P246 Persistent burden of disease in patients with Crohn’s disease treated with biologic therapy: results from a real-world survey in the United States (US), France, Germany, Italy, Spain, and United Kingdom (5EU)
Sikirica, M.(1);Lynch, J.(2);Kershaw, J.(3);Lukanova, R.(3);Baker, S.(3);Milligan, G.(3);
(1)Janssen, Market Access, Horsham, United States;(2)Janssen Research & Development- LLC, Immunology, Horsham, United States;(3)Adelphi Real World, Autoimmune, Bollington, United Kingdom;
Background
Crohn’s disease (CD) requires life-long disease management. The study objective was to investigate the burden of CD in patients who have only partially responded to biologic therapy.
Methods
Data were drawn from two waves (Nov 2014-Mar 2015; Sep 2017-Jan 2018) of the Adelphi Inflammatory Bowel Disease (IBD) Disease Specific Programme™, a point-in-time survey of gastroenterologists (GEs) and their IBD patients, in the US, and 5EU. GEs completed a physician-reported questionnaire (PRF) for 5-10 consecutively consulting patients with CD, covering demographics, clinical characteristics, and health care resource use (HCRU). Same patients completed a voluntary patient-reported questionnaire (PSC) covering the Short IBD Questionnaire (SIBDQ), EuroQol 5-dimension (EQ-5D), and Work Productivity and Activity Impairment (WPAI) questionnaires. Crohn’s Disease Activity Index (CDAI) score, derived per patient from the PRF and PSC, was used to stratify patients into four groups by degree of disease activity (DA). Since clinical remission (CDAI <150) and moderate to severe (mod/sev) (≥221) are well known in clinical trials, we explored stratification in between, creating a ‘mild’ group (CDAI 150 - <180) and a ‘partial responder’ (PR) group (CDAI 180 - 220).
Outcomes were compared between DA groups using linear regression (or logistic for binary outcome) that included the potential confounding variables age, gender, body mass index (BMI), comorbidities (using Charlson Comorbidity Index), and severity at diagnosis. From each regression, least square (LS) means were generated for each DA group and pairwise Wald tests were conducted to compare pairs of DA groups. Base sizes varied due to the voluntary PSC element.
Results
319 GEs and 853 CD patients receiving a biologic for at least 12 weeks at data collection were included in the analysis (mean age 38.1 years, proportion of female patients 52.3%, 65.3% employed, mean BMI 24.1). CDAI groups are reported in Table 1.
Levels of pain, sleep disturbance and fatigue were significantly lower in patients in remission (Table 2).
SIBDQ, EQ-5D, and WPAI Health-Related Quality of Life (HrQoL) measures indicated significantly better outcomes amongst remission patients (Table 3).
HCRU in the past 12 months, in terms of hospitalisations and surgery rates, was significantly lower amongst remission patients (Table 4).
Conclusion
Patients in remission showed significantly better outcomes compared with mild, PR and mod/sev. Patient stratification by CDAI demonstrated that patients in remission may considerably benefit from fewer symptoms and improved HrQoL, even vs ‘mild’ patients. The latter had unaddressed symptoms, which may negatively impact their wellbeing.