A British Society of Paediatric Gastroenterology, Hepatology and Nutrition survey of the effectiveness and safety of adalimumab in children with inflammatory bowel disease

Richard Kay Russell (1) , Michelle L Wilson (2) , Sabarinathan Loganathan (3) , Billy Bourke (4) , Fevrionia Kiparissi (5) , Franco Torrente (6) , Gamal Mahdi (7) , Astor Rodrigues (8) , Adrian Thomas (9) , Anthony Kwaku Akobeng (9) , Andrew Fagbemi (9) , Warren Hyer (10) , Christine Spray (11) , Paraic Mcgrogan (12) , Rob B Heuschkel (6) , Naeem Ayub (13) , John Fell (14) , Nadeem A Afzal (15) , Michael Green (16) , Stephen Murphy (17) , Prithviraj Rao (18) , Neil Shah (19) , Gwo-Tzer Ho (20) , Sandhia Naik (21) , David C Wilson (2)

1 Department of Paediatric Gastroenterology
2 Child Life and Health
3 Department of Medical Paediatrics
4 Children's Research Centre
5 Institute of Child Health
6 Addenbrooke's Hospital
7 Dalhousie University [Halifax]
8 Department of Paediatric Gastroenterology
9 Department of Paediatric Gastroenterology
10 Northwick Park and St Mark's Hospital
11 Bristol Royal Hospital for Children
12 Yorkhill Hospital
13 Royal Shrewsbury Hospital
14 Chelsea and Westminster Hospital
15 University of Southampton
16 Leicester Royal Infirmary
17 Institute of Child Health
18 The General Infirmary at Leeds
19 Paediatric Urology Department
20 Institute of Genetics and Molecular Medicine
21 Bart's and the London Children's Hospital

Background: Adalimumab is efficacious therapy for adults with Crohn's disease (CD). Aim: To summarise the United Kingdom and Republic of Ireland paediatric adalimumab experience. Methods: British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) members with Inflammatory Bowel Disease (IBD) patients <18 years old commencing adalimumab with at least 4 weeks follow up. Patient demographics and details of treatment were then collected. Response and remission was assessed using the Paediatric Crohn's Disease Activity Index (PCDAI) /Physicians Global Assessment (PGA). Results: 72 patients (70 CD, 1 Ulcerative Colitis (UC), 1 IBD Unclassified (IBDU)) from 19 paediatric-centres received adalimumab at a median age of 14.8 (IQR 3.1, range 6.1-17.8) years; 66/70 CD (94%) had previously received infliximab. A dose of 80mg then 40mg was used for induction in 41(59%) and 40mg fortnightly for maintenance in 61 (90%). Remission rates were 24%, 58% and 41% at 1, 6 and 12 months respectively. Overall 43 (61%) went into remission at some point, with 24 (35%) requiring escalation of therapy. Remission rates were higher in those on concomitant immunosuppression cf. those not on immunosuppression [34/46 (74%) vs. 9/24 (37%) respectively (Χ28.8, p=0.003)]. There were 15 adverse events (21%) including 4 (6%) serious adverse events with 2 sepsis related deaths in patients who were also on immunosuppression and home parenteral nutrition (3% mortality rate). Conclusions: Adalimumab is useful in treatment refractory paediatric patients with a remission rate of 61%. This treatment benefit should be balanced against side effects, including in this study a 3% mortality rate.

Mots clés: Medicine

Richard Kay Russell, Michelle L Wilson, Sabarinathan Loganathan, Billy Bourke, Fevrionia Kiparissi, et al.. A British Society of Paediatric Gastroenterology, Hepatology and Nutrition survey of the effectiveness and safety of adalimumab in children with inflammatory bowel disease. Alimentary Pharmacology and Therapeutics, 2011, 33 (8), pp.946. ⟨10.1111/j.1365-2036.2011.04603.x⟩. ⟨hal-00616295⟩