Session Type: Abstract Submissions (ACR)
There are few data available regarding the rates of serious and important medical events (SAEs and IMEs) for most of the medications used to treat JRA/JIA (Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis), including nonsteroidal anti-inflammatory drugs. These data are of particular importance as the use of biologic disease modifying antirheumatic drugs (DMARDs) in JRA/JIA has increased significantly over the past several years along with the number of medications that are FDA-approved for the treatment of these diseases. While the FDA has a voluntary MedWatch reporting system in place, only a small proportion of physicians fill out these reports and these data cannot be used to calculate SAE/IME rates. The Enhanced Drug Safety Surveillance (EDSS) Pilot Project was developed in partnership with Pfizer, as one of the US FDA post-marketing commitments for celecoxib in JIA, to implement a pilot process to capture of SAEs and IMEs, and to calculate SAE/IME rates in children with JRA/JIA utilizing the CARRA (Childhood Arthritis and Rheumatology Research Alliance) physician network. The objective of this analysis is to summarize the data resulting from the 4-year (2008-2012) EDSS Pilot Project.
Physicians at participating sites were surveyed monthly to determine whether any of their JIA/JRA patients had experienced a SAE or IME during the prior month. MedWatch forms were subsequently completed for each event, including attribution to medication(s). SAEs and IMEs were categorized by the primary organ system and/or the dominant symptoms (e.g. disease flare, infusion reaction). Each site was surveyed every 6 months regarding the number of JRA/JIA patients per site, to provide a denominator for the SAE/IME rates. Reporting rates were calculated per 100 person-years (p-y) and 95% CI were calculated based on a Poisson distribution.
37 sites with 115 physicians contributed at least one year of data. The overall response rate to the monthly surveys was 65% and the overall response to the 6 month surveys was 86%. There were a total of 139 total SAEs and 139 IMEs. The largest proportion of SAEs and IMEs occurred in children with polyarticular JIA (39% and 38%, respectively). The majority of SAEs and IMEs were reported for patients receiving biologic DMARDs (73% and 68%, respectively). NSAIDs and non-biologic DMARDs were the next most commonly reported medications, with 1 SAE and 2 IMEs attributed to celecoxib, and 12 SAEs and 11 IMEs attributed to other NSAIDs. Infection accounted for the largest proportion of both SAEs and IMEs (52% and 20%). The next most common categories of SAE were disease flare and macrophage activation syndrome. The next most common categories of IME were neurologic and elevated liver function tests. The total event rate for SAEs and IMEs combined was 1.2 SAE/IME per 100 p-y (95% CI: 1.1-1.4). The rate for SAEs was the same as IMEs (0.6 per 100 p-y; 95% CI: 0.5-0.7).
Conclusion: The EDSS provided a simple and effective tool for SAE/IME reporting. These data support the development of a long-term registry of children with JRA/JIA in North America to continue the collection of these critical data.
A. F. Hendrickson,
C. A. Wallace,
Genentech and Biogen IDEC Inc.,
Novartis Pharmaceutical Corporation,
R. E. Sobel,
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ACR Meeting Abstracts - http://acrabstracts.org/abstract/adverse-events-in-juvenile-idiopathic-arthritis-results-from-the-enhanced-drug-safety-surveillance-edss-pilot-project/