Two-year efficacy and safety of etanercept in pediatric patients with extended oligoarthritis, enthesitisrelated arthritis, or psoriatic arthritis

T. Constantin, Ivan Foeldvari, Jelena Vojinovic, Gerd Horneff, Ruben Burgos-Vargas, Irina Nikishina, Jonathan D. Akikusa, Tadej Avcin, Jeffrey Chaitow, Elena Koskova, Bernard R. Lauwerys, Inmaculada Calvo Penades, Berit Flato, Maria Luz Gamir, Hans Iko Huppertz, Juan Jose Jaller Raad, Katerina Jarosova, Jordi Anton, Marie Macku, William J. Otero Escalante & 11 others Lidia Rutkowska-Sak, Ralf Trauzeddel, Patricia J. Velez-Sanchez, Carine Wouters, Joseph Wajdula, Chuanbo Zang, Jack Bukowski, Deborah Woodworth, Bonnie Vlahos, Alberto Martini, Nicolino Ruperto

Research output: Contribution to journalArticle

16 Citations (Scopus)

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. The Journal of Rheumatology

Original languageEnglish
Pages (from-to)816-824
Number of pages9
JournalJournal of Rheumatology
Volume43
Issue number4
DOIs
Publication statusPublished - Apr 1 2016

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Psoriatic Arthritis
Juvenile Arthritis
Arthritis
Pediatrics
Safety
Rheumatology
Pharyngitis
Bronchitis
Gastroenteritis
Demyelinating Diseases
Rhinitis
Respiratory Tract Infections
Multicenter Studies
Headache
Diarrhea
Tuberculosis
Fever
Etanercept
Infection
Neoplasms

Keywords

  • Clinical trial
  • Enthesitis-related arthritis
  • Etanercept
  • Extended oligoarthritis
  • Juvenile idiopathic arthritis
  • Psoriatic arthritis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Medicine(all)

Cite this

Two-year efficacy and safety of etanercept in pediatric patients with extended oligoarthritis, enthesitisrelated arthritis, or psoriatic arthritis. / Constantin, T.; Foeldvari, Ivan; Vojinovic, Jelena; Horneff, Gerd; Burgos-Vargas, Ruben; Nikishina, Irina; Akikusa, Jonathan D.; Avcin, Tadej; Chaitow, Jeffrey; Koskova, Elena; Lauwerys, Bernard R.; Penades, Inmaculada Calvo; Flato, Berit; Gamir, Maria Luz; Huppertz, Hans Iko; Raad, Juan Jose Jaller; 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.

In: Journal of Rheumatology, Vol. 43, No. 4, 01.04.2016, p. 816-824.

Research output: Contribution to journalArticle

Constantin, T, Foeldvari, I, Vojinovic, J, Horneff, G, Burgos-Vargas, R, Nikishina, I, Akikusa, JD, Avcin, T, Chaitow, J, Koskova, E, Lauwerys, BR, Penades, IC, Flato, B, Gamir, ML, Huppertz, HI, Raad, JJJ, 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 2016, 'Two-year efficacy and safety of etanercept in pediatric patients with extended oligoarthritis, enthesitisrelated arthritis, or psoriatic arthritis', Journal of Rheumatology, vol. 43, no. 4, pp. 816-824. https://doi.org/10.3899/jrheum.150430
Constantin, T. ; Foeldvari, Ivan ; Vojinovic, Jelena ; Horneff, Gerd ; Burgos-Vargas, Ruben ; Nikishina, Irina ; Akikusa, Jonathan D. ; Avcin, Tadej ; Chaitow, Jeffrey ; Koskova, Elena ; Lauwerys, Bernard R. ; Penades, Inmaculada Calvo ; Flato, Berit ; Gamir, Maria Luz ; Huppertz, Hans Iko ; Raad, Juan Jose Jaller ; 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. / Two-year efficacy and safety of etanercept in pediatric patients with extended oligoarthritis, enthesitisrelated arthritis, or psoriatic arthritis. In: Journal of Rheumatology. 2016 ; Vol. 43, No. 4. pp. 816-824.
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TY - JOUR

T1 - Two-year efficacy and safety of etanercept in pediatric patients with extended oligoarthritis, enthesitisrelated arthritis, or psoriatic arthritis

AU - Constantin, T.

AU - Foeldvari, Ivan

AU - Vojinovic, Jelena

AU - Horneff, Gerd

AU - Burgos-Vargas, Ruben

AU - Nikishina, Irina

AU - Akikusa, Jonathan D.

AU - Avcin, Tadej

AU - Chaitow, Jeffrey

AU - Koskova, Elena

AU - Lauwerys, Bernard R.

AU - Penades, Inmaculada Calvo

AU - Flato, Berit

AU - Gamir, Maria Luz

AU - Huppertz, Hans Iko

AU - Raad, Juan Jose Jaller

AU - Jarosova, Katerina

AU - Anton, Jordi

AU - Macku, Marie

AU - Otero Escalante, William J.

AU - Rutkowska-Sak, Lidia

AU - Trauzeddel, Ralf

AU - Velez-Sanchez, Patricia J.

AU - Wouters, Carine

AU - Wajdula, Joseph

AU - Zang, Chuanbo

AU - Bukowski, Jack

AU - Woodworth, Deborah

AU - Vlahos, Bonnie

AU - Martini, Alberto

AU - Ruperto, Nicolino

PY - 2016/4/1

Y1 - 2016/4/1

N2 - 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. The Journal of Rheumatology

AB - 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. The Journal of Rheumatology

KW - Clinical trial

KW - Enthesitis-related arthritis

KW - Etanercept

KW - Extended oligoarthritis

KW - Juvenile idiopathic arthritis

KW - Psoriatic arthritis

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