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JOURNAL ARTICLE
Iman Satti, Julia L Marshall, Stephanie A Harris, Rachel Wittenberg, Rachel Tanner, Raquel Lopez Ramon, Morven Wilkie, Fernando Ramos Lopez, Michael Riste, Daniel Wright, Marco Polo Peralta Alvarez, Nicola Williams, Hazel Morrison, Elena Stylianou, Pedro Folegatti, Daniel Jenkin, Samantha Vermaak, Linnea Rask, Ingrid Cabrera Puig, Rebecca Powell Doherty, Alison Lawrie, Paul Moss, Timothy Hinks, Henry Bettinson, Helen McShane
BACKGROUND: Mycobacterium tuberculosis is the main causative agent of tuberculosis. BCG, the only licensed vaccine, provides inadequate protection against pulmonary tuberculosis. Controlled human infection models are useful tools for vaccine development. We aimed to determine a safe dose of aerosol-inhaled live-attenuated Mycobacterium bovis BCG as a surrogate for M tuberculosis infection, then compare the safety and tolerability of infection models established using aerosol-inhaled and intradermally administered BCG...
April 12, 2024: Lancet Infectious Diseases
#2
JOURNAL ARTICLE
David G Hancock, William Ditcham, Eleanor Ferguson, Yuliya V Karpievitch, Stephen M Stick, Grant W Waterer, Barry S Clements
BACKGROUND: Current treatments for respiratory infections are severely limited. Ethanol's unique properties including antimicrobial, immunomodulatory, and surfactant-like activity make it a promising candidate treatment for respiratory infections if it can be delivered safely to the airway by inhalation. Here, we explore the safety, tolerability, and pharmacokinetics of inhaled ethanol in a phase I clinical trial. METHODS: The study was conducted as a single-centre, open-label clinical trial in 18 healthy adult volunteers, six with no significant medical comorbidities, four with stable asthma, four with stable cystic fibrosis, and four active smokers...
2024: Frontiers in Medicine
#3
JOURNAL ARTICLE
Paola Maria Cutroneo, Elena Arzenton, Fabiana Furci, Fabio Scapini, Maria Bulzomì, Nicoletta Luxi, Marco Caminati, Gianenrico Senna, Ugo Moretti, Gianluca Trifirò
BACKGROUND: The management of uncontrolled severe asthma has greatly improved since the advent of novel biologic therapies. Up to August 2022, five biologics have been approved for the type 2 asthma phenotype: anti-IgE (omalizumab), anti-IL5 (mepolizumab, reslizumab, benralizumab), and anti-IL4 (dupilumab) monoclonal antibodies. These drugs are usually well tolerated, although long-term safety information is limited, and some adverse events have not yet been fully characterized. Spontaneous reporting systems represent the cornerstone for the detection of potential signals and evaluation of the real-world safety of all marketed drugs...
March 15, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
#4
JOURNAL ARTICLE
Amina Ahmed, Flor M Munoz, William J Muller, Allison Agwu, David W Kimberlin, Luisa Galli, Jaime G Deville, Paul K Sue, Ana Mendez-Echevarria, Rita Humeniuk, Susan Guo, Lauren Rodriguez, Dong Han, Charlotte Hedskog, Heather Maxwell, Ramesh Palaparthy, Kathryn Kersey, Pablo Rojo
OBJECTIVES: Remdesivir decreases the risk of SARS-CoV-2 infection progressing to severe disease in adults. This study evaluated remdesivir safety and pharmacokinetics in infants and children. METHODS: This was a phase 2/3, open-label trial in children aged 28 days to 17 years hospitalized for polymerase chain reaction-confirmed SARS-CoV-2 infection. Participants received for ≤10 days once-daily intravenous remdesivir doses defined using physiologically based pharmacokinetic modeling (for ≥40 kg, 200 mg day 1, then 100 mg/day; for age ≥28 days and ≥3 to <40 kg, 5 mg/kg day 1, then 2...
