Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry

作者：Daniel J. Lovell, Nikolay Tzaribachev, Michael Henrickson, Gabriele Simonini, Thomas A. Griffin, Е.I. Alexeeva, John F. Bohnsack, Andrew Zeft, Gerd Horneff, Richard K. Vehe, Valda Staņēviča, Stacey E. Tarvin, Maria Trachana, Ana Quintero del Río, Adam M. Huber, Daniel Kietz, I Orbán, Jason Dare, Ivan Foeldvari, Pierre Quartier, Alyssa Dominique, Teresa A. Simon, Alberto Martini, Hermine I. Brunner, Nicolino Ruperto, for PRINTO and the Pediatric Rheumatology Collaborative Study Group (PRCSG)§, Jürgen Brunner, Taciana de Albuquerque Pedrosa Fernandes, Simone Appenzeller, Sheila Oliveira, Maria Teresa Terreri, Nikolay Tzaribachev, Kirsten Minden, Mark Hufnagel, Ivan Foeldvari, Gerd Horneff, Astrid Helling-Bakki, Troels Herlin, E. Moreno, Jordi Antón, Pablo Mesa- del-Castillo, Clara Udaondo, Inmaculada Calvo Penadés, Pierre Quartier, Karine Brochard, Athimalaipet V Ramanan, Maria Trachana, I Orbán, Philip J. Hashkes, Nicolino Ruperto, Gabriele Simonini, Alma Nunzia Olivieri, Francesco Zulian, Davide Montin, Diego Peroni, Valda Staņēvicha, Gabriel Vega‐Cornejo, Nico Wulffraat, Sylvia Kamphuis, Maria Eliana Paz Gastañaga, Tatiana Miraval, Filipa Oliveira‐Ramos, Călin Lazăr, И. П. Никишина, Е.I. Alexeeva, Aleksej Sarychev, Vyacheslav Chasnyk, Lyudmila Grebenkina, Wafaa Mohammed Saad Suwairi, E Košková, Mahmood M. T. M. Ally, Ingrid Louw, Johannes Breedt, Hermine I. Brunner, Tracy V. Ting, Janalee Taylor, Jennifer Huggins, Michael Henrickson, Esi Morgan DeWitt, Alexei A. Grom, Daniel J. Lovell, Grant S. Schulert, Jackeline Rodriguez‐Smith, Jason Dare, Paula Morris, Sukesh Sukumarain, M Klein Gitelman, Michael Miller, Megan L. Curran, Risa Alperin, Kaveh Ardalan, Deirdre De Ranieri, M. Hiskey, Brian Nolan, Beth Chalom, Andy Zelf, Steven J. Spalding, D. Costanzo, Robert M. Rennebohm, Brenda Waugaman, Elizabeth Brodus, Angela Byun Robinson, Sirada Panupattanapong, D Kietz, Margalit Rosenkranz, Elaine Cassidy, Kathryn S. Torok, Dan Kingsbury, Victoria Cartwright, Andrew Lasky, Diane E. Brown, Andreas Reiff, Bracha Shaham, Katherine Marzan, Linda Wagner‐Weiner, Karen Onel, Melissa Tesher, Cuoghi Edens, Terry L. Moore, Reema Syed, Peri H. Pepmueller, Paul Tuttle, Austin Dalrymple, Srikanth Barhula, Lance Feller, Mara J. Horwitz, M. Ray Justice, James J. Nocton, Judyann C. Olson, Calvin L. Williams, James Versbsy, Dominic O. Co, Elizabeth Roth-Wojcicki, C. Correll, Richard K. Vehe, Bryce A. Binstadt, Patricia M. Hobday, Danielle Brueck, Tom Griffin, Miriah Gillispie‐Taylor, Sheetal S. Vora, Stacey E. Tarvin, Kathleen M. O’Neil, S. Ballinger, Michael Blakley, Thomas Klausmeier, Melissa Oliver, B. Crossfield Stevens, Martha Rodriguez, Ellen Go, John F. Bohnsack, C. Inman, Aimee O. Hersh, Sara Stern, Amy Woodward, D. Durkee, Sylvie Fadrhonc Boulva, Karen James, Erin Treemarcki, Donald P. Goldsmith, Svetlana Lvovich, D. Toib, J. S. Patel, Rita Jerath, Nirupma Sharma, Lauren Newhall, Ruy Carrasco, Nandini Moorthy, Alexis Boneparth, Ana Quintero, T.P. Graham, Stephanie Spence, Alaina M. Davis, Alisa Gotte, Jay Mehta, Heather Walters, Zanab Mian, Elizabeth I. Parkinson, Joyce Hui-Yen, Katherine Steigerwald, Marla Guzman, Beth S. Gottlieb, Ana Quintero, Connie Whitaker, Leslie Kelly, Ruy Carrasco, Rosie Succimarri, Elizabeth Hazel, Gaëlle Chédeville, Sarah Compillo, Claire LeBlance, Lori B. Tucker, David A. Cabral, Kristin Houghton, Jamie Guzman, Kimberly Morishita, Adam M. Huber, Elizabeth Stringer, Suzanne Ramsey, Bianca Lang, Deborah M. Levy, Earl D. Silverman, Heinrike Schmeling, Nicole Johnson, Nadia Luca, Muhammed Dhalla · 发表于：Lara D. Veeken · 年份：2024 · DOI：10.1093/rheumatology/keae025 · 被引用次数：16 · 研究领域：Autoimmune and Inflammatory Disorders Research、Ocular Diseases and Behçet’s Syndrome、Adolescent and Pediatric Healthcare

OBJECTIVE: The aim of this study was to report the interim 5-year safety and effectiveness of abatacept in patients with JIA in the PRINTO/PRCSG registry. METHODS: The Abatacept JIA Registry (NCT01357668) is an ongoing observational study of children with JIA receiving abatacept; enrolment started in January 2013. Clinical sites enrolled patients with JIA starting or currently receiving abatacept. Eligible patients were assessed for safety (primary end point) and effectiveness over 10 years. Effectiveness was measured by clinical 10-joint Juvenile Arthritis Disease Activity Score (cJADAS10) in patients with JIA over 5 years. As-observed analysis is presented according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. RESULTS: As of 31 March 2020, 587 patients were enrolled; 569 are included in this analysis (including 134 new users) with 1214.6 patient-years of safety data available. Over 5 years, the incidence rate (IR) per 100 patient-years of follow-up of serious adverse events was 5.52 (95% CI: 4.27, 7.01) and of events of special interest was 3.62 (95% CI: 2.63, 4.86), with 18 serious infections [IR 1.48 (95% CI: 0.88, 2.34)]. As early as month 3, 55.9% of patients achieved cJADAS10 low disease activity and inactive disease (20.3%, 72/354 and 35.6%, 126/354, respectively), sustained over 5 years. Disease activity measures improvement over 5 years across JIA categories. CONCLUSION: Abatacept was well tolerated in patients wit...