Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Tumor Necrosis Factor inhibitors (TNFi) are extremely effective in treating Juvenile Idiopathic Arthritis (JIA). However, TNF-α is critical in immune function, raising concerns of increased infection(INF) rates in patients(pts) on TNFi. With current pediatric data primarily from drug registries and hospitalized patient data, it is unclear whether pediatric pts on TNFi have increased risk of INF, and if so, what types.
Methods: This is a retrospective cohort study of pts seen in our institution’s pediatric rheumatology clinic with polyarticular JIA (pJIA) between 1/1/00 and 11/30/11. Demographic information (Table 1), diagnosis, medication history, and documented INFs (Table 2), classified as mild, moderate, and severe, were obtained from the medical record. Rates of INF were calculated and compared for pts on no immunosuppressants (IS), methotrexate(MTX), TNFi , and MTX plus TNFi (MTX+TNFi) (Table 3). Time periods on other IS or systemic corticosteroids were excluded. The data was evaluated in two ways: 1) each pt was analyzed under the therapy category that they were treated with for the longest length of time for that period of time, and 2) pts who had been on multiple categories of medications were analyzed with a paired t-test.
Results: 239 pts with pJIA were included in the study with a mean follow-up of 4.46 ± 2.91 years and a total of 531 INFs in 1067 patient years. Both analyses demonstrated that pts on MTX and MTX+TNFi had significantly higher INF rates than those on no IS (p<.001, p <.0005 and p <.0005, p <.0005), with INF rate ratios (IRR) of 3.2 (95%CI 2.1-4.8), and 5.5 (95% CI 3.7-8.2). Pts on MTX+TNFi also had significantly more INFs than those on TNFi (p=.02, p=.001, IRR 2.8 (95% CI 2.1-3.8)). Paired t-tests showed significantly higher INF rates in those on TNFi compared to no IS (p <.001, IRR 2.0 (95% CI 1.2-3.1)), and MTX+TNFi compared to MTX (p=.004, IRR 1.7(95% CI 1.4-2.1)). There was no significant difference between pts on MTX or TNFi.
Conclusion: Pts with pJIA treated with MTX, MTX+TNFi, and TNFi have higher rates of INF than those on no IS, with increased rates of INF with each additional medication. However, TNFi do not put pts at a significantly higher risk of INF than MTX. Notably, there were predominantly mild INFs, with only 29 moderate and 5 severe INFs during the course of the study.
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Table 1. Demographic Information |
N = 239 (%) |
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Female Sex |
195 (81) |
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Ethnicity |
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Hispanic |
146 (61) |
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Non-Hispanic |
93 (39) |
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Age at disease onset, mean years (range) |
9.6 (0.8-18) |
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Mean follow-up, years (SD) |
4.46 (2.91) |
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Total patient years |
1067 |
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Number of Patients Exposed to: |
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Systemic Corticosteroids |
63 |
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Other immunosuppressants |
32 |
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Table 2. Documented Infections |
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Mild |
Moderate |
Severe |
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Upper Respiratory Illnesses |
Soft tissue Infections |
Pneumonia |
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Pharyngitis |
-Abscess/Cellulitis |
EBV with hepatitis |
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Otitis Media |
Pneumonia |
Pyelonephritis |
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Urinary Tract Infection |
Varicella Zoster |
Systemic Coccidiomycosis |
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Gastroenteritis |
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Nonspecific viral infections |
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Mild skin infections |
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-Impetigo, Paronychiae |
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Superficial fungal infections |
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Table 3. Infection Rates |
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Medication Category |
Number of Patients N =234* |
Mean infections/100 patient year(SD) |
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No Immunosuppression |
34 |
12(29)** |
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Methotrexate |
58 |
54(66) |
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Methotrexate + TNFi |
85 |
61(70)*** |
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TNFi |
37 |
30(37) |
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* 5 excluded given same amount of time in multiple groups **Significantly different compared to MTX and MTX + TNF p = .001, p <.0005 ***Significantly different compared to TNF alone p = .022 |
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Disclosure:
C. Y. Chang,
None;
R. Meyer,
None;
K. A. Marzan,
None.
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