February 9, 2024: Pediatrics
#5
JOURNAL ARTICLE
Maria Gabriella Matera, Josuel Ora, Luigino Calzetta, Paola Rogliani, Mario Cazzola
OBJECTIVE: Modification of the immune system with biologics raises theoretical concerns about the risk of infections but it is still unclear whether currently routinely used biologics in severe asthma may facilitate the development of pneumonia. Therefore, we aimed to determine whether omalizumab, mepolizumab, benralizumab, and dupilumab are associated with pneumonia in a real-world setting. METHODS: A retrospective disproportionality analysis was performed using adverse event (AE) reports submitted to FAERS from January 2020 to September 30, 2023...
January 31, 2024: Journal of Asthma
#6
JOURNAL ARTICLE
Masao Yamaguchi, Yoshihiro Nishimura, Yuko Takumi, Nobuya Hayashi, Kei Sakamoto, Yuji Tohda
INTRODUCTION: This study aimed to demonstrate whether benralizumab maintained the safety and effectiveness profiles established in randomized controlled trials among all patients with severe uncontrolled asthma initially prescribed benralizumab in the real-world setting in Japan. METHODS: This was a prospective, observational, multicenter post-marketing study (ClinicalTrial.gov, NCT03588546). The safety and tolerability of benralizumab over 1 year were assessed by the incidence of adverse events (AEs), serious AEs, adverse drug reactions (ADRs), and serious ADRs...
2024: Journal of Asthma and Allergy
#7
JOURNAL ARTICLE
Leonard B Bacharier, Jorge F Maspero, Constance H Katelaris, Alessandro G Fiocchi, Remi Gagnon, Ines de Mir, Theresa W Guilbert, Daniel J Jackson, Heribert W Staudinger, Elizabeth Laws, Leda P Mannent, Bolanle Akinlade, Jennifer Maloney, Kelsey Tawo, Faisal A Khokhar, Ning Li, Megan Hardin, Raolat M Abdulai, David J Lederer, Lacey B Robinson
BACKGROUND: Dupilumab efficacy and safety in children aged 6-11 years with uncontrolled, moderate-to-severe asthma were shown in the VOYAGE study-a 52-week, multinational, multicentre, phase 3 randomised, double-blind, placebo-controlled trial. We aimed to evaluate the long-term safety and efficacy of dupilumab in children with moderate-to-severe asthma who previously participated in the VOYAGE study. METHODS: 365 of 408 children with moderate-to-severe asthma from VOYAGE enrolled in EXCURSION, a 52 week, open-label extension study conducted at 70 centres across 17 countries...
November 10, 2023: Lancet Respiratory Medicine
#8
JOURNAL ARTICLE
Moises A Huaman, Jay S Raval, James H Paxton, Giselle S Mosnaim, Bela Patel, Shweta Anjan, Barry R Meisenberg, Adam C Levine, Christi E Marshall, Anusha Yarava, Aarthi G Shenoy, Sonya L Heath, Judith S Currier, Yuriko Fukuta, Janis E Blair, Emily S Spivak, Joann R Petrini, Patrick B Broderick, William Rausch, MarieElena Cordisco, Jean Hammel, Benjamin Greenblatt, Valerie C Cluzet, Daniel Cruser, Kevin Oei, Matthew Abinante, Laura L Hammitt, Catherine G Sutcliffe, Donald N Forthal, Martin S Zand, Edward R Cachay, Seble G Kassaye, Malathi Ram, Ying Wang, Piyali Das, Karen Lane, Nichol A McBee, Amy L Gawad, Nicky Karlen, Daniel E Ford, Oliver Laeyendecker, Andrew Pekosz, Sabra L Klein, Stephan Ehrhardt, Bryan Lau, Sheriza N Baksh, David M Shade, Arturo Casadevall, Daniel F Hanley, Jiangda Ou, Thomas J Gniadek, Alyssa Ziman, Shmuel Shoham, Kelly A Gebo, Evan M Bloch, Aaron A R Tobian, David J Sullivan, Jonathan M Gerber
BACKGROUND: COVID-19 convalescent plasma (CCP) is an important therapeutic option for outpatients at high risk of hospitalization from SARS-CoV-2 infection. We assessed the safety of outpatient CCP transfusions administered during clinical trials. STUDY DESIGN AND METHODS: We analyzed data pertaining to transfusion-related reactions from two randomized controlled trials in the U.S. that evaluated the efficacy of CCP versus control plasma in various ambulatory settings...
