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Pilot study comparing the childhood arthritis and rheumatology research alliance consensus treatment plans for induction therapy of juvenile proliferative lupus nephritis.

Publication ,  Journal Article
Cooper, JC; Rouster-Stevens, K; Wright, TB; Hsu, JJ; Klein-Gitelman, MS; Ardoin, SP; Schanberg, LE; Brunner, HI; Eberhard, BA; Wagner-Weiner, L ...
Published in: Pediatr Rheumatol Online J
October 22, 2018

BACKGROUND: To reduce treatment variability and facilitate comparative effectiveness studies, the Childhood Arthritis and Rheumatology Research Alliance (CARRA) published consensus treatment plans (CTPs) including one for juvenile proliferative lupus nephritis (LN). Induction immunosuppression CTPs outline treatment with either monthly intravenous (IV) cyclophosphamide (CYC) or mycophenolate mofetil (MMF) in conjunction with one of three corticosteroid (steroid) CTPs: primarily oral, primarily IV or mixed oral/IV. The acceptability and in-practice use of these CTPs are unknown. Therefore, the primary aims of the pilot study were to demonstrate feasibility of adhering to the LN CTPs and delineate barriers to implementation in clinical care in the US. Further, we aimed to explore the safety and effectiveness of the treatments for induction therapy. METHODS: Forty-one patients were enrolled from 10 CARRA sites. Patients had new-onset biopsy proven ISN/RPS class III or IV proliferative LN, were starting induction therapy with MMF or IV CYC and high-dose steroids and were followed for up to 24 months. Routine clinical data were collected at each visit. Provider reasons for CTP selection were assessed at baseline. Adherence to the CTPs was evaluated by provider survey and medication logs. Complete and partial renal responses were reported at 6 months. RESULTS: The majority of patients were female (83%) with a mean age of 14.7 years, SD 2.8. CYC was used more commonly than MMF for patients with ISN/RPS class IV LN (vs. class III), those who had hematuria, and those with adherence concerns. Overall adherence to the immunosuppression induction CTPs was acceptable with a majority of patients receiving the target MMF (86%) or CYC (63%) dose. However, adherence to the steroid CTPs was poor (37%) with large variability in dosing. Renal response endpoints were exploratory and did not show a significant difference between CYC and MMF. CONCLUSIONS: Overall, the immunosuppression CTPs were followed as intended in the majority of patients however, adherence to the steroid CTPs was poor indicating revision is necessary. In addition, our pilot study revealed several sources of treatment selection bias that will need to be addressed in for future comparative effectiveness research.

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Published In

Pediatr Rheumatol Online J

DOI

EISSN

1546-0096

Publication Date

October 22, 2018

Volume

16

Issue

1

Start / End Page

65

Location

England

Related Subject Headings

  • Treatment Outcome
  • Rheumatology
  • Remission Induction
  • Registries
  • Prospective Studies
  • Pilot Projects
  • Mycophenolic Acid
  • Male
  • Lupus Nephritis
  • Kidney
 

Citation

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Cooper, J. C., Rouster-Stevens, K., Wright, T. B., Hsu, J. J., Klein-Gitelman, M. S., Ardoin, S. P., … CARRA registry investigators, . (2018). Pilot study comparing the childhood arthritis and rheumatology research alliance consensus treatment plans for induction therapy of juvenile proliferative lupus nephritis. Pediatr Rheumatol Online J, 16(1), 65. https://doi.org/10.1186/s12969-018-0279-0
Cooper, Jennifer C., Kelly Rouster-Stevens, Tracey B. Wright, Joyce J. Hsu, Marisa S. Klein-Gitelman, Stacy P. Ardoin, Laura E. Schanberg, et al. “Pilot study comparing the childhood arthritis and rheumatology research alliance consensus treatment plans for induction therapy of juvenile proliferative lupus nephritis.Pediatr Rheumatol Online J 16, no. 1 (October 22, 2018): 65. https://doi.org/10.1186/s12969-018-0279-0.
Cooper JC, Rouster-Stevens K, Wright TB, Hsu JJ, Klein-Gitelman MS, Ardoin SP, et al. Pilot study comparing the childhood arthritis and rheumatology research alliance consensus treatment plans for induction therapy of juvenile proliferative lupus nephritis. Pediatr Rheumatol Online J. 2018 Oct 22;16(1):65.
Cooper, Jennifer C., et al. “Pilot study comparing the childhood arthritis and rheumatology research alliance consensus treatment plans for induction therapy of juvenile proliferative lupus nephritis.Pediatr Rheumatol Online J, vol. 16, no. 1, Oct. 2018, p. 65. Pubmed, doi:10.1186/s12969-018-0279-0.
Cooper JC, Rouster-Stevens K, Wright TB, Hsu JJ, Klein-Gitelman MS, Ardoin SP, Schanberg LE, Brunner HI, Eberhard BA, Wagner-Weiner L, Mehta J, Haines K, McCurdy DK, Phillips TA, Huang Z, von Scheven E, CARRA registry investigators. Pilot study comparing the childhood arthritis and rheumatology research alliance consensus treatment plans for induction therapy of juvenile proliferative lupus nephritis. Pediatr Rheumatol Online J. 2018 Oct 22;16(1):65.
Journal cover image

Published In

Pediatr Rheumatol Online J

DOI

EISSN

1546-0096

Publication Date

October 22, 2018

Volume

16

Issue

1

Start / End Page

65

Location

England

Related Subject Headings

  • Treatment Outcome
  • Rheumatology
  • Remission Induction
  • Registries
  • Prospective Studies
  • Pilot Projects
  • Mycophenolic Acid
  • Male
  • Lupus Nephritis
  • Kidney