Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis

6-year efficacy and safety data from an open-label trial

Ivan Foeldvari, T. 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 & 4 others Jack F. Bukowski, Bonnie Vlahos, Alberto Martini, Nicolino Ruperto

Research output: Contribution to journalArticle

Abstract

Background: To describe the 6-year safety and efficacy of etanercept (ETN) in children with extended oligoarticular juvenile idiopathic arthritis (eoJIA), enthesitis-related arthritis (ERA), and psoriatic arthritis (PsA) Methods: Patients who completed the 2-year, open-label, phase III CLinical Study In Pediatric Patients of Etanercept for Treatment of ERA, PsA, and Extended Oligoarthritis (CLIPPER) were allowed to enroll in its 8-year long-term extension (CLIPPER2). Children received ETN at a once-weekly dose of 0.8 mg/kg, up to a maximum dose of 50 mg/week. Efficacy assessments included the JIA core set of outcomes, the JIA American College of Rheumatology response criteria (JIA-ACR), and the Juvenile Arthritis Disease Activity Score (JADAS). Efficacy data are reported as responder analyses using a hybrid method for missing data imputation and as observed cases. Safety assessments included treatment-emergent adverse events (TEAEs). Results: Out of 127 patients originally enrolled in CLIPPER, 109 (86%) entered CLIPPER2. After 6 years of trial participation (2 years in CLIPPER and 4 years in CLIPPER2), 41 (32%) patients were still taking ETN, 13 (11%) entered the treatment withdrawal phase after achieving low/inactive disease (of whom 7 had to restart ETN), 36 (28%) discontinued treatment for other reasons but are still being observed, and 37 (29%) discontinued treatment permanently. According to the hybrid imputation analysis, proportions of patients achieving JIA ACR90, JIA ACR100, and JADAS inactive disease after the initial 2 years of treatment were 58%, 48%, and 32%, respectively. After the additional 4 years, those proportions in patients who remained in the trial were 46%, 35%, and 24%. Most frequently reported TEAEs [n (%), events per 100 patient-years] were headache [28 (22%), 5.3], arthralgia [24 (19%), 4.6], and pyrexia [20 (16%), 3.8]. Number and frequency of TEAEs, excluding infections and injection site reactions, decreased over the 6-year period from 193 and 173.8, respectively, during year 1 to 37 and 61.3 during year 6. A single case of malignancy (Hodgkin's lymphoma) and no cases of active tuberculosis, demyelinating disorders, or deaths were reported. Conclusions: Open-label etanercept treatment for up to 6 years was safe, well tolerated, and effective in patients with eoJIA, ERA, and PsA. Trial registration: ClinicalTrials.gov: CLIPPER, NCT00962741, registered 20 August, 2009, CLIPPER2, NCT01421069, registered 22 August, 2011.

Original languageEnglish
Article number125
JournalArthritis Research and Therapy
Volume21
Issue number1
DOIs
Publication statusPublished - May 23 2019

Fingerprint

Psoriatic Arthritis
Juvenile Arthritis
Arthritis
Safety
Therapeutics
Etanercept
Arthralgia
Demyelinating Diseases
Hodgkin Disease
Headache
Tuberculosis
Fever
Pediatrics
Injections

Keywords

  • Clinical trial
  • Efficacy
  • Enthesitis-related arthritis
  • Enthesitis-related arthritis (ERA)
  • Etanercept
  • Extended oligoarticular juvenile idiopathic arthritis (eoJIA)
  • Juvenile idiopathic arthritis
  • Psoriatic arthritis (PsA)
  • Safety

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis : 6-year efficacy and safety data from an open-label trial. / Foeldvari, Ivan; Constantin, T.; Vojinović, Jelena; Horneff, Gerd; Chasnyk, Vyacheslav; Dehoorne, Joke; Panaviene, Violeta; Sušić, Gordana; Stanevicha, Valda; Kobusinska, Katarzyna; Zuber, Zbigniew; Dobrzyniecka, Bogna; Nikishina, Irina; Bader-Meunier, Brigitte; Breda, Luciana; Doležalová, Pavla; Job-Deslandre, Chantal; Rumba-Rozenfelde, Ingrida; Wulffraat, Nico; Pedersen, Ronald D.; Bukowski, Jack F.; Vlahos, Bonnie; Martini, Alberto; Ruperto, Nicolino.

In: Arthritis Research and Therapy, Vol. 21, No. 1, 125, 23.05.2019.

