Changes in the requirement for early surgery in inflammatory bowel disease in the era of biological agents

Guasch, Montserrat; Cañete, Fiorella; Ordás, Íngrid; Iglesias-Flores, Eva; Clos, Ariadna; Gisbert, Javier P.; Taxonera, Carlos; Vera, Isabel; Mínguez, Miguel; Guardiola, Jordi; Rivero, Montserrat; Nos, Pilar; Gomollón, Fernando; Barrio, Jesús; Francisco, Ruth de; López-Sanromán, Antonio; Martín-Arranz, María Dolores; García‐Planella, Esther; Camargo, Raquel; García-López, Santiago; Castro, Luísa; Calvet, Xavier; Mañosa, Míriam; Domènech, Eugeni; registry, Geteccu-Eneida

doi:10.1111/jgh.15084

Cited by 14 publications

(9 citation statements)

References 19 publications

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“…We did not find previous published studies that evaluated the patient journey in terms of UC and overall health care experience for such a long period. Our analysis revealed a progressively worsening disease pattern among UC patients before the initiation of biologics, which is consistent with the relatively low rate of biologic use in UC [12], and may in part help explain why observational studies to date did not find reduced colectomy risk in UC with "early" biologic treatment, despite evidence from clinical trials for reduced hospitalization and surgery with infliximab [14][15][16].…”

Section: Discussionsupporting

confidence: 78%

“…Biologic use overall is about 44% in CD compared to 16% in UC among commercially insured patients in the US [12]. While this possibly reflects difference in disease progression between CD and UC at least for some patients, it is also possibly related to the lack of real-world evidence in support of early biologic treatment to lower long-term risk of colectomy in UC, despite evidence from clinical trials for reduced hospitalization and surgery with infliximab [13][14][15]. On the other hand, the common practice of delayed biologic treatment in UC would present challenges such as confounding by disease severity to real-world evidence generation.…”

Section: Introductionmentioning

confidence: 99%

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Understanding patient journey in ulcerative colitis prior to biologic initiation: a 5-year exploration

et al. 2021

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Background There has been a more pronounced shift toward earlier, more aggressive therapies in Crohn’s disease than in ulcerative colitis (UC). The aim of this study was to describe the pre-biologic treatment and health care experience, including co-morbidities and overall health care utilization, for UC patients who initiated biologic therapies, in the 5 years prior to the initiation of the first biologic agent. Methods UC patients who initiated a biologic agent approved for UC between 9/15/2005 and 1/30/2018 were identified from the IBM® MarketScan® Commercial Database, a large US database. The date of the first recorded UC biologic exposure was defined as the index date, and ≥ 5 years of pre-index records were required to evaluate patients’ treatment, disease progression and overall health care utilization prior to initiating biologic agents. Results Among the 1891 eligible patients, treatment with oral corticosteroids, 5-aminosalicylates, and other non-biologic immunomodulators, all increased progressively across the 5 years prior to the index. From within year-five to within year-one prior to the index, the median duration of oral corticosteroid treatment increased from 34 to 88 days per year and the proportion of patients who experienced more extensive/pancolitis disease increased from 16 to 59%. Overall, the frequency of all-cause health care visits also increased. Conclusions Patients with UC experienced increasing morbidity and treatment burden in the 5 years prior to initiating biologic therapy. To achieve reduced corticosteroids in UC management, better risk stratification is needed to help identify patients for more timely biologic treatment.

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Section: Discussionsupporting

confidence: 78%

Section: Introductionmentioning

confidence: 99%

Understanding patient journey in ulcerative colitis prior to biologic initiation: a 5-year exploration

et al. 2021

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“…We did not nd previous published studies that evaluated the patient journey in terms of UC and overall health care experience for such a long period. Our analysis revealed a progressively worsening disease pattern among UC patients before the initiation of biologics, which is consistent with the relatively low rate of biologic use in UC [12], and may in part help explain why observational studies to date did not nd reduced colectomy risk in UC with "early" biologic treatment, despite evidence from clinical trials for reduced hospitalization and surgery with in iximab [14][15][16].…”

Section: Discussionsupporting

confidence: 78%

“…While this possibly re ects difference in disease progression between CD and UC at least for some patients, it is also possibly related to the lack of real-world evidence in support of early biologic treatment to lower long-term risk of colectomy in UC, despite evidence from clinical trials for reduced hospitalization and surgery with in iximab [13][14][15]. On the other hand, the common practice of delayed biologic treatment in UC would present challenges such as confounding by disease severity to real-world evidence generation.…”

