Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial

Publication date: September 2019Source: The Lancet Neurology, Volume 18, Issue 9Author(s): Michael G Hanna, Umesh A Badrising, Olivier Benveniste, Thomas E Lloyd, Merrilee Needham, Hector Chinoy, Masashi Aoki, Pedro M Machado, Christina Liang, Katrina A Reardon, Marianne de Visser, Dana P Ascherman, Richard J Barohn, Mazen M Dimachkie, James A L Miller, John T Kissel, Björn Oskarsson, Nanette C Joyce, Peter Van den Bergh, Jonathan BaetsSummaryBackgroundInclusion body myositis is an idiopathic inflammatory myopathy and the most common myopathy affecting people older than 50 years. To date, there are no effective drug treatments. We aimed to assess the safety, efficacy, and tolerability of bimagrumab—a fully human monoclonal antibody—in individuals with inclusion body myositis.MethodsWe did a multicentre, double-blind, placebo-controlled study (RESILIENT) at 38 academic clinical sites in Australia, Europe, Japan, and the USA. Individuals (aged 36–85 years) were eligible for the study if they met modified 2010 Medical Research Council criteria for inclusion body myositis. We randomly assigned participants (1:1:1:1) using a blocked randomisation schedule (block size of four) to either bimagrumab (10 mg/kg, 3 mg/kg, or 1 mg/kg) or placebo matched in appearance to bimagrumab, administered as intravenous infusions every 4 weeks for at least 48 weeks. All study participants, the funder, investigators, site personnel, and people doing assessments were masked to ...
Source: The Lancet Neurology - Category: Neurology Source Type: research

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Publication date: Available online 21 September 2019Source: Actas Urológicas Españolas (English Edition)Author(s): O. Yazici, A. Kafkasli, A. Erbin, M. Bilal Hamarat, A. Cubuk, O. Sarilar, K. SaricaAbstractPurposeTo evaluate the effect of JJ stents on SWL treatment of moderate (15–25 mm) renal pelvic stones.Materials and methodsBetween January 2016 and December 2017, a total of 152 adult patients who were planned to undergo SWL for a single radiopaque renal pelvic stone were included in the study. Patients with solitary kidney, congenital abnormality, skeletal tract abnormalities, previous urinary ...
Source: Actas Urologicas Espanolas - Category: Urology & Nephrology Source Type: research
Publication date: Available online 20 September 2019Source: Advances in Space ResearchAuthor(s): Hongmei Bai, Feng Feng, Jian Wang, Taosuo WuAbstractThis paper presents an novel extreme learning machine (ELM)-based prediction model for the ionospheric propagation factor M(3000)F2 at Darwin station (12.4°S, 131.5°E; -44.5°dip) in Australia. The proposed ELM model is trained with hourly daily values of M(3000)F2 from the period 1998–2014 except 2001 and 2009. The hourly daily values of 2001 (high solar activity) and 2009 (low solar activity) are used for validating the prediction accuracy. The proposed ELM ...
Source: Advances in Space Research - Category: Science Source Type: research
Publication date: Available online 20 September 2019Source: Advances in Space ResearchAuthor(s): Madeeha Talha, Nabeel Ahmed, Muneeza M. Ali, Ghulam MurtazaAbstractThe variability of NmF2 during solar minima of solar cycle 21-22, 22-23 and 23-24 has been studied for two low latitude stations, Karachi (Pakistan) and Okinawa (Japan), as both stations are situated at the Equatorial Ionization Anomaly (EIA) crest region. Diurnal, seasonal and annual behaviour of variability has been investigated using relative standard deviation approach. At both the stations, a direct relation of variability (CV) with Smoothed Sunspot Numbers...