Research output: Contribution to journalArticle

Foeldvari, I, Constantin, T, Vojinović, J, Horneff, G, Chasnyk, V, Dehoorne, J, Panaviene, V, Sušić, G, Stanevicha, V, Kobusinska, K, Zuber, Z, Dobrzyniecka, B, Nikishina, I, Bader-Meunier, B, Breda, L, Doležalová, P, Job-Deslandre, C, Rumba-Rozenfelde, I, Wulffraat, N, Pedersen, RD, Bukowski, JF, Vlahos, B, Martini, A & Ruperto, N 2019, 'Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial', Arthritis Research and Therapy, vol. 21, no. 1, 125. https://doi.org/10.1186/s13075-019-1916-9
Foeldvari, Ivan ; Constantin, T. ; Vojinović, Jelena ; Horneff, Gerd ; Chasnyk, Vyacheslav ; Dehoorne, Joke ; Panaviene, Violeta ; Sušić, Gordana ; Stanevicha, Valda ; Kobusinska, Katarzyna ; Zuber, Zbigniew ; Dobrzyniecka, Bogna ; Nikishina, Irina ; Bader-Meunier, Brigitte ; Breda, Luciana ; Doležalová, Pavla ; Job-Deslandre, Chantal ; Rumba-Rozenfelde, Ingrida ; Wulffraat, Nico ; Pedersen, Ronald D. ; Bukowski, Jack F. ; Vlahos, Bonnie ; Martini, Alberto ; Ruperto, Nicolino. / Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis : 6-year efficacy and safety data from an open-label trial. In: Arthritis Research and Therapy. 2019 ; Vol. 21, No. 1.
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abstract = "Background: To describe the 6-year safety and efficacy of etanercept (ETN) in children with extended oligoarticular juvenile idiopathic arthritis (eoJIA), enthesitis-related arthritis (ERA), and psoriatic arthritis (PsA) Methods: Patients who completed the 2-year, open-label, phase III CLinical Study In Pediatric Patients of Etanercept for Treatment of ERA, PsA, and Extended Oligoarthritis (CLIPPER) were allowed to enroll in its 8-year long-term extension (CLIPPER2). Children received ETN at a once-weekly dose of 0.8 mg/kg, up to a maximum dose of 50 mg/week. Efficacy assessments included the JIA core set of outcomes, the JIA American College of Rheumatology response criteria (JIA-ACR), and the Juvenile Arthritis Disease Activity Score (JADAS). Efficacy data are reported as responder analyses using a hybrid method for missing data imputation and as observed cases. Safety assessments included treatment-emergent adverse events (TEAEs). Results: Out of 127 patients originally enrolled in CLIPPER, 109 (86{\%}) entered CLIPPER2. After 6 years of trial participation (2 years in CLIPPER and 4 years in CLIPPER2), 41 (32{\%}) patients were still taking ETN, 13 (11{\%}) entered the treatment withdrawal phase after achieving low/inactive disease (of whom 7 had to restart ETN), 36 (28{\%}) discontinued treatment for other reasons but are still being observed, and 37 (29{\%}) discontinued treatment permanently. According to the hybrid imputation analysis, proportions of patients achieving JIA ACR90, JIA ACR100, and JADAS inactive disease after the initial 2 years of treatment were 58{\%}, 48{\%}, and 32{\%}, respectively. After the additional 4 years, those proportions in patients who remained in the trial were 46{\%}, 35{\%}, and 24{\%}. Most frequently reported TEAEs [n ({\%}), events per 100 patient-years] were headache [28 (22{\%}), 5.3], arthralgia [24 (19{\%}), 4.6], and pyrexia [20 (16{\%}), 3.8]. Number and frequency of TEAEs, excluding infections and injection site reactions, decreased over the 6-year period from 193 and 173.8, respectively, during year 1 to 37 and 61.3 during year 6. A single case of malignancy (Hodgkin's lymphoma) and no cases of active tuberculosis, demyelinating disorders, or deaths were reported. Conclusions: Open-label etanercept treatment for up to 6 years was safe, well tolerated, and effective in patients with eoJIA, ERA, and PsA. Trial registration: ClinicalTrials.gov: CLIPPER, NCT00962741, registered 20 August, 2009, CLIPPER2, NCT01421069, registered 22 August, 2011.",
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TY - JOUR

T1 - Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis

T2 - 6-year efficacy and safety data from an open-label trial

AU - Foeldvari, Ivan

AU - Constantin, T.

AU - Vojinović, Jelena

AU - Horneff, Gerd

AU - Chasnyk, Vyacheslav

AU - Dehoorne, Joke

AU - Panaviene, Violeta

AU - Sušić, Gordana

AU - Stanevicha, Valda

AU - Kobusinska, Katarzyna

AU - Zuber, Zbigniew

AU - Dobrzyniecka, Bogna

AU - Nikishina, Irina

AU - Bader-Meunier, Brigitte

AU - Breda, Luciana

AU - Doležalová, Pavla

AU - Job-Deslandre, Chantal

AU - Rumba-Rozenfelde, Ingrida

AU - Wulffraat, Nico

AU - Pedersen, Ronald D.

AU - Bukowski, Jack F.

