Cephalalgia Reports最新文献_第5页

Placebo response with subcutaneous injections in calcitonin gene-related peptide receptor monoclonal antibody migraine preventative trials – A systematic review and meta-analysis 降钙素基因相关肽受体单克隆抗体偏头痛预防试验中皮下注射安慰剂的反应——系统综述和荟萃分析

Cephalalgia Reports Pub Date : 2022-01-01 DOI: 10.1177/25158163221120103

S. Gorantla, Murali Mohan Reddy Gopireddy, Archana Bhat, Lavanya Ayyasamy, Sarath Kumar Jaganathan Jaishankar, Bassil Kherallah, H. Nersesyan

{"title":"Placebo response with subcutaneous injections in calcitonin gene-related peptide receptor monoclonal antibody migraine preventative trials – A systematic review and meta-analysis","authors":"S. Gorantla, Murali Mohan Reddy Gopireddy, Archana Bhat, Lavanya Ayyasamy, Sarath Kumar Jaganathan Jaishankar, Bassil Kherallah, H. Nersesyan","doi":"10.1177/25158163221120103","DOIUrl":"https://doi.org/10.1177/25158163221120103","url":null,"abstract":"Background: The majority of CGRP monoclonal antibodies for migraine prevention are administered subcutaneously. Therefore, we attempted to calculate the pooled placebo response with subcutaneous placebo injections in this systematic review and meta-analysis. Methods: We identified 16 randomized controlled trials that met our inclusion and exclusion criteria through a comprehensive search in five electronic databases (PubMed Central, EMBASE, MEDLINE, Cochrane library and clinicaltrials.gov). The risk of bias was assessed for all included studies. Random effects model was used to calculate pooled mean monthly migraine days and 50% response rates. Results: A total of 4240 subjects were included from 16 studies in this meta-analysis. The pooled mean monthly migraine day reduction with subcutaneous placebo injections was 2.15 (95% CI: 1.60–2.69). The pooled proportion of patients achieving a 50% reduction in mean monthly headache days was 26% (95% CI: 20%–31%). Placebo response accounted for more than 50% of therapeutic gain in our study. Conclusion: A substantial placebo response was noted with subcutaneous injections in migraine CGRP monoclonal antibody clinical trials. This meta-analysis may serve as a reference point to calculate sample size in clinical trials using subcutaneous interventions for migraine prevention. We registered our study at PROSPERO (CRD42020185300).","PeriodicalId":9702,"journal":{"name":"Cephalalgia Reports","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49644830","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Orofacial pain disorders: An overview and diagnostic approach 口腔面部疼痛疾病:概述和诊断方法

Cephalalgia Reports Pub Date : 2022-01-01 DOI: 10.1177/25158163221097349

K. Peng, Thalea Oppermann

引用次数: 0

Predictors of clinical response to erenumab in patients with migraine 偏头痛患者对艾仑单抗临床反应的预测因素

Cephalalgia Reports Pub Date : 2022-01-01 DOI: 10.1177/25158163221128185

Olga N Lekontseva, Meng Wang, F. Amoozegar

{"title":"Predictors of clinical response to erenumab in patients with migraine","authors":"Olga N Lekontseva, Meng Wang, F. Amoozegar","doi":"10.1177/25158163221128185","DOIUrl":"https://doi.org/10.1177/25158163221128185","url":null,"abstract":"Background: Anti-CGRP monoclonal antibodies have emerged as efficacious preventive therapies for some, but not all patients with migraine. It is not yet fully understood what predicts treatment response. Objective: To identify factors associated with good or poor response to erenumab, the first available CGRP monoclonal antibody. Methods: A chart review of patients with migraine from a large headache center who received at least three 4-weekly doses of erenumab between 2018 and 2020 was conducted. Clinical variables were compared between erenumab responders (defined as ≥30% reduction in monthly headache or migraine days at 3 months) and non-responders via logistic regression analyses. Results: Among 90 enrolled patients, 62.2% were erenumab responders and 37.8% non-responders. A significantly larger proportion of non-responders were unemployed (58.8% vs. 28.6%), had complex diagnosis (chronic migraine overlapping another primary or secondary headache) (47.1% vs. 14.3%), higher monthly headache days (30 vs. 25.5) and migraine days (20 vs. 12), a higher frequency of daily headache (76.5% vs. 48.2%), and failed more preventive therapies (5.5 vs. 3). Based on logistic regressions, erenumab responsiveness did not significantly associate with duration of migraine, presence of aura, medication overuse, number of concurrent preventives, response to onabotulinumtoxinA or triptans, or certain comorbidities and substance use. Conclusions: This work may help improve selection of patients who may benefit from erenumab, but further prospective research studies are needed.","PeriodicalId":9702,"journal":{"name":"Cephalalgia Reports","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45485119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 3