August 3, 2023: Transfusion
#9
JOURNAL ARTICLE
Francesca Galletta, Lucia Caminiti, Cecilia Lugarà, Simone Foti Randazzese, Paolo Barraco, Federica D'Amico, Pierangela Irrera, Giuseppe Crisafulli, Sara Manti
Background: Insufficient data are available on the long-term "real-life" safety profile of omalizumab in children. This study evaluated the long-term safety of omalizumab in a pediatric cohort with severe asthma or chronic spontaneous urticaria (CSU). Methods: A monocentric, prospective study evaluated the long-term safety of omalizumab in patients aged 6-18 years. Each patient completed the standardized MedDRA questionnaire to identify adverse events (AEs). Results: In total, 23 patients, median age 15 (14-18) years, affected by severe asthma (60...
June 29, 2023: Journal of Personalized Medicine
#10
JOURNAL ARTICLE
Claudia Stöllberger, Kastriot Kastrati, Clemens Dejaco, Martina Scharitzer, Josef Finsterer, Patrick Bugingo, Madeleine Melichart-Kotik, Astrid Wilfing
Implementing vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a major asset in slowing down the coronavirus disease 2019 (COVID-19) pandemic. For mRNA vaccines, the main severe adverse events reported in pharmacovigilance systems and post-authorization studies were anaphylaxis and myocarditis. Pancreatitis after Pfizer/BioNTech COVID-19 vaccination has been reported only in 10 patients.We report a 31-year-old female with a history of borderline personality disorder, intravenous drug abuse, allergic asthma, eating disorder, psoriatic arthritis treated with tofacitinib, neurogenic bladder disturbance, cholecystectomy, recurrent thoracic herpes zoster, vaginal candida infections and urinary tract infections, who developed pancreatitis associated with thrombotic microangiopathy and hemolytic-uremic syndrome 10 days after the second vaccination, whereas the first has been well tolerated...
August 2023: Wiener Klinische Wochenschrift
#11
JOURNAL ARTICLE
Aakash Bavishi, Stephanie A Kliethermes, Bradley Petek, Nathaniel Moulson, Pranav Mellacheruvu, Timothy W Churchill, Kimberly Harmon, Manesh R Patel, Aaron L Baggish, Jonathan A Drezner, Raja Kannan Mutharasan
BACKGROUND: While young adults 18-24 years old bear a significant proportion of COVID-19 diagnoses, the risk factors for hospitalisation and severe COVID-19 complications in this population are poorly understood. OBJECTIVE: The objective of this study was to identify risk factors for hospitalisation and other COVID-19 complications across the health spectrum of young adults diagnosed with COVID-19 infection. STUDY DESIGN: Retrospective cohort study...
April 12, 2023: BMJ Open
#12
REVIEW
J Christopher Gallagher, Clifford J Rosen
Over the past 100 years, many major breakthroughs and discoveries have occurred in relation to vitamin D research. These developments include the cure of rickets in 1919, the discovery of vitamin D compounds, advances in vitamin D molecular biology, and improvements in our understanding of endocrine control of vitamin D metabolism. Furthermore, recommended daily allowances for vitamin D have been established and large clinical trials of vitamin D, aimed at clarifying the effect of Vitamin D in the prevention of multiple diseases, have been completed...
