Background: Recently, the United States Food and Drug Administration (USFDA) approved viloxazine extended-release (ER) to manage attention-deficit hyperactivity disorder (ADHD) in pediatric patients of 6-17 years of age.
Objective: To perform a meta-analysis to determine the safety and efficacy of viloxazine ER in the management of ADHD.
Data source and methods: A literature search was performed through the databases Cochrane Library, PubMed, and clinicaltrials.gov, for a period from inception to August 2021, with the keywords: viloxazine, SPN-812, ADHD, and randomized clinical trials. The randomized controlled trials published in English language that analyzed the efficacy and safety were included. The risk of bias (RoB) was assessed by RoB tool. The outcomes included in this study were the proportion of patients with a 50% reduction in ADHD-Rating Scale-5 (ADHD-RS-5 responders) and improvement in CGI-I scale and the proportion of patients with at least one adverse event, the incidence of somnolence and Serious Adverse Events (SAEs).
Results: This meta-analysis includes 1605 patients from five randomized clinical trials; all of the trials were at low risk of bias. Viloxazine group had more ADHD-RS-5 responders as compared to placebo; RR = 1.62; 95% CI = 1.36-1.93; P = <.00001. Significantly higher number of patients showed improved CGI-I score; RR = 1.53; 95% CI = 1.32-1.78; P = <.00001. A higher proportion of patients was observed with at least one adverse event (RR = 1.52; 95% CI = 1.24-1.85; P = <.0001), and somnolence (RR = 3.93; 95% CI = 2.11-7.31; P = <.0001) in viloxazine group. The incidence of SAEs was more in viloxazine group (RR = 2.98; 95% CI = .67-13.3; P = .15).
Conclusions: Viloxazine was found to be significantly superior to placebo in both efficacy outcomes. Adverse events and somnolence were significantly more than the placebo. The incidence was SAEs was more in the viloxazine group but was not statistically significant.
背景：最近，美国食品和药物管理局（USFDA）批准了维洛氮平缓释片（ER），用于治疗6-17岁儿童患者的注意力缺陷多动障碍（ADHD）：进行一项荟萃分析，以确定维洛沙嗪缓释片治疗多动症的安全性和有效性：在Cochrane Library、PubMed和clinicaltrials.gov等数据库中进行文献检索，检索期从开始到2021年8月，关键词为：viloxazine、SPN-812、ADHD和随机临床试验。纳入的随机对照试验均以英文发表，对疗效和安全性进行了分析。采用RoB工具评估偏倚风险（RoB）。研究结果包括ADHD-Rating Scale-5（ADHD-RS-5应答者）降低50%和CGI-I量表改善的患者比例，以及出现至少一种不良事件、嗜睡和严重不良事件（SAEs）的患者比例：这项荟萃分析包括来自五项随机临床试验的1605名患者；所有试验的偏倚风险都很低。与安慰剂相比，维洛沙嗪组有更多的ADHD-RS-5应答者；RR = 1.62；95% CI = 1.36-1.93；P = P = P = P = .15）：结论：在两种疗效结果中，维洛氮平都明显优于安慰剂。不良反应和嗜睡明显多于安慰剂。维罗沙嗪组的 SAE 发生率更高，但无统计学意义。
{"title":"Viloxazine for Attention-Deficit Hyperactivity Disorder: A Systematic Review and Meta-analysis of Randomized Clinical Trials.","authors":"Alok Singh, Mahesh Kumar Balasundaram, Abhishek Singh","doi":"10.1177/11795735221092522","DOIUrl":"10.1177/11795735221092522","url":null,"abstract":"<p><strong>Background: </strong>Recently, the United States Food and Drug Administration (USFDA) approved viloxazine extended-release (ER) to manage attention-deficit hyperactivity disorder (ADHD) in pediatric patients of 6-17 years of age.</p><p><strong>Objective: </strong>To perform a meta-analysis to determine the safety and efficacy of viloxazine ER in the management of ADHD.