Early use of erenumab in US real-world practice 艾仑单抗在美国实际应用中的早期应用

Cephalalgia Reports Pub Date : 2021-01-01 DOI: 10.1177/25158163211020419

A. Bogdanov, V. Chia, M. Bensink, Robert Urman, L. Fischer, Soeren Rasmussen, C. Szekely, L. Kallenbach

{"title":"Early use of erenumab in US real-world practice","authors":"A. Bogdanov, V. Chia, M. Bensink, Robert Urman, L. Fischer, Soeren Rasmussen, C. Szekely, L. Kallenbach","doi":"10.1177/25158163211020419","DOIUrl":"https://doi.org/10.1177/25158163211020419","url":null,"abstract":"Background: Erenumab, a monoclonal antibody (mAb) developed to block the calcitonin gene-related peptide (CGRP) receptor, is approved for the prevention of migraine in adults. This retrospective observational study sought to describe early real-world use of erenumab. Methods: This study used the Practice Fusion ambulatory Electronic Health Record database, which represents approximately 6% of ambulatory care among primary care and specialist practices in the United States. Among migraine patients initiating erenumab, demographics, migraine type, comorbidities, and prior treatments were assessed during the 12-month baseline period. Treatment patterns including changes in acute and preventive medications, switches to other CGRP mAbs (fremanezumab and galcanezumab), and for erenumab, changes in dose and adherence were examined among patients with 6 months of follow-up. Results: Of 3,336 patients identified (85.9% female; mean age = 49.1 years), approximately 40% had documentation of chronic migraine. Common comorbidities included non-migraine headache, anxiety, depression, and hypertension. Most patients (76.3%) initiated on the 70 mg dose of erenumab. Among 1,638 patients included in the treatment pattern analysis, 53.1% used acute medications and 55.7% used other non-specific preventive migraine medications during follow-up, reductions of 9.8% and 10.2%, respectively, over the same period of time before index. Switching to fremanezumab and galcanezumab were observed in 12.2% and 13.8% of patients, respectively. The mean proportion of days covered by erenumab at 6 months was 79%. Dosage of erenumab increased (from 70 mg to 140 mg) in 13.0% and decreased (from 140 mg to 70 mg) in 24.9% of patients. Conclusion: This early real-world study showed high adherence among erenumab users. This combined with observed reductions in previously used acute and preventive medications are suggestive of erenumab’s benefit.","PeriodicalId":9702,"journal":{"name":"Cephalalgia Reports","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/25158163211020419","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46690593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 3

Results of a web-based questionnaire: A gender-based study of migraine with and without aura and possible differences in pain perception and drug effectiveness 基于网络的问卷调查结果：对有先兆和无先兆偏头痛的性别研究以及疼痛感知和药物有效性的可能差异

Cephalalgia Reports Pub Date : 2021-01-01 DOI: 10.1177/25158163211062257

Johannes Drescher, Tina Katharina Amann, C. Gaul, P. Kropp, Yannic Siebenhaar, Jörg Scheidt

{"title":"Results of a web-based questionnaire: A gender-based study of migraine with and without aura and possible differences in pain perception and drug effectiveness","authors":"Johannes Drescher, Tina Katharina Amann, C. Gaul, P. Kropp, Yannic Siebenhaar, Jörg Scheidt","doi":"10.1177/25158163211062257","DOIUrl":"https://doi.org/10.1177/25158163211062257","url":null,"abstract":"Background: The aim of this work is to analyze reports of migraine attacks collected online in the citizen science project CLUE with respect to gender- and migraine type-specific differences in drug effectiveness and pain perception. Citizen science project data collection opens the possibility to examine these differences based on a large number of individual attacks instead of a simple survey of patients. Methods: One thousand three hundred and ninety four participants reported 47,274 migraine attacks via an online platform and smartphone apps. The reports contained information on the acute medications taken, the evaluation of their effect, and information on pain parameters such as pain intensity, origin, and localization. Chi-square tests were used to investigate whether the effect of acute medications and pain parameters differed when collated by gender and migraine type (migraine with and without aura). Results: Our participants rated the effectiveness of triptans as significantly better than that of ibuprofen. For triptans, significant differences in effectiveness were found when migraine types were distinguished, but no difference was found between genders. For ibuprofen, there were no differences between migraine types but significant differences between gender groups. Examination of pain parameters reveals differences between groups in pain intensity, pain origin, and pain location. The differences are statistically significant, but the effects are small. Conclusions: Despite some methodological limitations, web-based data collection is able to support findings from clinical trials in a real-world setting. Due to the high numbers of participants included and attacks reported, even small differences in medication efficacy and pain parameters between the groups considered can be demonstrated to be statistically significant.","PeriodicalId":9702,"journal":{"name":"Cephalalgia Reports","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41679184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Comparative effectiveness of erenumab versus oral preventive medications among migraine patients: A US claims database study 阿仑单抗与口服预防药物在偏头痛患者中的疗效比较：一项美国索赔数据库研究

