Pilot study comparing the Childhood Arthritis & Rheumatology Research Alliance (CARRA) systemic Juvenile Idiopathic Arthritis Consensus Treatment Plans

Yukiko Kimura, Sriharsha Grevich, Timothy Beukelman, Esi Morgan, Peter A. Nigrovic, Kelly Mieszkalski, T. Brent Graham, Maria Ibarra, Norman Ilowite, Marisa Klein-Gitelman, Karen Onel, Sampath Prahalad, Marilynn Punaro, Sarah Ringold, Dana Toib, Heather Van Mater, Jennifer E. Weiss, Pamela F. Weiss, Laura E. Schanberg, L. Abramson & 31 others E. Anderson, M. Andrew, N. Battle, M. Becker, H. Benham, J. Birmingham, P. Blier, A. Brown, H. Brunner, A. Cabrera, D. Canter, D. Carlton, B. Caruso, L. Ceracchio, E. Chalom, J. Chang, P. Charpentier, K. Clark, J. Dean, F. Dedeoglu, B. Feldman, P. Ferguson, M. Fox, K. Francis, M. Gervasini, D. Goldsmith, G. Gorton, B. Gottlieb, T. Griffin, H. Grosbein, The CARRA Registry Investigators

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Objectives: To assess the feasibility of studying the comparative effectiveness of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) consensus treatment plans (CTPs) for systemic Juvenile Idiopathic Arthritis (JIA) using an observational registry. Methods: Untreated systemic JIA patients enrolled in the CARRA Registry were begun on one of 4 CTPs chosen by the treating physician and patient/family (glucocorticoid [GC] alone. methotrexate [MTX] ± GC; IL1 inhibitor [IL1i] ± GC; IL6 inhibitor [IL6i] ± GC). The primary outcome of clinical inactive disease (CID) without current GC use was assessed at 9 months. Trial registration: clinicaltrials.gov NCT01697254; first registered 9/28/12 (retrospectively enrolled). Results: Thirty patients were enrolled at 13 sites; eight patients were started on a non-biologic CTP (2 GC, 6 MTX) and 22 patients on a biologic CTP (12 IL1i, 10 IL6i) at disease onset. Demographic and disease features were similar between CTP groups. CTP choice appeared to segregate by site preference. CID off GC was achieved by 37% (11 of 30) including 11/22 (50%) starting a biologic CTP compared to 0/8 starting a non-biologic CTP (p = 0.014). There were four serious adverse events: two infections, one appendicitis and one macrophage activation syndrome. Conclusions: The CARRA systemic JIA CTP pilot study demonstrated successful implementation of CTPs using the CARRA registry infrastructure. Having demonstrated feasibility, a larger study using CTP response to better determine the relative effectiveness of treatments for new-onset systemic JIA is now underway.

Original languageEnglish (US)
Article number23
JournalPediatric Rheumatology
Volume15
Issue number1
DOIs
StatePublished - Apr 11 2017

Fingerprint

Juvenile Arthritis
Rheumatology
Arthritis
Glucocorticoids
Research
Therapeutics
Registries
Methotrexate
Interleukin-6
Macrophage Activation Syndrome
Family Physicians
Appendicitis
Demography

Keywords

  • Biologic response modifiers
  • Comparative effectiveness
  • Pediatric rheumatology
  • Registries
  • Still's disease
  • Systemic Juvenile Idiopathic Arthritis

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Immunology and Allergy
  • Rheumatology

Cite this

Kimura, Y., Grevich, S., Beukelman, T., Morgan, E., Nigrovic, P. A., Mieszkalski, K., ... The CARRA Registry Investigators (2017). Pilot study comparing the Childhood Arthritis & Rheumatology Research Alliance (CARRA) systemic Juvenile Idiopathic Arthritis Consensus Treatment Plans. Pediatric Rheumatology, 15(1), [23]. https://doi.org/10.1186/s12969-017-0157-1

Pilot study comparing the Childhood Arthritis & Rheumatology Research Alliance (CARRA) systemic Juvenile Idiopathic Arthritis Consensus Treatment Plans. / Kimura, Yukiko; Grevich, Sriharsha; Beukelman, Timothy; Morgan, Esi; Nigrovic, Peter A.; Mieszkalski, Kelly; Graham, T. Brent; Ibarra, Maria; Ilowite, Norman; Klein-Gitelman, Marisa; Onel, Karen; Prahalad, Sampath; Punaro, Marilynn; Ringold, Sarah; Toib, Dana; Van Mater, Heather; Weiss, Jennifer E.; Weiss, Pamela F.; Schanberg, Laura E.; Abramson, L.; Anderson, E.; Andrew, M.; Battle, N.; Becker, M.; Benham, H.; Birmingham, J.; Blier, P.; Brown, A.; Brunner, H.; Cabrera, A.; Canter, D.; Carlton, D.; Caruso, B.; Ceracchio, L.; Chalom, E.; Chang, J.; Charpentier, P.; Clark, K.; Dean, J.; Dedeoglu, F.; Feldman, B.; Ferguson, P.; Fox, M.; Francis, K.; Gervasini, M.; Goldsmith, D.; Gorton, G.; Gottlieb, B.; Griffin, T.; Grosbein, H.; The CARRA Registry Investigators.

