S0725 Impact of Infliximab-dyyb (Infliximab Biosimilar) on Clinical and Patient-Reported Outcomes: 1-Year Follow-Up Results From an Observational Real World Study Among Patients With Inflammatory Bowel Disease (ONWARD Study)

Abstract

INTRODUCTION: The objective of this study was to describe the effects of infliximab-dyyb, a biosimilar to reference product (RP) infliximab, on clinical and patient-reported outcomes (PROs) in inflammatory bowel disease (IBD) including Crohn’s disease (CD) and ulcerative colitis (UC) patients in a real-world setting. METHODS: In this prospective, observational study, patients with IBD in the US and Canada were recruited to begin treatment with infliximab-dyyb. Patients, divided into biological naive users of infliximab-dyyb (naive users) and those switching from RP infliximab to infliximab-dyyb, were followed for 1 year. Clinical outcomes assessed were partial Mayo score (PMS) and Harvey Bradshaw Index (HBI) for the UC and CD cohort, respectively. Clinical response (PMS/HBI reduction ≥3 points) and remission (PMS <3 or HBI <5) were measured. Patient reported outcomes (PROs) included: Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and EuroQol Visual Analog Scale (EQ-VAS). Changes from baseline were assessed using mixed models for repeated measures. Adverse events (overall/treatment-related) were assessed. RESULTS: A total of 67 CD and 48 UC patients initiating treatment with infliximab-dyyb were enrolled (51% female; mean age 44 years; 87% Caucasian; mean BMI 27.9). Of them, 39 patients were naive users, 57 were switched from RP infliximab, and 19 were switched from other biologics. Among UC naïve users, PMS improved (P < 0.0001) and remission rate increased from baseline (P = 0.0015; Table 1). For UC patients switching from RP infliximab to infliximab-dyyb, PMS improved from baseline (P = 0.0103; Table 1). CD naive users and patients switching from RP infliximab had low baseline HBI scores which where maintained over time (Table 2). Among all naïve users, SIBDQ and EQ-VAS scores improved from baseline (P < 0.0001 and 0.0135; Table 3). Patients switching from RP infliximab maintained SIBDQ and EQ-VAS scores (P = 0.1416 and 0.0675; Table 3). Regarding adverse events, 22 occurred related to treatment (including 5 lack of response, 4 infusion reaction, 2 immunogenicity, and 2 hypersensitivity reaction). Overall, 19 (17%) patients discontinued infliximab-dyyb. CONCLUSION: Clinical outcomes among naive users of infliximab-dyyb improved for UC and were maintained for CD patients. Naive users of infliximab-dyyb showed significant improvements in PROs. Patients switching from RP infliximab to infliximab-dyyb maintained their clinical outcomes and quality of life.Table 1Table 2Table 3