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First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study.

ABSTRACT: OBJECTIVES:Brivaracetam (BRV) is the latest approved antiepileptic drug and acts as a synaptic vesicle protein 2A ligand. The aim of the present study was to evaluate the efficacy and tolerability of BRV in the clinical setting. DESIGN:Retrospective, observational multicentre study. SETTING:We retrospectively collected clinical data of patients who received BRV in 10 epilepsy centres using a questionnaire that was answered by the reporting neurologist. PARTICIPANTS:Data of 615 epilepsy patients treated with BRV were included in the study. PRIMARY AND SECONDARY OUTCOME MEASURES:Efficacy regarding seizure frequency and tolerability of BRV were evaluated. Descriptive statistics complemented by X2 contingency tests and effect sizes were performed. RESULTS:Overall, 44% of the patients had a decreased, 38% a stable and 18% an increased seizure frequency. 17% of patients achieved seizure freedom after initiation of BRV. The seizure frequency decreased in 63% of 19 patients with BRV monotherapy. 27% reported adverse effects, but only 10% of patients with monotherapy. Brivaracetam was significantly more often associated with decreased seizure frequency in levetiracetam (LEV) naïve patients (p=0.012), but BRV also led to a decreased seizure frequency in 42% of patients who had been treated with LEV before, including 17% of patients who were completely seizure free. Adverse effects under LEV improved in 62% and deteriorated in 2% of patients after the switch to BRV. At latest follow-up (mean±SD = 26.3±6.5 months), 68% were still on BRV. CONCLUSIONS:The present study shows that results of the phase III studies on BRV match data from real life clinical settings. Brivaracetam seems to be a useful alternative in patients who have suffered adverse effects while taking LEV.

SUBMITTER: Menzler K

PROVIDER: S-EPMC6858140 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study.

Menzler Katja K Mross Peter Michael PM Rosenow Felix F Schubert-Bast Susanne S Willems Laurent Maximilian LM Zahnert Felix F Immisch Ilka I Fuest Sven S von Podewils Felix F Kunz Rhina R Hirsch Martin M Mueller Tamara T Marquetand Justus J Winter Yaroslav Y Langenbruch Lisa L Cicanic Michal M Beyenburg Stefan S Strzelczyk Adam A Knake Susanne S

BMJ open 20191104 11

<h4>Objectives</h4>Brivaracetam (BRV) is the latest approved antiepileptic drug and acts as a synaptic vesicle protein 2A ligand. The aim of the present study was to evaluate the efficacy and tolerability of BRV in the clinical setting.<h4>Design</h4>Retrospective, observational multicentre study.<h4>Setting</h4>We retrospectively collected clinical data of patients who received BRV in 10 epilepsy centres using a questionnaire that was answered by the reporting neurologist.<h4>Participants</h4>D ...[more]

PMID: 31690606

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Project description:BackgroundIn randomised controlled trials, adjunctive cenobamate (CNB) has been shown to reduce seizure frequency in patients with drug-resistant focal epilepsy. Studies conducted in real-world settings provide valuable complementary data to further characterise the drug's profile.ObjectiveTo assess the efficacy, retention and tolerability of adjunctive cenobamate (CNB), and to identify factors that might predict these outcomes in the clinical treatment of focal epilepsies.MethodsThis multicentre, retrospective cohort study included all patients who began CNB treatment between October 2020 and April 2023 at seven participating epilepsy centres. Baseline and follow-up data were collected from patients' medical records, covering clinical characteristics and outcome data such as seizure frequency, dosing of CNB, physician-assessed Clinical Global Impression of Change, treatment-emergent adverse events (TEAEs), CNB retention and reasons for discontinuation.ResultsA total of 234 patients [mean age 40.7 ± 14 years, median 40 years, range 11-82 years; five adolescents under 18 years; 99 (42.3%) males] were analysed. The mean epilepsy duration at study entry was 23.2 ± 14.5 years (median 21 years, range 0.75-63 years), with the average age of epilepsy onset being 17.5 ± 13.0 years (median 17 years, range 0.1-71 years). The patients were taking a mean of 2.6 ± 0.8 (median 3) anti-seizure medications (ASMs) before starting CNB, and had failed a mean of 6 ± 3.3 (median 6) of further ASMs in the past. CNB exposure ranged from 5 to 1162 days, amounting to a total exposure time of 264.7 years. The retention rate was 92.6% at 3 months, 87.2% at 6 months and 77.8% at 12 months. At 3 months, 52.6% achieved a 50% seizure reduction, with 14.5% reporting seizure freedom; by 12 months, 47.7% maintained a 50% response rate and 11.9% were seizure-free. No significant differences in responder rates were observed based on sex, aetiology, seizure localisation, number of ASMs or target dose. The mean maximum CNB dose was 236.7 ± 97.4 mg (median 200 mg, range 12.5-450 mg), with 28 patients (12.0%) titrated up to 400 mg or above. During CNB treatment, 43.6% of patients were able to discontinue, and a further 24.4% were able to reduce the dose of a concomitant ASM. During CNB treatment, 144 patients (61.5%) experienced TEAEs. The most common TEAEs were sedation (n = 84, 35.9%), dizziness (n = 58, 24.8%) and ataxia (n = 23, 9.8%).ConclusionsCNB showed a relatively high and clinically useful 50% responder rate of 47.7% and an overall retention of 77.8% at 1 year. We were unable to identify specific predictors for response and retention, indicating that CNB may be beneficial for patients with a history of multiple failed ASMs, a high number of concomitant ASMs and any localisation or aetiology of focal epilepsy.

