Efficacy and safety of open-label etanercept on extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis and psoriatic arthritis: Part 1 (week 12) of the CLIPPER study

Gerd Horneff, Ruben Burgos-Vargas, T. Constantin, Ivan Foeldvari, Jelena Vojinovic, Vyacheslav G. Chasnyk, Joke Dehoorne, Violeta Panaviene, Gordana Susic, Valda Stanevica, Katarzyna Kobusinska, Zbigniew Zuber, Richard Mouy, Ingrida Rumba-Rozenfelde, Luciana Breda, Pavla Dolezalova, Chantal Job-Deslandre, Nico Wulffraat, Daniel Alvarez, Chuanbo ZangJoseph Wajdula, Deborah Woodworth, Bonnie Vlahos, Alberto Martini, Nicolino Ruperto

Research output: Contribution to journalArticle

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Abstract

Objective To investigate the efficacy and safety of etanercept (ETN) in paediatric subjects with extended oligoarticular juvenile idiopathic arthritis (eoJIA), enthesitisrelated arthritis (ERA), or psoriatic arthritis (PsA). Methods: CLIPPER is an ongoing, Phase 3b, open-label, multicentre study; the 12-week (Part 1) data are reported here. Subjects with eoJIA (2-17 years), ERA (12-17 years), or PsA (12-17 years) received ETN 0.8 mg/kg once weekly (maximum 50 mg). Primary endpoint was the percentage of subjects achieving JIA American College of Rheumatology (ACR) 30 criteria at week 12; secondary outcomes included JIA ACR 50/70/90 and inactive disease. Results: 122/127 (96.1%) subjects completed the study (mean age 11.7 years). JIA ACR 30 (95% CI) was achieved by 88.6% (81.6% to 93.6%) of subjects overall; 89.7% (78.8% to 96.1%) with eoJIA, 83.3% (67.2% to 93.6%) with ERA and 93.1% (77.2% to 99.2%) with PsA. For eoJIA, ERA, or PsA categories, the ORs of ETN vs the historical placebo data were 26.2, 15.1 and 40.7, respectively. Overall JIA ACR 50, 70, 90 and inactive disease were achieved by 81.1, 61.5, 29.8 and 12.1%, respectively. Treatment-emergent adverse events (AEs), infections, and serious AEs, were reported in 45 (35.4%), 58 (45.7%), and 4 (3.1%), subjects, respectively. Serious AEs were one case each of abdominal pain, bronchopneumonia, gastroenteritis and pyelocystitis. One subject reported herpes zoster and another varicella. No differences in safety were observed across the JIA categories. Conclusions: ETN treatment for 12 weeks was effective and well tolerated in paediatric subjects with eoJIA, ERA and PsA, with no unexpected safety findings.

Original languageEnglish
Pages (from-to)1114-1122
Number of pages9
JournalAnnals of the Rheumatic Diseases
Volume73
Issue number6
DOIs
Publication statusPublished - 2014

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Psoriatic Arthritis
Juvenile Arthritis
Arthritis
Labels
Safety
Rheumatology
Pediatrics
Pyelocystitis
Bronchopneumonia
Chickenpox
Herpes Zoster
Gastroenteritis
Abdominal Pain
Multicenter Studies
Placebos
Etanercept
Therapeutics
Infection

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)
  • Immunology and Allergy

Cite this

Efficacy and safety of open-label etanercept on extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis and psoriatic arthritis : Part 1 (week 12) of the CLIPPER study. / Horneff, Gerd; Burgos-Vargas, Ruben; Constantin, T.; Foeldvari, Ivan; Vojinovic, Jelena; Chasnyk, Vyacheslav G.; Dehoorne, Joke; Panaviene, Violeta; Susic, Gordana; Stanevica, Valda; Kobusinska, Katarzyna; Zuber, Zbigniew; Mouy, Richard; Rumba-Rozenfelde, Ingrida; Breda, Luciana; Dolezalova, Pavla; Job-Deslandre, Chantal; Wulffraat, Nico; Alvarez, Daniel; Zang, Chuanbo; Wajdula, Joseph; Woodworth, Deborah; Vlahos, Bonnie; Martini, Alberto; Ruperto, Nicolino.

In: Annals of the Rheumatic Diseases, Vol. 73, No. 6, 2014, p. 1114-1122.

