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Infliximab Originator, Infliximab Biosimilar, and Adalimumab Are More Effective in Crohn's Disease Than Ulcerative Colitis: A Real-Life Cohort Study.

ABSTRACT: INTRODUCTION:There are no real-life studies comparing the efficacy and safety of the different antitumor necrosis factor (TNF)-? drugs available in patients with ulcerative colitis (UC) and Crohn's disease (CD). To verify the effectiveness and tolerability of different anti–TNF-? agents (infliximab [IFX] originator, biosimilar CTP13, and adalimumab [ADA]) in patients with moderate-to-severe CD and UC.METHODS:Retrospectively, patients with moderate-to-severe inflammatory bowel disease who completed induction with either ADA, IFX originator, or biosimilar from 2015 to 2017 were included. Patients were evaluated after induction at 30 and 52 weeks. We performed an intention-to-treat analysis to evaluate clinical response and remission, steroid-free clinical remission, and endoscopy response according to different time points. At every time point, the need for dose escalation and occurrence of adverse events have been reported.RESULTS:Eighty-nine patients with UC (31 ADA, 30 IFX originator, and 28 IFX biosimilar) and 90 patients with CD (30 for each drug groups) were enrolled. After induction at week 30 and 52, clinical response was obtained by the following: 84.3%, 86.5%, and 82% of UC and 93.3%, 88.9%, and 80% of CD. Clinical steroid-free remission rates were significantly higher in the CD group compared with the UC group at every time point (P < 0.05). At week 52, 31.1% of ADA, 16.7% of IFX originator, and 36.2% of biosimilar patients needed treatment optimization. At week 52, 13 patients had suspended therapy because of severe adverse events, including 3 cases of malignant disease.DISCUSSION:Anti–TNF-? treatment was more effective in patients with CD compared to patients with UC, independently of the drug used.

SUBMITTER: Barberio B

PROVIDER: S-EPMC7263644 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Project description:Background:The purpose of this study was to compare the long-term safety of infliximab and nonbiologic agents as Crohn's disease (CD) therapy. Methods:Patients with CD were prospectively evaluated in this large, observational registry. Results:Patients (n = 6273) participated in this observational registry from July 1999 through March 2012; 3440 (54.8%) received infliximab (20,971 patient-years), and 2833 (45.2%) received other treatments only (14,806 patient-years). Overall, 59,875 infliximab infusions were administered (80%, 5 mg/kg); 3006 (89.9%) patients received ?2 infusions. Adverse events (AEs), most commonly those related to CD (eg, abdominal pain, diarrhea), and serious AEs occurred at a higher rate among infliximab-treated patients. Mortality (0.57/100 patient-years, 0.67/100 patient-years) and malignancy rates (0.69/100 patient-years, 0.71/100 patient-years) for infliximab-treated and other-treatments-only patients, respectively, were generally similar. Serious infection rates were higher for infliximab-treated (2.15/100 patient-years) than other-treatments-only patients (0.86/100 patient-years). Infliximab dose was not associated with mortality or serious infection. An increased risk of serious infection was observed with age (>52 years vs ?30 years) when examined in infliximab-treated patients. Nonserious cerebrovascular accidents (13 events, 0.06/100 patient-years; 5 events, 0.03/100 patient-years) and pulmonary embolisms (11 events, 0.05/100 patient-years; 4 events 0.03/100 patient-years) also occurred at higher rates among infliximab-treated patients than other-treatments-only patients. Conclusions:Through more than 13 years of registry experience and an overall median duration of patient follow-up >6 years, mortality was similar between the infliximab-treated and other-treatments-only groups. These final cumulative results are representative of real-world experience among infliximab-treated patients with CD and are consistent with the known risks of disease activity and tumor necrosis factor antagonist therapy.

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Infliximab Originator, Infliximab Biosimilar, and Adalimumab Are More Effective in Crohn's Disease Than Ulcerative Colitis: A Real-Life Cohort Study.

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