Cephalalgia Reports Pub Date : 2021-01-01 DOI: 10.1177/25158163211040061

S. Tepper, Juanzhi Fang, Lujia Zhou, P. Vo, Ahmad M. Abdrabboh, M. Glassberg, M. Ferraris

{"title":"Comparative effectiveness of erenumab versus oral preventive medications among migraine patients: A US claims database study","authors":"S. Tepper, Juanzhi Fang, Lujia Zhou, P. Vo, Ahmad M. Abdrabboh, M. Glassberg, M. Ferraris","doi":"10.1177/25158163211040061","DOIUrl":"https://doi.org/10.1177/25158163211040061","url":null,"abstract":"Background: Erenumab, a fully human monoclonal antibody targeting the calcitonin gene-related peptide pathway, was developed specifically for preventive treatment of migraine. Objective: To compare the real-world effectiveness of erenumab and non-specific oral migraine preventive medication (OMPM) on acute medication usage and healthcare resource utilization (HCRU) among migraine patients. Methods: This retrospective US claims analysis included patients (≥18 years) diagnosed with migraine who initiated erenumab (May 01, 2018 and September 30, 2019) or OMPM (May 01, 2016 and October 31, 2017). Cohorts were matched 1:1 using the propensity score (PS) method with stratification. Acute medication usage, HCRU, and a composite endpoint of 1) outpatient visit with a migraine diagnosis and associated acute medication claim, 2) hospital admission with a primary migraine diagnosis, or 3) emergency room visit with a primary migraine diagnosis were assessed 6 months post-treatment initiation. Results: Following PS matching, both cohorts included 2,343 patients. At 6 months, erenumab was associated with significantly less acute medication usage versus OMPM, including number of types of acute medications used, number of claims per person, and proportion of patients using acute medication. HCRU and number of composite events were also significantly lower among erenumab users. Conclusion: Erenumab is more effective than OMPM at reducing acute medication usage and HCRU among migraine patients. Trial registration: N/A.","PeriodicalId":9702,"journal":{"name":"Cephalalgia Reports","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46210662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 2

A pilot study of the feasibility of a Swedish multimodal group intervention for severe migraine—The migraine patient school 瑞典多模式集体干预治疗严重偏头痛可行性的初步研究——偏头痛患者学校

Cephalalgia Reports Pub Date : 2021-01-01 DOI: 10.1177/25158163211020447

Birgitta Helmerson, A. Sundholm, K. Hedborg, E. Waldenlind, M. Kierkegaard, A. N. Remahl

