Inflammatory bowel disease patients prioritize mucosal healing, symptom control, and pain when choosing therapies: results of a prospective cross-sectional willingness-to-pay study

James C Gregor,1 Martin Williamson,2 Dorota Dajnowiec,2 Bernie Sattin,2 Erik Sabot,3 Baljinder Salh4 1Division of Gastroenterology, Department of Medicine, Western University, London, ON, Canada; 2Janssen Inc., Toronto, ON, Canada; 3OptumInsight, Boston, MA, USA; 4Division of Gastroenterology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada Background: Given the large armamentarium of therapies for inflammatory bowel disease (IBD), physicians cannot fully describe all treatments to patients and, therefore, make assumptions regarding treatment attributes communicated to patients. This study aimed to assess out-of-pocket willingness-to-pay that IBD patients allocate to treatment attributes.Methods: Adult patients receiving therapy for IBD were invited to access a cross-sectional web-based discrete-choice experiment (May 22–August 31, 2015) that presented paired medication scenarios with varying efficacy, safety, and administration parameters. Preference weights and willingness-to-pay for each attribute level were assessed by a hierarchical Bayes method including a multinomial logit model.Results: A total of 586 IBD patients were included, 404 (68.9%) with Crohn’s disease and 182 (31.1%) with ulcerative colitis. Genders were evenly distributed; the majority of patients (70.1%) were 50 years or younger and had postsecondary education (75.4%), while the median health status was 7 (Likert scale: 1 [poor] – 10 [perfect]). Regarding relative preference-weight estimates, for the average respondent, reducing pain during administration, mucosal healing, and symptom relief were the highest-ranking attributes. Conversely, infusion reactions and risk of hospitalization or surgery were the lowest-ranking attributes. In multivariate analysis, patient sociodemographics did not affect the rank order of attributes although small differences were observed between asymptomatic and symptomatic patients in the previous year.Conclusion: This study has important implications related to understanding patient preferences and designing patient-centered strategies. IBD patients prioritize treatments with low administration pain. Additionally, these results concur with treatment guidelines emphasizing patients’ preference for mucosal healing and symptom control. Keywords: inflammatory bowel disease, patient preference, willingness-to-pay, discrete choic

P511 Association of ustekinumab serum concentrations and clinical outcomes: results from the mUST-DECIDE trial

Abstract Background Therapeutic drug monitoring is an important adjunct in optimising IBD management in patients treated with anti-TNF therapies. However, it remains unclear whether these principles apply to non-anti-TNF biologic therapies, such as the anti-IL12/23 agent, ustekinumab (UST). A follow-up analysis of the ‘mUST-DECIDE’ study explores the correlation between UST drug level and clinical outcomes. Methods 111 consecutive UST-treated adult CD patients across 11 sites in Canada from April 2017 to January 2018 were evaluated. Clinical decisions were recorded for all subjects at the single study visit and blood was drawn for TDM (Sanquin, radioimmunoassay). A retrospective chart review was completed in patients who had a follow-up visit ≥ 30 days after the baseline visit. Improved disease control (primary outcome) was defined as a composite assessment outcome meeting ≥ 1 disease control criterion (symptomatic, endoscopic/imaging, biochemical) without any of the non-response criteria (inadequate or loss of response, worsening of any disease control criteria, initiation of any CD-related medications and adverse events). Serum [UST] were categorised as therapeutic, subtherapeutic or uninterpretable based on their position in a 2 compartment PK model [subjects on Q8W dosing were assessed as per the log-linear model which projected a therapeutic level of ≥4.5 µg/ml at 4 weeks and ≥1.0 µg/ml at 8 weeks]. Results 53 patients had a clinical follow-up visit and an interpretable serum [UST]. Patients had refractory disease (89% anti-TNF-exposed, median 16.4 years since diagnosis), but clinically well (66% had baseline HBI &amp;lt;5) on treatment with UST for a median [IQR] of 16.5 [10.4–26.8] months. At baseline, the majority had serum [UST] in the therapeutic range (n = 44/53, 83%). After a median [IQR] of 148 [104–193] days, improved disease control was achieved by 51% of patients at next clinic visit. The outcome appeared independent of achieving therapeutic [UST] at baseline (OR[95% CI] = 0.80[0.19–3.38]). Dose-adjustment occurred in eight (15%) patients and improvements were observed in 75% of these patients. Subgroup analyses failed to detect clinical outcomes that were dependent on therapeutic serum [UST] (Table 1). No new safety signal was observed, no patient samples were positive for antibodies to UST. Conclusion The sub-study did not detect any association between routine serum [UST] and short-term clinical outcomes at the next patient visit. These data broadly suggests that the routine measurement of serum UST in CD patients does not aid in disease management, though further studies across different clinical scenarios (e.g. loss of response) are warranted. </jats:sec