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Abstract Number: 2381

Long-Term Disease Control Among Patients with Juvenile Idiopathic Arthritis Receiving Adalimumab (Humira) Treatment for up to Six Years

Daniel J Lovell1, Nicola Ruperto2, Andreas Reiff3, Lawrence Jung4, Katerina Jarosova5, Richard Mouy6, Isabelle Koné-Paut7, Olcay Y. Jones8, Veronika Vargova9, Carine Wouters10, Ivan Lagunes Galindo11, Carmen Mak12, Hermine I. Brunner13 and Alberto Martini2, 1Cincinnati Children’s Medical Center and Pediatric Rheumatology Collaborative Study Group Coordinating Center, Cincinnati, OH, 2Gaslini Institute and Pediatric Rheumatology International Trials Organisation, Genoa, Italy, 3Children's Hospital Los Angeles, Los Angeles, CA, 4Children’s National Health Systems, Washington, DC, 5Institute of Rheumatology, Prague, Czech Republic, 6Hôpital Necker-Enfants Malades, Paris, France, 7Bicetre Hospital, APHP, University of Paris Sud, Paris, France, 8Walter Reed National Military Medical Center, Bethesda, MD, 9Faculty Hospital, Kosice, Slovakia, 10University Hospital Gasthuisberg, Leuven, Belgium, 11AbbVie Inc., North Chicago, IL, 12AbbVie, North Chicago, IL, 13Pediatric Rheumatology Collaborative Study Group (PRCSG), Cincinnati Children’s Hospital Medical Center, Cincinnati, OH

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Adalimumab, juvenile idiopathic arthritis (JIA) and treatment

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Session Information

Date: Tuesday, October 23, 2018

Session Title: Pediatric Rheumatology – Clinical Poster III: Juvenile Idiopathic Arthritis and Uveitis

Session Type: ACR Poster Session C

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

Background/Purpose: Juvenile idiopathic arthritis (JIA) is a broad term that describes a clinically heterogeneous group of arthritides of unknown cause, which begin before 16 years (yrs) of age and     continues into adulthood.1 The purpose of this analysis was to evaluate the long-term safety and effectiveness, including predictors of sustained disease control, of adalimumab (ADA) among patients (pts) with JIA through 6 yrs of treatment.

Methods: Children aged 4 – 17 yrs with polyarticular JIA were enrolled in a 32-week (wk), phase 3, randomized-withdrawal, double-blind, placebo (PBO)-controlled trial following a 16-wk open-label (OL) lead-in period. Following completion of the double-blind (DB) period, pts were eligible to enter into a long-term extension (LTE) through 360 wks and receive OL ADA based on body surface area (BSA, 24 mg/m2, maximum of 40 mg eow) for ≥44 wks and fixed dosing (FD, <30 kg: 20 mg eow; ≥30 kg: 40 mg eow) thereafter. Pts were stratified by baseline (BL) MTX use. Adverse events (AEs) were monitored throughout study duration and 70 days beyond last dose. Effectiveness assessments by visit included JIA ACR30/70/90 responses, and the proportions of pts achieving JADAS27 low disease activity (LDA, 1.1 – 3.8) and inactive disease (ID, ≤1). Pts achieving sustained LDA and ID for ≥6 continuous months were evaluated. Regression tree analysis was used to identify BL and post-BL factors associated with sustained ID. Data were as observed without imputation.

Results: A total of 171 pts were enrolled, and 133 were randomized to PBO or ADA. Of these pts, 128 completed the DB period and entered the LTE. Sixty-two pts completed the LTE (primary reasons for study discontinuation: lost to follow-up [n=14], withdrawal of consent [n=20], other [n=22]). Pts on average were 11 yrs of age, and three-fourths were female with nearly 4 yrs of active disease (mean JADAS27, 22.5). Twelve serious infections in 11 pts were reported through >500 pt-yrs of ADA exposure. There were no cases of congestive heart failure-related AEs, demyelinating disease, lupus-like syndrome, malignancies, TB, or deaths reported during any period of the study. At wk 312, 19/28 (68%) and 17/30 (57%) of pts achieved JIA ACR90 and JADAS27 ID, respectively; mean JADAS27 was reduced to 2.5. A total of 63 pts (37%) achieved sustained ID, with a median time of 216 wks to reach sustained ID (Figure). BL factors did not consistently predict sustained ID; however, early JIA ACR responses were associated, with ~75% of pts who achieved JIA ACR90 by wk 12 attaining sustained ID.

Conclusion: ADA appeared well-tolerated among children aged 4-17 with polyarticular JIA through up to nearly 7 yrs of exposure. Significant clinical responses, such as JIA ACR90 and JADAS27 ID, were readily achieved among pts who continued in the study. Early clinical response appeared to predict sustained ID.

Reference:

1.       Giancane, et al. Rheumatol Ther 2016(3):187–207.

 


Disclosure: D. J. Lovell, CCHMC has received consulting fees from AbbVie, AstraZeneca, Centocor, Bristol-Myers Squibb, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UBC, Xoma, and Genentech for the work of DJL, 5,Wyeth Pharmaceuticals, 8,Amgen and Forest Research, 9; N. Ruperto, full-time employee of the GASLINI Hospital, which has received contributions to support the research activities of the network of PRINTO from AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., “Francesco Angelini”, , 9,Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, Janssen Biologics B.V., MedImmune, Roche, and Wyeth/Pfizer, 8; A. Reiff, AbbVie and Amgen, 5, 9; L. Jung, OncoImmune and Novartis, 5,AbbVie Inc., 9; K. Jarosova, None; R. Mouy, AbbVie, BMS and Novartis, 5; I. Koné-Paut, AbbVie Inc., 5; O. Y. Jones, None; V. Vargova, AbbVie and Pfizer, 9; C. Wouters, None; I. Lagunes Galindo, AbbVie Inc., 1, 3; C. Mak, AbbVie Inc., 1, 3; H. I. Brunner, AbbVie Inc., AstraZeneca, Centocor, Bristol-Myers Squibb, Boehringer-Ingelheim, Pfizer, Regeneron, Hoffman La-Roche, Novartis, Takeda, UCB, and Genentech, Lilly, Janssen, Ablynx, R-Pharm, 5, 9,Genentech Pharmaceuticals and Novartis, 8; A. Martini, full-time employee of the GASLINI Hospital, which has received contributions to support the research activities of the network of PRINTO from AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., “Francesco Angelini”, 9,Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, and MedImmune, 8.

To cite this abstract in AMA style:

Lovell DJ, Ruperto N, Reiff A, Jung L, Jarosova K, Mouy R, Koné-Paut I, Jones OY, Vargova V, Wouters C, Lagunes Galindo I, Mak C, Brunner HI, Martini A. Long-Term Disease Control Among Patients with Juvenile Idiopathic Arthritis Receiving Adalimumab (Humira) Treatment for up to Six Years [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/long-term-disease-control-among-patients-with-juvenile-idiopathic-arthritis-receiving-adalimumab-humira-treatment-for-up-to-six-years/. Accessed February 3, 2023.
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