Session Information
Date: Tuesday, November 10, 2015
Session Title: Pediatric Rheumatology - Clinical and Therapeutic Aspects Posters (ACR): Imaging and Novel Clinical Interventions
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: The long-term safety of anti-tumor necrosis factor (TNF) drugs is particularly important in pediatric patients (pts) who may require prolonged treatment of their inflammatory disease. The purpose of the study is to evaluate long-term rates of serious adverse events (AE) and anti-TNF AEs of special interest in adalimumab (ADA) clinical trials in pediatric pts with polyarticular or polyarticular course juvenile idiopathic arthritis (pJIA) or enthesitis-related arthritis (ERA)
Methods: Safety data from pts treated with ADA, either dosed 24 mg/m2 BSA every other week (eow) or 20 mg eow (<30 kg) to 40 mg eow (≥30 kg), in 4 clinical trials in pJIA and ERA were analyzed. Three studies in pJIA enrolled pts aged 2–17 years (yrs) treated with ADA for up to approximately 7 yrs. One study enrolled pts with ERA aged 6–17 yrs to be treated with ADA for up to 144 wks (interim results through 52 weeks were included in this analysis). AEs of special interest included malignancy, serious infections, tuberculosis (TB) and other opportunistic infections, and death. Events per 100 patient-years (PY) were calculated using AEs reported after first ADA dose through 70 days after last dose.
Results: ADA was administered to 274 pts, representing 705.0 PY of exposure. Infections, the most common AE, occurred in ≥10% of pts. Serious infection was the most frequently reported SAE (table). No cases of active or latent TB were reported. No malignancies, opportunistic infections, or deaths were reported. 7.3% of pts (20/274) discontinued study due to AE (range, 5.1% in age <5 yr to 9.6% in ages 5 – <12 yrs). Other than uveitis, liver events, and injection site-related AEs, no differences in AE rates were observed between age groups. (Table)
Conclusion: These data provide support for the long-term safety of ADA in pediatric pts aged 2–17 yrs with pJIA or aged ≥6 to <18 with ERA and demonstrate a safety profile consistent with ADA in adult pts and known information about the anti-TNF class.
|
Rates (E, E/100PY) |
Age <5 yr N=39 |
Age 5 – <12 yr N=104 |
Age 12 – <18 yr N=131 |
Total N=274 |
|
Adalimumab exposure, PY |
65.4 |
285.1 |
354.5 |
705.0 |
|
Serious AE* |
8 (12.2) |
31 (10.9) |
64 (16.6) |
103 (13.9) |
|
Infectious AE |
106 (162.1) |
477(167.3) |
513 (144.7) |
1096 (155.5) |
|
Serious infectious AE |
2 (3.1) |
7 (2.5) |
10 (2.8) |
19 (2.7) |
|
Tuberculosis (latent) |
0 |
0 |
0 |
0 |
|
New onset/worsening psoriasis |
0 |
5 (1.8) |
0 |
5 (0.7) |
|
Allergic reactions |
4 (6.1) |
28 (9.8) |
27 (7.6) |
59 (8.4) |
|
Liver events |
1 (1.5) |
1 (0.4) |
3 (0.8) |
5 (0.7) |
|
Uveitis |
2 (3.1) |
3 (1.1) |
1 (0.3) |
6 (0.9) |
|
Injection site-related AE |
14 (21.4) |
450 (157.8) |
378 (106.6) |
842 (119.4) |
*Death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability, or important medical event. AEs coded by Medical Dictionary for Regulatory Activities version 16.1.
To cite this abstract in AMA style:
Lovell D, Ruperto N, Kingsbury DJ, Burgos-Vargas R, Imagawa T, Horneff G, Quartier P, Goodman S, Reiff A, Giannini EH, Cardoso A, Anderson JK, Varothai NA, Kalabic J, Martini A. Long-Term Safety of Adalimumab Treatment in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis and Enthesitis-Related Arthritis [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/long-term-safety-of-adalimumab-treatment-in-pediatric-patients-with-polyarticular-juvenile-idiopathic-arthritis-and-enthesitis-related-arthritis/. Accessed January 24, 2021.« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-safety-of-adalimumab-treatment-in-pediatric-patients-with-polyarticular-juvenile-idiopathic-arthritis-and-enthesitis-related-arthritis/