Clinical outcomes, predictors of prognosis and health economics consequences in IBD patients after discontinuation of the first biological therapy

Abstract

Background: In real-world clinical practice, biologics in inflammatory bowel diseases (IBD) may be discontinued for a variety of reasons, including discontinuation initiated by gastroenterologists. The aims of the study are to report outcomes after discontinuation and predictors of prognosis after a minimum follow-up of 24 months; outcomes of gastroenterologist-initiated discontinuation with resulting direct cost implications on the health system were also studied. Methods: IBD patients who discontinued their first-use biologics between January 2013 and December 2016 were identified at our tertiary centre. Reasons for discontinuation and pre-defined adverse outcomes (AO) were recorded. Data were analysed using univariable and multivariable logistic regressions within a machine learning technique to predict AO. Gastroenterologist-initiated discontinuations were analysed separately, and Kaplan–Meier survival analysis performed; direct costs of AO due to discontinuation were assessed. Results: A total of 147 patients discontinued biologics (M = 74; median age 39 years; Crohn’s Disease = 110) with median follow-up of 40 months (range 24–60 months). In the total cohort, there were fewer AO among gastroenterologist-initiated discontinuations compared with patient-initiated; 54% (of the total group) had AO within 6 months. Among 59 gastroenterologist-initiated discontinuations, 23 (40%) had IBD-related AO within 6 months and 53 (90%) patients had AO by end of follow-up. Some 44 (75%) patients needed to restart biologics during follow-up, and direct costs due to AO and restart of biologics were high. Conclusions: The proportion of patients who have AO following discontinuation of biologics is high; clinicians need to carefully consider predictors of poor prognosis and high relapse rates when discussing discontinuation. The direct costs of managing AO probably offset theoretical economic gains, especially in the era where cost of biologics is reducing. Biologics should probably be continued without interruptions in most patients who have achieved remission for the duration these remain effective and safe.

A Systematic Review of Artificial Intelligence and Machine Learning Applications to Inflammatory Bowel Disease, with Practical Guidelines for Interpretation

“… 23 , 29 , 45 , 59 , 61 , 66 , 73 Crohn’s disease data (only) was used in 27 studies, 12 , 17 , 19 , 26–29 , 32 , 37–39 , 41 , 44 , 47–50 , 58 , 60 , 63 , 65 , 74–79 and UC data (only) was used in 15 studies, 25 , 40 , 42 , 46 , 52 , 55 , 59 , 61 , 62 , 64 , 68–70 , 80 , 81 with the remainder ( n = 36) using a mix of CD and UC data, or IBD data as one class. 11 , 13–16 , 18 , 20–24 , 30 , 31 , 33–36 , 43 , 45 , 51 , 53 , 54 , 56 , 57 , 66 , 67 , 71–73 , 82–88 Half of the research using UC-only data focused on predicting disease activity with endoscopy data, whereas the aims of ML classifications on CD data were varied. A breakdown of the method and classification task can be found in Figure 3 , which can be customized here (isstafford.github.io/review_ml_ibd_2021/).…”

Resveratrol for inflammatory bowel disease in preclinical studies: a systematic review and meta-analysis

“…Conventional treatment often involves the use of immunosuppressive and anti-inflammatory drugs, which can lead to serious side effects and complications. Biologic therapy, while effective, can vary greatly in its effectiveness among individuals and is often expensive, impacting patient compliance ( Shivaji et al, 2020 ). Many patients demonstrate both primary and secondary drug resistance, and adjusting the biological treatment plan following the detection of resistance can lead to an increase in the patient’s side effects and medical costs ( Zhou WP.…”

Tandem use of Anti-TNF Agents in Patients with IBD who Fail First Line Anti-TNF Therapy: Real Life Lessons from a National Database.

“…Although newer classes of biologic agents for IBD have become available and treatment guidelines are recommending them, access to them are limited as healthcare funding agencies insist that a second anti-TNF agent be tried before switching. In addition, there are other barriers to drug access as discussed by Shajiva et al [9]. Therapeutic drug monitoring has simpli ed the process of choice of biologic use in IBD.…”