Su1711 EFFICACY AND SAFETY OF TOFACITINIB AFTER FAILURE OF ANTI-TNF AGENT IN PATIENTS WITH ULCERATIVE COLITIS: A US-BASED PROPENSITY MATCHED COHORT STUDY
Year: 2023
Type: conference-abstract
Abstract: study of CD and UC patients who received maintenance originator IFX from 2017-2019 in the VA.CD and UC patients were identified using a previously validated algorithm and confirmed by chart review.Patents on maintenance IFX originator were identified by dispensed medication from Corporate Data Warehouse (CDW).Patients switched to IFX biosimilar after 2017 were identified in CDW by dispensed medication and confirmed by chart review.Adverse outcomes were defined as infusion reaction, serious infection (intravenous antibiotic, or delay of IFX), or immunogenicity (anti-IFX antibody or IFX escalation), and confirmed by chart review.Adverse event rates at 12 months of patients continued on originator IFX were compared to patients switched to IFX biosimilar using univariate and multivariate logistic regression models adjusting for patient and non-patient factors.Results: A total of 790 patients (488 CD, 298 UC, and 4 IBDU) on maintenance originator IFX were identified during the study period.Of these, 380 patients were identified to have switched to IFX biosimilar, and 410 patients continued on IFX originator during the study period.Overall adverse outcomes occurred in 35.6% of patients at 12 months (35.6% switch, 35.3% non-switch, p=0.87).No statistically significant difference in rates of infusion reaction, serious reaction, or immunogenicity was identified between the switch and non-switch groups.In multivariate logistic regression including age, race, gender, concomitant medication, and VA priority status, no significant difference in adverse outcomes at 12 months was observed between the switch and non-switch groups (aOR 1.09, 95% CI 0.76-1.42).Conclusion: In a real-world national U.S. cohort of patients with CD and UC, we observed IFX biosimilar switching was not associated with adverse events compared to continuation on IFX originator.These findings provide further reassurance that IFX biosimilar switching for CD and UC is safe.
Source: Gastroenterology
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Genetics
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $3,800
OpenAlex ID: W4383420922