Article
Immunology
Remigius Groning, Andy Dernstedt, Clas Ahlm, Johan Normark, Peter Sundstrom, Mattias N. E. Forsell
Summary: Peripheral B cell depletion via anti-CD20 treatment is effective for reducing new relapses in MS patients, but impairs vaccine response. This study shows that MS patients can achieve antibody levels comparable to healthy controls after two vaccine doses during RTX treatment, and that DN B cell stimulation and impairment of germinal center activity are important in these patients.
FRONTIERS IN IMMUNOLOGY
(2023)
Article
Clinical Neurology
Ki Hoon Kim, Su-Hyun Kim, Na Young Park, Jae-Won Hyun, Ho Jin Kim
Summary: This study evaluated the efficacy and safety of natalizumab in Korean patients with active MS, showing high efficacy in reducing annual relapse rate and improving or stabilizing disability in the majority of patients. NEDA-3 was achieved in 92% and 82% of patients at 1 and 2 years after initiating natalizumab treatment, respectively. No serious adverse events leading to discontinuation of natalizumab were observed.
FRONTIERS IN NEUROLOGY
(2021)
Article
Clinical Neurology
Chao Zhu, Zhen Zhou, Izanne Roos, Daniel Merlo, Tomas Kalincik, Serkan Ozakbas, Olga Skibina, Jens Kuhle, Suzanne Hodgkinson, Cavit Boz, Raed Alroughani, Jeannette Lechner-Scott, Michael Barnett, Guillermo Izquierdo, Alexandre Prat, Dana Horakova, Eva Kubala Havrdova, Richard Macdonell, Francesco Patti, Samia Joseph Khoury, Mark Slee, Rana Karabudak, Marco Onofrj, Vincent Van Pesch, Julie Prevost, Mastura Monif, Vilija Jokubaitis, Anneke van der Walt, Helmut Butzkueven
Summary: Ocrelizumab and natalizumab are more effective than cladribine in reducing relapses in patients with relapsing-remitting multiple sclerosis switching from fingolimod. Additional observation time is needed to determine if the statistical difference in annualized relapse rate (ARR) results in long-term disability differences.
JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY
(2022)
Article
Medical Laboratory Technology
Lesley J. Page, Jacqueline Lagunas-Acosta, Raphaela Heussen, Edward T. Castellana, Bradley T. Messmer
Summary: A novel assay was developed to quantify unexchanged and exchanged natalizumab variants in clinical samples. This assay will enable investigations into the clinical significance of the relationship between PK/PD and the monovalent-to-bivalent ratio, as it relates to the efficacy of the drug and risk of PML.
THERAPEUTIC DRUG MONITORING
(2023)
Article
Medicine, General & Internal
Anna Jamroz-Wisniewska, Radoslaw Zajdel, Agnieszka Slowik, Monika Marona, Marcin Wnuk, Monika Adamczyk-Sowa, Bozena Adamczyk, Anetta Lasek-Bal, Przemyslaw Puz, Arkadiusz Steposz, Ewa Krzystanek, Maja Patalong-Ogiewa, Anna Pokryszko-Dragan, Slawomir Budrewicz, Dorota Koziarska, Anna Karbicka, Slawomir Wawrzyniak, Waldemar Fryze, Marzena Furtak-Niczyporuk, Konrad Rejdak
Summary: The study found that the NEDA-3 rate after the first year of therapy was higher for natalizumab compared to fingolimod. Patients with lower MRS on platform therapy had better outcomes when switching to second-line therapy. Early switching to second-line therapy may lead to better results for patients treated with natalizumab or fingolimod.
JOURNAL OF CLINICAL MEDICINE
(2021)
Article
Clinical Neurology
Michael Guger, Christian Enzinger, Fritz Leutmezer, Franziska Di Pauli, Joerg Kraus, Stefan Kalcher, Erich Kvas, Thomas Berger
Summary: The study evaluated the long-term effectiveness of natalizumab (NTZ) in treating multiple sclerosis and identified several demographic, clinical, and radiological predictors related to long-term disease activity. It found that NTZ treatment led to stable disease course in relapse activity and progression for over 7 years, with factors such as higher relapse rate before treatment initiation, higher disability, shorter disease duration, and the absence of Gadolinium-enhancing MRI lesions being associated with reduced relapse risk. Additionally, older age at NTZ start was identified as the only significant risk factor for disease progression over the long-term.