In: Pediatric Rheumatology, Vol. 15, No. 1, 23, 11.04.2017.

Research output: Contribution to journalArticle

Kimura, Y, Grevich, S, Beukelman, T, Morgan, E, Nigrovic, PA, Mieszkalski, K, Graham, TB, Ibarra, M, Ilowite, N, Klein-Gitelman, M, Onel, K, Prahalad, S, Punaro, M, Ringold, S, Toib, D, Van Mater, H, Weiss, JE, Weiss, PF, Schanberg, LE, Abramson, L, Anderson, E, Andrew, M, Battle, N, Becker, M, Benham, H, Birmingham, J, Blier, P, Brown, A, Brunner, H, Cabrera, A, Canter, D, Carlton, D, Caruso, B, Ceracchio, L, Chalom, E, Chang, J, Charpentier, P, Clark, K, Dean, J, Dedeoglu, F, Feldman, B, Ferguson, P, Fox, M, Francis, K, Gervasini, M, Goldsmith, D, Gorton, G, Gottlieb, B, Griffin, T, Grosbein, H & The CARRA Registry Investigators 2017, 'Pilot study comparing the Childhood Arthritis & Rheumatology Research Alliance (CARRA) systemic Juvenile Idiopathic Arthritis Consensus Treatment Plans', Pediatric Rheumatology, vol. 15, no. 1, 23. https://doi.org/10.1186/s12969-017-0157-1
Kimura, Yukiko ; Grevich, Sriharsha ; Beukelman, Timothy ; Morgan, Esi ; Nigrovic, Peter A. ; Mieszkalski, Kelly ; Graham, T. Brent ; Ibarra, Maria ; Ilowite, Norman ; Klein-Gitelman, Marisa ; Onel, Karen ; Prahalad, Sampath ; Punaro, Marilynn ; Ringold, Sarah ; Toib, Dana ; Van Mater, Heather ; Weiss, Jennifer E. ; Weiss, Pamela F. ; Schanberg, Laura E. ; Abramson, L. ; Anderson, E. ; Andrew, M. ; Battle, N. ; Becker, M. ; Benham, H. ; Birmingham, J. ; Blier, P. ; Brown, A. ; Brunner, H. ; Cabrera, A. ; Canter, D. ; Carlton, D. ; Caruso, B. ; Ceracchio, L. ; Chalom, E. ; Chang, J. ; Charpentier, P. ; Clark, K. ; Dean, J. ; Dedeoglu, F. ; Feldman, B. ; Ferguson, P. ; Fox, M. ; Francis, K. ; Gervasini, M. ; Goldsmith, D. ; Gorton, G. ; Gottlieb, B. ; Griffin, T. ; Grosbein, H. ; The CARRA Registry Investigators. / Pilot study comparing the Childhood Arthritis & Rheumatology Research Alliance (CARRA) systemic Juvenile Idiopathic Arthritis Consensus Treatment Plans. In: Pediatric Rheumatology. 2017 ; Vol. 15, No. 1.
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abstract = "Objectives: To assess the feasibility of studying the comparative effectiveness of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) consensus treatment plans (CTPs) for systemic Juvenile Idiopathic Arthritis (JIA) using an observational registry. Methods: Untreated systemic JIA patients enrolled in the CARRA Registry were begun on one of 4 CTPs chosen by the treating physician and patient/family (glucocorticoid [GC] alone. methotrexate [MTX] ± GC; IL1 inhibitor [IL1i] ± GC; IL6 inhibitor [IL6i] ± GC). The primary outcome of clinical inactive disease (CID) without current GC use was assessed at 9 months. Trial registration: clinicaltrials.gov NCT01697254; first registered 9/28/12 (retrospectively enrolled). Results: Thirty patients were enrolled at 13 sites; eight patients were started on a non-biologic CTP (2 GC, 6 MTX) and 22 patients on a biologic CTP (12 IL1i, 10 IL6i) at disease onset. Demographic and disease features were similar between CTP groups. CTP choice appeared to segregate by site preference. CID off GC was achieved by 37{\%} (11 of 30) including 11/22 (50{\%}) starting a biologic CTP compared to 0/8 starting a non-biologic CTP (p = 0.014). There were four serious adverse events: two infections, one appendicitis and one macrophage activation syndrome. Conclusions: The CARRA systemic JIA CTP pilot study demonstrated successful implementation of CTPs using the CARRA registry infrastructure. Having demonstrated feasibility, a larger study using CTP response to better determine the relative effectiveness of treatments for new-onset systemic JIA is now underway.",
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TY - JOUR

T1 - Pilot study comparing the Childhood Arthritis & Rheumatology Research Alliance (CARRA) systemic Juvenile Idiopathic Arthritis Consensus Treatment Plans

AU - Kimura, Yukiko

AU - Grevich, Sriharsha

AU - Beukelman, Timothy

AU - Morgan, Esi

AU - Nigrovic, Peter A.

