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Outcomes in Patients with IBS Who Initiate or Switch to the Infliximab Biosimilar Infliximab-dyyb (ONWARD Study)

2020 Year in Review - Biosimilars - Biosimilars

Real-world data from the ONWARD study indicate that patients with inflammatory bowel syndrome (IBS) who initiate or switch to infliximab-dyyb achieve significant improvement of clinical outcomes and quality of life.

At the 2020 American College of Gastroenterology meeting, the results of the observational ONWARD study, evaluating the clinical and patient-reported outcomes (PROs) of the infliximab biosimilar infliximab-dyyb in patients with inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), were reported.

This multicenter, observational study recruited patients with confirmed diagnosis of IBD who were treated with infliximab-dyyb across 24 sites in the United States and Canada between February 2018 and February 2019. These patients were categorized into 2 groups; the first group included patients initiated with infliximab-dyyb as their first biologic (naïve users), and the second included patients who switched from reference infliximab to infliximab-dyyb or from another antitumor necrosis factor biologic to infliximab-dyyb (switch cohort). Clinical outcomes assessed were partial Mayo score (PMS) for the UC cohort and Harvey-Bradshaw Index (HBI) for the CD cohort. Clinical response (defined as PMS/HBI reduction ≥3 points) and remission (defined as PMS <3 or HBI <5) were measured. PROs included Short Inflammatory Bowel Disease Questionnaire (SIBDQ), EuroQol visual analog scale (EQ-VAS), Work Productivity and Activity Impairment questionnaire, Generalized Anxiety Disorder questionnaire, Treatment Satisfaction Questionnaire for Medication, and 8-item Patient Health Questionnaire (PHQ-8).

The study included a total of 115 patients. Of these, 48 patients were diagnosed with UC and 67 patients with CD; 39 patients were naïve users, 57 patients switched from reference infliximab to infliximab-dyyb, and 19 patients switched from other biologics. The median age of the study population was 44.25 years, 51% of patients were female, and mean body mass index was 27.9 kg/m2. The baseline characteristics of the naïve users cohort and switch cohort were largely similar.

Patients with UC who were naïve users showed a statistically significant increase in remission (P = .0015) and improvement in PMS (P <.0001) from baseline. Patients with CD who were naïve users, as well as patients who switched from reference infliximab to biosimilar, had low baseline HBI scores, which were maintained over time.

In terms of PROs, all naïve users showed statistically significant improvements from baseline to 12 months in several PROs, including SIBDQ and EQ-VAS scores. Patients switching from reference infliximab to biosimilar maintained their SIBDQ and EQ-VAS scores. In addition, work impairment scores, presenteeism scores, and side-effect scores substantially improved in naïve users and marginally improved or were maintained for patients who switched to biosimilar.

In the safety population, 59 adverse events (AEs; 34.8%) were reported in 40 patients, the majority of which were of mild and moderate severity. A total of 7 (11.9%) severe AEs were reported. The most common AEs were gastrointestinal events, respiratory, and serious infections. Overall, 19 (17%) patients discontinued infliximab-dyyb.

These data indicate that, in a real-world setting, clinical outcomes and PROs greatly improved for naïve users of infliximab-dyyb with UC, whereas patients with CD and patients switching from reference infliximab to infliximab-dyyb maintained their clinical outcomes and quality of life.

Reference
Abraham B, et al. American College of Gastroenterology (ACG) 2020 Virtual Annual Scientific Meeting & Postgraduate Course. Abstract P1530.

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Last modified: July 22, 2021