BACKGROUND & AIMS: We investigated the effects of inducing deep remission in patients with early Crohn's disease (CD). METHODS: We collected follow-up data from 122 patients (mean age, 31.2 ± 11.3 y) with early, moderate to severe CD (median duration, 0.2 years; interquartile range, 0.1-0.5) who participated in the Effect of Tight Control Management on CD (CALM) study, at 31 sites, representing 50% of the original CALM patient population. Fifty percent of patients (n = 61) were randomly assigned to a tight control strategy (increased therapy based on fecal level of calprotectin, serum level of C-reactive protein, and symptoms), and 50% were assigned to conventional management. We categorized patients as those who were vs were not in deep remission (CD endoscopic index of severity scores below 4, with no deep ulcerations or steroid treatment, for 8 or more weeks) at the end of the follow-up period (median, 3.02 years; range, 0.05-6.26 years). The primary outcome was a composite of major adverse outcomes that indicate CD progression during the follow-up period: new internal fistulas or abscesses, strictures, perianal fistulas or abscesses, or hospitalization or surgery for CD. Kaplan-Meier and penalized Cox regression with bootstrapping were used to compare composite rates between patients who achieved or did not achieve remission at the end of the follow-up period. RESULTS: Major adverse outcomes were reported for 34 patients (27.9%) during the follow-up period. Significantly fewer patients in deep remission at the end of the CALM study had major adverse outcomes during the follow-up period (P = .01). When we adjusted for potential confounders, deep remission (adjusted hazard ratio, 0.19; 95% confidence interval, 0.07-0.31) was significantly associated with a lower risk of major adverse outcome. CONCLUSIONS: In an analysis of follow-up data from the CALM study, we associated induction of deep remission in early, moderate to severe CD with decreased risk of disease progression over a median time of 3 years, regardless of tight control or conventional management strategy.

• MeSH
• adalimumab aplikace a dávkování   škodlivé účinky   MeSH
• antiflogistika aplikace a dávkování   škodlivé účinky   MeSH
• azathioprin aplikace a dávkování   škodlivé účinky   MeSH
• časové faktory MeSH
• Crohnova nemoc diagnóza   farmakoterapie   imunologie   patologie   MeSH
• dospělí MeSH
• hospitalizace statistika a číselné údaje   MeSH
• indukce remise metody   MeSH
• kombinovaná farmakoterapie škodlivé účinky   metody   MeSH
• lidé MeSH
• mladý dospělý MeSH
• následné studie MeSH
• prednison aplikace a dávkování   škodlivé účinky   MeSH
• progrese nemoci MeSH
• retrospektivní studie MeSH
• stupeň závažnosti nemoci MeSH
• TNF-alfa antagonisté a inhibitory   imunologie   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Research Support, N.I.H., Extramural MeSH

BACKGROUND: This study aims to compare the cost-effectiveness of treatment sequences with available biologics, including adalimumab (ADA), biosimilar infliximab (bsIFX), originator infliximab (IFX) and vedolizumab (VEDO) for luminal Crohn's disease in nine European countries. METHODS: A Markov-model was constructed to simulate five-year medical costs and quality-adjusted life years (QALYs). Data on clinical efficacy were obtained from randomised controlled trials. Country-specific unit costs, discount rates and a third-party payer perspective were applied. RESULTS: The bsIFX versus conventional therapy resulted in the most favourable incremental cost-utility ratios (ICURs) ranging from €34,580 (Hungary) to €77,062/QALY (Sweden). Compared to bsIFX, the bsIFX-ADA sequence was more cost-effective than the bsIFX-VEDO sequence with ICURs varying between €70,277 (France) and €162,069/QALY (Germany). The ICURs of the bsIFX-ADA-VEDO sequence versus the bsIFX-ADA strategy were between €206,266 (The Netherlands) and €363,232/QALY (Spain). CONCLUSION: We are the first to compare cost-effectiveness of multiple biological sequences for luminal Crohn's disease. Based on our findings, bsIFX can be recommended as a first-line treatment in patients unresponsive to conventional treatments. While biological sequences only slightly differ in their associated health gains, their costs vary greatly. The bsIFX-ADA-VEDO seems to be the most cost-effective sequence of the available biologics across Europe.

• MeSH
• adalimumab aplikace a dávkování   ekonomika   terapeutické užití   MeSH
• analýza nákladů a výnosů MeSH
• biosimilární léčivé přípravky aplikace a dávkování   ekonomika   terapeutické užití   MeSH
• Crohnova nemoc farmakoterapie   ekonomika   MeSH
• ekonomické modely MeSH
• gastrointestinální látky aplikace a dávkování   ekonomika   terapeutické užití   MeSH
• humanizované monoklonální protilátky aplikace a dávkování   ekonomika   terapeutické užití   MeSH
• infliximab aplikace a dávkování   ekonomika   terapeutické užití   MeSH
• kombinovaná farmakoterapie MeSH
• kvalitativně upravené roky života MeSH
• lidé MeSH
• Markovovy řetězce MeSH
• randomizované kontrolované studie jako téma MeSH
• rozvrh dávkování léků MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• srovnávací studie MeSH
• Geografické názvy
• Evropa MeSH