May 2023: Lancet Diabetes & Endocrinology
#13
RANDOMIZED CONTROLLED TRIAL
Alok Srivastava, Savita Rangarajan, Kaan Kavakli, Robert Klamroth, Gili Kenet, Liane Khoo, Chur-Woo You, Weiqun Xu, Niel Malan, Laurent Frenzel, Catherine N Bagot, Oleksandra Stasyshyn, Chia-Yau Chang, Stacey Poloskey, Zhiying Qiu, Shauna Andersson, Baisong Mei, Steven W Pipe
BACKGROUND: Fitusiran, a subcutaneous investigational siRNA therapeutic, targets antithrombin with the goal of rebalancing haemostasis in people with haemophilia A or haemophilia B, regardless of inhibitor status. We aimed to evaluate the efficacy and safety of fitusiran prophylaxis in people with severe haemophilia without inhibitors. METHODS: This multicentre, open-label, randomised phase 3 study was conducted at 45 sites in 17 countries. Male participants aged at least 12 years with severe haemophilia A or B without inhibitors, who had previously been treated on-demand with clotting factor concentrates, were randomly assigned in a 2:1 ratio to receive 80 mg subcutaneous fitusiran prophylaxis once per month or to continue on-demand clotting factor concentrates for a total of 9 months...
May 2023: Lancet Haematology
#14
JOURNAL ARTICLE
Sara Manti, Alessandro Giallongo, Giulia Pecora, Giuseppe Fabio Parisi, Maria Papale, Enza Mulè, Donatella Aloisio, Novella Rotolo, Salvatore Leonardi
BACKGROUND: Asthma guidelines have recommended to continue treatment with biologics during COVID-19 pandemic. However, continuation of treatment with biologics in patients with SARS-CoV-2 has been little investigated. OBJECTIVE: To assess the safety of biologics in patients with SARS-CoV-2 infection. METHODS: A pilot, monocentre, prospective study. Patients aged 12 years old and older with severe asthma on treatment with biologics and confirmed SARS-CoV-2 infection were enrolled...
January 2, 2023: Pediatric Pulmonology
#15
JOURNAL ARTICLE
Ajay Kumar Shukla, Shubham Atal, Aditya Banerjee, Ratinder Jhaj, Sadasivam Balakrishnan, Preeta Kaur Chugh, Denis Xavier, Atiya Faruqui, Aakanksha Singh, Ramasamy Raveendran, Jayanthi Mathaiyan, Jeevitha Gauthaman, Urwashi I Parmar, Raakhi K Tripathi, Sandhya K Kamat, Niyati Trivedi, Prashant Shah, Janki Chauhan, Harihar Dikshit, Hitesh Mishra, Rajiv Kumar, Dinesh Kumar Badyal, Monika Sharma, Mamta Singla, Bikash Medhi, Ajay Prakash, Rupa Joshi, Nabendu S Chatterjee, Jerin Jose Cherian, Ved Prakash Kamboj, Nilima Kshirsagar
India have seen more than 43 million confirmed cases of COVID-19 as of April 2022, with a recovery rate of 98.8%, resulting in a large section of the population including the healthcare workers (HCWs), susceptible to develop post COVID sequelae. This study was carried out to assess the nature and prevalence of medical sequelae following COVID-19 infection, and risk factors, if any, associated with them. Methods : This was an observational, multicenter cross-sectional study conducted at eight tertiary care centers...
December 13, 2022: Lancet Reg Health Southeast Asia
#16
JOURNAL ARTICLE
Tara F Carr, Merritt L Fajt, Monica Kraft, Wanda Phipatanakul, Stanley J Szefler, Amir A Zeki, David B Peden, Steven R White
The Precision Interventions for Severe and/or Exacerbation-Prone Asthma clinical trials network is actively assessing novel treatments for severe asthma during the coronavirus disease (COVID-19) pandemic and has needed to adapt to various clinical dilemmas posed by the COVID-19 pandemic. Pharmacologic interactions between established asthma therapies and novel drug interventions for COVID-19 infection, including antivirals, biologics, and vaccines, have emerged as a critical and unanticipated issue in the clinical care of asthma...
