依那西普治疗儿童扩展性少关节炎、附着点炎相关关节炎或银屑病关节炎的两年疗效及安全性
Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis.
作者信息
Constantin Tamas, Foeldvari Ivan, Vojinovic Jelena, Horneff Gerd, Burgos-Vargas Ruben, Nikishina Irina, Akikusa Jonathan D, Avcin Tadej, Chaitow Jeffrey, Koskova Elena, Lauwerys Bernard R, Calvo Penades Inmaculada, Flato Berit, Gamir Maria Luz, Huppertz Hans-Iko, Jaller Raad Juan Jose, Jarosova Katerina, Anton Jordi, Macku Marie, Otero Escalante William J, Rutkowska-Sak Lidia, Trauzeddel Ralf, Velez-Sanchez Patricia J, Wouters Carine, Wajdula Joseph, Zang Chuanbo, Bukowski Jack, Woodworth Deborah, Vlahos Bonnie, Martini Alberto, Ruperto Nicolino
机构信息
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
出版信息
J Rheumatol. 2016 Apr;43(4):816-24. doi: 10.3899/jrheum.150430. Epub 2016 Mar 1.
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.
目的
主要目的是确定依那西普（ETN）在患有扩展性寡关节炎（eoJIA）、附着点炎相关关节炎（ERA）或银屑病关节炎（PsA）等青少年特发性关节炎（JIA）类别的儿童中的2年临床疗效和安全性。
方法
CLIPPER是一项为期96周的IIIb期开放标签多中心研究。eoJIA、ERA或PsA患者接受ETN 0.8mg/kg，每周一次（最大50mg），持续96周。计算在第96周达到JIA美国风湿病学会（ACR）30/50/70/90/100和疾病缓解的患者比例。在整个研究过程中收集不良事件（AE）（意向性治疗样本）。
结果
有127例患者（eoJIA n = 60，ERA n = 38，PsA n = 29）接受了≥1剂ETN。平均病程为31.6个月（eoJIA）、23.0个月（ERA）和21.8个月（PsA）。在第96周，达到JIA ACR 30/50/70/90/100/疾病缓解的患者比例（9
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