1 LOW RISK OF LYMPHOMA IN PEDIATRIC PATIENTS WITH INFLAMMATORY BOWEL DISEASE TREATED USING ANTI-TUMOR NECROSIS FACTOR AGENTS

Anti-Tumor Necrosis Factor (aTNF) agents are among the most effective medications used to treat pediatric inflammatory bowel diseases (pIBD). Despite their effectiveness, concerns regarding an association with lymphoma limit their use in everyday practice. We sought to determine the incidence rate and absolute risk of lymphoma in pIBD patients receiving aTNF treatment using a large, geographically diverse administrative insurance claims database.

We used the IQVIA Legacy PharMetrics Administrative Claims Database to identify pediatric (≤18 years) IBD patients (Crohn’s disease and ulcerative colitis) enrolled between 2007 and 2016. The IQVIA dataset contains enrollees’ clinical utilization, expenditures, and outpatient prescription information. We identified patient baseline data and medication exposure history over time to determine the incidence and absolute risk of lymphoma in our pIBD cohort.

We identified 9,284 pIBD patients enrolled between 2007 and 2016, 62% with Crohn’s disease. The mean age of the cohort was 13.7 years (SD, 4.2) and comprised of 47% females. The median follow-up was 24 months (IQR, 33). Twenty-one percent of the cohort were treated with an aTNF agent during follow-up and 38% with an immune modulator (Thiopurine or Methotrexate). Nearly 8.5% were started on an aTNF agent while treated with an immune modulator, of which 90% were Thiopurines. We identified 3 cases of lymphoma occurring over 25,413 person-years of follow-up (Incidence rate, 11.8 cases/100,000 person-years). The absolute risk of lymphoma in our pIBD sample was 0.3 x 10^–3. There were no cases of hepatosplenic T cell lymphoma observed. The medication exposure history for cases of lymphoma did not include treatment with an aTNF agent and/or an immune modulator.

Among our cohort of pIBD, the overall incidence and absolute risk of lymphoma were extremely low. Treatment with aTNF agents and/or immune modulators was not associated with an increased risk of malignancy. Our results would support prioritization of the clinical benefits of aTNF agents over the low risk for malignancy.