Article
Multidisciplinary Sciences
Michael Schaefer, Kurt Zimmermann, Paul Enck
Summary: Placebos can have effects on clinical symptoms even without deception. This study compared the efficacy of open-label placebos, double-blind placebos, and treatment as usual in relieving seasonal allergic symptoms, and found that open-label placebos were more effective. The COVID-19 pandemic also had an impact on allergic symptoms and the effects of open-label placebos.
SCIENTIFIC REPORTS
(2023)
Article
Clinical Neurology
C. Louapre, M. Rosenzwajg, M. Golse, A. Roux, F. Pitoiset, L. Adda, N. Tchitchek, C. Papeix, E. Maillart, A. Ungureanu, F. Charbonnier-Beaupel, D. Galanaud, J. C. Corvol, E. Vicaut, C. Lubetzki, D. Klatzmann
Summary: The effect of low-dose interleukin-2 (IL2(LD)) treatment on regulatory T cells (Tregs) in multiple sclerosis (MS) patients was modest and delayed, compared to other autoimmune diseases. Larger studies with increased dosages and/or modified modalities of administration are needed.
JOURNAL OF NEUROLOGY
(2023)
Article
Oncology
Craig L. Slingluff, Karl D. Lewis, Robert Andtbacka, John Hyngstrom, Mohammed Milhem, Svetomir N. Markovic, Tawnya Bowles, Omid Hamid, Leonel Hernandez-Aya, Joel Claveau, Sekwon Jang, Prejesh Philips, Shernan G. Holtan, Montaser F. Shaheen, Brendan Curti, William Schmidt, Marcus O. Butler, Juan Paramo, Jose Lutzky, Arvinda Padmanabhan, Sajeve Thomas, Daniel Milton, Andrew Pecora, Takami Sato, Eddy Hsueh, Suprith Badarinath, John Keech, Sujith Kalmadi, Pallavi Kumar, Robert Weber, Edward Levine, Adam Berger, Anna Bar, J. Thaddeus Beck, Jeffrey B. Travers, Catalin Mihalcioiu, Brian Gastman, Peter Beitsch, Suthee Rapisuwon, John Glaspy, Edward C. McCarron, Vinay Gupta, Deepti Behl, Brent Blumenstein, Joanna J. Peterkin
Summary: The study evaluated the efficacy of Seviprotimut-L, a vaccine containing human melanoma antigens, in early-stage melanoma patients. Results showed that the impact of Seviprotimut-L on recurrence-free survival varied among different stage patients, with the most significant effect observed in patients in the IIB/IIC stage, especially among younger patients and those with ulcerated melanomas.
JOURNAL FOR IMMUNOTHERAPY OF CANCER
(2021)
Article
Respiratory System
Hye Jung Park, Sae-Hoon Kim, Yoo Seob Shin, Chul Hwan Park, Eun-Suk Cho, Seung Joon Choi, So Hyun Park, Joo Hyun Jung, Il Gyu Kang, Myoung Seok Lee, Dae Woo Kim, Sang Min Lee, Min-Suk Yang, Sang Pyo Lee
Summary: This study evaluated the therapeutic efficacy and safety of ILAIT with L-tyrosine-adsorbed allergen extracts. Although there were some effects in the treatment group at 4 months post-treatment, there were no significant differences at 1 year, and injection site pain and systemic adverse reactions were common.
RESPIRATORY RESEARCH
(2021)
Article
Allergy
Lars Ahlbeck, Emelie Ahlberg, Linn Stuivers, Janne Bjorkander, Ulla Nystrom, Pavlos Retsas, Dhanapal Govindaraj, Maria C. Jenmalm, Karel Duchen
Summary: This study evaluated the safety and efficacy of intralymphatic immunotherapy (ILIT) for inducing tolerance in patients with allergic rhinitis. The results showed that two years after ILIT treatment, the actively treated group reported reduced symptoms, decreased medication use, and improved quality of life compared to the placebo group. Further studies are needed to confirm the efficacy of this treatment.
