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Association Between Tumor Necrosis Factor Inhibitors and the Risk of Hospitalization or Death Among Patients With Immune-Mediated Inflammatory Disease and COVID-19

2021· article· en· W3207275561 on OpenAlexaff
Zara Izadi, Erica J. Brenner, Satveer K. Mahil, Nick Dand, Zenas Z N Yiu, Mark Yates, Ryan C. Ungaro, Xian Zhang, Manasi Agrawal, Jean‐Frédéric Colombel, Milena Gianfrancesco, Kimme L Hyrich, Anja Strangfeld, Loreto Carmona, Elsa F Mateus, Saskia Lawson‐Tovey, Eva Klingberg, Giovanna Cuomo, Marta Caprioli, Ana Rita Cruz-Machado, Rebecca Hasseli, Alexander Pfeil, Hanns‐Martin Lorenz, Bimba F. Hoyer, Laura Trupin, Stephanie Rush, Patricia Katz, Gabriela Schmajuk, Lindsay Jacobsohn, Andrea M. Seet, Samar Al Emadi, Leanna Wise, Emily Gilbert, Alí Duarte‐García, Maria O Valenzuela-Almada, C. A. Isnardi, Rosana Quintana, Enrique R. Soriano, Tiffany Hsu, Kristin M. D’Silva, Jeffrey A. Sparks, Naomi J. Patel, Ricardo Machado Xavier, Cláudia Diniz Lopes Marques, Adriana María Kakehasi, René‐Marc Flipo, Pascal Claudepierre, A. Cantagrel, Philippe Goupille, Zachary S. Wallace, Suleman Bhana, Wendy Costello, Rebecca Grainger, Jonathan S. Hausmann, Jean W. Liew, Emily Sirotich, Paul Sufka, Philip C. Robinson, Pedro Machado, C.E.M. Griffiths, Catherine Smith, Jinoos Yazdany, Michael D. Kappelman, H. Bachelez, Francesca Capon, Bola Coker, Claudia de la Cruz, K.J. Mason, Paola Di Meglio, Joel M. Gelfand, Paolo Gisondi, Lars Iversen, D. Jullien, Jo Lambert, Sinéad Langan, Helen McAteer, Freya Meynell, Lucy Moorhead, Luigi Naldi, L. Puig, Nick J. Reynolds, Phyllis Spuls, Tiago Torres, Teresa Tsakok, Alexandra Vincent, Richard B. Warren, H Waweru, Siew C. Ng, Richard B. Gearry, Walter Reinisch, Jean‐François Rahier, James D. Lewis, Gilaad G. Kaplan, Flávio Steinwurz, Michele Kissous-Hunt, Irene Modesto, Marishka Konings, Brahim Dahou, Gimena Gómez, Karen Roberts, Roberto Miguel Báez, Vanessa Viviana Castro Coello, María Jezabel Haye Salinas, F. Maldonado, Alvaro A. Reyes, Gelsomina Alle, Romina Tanten, Hernán Maldonado Ficco, Romina Nieto, Carla Gobbi, Yohana Tissera, Cecilia Pisoni, Alba Paula, Juan Alejandro Albiero, María Marcela Schmid, Micaela Cosatti, María Julieta Gamba, Carlevaris Leandro, María Alejandra Cusa, Noelia Germán, Verónica Bellomio, Lorena Takashima, Mariana Pera, Karina Cogo, M. S. Gálvez Elkin, María Alejandra Medina, V. Savio, Romina Rojas Tessel, Rodolfo Pérez Alamino, Marina Laura Werner, Sofía Ornella, Luciana Casalla, María Celina De la Vega, María de los Ángeles Severina, Mercedes García, Luciana González Lucero, Cecilia Romeo, Sebastián Moyano, Tatiana Barbich, Ana M. Bertoli, Andrea Baños, Sandra Petruzzelli, Carla Matellan, Silvana Conti, María Alicia Lázaro, Gustavo Fabián Rodriguez Gil, Fabián Risueño, María Isabel Quaglia, Julia Scafati, Natalia Lili Cuchiaro, J. Rebak, Susana Pineda, María Elena Calvo, Eugenia Picco, Josefina Gallino Yanzi, Pablo Maid, Debora Guaglianone, Julieta Silvana Morbiducci, Sabrina Porta, Natalia Herscovich, José Luis Velasco Zamora, Boris