Tamas Constantin1, Ivan Foeldvari1, Jelena Vojinovic1, Gerd Horneff1, Ruben Burgos-Vargas1, Irina Nikishina1, Jonathan D Akikusa1, Tadej Avcin1, Jeffrey Chaitow1, Elena Koskova1, Bernard R Lauwerys1, Inmaculada Calvo Penades1, Berit Flato1, Maria Luz Gamir1, Hans-Iko Huppertz1, Juan Jose Jaller Raad1, Katerina Jarosova1, Jordi Anton1, Marie Macku1, William J Otero Escalante1, Lidia Rutkowska-Sak1, Ralf Trauzeddel1, Patricia J Velez-Sanchez1, Carine Wouters1, Joseph Wajdula1, Chuanbo Zang1, Jack Bukowski1, Deborah Woodworth1, Bonnie Vlahos1, Alberto Martini1, Nicolino Ruperto1. 1. From the Paediatric Rheumatology International Trials Organisation (PRINTO), Istituto G. Gaslini, Pediatria II-Reumatologia, PRINTO, Genoa, Italy.T. Constantin, MD, PhD, 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary; I. Foeldvari, MD, Hamburg Centre for Child and Adolescent Rheumatology, Hamburg, Germany; J. Vojinovic, MD, PhD, Clinic of Pediatrics, Clinical Centre, Faculty of Medicine, University of Nis, Serbia; G. Horneff, MD, Asklepios Clinic, Sankt Augustin, Germany; R. Burgos-Vargas, MD, Hospital General de Mexico, Mexico City, Mexico; I. Nikishina, MD, V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; J.D. Akikusa, MD, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia; T. Avcin, MD, PhD, University Medical Centre Ljubljana, Pediatric Clinic, Ljubljana, Slovenia; J. Chaitow, MD, The Sydney Children's Hospital Network, Westmead, Sydney, Australia; E. Koskova, MD, PhD, National Institute of Rheumatic Diseases, Piestany, Slovakia; B.R. Lauwerys, MD, PhD, Institut de Recherche Expérimentale et Clinique, Université catholique de Louvain and Department of Rheumatology, Cliniques Universitaires Saint-Luc, Brussels, Belgium; I. Calvo Penades, MD, PhD, Hospital Universitario y Politécnico La Fe, Pediatric Rheumatology Unit, Valencia, Spain; B. Flato, MD, PhD, Oslo University Hospital, Department of Rheumatology, Oslo, Norway; M.L. Gamir, MD, Hospital Ramon y Cajal Unidad de Reumatologia Pediatrica, Madrid, Spain; H.I. Huppertz, MD, Klinikum Bremen-Mitte, Prof. Hess-Kinderklinik, Bremen, Germany; J.J. Raad, MD, Centro de Reumatologia y Ortopedia, Barranquilla, Atlantico, Colombia; K. Jarosova, MD, Revmatologicky Ustav, Prague, Czech Republic; J. Anton, MD, PhD, Pediatric Rheumatology Unit, Hospital Sant Joan de Déu, Universitat de Barcelona, Espluges (Barcelona), Spain; M. Macku, MD, Fakultni nemocnice Brno, Bohunice, Detska Nemocnice, Ambulance detske revmatologie detske kliniky, Brno, Czech Republic; W.J. O
Abstract
OBJECTIVE: The main objective was to determine the 2-year clinical benefit and safety of etanercept (ETN) in children with the juvenile idiopathic arthritis (JIA) categories of extended oligoarthritis (eoJIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA). METHODS: CLIPPER was a 96-week, phase IIIb, open-label, multicenter study. Patients with eoJIA, ERA, or PsA received ETN 0.8 mg/kg once weekly (50 mg max) for up to 96 weeks. The proportions of patients reaching the JIA American College of Rheumatology (ACR) 30/50/70/90/100 and inactive disease responses at Week 96 were calculated. Adverse events (AE) were collected throughout the study (intention-to-treat sample). RESULTS: There were 127 patients (eoJIA n = 60, ERA n = 38, PsA n = 29) who received ≥ 1 dose of ETN. The mean disease duration was 31.6 (eoJIA), 23.0 (ERA), and 21.8 (PsA) months. At Week 96, JIA ACR 30/50/70/90/100/inactive disease responses (95% CI) were achieved by 84.3% (76.7, 90.1), 83.5% (75.8, 89.5), 78.7% (70.6, 85.5), 55.1% (46.0, 63.9), 45.7% (36.8, 54.7), and 27.6% (20.0, 36.2) of patients, respectively. The most common AE (no. events, events per 100 patient-yrs) overall were headache (23, 10.7), pyrexia (12, 5.6), and diarrhea (10, 4.6). The most common infections were upper respiratory tract infection (83, 38.6), pharyngitis (50, 23.2), gastroenteritis (22, 10.2), bronchitis (19, 8.8), and rhinitis (17, 7.9). No cases of malignancy, active tuberculosis, demyelinating disorders, or death were reported. CONCLUSION: Over 96 weeks of therapy, ETN demonstrated sustained efficacy at treating the clinical symptoms of all 3 JIA categories, with no major safety issues.