</p><p><strong>Data source and methods: </strong>A literature search was performed through the databases Cochrane Library, PubMed, and clinicaltrials.gov, for a period from inception to August 2021, with the keywords: viloxazine, SPN-812, ADHD, and randomized clinical trials. The randomized controlled trials published in English language that analyzed the efficacy and safety were included. The risk of bias (RoB) was assessed by RoB tool. The outcomes included in this study were the proportion of patients with a 50% reduction in ADHD-Rating Scale-5 (ADHD-RS-5 responders) and improvement in CGI-I scale and the proportion of patients with at least one adverse event, the incidence of somnolence and Serious Adverse Events (SAEs).</p><p><strong>Results: </strong>This meta-analysis includes 1605 patients from five randomized clinical trials; all of the trials were at low risk of bias. Viloxazine group had more ADHD-RS-5 responders as compared to placebo; RR = 1.62; 95% CI = 1.36-1.93; <i>P</i> = <.00001. Significantly higher number of patients showed improved CGI-I score; RR = 1.53; 95% CI = 1.32-1.78; <i>P</i> = <.00001. A higher proportion of patients was observed with at least one adverse event (RR = 1.52; 95% CI = 1.24-1.85; <i>P</i> = <.0001), and somnolence (RR = 3.93; 95% CI = 2.11-7.31; <i>P</i> = <.0001) in viloxazine group. The incidence of SAEs was more in viloxazine group (RR = 2.98; 95% CI = .67-13.3; <i>P</i> = .15).</p><p><strong>Conclusions: </strong>Viloxazine was found to be significantly superior to placebo in both efficacy outcomes. Adverse events and somnolence were significantly more than the placebo. The incidence was SAEs was more in the viloxazine group but was not statistically significant.</p>","PeriodicalId":15218,"journal":{"name":"Journal of Central Nervous System Disease","volume":"14 ","pages":"11795735221092522"},"PeriodicalIF":2.6,"publicationDate":"2022-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/35/ee/10.1177_11795735221092522.PMC9125110.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10250403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-05-01DOI: 10.1177/11795735221102727
L. Diem, Livia Fregolente-Gomes, J. Warncke, H. Hammer, C. Friedli, N. Kamber, Simon Jung, S. Bigi, M. Funke-Chambour, A. Chan, C. Bassetti, A. Salmen, R. Hoepner
Introduction Post-COVID-19 syndrome affects approximately 10-25% of people suffering from COVID-19 infection, irrespective of initial COVID-19 severity. Fatigue is one of the major symptoms, occurring in 30-90% of people with post-COVID-19 syndrome. This study aims at describing factors associated with fatigue in people with Post-COVID-19 seen in our newly established Post-Covid clinic. Methods This retrospective single center study included 42 consecutive patients suffering from Post-COVID-19 syndrome treated at the Department of Neurology, University Hospital Bern, between 11/2020 and05/2021. Clinical phenomenology of Post-COVID-19 syndrome with a special focus on fatigue and risk factor identification was performed using Mann-Whitney U Test, Pearson Correlation, and Chi-Quadrat-Test. Results Fatigue (90.5%) was the most prevalent Post-COVID-19 symptom followed by depressive mood (52.4%) and sleep disturbance (47.6%). Fatigue was in mean severe (Fatigue severity scale (FSS) mean 5.5 points (95% Confidence interval (95CI) 5.1 - 5.9, range .9 - 6.9, n = 40), and it was unrelated to age, COVID-19 severity or sex. The only related factors with fatigue severity were daytime sleepiness and depressed mood. Conclusion Fatigue is the main symptom of the Post-COVID-19 syndrome in our cohort. Further studies describing this syndrome are needed to prepare the healthcare systems for the challenge of treating patients with Post-COVID-19 syndrome.