Kisluk, Maria Sol Castaños Menescardi, Rosana Gallo, María Victoria Martiré, Carla Maldini, Cecilia Goizueta, Sabrina Solange de la Vega Fernandez, Carolina Aeschlimann, Gisela Subils, Eva Rath, Y Piette, Mieke Devinck, Bea Maeyaert, Francinne Machado Ribeiro, Sandra Lúcia Euzébio Ribeiro, Marcelo M. Pinheiro, Sebastián Ibañez, Anne-Marie Chassin Trubert, Lingli Dong, Lui Cajas, Marko Barešić, Branimir Anić, Melanie-Ivana Čulo, Tea Ahel Pavelic, Kristina Kovacevic Stranski, Boris Karanović, Jiří Vencovský, Marta Píchová, Mária Filková, Hesham Hamoud, Dimitrios Vassilopoulos, Gabriela Maria Guzman Melgar, Ho So, Márta Király, Mahdi Vojdanian, Alexandra Balbir‐Gurman, Fatemah Abutiban, Jūlija Zepa, Inita Buliņa, Loreta Bukauskienė, Beatriz E Zazueta Montiel, Angel Alejandro Castillo Ortiz, Erick Adrian Zamora Tehozol, David Vega‐Morales, Diana Cervántes Rosete, Eduardo Martín Nares, Tatiana S Rodriguez Reyna, Marina Rull Gabayet, Deshiré Alpízar Rodríguez, Fedra Irazoque, Xochitl Jimenez, Lenny Geurts van Bon, T. R. Zijlstra, Monique Hoekstra, Nasra Al Adhoubi, Babur Salim, Enrique Giraldo, Ariel Salinas, Manuel Ugarte Gil, Jarosław Nowakowski, Richard Conway, Rachael Flood, Géraldine McCarthy, Ioana Felea, Ileana Filipescu, Simona Rednic, L. Groşeanu, Maria Magdelena Tamas, Vanda Mlynáriková, Martina Skamlova, Martin Žlnay, Dagmar Mičeková, L Cápová, Želmíra Macejová, Emὄke Šteňová, Helena Raffayová, Gabriela Belakova, Eva Straková, Marieta Senčarová, Soňa Žlnayová, Anna Sabová, Daniela Spišáková, Mária Oetterová, Oľga Lukáčová, Martina Bakošová, Alojzija Hočevar, N. De la Torre Rubio, Juan José Alegre Sancho, Montserrat Corteguera Coro, Juan Carlos Cobeta García, Maria Carmen Torres Martin, José Luis Michi Campos, José A. Gómez‐Puerta, Gozd Kubra Yardimci, Servet Akar, Ozan Cemal İçaçan, Selda Çelik, Viktoriia Vasylets, Su‐Ann Yeoh, Claire Vandevelde, Sasha Dunt, Jane Leeder, Elizabeth MacPhie, Rosaria Salerno, Christine Graver, Sheila O’Reilly, Kirsty Devine, Jennifer Tyler, Elizabeth Warner, James Pilcher, Samir J. Patel, Elena Nikiphorou, Laura Chadwick, Caroline Mulvaney Jones, Beverley Harrison, Lucy Thornton, Diana O'Kane, Lucia Fusi, Audrey Low, Sarah Horton, Shraddha Jatwani, Sara Baig, Hammad Bajwa, Vernon Berglund, Angela Dahle, Walter Dorman, Jody Hargrove, Maren Hilton, Nicholas Lebedoff, Susan Leonard, Jennifer Morgan, Emily Pfeifer, Archibald Skemp, Jeffrey M. Wilson, Anne Wolff, Eduardo Cepeda, Derrick J. Todd, Denise Hare, Cassandra Calabrese, Christopher Adams, Arezou Khosroshahi, Adam Kilian, Douglas White, Melanie Winter, Theodore Fields, Caroline H. Siegel, Nicole Daver, Melissa Harvey, Neil Kramer, Concetta Lamore, Suneya Hogarty, Karen Yeter, Byung Ban, Tamar Tanner, Eric Ruderman, William E. Davis, Robert Quinet, Evangeline Scopelitis, Karen Toribio Toribio, Tameka Webb Detiege, Jerald Zakem, Khurram Abbass, Gilbert Kepecs, Lilliam Miranda, Michael Guma, Ammar Haikal, Sushama Mody, Daric Mueller, Arundathi Jayatilleke, JoAnn Zell, Alison Bays, Kathryn H. Dao, Fatemeh Ezzati, Deborah Parks, David R. Karp, Guillermo Andrés Quiceno