CLINICAL AND EXPERIMENTAL ALLERGY
(2023)
Article
Rheumatology
Tsutomu Takeuchi, Sakae Tanaka, Mitsuru Murata, Yoshiya Tanaka
Summary: This study aimed to evaluate the efficacy and safety of TAS5315 in Japanese patients with refractory rheumatoid arthritis. The results showed numerical differences in disease activity improvement rates between the TAS5315 group and the placebo group at week 12, but the primary endpoint was not achieved. However, TAS5315 demonstrated advantages in disease activity and biomarker improvement, as well as higher risk of bleeding events within 36 weeks. Therefore, a risk-benefit analysis of TAS5315 should be considered.
ANNALS OF THE RHEUMATIC DISEASES
(2023)
Article
Rheumatology
Jing Li, Mengtao Li, Di Wu, Jiaxin Zhou, Shui-on Leung, Fengchun Zhang
Summary: This study evaluated the efficacy and safety of SM03 in Chinese patients with RA. The results showed that SM03 had good efficacy and safety at cumulative doses of 2400mg and 3600mg.
Article
Pharmacology & Pharmacy
Kai Huang, Ying Ding, Linling Que, Nannan Chu, Yunfei Shi, Zhenzhong Qian, Wei Qin, Yuanxin Chen, Xianghong Gu, Jiakun Wang, Zhiwei Zhang, Jianguo Xu, Qing He
Summary: This study aimed to investigate the safety, tolerability, and pharmacokinetics of WXFL10203614 in healthy Chinese subjects. A total of 592 subjects were enrolled, and results showed good safety and tolerability of WXFL10203614 in all dose levels, with dose-related changes in pharmacokinetic parameters. The findings support further clinical development of WXFL10203614 in patients with rheumatoid arthritis.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Chemistry, Medicinal
Mona Maddahi, Elyas Nattagh-Eshtivani, Mohammadhassan Jokar, Mehdi Barati, Hamed Tabesh, Mohammad Safarian, Maryam Khosravi
Summary: This study aimed to evaluate the effects of propolis supplementation on cardiovascular risk factors in women with rheumatoid arthritis. The results of a randomized, double-blind, placebo-controlled clinical trial showed that propolis supplementation significantly reduced cardiovascular risk factors and could be a promising treatment strategy for cardiovascular complications among rheumatoid arthritis patients.
PHYTOTHERAPY RESEARCH
(2023)
Article
Rheumatology
Richard A. Furie, Gustavo Aroca, Matthew D. Cascino, Jay P. Garg, Brad H. Rovin, Analia Alvarez, Hilda Fragoso-Loyo, Elizabeth Zuta-Santillan, Thomas Schindler, Paul Brunetta, Cary M. Looney, Imran Hassan, Ana Malvar
Summary: This study compared the efficacy of obinutuzumab with standard therapies and placebo in the treatment of LN. The results showed that obinutuzumab achieved better complete renal responses at 52 and 104 weeks compared to standard therapies alone. It also showed improvements in other renal response measures, serologies, estimated glomerular filtration rate and proteinuria. Obinutuzumab was well tolerated and no new safety signals were identified.
ANNALS OF THE RHEUMATIC DISEASES
(2022)
Article
Medicine, General & Internal
Brian G. Feagan, Silvio Danese, Edward V. Loftus, Severine Vermeire, Stefan Schreiber, Timothy Ritter, Ronald Fogel, Rajiv Mehta, Sandeep Nijhawan, Radoslaw Kempinski, Rafal Filip, Ihor Hospodarskyy, Ursula Seidler, Frank Seibold, Ian L. P. Beales, Hyo Jong Kim, John McNally, Chohee Yun, Sally Zhao, Xiaopeng Liu, Chia-Hsiang Hsueh, Chantal Tasset, Robin Besuyen, Mamoru Watanabe, William J. Sandborn, Gerhard Rogler, Toshifumi Hibi, Laurent Peyrin-Biroulet
Summary: The study assessed the efficacy and safety of filgotinib in treating ulcerative colitis, with the results showing that 200 mg of filgotinib was more effective than placebo in inducing and maintaining clinical remission.
Article
Immunology
Isabel Leroux-Roels, Jacques Bruhwyler, Lilli Stergiou, Mark Sumeray, Jasper Joye, Cathy Maes, Paul-Henri Lambert, Geert Leroux-Roels
Summary: V-306, a synthetic virus-like particle-based vaccine candidate, displaying multiple respiratory syncytial virus (RSV) F site II protein mimetics (FsIIm), was found to be safe and induced an increase in immunoglobulin G specific to FsIIm in a study on healthy young women. However, this did not result in an increase in RSV-neutralizing antibody titers, which were already high at baseline.
Article
Medicine, General & Internal
Miriam Frenken, Benedikt Ostendorf, Ralph Brinks, Christoph Schleich, Lena M. Wilms, Stefan Vordenbaeumen, Anja Mueller-Lutz, Jutta G. Richter, Oliver Sander, Gerald Antoch, Matthias Schneider, Xenofon Baraliakos, Daniel B. Abrar, Philipp Sewerin
Summary: This study evaluated the effect of combination therapy with methotrexate and adalimumab versus methotrexate alone on cartilage status in patients with early rheumatoid arthritis using delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC). The results showed that combination therapy resulted in improved cartilage composition, while methotrexate alone did not have any effect on cartilage composition.
JOURNAL OF CLINICAL MEDICINE
(2023)
Article
Rheumatology
Ho So, Isaac T. Cheng, Sze-Lok Lau, Evelyn Chow, Tommy Lam, Vivian W. Hung, Edmund K. Li, James F. Griffith, Vivian W. Lee, Lin Shi, Junbin Huang, Kitty Yan Kwok, Cheuk-Wan Yim, Tena K. Li, Vincent Lo, Jolie Lee, Jack Jock-Wai Lee, Ling Qin, Lai-Shan Tam
Summary: Denosumab showed greater efficacy than placebo in erosion repair in patients with rheumatoid arthritis after 24 months, as seen on HR-pQCT scans. A significant proportion of patients in the denosumab group experienced erosion healing, while no differences in erosion parameters were observed at 12 months.
ANNALS OF THE RHEUMATIC DISEASES
(2021)
Article
Engineering, Multidisciplinary
Ying Shi, Hu-Dan Pan, Jian-Lin Wu, Qing-Hua Zou, Xin-Yi Xie, Hong-Gang Li, Hua Zhou, Xi-Qing Bian, Wen-Fei Leng, Can-Jian Wang, Ya-Feng Wang, Yong-Fei Fang, Liang Liu
Summary: This study investigated the efficacy and safety of Sinomenine (SIN) in treating rheumatoid arthritis (RA) patients and found that SIN had comparable efficacy to methotrexate (MTX) with fewer side effects. Additionally, the study discovered for the first time a close correlation between serum ornithine level and the alleviation of RA, demonstrating the value of this measure as an assessment indicator for RA treatment.
Article
Clinical Neurology
Matteo Garibaldi, Tommaso Nicoletti, Elisabetta Bucci, Laura Fionda, Luca Leonardi, Stefania Morino, Laura Tufano, Girolamo Alfieri, Antonio Lauletta, Gioia Merlonghi, Alessia Perna, Salvatore Rossi, Enzo Ricci, Jorge Alonso Perez, Tommaso Tartaglione, Antonio Petrucci, Elena Maria Pennisi, Marco Salvetti, Gary Cutter, Jordi Diaz-Manera, Gabriella Silvestri, Giovanni Antonini
Summary: In a large cohort of DM1 patients, muscle involvement was characterized by fat replacement, muscle atrophy and STIR positivity, which correlated with disease severity and duration. The study also identified STIR hyperintensity as an early marker of muscle involvement, providing potential therapeutic targets for future clinical trials.