{"title":"Fatigue in Post-COVID-19 Syndrome: Clinical Phenomenology, Comorbidities and Association With Initial Course of COVID-19","authors":"L. Diem, Livia Fregolente-Gomes, J. Warncke, H. Hammer, C. Friedli, N. Kamber, Simon Jung, S. Bigi, M. Funke-Chambour, A. Chan, C. Bassetti, A. Salmen, R. Hoepner","doi":"10.1177/11795735221102727","DOIUrl":"https://doi.org/10.1177/11795735221102727","url":null,"abstract":"Introduction Post-COVID-19 syndrome affects approximately 10-25% of people suffering from COVID-19 infection, irrespective of initial COVID-19 severity. Fatigue is one of the major symptoms, occurring in 30-90% of people with post-COVID-19 syndrome. This study aims at describing factors associated with fatigue in people with Post-COVID-19 seen in our newly established Post-Covid clinic. Methods This retrospective single center study included 42 consecutive patients suffering from Post-COVID-19 syndrome treated at the Department of Neurology, University Hospital Bern, between 11/2020 and05/2021. Clinical phenomenology of Post-COVID-19 syndrome with a special focus on fatigue and risk factor identification was performed using Mann-Whitney U Test, Pearson Correlation, and Chi-Quadrat-Test. Results Fatigue (90.5%) was the most prevalent Post-COVID-19 symptom followed by depressive mood (52.4%) and sleep disturbance (47.6%). Fatigue was in mean severe (Fatigue severity scale (FSS) mean 5.5 points (95% Confidence interval (95CI) 5.1 - 5.9, range .9 - 6.9, n = 40), and it was unrelated to age, COVID-19 severity or sex. The only related factors with fatigue severity were daytime sleepiness and depressed mood. Conclusion Fatigue is the main symptom of the Post-COVID-19 syndrome in our cohort. Further studies describing this syndrome are needed to prepare the healthcare systems for the challenge of treating patients with Post-COVID-19 syndrome.","PeriodicalId":15218,"journal":{"name":"Journal of Central Nervous System Disease","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47691164","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}
Pub Date : 2022-03-29eCollection Date: 2022-01-01DOI: 10.1177/11795735221084842
Victoria A Levasseur, Biao Xiang, Amber Salter, Dmitriy A Yablonskiy, Anne H Cross
Background: Multiple sclerosis (MS) lesions typically form around a central vein that can be visualized with FLAIR* MRI, creating the central vein sign (CVS) which may reflect lesion pathophysiology. Herein we used gradient echo plural contrast imaging (GEPCI) MRI to simultaneously visualize CVS and measure tissue damage in MS lesions. We examined CVS in relation to tissue integrity in white matter (WM) lesions and among MS subtypes.
Objective: We aimed to determine if CVS positive lesions were specific to MS subtype, if CVS can be detected consistently among readers using the GEPCI method, and if there were differences in tissue damage in lesions with vs without CVS.
Subjects and methods: Thirty relapsing-remitting MS (RRMS) subjects and 38 primary and secondary progressive MS (PMS) subjects were scanned with GEPCI protocol at 3T. GEPCI T2*-SWI images were generated to visualize CVS. Two investigators independently evaluated WM lesions for CVS and measured lesion volumes. To estimate tissue damage severity, total lesion volume, and mean lesion volume, R2t*-based tissue damage score (TDS) of individual lesions and tissue damage load (TDL) were measured for CVS+, CVS-, and confluent lesions. Spearman correlations were made between MRI and clinical data. One-way ANCOVA with age and sex as covariates was used to compare measurements of CVS+ vs CVS- lesions in each individual.
Results: 398 of 548 lesions meeting inclusion criteria showed CVS. Most patients had ≥40% CVS+ lesions. CVS+ lesions were present in similar proportion among MS subtypes. Interobserver agreement was high for CVS detection. CVS+ and confluent lesions had higher average and total volumes vs CVS- lesions. CVS+ and confluent lesions had more tissue damage than CVS- lesions based on TDL and mean TDS.
Conclusion: CVS occurred in RRMS and PMS in similar proportions. CVS+ lesions had greater tissue damage and larger size than CVS- lesions.