AU - Vlahos, Bonnie

AU - Martini, Alberto

AU - Ruperto, Nicolino

PY - 2019/5/23

Y1 - 2019/5/23

N2 - Background: To describe the 6-year safety and efficacy of etanercept (ETN) in children with extended oligoarticular juvenile idiopathic arthritis (eoJIA), enthesitis-related arthritis (ERA), and psoriatic arthritis (PsA) Methods: Patients who completed the 2-year, open-label, phase III CLinical Study In Pediatric Patients of Etanercept for Treatment of ERA, PsA, and Extended Oligoarthritis (CLIPPER) were allowed to enroll in its 8-year long-term extension (CLIPPER2). Children received ETN at a once-weekly dose of 0.8 mg/kg, up to a maximum dose of 50 mg/week. Efficacy assessments included the JIA core set of outcomes, the JIA American College of Rheumatology response criteria (JIA-ACR), and the Juvenile Arthritis Disease Activity Score (JADAS). Efficacy data are reported as responder analyses using a hybrid method for missing data imputation and as observed cases. Safety assessments included treatment-emergent adverse events (TEAEs). Results: Out of 127 patients originally enrolled in CLIPPER, 109 (86%) entered CLIPPER2. After 6 years of trial participation (2 years in CLIPPER and 4 years in CLIPPER2), 41 (32%) patients were still taking ETN, 13 (11%) entered the treatment withdrawal phase after achieving low/inactive disease (of whom 7 had to restart ETN), 36 (28%) discontinued treatment for other reasons but are still being observed, and 37 (29%) discontinued treatment permanently. According to the hybrid imputation analysis, proportions of patients achieving JIA ACR90, JIA ACR100, and JADAS inactive disease after the initial 2 years of treatment were 58%, 48%, and 32%, respectively. After the additional 4 years, those proportions in patients who remained in the trial were 46%, 35%, and 24%. Most frequently reported TEAEs [n (%), events per 100 patient-years] were headache [28 (22%), 5.3], arthralgia [24 (19%), 4.6], and pyrexia [20 (16%), 3.8]. Number and frequency of TEAEs, excluding infections and injection site reactions, decreased over the 6-year period from 193 and 173.8, respectively, during year 1 to 37 and 61.3 during year 6. A single case of malignancy (Hodgkin's lymphoma) and no cases of active tuberculosis, demyelinating disorders, or deaths were reported. Conclusions: Open-label etanercept treatment for up to 6 years was safe, well tolerated, and effective in patients with eoJIA, ERA, and PsA. Trial registration: ClinicalTrials.gov: CLIPPER, NCT00962741, registered 20 August, 2009, CLIPPER2, NCT01421069, registered 22 August, 2011.

AB - Background: To describe the 6-year safety and efficacy of etanercept (ETN) in children with extended oligoarticular juvenile idiopathic arthritis (eoJIA), enthesitis-related arthritis (ERA), and psoriatic arthritis (PsA) Methods: Patients who completed the 2-year, open-label, phase III CLinical Study In Pediatric Patients of Etanercept for Treatment of ERA, PsA, and Extended Oligoarthritis (CLIPPER) were allowed to enroll in its 8-year long-term extension (CLIPPER2). Children received ETN at a once-weekly dose of 0.8 mg/kg, up to a maximum dose of 50 mg/week. Efficacy assessments included the JIA core set of outcomes, the JIA American College of Rheumatology response criteria (JIA-ACR), and the Juvenile Arthritis Disease Activity Score (JADAS). Efficacy data are reported as responder analyses using a hybrid method for missing data imputation and as observed cases. Safety assessments included treatment-emergent adverse events (TEAEs). Results: Out of 127 patients originally enrolled in CLIPPER, 109 (86%) entered CLIPPER2. After 6 years of trial participation (2 years in CLIPPER and 4 years in CLIPPER2), 41 (32%) patients were still taking ETN, 13 (11%) entered the treatment withdrawal phase after achieving low/inactive disease (of whom 7 had to restart ETN), 36 (28%) discontinued treatment for other reasons but are still being observed, and 37 (29%) discontinued treatment permanently. According to the hybrid imputation analysis, proportions of patients achieving JIA ACR90, JIA ACR100, and JADAS inactive disease after the initial 2 years of treatment were 58%, 48%, and 32%, respectively. After the additional 4 years, those proportions in patients who remained in the trial were 46%, 35%, and 24%. Most frequently reported TEAEs [n (%), events per 100 patient-years] were headache [28 (22%), 5.3], arthralgia [24 (19%), 4.6], and pyrexia [20 (16%), 3.8]. Number and frequency of TEAEs, excluding infections and injection site reactions, decreased over the 6-year period from 193 and 173.8, respectively, during year 1 to 37 and 61.3 during year 6. A single case of malignancy (Hodgkin's lymphoma) and no cases of active tuberculosis, demyelinating disorders, or deaths were reported. Conclusions: Open-label etanercept treatment for up to 6 years was safe, well tolerated, and effective in patients with eoJIA, ERA, and PsA. Trial registration: ClinicalTrials.gov: CLIPPER, NCT00962741, registered 20 August, 2009, CLIPPER2, NCT01421069, registered 22 August, 2011.

KW - Clinical trial

KW - Efficacy

KW - Enthesitis-related arthritis

KW - Enthesitis-related arthritis (ERA)

KW - Etanercept

KW - Extended oligoarticular juvenile idiopathic arthritis (eoJIA)

KW - Juvenile idiopathic arthritis

KW - Psoriatic arthritis (PsA)

KW - Safety

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