Department of Neurology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, Berlin, 10117, Germany.
Clinician Scientist Program, Berlin Institute of Health at Charité (BIH), Berlin, Germany.
J Headache Pain. 2023 Feb 27;24(1):16. doi: 10.1186/s10194-023-01552-x.
Clinical trials and real-world studies revealed a spectrum of response to CGRP(-receptor) monoclonal antibodies (mAbs) in migraine prophylaxis, ranging from no effect at all to total migraine freedom. In this study, we aimed to compare clinical characteristics between super-responders (SR) and non-responders (NR) to CGRP(-receptor) mAbs.
We performed a retrospective cohort study at the Headache Center, Charité - Universitätsmedizin Berlin. The definition of super-response was a ≥ 75% reduction in monthly headache days (MHD) in the third month after treatment initiation compared to the month prior to treatment begin (baseline). Non-response was defined as ≤ 25% reduction in MHD after three months of treatment with a CGRP-receptor mAb and subsequent three months of treatment with CGRP mAb, or vice versa. We collected demographic data, migraine disease characteristics, migraine symptoms during the attacks in both study groups (SR/NR) as well as the general medical history. SR and NR were compared using Chi-square test for categorical variables, and t-test for continuous variables.
Between November 2018 and June 2022, n = 260 patients with migraine received preventive treatment with CGRP(-receptor) mAbs and provided complete headache documentation for the baseline phase and the third treatment month. Among those, we identified n = 29 SR (11%) and n = 26 NR (10%). SR reported more often especially vomiting (SR n = 12/25, 48% vs. NR n = 4/22, 18%; p = 0.031) and typical migraine characteristics such as unilateral localization, pulsating character, photophobia and nausea. A subjective good response to triptans was significantly higher in SR (n = 26/29, 90%) than in NR (n = 15/25, 60%, p = 0.010). NR suffered more frequently from chronic migraine (NR n = 24/26, 92% vs. SR n = 15/29, 52%; p = 0.001), medication overuse headache (NR n = 14/24, 58% versus SR n = 8/29, 28%; p = 0.024), and concomitant depression (NR n = 17/26, 65% vs. SR n = 8/29, 28%; p = 0.005).
Several clinical parameters differ between SR and NR to prophylactic CGRP(-R) mAbs. A thorough clinical evaluation prior to treatment initiation might help to achieve a more personalized management in patients with migraine.
临床试验和真实世界研究显示,在偏头痛预防治疗中,CGRP(-受体)单克隆抗体(mAb)的反应呈谱性,从完全无效到完全无偏头痛。在这项研究中,我们旨在比较 CGRP(-受体)mAb 的超级应答者(SR)和无应答者(NR)之间的临床特征。
我们在柏林夏里特医科大学头痛中心进行了一项回顾性队列研究。超级应答的定义是治疗开始后第三个月的每月头痛天数(MHD)与治疗前一个月相比减少≥75%(基线)。无应答定义为 CGRP 受体 mAb 治疗 3 个月后 MHD 减少≤25%,随后 CGRP mAb 治疗 3 个月,或反之亦然。我们收集了人口统计学数据、偏头痛疾病特征、两组(SR/NR)偏头痛发作期间的偏头痛症状以及一般病史。SR 和 NR 之间的比较采用卡方检验进行分类变量,采用 t 检验进行连续变量。
2018 年 11 月至 2022 年 6 月期间,n=260 例偏头痛患者接受了 CGRP(-受体)mAb 的预防性治疗,并提供了基线期和第三个治疗月的完整头痛记录。其中,我们确定了 n=29 例 SR(11%)和 n=26 例 NR(10%)。SR 更常报告呕吐(SR n=12/25,48% vs. NR n=4/22,18%;p=0.031)和典型偏头痛特征,如单侧定位、搏动性、畏光和恶心。SR 对曲普坦类药物的主观良好反应明显高于 NR(SR n=26/29,90% vs. NR n=15/25,60%,p=0.010)。NR 更频繁地患有慢性偏头痛(NR n=24/26,92% vs. SR n=15/29,52%;p=0.001)、药物过度使用性头痛(NR n=14/24,58% vs. SR n=8/29,28%;p=0.024)和并存的抑郁症(NR n=17/26,65% vs. SR n=8/29,28%;p=0.005)。
预防性 CGRP(-R)mAb 的 SR 和 NR 之间存在几个临床参数差异。在开始治疗前进行全面的临床评估可能有助于在偏头痛患者中实现更个性化的管理。