P587 Adalimumab in pediatric Crohn’s disease: A long-term multi-centre real-world experience
S. Lawrence1, H. Huynh2, W. El-Matary3, J. DeBruyn4, M. Carroll2, E. Wine2, J. Chan1, K. Jacobson1
1University of British Columbia, Department of Pediatric Gastroenterology, Vancouver, Canada, 2University of Alberta, Department of Pediatric Gastroenterology, Edmonton, Canada, 3University of Manitoba, Department of Pediatric Gastroenterology, Winnipeg, Canada, 4University of Calgary, Section of Pediatric Gastroenterology, Calgary, Canada
Background
There is a paucity of data regarding long-term outcomes for adalimumab (ADA) in pediatric Crohn’s disease (CD). We describe the long-term effectiveness of ADA, in achieving clinical and biochemical remission in a Canadian multi-centre pediatric CD cohort. Moreover, we report the effects of prior anti-TNF exposure and use of a concomitant immunomodulator (IM) on durability of clinical and biochemical response. The primary outcome was 24-month corticosteroid (CS) free remission. Secondary objectives included biochemical and faecal calprotectin response over the study period.
Methods
Retrospective review of electronic records of all children aged 3–18 years with CD requiring ADA at 4 centres across Canada (Vancouver, Edmonton, Winnipeg and Calgary) between January 2005 and December 2017.
Results
One hundred and nine children (68% male; median age 13.07 [IQR 10.6–15.1]) with CD (L1 21.7%, L2 28.3%, L3 50%) were included with a median follow-up of 15.9 months [IQR 7.6–24]. Seventy-four patients (67.9%) were anti-tumour necrosis factor (TNF) naïve. Concomitant IM therapy was used in 51 (46.8%). CS free clinical remission at 24 months was observed in 45/66 (68%). Over time, the median PCDAI, CRP, ESR and faecal calprotectin significantly improved (Table 1). During follow-up, 36 (33%) patients discontinued ADA; 6 (5.5%) had primary non-response, 28 (25.7%) had secondary LOR and 2 (1.8%) had intolerance. At 24 months, clinical remission was achieved more frequently in patients who were Anti-TNF naïve (81% vs. 43.5% p 0.002). There was no significant difference in biochemical or faecal calprotectin outcomes between those who were bio-naive or experienced. There was no significant difference in the time to loss of response between those on monotherapy and combination therapy with an IM and ADA (HR 0.64 [95% CI 0.33–1.26] p0.2).
| Pediatric Crohn’s disease activity index | 23.75 [15–35] | 8.75 [0–20] | *<0.0001 |
| CRP, mg/l | 11 [4.6–27.5] | 2.81 [0.9–6.25] | *<0.0001 |
| ESR, mg/l | 20.00 [11–42] | 8 [4–21.25] | *<0.0001 |
| Fecal calprotectin, μg/g | 1171.4 [469.9–1976] | 362 [85–1050] | *<0.0001 |
Conclusion
This study demonstrates that ADA is effective and durable in pediatric CD. Over 24 months, clinical, biochemical and faecal calprotectin improvement was seen. In our cohort, clinical response to ADA was greater in anti-TNF naïve compared with anti-TNF experienced patients; however,, biochemical and faecal calprotectin outcomes did not differ. ADA response appears durable with no significant difference in patients on monotherapy or combination therapy.