Table 1 Outline of the results of the systematic literature review of the risk of malignancy in individuals with juvenile idiopathic arthritis
Authors/Year published | Study setting/number of JIA patients | Outcome measure | Risk in JIA cohort | Risk in MTX exposed, biologics-naïve | Risk in TNF-alpha inhibitor exposed | Ref. |
|---|---|---|---|---|---|---|
Beukelman T et al/2012 | Using national Medicaid data/7,812 | SIR | The SIR was 4.4 (95% CI, 1.8 – 9.0) for probable and highly probable incident malignancies. The unexposed (to both non-biologic and biologic DMARDs) group: the SIR = 6.9 (2.3 – 16). | SIR = 3.9 (95% CI 0.4 – 14) | Following any use of TNF inhibitors, SIR was 0 (95% CI 0 – 13). | 20 |
Simard JF et al/2010 | Nationwide cohort study through linkage with the Swedish Patient Register/5,296 | RR | Subjects with JIA (biologics-naïve) identified in 1987 beyond (n = 5,296) was significantly associated with incident lymphoproliferative malignancies (RR 4.2, 95% CI 1.7–10.7) and cancers overall (RR 2.3, 95% CI 1.2–4.4). | - | 18 | |
Nordstrom BL et al/2012 | Large claims database American cohort study/3,605 | IR, SIR | The IRs of probable or highly probable cancer: 67.0 (95% CI, 1.3 – 132.5) cases/100,000 PY for biologics-naïve JIA and 23.2 (12.2 – 34.2) cases/100,000 PY for non-JIA. The JIA cohort had an elevated SIR of 4.0 (95% CI 2.6 – 6.0) above SEER rate. | 19 | ||
Kok VC et al/this study | Nationwide population-based Retrospective cohort study/2,892 | RR, IRR | The RR and IRR for developing a malignancy in JIA individuals who were both MTX- and anti-TNF biologics-naïve were 2.75 (95% CI, 1.75 – 4.32) and 3.21 (95% CI, 2.01 – 5.05), respectively, with the population attributable risk of 23.38% (95% CI, 10.56 – 36.21). For leukemia, the RR was 6.33 (2.30 – 17.44); lymphoma, 7.12 (1.42 – 35.61); and soft tissue sarcoma, 9.50 (1.24-72.46). The aHR on cancer risk was 3.14 (1.98 – 4.98) in MTX- and biologics-naïve group. | No further increase in risk | No further increase in risk | This study |
Bernatsky S et al/2011 | JIA registries at 3 Canadian pediatric rheumatology centers/1,834 | SIR | Only one invasive cancer was identified in individuals with JIA observed for an average of 12.2 (SD 7.8) years (observation period: 1974 – 2006). SIR = 0.12 (95% CI, 0.0 – 0.7). The risk of invasive cancers overall is NOT increased. No further information on its relationship to drug exposure. | 16 | ||
Thomas E et al/ 2000 | Scottish nationwide population-based inpatient cohort/896 | SIR | SIR in boys JIA with 2,647 person-years at risk: 1.29 (95% CI, 0.14–4.64); girls JIA with 3,940 person-years at risk, 0.83 (95% CI, 0.09–3.01)./Not increased | - | 17 | |