P315 High symptom burden and impact on health-related quality of life in patients with Crohn’s perianal fistulas: results from a global burden of illness study
Karki, C.(1);Sharpe, E.(2);Hantsbarger, G.(3);Lee, K.(4);Perovic, M.(5);Raven, L.(6);Sajak-Szczerba, M.(7);Silber, A.(2);Yoon, A.(8);Tozer, P.(9);
(1)Takeda Pharmaceuticals USA- Inc., Global Evidence and Outcomes, Cambridge MA, United States;(2)Trinity Partners- LLC, Heath Economics & Outcomes Research, Waltham- MA, United States;(3)Takeda Pharmaceuticals USA Inc., Safety and Health Value Statistics, Cambridge- MA, United States;(4)Crohn's & Colitis Canada, Research & Patient Programs, Toronto, Canada;(5)European Federation of Crohn’s and Ulcerative Colitis Associations, European Federation of Crohn’s and Ulcerative Colitis Associations, Brussels, Belgium;(6)Crohn's & Colitis Australia, n/a, Camberwell, Australia;(7)European Federation of Crohn’s and Ulcerative Colitis Associations, n/a, Brussels, Belgium;(8)Takeda Pharmaceuticals, Gastroenterology- Japan Medical Office, Tokyo, Japan;(9)St Mark’s Hospital and Academic Institute, Fistula Research Unit, London, United Kingdom;
Background
Perianal fistulas (PAF) are a common complication in Crohn’s disease (CD) and can be associated with an increased burden of illness. A global study was conducted to assess the burden of illness in patients with Crohn’s perianal fistulas (CPF) compared with patients with CD without PAF (non-PAF CD). Here we present patient symptom burden and impact on HRQoL.
Methods
This cross-sectional study was conducted in seven countries (France, Germany, Spain, UK, Canada, Australia and Japan) in patients aged ≥21 and ≤90 years with self-reported physician-diagnosed CD. Patients were classified as having non-PAF CD (cohort 1) or CPF without PAF-related surgery (cohort 2) or CPF with PAF-related surgery (cohort 3). Customised questions and validated general and disease-specific patient-reported outcome data were collected via a 45-min IRB/EC-approved web-enabled questionnaire. Symptom burden and impact on HRQoL were evaluated using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ, scores 1–7 [low–optimum] with 2-week recall period) in all cohorts and Quality of Life in Patients with Anal Fistula (QoLAF, scores 14–70 [low–high impact]) in cohorts 2 and 3. Data were analysed using descriptive statistics.
Results
Of 929 patients recruited (cohort 1, n=620; cohort 2, n=174; cohort 3, n=135) 58–69% were male and 55–67% were aged 21–40 years across all cohorts. Cohorts 2 and 3 experienced a significantly higher frequency of CD-related complications than cohort 1 (mean [standard deviation, SD]: 9.4 [4.5] and 11.1 [5.2] vs 6.0 [4.1], respectively; both p <0.05, Table 1) and had a higher number of CD-related surgeries (other than PAF-related surgeries) in the past 12 months (mean [SD]: 1.8 [1.1], p =0.109 and 2.2 [1.3], p <0.0001 vs 1.5 [0.9], respectively). In patients with CPF, a smaller proportion in cohort 2 had active PAF vs cohort 3 (136 [78%] vs 119 [88%], respectively; p =0.022) and a smaller proportion had experience with post-treatment PAF recurrence/persistence in cohort 2 vs cohort 3 (84 [48%] vs 80 [59%], respectively; p =0.055). Overall SIBDQ scores were significantly lower (worse) in cohorts 2 and 3 than in cohort 1 (3.8 and 3.7 vs 4.1 respectively; both p <0.001). In patients with CPF, total QoLAF scores were comparable between cohorts 2 and 3 (41 and 42, respectively), although patients in cohort 3 had a significantly higher (worse) score in the physical impact domain compared with cohort 2 (21 vs 19, respectively; p <0.05).
Conclusion
In this large global study, we observed that patients with CPF had incrementally higher symptom burden, owing to both CD and PAF, compared with patients with non-PAF CD. For patients with CPF, there was no difference in HRQoL irrespective of whether they had received PAF-related surgery or not.