{"title":"Stronger Microstructural Damage Revealed in Multiple Sclerosis Lesions With Central Vein Sign by Quantitative Gradient Echo MRI.","authors":"Victoria A Levasseur, Biao Xiang, Amber Salter, Dmitriy A Yablonskiy, Anne H Cross","doi":"10.1177/11795735221084842","DOIUrl":"10.1177/11795735221084842","url":null,"abstract":"<p><strong>Background: </strong>Multiple sclerosis (MS) lesions typically form around a central vein that can be visualized with FLAIR* MRI, creating the central vein sign (CVS) which may reflect lesion pathophysiology. Herein we used gradient echo plural contrast imaging (GEPCI) MRI to simultaneously visualize CVS and measure tissue damage in MS lesions. We examined CVS in relation to tissue integrity in white matter (WM) lesions and among MS subtypes.</p><p><strong>Objective: </strong>We aimed to determine if CVS positive lesions were specific to MS subtype, if CVS can be detected consistently among readers using the GEPCI method, and if there were differences in tissue damage in lesions with vs without CVS.</p><p><strong>Subjects and methods: </strong>Thirty relapsing-remitting MS (RRMS) subjects and 38 primary and secondary progressive MS (PMS) subjects were scanned with GEPCI protocol at 3T. GEPCI T2*-SWI images were generated to visualize CVS. Two investigators independently evaluated WM lesions for CVS and measured lesion volumes. To estimate tissue damage severity, total lesion volume, and mean lesion volume, R2t*-based tissue damage score (TDS) of individual lesions and tissue damage load (TDL) were measured for CVS+, CVS-, and confluent lesions. Spearman correlations were made between MRI and clinical data. One-way ANCOVA with age and sex as covariates was used to compare measurements of CVS+ vs CVS- lesions in each individual.</p><p><strong>Results: </strong>398 of 548 lesions meeting inclusion criteria showed CVS. Most patients had ≥40% CVS+ lesions. CVS+ lesions were present in similar proportion among MS subtypes. Interobserver agreement was high for CVS detection. CVS+ and confluent lesions had higher average and total volumes vs CVS- lesions. CVS+ and confluent lesions had more tissue damage than CVS- lesions based on TDL and mean TDS.</p><p><strong>Conclusion: </strong>CVS occurred in RRMS and PMS in similar proportions. CVS+ lesions had greater tissue damage and larger size than CVS- lesions.</p>","PeriodicalId":15218,"journal":{"name":"Journal of Central Nervous System Disease","volume":"14 ","pages":"11795735221084842"},"PeriodicalIF":4.8,"publicationDate":"2022-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9e/9f/10.1177_11795735221084842.PMC8973074.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10361599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01DOI: 10.1177/11795735221098140
Y. Aburto-Murrieta, Beatriz Méndez, J. Marquez-Romero
Endovascular thrombectomy (EVT) for the treatment of acute ischemic stroke (AIS) remains an off-label procedure seldom utilized in the pediatric population; this holds especially true for patients presenting outside the standard 6-hour time window. In this review we describe the published literature regarding usage of the extended time window EVT in pediatric stroke. We searched PubMed for all pediatric AIS cases and case series that included patients treated with extended time window EVT. We found data from 38 cases found in 27 publications (15 case reports and 12 case series). The median age was 10 years; 60.5% males. The median NIHSS before EVT was 13 with a median time-to-treatment of 11 hours. The posterior circulation was involved in 50.0%. Stent retrievers were used in 68.5%, and aspiration in 13.2%. Angiographic outcome TICI ≥2B was achieved in 84.2%, whereas TICI˂2B was reported in 10.6%. A favorable clinical outcome (NIHSS score ≤4, modified Rankin score ≤1, or Pediatric Stroke Outcome measure score ≤1) occurred in 84.2%. Eight cases that did not report the clinical outcome employing a standardized scale described mild to absent neurological residual deficits. This study found data that supports that extended window EVT produces high recanalization rates and good clinical outcomes in pediatric patients with AIS. Nevertheless, the source materials are indirect and contain substantial inconsistencies with an increased risk of bias that amount to low evidence strength.
{"title":"Extended time window mechanical thrombectomy for pediatric acute ischemic stroke","authors":"Y. Aburto-Murrieta, Beatriz Méndez, J. Marquez-Romero","doi":"10.1177/11795735221098140","DOIUrl":"https://doi.org/10.1177/11795735221098140","url":null,"abstract":"Endovascular thrombectomy (EVT) for the treatment of acute ischemic stroke (AIS) remains an off-label procedure seldom utilized in the pediatric population; this holds especially true for patients presenting outside the standard 6-hour time window. In this review we describe the published literature regarding usage of the extended time window EVT in pediatric stroke. We searched PubMed for all pediatric AIS cases and case series that included patients treated with extended time window EVT. We found data from 38 cases found in 27 publications (15 case reports and 12 case series). The median age was 10 years; 60.5% males. The median NIHSS before EVT was 13 with a median time-to-treatment of 11 hours. The posterior circulation was involved in 50.0%. Stent retrievers were used in 68.5%, and aspiration in 13.2%. Angiographic outcome TICI ≥2B was achieved in 84.2%, whereas TICI˂2B was reported in 10.6%. A favorable clinical outcome (NIHSS score ≤4, modified Rankin score ≤1, or Pediatric Stroke Outcome measure score ≤1) occurred in 84.2%. Eight cases that did not report the clinical outcome employing a standardized scale described mild to absent neurological residual deficits. This study found data that supports that extended window EVT produces high recanalization rates and good clinical outcomes in pediatric patients with AIS. Nevertheless, the source materials are indirect and contain substantial inconsistencies with an increased risk of bias that amount to low evidence strength.","PeriodicalId":15218,"journal":{"name":"Journal of Central Nervous System Disease","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46530526","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}