OBJECTIVE: The main objective was to determine the 2-year clinical benefit and safety of etanercept (ETN) in children with the juvenile idiopathic arthritis (JIA) categories of extended oligoarthritis (eoJIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA). METHODS:CLIPPER was a 96-week, phase IIIb, open-label, multicenter study. Patients with eoJIA, ERA, or PsA received ETN 0.8 mg/kg once weekly (50 mg max) for up to 96 weeks. The proportions of patients reaching the JIA American College of Rheumatology (ACR) 30/50/70/90/100 and inactive disease responses at Week 96 were calculated. Adverse events (AE) were collected throughout the study (intention-to-treat sample). RESULTS: There were 127 patients (eoJIA n = 60, ERA n = 38, PsA n = 29) who received ≥ 1 dose of ETN. The mean disease duration was 31.6 (eoJIA), 23.0 (ERA), and 21.8 (PsA) months. At Week 96, JIA ACR 30/50/70/90/100/inactive disease responses (95% CI) were achieved by 84.3% (76.7, 90.1), 83.5% (75.8, 89.5), 78.7% (70.6, 85.5), 55.1% (46.0, 63.9), 45.7% (36.8, 54.7), and 27.6% (20.0, 36.2) of patients, respectively. The most common AE (no. events, events per 100 patient-yrs) overall were headache (23, 10.7), pyrexia (12, 5.6), and diarrhea (10, 4.6). The most common infections were upper respiratory tract infection (83, 38.6), pharyngitis (50, 23.2), gastroenteritis (22, 10.2), bronchitis (19, 8.8), and rhinitis (17, 7.9). No cases of malignancy, active tuberculosis, demyelinating disorders, or death were reported. CONCLUSION: Over 96 weeks of therapy, ETN demonstrated sustained efficacy at treating the clinical symptoms of all 3 JIA categories, with no major safety issues.
Authors: Sarah Ringold; Sheila T Angeles-Han; Timothy Beukelman; Daniel Lovell; Carlos A Cuello; Mara L Becker; Robert A Colbert; Brian M Feldman; Polly J Ferguson; Harry Gewanter; Jaime Guzman; Jennifer Horonjeff; Peter A Nigrovic; Michael J Ombrello; Murray H Passo; Matthew L Stoll; C Egla Rabinovich; Rayfel Schneider; Olha Halyabar; Kimberly Hays; Amit Aakash Shah; Nancy Sullivan; Ann Marie Szymanski; Marat Turgunbaev; Amy Turner; James Reston Journal: Arthritis Care Res (Hoboken) Date: 2019-04-25 Impact factor: 4.794
Authors: Sarah Ringold; Sheila T Angeles-Han; Timothy Beukelman; Daniel Lovell; Carlos A Cuello; Mara L Becker; Robert A Colbert; Brian M Feldman; Polly J Ferguson; Harry Gewanter; Jaime Guzman; Jennifer Horonjeff; Peter A Nigrovic; Michael J Ombrello; Murray H Passo; Matthew L Stoll; C Egla Rabinovich; Rayfel Schneider; Olha Halyabar; Kimberly Hays; Amit Aakash Shah; Nancy Sullivan; Ann Marie Szymanski; Marat Turgunbaev; Amy Turner; James Reston Journal: Arthritis Rheumatol Date: 2019-04-25 Impact factor: 10.995
Authors: Jelena Bašić; Jelena Vojinović; Tatjana Jevtović-Stoimenov; Milena Despotović; Tatjana Cvetković; Dragana Lazarević; Gordana Sušić; Vuk Milošević; Mina Cvetković; Dušica Pavlović Journal: Rheumatol Int Date: 2019-01-24 Impact factor: 2.631
Authors: Ivan Foeldvari; Tamàs Constantin; Jelena Vojinović; Gerd Horneff; Vyacheslav Chasnyk; Joke Dehoorne; Violeta Panaviene; Gordana Sušić; Valda Stanevicha; Katarzyna Kobusinska; Zbigniew Zuber; Bogna Dobrzyniecka; Irina Nikishina; Brigitte Bader-Meunier; Luciana Breda; Pavla Doležalová; Chantal Job-Deslandre; Ingrida Rumba-Rozenfelde; Nico Wulffraat; Ronald D Pedersen; Jack F Bukowski; Bonnie Vlahos; Alberto Martini; Nicolino Ruperto Journal: Arthritis Res Ther Date: 2019-05-23 Impact factor: 5.156
Authors: Pamela F Weiss; Timothy G Brandon; Meghan E Ryan; Erin B Treemarcki; Stephanie Armendariz; Tracey B Wright; Chetna Godiwala; Matthew L Stoll; Rui Xiao; Daniel Lovell Journal: Arthritis Care Res (Hoboken) Date: 2021-08-07 Impact factor: 5.178