (SD) 15.5 (5.0) 14.9 (5.4) 14.8 (5.4) 10.5 (4.8) 10.5 (5.3) 11.7 (5.8)\n Number of migraine days,c mean (SD) 17.2 (4.6) 17.5 (4.9) 17.3 (5.0) 15.0 (4.9) 14.3 (5.0) 15.4 (5.1)\n Number of days of acute medication use, mean (SD) 18.1 (4.0) 18.4 (4.5) 18.2 (4.4) 7.4 (4.4) 7.1 (4.5) 7.7 (4.5)\n HIT-6 score, mean (SD) 64.5 (5.1) 65.3 (4.4) 63.8 (5.2) 64.0 (4.3) 63.9 (4.3) 64.3 (4.4)\n PHQ-9 score, mean (SD) 4.3 (5.5) 5.9 (6.7) 3.7 (5.7) 4.1 (5.6) 4.0 (5.6) 4.0 (5.6)\nMSQoL domain scores\n RFR, mean (SD) 49.1 (18.9) 46.8 (19.7) 49.7 (20.5) 48.2 (18.3) 49.7 (18.7) 48.8 (19.2)\n RFP, mean (SD) 67.5 (21.1) 63.2 (23.5) 67.5 (22.9) 67.1 (20.4) 68.7 (20.6) 67.4 (21.7)\n EF, mean (SD) 58.4 (26.2) 54.3 (27.1) 58.0 (27.5) 55.8 (26.9) 60.4 (25.1) 57.7 (25.4)\nBMI Body mass index, CM Chronic migraine, EF Emotional function, HIT-6 Six-item Headache Impact Test, MO Medication overuse, MSQoL Migraine-Specific Quality of Life, RFP Role function−preventive, RFR Role function−restrictive, SD Standard deviation\naMO was defined as use of acute headache medication on ≥ 15 days, migraine-specific acute medication on ≥ 10 days, or combination medication for headache on ≥ 10 days during the 28-day pretreatment period. bA headache day of at least moderate severity was defined as a calendar day in which headache pain lasted at least 4 consecutive hours and had a peak severity of at least a moderate level, or a day in which acute migraine-specific medication (triptan or ergot) was used to treat a headache of any severity or duration. cA migraine day was defined as a calendar day in which headache pain lasted at least 4 consecutive hours and met criteria for migraine (with or without aura) or probable migraine (subtype in which only one migraine criterion is absent), or a day in which acute migraine-specific medication (triptan or ergot) was used to treat a headache of any 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