Research output: Contribution to journalArticle

Horneff, G, Burgos-Vargas, R, Constantin, T, Foeldvari, I, Vojinovic, J, Chasnyk, VG, Dehoorne, J, Panaviene, V, Susic, G, Stanevica, V, Kobusinska, K, Zuber, Z, Mouy, R, Rumba-Rozenfelde, I, Breda, L, Dolezalova, P, Job-Deslandre, C, Wulffraat, N, Alvarez, D, Zang, C, Wajdula, J, Woodworth, D, Vlahos, B, Martini, A & Ruperto, N 2014, 'Efficacy and safety of open-label etanercept on extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis and psoriatic arthritis: Part 1 (week 12) of the CLIPPER study', Annals of the Rheumatic Diseases, vol. 73, no. 6, pp. 1114-1122. https://doi.org/10.1136/annrheumdis-2012-203046
Horneff, Gerd ; Burgos-Vargas, Ruben ; Constantin, T. ; Foeldvari, Ivan ; Vojinovic, Jelena ; Chasnyk, Vyacheslav G. ; Dehoorne, Joke ; Panaviene, Violeta ; Susic, Gordana ; Stanevica, Valda ; Kobusinska, Katarzyna ; Zuber, Zbigniew ; Mouy, Richard ; Rumba-Rozenfelde, Ingrida ; Breda, Luciana ; Dolezalova, Pavla ; Job-Deslandre, Chantal ; Wulffraat, Nico ; Alvarez, Daniel ; Zang, Chuanbo ; Wajdula, Joseph ; Woodworth, Deborah ; Vlahos, Bonnie ; Martini, Alberto ; Ruperto, Nicolino. / Efficacy and safety of open-label etanercept on extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis and psoriatic arthritis : Part 1 (week 12) of the CLIPPER study. In: Annals of the Rheumatic Diseases. 2014 ; Vol. 73, No. 6. pp. 1114-1122.
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title = "Efficacy and safety of open-label etanercept on extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis and psoriatic arthritis: Part 1 (week 12) of the CLIPPER study",
abstract = "Objective To investigate the efficacy and safety of etanercept (ETN) in paediatric subjects with extended oligoarticular juvenile idiopathic arthritis (eoJIA), enthesitisrelated arthritis (ERA), or psoriatic arthritis (PsA). Methods: CLIPPER is an ongoing, Phase 3b, open-label, multicentre study; the 12-week (Part 1) data are reported here. Subjects with eoJIA (2-17 years), ERA (12-17 years), or PsA (12-17 years) received ETN 0.8 mg/kg once weekly (maximum 50 mg). Primary endpoint was the percentage of subjects achieving JIA American College of Rheumatology (ACR) 30 criteria at week 12; secondary outcomes included JIA ACR 50/70/90 and inactive disease. Results: 122/127 (96.1{\%}) subjects completed the study (mean age 11.7 years). JIA ACR 30 (95{\%} CI) was achieved by 88.6{\%} (81.6{\%} to 93.6{\%}) of subjects overall; 89.7{\%} (78.8{\%} to 96.1{\%}) with eoJIA, 83.3{\%} (67.2{\%} to 93.6{\%}) with ERA and 93.1{\%} (77.2{\%} to 99.2{\%}) with PsA. For eoJIA, ERA, or PsA categories, the ORs of ETN vs the historical placebo data were 26.2, 15.1 and 40.7, respectively. Overall JIA ACR 50, 70, 90 and inactive disease were achieved by 81.1, 61.5, 29.8 and 12.1{\%}, respectively. Treatment-emergent adverse events (AEs), infections, and serious AEs, were reported in 45 (35.4{\%}), 58 (45.7{\%}), and 4 (3.1{\%}), subjects, respectively. Serious AEs were one case each of abdominal pain, bronchopneumonia, gastroenteritis and pyelocystitis. One subject reported herpes zoster and another varicella. No differences in safety were observed across the JIA categories. Conclusions: ETN treatment for 12 weeks was effective and well tolerated in paediatric subjects with eoJIA, ERA and PsA, with no unexpected safety findings.",
author = "Gerd Horneff and Ruben Burgos-Vargas and T. Constantin and Ivan Foeldvari and Jelena Vojinovic and Chasnyk, {Vyacheslav G.} and Joke Dehoorne and Violeta Panaviene and Gordana Susic and Valda Stanevica and Katarzyna Kobusinska and Zbigniew Zuber and Richard Mouy and Ingrida Rumba-Rozenfelde and Luciana Breda and Pavla Dolezalova and Chantal Job-Deslandre and Nico Wulffraat and Daniel Alvarez and Chuanbo Zang and Joseph Wajdula and Deborah Woodworth and Bonnie Vlahos and Alberto Martini and Nicolino Ruperto",
year = "2014",
doi = "10.1136/annrheumdis-2012-203046",
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TY - JOUR

T1 - Efficacy and safety of open-label etanercept on extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis and psoriatic arthritis

T2 - Part 1 (week 12) of the CLIPPER study

AU - Horneff, Gerd

AU - Burgos-Vargas, Ruben

AU - Constantin, T.