EUROPEAN JOURNAL OF NEUROLOGY
(2022)
Article
Clinical Neurology
Maria Petracca, Gary Cutter, Sirio Cocozza, Leorah Freeman, John Kangarlu, Monica Margoni, Matteo Moro, Stephen Krieger, Mohamed Mounir El Mendili, Amgad Droby, Jerry S. Wolinsky, Fred Lublin, Matilde Inglese
Summary: In patients with relapsing-remitting multiple sclerosis, higher baseline Expanded Disability Status Scale (EDSS) score and higher volume of supratentorial and cerebellar T2 lesions are associated with manual dexterity worsening over time. Additionally, older age, lower baseline EDSS score, and higher volume of supratentorial T2 lesions are associated with confirmed disability progression.
EUROPEAN JOURNAL OF NEUROLOGY
(2022)
Article
Genetics & Heredity
Phillip H. Allman, Inmaculada Aban, Dustin M. Long, Amit Patki, Todd MacKenzie, Marguerite R. Irvin, Leslie A. Lange, Ethan Lange, Gary Cutter, Hemant K. Tiwari
Summary: The study proposed a general Mendelian randomization (MR) method applicable to any full-rank distribution from the exponential family. Through simulations and real data analyses, the method was found to have low bias and acceptable coverage across various scenarios.
GENETIC EPIDEMIOLOGY
(2022)
Article
Clinical Neurology
Anthony Feinstein, Maria Pia Amato, Giampaolo Brichetto, Jeremy Chataway, Nancy D. Chiaravalloti, Gary Cutter, Ulrik Dalgas, John DeLuca, Rachel Farrell, Peter Feys, Massimo Filippi, Jennifer Freeman, Matilde Inglese, Cecilia Meza, Rob Motl, Maria Assunta Rocca, Brian M. Sandroff, Amber Salter
Summary: The pandemic restrictions have significantly affected the CogEx trial, leading to delays and challenges in conducting the international study. Despite the disruptions, participants and staff have shown flexibility and resilience in keeping the trial running, with cautious optimism that the study will be completed successfully.
JOURNAL OF NEUROLOGY
(2022)
Editorial Material
Clinical Neurology
Gary Cutter
MULTIPLE SCLEROSIS JOURNAL
(2023)
Article
Clinical Neurology
Sammita Satyanarayan, Gary Cutter, Stephen Krieger, Stacey Cofield, Jerry S. Wolinsky, Fred Lublin
Summary: The stringency of relapse definition affects measurements of relapse rate and composite endpoints in RRMS. Even with the most inclusive relapse definition, 43% of patients did not have durable worsening in the clinical trial. Therefore, relapse definition and durability should be considered in RRMS research to avoid overestimating disease progression.
MULTIPLE SCLEROSIS JOURNAL
(2023)
Article
Clinical Neurology
Robert W. Motl, Ariel Kidwell-Chandler, Brian M. Sandroff, Lara A. Pilutti, Gary R. Cutter, Roberto Aldunate, Rachel E. Bollaert
Summary: A randomized controlled trial was conducted to examine the effectiveness of an Internet-based behavioral intervention on increasing physical activity in persons with multiple sclerosis (MS). The study found that the intervention led to immediate and sustained increases in moderate-to-vigorous physical activity among participants. This study provides evidence for a scalable approach to promote physical activity in persons with MS.
MULTIPLE SCLEROSIS JOURNAL
(2023)
Article
Biology
Carlos Castrillon, Lea Simoni, Theo van den Broek, Cees van der Poel, Elliot H. Akama-Garren, Minghe Ma, Michael C. Carroll
Summary: This study characterized the post-germinal center B cell compartment in a new mouse model of autoimmunity using single-cell transcriptomics and antibody repertoire analysis. The results revealed multiple subclusters of antibody-secreting cells and memory B cells, each with distinct characteristics and in vivo localization. Additionally, a clonal redundancy was observed within these subsets, suggesting a potential mechanism for the perpetuation of self-reactivity in autoimmune diseases.