Pub Date : 2022-01-01DOI: 10.1177/11795735211069441
G. Tsivgoulis, S. Deftereos, C. Gobbi, Elisabeth Gulowsen Celius, A. Kułakowska, G. Maniscalco, Irene Mendes, N. Grigoriadis
Background Recently, the number of available disease modifying therapies for multiple sclerosis (MS) has increased. However, a proportion of patients treated with these agents continue to experience relapses and disease progression. Cladribine tablets, approved in 2017 for highly active relapsing MS, comprise a sparsely administered oral treatment which exerts its therapeutic effect through a reduction and subsequent repletion of the lymphocyte population. Purpose/Study Sample Here we describe the design of CLAD CROSS, a prospective, non-interventional, multicenter, Phase IV study in patients with a confirmed diagnosis of RRMS who switch from first-line disease modifying drugs (DMDs) to treatment with cladribine tablets in routine clinical practice. 242 adult patients will be recruited in 61 sites (6 countries) over 30 months and will be followed up for 2 years following prescription of cladribine tablets per the decision of the treating physicians. Research Design The primary endpoint is the change in annualized relapse rate (ARR) between the 12-month pre-baseline period and over the 12-month period before end of study. Secondary endpoints are the percentage of patients with 6-month disability progression or improvement at the end of the study, measured by the Expanded Disability Status Scale, Timed 25 Foot Walk and 9-Hole Peg Test scales and quality of life, treatment satisfaction, and healthcare resource utilization, measured through the MSIS-29, TSQM 1.4, and EQ-5D-3L scales, respectively. MRI lesions will be compared in the exploratory setting between the 12-month pre-baseline period, baseline, and at years 1 and 2. Adverse events will be monitored throughout the study. Interim analyses are pre-planned when 30% and 60% of patients will complete the 12-month follow-up visit. Conclusions CLAD CROSS will provide efficacy data on cladribine tablets, used as a follow-up treatment to first-line DMDs in the real-world setting, will further establish its safety profile and will collect information to support pharmacoeconomic studies.
{"title":"Oral Cladribine in Patients who Change From First-Line Disease Modifying Treatments for Multiple Sclerosis: Protocol of a Prospective Effectiveness and Safety Study (CLAD CROSS)","authors":"G. Tsivgoulis, S. Deftereos, C. Gobbi, Elisabeth Gulowsen Celius, A. Kułakowska, G. Maniscalco, Irene Mendes, N. Grigoriadis","doi":"10.1177/11795735211069441","DOIUrl":"https://doi.org/10.1177/11795735211069441","url":null,"abstract":"Background Recently, the number of available disease modifying therapies for multiple sclerosis (MS) has increased. However, a proportion of patients treated with these agents continue to experience relapses and disease progression. Cladribine tablets, approved in 2017 for highly active relapsing MS, comprise a sparsely administered oral treatment which exerts its therapeutic effect through a reduction and subsequent repletion of the lymphocyte population. Purpose/Study Sample Here we describe the design of CLAD CROSS, a prospective, non-interventional, multicenter, Phase IV study in patients with a confirmed diagnosis of RRMS who switch from first-line disease modifying drugs (DMDs) to treatment with cladribine tablets in routine clinical practice. 242 adult patients will be recruited in 61 sites (6 countries) over 30 months and will be followed up for 2 years following prescription of cladribine tablets per the decision of the treating physicians. Research Design The primary endpoint is the change in annualized relapse rate (ARR) between the 12-month pre-baseline period and over the 12-month period before end of study. Secondary endpoints are the percentage of patients with 6-month disability progression or improvement at the end of the study, measured by the Expanded Disability Status Scale, Timed 25 Foot Walk and 9-Hole Peg Test scales and quality of life, treatment satisfaction, and healthcare resource utilization, measured through the MSIS-29, TSQM 1.4, and EQ-5D-3L scales, respectively. MRI lesions will be compared in the exploratory setting between the 12-month pre-baseline period, baseline, and at years 1 and 2. Adverse events will be monitored throughout the study. Interim analyses are pre-planned when 30% and 60% of patients will complete the 12-month follow-up visit. Conclusions CLAD CROSS will provide efficacy data on cladribine tablets, used as a follow-up treatment to first-line DMDs in the real-world setting, will further establish its safety profile and will collect information to support pharmacoeconomic studies.","PeriodicalId":15218,"journal":{"name":"Journal of Central Nervous System Disease","volume":"14 1","pages":""},"PeriodicalIF":4.8,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41545226","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}
Pub Date : 2022-01-01DOI: 10.1177/11795735221084837
M. Auer, H. Hegen, A. Hotter, W. Löscher, K. Berek, Anne Zinganell, E. Fava, Paul Rhomberg, F. Deisenhammer, F. Di Pauli
The chimeric anti-CD20 antibody rituximab has demonstrated good efficacy as an off-label treatment in chronic inflammatory demyelinating polyneuropathy (CIDP), while the humanized anti-CD20 antibody ocrelizumab has been approved for treatment of multiple sclerosis (MS), whereas there is no evidence for its use in CIDP so far. We present a patient suffering from CIDP and MS, both refractory to standard treatment and both showing marked improvement on ocrelizumab. To the best of our knowledge, this is a unique report of CIDP with an almost full electrophysiological recovery on ocrelizumab which could be considered as a potential treatment option for refractory CIDP.