AU - Mieszkalski, Kelly

AU - Graham, T. Brent

AU - Ibarra, Maria

AU - Ilowite, Norman

AU - Klein-Gitelman, Marisa

AU - Onel, Karen

AU - Prahalad, Sampath

AU - Punaro, Marilynn

AU - Ringold, Sarah

AU - Toib, Dana

AU - Van Mater, Heather

AU - Weiss, Jennifer E.

AU - Weiss, Pamela F.

AU - Schanberg, Laura E.

AU - Abramson, L.

AU - Anderson, E.

AU - Andrew, M.

AU - Battle, N.

AU - Becker, M.

AU - Benham, H.

AU - Birmingham, J.

AU - Blier, P.

AU - Brown, A.

AU - Brunner, H.

AU - Cabrera, A.

AU - Canter, D.

AU - Carlton, D.

AU - Caruso, B.

AU - Ceracchio, L.

AU - Chalom, E.

AU - Chang, J.

AU - Charpentier, P.

AU - Clark, K.

AU - Dean, J.

AU - Dedeoglu, F.

AU - Feldman, B.

AU - Ferguson, P.

AU - Fox, M.

AU - Francis, K.

AU - Gervasini, M.

AU - Goldsmith, D.

AU - Gorton, G.

AU - Gottlieb, B.

AU - Griffin, T.

AU - Grosbein, H.

AU - The CARRA Registry Investigators

PY - 2017/4/11

Y1 - 2017/4/11

N2 - Objectives: To assess the feasibility of studying the comparative effectiveness of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) consensus treatment plans (CTPs) for systemic Juvenile Idiopathic Arthritis (JIA) using an observational registry. Methods: Untreated systemic JIA patients enrolled in the CARRA Registry were begun on one of 4 CTPs chosen by the treating physician and patient/family (glucocorticoid [GC] alone. methotrexate [MTX] ± GC; IL1 inhibitor [IL1i] ± GC; IL6 inhibitor [IL6i] ± GC). The primary outcome of clinical inactive disease (CID) without current GC use was assessed at 9 months. Trial registration: clinicaltrials.gov NCT01697254; first registered 9/28/12 (retrospectively enrolled). Results: Thirty patients were enrolled at 13 sites; eight patients were started on a non-biologic CTP (2 GC, 6 MTX) and 22 patients on a biologic CTP (12 IL1i, 10 IL6i) at disease onset. Demographic and disease features were similar between CTP groups. CTP choice appeared to segregate by site preference. CID off GC was achieved by 37% (11 of 30) including 11/22 (50%) starting a biologic CTP compared to 0/8 starting a non-biologic CTP (p = 0.014). There were four serious adverse events: two infections, one appendicitis and one macrophage activation syndrome. Conclusions: The CARRA systemic JIA CTP pilot study demonstrated successful implementation of CTPs using the CARRA registry infrastructure. Having demonstrated feasibility, a larger study using CTP response to better determine the relative effectiveness of treatments for new-onset systemic JIA is now underway.

AB - Objectives: To assess the feasibility of studying the comparative effectiveness of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) consensus treatment plans (CTPs) for systemic Juvenile Idiopathic Arthritis (JIA) using an observational registry. Methods: Untreated systemic JIA patients enrolled in the CARRA Registry were begun on one of 4 CTPs chosen by the treating physician and patient/family (glucocorticoid [GC] alone. methotrexate [MTX] ± GC; IL1 inhibitor [IL1i] ± GC; IL6 inhibitor [IL6i] ± GC). The primary outcome of clinical inactive disease (CID) without current GC use was assessed at 9 months. Trial registration: clinicaltrials.gov NCT01697254; first registered 9/28/12 (retrospectively enrolled). Results: Thirty patients were enrolled at 13 sites; eight patients were started on a non-biologic CTP (2 GC, 6 MTX) and 22 patients on a biologic CTP (12 IL1i, 10 IL6i) at disease onset. Demographic and disease features were similar between CTP groups. CTP choice appeared to segregate by site preference. CID off GC was achieved by 37% (11 of 30) including 11/22 (50%) starting a biologic CTP compared to 0/8 starting a non-biologic CTP (p = 0.014). There were four serious adverse events: two infections, one appendicitis and one macrophage activation syndrome. Conclusions: The CARRA systemic JIA CTP pilot study demonstrated successful implementation of CTPs using the CARRA registry infrastructure. Having demonstrated feasibility, a larger study using CTP response to better determine the relative effectiveness of treatments for new-onset systemic JIA is now underway.

KW - Biologic response modifiers

KW - Comparative effectiveness

KW - Pediatric rheumatology

KW - Registries

KW - Still's disease

KW - Systemic Juvenile Idiopathic Arthritis

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