Trends in the use of biologicals and their treatment outcomes among patients with inflammatory bowel diseases – a Danish nationwide cohort study

Abstract

Summary Background Therapeutic management of inflammatory bowel diseases (IBD) is rapidly evolving, with an expanding armoury of biological drugs at our disposal. However, real‐world findings about treatment persistence and the impact of biologicals on surgery remain inconsistent. Aims This study aimed to investigate trends in biological use and surgery rates in a nationwide cohort of biological‐naïve IBD patients. Methods Patients with IBD who initiated biological treatment between 2011 and 2018 were identified in the Danish National Patient Registry. Data on use of biologicals, surgeries and healthcare costs were retrieved and analysed for time trends. Results Between 2011 and 2018, a total of 6,036 IBD (51% ulcerative colitis (UC), 49% Crohn's disease (CD)) patients received biological treatment for the first time. Cumulative use of biologicals increased from 5.0% to 10.8% among UC and 8.9%‐14.5% among CD patients. Infliximab remained the most‐prescribed first‐line biological for UC and CD. Treatment persistence was 44.3% and 16.9% after 1 and 3 years in UC, compared to 59.9% and 33.6% in CD patients. Overall, 32.8% of patients switched to a second biological. Surgery rates decreased in both UC (P = 0.015) and CD (P = 0.008) patients and remained significant for UC in the Cox regression model (P = 0.002). Outpatient and surgical costs also fell among both UC and CD patients. Conclusions Persistence rates for first‐line biologicals among IBD patients were low and one‐third switched treatment. Surgery rates and direct costs decreased over time, but whether this is related to the use of biologicals has yet to be determined.

Classic drugs in the time of new drugs: real‐world, long‐term outcomes of thiopurine monotherapy in 1016 patients with inflammatory bowel disease

“…A recent Danish study investigated trends in biological use in a population‐based cohort of over 6000 biological‐naïve IBD patients. Strikingly, persistence rates of first‐line biologicals were low with only 44% and 17% of UC, and 60% and 34% of CD patients still on treatment after 1 and 3 years 47 . Similar secondary loss of response (LOR) rates have been described in other real‐world observational cohorts and even though biological users are generally characterised by higher disease severity, these LOR rates are all considerably higher than the rates observed in our and other thiopurine cohorts 48–51 .…”

Editorial: early and persistent biological treatment and its impact on long term surgical outcomes in inflammatory bowel disease

“…In 2018, 10% and 15% of individuals with ulcerative colitis (UC) and Crohn's disease (CD) respectively received biologics, double that of a decade earlier. 1 Anti-tumour necrosis factor (anti-TNF) therapy accounted almost all first-line biologic use. In keeping with others, 2 treatment persistence, a surrogate of biologic efficacy and tolerability, halved after one year and was a third after 3 years.…”

“…The authors report persistence was greatest with vedolizumab for UC and others report ustekinumab persistence is greatest for CD even when used as second-line therapy. 1,7…”

Letter: the clinical course of Crohn’s disease—the Sicilian experience. Authors’ reply

“…1,5,6 Crohn's disease is a progressive disease and modern treatment options were not introduced until late in the observation period.Hence, most Crohn's disease patients in our cohort undergoing surgery needed additional surgeries during the course of their disease.It would be interesting to know whether re-operation rates were similar in the Sicilian cohort, despite the cohorts differing in terms of design and representativeness of the general patient population.Even with the most effective treatments available today, many patients do not achieve long-term remission and will need surgery. 7 It is important to know and learn from the past and the data from Sicily, as well as from Copenhagen, demonstrate the progressive 'natural course' of Crohn's disease, as well as its consequences when not treated effectively.…”

“…Even with the most effective treatments available today, many patients do not achieve long-term remission and will need surgery. 7 It is important to know and learn from the past and the data from Sicily, as well as from Copenhagen, demonstrate the progressive 'natural course' of Crohn's disease, as well as its consequences when not treated effectively.…”