P350 The use of concomitant immunomodulators with adalimumab therapy in paediatric Crohn’s disease
K. Benkov*1, G. Russell2, C. Samson3, S. Steiner4, E.C. King5, J. Pratt5, S. Eichner6, R.B. Colletti7, ImproveCareNow Network8
1Icahn School of Medicine at Mount Sinai, Division of Pediatric Gastroenterology, New York, New York, United States, 2Boston Children’s Hospital, Harvard School of Medicine, Boston, Massachusetts, United States, 3Washington University School of Medicine, Saint Louis, Missouri, United States, 4Riley Hospital for Children, Pediatric Gastroenterology, Hepatology and Nutrition, Indianapolis, Indiana, United States, 5Cincinnati Children’s Hospital Medical Centre, Division of Biostatistics and Epidemiology, Cincinnati, Ohio, United States, 6AbbVie, Chicago, Illinois, United States, 7University of Vermont Children’s Hospital, Burlington, Vermont, United States, 8ImproveCareNow, Burlington, Vermont, United States
Anti-tumour necrosis factor-α (ATNF) therapy is an effective treatment of Crohn’s disease (CD) in up to 85% of patients, but as many as 50% will experience a loss of response (LOR) at 12 months. LOR is likely multi-factorial but often is associated with the development of antibodies to ATNF. Studies have shown that concomitant use of an immunomodulator (IM), either thiopurine (TP) or methotrexate (MTX), significantly reduces the development of antibodies. We aimed to determine the use of adalimumab (ADA) and concomitant therapy over the last 5 years in a large paediatric CD population.
We identified all consented patients with CD aged <18 years in the ImproveCareNow registry who ever received ADA between June 2010 and June 2015, and determined the rates of treatment with ADA and concomitant therapy with TP or MTX, including variation by age, gender, geographical region and annual change in the last 5 years. We used Chi-square tests to compare percentages and the Cochran Armitage Trend Test to test percentages over time and age groups.
Of 7 271 patients, 1 009 (14%) were treated with ADA. ADA treatment was more common with increasing age (16% in ages 15–17 years vs 5% in ages 05– years; p < 0.001); in females than males (16% vs 13%; p < 0.001); and in the West than the Northeast (17% vs 11%; p < 0.001) of the United States. From year 1 (2010–2011) to year 5 (2014–2015), the use of ADA increased from 7% to 13% of patients (p < 0.001). Of the 1 009 treated with ADA, 47% received concomitant therapy with either TP (19%) or MTX (28%). Concomitant therapy occurred in 63% of patients aged 0–5 years, 59% aged 6–10, 49% aged 11–14, and 43% aged 151–7 (overall p < 0.01); and in 49% of males and 44% of females (p = 0.17). Concomitant therapy occurred in 54% of patients in the West, 54% in the Midwest, 43% in the South and 38% in the Northeast of the United States (overall p = <0.001). From year 1 to year 5, the use of concomitant therapy increased from 25% to 49% of patients treated with ADA (p < 0.001) (Figure). Of patients taking concomitant therapy, use of TP vs MTX was 31% vs 69% in males, 56% vs 44% in females, and 40% vs 60% overall. Over the last 5 years, there was an increase in the use of MTX (14% in year 1, 30% in year 5; p < 0.001) and of TP (11% in year 1 and 19% in year 5; p = 0.01).
In paediatric CD patients, there is increasing use of ADA, with 13% treated in the last year. Of these, about half receive concomitant therapy, and of this group, 40% receive TP and 60% MTX. Males are more likely to receive MTX. There are also regional differences in the use of ADA and IM. There is no consensus in the use of concomitant therapy with ADA and in the choice of IM. Further studies are needed to determine whether IM therapy is indicated with ADA treatment.