JOURNAL OF NEUROLOGY
(2021)
Article
Clinical Neurology
Jussi Lehto, Marjo Nylund, Markus Matilainen, Marcus Sucksdorff, Anna Vuorimaa, Johan Rajander, Saara Wahlroos, Parisa Hariri, Laura Airas
Summary: This study aimed to investigate the activation of brain innate immune cells in teriflunomide-treated patients with relapsing-remitting multiple sclerosis. Imaging techniques including TSPO-PET and MRI were used to assess microglial activity, lesion load, and brain volume. The results showed that treated patients had slightly increased innate immune cell activation in the brain, but no significant changes in lesion-associated smoldering inflammation were observed.
EUROPEAN JOURNAL OF NEUROLOGY
(2023)
Article
Clinical Neurology
Eva M. Strijbis, Eline Coerver, Jop Mostert, Zoe L. E. van Kempen, Joep Killestein, Jacynthe Comtois, Pavle Repovic, James D. Bowen, Gary Cutter, Marcus Koch
Summary: This study investigates the association between age and inflammatory disease activity in relapsing-remitting multiple sclerosis (RRMS) using patient-level data from randomized controlled trials (RCTs) of natalizumab treatment. The results show that older age is associated with lower prevalence and degree of focal inflammatory disease activity in treated and untreated RRMS patients. These findings provide important insights for the design of RCTs and the decision-making process of immunomodulatory treatment in RRMS.
JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY
(2023)
Article
Virology
Simone Agostini, Roberta Mancuso, Andrea Saul Costa, Domenico Caputo, Mario Clerici
Summary: The detection of miR-J1-5p in urine of MS patients treated with Natalizumab could potentially serve as a biomarker to monitor JCPyV infection and better identify the risk of developing PML. The study found miR-J1-5p in the urine of 28% of patients, even in some cases where JCPyV DNA was not detected in urine or blood. This suggests that miR-J1-5p measurement could be valuable in assessing PML risk in Natalizumab-treated MS patients.
Article
Clinical Neurology
Alyssa A. Toorop, Zoe L. E. van Kempen, Maurice Steenhuis, Jessica Nielsen, L. G. F. Sinnige, Gert van Dijk, Christiaan M. Roosendaal, Edo P. J. Arnoldus, Elske Hoitsma, Birgit Lissenberg-Witte, Brigit A. de Jong, Bob W. van Oosten, Eva M. M. Strijbis, Bernard M. J. Uitdehaag, Theo Rispens, Joep Killestein
Summary: The study evaluated the change in natalizumab trough drug levels when switching from intravenous to subcutaneous administration. It was found that the drug levels were on average 55% lower with subcutaneous administration, leading to very low levels in some patients. Monitoring of trough drug levels is advised when switching to subcutaneous administration in patients with low intravenous drug levels, higher body mass index, or extended treatment intervals.
JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY
(2023)
Article
Clinical Neurology
Tobias Monschein, Sarinah Dekany, Tobias Zrzavy, Markus Ponleitner, Patrick Altmann, Gabriel Bsteh, Barbara Kornek, Paulus Rommer, Christian Enzinger, Franziska Di Pauli, Jorg Kraus, Thomas Berger, Fritz Leutmezer, Michael Guger
Summary: With data from the Austrian Multiple Sclerosis Therapy Registry, the effectiveness and safety of natalizumab in multiple sclerosis patients were assessed for up to 14 years. The results showed that natalizumab was effective in treating relapsing-remitting multiple sclerosis and had a favorable safety profile during long-term use.
JOURNAL OF NEUROLOGY
(2023)
Article
Clinical Neurology
Shay Menascu, Aviva Fattal-Valevski, Adi Vaknin-Dembinsky, Ron Milo, Keren Geva, David Magalashvili, Mark Dolev, Shlomo Flecther, Alon Kalron, Shmulik Miron, Chen Hoffmann, Roy Aloni, Michael Gurevich, Anat Achiron
Summary: This study retrospectively analyzed the data of 36 children and young adults with highly active MS and found that natalizumab is an effective and well-tolerated treatment for young-onset multiple sclerosis patients.