Section: Introductionmentioning

confidence: 99%

Understanding Patient Journey in Ulcerative Colitis Prior to Biologic Initiation: A 5-Year Exploration

Wang

Makadia

Knoll

et al. 2020

Preprint

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Background There has been a more pronounced shift toward earlier, more aggressive therapies in Crohn’s disease than in ulcerative colitis (UC). The aim of this study was to describe the pre-biologic treatment and health care experience, including co-morbidities and overall health care utilization, for UC patients who initiated biologic therapies in the five years prior to the initiation of the first biologic agent.MethodsUC patients who initiated a biologic agent approved for UC between 9/15/2005 and 1/30/2018 were identified from the IBM® MarketScan® Commercial claims database. The date of the first recorded UC biologic exposure was defined as the index date, and ≥ 5 years of pre-index records were required to evaluate patients’ treatment, disease progression and overall health care utilization prior to initiating biologic agents.ResultsAmong the 1891 eligible patients, treatment with oral corticosteroids, 5-aminosalicylates, and other non-biologic immunomodulators all increased progressively across the five years prior to the index. From within year-five to within year-one prior to the index, the median duration of oral corticosteroids increased from 34 to 88 days per year and the proportion of patients who experienced more extensive/pancolitis disease increased from 16% to 59%. Overall, the frequency of all-cause health care visits also increased.ConclusionsPatients with UC experienced increasing morbidity and treatment burden in the five years prior to initiating biologic therapy. To achieve sustained remission and mucosal healing with reduced corticosteroids in UC management, better risk stratification is needed to help identify patients for more timely biologic treatment.

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“…The effect of biologic agents on the rate of IBD-related surgery is also a controversial matter. Several studies reported reductions in surgery rates among IBD patients treated by biologic agents [42][43][44], while others reported no change [20,22,34]. It is important to note that the use of biologic agents in clinical practice involves a greater variability in patient selection, dosing, timing, monitoring, and optimization of therapy.…”

Section: Discussionmentioning

confidence: 99%

Biologic therapy is associated with a mild decrease in the rate of hospitalizations in pediatric IBD

et al. 2021

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Background The effect of biologic therapy on the incidence of inflammatory bowel disease (IBD)-related hospitalizations is controversial. The high efficacy of biologic agents is weighted against potential therapy-related adverse events, however, there are no data on the effect of biologic therapy on the indications for hospitalization in IBD. We aimed to evaluate the impact of biologic therapy on the indications and rate of hospitalization in pediatric IBD. Methods This retrospective cohort study included all children (< 18 years of age) with IBD who were hospitalized in our medical center from January 2004 to December 2019. Data on demographics, disease characteristics and course, and therapy were collected, as were the indications for and course of hospitalizations. We evaluated the relationship between therapy with biologic agents, indications and rates of hospitalization. Results Included were 218 hospitalizations of 100 children, of whom 65 (65%) had Crohn’s disease and 35 (35%) had ulcerative colitis. The indications for hospitalization were IBD exacerbations or complications in 194 (89%) and therapy-related adverse events in 24 (11%). The patients of 56 (25.7%) hospitalizations were receiving biologic therapy. In a multivariate analysis, no correlation between therapy and indication for hospitalization was found (p = 0.829). Among children under biologic therapy, a decrease in the rate of hospitalizations from 1.09 (0.11–3.33) to 0.27 (0–0.47) per year was observed for patients that were hospitalized during 2016–2019 (p = 0.043). Conclusion Biologic therapy did not influence the indication for hospitalization, but were associated with a decrease in the rate of hospitalization during 2016–2019 in pediatric IBD.

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Changes in the requirement for early surgery in inflammatory bowel disease in the era of biological agents

Cited by 14 publications

References 19 publications

Understanding patient journey in ulcerative colitis prior to biologic initiation: a 5-year exploration

Understanding patient journey in ulcerative colitis prior to biologic initiation: a 5-year exploration

Understanding Patient Journey in Ulcerative Colitis Prior to Biologic Initiation: A 5-Year Exploration

Biologic therapy is associated with a mild decrease in the rate of hospitalizations in pediatric IBD

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