{"title":"A pilot study of the feasibility of a Swedish multimodal group intervention for severe migraine—The migraine patient school","authors":"Birgitta Helmerson, A. Sundholm, K. Hedborg, E. Waldenlind, M. Kierkegaard, A. N. Remahl","doi":"10.1177/25158163211020447","DOIUrl":"https://doi.org/10.1177/25158163211020447","url":null,"abstract":"Objectives: To evaluate a multidisciplinary group intervention, the migraine patient school (MPS), for patients with severe, mostly chronic migraine. Method: A 13-week group intervention program including seven sessions of patient education, practical body awareness and relaxation exercises, and home assignments was performed in small groups with 5–11 participants. Four groups were consecutively included from spring 2014 to fall 2015. Headache diaries and standardized and study-specific questionnaires were used for evaluation at baseline before MPS (pre-interventional phase), and at follow-up. Results: Twenty-four of 30 included patients completed the study, i.e. attended ≥ four sessions. Most participants found it rewarding to participate in the MPS and easy to take part in, understand and complete home assignments. Validated standardized questionnaires delivered before, and after (follow-up) MPS showed that the impact on life (HIT-6) and avoidance behavior (PIPS-A) were significantly improved whereas quality of life (MSQL), anxiety and depression (HAD) and perceived stress (PSS-14) did not show a statistically significant change. Conclusion: The Migraine patient school with a multimodal educational and behavioral group intervention program was feasible to perform and seem to benefit patients with severe (high-frequency or chronic) migraine.","PeriodicalId":9702,"journal":{"name":"Cephalalgia Reports","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/25158163211020447","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43954372","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Effects of CYP3A4 and P-glycoprotein inhibition or induction on the pharmacokinetics of ubrogepant in healthy adults: Two phase 1, open-label, fixed-sequence, single-center, crossover trials CYP3A4和p -糖蛋白抑制或诱导对健康成人增厚剂药代动力学的影响:两项开放标签、固定序列、单中心、交叉试验

Cephalalgia Reports Pub Date : 2021-01-01 DOI: 10.1177/25158163211037344

Abhijeet S. Jakate, R. Boinpally, M. Butler, Wendy Ankrom, M. Dockendorf, A. Periclou

{"title":"Effects of CYP3A4 and P-glycoprotein inhibition or induction on the pharmacokinetics of ubrogepant in healthy adults: Two phase 1, open-label, fixed-sequence, single-center, crossover trials","authors":"Abhijeet S. Jakate, R. Boinpally, M. Butler, Wendy Ankrom, M. Dockendorf, A. Periclou","doi":"10.1177/25158163211037344","DOIUrl":"https://doi.org/10.1177/25158163211037344","url":null,"abstract":"Background: Ubrogepant is metabolized by cytochrome P450 3A4 (CYP3A4) and is a P-glycoprotein (P-gp) substrate. Objective: To assess effects of multiple-dose moderate-strong CYP3A4 and strong P-gp inhibitors and inducers on ubrogepant pharmacokinetic (PK) parameters. Methods: Two phase 1, open-label, fixed-sequence, single-center, crossover trials enrolled healthy adults to receive ubrogepant 20 mg with/without verapamil 240 mg (a moderate CYP3A4 inhibitor) or ketoconazole 400 mg (a strong CYP3A4 and P-gp transporter inhibitor) (Study A), or ubrogepant 100 mg with/without rifampin 600 mg (a strong CYP3A4 inducer and P-gp inducer) (Study B). Outcomes included ubrogepant PK parameters (area under plasma concentration-time curve, time 0 through infinity [AUC0-∞], peak plasma concentration [Cmax]), and safety (treatment-emergent adverse events [TEAEs]). PK parameters were compared between ubrogepant with/without coadministered medications using linear mixed-effects models. Cmax and AUC0-∞ least-squares geometric mean ratios (GMR) of ubrogepant with/without coadministration were constructed. Results: Twelve participants enrolled in Study A and 30 in Study B. AUC0-∞ and Cmax GMR (90% CI) were 3.53 (3.32–3.75) and 2.80 (2.48–3.15), respectively, for ubrogepant with verapamil; 9.65 (7.27–12.81) and 5.32 (4.19–6.76) with ketoconazole; and 0.22 (0.20–0.24) and 0.31 (0.27–0.36) with rifampin. TEAEs were predominantly mild; no treatment-related serious TEAEs or TEAE-related discontinuations occurred. Conclusion: The PK of ubrogepant were significantly affected by the concomitant use of CYP3A4 moderate-strong inhibitors and strong inducers.","PeriodicalId":9702,"journal":{"name":"Cephalalgia Reports","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43609186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Case report: Therapeutic response for new daily persistent headache by a tumor necrosis factor alpha antagonist, lithium 病例报告:肿瘤坏死因子α拮抗剂锂治疗新发每日持续性头痛的疗效

Cephalalgia Reports Pub Date : 2021-01-01 DOI: 10.1177/25158163211000316

E. Bancalari, A. Wicht

引用次数: 1

The quest for a headache pattern in giant cell arteritis: A cohort study 巨细胞动脉炎头痛模式的探索:一项队列研究

Cephalalgia Reports Pub Date : 2021-01-01 DOI: 10.1177/25158163211024134

S. Vincenten, W. Mulleners

引用次数: 1