Medical and Non-Medical Reasons for Discontinuation of Anti-TNF Agents Among Patients With Ulcerative Colitis in Real-World Setting: A Systematic Review

OBJECTIVES: Anti-TNF agents (ATAs) are generally the first-line biological therapy in ulcerative colitis (UC) patients who have failed treatment with corticosteroids and/or immunomodulators. However, a systematic assessment of literature detailing discontinuation of ATAs is lacking. We aimed to identify the medical and non-medical reasons for discontinuation of ATAs in real-world UC patients.

METHODS: A systematic literature review was conducted using comprehensive searches in Embase and Medline databases to identify real-world studies published in English during 2005−January 2022. Studies were included if conducted in biological-naïve UC patients who initiated ATAs, had ≥50 patients, and published as full manuscripts. Exclusion criteria were mixed population, <50 patients, conference abstracts and non-English articles.

RESULTS: Of the 2593 records retrieved from literature, 26 were included which provided 24 distinct studies. These studies were from Europe (number of studies [n]=15), Japan (n=3), US, Canada, and Korea (n=2 each). The study design was retrospective (n=15) and prospective observational (n=8). Median age of patients in these studies varied 33−46 years; 45−62% were male; median disease duration was 3−8 years. Studies assessed at least one of the following ATAs: infliximab-originator (n=16), adalimumab (n=6), golimumab, infliximab-biosimilar, and ATAs as group (n=3 each). The follow-up duration ranged from 10 weeks to 5.8 years. The medical reasons for discontinuation of ATAs included adverse events [AEs] (n=21), primary non-response (PNR), loss of response [LOR] (n=8 each), worsening of UC (n=7), control of disease, lost to follow-up (n=3 each), issues related to drug dosing/administration, physicians’ decision, and pregnancy (n=1 each). The non-medical reasons for discontinuation of ATAs were patients’ choice (n=5), administrative issues (n=2), finance/insurance-related, and location change (n=1 each).

CONCLUSIONS: This review suggests that while AEs, PNR, LOR, and worsening of UC are predominant medical reasons, patients’ choice is the main non-medical reason for discontinuation of ATAs among UC patients in real-world setting.