{"title":"Recovery of Chronic Inflammatory Demyelinating Polyneuropathy on Treatment With Ocrelizumab in a Patient With Co-Existing Multiple Sclerosis","authors":"M. Auer, H. Hegen, A. Hotter, W. Löscher, K. Berek, Anne Zinganell, E. Fava, Paul Rhomberg, F. Deisenhammer, F. Di Pauli","doi":"10.1177/11795735221084837","DOIUrl":"https://doi.org/10.1177/11795735221084837","url":null,"abstract":"The chimeric anti-CD20 antibody rituximab has demonstrated good efficacy as an off-label treatment in chronic inflammatory demyelinating polyneuropathy (CIDP), while the humanized anti-CD20 antibody ocrelizumab has been approved for treatment of multiple sclerosis (MS), whereas there is no evidence for its use in CIDP so far. We present a patient suffering from CIDP and MS, both refractory to standard treatment and both showing marked improvement on ocrelizumab. To the best of our knowledge, this is a unique report of CIDP with an almost full electrophysiological recovery on ocrelizumab which could be considered as a potential treatment option for refractory CIDP.","PeriodicalId":15218,"journal":{"name":"Journal of Central Nervous System Disease","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42620595","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}
Pub Date : 2022-01-01DOI: 10.1177/11795735221098143
Lauren M Tardo, M. McCreary, Harris Majeed, Benjamin M. Greenberg
Background Depression is one of the most common symptoms experienced by multiple sclerosis patients and may be secondary to the disease itself as well as other variables such as age, disease severity and side effects of treatment. Objective To determine if there is an association between disease modifying therapies and depression rates based on PHQ9 scores in multiple sclerosis. Methods This was a retrospective chart review. Patients followed at the University of Texas Southwestern Multiple Sclerosis and Neuroimmunology Clinic from 2017 to 2020 were included in this study. Patients’ most recent PHQ-9 scores were used. The following data was extracted from patient charts: disease modifying therapy, age, disease duration, gender, antidepressant use and ambulatory status. Results Data from our study included 2611 individual PHQ-9 scores. The majority of our patients were female and the mean age across all treatment groups was 50.37 years old. The median disease duration across all treatment groups was 12.74 years. Most patients in this cohort required no ambulatory assistance. 43.86% of patients were on antidepressants and use was correlated with a higher PHQ9 score. The median PHQ 9 score across all treatment groups was 4 (Interquartile range = 7). Across treatment groups, patients on interferon therapy had the lowest PHQ 9 scores with a median of 2. Conclusions Our study demonstrated that there were lower PHQ-9 scores among interferon treatment group as compared to other disease modifying therapies and non-treatment groups
{"title":"Determining Prevalence of Depression and Covariates of Depression in a Cohort of Multiple Sclerosis Patients","authors":"Lauren M Tardo, M. McCreary, Harris Majeed, Benjamin M. Greenberg","doi":"10.1177/11795735221098143","DOIUrl":"https://doi.org/10.1177/11795735221098143","url":null,"abstract":"Background Depression is one of the most common symptoms experienced by multiple sclerosis patients and may be secondary to the disease itself as well as other variables such as age, disease severity and side effects of treatment. Objective To determine if there is an association between disease modifying therapies and depression rates based on PHQ9 scores in multiple sclerosis. Methods This was a retrospective chart review. Patients followed at the University of Texas Southwestern Multiple Sclerosis and Neuroimmunology Clinic from 2017 to 2020 were included in this study. Patients’ most recent PHQ-9 scores were used. The following data was extracted from patient charts: disease modifying therapy, age, disease duration, gender, antidepressant use and ambulatory status. Results Data from our study included 2611 individual PHQ-9 scores. The majority of our patients were female and the mean age across all treatment groups was 50.37 years old. The median disease duration across all treatment groups was 12.74 years. Most patients in this cohort required no ambulatory assistance. 43.86% of patients were on antidepressants and use was correlated with a higher PHQ9 score. The median PHQ 9 score across all treatment groups was 4 (Interquartile range = 7). Across treatment groups, patients on interferon therapy had the lowest PHQ 9 scores with a median of 2. Conclusions Our study demonstrated that there were lower PHQ-9 scores among interferon treatment group as compared to other disease modifying therapies and non-treatment groups","PeriodicalId":15218,"journal":{"name":"Journal of Central Nervous System Disease","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45075025","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}
