Safety and efficacy of fremanezumab in real clinical practice in patients with chronic migraine

G. Belskaya, A. V. Krasnikov, E. A. Kiryanova, M. E. Prokopovich, E. V. Sakharova, G. V. Makarov
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Abstract

Objective: to evaluate the efficacy and safety of fremanezumab in patients with chronic migraine (CM) in real-life clinical practice.Material and methods. In a 12-week, open-label, prospective study, 27 patients (21 women and 6 men, mean age 41±10 years) with CM were administered with fremanezumab 225 mg subcutaneously monthly or 675 mg once (quarterly). We assessed changes in migraine attack intensity using a visual analogue scale (VAS), a reduction in the number of headache days per month by 50% or more, the impact of headache on daily activities (HIT-6 scale), adverse events (AEs) and tolerability of fremanezumab.Results. The number of migraine days per month decreased by 50% or more in 52%, 63% and 70% of patients at weeks 4, 8 and 12, respectively. In 26% of patients, the number of days with headaches was reduced by 75% or more by the end of the study. On average, the number of days with migraine decreased by 11.6 per month, with monthly injections – by 12.6 per month (p<0.01). In patients who had negative experience with treatment with two or more groups of preventive therapies, the number of days with migraine was reduced by an average of 10.6 per month (p<0.01). The pain intensity according to VAS decreased from 9 to 5.7 points (p<0.001), the HIT-6 index decreased from 66 to 55 points (p<0.001). AEs occurred in 26% of cases, were transient and did not lead to discontinuation of treatment.Conclusion. The efficacy and safety of the use of fremanezumab in CM in real-world clinical practice has been demonstrated.
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在慢性偏头痛患者的实际临床实践中使用氟马尼珠单抗的安全性和有效性
材料和方法:在为期12周的开放标签前瞻性研究中,27名慢性偏头痛患者(21名女性和6名男性,平均年龄(41±10)岁)每月皮下注射225毫克或675毫克fremanezumab。在一项为期12周的开放标签前瞻性研究中,27名慢性偏头痛患者(21名女性和6名男性,平均年龄(41±10)岁)每月皮下注射225毫克或一次(每季度)注射675毫克fremanezumab。我们用视觉模拟量表(VAS)评估了偏头痛发作强度的变化、每月头痛天数减少50%或更多的情况、头痛对日常活动的影响(HIT-6量表)、不良事件(AEs)以及对fremanezumab的耐受性。在第4周、第8周和第12周,分别有52%、63%和70%的患者每月偏头痛天数减少了50%或更多。研究结束时,26%的患者头痛天数减少了75%或更多。偏头痛天数平均每月减少 11.6 天,每月注射一次则每月减少 12.6 天(p<0.01)。在接受过两组或更多组预防性疗法的患者中,偏头痛天数平均每月减少 10.6 天(p<0.01)。VAS显示的疼痛强度从9点降至5.7点(P<0.001),HIT-6指数从66点降至55点(P<0.001)。26%的病例出现了AEs,这些AEs是一过性的,不会导致治疗中断。结论:在现实世界的临床实践中,fremanezumab用于CM的有效性和安全性已得到证实。
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