Deep Remission at 1 Year Prevents Progression of Early Crohn's Disease.
Обработка статьи · этапы, ошибки и управление
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Ungaro Ryan C, Yzet Clara, Bossuyt Peter, Baert Filip J, Vanasek Thomas, D'Haens Geert R, Joustra Vincent Wilhelmus, Panaccione Remo, Novacek Gottfried, Reinisch Walter, Armuzzi Alessandro, Golovchenko Oleksandr, Prymak Olga, Goldis Adrian, Travis Simon P, Hébuterne Xavier, Ferrante Marc, Rogler Gerhard, Fumery Mathurin, Danese Silvio, Rydzewska Grazyna, Pariente Benjamin, Hertervig Erik, Stanciu Carol, Serrero Melanie, Diculescu Mircea, Peyrin-Biroulet Laurent, Laharie David, Wright John P, Gomollón Fernando, Gubonina Irina, Schreiber Stefan, Motoya Satoshi, Hellström Per M, Halfvarson Jonas, Butler James W, Petersson Joel, Petralia Francesca, Colombel Jean-Frederic
Аннотация
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.