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Biological therapy for paediatric IBD – effective but associated with financial and safety issues
  1. F Cameron1,
  2. M Wilson2,
  3. N Basheer2,
  4. A Jamieson3,
  5. W M Bisset4,
  6. R Russell1,
  7. D Wilson2
  1. 1PICU, Yorkhill Hospital, Glasgow, UK
  2. 2University of Edinburgh, Edinburgh, UK
  3. 3University of Glasgow, Glasgow, UK
  4. 4Royal Aberdeen Children's Hospital, Aberdeen, UK

Abstract

Background Biological agents are increasingly used as treatment for paediatric inflammatory bowel disease (PIBD) in the UK, but with a weak evidence base and rising safety concerns. We aimed to evaluate pattern of usage, effectiveness and safety in the clinical setting using a Scottish national framework.

Methods Usage of infliximab (IFX), adalimumab (ADA) and natalizumab (NAT) for treatment of PIBD (aged <18 years of age at start of biological therapy) from 1 January 2000 to 30 April 2010 was collated in a retrospective audit. Treatment was administered by members of the Scottish Society of Paediatric Gastroenterology, Hepatology and Nutrition.

Results 112 children had ≥1 biological agent administered from a median (range) age of 14.3 (6.6–17.9) years; 50 (45%) were female and 102 (91%) had Crohn's disease (CD), 8 (7%) had ulcerative colitis and 2 (2%) had IBD unclassified (IBDU). 22 (20%) had trials of 2 biological agents. 104 children (98 CD) had IFX, with a median (range) of 4 (1–25) infusions mostly with moderate-severe IBD. 38 entered remission, 34 responded, and 32 had no response. 11 of the 46 (24%) proceeding to maintenance IFX required escalation of therapy. 14 (13%) had infusion events with 3 having anaphylaxis, and 7 reactions led to discontinuation. 1 child developed a lupus-like reaction requiring prolonged hospitalisation and 1 had severe infection, with no deaths. 19 (18%) proceeded to ADA. 23 children (all CD) had ADA therapy (including 19 after IFX, 2 as first biological and 2 with inflammatory arthritis in whom CD developed on etanercept), with a median of 20 doses and most with moderate-severe IBD. 11 entered remission, 6 responded, and 6 had no response. All proceeded to maintenance; 11 (50%) required escalation of therapy. 13 had pain at injection site with none discontinuing. 1 child developed leucopaenia and 1 a severe viral infection, with no deaths. 2 children with CD had NAT, both in a trial, and both proceeded to IFX after the agent was withdrawn.

Conclusions Our nationwide ‘real-life’ experience shows that biological agents are effective in moderate-severe paediatric IBD in the clinical setting, but there are significant financial and safety issues.

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