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P311. Adalimumab treatment is associated with improved quality of life in pediatric Crohn's disease

J.C. Escher1, G. Veereman-Wauters2, W. Crandall3, F.M. Ruemmele4, A. Lazar5, M. Yang5, M. Skup5, P.M. Mulani5, J. Chao5, R.B. Thakkar5, J. Hyams6, 1Erasmus MC-Sophia Children's Hospital, Rotterdam, Netherlands, 2UZ Brussels, Brussels, Belgium, 3Nationwide Children's Hospital, Columbus, OH, United States, 4Hôpital Necker-Enfants Malades, Paris, France, 5Abbott Laboratories, Abbott Park, IL, United States, 6Connecticut Children's Medical Center, Hartford, CT, United States

Background

Adalimumab (ADA) has been shown to induce response and remission in moderate/severe pediatric Crohn's disease (CD). We aimed to assess the effect of ADA treatment on quality of life (QOL) in pediatric patients (pts) with CD.

Methods

IMAgINE 1 was a 52-week (wk), multi-center, double-blind study assessing efficacy and safety of ADA in pts aged 6–17 years with moderate to severe CD (Pediatric CD Activity Index [PCDAI] >30) failing prior therapy, including infliximab. Following 4 wks of open-label induction, 188 pts were randomized 1:1 to standard dose (20 mg, bodyweight [BW] <40 kg, or 40 mg, BW ≥40 kg) or low dose (10 mg, BW <40 kg, or 20 mg, BW ≥40 kg) double-blind ADA every other wk. After wk 12, pts who experienced flare or nonresponse could switch to blinded weekly dosing and to standard dose open label therapy. To assess QOL, pts ≥10 years (N = 176) completed the IMPACT III, a 35-item questionnaire with scores ranging from 35 (poor) to 175 (best), at baseline and wks 12, 26, and 52. A change of 10.8 has been shown to indicate clinical improvement. Within group changes from baseline were assessed using paired t-tests. Changes from baseline were compared between dose groups using ANCOVA (adjusting for anti-TNF exposure, wk 4 response, and baseline IMPACT III score). LOCF was used for pts who discontinued or dose escalated.

Results

At baseline, no significant differences were observed between dose groups in demographics, mean PCDAI scores, and prior anti-TNF exposure. The low dose group exhibited higher mean IMPACT III scores at baseline (117.7±15.5 vs. 111.6±18.7, P = 0.018). Both groups demonstrated significant improvements in mean IMPACT III scores at wks 12, 26, and 52 (figure). Improvements were observed in each domain, particularly in the bowel symptoms domain (4.7–4.8 change from baseline by week 12 in both dose groups). The effect was most pronounced in anti-TNF naïve pts and early responders. The standard dose group demonstrated slightly more improvement, but differences were not statistically significant.

Figure: Mean change from baseline in total IMPACT III score.

Conclusion

ADA treatment was associated with improved QOL in pediatric pts with CD by wk 12 and remained over the 52-week study.