Project description:IntroductionPrimary angle-closure glaucoma (PACG) is a leading cause of irreversible blindness globally, and the number of patients with PACG rises every year. Yet, there is a lack of knowledge about the clinical characteristics, therapeutic options and profile of patients with PACG in China. Hence, we design the China Glaucoma Treatment Pattern Study Ⅰ-Primary Angle-Closure Glaucoma (Ch-GTPⅠ). The objective of this paper is to describe the design and methodology of Ch-GTP. The aim of this study is to characterise the profile and trend associated with initial PACG treatment for the last 10 years in China.MethodsCh-GTPⅠ is a national multicentre retrospective observational study that will randomly sample from 50 hospitals throughout China. Over 7000 patient records hospitalised for initial PACG treatment from 2011 to 2020 will be selected randomly. The data from electronic medical records will be uploaded to an encrypted online platform that will receive and collate data from all collaborating hospitals. Data abstraction and monitoring will be performed in a standardised manner by trained statisticians to ensure consistency. Systematic data cleaning will also be conducted by statisticians to ensure data integrity before final data storage. The outcomes will include four broad categories: (1) demographics, (2) clinical characteristics, (3) therapeutic strategies and procedures and (4) early outcomes at discharge. The demographic characteristics and early outcomes will be summarised using descriptive statistics. Comparative analyses of characteristics and treatment pattern changing trends for different regions and years will be used to test for significant differences (t-test or Mann-Whitney U test).Ethics and disseminationThe collaborating hospitals obtained local approval based on a standard ethics application from internal ethics committees or acknowledged an existent ethics approval of the leading institution with approval from internal ethics committees. Due to the retrospective nature, written informed consent from patients was waived by the ethics committee. The results will be published in academic journals and presented at national and international academic conferences.Trial registration numberChiCTR2100054643.

Project description:BackgroundThere was a complete lack of information about the treatment outcomes of rifampicin/multidrug resistant (RR/MDR) childhood TB patients (age ≤ 14 years) from Pakistan, an MDR-TB 5th high burden country. Therefore, this study evaluated the socio-demographic characteristics, drug resistance pattern, treatment outcomes and factors associated with unsuccessful outcomes among childhood RR/MDR-TB patients in Pakistan.MethodsThis was a multicentre retrospective record review of all microbiologically confirmed childhood RR/MDR-TB patients (age ≤ 14 years) enrolled for treatment at seven units of programmatic management of drug-resistant TB (PMDT) in Pakistan. The baseline and follow-up information of enrolled participants from treatment initiation until the end of treatment were retrieved from electronic nominal recording and reporting system. World Health Organization (WHO) defined criterion was used for deciding treatment outcomes. The outcomes of "cured" and "treatment completed" were collectively grouped as successful, whereas "death", "treatment failure" and "lost to follow-up" were grouped together as unsuccessful outcomes. Multivariable binary logistic regression analysis was used to find factors associated with unsuccessful outcomes. A p-value < 0.05 reflected statistically significant findings.ResultsA total of 213 children RR/MDR-TB (84 RR and 129 MDR-TB) were included in the study. Majority of them were females (74%), belonged to the age group 10-14 years (82.2%) and suffered from pulmonary TB (85.9%). A notable proportion (37.1%) of patients had no history of previous TB treatment. Patients were resistant to a median of two drugs (interquartile range: 1-4) and 23% were resistant to any second line anti-TB drug. A total of 174 (81.7%) patients achieved successful treatment outcomes with 144 (67.6%) patients being cured and 30 (14.1%) declared treatment completed. Among the 39 (18.3%) patients with unsuccessful outcomes, 35 (16.4%) died and 4 (1.9%) experienced treatment failure. In multivariable analysis, the use of ethambutol had statistically significant negative association with unsuccessful outcomes (odds ratio = 0.36, p-value = 0.02).ConclusionsIn this study, the WHO target of successful treatment outcomes (≥ 75%) among childhood RR/MDR-TB patients was achieved. The notable proportion of patients with no history of previous TB treatment (37.1%) and the disproportionately high number of female patients (74%) respectively stress for infection control measures and provision of early and high quality care for female drug susceptible TB patients.