April 2023: Journal of Allergy and Clinical Immunology
#17
JOURNAL ARTICLE
Marto Leal, Ligia Kerr, Rosa Maria Salani Mota, Roberto da Justa Pires Neto, David Seal, Carl Kendall
The majority of the women in prisons comes from the poorest strata of society with limited access to education, income and health services. This contributes to the fact that female prisoners have a higher burden of adverse health events than both male prisoners and women in general population We objectived to estimate the prevalence of different morbidities and risk factors among female prisoners in Brazil. A total of 1,327 women were recruited in this cross-sectional study. Data were collected using a using audio computer-assisted self-interviewing questionnaire, rapid antibody tests and physical examination...
December 2022: Ciência & Saúde Coletiva
#18
RANDOMIZED CONTROLLED TRIAL
Banafsheh Hosseini, Bronwyn S Berthon, Megan E Jensen, Rebecca F McLoughlin, Peter A B Wark, Kristy Nichol, Evan J Williams, Katherine J Baines, Adam Collison, Malcolm R Starkey, Joerg Mattes, Lisa G Wood
Children with asthma are at risk of acute exacerbations triggered mainly by viral infections. A diet high in fruit and vegetables (F&V), a rich source of carotenoids, may improve innate immune responses in children with asthma. Children with asthma (3-11 years) with a history of exacerbations and low F&V intake (≤3 serves/d) were randomly assigned to a high F&V diet or control (usual diet) for 6 months. Outcomes included respiratory-related adverse events and in-vitro cytokine production in peripheral blood mononuclear cells (PBMCs), treated with rhinovirus-1B (RV1B), house dust mite (HDM) and lipopolysaccharide (LPS)...
July 27, 2022: Nutrients
#19
JOURNAL ARTICLE
Upinder Kaur, Sapna Bala, Aditi Joshi, Noti Taruni Srija Reddy, Chetan Japur, Mayank Chauhan, Nikitha Pedapanga, Shubham Kumar, Anurup Mukherjee, Vaibhav Mishra, Dolly Talda, Rohit Singh, Rohit Kumar Gupta, Ashish Kumar Yadav, Poonam Jyoti Rana, Jyoti Srivastava, Shobha Bhat K, Anup Singh, Naveen Kumar P G, Manoj Pandey, Kishor Patwardhan, Sangeeta Kansal, Sankha Shubhra Chakrabarti
Background There is paucity of real-world data on COVID-19 vaccine effectiveness from cohort designs. Variable vaccine performance has been observed in test-negative case-control designs. There is also scarce real-world data of health issues in individuals receiving vaccines after prior COVID-19, and of adverse events of significant concern (AESCs) in the vaccinated. Methods : A cohort study was conducted from July 2021 to December 2021 in a tertiary hospital of North India. The primary outcome was vaccine effectiveness against COVID-19 during the second wave in India...
July 20, 2022: Vaccines
#20
REVIEW
Arnold Lee, Yvette N Lamb, Matt Shirley
Delafloxacin (BAXDELA® in the USA; Quofenix® in the EU) is an anionic fluoroquinolone antibacterial that is approved for the treatment of community-acquired pneumonia (CAP) and acute bacterial skin and skin structure infections in adults. Delafloxacin demonstrated in vitro activity against Gram-positive and Gram-negative pathogens, including drug-resistant isolates. In a phase III trial in adults with CAP, delafloxacin was noninferior to moxifloxacin when assessed against FDA- and EMA-defined primary endpoints, with both fluoroquinolones achieving high treatment success rates...
June 2022: Drugs
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