Article
Clinical Neurology
Amber Salter, Alexander Keenan, Hoa H. Le, Kavita Gandhi, Maria Ait-Tihyaty, Samantha Lancia, Gary R. Cutter, Robert J. Fox, Ruth Ann Marrie
Summary: Fatigue is commonly experienced by multiple sclerosis patients, with a majority reporting worsening of fatigue over time. Factors associated with fatigue worsening include lower income, higher disability, lower initial fatigue level, use of injectable disease-modifying therapies, and increased levels of depression.
MULTIPLE SCLEROSIS JOURNAL-EXPERIMENTAL TRANSLATIONAL AND CLINICAL
(2023)
Article
Clinical Neurology
Gary Cutter, Richard A. Rudick, Carl de Moor, Carol M. Singh, Elizabeth Fisher, Thijs Koster, Fred D. Lublin, Jerry S. Wolinsky, Henry McFarland, Steven Jacobson, Maria L. Naylor
Summary: This study investigated the changes in serum neurofilament light-chain (sNfL) levels in response to treatment and assessed baseline sNfL as a predictor of relapse in treatment-naive RRMS patients. The results showed that sNfL levels decreased significantly within 6 months and remained low at 36 months in all treatment arms. The combination of lesion activity and sNfL was found to be a stronger predictor of relapse.
MULTIPLE SCLEROSIS JOURNAL-EXPERIMENTAL TRANSLATIONAL AND CLINICAL
(2023)
Article
Urology & Nephrology
Michael Allon, Alian Al-Balas, Carlton J. Young, Gary R. Cutter, Timmy Lee
Summary: In CKD patients with an eGFR less than 15 ml/min per 1.73 m2, placement of an AV graft instead of an AV fistula reduces the likelihood of catheter use at the initiation of dialysis.
CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY
(2023)
Article
Urology & Nephrology
Michael Allon, Gary R. Cutter, Carlton J. Young
Summary: This study found that access-related distal ischemia requiring intervention was rare. It was more common in women and patients with peripheral vascular disease or coronary artery disease. In some cases, a subsequent vascular access could be placed with a low likelihood of recurrent distal ischemia.
CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY
(2023)
Article
Urology & Nephrology
Michael Allon, Alian Al-Balas, Carlton J. Young, Gary R. Cutter, Timmy Lee
Summary: This study compared two strategies for the choice of initial vascular access in hemodialysis patients. The results showed that a more selective approach to arteriovenous fistula (AVF) placement can reduce the frequency of vascular access procedures and the cost of access management.
JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY
(2023)
Review
Clinical Neurology
Ruth Ann Marrie, Maria Pia Sormani, Sean Apap Mangion, Francesca Bovis, Winson Y. Cheung, Gary R. Cutter, Peter Feys, Michael D. Hill, Marcus Werner Koch, Morgan McCreary, Ellen M. Mowry, Jay J. H. Park, Fredrik Piehl, Amber Salter, Jeremy Chataway
Summary: The current designs for clinical trials treating progressive multiple sclerosis (MS) have limitations and have not been successful. This paper discusses complex innovative trial designs and intermediate and composite outcomes to improve trial design efficiency in MS. Recommendations include increasing the use of complex innovative designs, developing biomarkers to enrich trial populations, prioritizing intermediate outcomes targeting therapeutic mechanisms, and investigating data linkage for long-term outcomes. Novel trial designs and further development of intermediate outcomes may improve clinical trial efficiency and address novel therapeutic questions in MS.
MULTIPLE SCLEROSIS JOURNAL
(2023)
Article
Health Care Sciences & Services
Marissa Betts, Kyle Fahrbach, Binod Neupane, Mahmoud Slim, Maria Pia Sormani, Gary Cutter, Thomas P. A. Debray, Marvin Rock
Summary: This study evaluates eight approaches for handling overlapping publications in network meta-analyses of real-world evidence (RWE) studies and recommends establishing an a priori hierarchy for selection.
JOURNAL OF COMPARATIVE EFFECTIVENESS RESEARCH
(2023)