Pub Date : 2022-01-01DOI: 10.1177/11795735221098147
Hana Larassati, J. Pandelaki, R. Estiasari, J. Prihartono, S. Firdausia, R. E. Yunus, R. Mulyadi
Background Diffusion magnetic resonance imaging (MRI) abnormalities in multiple sclerosis (MS) are not limited to lesions, but have also been observed in the white matter that appears normal on conventional MRI sequences, known as normal-appearing white matter (NAWM). There is evidence of microstructural processes occurring in the NAWM. Objective To assess the correlation between NAWM apparent diffusion coefficient (ADC) and fractional anisotropy (FA) with brain volume and clinical disability in MS. Methods Brain MRI from 33 MS patients were included. ADC and FA measurements of the genu, body, and splenium of corpus callosum (CC) were done. ADC and FA values were analyzed to measure their correlation with brain volume from MR volumetry and clinical disability represented by Expanded Disability Status Scale (EDSS). Results The mean ADC of CC NAWM was .93 ×10−3 mm2/s (±.13 SD), and the mean FA .72 (±.12 SD). ADC and FA of CC NAWM were significantly correlated with the ratio of brain volume to intracranial volume (R = −0,70 and 0,78 respectively), and with EDSS (R = .52 and −.59 respectively). Conclusion There were significant correlations between ADC and FA of NAWM with brain volume and EDSS of MS patients. Further longitudinal studies were needed to evaluate the potential of diffusion MRI in the evaluation of MS.
{"title":"Diffusion magnetic resonance imaging of normal-appearing white matter in multiple sclerosis: correlation with brain volume and clinical disability","authors":"Hana Larassati, J. Pandelaki, R. Estiasari, J. Prihartono, S. Firdausia, R. E. Yunus, R. Mulyadi","doi":"10.1177/11795735221098147","DOIUrl":"https://doi.org/10.1177/11795735221098147","url":null,"abstract":"Background Diffusion magnetic resonance imaging (MRI) abnormalities in multiple sclerosis (MS) are not limited to lesions, but have also been observed in the white matter that appears normal on conventional MRI sequences, known as normal-appearing white matter (NAWM). There is evidence of microstructural processes occurring in the NAWM. Objective To assess the correlation between NAWM apparent diffusion coefficient (ADC) and fractional anisotropy (FA) with brain volume and clinical disability in MS. Methods Brain MRI from 33 MS patients were included. ADC and FA measurements of the genu, body, and splenium of corpus callosum (CC) were done. ADC and FA values were analyzed to measure their correlation with brain volume from MR volumetry and clinical disability represented by Expanded Disability Status Scale (EDSS). Results The mean ADC of CC NAWM was .93 ×10−3 mm2/s (±.13 SD), and the mean FA .72 (±.12 SD). ADC and FA of CC NAWM were significantly correlated with the ratio of brain volume to intracranial volume (R = −0,70 and 0,78 respectively), and with EDSS (R = .52 and −.59 respectively). Conclusion There were significant correlations between ADC and FA of NAWM with brain volume and EDSS of MS patients. Further longitudinal studies were needed to evaluate the potential of diffusion MRI in the evaluation of MS.","PeriodicalId":15218,"journal":{"name":"Journal of Central Nervous System Disease","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44180177","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}
Pub Date : 2022-01-01DOI: 10.1177/11795735221127130
H. Goischke
With great interest we read the publication by Porwal MH et al. With 117 registered cases, a high number of unreported cases can be postulated. If younger patients with multiple sclerosis (PwMS) tend to be affected more frequently, preventive oral vitamin D (VitD) supplementation should be discussed. This adjuvant VitD administration during the entire 48-month therapy with alemtuzumab (ALEM) has a double benefit. There is increasing evidence that the serum level of VitD influences the severity and duration of alopecia areata (AA). VitD deficiency plays a major role in pathogenesis and therapy. Several studies revealed that serum VitD levels significantly and inversely correlate with the duration and severity of AA. Patient affected by various autoimmune diseases showed low serum levels of VitD (25(OH)D). VitD plays a role in the pathogenesis of AA. Lin et al are currently showing the connections between vitD and AA. VitD plays a role in the pathogenesis of AArelated
{"title":"Comment on: Alopecia in Multiple Sclerosis Patients Treated with Disease Modifying Therapies","authors":"H. Goischke","doi":"10.1177/11795735221127130","DOIUrl":"https://doi.org/10.1177/11795735221127130","url":null,"abstract":"With great interest we read the publication by Porwal MH et al. With 117 registered cases, a high number of unreported cases can be postulated. If younger patients with multiple sclerosis (PwMS) tend to be affected more frequently, preventive oral vitamin D (VitD) supplementation should be discussed. This adjuvant VitD administration during the entire 48-month therapy with alemtuzumab (ALEM) has a double benefit. There is increasing evidence that the serum level of VitD influences the severity and duration of alopecia areata (AA). VitD deficiency plays a major role in pathogenesis and therapy. Several studies revealed that serum VitD levels significantly and inversely correlate with the duration and severity of AA. Patient affected by various autoimmune diseases showed low serum levels of VitD (25(OH)D). VitD plays a role in the pathogenesis of AA. Lin et al are currently showing the connections between vitD and AA. VitD plays a role in the pathogenesis of AArelated","PeriodicalId":15218,"journal":{"name":"Journal of Central Nervous System Disease","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48308333","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}
Pub Date : 2022-01-01DOI: 10.1177/11795735221102747
Shirley Lee, J. Y. Hor, Kee Leong Koh, Y. K. Chia
As the world embarks on mass vaccination against SARS-CoV2 to alleviate the spread of this highly contagious novel coronavirus, there are growing anecdotal reports on immune-related neurological complications following immunisation. Similarly, we encountered 2 cases of central nervous system demyelination at our centre with Comirnaty (BNT162b2), a mRNA-based COVID-19 vaccine. Our first patient had typical clinical-radiological manifestations of acute disseminated encephalomyelitis (ADEM) after his COVID-19 vaccination. This was the sixth reported case to date. Our second patient presented with an unusual complaint of trigeminal neuralgia, with an identifiable demyelinating lesion observed in the pons on neuroimaging. Both cases responded well to immunotherapy. However, larger prospective controlled studies and formal registries are much needed to ascertain a possible relationship between COVID-19 vaccines and acute central nervous system demyelination.
{"title":"Central Nervous System Demyelination Following COVID-19 mRNA-Based Vaccination: Two Case Reports and Literature Review","authors":"Shirley Lee, J. Y. Hor, Kee Leong Koh, Y. K. Chia","doi":"10.1177/11795735221102747","DOIUrl":"https://doi.org/10.1177/11795735221102747","url":null,"abstract":"As the world embarks on mass vaccination against SARS-CoV2 to alleviate the spread of this highly contagious novel coronavirus, there are growing anecdotal reports on immune-related neurological complications following immunisation. Similarly, we encountered 2 cases of central nervous system demyelination at our centre with Comirnaty (BNT162b2), a mRNA-based COVID-19 vaccine. Our first patient had typical clinical-radiological manifestations of acute disseminated encephalomyelitis (ADEM) after his COVID-19 vaccination. This was the sixth reported case to date. Our second patient presented with an unusual complaint of trigeminal neuralgia, with an identifiable demyelinating lesion observed in the pons on neuroimaging. Both cases responded well to immunotherapy. However, larger prospective controlled studies and formal registries are much needed to ascertain a possible relationship between COVID-19 vaccines and acute central nervous system demyelination.","PeriodicalId":15218,"journal":{"name":"Journal of Central Nervous System Disease","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49525578","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}
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