Project description:IntroductionPneumonic-type primary pulmonary lymphoma (PPL) is often misdiagnosed as pneumonia in clinical practice. However, this disease requires different treatments, which calls for a correct diagnosis.Materials and methodsA total of 227 patients with pneumonic-type PPL (n=72) and pneumonia (n=155) from 7 institutions were retrospectively enrolled between January 2017 and January 2022. Clinical features (age, sex, cough, sputum, fever, haemoptysis, chest pain, smoking, weight loss and laboratory results (haemoglobin, white blood cell count, C reactive protein level and erythrocyte sedimentation rate)) and CT imaging characteristics (air bronchogram, bronchiectasis, halo sign, pleural traction, pleural effusion, lymphadenopathy, lesion maximum diameter and CT attenuation value) were analysed. Receiver operating characteristic curve analysis was performed for model construction based on independent predictors in identifying pneumonic-type PPL. In addition, we used a calibration curve and decision curve analysis to estimate the diagnostic efficiency of the model.ResultsThe patients with pneumonia showed a higher prevalence of sputum, fever, leucocytosis and elevation of C reactive protein level than those with pneumonic-type PPL (p=0.002, p<0.001, p=0.011 and p<0.001, respectively). Bronchiectasis, halo sign and higher CT attenuation value were more frequently present in pneumonic-type PPL than in pneumonia (all p<0.001). Pleural effusion was more commonly observed in patients with pneumonia than those with pneumonic-type PPL (p<0.001). Also, sputum, fever, elevation of C reactive protein level, halo sign, bronchiectasis, pleural effusion and CT attenuation value were the independent predictors of the presence of pneumonic-type PPL with an area under the curve value of 0.908 (95% CI, 0.863 to 0.942).ConclusionPneumonic-type PPL and pneumonia have different clinical and imaging features. These differential features could be beneficial in guiding early diagnosis and subsequent initiation of therapy.

Project description:IntroductionOur aim was to investigate the efficacy and safety of upadacitinib (UPA) in patients with either oligo- or polyarticular active psoriatic arthritis (PsA) using routine clinical practice data from an observational, prospective, multicentre study.MethodsThis interim analysis contains upadacitinib efficacy and safety data from the UPJOINT study, collected from baseline to the week 24 visit with a focus on composite measures, clinical assessments and patient-reported outcomes, amongst others, including minimal disease activity (MDA), very low disease activity (VLDA), Disease Activity Index for Psoriatic Arthritis (DAPSA), Leeds Enthesitis Index (LEI), resolution of dactylitis and nail psoriasis and body surface area affected by skin psoriasis (BSA).ResultsA total of 296 patients with baseline data and 192 with completed week 24 visits were included in the analysis. The proportion of patients achieving MDA increased from 2.7% at baseline to 39.1% at week 24 (95% CI 32.1, 46.3). Similarly, the number of patients in DAPSA remission (DAPSA ≤ 4) increased from 0 at baseline to 32 (16.7%) by week 24. At that time, 59.4% of the patients were either in DAPSA remission or had low disease activity (DAPSA ≤ 14). During the 24 weeks time frame, the proportion of patients with BSA ≤ 3 increased from 80.7% to 91.1%. Furthermore, at weeks 12 and 24, 45.14% and 47.19% of affected patients showed a resolution of enthesitis. Active dactylitis and nail psoriasis at baseline were reported to affect 10.5% and 22.0%, decreasing to 2.6% and 5.7% at week 24, respectively. The safety findings are consistent with the known safety profile of upadacitinib in rheumatoid arthritis and PsA; no new safety risks were identified.ConclusionThe data from this study confirm the findings of previous randomized controlled trials suggesting UPA is an effective treatment for active PsA without any new safety signals in patients from daily clinical practice.Clinical trial registrationClinicalTrials.gov identifier, NCT04758117.

Dataset Information

First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study.

Publications

First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study.

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