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P638 Assessment of IMPACT III emotional and social functioning domain scores in adalimumab-treated paediatric patients with Crohn’s disease

A. Grant*1, A. Otley1, 2, J. Escher3, J. S. Hyams4, J.-F. Maa5, G. Alperovich5, A. Lazar6, A. M. Robinson5, A. W. Wang5, S. Eichner5

1IWK Health Centre, Nova Scotia, Canada, 2Dalhousie University, Nova Scotia, Canada, 3Erasmus MC Sophia Children’s Hospital, Rotterdam, Netherlands, 4Connecticut Children’s Medical Centre, Hartford, Connecticut, United States, 5AbbVie Inc, North Chicago, Illinois, United States, 6AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany

Background

IMPACT III is a validated, disease-specific health-related quality of life (HRQoL) questionnaire for children with inflammatory bowel disease. The 35-item IMPACT III questionnaire has been restructured to 4 domains for improved construct validity and reliability: emotional functioning, social functioning, body image, and well-being.1 Using the re-categorised tool, we assessed the effect of adalimumab (ADA) on social and emotional function and examined the consistency of changes in individual questions within these domains in patients (pts) enrolled in the IMAgINE 1 trial.2

Methods

IMAgINE 1 was a 52-week (wk) trial of ADA that enrolled 6–17 year (yr)-old pts with moderate-to-severe CD (baseline [BL] PCDAI >30) who failed or were intolerant to conventional therapy.2 Pts experiencing disease flare/non-response could move to blinded weekly (ewk) ADA after wk 12, followed by open-label (OL) ewk ADA for continued flare/non-response. The IMPACT III questionnaire was administered to pts ≥10 yr at BL; the range for each individual question is 0 to 100; higher scores represent better quality of life (QoL). Total IMPACT III scores were normalised (sum of responses divided by number of questions answered; scale 0 = poor to 100 = best), each domain score was normalised (sum of responses for each question within domain divided by total number of questions answered; scale 0 to 100). Change from BL at wk 12, 26, and 52 in the score for each domain and in individual IMPACT III questions were reported. Last observation carried forward (LOCF) was used to account for missing data (post-BL), pts who discontinued, or who moved to OL ewk ADA.

Results

In total, 172 pts in IMAgINE 1 were analysed (54.7% male; median PCDAI 40; median CRP 1.2 mg/dL; and mean IMPACT III total score 57 at BL). Mean emotional and social domain scores at BL were 54 and 72, respectively. Statistically significant improvements were observed for both domain scores and some individual questions in each domain as early as wk 12, and were sustained to wk 52 (Table 1).

Conclusion

ADA treatment was associated with early and substantial HRQoL improvements in children with CD, as indicated by statistically significant mean increases in emotional and social functioning domain scores and in most individual questions in each domain.

Table 1 Mean changes from baseline to weeks 12, 26, and 52 in IMPACT III emotional functioning and social functioning domain scores, and in selected individual questions from each domain in ≥ 10 years-old adalimumab-treated paediatric patients

References

[1] Grant A, Kappelman MD, Martin CF, et al. Development and validation of a new domain structure for the IMPACT-III Health Reported Quality of Life (HRQOL) tool for pediatric patients with Inflammatory Bowel Disease (IBD). Oral presentation at the 2015 Advances in Inflammatory Bowel Diseases Annual Meeting. [Abstract #O-021]. Orlando, FL December 10–12, 2015.

[2] Hyams J. S, Griffiths A, Markowitz J, et al. Safety and efficacy of adalimumab for moderate to severe Crohn’s disease in children. Gastroenterol 2012;143:365.