Session Information
Date: Sunday, November 8, 2015
Title: Pediatric Rheumatology - Clinical and Therapeutic Aspects I: Juvenile Idiopathic Arthritis
Session Type: ACR Concurrent Abstract Session
Session Time: 2:30PM-4:00PM
Background/Purpose:
Treatment of juvenile idiopathic
arthritis (JIA) has greatly changed in the past 15 years thanks to the
introduction of biologic agents but little is known on
the long-term safety profiles.
Methods:
Pharmachild is an ongoing, multicenter,
non-interventional, retrospective/prospective observational registry of
patients with JIA treated with either methotrexate (MTX) alone or in
combination with one or more biologic agents as part of their standard clinical
care. Three treatment groups of patients were considered: MTX only (± other
synthetic DMARD or corticosteroids), MTX followed by 1
biologic agent (1Bio±MTX) and treated with more sequentially given biologic
agent (>1Bio±MTX). For the purpose of the analysis we divided drug exposure
into 3 phases based on the starting date of each drug: MTX phase (11239 PY), 1 bio (9158 PY),
> 1 bio (2814 PY). Safety was re-coded by certified assessors according to the Medical
Dictionary for Regulatory Activities (MedDRA). True
incidence rate events x100 patient-years (PY) for events of special interest
(ESI) or at least moderate other adverse events (AE) were
calculated for all MedDRA System Organ Class
(SOC).
Results:
5862/7250 (81%) of the JIA patients
in the database for a total of 23211 PY, were analyzed.
There were 601 (10%) systemic, 1198 (20%) oligo
persistent and 865 (15%) oligo extended, 2042 (35%)
poly RF neg and pos and 1156
(20%) other JIA categories. Out of 5862 JIA patients, 1674 (23%, median disease
duration, DD 4 years) were treated primarily with MTX (no biologics), 3025 (42%,
DD 6 years) with 1 Bio±MTX (66% etanercept,
18.5% adalimumab, infliximab/tocilizumab
5% each) and 1163 (16%, DD 8 years) with >1Bio±MTX (30% etanercept,
27% adalimumab, 14% infliximab, 9% tocilizumab).
The incidence rates (Table) of AE increase with the
addition of at least 1 biologic agent (10.7, 13.9, 19.5).
A similar trend was observed for infections (2.9, 4.6, 4.8)
and serious infections rates (0.7, 1.4, 2.0). Incidence rates for injury,
poisoning and procedural complications (such as infusion/injection related
reaction) and blood and lymphatic system (such as MAS) were higher in the group
treated with more than 1 biologic agent. Incidence
rates for gastrointestinal and hepatobiliary
disorders (e.g. Hypertransaminasaemia) were higher
for the MTX only group when compared to the other 2
(1.7, 0.9, 0.5).
Conclusion:
The introduction of one or more
sequential biologic agent increase the rate of adverse events, infection and
serious infections, when compared to the treatment with MTX alone. This risk can
be 3 times higher during the use of a second or further biological.
To cite this abstract in AMA style:
Swart J, Pistorio A, Bovis F, Alexeeva E, Hofer M, Nielsen S, Anton J, Consolaro A, Panaviene VV, Stanevicha V, Trachana M, Ailioaie C, Uettwiller F, De Benedetti F, Tsitsami E, Flato B, Dolezalová P, Constantin T, Herlin T, Kamphuis S, Sawhney S, Maritsi D, Vargova V, Villa L, Pallotti C, Ravelli A, Martini A, Wulffraat N, Ruperto N. The Addition of One or More Biologics to Methotrexate in Children with Juvenile Idiopathic Arthritis Increases the Incidence of Infections and Other Adverse Events [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/the-addition-of-one-or-more-biologics-to-methotrexate-in-children-with-juvenile-idiopathic-arthritis-increases-the-incidence-of-infections-and-other-adverse-events/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-addition-of-one-or-more-biologics-to-methotrexate-in-children-with-juvenile-idiopathic-arthritis-increases-the-incidence-of-infections-and-other-adverse-events/