Ailani Jessica, Andrews Jeffrey Scott, Tockhorn-Heidenreich Antje, Wenzel Richard, Rettiganti Mallikarjuna
Medstar Georgetown University, Washington D.C., USA.
Eli Lilly and Company, Indianapolis, IN, USA.
Adv Ther. 2022 Oct;39(10):4544-4555. doi: 10.1007/s12325-022-02233-y. Epub 2022 Aug 5.
In evaluating therapies for migraine prevention, emphasis is placed on frequency and less attention is paid to duration or severity. Total pain burden (TPB) combines frequency, duration, and severity of migraine headache, and has the potential to further characterize the benefit of preventive treatment using a single composite measure. TPB was previously used to characterize response to galcanezumab (GMB) in patients with migraine. In this post hoc analysis we assessed the impact of GMB in lowering TPB in patients who had previously not benefited from two to four categories of migraine preventive medication.
CONQUER trial patients (N = 462), 18-75 years old who had previously not benefited from two to four categories of migraine preventive medication, were randomized (1:1) to monthly placebo or GMB 120 mg with 240 mg loading dose. For each patient, monthly TPB in severity-weighted hours was calculated by multiplying migraine headache duration (hours) by maximum severity for each migraine headache day, then summing these daily scores over the month for the monthly score. Changes from baseline in monthly TPB across months 1-3 were analyzed. Spearman correlations between TPB and scores on the Migraine-Specific Quality-of-Life Questionnaire (MSQ) total and Migraine Disability Assessment Scale (MIDAS) were assessed at baseline.
Mean (SD) baseline monthly TPB was 192.1 (158.3) and 188.2 (197.4) severity-weighted hours for GMB-treated and placebo-treated patients, respectively. Across the 3-month double-blind period, GMB-treated patients experienced significantly greater mean reductions from baseline in monthly TPB compared with placebo-treated patients, both for mean change (GMB - 82.7, placebo - 15.8, p < 0.001) and percentage change (GMB - 38.6%, placebo 9.4%, p < 0.001). Furthermore, baseline TPB correlated with MSQ score (r = - 0.39) and MIDAS score (r = 0.40), suggesting good association of TPB with functional and disability outcomes.
GMB reduced mean TPB in patients who had previously not benefited from two to four categories of migraine preventive medication.
NCT03559257.
在评估偏头痛预防疗法时，重点在于发作频率，而对发作持续时间或严重程度关注较少。总疼痛负担（TPB）综合了偏头痛的发作频率、持续时间和严重程度，并且有可能使用单一综合指标进一步描述预防性治疗的益处。TPB先前已被用于描述偏头痛患者对加卡尼单抗（GMB）的反应。在这项事后分析中，我们评估了GMB对降低先前未从两到四类偏头痛预防性药物中获益的患者的TPB的影响。
CONQUER试验的患者（N = 462），年龄在18至75岁之间，先前未从两到四类偏头痛预防性药物中获益，被随机（1:1）分为每月接受安慰剂或120 mg GMB且负荷剂量为240 mg。对于每位患者，通过将偏头痛发作持续时间（小时）乘以每个偏头痛发作日的最大严重程度来计算每月严重程度加权小时数的TPB，然后将这些每日得分在一个月内相加得出每月得分。分析了第1至3个月每月TPB相对于基线的变化。在基线时评估了TPB与偏头痛特异性生活质量问卷（MSQ）总分以及偏头痛残疾评估量表（MIDAS）得分之间的Spearman相关性。
GMB治疗组和安慰剂治疗组患者的平均（标准差）基线每月TPB分别为192.1（158.3）和188.2（197.4）严重程度加权小时数。在3个月的双盲期内，与安慰剂治疗组患者相比，GMB治疗组患者每月TPB相对于基线的平均降低幅度显著更大，无论是平均变化（GMB - 82.7，安慰剂 - 15.8，p < 0.001）还是百分比变化（GMB - 38.6%，安慰剂9.4%，p < 0.001）。此外，基线TPB与MSQ得分（r = - 0.39）和MIDAS得分（r = 0.40）相关，表明TPB与功能和残疾结局具有良好的相关性。
GMB降低了先前未从两到四类偏头痛预防性药物中获益的患者的平均TPB。
NCT03559257。