AU - Foeldvari, Ivan

AU - Vojinovic, Jelena

AU - Chasnyk, Vyacheslav G.

AU - Dehoorne, Joke

AU - Panaviene, Violeta

AU - Susic, Gordana

AU - Stanevica, Valda

AU - Kobusinska, Katarzyna

AU - Zuber, Zbigniew

AU - Mouy, Richard

AU - Rumba-Rozenfelde, Ingrida

AU - Breda, Luciana

AU - Dolezalova, Pavla

AU - Job-Deslandre, Chantal

AU - Wulffraat, Nico

AU - Alvarez, Daniel

AU - Zang, Chuanbo

AU - Wajdula, Joseph

AU - Woodworth, Deborah

AU - Vlahos, Bonnie

AU - Martini, Alberto

AU - Ruperto, Nicolino

PY - 2014

Y1 - 2014

N2 - Objective To investigate the efficacy and safety of etanercept (ETN) in paediatric subjects with extended oligoarticular juvenile idiopathic arthritis (eoJIA), enthesitisrelated arthritis (ERA), or psoriatic arthritis (PsA). Methods: CLIPPER is an ongoing, Phase 3b, open-label, multicentre study; the 12-week (Part 1) data are reported here. Subjects with eoJIA (2-17 years), ERA (12-17 years), or PsA (12-17 years) received ETN 0.8 mg/kg once weekly (maximum 50 mg). Primary endpoint was the percentage of subjects achieving JIA American College of Rheumatology (ACR) 30 criteria at week 12; secondary outcomes included JIA ACR 50/70/90 and inactive disease. Results: 122/127 (96.1%) subjects completed the study (mean age 11.7 years). JIA ACR 30 (95% CI) was achieved by 88.6% (81.6% to 93.6%) of subjects overall; 89.7% (78.8% to 96.1%) with eoJIA, 83.3% (67.2% to 93.6%) with ERA and 93.1% (77.2% to 99.2%) with PsA. For eoJIA, ERA, or PsA categories, the ORs of ETN vs the historical placebo data were 26.2, 15.1 and 40.7, respectively. Overall JIA ACR 50, 70, 90 and inactive disease were achieved by 81.1, 61.5, 29.8 and 12.1%, respectively. Treatment-emergent adverse events (AEs), infections, and serious AEs, were reported in 45 (35.4%), 58 (45.7%), and 4 (3.1%), subjects, respectively. Serious AEs were one case each of abdominal pain, bronchopneumonia, gastroenteritis and pyelocystitis. One subject reported herpes zoster and another varicella. No differences in safety were observed across the JIA categories. Conclusions: ETN treatment for 12 weeks was effective and well tolerated in paediatric subjects with eoJIA, ERA and PsA, with no unexpected safety findings.

AB - Objective To investigate the efficacy and safety of etanercept (ETN) in paediatric subjects with extended oligoarticular juvenile idiopathic arthritis (eoJIA), enthesitisrelated arthritis (ERA), or psoriatic arthritis (PsA). Methods: CLIPPER is an ongoing, Phase 3b, open-label, multicentre study; the 12-week (Part 1) data are reported here. Subjects with eoJIA (2-17 years), ERA (12-17 years), or PsA (12-17 years) received ETN 0.8 mg/kg once weekly (maximum 50 mg). Primary endpoint was the percentage of subjects achieving JIA American College of Rheumatology (ACR) 30 criteria at week 12; secondary outcomes included JIA ACR 50/70/90 and inactive disease. Results: 122/127 (96.1%) subjects completed the study (mean age 11.7 years). JIA ACR 30 (95% CI) was achieved by 88.6% (81.6% to 93.6%) of subjects overall; 89.7% (78.8% to 96.1%) with eoJIA, 83.3% (67.2% to 93.6%) with ERA and 93.1% (77.2% to 99.2%) with PsA. For eoJIA, ERA, or PsA categories, the ORs of ETN vs the historical placebo data were 26.2, 15.1 and 40.7, respectively. Overall JIA ACR 50, 70, 90 and inactive disease were achieved by 81.1, 61.5, 29.8 and 12.1%, respectively. Treatment-emergent adverse events (AEs), infections, and serious AEs, were reported in 45 (35.4%), 58 (45.7%), and 4 (3.1%), subjects, respectively. Serious AEs were one case each of abdominal pain, bronchopneumonia, gastroenteritis and pyelocystitis. One subject reported herpes zoster and another varicella. No differences in safety were observed across the JIA categories. Conclusions: ETN treatment for 12 weeks was effective and well tolerated in paediatric subjects with eoJIA, ERA and PsA, with no unexpected safety findings.

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