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P391 Effect of Adalimumab on Clinical Laboratory Parameters in Paediatric Crohn's Disease Patients from IMAgINE 1

J. Hyams*1, J. Rosh2, J. Markowitz3, J. Kierkus4, M. Dubinsky5, D. Turner6, W. Faubion7, S. Eichner8, A. Lazar9, Y. Li8, R.B. Thakkar8

1Connecticut Children’s Medical Centre, Gastroenterology, Hartford, United States, 2Goryeb Children’s Hospital/Atlantic Health, Gastroenterology, Morristown, United States, 3Cohen’s Children’s Medical Centre of NY, Gastroenterology, New Hyde Park, United States, 4Children’s Memorial Health Institute, Gastroenterology, Warsaw, Poland, 5Mount Sinai Hospital, Gastroenterology, New-York, United States, 6Shaare Zedek Medical Centre, Gastroenterology, Jerusalem, Israel, 7Mayo Clinic, Gastroenterology, Rochester, United States, 8AbbVie Inc., Global Pharmaceutical Research & Development, North Chicago, United States, 9AbbVie Deutschland GmbH & Co, KG, GPRD, Ludwigshafen, Germany

Background

Adalimumab (ADA) was shown to be effective for inducing and maintaining clinical remission in children with moderately to severely active Crohn's disease (CD) in IMAgINE 1.1 Changes in laboratory values indicative of systemic inflammation were evaluated.

Methods

Patients (pts), 6-17 years-old, with baseline (BL) Paediatric CD Activity Index >30 received open-label induction ADA at weeks (wks) 0/2 by body weight (<40 kg, 80/40 mg; ≥40 kg, 160/80 mg). At wk 4, pts were randomized to double-blind (DB) higher-dose (HD) ADA (<40 kg, 20 mg every other wk [eow]; ≥40 kg, 40 mg eow) or lower-dose (LD) ADA (< 40 kg, 10 mg eow; ≥40 kg, 20 mg eow) for 48 wks. The proportion of pts with abnormal values at BL, who later achieved normal values at wk 52 were evaluated. Albumin levels of >3.4 g/dL, platelet counts of <500x109 platelets/L, and CRP levels of <1 mg/dL were considered normal. Mean change in hemoglobin from BL to wk 52 was also assessed. Last observation carried forward (LOCF) was used for missing data.

Normalization of laboratory values in pts with abnormal values at BL (LOCF)

Wk 52Wk 52Wk 52
n/N (%)LDHDOverall
Albumin (N=36)6/24 (25.0)9/12 (75.0)**15/36 (41.7)
Platelet count (N=75)11/30 (36.7)24/45 (53.3)25/75 (46.7)
CRP (N=103)28/53 (52.8)32/50 (64.0)60/103 (58.3)

**p<0.01 for HD v. LD by Pearson’s chi-square test and Fisher’s exact test

Results

Overall, HD ADA-treated pts with abnormal laboratory values at BL achieved normal albumin levels (75%), platelet counts (53%), and CRP levels (64%) at wk 52 (Table). HD ADA also improved mean hemoglobin levels at wk 52 (mean change from BL LD -0.96 v. HD 3.43 g/L, p<0.001).

Conclusion

ADA led to normalization of laboratory values in clinically meaningful proportions of pts who had abnormal albumin levels, platelet counts, and CRP levels at BL in IMAGINE 1. Improvements in hemoglobin levels were also observed at wk 52.

Reference:

1. Hyams et al Gastroenterol 2012;143:365

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