Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry
Author:
Lovell Daniel J1ORCID, Tzaribachev Nikolay2, Henrickson Michael1, Simonini Gabriele3, Griffin Thomas A4, Alexeeva Ekaterina56, Bohnsack John F7, Zeft Andrew8, Horneff Gerd910ORCID, Vehe Richard K11, Staņēviča Valda12, Tarvin Stacey13, Trachana Maria14, del Río Ana Quintero15, Huber Adam M16ORCID, Kietz Daniel17, Orbán Ilonka18, Dare Jason19, Foeldvari Ivan20, Quartier Pierre2122, Dominique Alyssa23, Simon Teresa A23, Martini Alberto24, Brunner Hermine I1ORCID, Ruperto Nicolino25ORCID, , Brunner Jurgen, Fernandes Taciana, Appenzeller Simone, Oliveira Sheila, Terreri Maria Teresa, Tzaribachev Nikolay, Minden Kirsten, Hufnagel Mark, Foeldvari Ivan, Horneff Gerd, Helling-Bakki Astrid, Herlin Troels, Moreno Estefania, Anton Jordi, del-Castillo Pablo Mesa-, Udaondo Clara, Penades Inmaculada Calvo, Quartier Pierre, Brochard Karine, Ramanan Athimalaipet, Trachana Maria, Orban Ilonka, Hashkes Philip (Pinchas), Ruperto Nicolino, Simonini Gabriele, Olivieri Alma Nunzia, Zulian Francesco, Montin Davide, Peroni Diego, Stanevicha Valda, Cornejo Gabriel Vega, Wulffraat Nico, Kamphuis Sylvia, Gastanaga Maria Eliana Paz, Miraval Tatiana, Oliveira-Ramos Filipa, Lazar Calin, Nikishina Irina, Alexeeva Ekaterina, Sarychev Aleksej, Chasnyk Vyacheslav, Grebenkina Lyudmila, Suwairi Wafaa Mohammed Saad, Koskova Elena, Ally Mahmood, Louw Ingrid, Breedt Johannes, Brunner Hermine, Ting Tracy, Taylor Janalee, Huggins Jennifer, Henrickson Michael, DeWitt Esi Morgan, Grom Alexei, Lovell Daniel, Schulert Grant, Rodriguez-Smith Jackeline, Dare Jason, Morris Paula, Sukumarain Sukesh, Gitelman Marissa Klein, Miller Michael, Curran Megan, Alperin Risa, Ardalan Kaveh, De Ranieri Deirdre, Hiskey Megan, Nolan Brian, Chalom Beth, Zelf Andy, Spalding Steven, Costanzo Denise, Rennebohm Robert, Waugaman Brenda, Brodus Elizabeth, Robinson Angela, Panupattanapong Sirada, Kietz Dan, Rosenkranz Margalit, Cassidy Elaine, Torok Kathryn, Kingsbury Dan, Cartwright Victoria, Lasky Andrew, Brown Diane, Reiff Andreas, Shaham Bracha, Marzan Katherine, Wagner-Weiner Linda, Onel Karen, Tesher Melissa, Edens Cuoghi, Moore Terry, Syed Reema, Pepmueller Peri, Tuttle Paul, Dalrymple Austin, Barhula Srikanth, Feller Lance, Horwitz Mara, Justice Matt, Nocton James, Olson Judyann, Williams Calvin, Versbsy James, Co Dominic, Roth-Wojcicki Elizabeth, Correll Colleen, Vehe Richard, Binstadt Bryce, Hobday Patricia, Brueck Danielle, Griffin Tom, Gillispie-Taylor Miriah, Vora Sheetal, Tarvin Stacey, O'Neil Kathleen, Ballinger Susan, Blakley Michael, Klausmeier Thomas, Oliver Melissa, Stevens Brandi, Rodriguez Martha, Go Ellen, Bohnsack John, Inman Christi, Hersh Aimee, Stern Sara, Woodward Amy, Durkee Debbie, Boulva Sylvie Fadrhonc, James Karen, Treemarcki Erin, Goldsmith Donald, Lvovich Svetlana, Toib Dana, Patel Julisa, Jerath Rita, Sharma Nirupma, Newhall Lauren, Carrasco Ruy, Moorthy Nandini, Boneparth Alexis, Quintero Ana, Graham Thomas, Spence Stephanie, Davis Alaina, Gotte Alisa, Mehta Jay, Walters Heather, Mian Zanab, Parkinson Elizabeth, Hui-Yen Joyce, Steigerwald Katherine, Guzman Marla, Gottlieb Beth, Quintero Ana, Whitaker Connie, Kelly Leslie, Carrasco Ruy, Succimarri Rosie, Hazel Elizabeth, Chedeville Gaelle, Compillo Sarah, LeBlance Claire, Tucker Lori, Cabral David, Houghton Kristin, Guzman Jamie, Morishita Kim, Huber Adam, Stringer Elizabeth, Ramsey Suzanne, Lang Bianca, Levy Deborah, Silverman Earl, Schmeling Heinrike, Johnson Nicole, Luca Nadia, Dhalla Muhammed
Affiliation:
1. Division of Rheumatology, Cincinnati Children’s Hospital Medical Center, University of Cincinnati , Cincinnati, OH, USA 2. PRI Research , Bad Bramstedt, Germany 3. IRCCS Meyer Children’s Hospital, Rheumatology Unit, ERN-ReCONNECT Center , Florence, Italy 4. Atrium Health, Levine Children’s Hospital , Charlotte, NC, USA 5. Department of Rheumatology, National Medical Research Center of Children’s Health , Moscow, Russia 6. Sechenov First Moscow State Medical University , Moscow, Russia 7. Division of Allergy, Immunology and Pediatric Rheumatology, University of Utah , Salt Lake City, UT, USA 8. Center for Pediatric Rheumatology and Immunology, Cleveland Clinic , Cleveland, OH, USA 9. Asklepios Clinic Sankt Augustin , Sankt Augustin, Germany 10. Department of Pediatric and Adolescent Medicine, Medical Faculty, University Hospital of Cologne , Cologne, Germany 11. Department of Pediatrics, Division of Pediatric Rheumatology, University of Minnesota , Minneapolis, MN, USA 12. Riga Stradins University , Riga, Latvia 13. Riley Hospital for Children at Indiana University , Indianapolis, IN, USA 14. Aristotle University of Thessaloniki , Thessaloníki, Greece 15. University of Oklahoma Health Science Center , Oklahoma City, OK, USA 16. IWK Health Centre and Dalhousie University , Halifax, NS, Canada 17. Children’s Hospital of Pittsburgh , Pittsburgh, PA, USA 18. National Institute of Locomotor Diseases and Disabilities , Budapest, Hungary 19. University of Arkansas for Medical Sciences , Little Rock, AR, USA 20. Hamburg Centre for Pediatric and Adolescent Rheumatology , Hamburg, Germany 21. Necker-Enfants Malades University Hospital, Assistance Publique-Hopitaux de Paris , Paris, France 22. Université Paris-Cité , Paris, France 23. Bristol Myers Squibb , Princeton, NJ, USA 24. Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI), Università degli Studi di Genova , Genova, Italy 25. IRCCS Istituto Giannina Gaslini, UOSID Centro Trial—PRINTO , Genova, Italy
Abstract
Abstract
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 with JIA, with no new safety signals identified and with well-controlled disease activity, including some patients achieving inactive disease or remission.
Trial registration
Clinicaltrials.gov, NCT01357668.
Funder
Bristol Myers Squibb
Publisher
Oxford University Press (OUP)
Cited by
2 articles.
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