Bibliographic record

VenueJAMA Network Open · 2021
Typearticle
Languageen
FieldMedicine
TopicCOVID-19 Clinical Research Studies
Canadian institutionsMcMaster UniversityImpactCanadian Arthritis Patient Alliance
FundersJanssen PharmaceuticalsMedical Research CouncilManchester Biomedical Research CentreBristol-Myers SquibbSamsungHorizon TherapeuticsGenentechNational Institute for Health and Care ResearchChugai PharmaceuticalPsoriasis AssociationCelltrionNational Institute of Arthritis and Musculoskeletal and Skin DiseasesNational Institute of Diabetes and Digestive and Kidney DiseasesSanofiNIHR Biomedical Research Centre, Royal Marsden NHS Foundation Trust/Institute of Cancer ResearchGilead SciencesLEO PharmaAmgenRheumatology Research FoundationMedpaceCelgenePfizerBiogenEuropean League Against RheumatismKing's College LondonChildhood Arthritis and Rheumatology Research AllianceAstraZenecaEli Lilly and Company
KeywordsMedicineAzathioprineInternal medicinePsoriasisAdalimumabPsoriatic arthritisTNF inhibitorInflammatory bowel diseaseTumor necrosis factor alphaRheumatoid arthritisDiseaseImmunologyOncology

Abstract

fetched live from OpenAlex

Importance: Although tumor necrosis factor (TNF) inhibitors are widely prescribed globally because of their ability to ameliorate shared immune pathways across immune-mediated inflammatory diseases (IMIDs), the impact of COVID-19 among individuals with IMIDs who are receiving TNF inhibitors remains insufficiently understood. Objective: To examine the association between the receipt of TNF inhibitor monotherapy and the risk of COVID-19-associated hospitalization or death compared with other commonly prescribed immunomodulatory treatment regimens among adult patients with IMIDs. Design, Setting, and Participants: This cohort study was a pooled analysis of data from 3 international COVID-19 registries comprising individuals with rheumatic diseases, inflammatory bowel disease, and psoriasis from March 12, 2020, to February 1, 2021. Clinicians directly reported COVID-19 outcomes as well as demographic and clinical characteristics of individuals with IMIDs and confirmed or suspected COVID-19 using online data entry portals. Adults (age ≥18 years) with a diagnosis of inflammatory arthritis, inflammatory bowel disease, or psoriasis were included. Exposures: Treatment exposure categories included TNF inhibitor monotherapy (reference treatment), TNF inhibitors in combination with methotrexate therapy, TNF inhibitors in combination with azathioprine/6-mercaptopurine therapy, methotrexate monotherapy, azathioprine/6-mercaptopurine monotherapy, and Janus kinase (Jak) inhibitor monotherapy. Main Outcomes and Measures: The main outcome was COVID-19-associated hospitalization or death. Registry-level analyses and a pooled analysis of data across the 3 registries were conducted using multilevel multivariable logistic regression models, adjusting for demographic and clinical characteristics and accounting for country, calendar month, and registry-level correlations. Results: A total of 6077 patients from 74 countries were included in the analyses; of those, 3215 individuals (52.9%) were from Europe, 3563 individuals (58.6%) were female, and the mean (SD) age was 48.8 (16.5) years. The most common IMID diagnoses were rheumatoid arthritis (2146 patients [35.3%]) and Crohn disease (1537 patients [25.3%]). A total of 1297 patients (21.3%) were hospitalized, and 189 patients (3.1%) died. In the pooled analysis, compared with patients who received TNF inhibitor monotherapy, higher odds of hospitalization or death were observed among those who received a TNF inhibitor in combination with azathioprine/6-mercaptopurine therapy (odds ratio [OR], 1.74; 95% CI, 1.17-2.58; P = .006), azathioprine/6-mercaptopurine monotherapy (OR, 1.84; 95% CI, 1.30-2.61; P = .001), methotrexate monotherapy (OR, 2.00; 95% CI, 1.57-2.56; P < .001), and Jak inhibitor monotherapy (OR, 1.82; 95% CI, 1.21-2.73; P = .004) but not among those who received a TNF inhibitor in combination with methotrexate therapy (OR, 1.18; 95% CI, 0.85-1.63; P = .33). Similar findings were obtained in analyses that accounted for potential reporting bias and sensitivity analyses that excluded patients with a COVID-19 diagnosis based on symptoms alone. Conclusions and Relevance: In this cohort study, TNF inhibitor monotherapy was associated with a lower risk of adverse COVID-19 outcomes compared with other commonly prescribed immunomodulatory treatment regimens among individuals with IMIDs.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.004
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.007
Threshold uncertainty score0.015

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0010.004
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.001
Bibliometrics0.0010.001
Science and technology studies0.0000.000
Scholarly communication0.0010.000
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0020.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.018
GPT teacher head0.323
Teacher spread0.305 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

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Citations116
Published2021
Admission routes1
Has abstractyes

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