JOURNAL OF THE NEUROLOGICAL SCIENCES
(2022)
Article
Clinical Neurology
Alyssa A. Toorop, Theo Rispens, Eva M. M. Strijbis, Bob W. van Oosten, Brigit A. de Jong, Bernard M. J. Uitdehaag, Joep Killestein, Zoe L. E. van Kempen
Summary: In pregnant women with very active multiple sclerosis, Natalizumab concentrations gradually decrease during pregnancy, especially in patients with low initial trough concentrations or extended interval dosing. After delivery, Natalizumab concentrations return to pre-pregnancy levels, and patients remain clinically and radiologically stable. MS neurologists should be aware of these changes in drug concentrations during pregnancy.
MULTIPLE SCLEROSIS JOURNAL
(2022)
Article
Immunology
Javier Riancho, Sonia Setien, Jose Ramon Sanchez de la Torre, Marta Torres-Barquin, Mercedes Misiego, Jose Luis Perez, Tamara Castillo-Trivino, Cristina Menendez-Garcia, Manuel Delgado-Alvarado
Summary: Observational study on the long-term effectiveness of natalizumab with extended interval dosing (EID) in multiple sclerosis patients treated for over 7 years showed that EID preserved treatment efficacy and prevented disability worsening during follow-up. Patients treated with natalizumab for the first time showed slightly better response to EID therapy compared to those previously treated with other immunosuppressive drugs.
FRONTIERS IN IMMUNOLOGY
(2021)
Article
Clinical Neurology
Ilaria Callegari, Mika Schneider, Vera Aebischer, Margarete M. M. Voortman, Undine Proschmann, Tjalf Ziemssen, Raija Lindberg, Bettina Fischer-Barnicol, Michael Khalil, Ludwig Kappos, Jens Kuhle, Nicholas S. R. Sanderson, Tobias Derfuss
Summary: This study found that natalizumab can diffuse in different anatomical compartments, including cerebrospinal fluid and milk. By developing a flow-cytometry-based assay and applying it to quantify natalizumab in body fluids, including cerebrospinal fluid, breastmilk, and serum, a better understanding of the safety of therapeutic antibody administration during pregnancy and lactation can be achieved.
THERAPEUTIC ADVANCES IN NEUROLOGICAL DISORDERS
(2023)
Review
Health Care Sciences & Services
Paul O'connor, Roisin O'malley, Anne-Marie Oglesby, Kathryn Lambe, Sinead Lydon
Summary: There is no single method of measuring and monitoring safety in prehospital care. Most safety monitoring systems have evolved rather than been designed, leading to safety blind spots and redundancy.
INTERNATIONAL JOURNAL FOR QUALITY IN HEALTH CARE
(2021)
Review
Education, Scientific Disciplines
Caoimhe Madden, Roisin O'Malley, Paul O'Connor, Emily O'Dowd, Dara Byrne, Sinead Lydon
Summary: Gender bias has been observed in the authorship and editorship of academic literature in various medical specialties. However, there has been positive progress towards gender parity in leading medical education journals, with an increase in the proportion of women authors and editors. Further research and efforts are needed to ensure the continued participation and highlighting of women in medical education scholarship.
Review
Medicine, General & Internal
Sinead Lydon, Emily O'Dowd, Chloe Walsh, Angela O'Dea, Dara Byrne, Andrew W. Murphy, Paul O'Connor
Summary: The study reviewed interventions aiming to improve gender equity in medicine, with findings suggesting a focus on equipping women for professional development. Few interventions addressed cultural or systemic changes, and even fewer were implemented in clinical settings. While outcomes were largely positive, the reliance on subjective measurement methods and weak methodological rigour indicate the need for further research and action to promote gender equity.
POSTGRADUATE MEDICAL JOURNAL
(2022)
Article
Medicine, General & Internal
Akke Vellinga, Marc Mellotte, P. J. Mealy, Anthony Staines, Paul O'Connor, Galina Brychkova, Mathieu d'Aquin
Summary: The COVID-19 pandemic and subsequent restrictive measures have significantly impacted people's activities, work, schooling, and childcare in Ireland. The Corona Citizens' Science Project conducted a population-wide survey to record these impacts and support decision-making, revealing detailed findings over four waves of data collection.
IRISH JOURNAL OF MEDICAL SCIENCE
(2022)
Review
Nursing
Nuala Walshe, Stephanie Ryng, Jonathan Drennan, Paul O'Connor, Sinead O'Brien, Clare Crowley, Josephine Hegarty
Summary: Accurate situation awareness is crucial in deteriorating patient response systems. Research shows that in healthcare, there is a widespread use of Endsley's situation awareness model, but some studies also explore alternative theories. Nurses need to be aware of the complexity of situation awareness and the practical demands in busy ward contexts.
