Evaluation of a daily practice composite score for the assessment of Crohn's disease: the treatment impact of certolizumab pegol

Abstract

Background: Successful treatment of systemic inflammatory symptoms is essential for improving health-related quality of life in patients with active Crohn's disease. Patient-reported outcomes provide unique perspectives on the impact of chronic disease. It is unknown whether a combination of different instruments might improve sensitivity to clinically relevant changes in health status.

Aim: To develop a composite score based upon Crohn's Disease Activity Index (CDAI) and Inflammatory Bowel Disease Questionnaire (IBDQ) items.

Methods: Patients from the PRECiSE 2 trial who responded at week 6 to certolizumab pegol (CZP) were randomised to receive treatment with CZP 400 mg or placebo for up to 26 weeks. IBDQ and CDAI scores were assessed at weeks 0, 6, 16 and 26. A 'daily practice' composite score (DP-6) containing two items from the CDAI and four items from IBDQ was constructed.

Results: Correlation coefficients between the CDAI score and IBDQ total score at baseline and at week 26 were -0.344 and -0.603, respectively (P<0.05). All IBDQ items were improved following CZP treatment. The DP-6 had the highest responsiveness at assessing response to treatment, relative to CDAI total score, when compared with other scores.

Conclusions: The DP-6 composite score could be used to optimise the use of existing instruments by serving as an index of symptoms due to systemic inflammation. Additional studies are needed to determine if the DP-6 composite score differentiates the impact of different treatments on patient-reported outcomes, and to determine if the use of the DP-6 improves the care of patients in clinical practice.

Trial registration: ClinicalTrials.gov NCT00152425.