ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 398

Predictors of Clinical Remission with Etanercept in Pediatric Patients with Extended Oligoarticular, Enthesitis-Related Arthritis and Psoriatic Arthritis: Findings from the Clipper Study

Nicolino Ruperto1, Alessandro Consolaro2, Gerd Horneff1, Rubén Burgos-Vargas1, Tamas Constantin1, Ivan Foeldvari1, Jelena Vojinovic1, Joke Dehoorne1, Violeta Vladislava Panaviene1, Gordana Susic1, Valda Stanevicha1, Katarzyna Kobusinska1, Zbigniew Zuber3, Richard Mouy1, Ingrida Rumba-Rozenfelde1, Pavla Dolezalová1, Chantal Job-deslandre4, Nico M Wulffraat1, Ronald Pedersen5, Jack F Bukowski6, Tina Hinnershitz7, Bonnie Vlahos8 and Alberto Martini9, 1Paediatric Rheumatology International Trials Organisation (PRINTO), Genoa, Italy, 2Istituto Giannina Gaslini, Genoa, Italy, 3St Louis Children’s Hospital ODS Rheumatology and Neurology, Krakow, Poland, 4Pediatria II, Reumatologia, PRINTO, Istituto Giannina Gaslini, Genoa, Italy, 5Department of Biostatistics, Pfizer, Collegeville, PA, 6Clinical Affairs, Pfizer, Collegeville, PA, 7Specialty Care MDG, Pfizer, Collegeville, PA, 8GIPB - Clinical Sciences, Pfizer, Collegeville, PA, 9PRINTO-IRCCS, Genoa, Italy

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: , ,

Session Information

Date: Sunday, November 13, 2016

Title: Pediatric Rheumatology – Clinical and Therapeutic Aspects - Poster I: Juvenile Idiopathic Arthritis, Uveitis

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Etanercept (ETN) is approved in the EU for the treatment of children with juvenile idiopathic arthritis (JIA) categories of polyarticular, extended oligoarticular (eoJIA), enthesitis-related arthritis (ERA), and psoriatic arthritis (PsA), but little evidence is currently available regarding predictors of clinical remission. We evaluated characteristics that may have predicted the achievement of clinical remission with ETN in the CLIPPER study.

Methods: In this ongoing, Phase 3b, open-label study, pediatric patients with eoJIA (2–17 y), ERA (12–17 y), or PsA (12–17 y) received ETN 0.8 mg/kg once weekly (maximum, 50 mg) for up to 96 weeks. Baseline demographic and disease characteristics that were significantly different (p<0.05) between children in remission or with active disease were analysed post hoc as categorical predictors (i.e., dichotomized continuous characteristics) in univariate logistic regression models; response and disease activity status after 12 weeks of ETN treatment were also considered as predictive factors. Clinical remission was defined with the JIA ACR Wallace 2011 remission criteria or Juvenile Arthritis Disease Activity Score 71-joint reduced count (JADAS71) clinical remission criteria (≤1) persisting for ≥24 weeks.

Results: Of the 127 patients enrolled in the trial, 42 (33%) and 54 (43%) achieved JIA ACR or JADAS71 clinical remission over 24 weeks, respectively. In univariate analyses, patients who had lower BMI and were shorter at baseline and those who were younger at the time of disease onset were significantly more likely to achieve JIA ACR and JADAS71 remission (table). Age >11 vs ≤11 years at baseline and C-reactive protein level >2.4 mg/L vs ≤2.4 were significant predictors of JIA ACR remission; HLA-B27+ vs HLA-B27– status and >11 vs ≤11 joints with limitation of motion at baseline were predictors of JADAS71 remission. Induction of JIA ACR and JADAS71 responses at 12 weeks was also predictive of sustained ACR and JADAS71 responses for 24 weeks.

Conclusion: Clinical remission after 12 weeks of etanercept treatment was the most important predictor of sustained clinical response over 24 weeks in pediatric patients with eoJIA, ERA, or PsA JIA subtypes. Trial registration identifying number: NCT00962741/NCT01421069

 

Disclosure: N. Ruperto, Abbott, AbbVie, Amgen, Biogen Idec, Astellas, Alter, AstraZeneca, Boehringer, Bristol-Myers Squibb, CD-Pharma, Celgene, Crescendo Bioscience, EMD Serono,Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, Sanofi Avent, 2,Abbott, AbbVie, Amgen, Biogen Idec, Astellas, Alter, AstraZeneca, Boehringer, Bristol-Myers Squibb, CD-Pharma, Celgene, Crescendo Bioscience, EMD Serono, Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, Sanofi Aven, 8; A. Consolaro, None; G. Horneff, AbbVie, Bristol-Myers Squibb, Novartis, Pfizer and Roche, 2; R. Burgos-Vargas, Abbvie, Janssen, Pfizer, and UCB, 8; T. Constantin, Abbvie, Novartis, Pfizer and Roche, 5,Abbvie, Novartis, Pfizer and Roche, 8; I. Foeldvari, Novartis, Chugai, Beyer, Roche, 5; J. Vojinovic, Abbvie, Roche, Pfizer, MSD, TEVA, 8; J. Dehoorne, Abbvie, 5; V. V. Panaviene, None; G. Susic, None; V. Stanevicha, Pfzer, 2,AbbVie, Roche, 5; K. Kobusinska, None; Z. Zuber, None; R. Mouy, Pfizer, Novartis, 2; I. Rumba-Rozenfelde, Pfizer,, 2; P. Dolezalová, Abbvie, Roche, Medac, Novartis, Pfizer, 2,Roche Pharmaceuticals, 5,Pfizer, Novartis, Medac, 8; C. Job-deslandre, None; N. M. Wulffraat, Abbvie, Roche, Sobi, 2,Novartis, Pfizer, Sobi, 5; R. Pedersen, Pfizer Inc, 1,Pfizer Inc, 3; J. F. Bukowski, Pfizer Inc, 1,Pfizer Inc, 3; T. Hinnershitz, Pfizer Inc, 1,Pfizer Inc, 3; B. Vlahos, Pfizer Inc, 1,Pfizer Inc, 3; A. Martini, Abbott, Abbvie, Amgen, Biogen Idec, Bristol-Myers Squibb, Astellas,Boehringer, Italfarmaco, Janssen, MedImmune, Novartis, Novo Nordisk, Pfizer, Sanofi, Roche, Servier, Takeda, 2,Abbott, Abbvie, Amgen, Biogen Idec, Bristol-Myers Squibb, Astellas, Boehringer, Italfarmaco, Janssen, MedImmune, Novartis, Novo Nordisk, Pfizer, Sanofi, Roche, Servier, Takeda,, 8.

To cite this abstract in AMA style:

Ruperto N, Consolaro A, Horneff G, Burgos-Vargas R, Constantin T, Foeldvari I, Vojinovic J, Dehoorne J, Panaviene VV, Susic G, Stanevicha V, Kobusinska K, Zuber Z, Mouy R, Rumba-Rozenfelde I, Dolezalová P, Job-deslandre C, Wulffraat NM, Pedersen R, Bukowski JF, Hinnershitz T, Vlahos B, Martini A. Predictors of Clinical Remission with Etanercept in Pediatric Patients with Extended Oligoarticular, Enthesitis-Related Arthritis and Psoriatic Arthritis: Findings from the Clipper Study [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/predictors-of-clinical-remission-with-etanercept-in-pediatric-patients-with-extended-oligoarticular-enthesitis-related-arthritis-and-psoriatic-arthritis-findings-from-the-clipper-study/. Accessed .

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