INTERNATIONAL JOURNAL OF NURSING STUDIES
(2021)
Editorial Material
Education, Scientific Disciplines
Paul O'Connor, Sinead Lydon, Emily O'Dowd, Dara Byrne
Review
Medicine, General & Internal
Paul O'Connor, Roisin O'Malley, Yazeed Kaud, Emily St Pierre, Rosie Dunne, Dara Byrne, Sinead Lydon
Summary: This study examines the extent, range, and nature of patient safety research activities in the Republic of Ireland (RoI) and makes recommendations for future research. It found that there is a modest, but growing, body of patient safety research conducted in Ireland, with potential for improvement. The study aims to provide direction to researchers and practitioners to improve patient safety.
IRISH JOURNAL OF MEDICAL SCIENCE
(2023)
Editorial Material
Education, Scientific Disciplines
Sinead Lydon, Caoimhe Madden, Dara Byrne, Paul O'Connor
Article
Medicine, General & Internal
Yazeed Kaud, Darragh McKeon, Sinead Lydon, Paul O'Connor
Summary: This study evaluated the methods of measuring and monitoring safety (MMS) in Irish hospitals using Vincent et al.'s MMS framework. A total of 162 MMS methods were identified, with various focuses such as past harm, reliability of safety critical processes, sensitivity to operations, anticipation and preparedness, and integration and learning.
IRISH JOURNAL OF MEDICAL SCIENCE
(2023)
Review
Primary Health Care
Roisin O'Malley, Paul O'Connor, Caoimhe Madden, Sinead Lydon
Summary: The Positive Deviance approach focuses on identifying individuals/organizations performing exceptionally well despite resource constraints and learning from their success. It has been applied in healthcare to improve patient care quality and safety.
Article
Primary Health Care
Caoimhe Madden, Sinead Lydon, Andrew W. Murphy, Paul O'Connor
Summary: This study collected and analyzed patients' accounts of patient safety incidents (PSIs) and compared them with the perspectives of clinicians. The findings highlighted safety deficiencies related to communication, staff performance, and compassion/dignity/respect. There were significant differences in the perceived severity and likelihood of PSIs between general practitioners (GPs) and patients.
Article
Primary Health Care
Emily O'Dowd, Sinead Lydon, Kathryn Lambe, Chris Rudland, Aoife Hilton, Paul O'Connor
Summary: Complaints are valuable data for improving general practice. This study used HCAT(GP) to systematically analyze complaints and identify hot spots and blind spots in general practice.
Article
Primary Health Care
Emily O'Dowd, Sinead Lydon, Paul O'Connor
Summary: Healthcare complaints are an important source of information for safety improvement, but are often underutilised. A study in Ireland explored perceptions of complaints among general practitioners, practice nurses and managers, medico-legal professionals, and policymakers. The study identified three main themes related to complaints: reasons for patients submitting complaints, management of complaints, and impact of complaints, with subthemes including barriers and facilitators to complaining, practice processes for complaints management, and impacts on staff.
EUROPEAN JOURNAL OF GENERAL PRACTICE
(2021)
Review
Health Care Sciences & Services
Evismar Andrade, Leo Quinlan, Richard Harte, Dara Byrne, Enda Fallon, Martina Kelly, Siobhan Casey, Frank Kirrane, Paul O'Connor, Denis O'Hora, Michael Scully, John Laffey, Patrick Pladys, Alain Beuchee, Gearoid OLaighin
Summary: The review discusses the potential of wearable devices in overcoming limitations of traditional patient monitors in critical care settings. Tactile, head-mounted, and smartwatch displays were identified as potential solutions, particularly for anesthesiologists, nurses, and surgeons. Usability and human factors, such as comfort and ease of use, are crucial considerations for the development and adoption of wearable devices in clinical practice.
JMIR HUMAN FACTORS
(2021)
Article
Medicine, General & Internal
Paul O'Connor, Sinead Lydon, Emily O'Dowd, Dara Byrne
Summary: This study explores the relationship between psychological resilience and burnout in doctors, and how to improve doctors' psychological resilience. Being a man is more positively related to protective attitudes than being a woman. Emotional exhaustion and personal accomplishment are significant predictors in this study.
IRISH JOURNAL OF MEDICAL SCIENCE
(2021)