Effectiveness and Safety Profiles of Biological Therapies in Inflammatory Bowel Disease: Real Life Data from an Active Pharmacovigilance Project

Abstract

Post-marketing surveillance is essential to evaluate the risk/benefit profile of drugs; however, pharmacovigilance studies comparing persistence and safety of biologic therapies in patients with inflammatory bowel disease (IBD) are scant. The aim of this study was to prospectively investigate persistence together with safety profiles of biologics in a cohort of patients diagnosed with Crohn’s Disease (CD) or ulcerative colitis (UC) followed by the IBD unit of Messina and treated with infliximab (IFX), adalimumab (ADA), golimumab (GOL), vedolizumab (VED), and ustekinumab (UST) from 2017 through 2021. Descriptive and treatment persistence analyses with predictors for discontinuation and occurrence of adverse drug reactions (ADRs) were performed. A total of 675 IBD patients were enrolled. A higher persistence rate was noted for UST and ADA in the first year (83.8% and 83.1%, respectively) and for IFX in the fifth year of treatment (58.1%). GOL, VED, and UST—all used as second/third-line therapies—seemed to have a higher risk of non-persistence than IFX (in order HR: 2.19; CI 95%: 1.33–3.61, 1.45; 1.04–2.04, 2.25; 1.25–4.07) as well as switchers and those who had at least one ADR (18.1; 13.22–24.68 and 1.55; 1.20–1.99, respectively). The reported ADRs, which were generally mild–moderate, were largely known. However, real-world data should be implemented to further study undetected safety concerns, including risk of malignancy.

Effectiveness and Safety Profile of Dupilumab in Chronic Rhinosinusitis with Nasal Polyps: Real-Life Data in Tertiary Care

“…The study has some strengths and limitations. Among the former, there is the prospective nature of data collection in a real-world setting, as already known in previous studies overcoming the efficacy-effectiveness gap with clinical trials [40][41][42]. Monoclonal therapy with dupilumab is effective in the control of type 2 inflammation leading to CRSwNP, supporting the indications of the AIFA for biological treatment with dupilumab.…”

Meta‐analysis: Persistence of advanced therapies in the treatment of inflammatory bowel disease

“…Among the 63 publications, 10‐72 58 were journal articles and 5 were international conference abstracts. Two conference abstracts 71,72 were replaced by subsequent published articles found in our search.…”

Effectiveness of vedolizumab and ustekinumab as second biologic agent in achieving target outcomes in tumor necrosis factor antagonists experienced patients with inflammatory bowel disease (enroll-ex study)

“…A study suggested that a high proportion of patients continued on their initial biologics for 1 year and approximately half of patients were persistent after 5 years of treatment ( Barbieri et al, 2022 ). The same study, found that patients treated with vedolizumab and ustekinumab seemed to have a higher risk of non-persistence compared to patients treated with infliximab.…”

“…However, some can argue that study populations in clinical trials may not accurately represent the general IBD population, which may limit the generalizability of their results ( Ha et al, 2012 ). Additionally, despite the availability of some real-world data regarding the effectiveness and safety of ustekinumab and vedolizumab in patients with IBD after failure of or intolerance to anti-TNF therapy ( Barbieri et al, 2022 ; Onali et al, 2022 ; Rayer et al, 2022 ), limited evidence exists with respect to real-life data in IBD from Kuwait specifically and the middle east region generally. Therefore, the aim of this study was to assess the effectiveness of vedolizumab and ustekinumab in a real-life cohort of patients with IBD who had failed to respond to an anti-TNF agent.…”