Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis

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 9...

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Autores: Constantin T, Foeldvari I, Vojinovic J, Horneff G, Burgos-Vargas R, Nikishina I, Akikusa JD, Avcin T, Chaitow J, Koskova E, Lauwerys BR, Calvo Penades I, Flato B, Gamir ML, Huppertz HI, Raad JJ, Jarosova K, Anton J, Macku M, Otero Escalante WJ, Rutkowska-Sak L, Trauzeddel R, Velez-Sanchez PJ, Wouters C, Wajdula J, Zang C, Bukowski J, Woodworth D, Vlahos B, Martini A, Ruperto N, Paediatric Rheumatology International Trials Organisation (PRINTO)
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2016
País:España
Institución:Fundació Sant Joan de Déu
Repositorio:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
OAI Identifier:oai:fsjd.fundanetsuite.com:p9183
Acceso en línea:https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=9183
Access Level:acceso abierto
Palabra clave:JUVENILE IDIOPATHIC ARTHRITIS
EXTENDED OLIGOARTHRITIS
ETANERCEPT
ENTHESITIS-RELATED ARTHRITIS
PSORIATIC ARTHRITIS
CLINICAL TRIAL
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spelling Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic ArthritisConstantin TFoeldvari IVojinovic JHorneff GBurgos-Vargas RNikishina IAkikusa JDAvcin TChaitow JKoskova ELauwerys BRCalvo Penades IFlato BGamir MLHuppertz HIRaad JJJarosova KAnton JMacku MOtero Escalante WJRutkowska-Sak LTrauzeddel RVelez-Sanchez PJWouters CWajdula JZang CBukowski JWoodworth DVlahos BMartini ARuperto NPaediatric Rheumatology International Trials Organisation (PRINTO)JUVENILE IDIOPATHIC ARTHRITISEXTENDED OLIGOARTHRITISETANERCEPTENTHESITIS-RELATED ARTHRITISPSORIATIC ARTHRITISCLINICAL TRIALObjective. 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.J RHEUMATOL PUBL CO2016info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=9183JOURNAL OF RHEUMATOLOGYISSN: 0315162XISSNe: 14992752reponame:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déuinstname:Fundació Sant Joan de DéuInglésinfo:eu-repo/semantics/openAccessoai:fsjd.fundanetsuite.com:p91832026-05-27T12:37:41Z
dc.title.none.fl_str_mv Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis
title Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis
spellingShingle Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis
Constantin T
JUVENILE IDIOPATHIC ARTHRITIS
EXTENDED OLIGOARTHRITIS
ETANERCEPT
ENTHESITIS-RELATED ARTHRITIS
PSORIATIC ARTHRITIS
CLINICAL TRIAL
title_short Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis
title_full Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis
title_fullStr Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis
title_full_unstemmed Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis
title_sort Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis
dc.creator.none.fl_str_mv Constantin T
Foeldvari I
Vojinovic J
Horneff G
Burgos-Vargas R
Nikishina I
Akikusa JD
Avcin T
Chaitow J
Koskova E
Lauwerys BR
Calvo Penades I
Flato B
Gamir ML
Huppertz HI
Raad JJ
Jarosova K
Anton J
Macku M
Otero Escalante WJ
Rutkowska-Sak L
Trauzeddel R
Velez-Sanchez PJ
Wouters C
Wajdula J
Zang C
Bukowski J
Woodworth D
Vlahos B
Martini A
Ruperto N
Paediatric Rheumatology International Trials Organisation (PRINTO)
author Constantin T
author_facet Constantin T
Foeldvari I
Vojinovic J
Horneff G
Burgos-Vargas R
Nikishina I
Akikusa JD
Avcin T
Chaitow J
Koskova E
Lauwerys BR
Calvo Penades I
Flato B
Gamir ML
Huppertz HI
Raad JJ
Jarosova K
Anton J
Macku M
Otero Escalante WJ
Rutkowska-Sak L
Trauzeddel R
Velez-Sanchez PJ
Wouters C
Wajdula J
Zang C
Bukowski J
Woodworth D
Vlahos B
Martini A
Ruperto N
Paediatric Rheumatology International Trials Organisation (PRINTO)
author_role author
author2 Foeldvari I
Vojinovic J
Horneff G
Burgos-Vargas R
Nikishina I
Akikusa JD
Avcin T
Chaitow J
Koskova E
Lauwerys BR
Calvo Penades I
Flato B
Gamir ML
Huppertz HI
Raad JJ
Jarosova K
Anton J
Macku M
Otero Escalante WJ
Rutkowska-Sak L
Trauzeddel R
Velez-Sanchez PJ
Wouters C
Wajdula J
Zang C
Bukowski J
Woodworth D
Vlahos B
Martini A
Ruperto N
Paediatric Rheumatology International Trials Organisation (PRINTO)
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv JUVENILE IDIOPATHIC ARTHRITIS
EXTENDED OLIGOARTHRITIS
ETANERCEPT
ENTHESITIS-RELATED ARTHRITIS
PSORIATIC ARTHRITIS
CLINICAL TRIAL
topic JUVENILE IDIOPATHIC ARTHRITIS
EXTENDED OLIGOARTHRITIS
ETANERCEPT
ENTHESITIS-RELATED ARTHRITIS
PSORIATIC ARTHRITIS
CLINICAL TRIAL
description 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.
publishDate 2016
dc.date.none.fl_str_mv 2016
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=9183
url https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=9183
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv J RHEUMATOL PUBL CO
publisher.none.fl_str_mv J RHEUMATOL PUBL CO
dc.source.none.fl_str_mv JOURNAL OF RHEUMATOLOGY
ISSN: 0315162X
ISSNe: 14992752
reponame:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
instname:Fundació Sant Joan de Déu
instname_str Fundació Sant Joan de Déu
reponame_str r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
collection r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
repository.name.fl_str_mv
repository.mail.fl_str_mv
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