Source: Advances in Space Research - Category: Science Source Type: research
Publication date: Available online 21 September 2019Source: Pathology - Research and PracticeAuthor(s): Rahul Mannan, Alexander S. Taylor, Daniel E. Spratt, Arul M. Chinnaiyan, Jeffrey S. Montgomery, Noah A. Brown, Rohit MehraAbstractBladder cancer continues to be a source of disease burden worldwide. In patients with a long-standing history of prostate cancer, distinguishing between new/independent and synchronous poorly differentiated urothelial carcinoma (UCA) and residual/recurrent high grade/poorly differentiated prostatic adenocarcinoma or prostatic adenocarcinoma with therapy-related changes can be diagnostically an...
Source: Pathology Research and Practice - Category: Pathology Source Type: research
Authors: Martínez-Acitores D, Hernández Ainsa M, Cortés García L, Bengochea Martínez ML, Palacios Fanlo MJ Abstract Ectopic hepatocellular carcinoma is a rare entity. Most cases are asymptomatic and are occasionally found during autopsy or laparoscopy. They may sometimes cause relevant clinical problems such as abdominal pain or intra-abdominal bleeding. In this clinical case report, we review the literature in order to decipher the case of a 68-year-old female with an ectopic hepatocellular carcinoma that arose from the peritoneum. The patient was diagnosed after being studied du...
Source: Revista Espanola de Enfermedades Digestivas - Category: Gastroenterology Tags: Rev Esp Enferm Dig Source Type: research
The objective of this study was to compare the practices of surgeons in France versus other countries regarding the diagnosis and treatment of IIS.HypothesisDiagnostic and therapeutic practices regarding IIS differ between surgeons in France and in other countries.Material and methodsA 21-item questionnaire in French and English was emailed to the 1300 members of the French Arthroscopy Society and to surgeons from countries other than France. The questionnaire collected information on knowledge about IIS (2 items), the frequency of IIS in clinical practice (2 items), the diagnosis of IIS (6 items), the non-operative and su...
Source: Orthopaedics and Traumatology: Surgery and Research - Category: Orthopaedics Source Type: research
EMMA WEYMOUTH will be seen strutting her stuff in this year ’s Strictly Come Dancing. The socialite suffered a very difficult time to becoming a mother during her first pregnancy and developed a life-threatening condition.
Source: Daily Express - Health - Category: Consumer Health News Source Type: news
Authors: Leo M, Ponziani FR, Nesci A, Santoliquido A, Vecchio FM, Francalanci P, Pompili M Abstract Low molecular weight heparins (LMWH) are a class of drugs including various molecules that inhibit predominantly the factor V of coagulation and are used in a wide range of clinical settings for the management of venous thromboembolism and acute coronary syndrome. Despite LMWH are considered safe and associated with a lower incidence of side effects compared to unfractioned heparin, it is worth considering that the use of LWMH can be associated with complications. Some of these, such as bleeding and thrombocytopenia,...
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
Authors: Yin RL, You H, Wu YM, Ye FL, Gu WX, Shen J Abstract OBJECTIVE: To investigate the effect and mechanism of long non-coding ribonucleic acid (lncRNA) PFL on myocardial ischemia/reperfusion (I/R) injury in rats, and to provide a reference for the prevention and treatment of myocardial infarction (MI) in clinic. MATERIALS AND METHODS: According to the random number table, 60 male Sprague-Dawley (SD) rats were randomly divided into 3 groups: Control group (n=20), I/R group (n=20), and I/R + PFL small interfering ribonucleic acid (siRNA) group (n=20). The I/R model was established by ligating the left anteri...
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
Authors: Tian HB, Li SH, Hu KQ, Zan YS, Zhang XL, Su GH Abstract OBJECTIVE: The aim of this study was to investigate the effect of microRNA-150 on the regulation of myocardial fibrosis and ventricular remodeling in rats with acute myocardial infarction (AMI). MATERIALS AND METHODS: The AMI rats model was established by the ligation of the left anterior descending coronary artery (LAD) in vivo. After AMI procedures, the rats were injected with microRNA-150 lentivirus overexpression or negative control, respectively. Cardiac function of rats was evaluated by echocardiography. Hematoxylin and eosin (HE) staining a...
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
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