ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 1678

Safety and Efficacy of Adalimumab in Children with Active Polyarticular Juvenile Idiopathic Arthritis Aged 2 to <4 Years or ≥4 Years Weighing <15 Kg

Daniel J. Kingsbury1, Pierre Quartier2, Gina Patel3, Vipin Arora4, Hartmut Kupper5 and Neelufar Mozaffarian3, 1Randall Children's Hospital at Legacy Emanuel, Portland, OR, 2Unite d'Immuno-Hematologie et Rhumatologie Pediatriques, Paris, France, 3Abbott, Abbott Park, IL, 4Health Outcomes Research, Abbott, Abbott Park, IL, 5Immunology Development, Abbott GmbH and Co. KG, Ludwigshafen, Germany

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Adalimumab and juvenile arthritis

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print
Session Information

Title: Pediatric Rheumatology: Clinical and Therapeutic Disease II: Juvenile Idiopathic Arthritis II

Session Type: Abstract Submissions (ACR)

Background/Purpose: Adalimumab (ADA) is approved for use in moderate to severe JIA in patients (pts) ≥4 yrs old in the US, EU,and Japan. ADA has not been studied in pts <4 yrs old, and limited data are available in pts ≥4 yrs old weighing <15 kg. The primary objective of this study was to assess the safety of ADA in pts 2 to <4 yrs old or ≥4 yrs old weighing <15 kg with moderately to severely active polyarticular onset/polyarticular course JIA. The secondary objectives were to evaluate the pharmacokinetics (PK) and clinical effectiveness of ADA in these pts.

Methods: This is an interim analysis of the multicenter, open-label, phase 3b ADA study in pts 2 to <4 yrs old or ≥4 yrs weighing <15 kg with moderately to severely active JIA in the US and EU. ADA was given subcutaneously every other wk, 24 mg/m2 BSA up to 20 mg/dose, for a minimum of 24 wks and continued until pts reached 4 yrs old and weighed 15 kg. Concomitant methotrexate use was allowed. Adverse events (AE) were collected throughout the treatment period and include safety data up to 96 wks. Serum trough concentrations of ADA were determined for each subject using validated methods. Key effectiveness endpoints were the proportion of pts achieving PedACR30/50/70/90 at wk 24. Other outcomes included tender joint count (TJC), swollen joint count (SJC), Pain on Passive Motion (POM75), Limitation on Passive Motion (LOM69), Active Joint Count (AJC73), Child Health Assessment Questionnaire (DICHAQ), and Physician’s and Parent’s Global Assessment of Disease (PhGA and PaGA).

Results: 88% of the pts were female. At baseline, mean age=3 yrs, mean weight=13 kg, mean duration of JIA=12 months, and 39% had elevated CRP (≥0.9 mg/dL). AE incidence rates through 96 wks included: any AEs (84%, 27/32), serious AEs (16%, 5/32), infectious AEs (69%, 22/32), and serious infections (9%, 3/32). No deaths, malignancies, opportunistic infections/TB, congestive heart failure, demyelinating disease, allergic reactions, lupus-like syndrome, or blood dyscrasias were reported. The mean serum ADA trough concentrations achieved a steady-state of 7 – 8 µg/mL at weeks 12 and 24 (n=15). Of 32 pts enrolled, 31 completed 24 wks of ADA treatment; 90% achieved PedACR30 and 70% achieved PedACR70 (Table 1).

 

Table 1. PedACR Response at Week 24

 

Response Ratea

N=30

Response Rateb

N=32

PedACR30, n (%)

27 (90.0)

27 (84.4)

PedACR50, n (%)

25 (83.3)

25 (78.1)

PedACR70, n (%)

22 (73.3)

22 (68.8)

PedACR90, n (%)

11 (36.7)

11 (34.4)

aObserved. bNonresponder imputation.

Improvements in other JIA outcomes were also seen at wk 24 of ADA treatment (Table 2). 

 

Table 2. JIA Outcomes at Week 24a

 

Mean Change (SD) from Baseline

Tender Joint count (TJC75)b

-3.0 (5.5)

Swollen Joint Count (SJC66)b

-6.3 (5.8)

Pain on Passive Motion (POM75)b

-3.9 (7.3)

Limitation on Passive Motion (LOM69)b

-5.6 (5.6)

Active Joint Count (AJC73)b

-7.0 (5.7)

Child Health Assessment Questionnaire (DICHAQ)b

-0.5 (0.7)

PhGA of Disease Activityb (VAS 0–100 mm)

-45.3 (21.3)

PaGA of Disease Activityb (VAS 0–100 mm)

-32.2 (29.7)

PaGA of Painb (VAS 0–100 mm)

-29.5 (28.3)

CRPc (mg/dL)

-0.2 (3.2)

  aObserved data. bn=30; cn=28.

Conclusion: The safety profile, PK, and effectiveness of ADA were similar to that seen in older pediatric patients with JIA, demonstrating that ADA is also safe and effective in younger patients 2 to <4 years old or ≥4 yrs old weighing <15 kg with active polyarticular JIA.


Disclosure:

D. J. Kingsbury,

Abbott Laboratories,

2;

P. Quartier,

Abbott Laboratories,

2;

G. Patel,

Abbott Laboratories,

1,

Abbott Laboratories,

3;

V. Arora,

Abbott Laboratories,

1,

Abbott Laboratories,

3;

H. Kupper,

Abbott Laboratories,

1,

Abbott Laboratories,

3;

N. Mozaffarian,

Abbott Laboratories,

1,

Abbott Laboratories,

3.

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

« Back to 2012 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-efficacy-of-adalimumab-in-children-with-active-polyarticular-juvenile-idiopathic-arthritis-aged-2-to/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology