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1.
Am J Gastroenterol ; 112(1): 120-131, 2017 01.
Article in English | MEDLINE | ID: mdl-27958281

ABSTRACT

OBJECTIVES: The aims of this study were to assess the risk of relapse after discontinuation of anti-tumor necrosis factor (anti-TNF) drugs in patients with inflammatory bowel disease (IBD), to identify the factors associated with relapse, and to evaluate the overcome after retreatment with the same anti-TNF in those who relapsed. METHODS: This was a retrospective, observational, multicenter study. IBD patients who had been treated with anti-TNFs and in whom these drugs were discontinued after clinical remission was achieved were included. RESULTS: A total of 1,055 patients were included. The incidence rate of relapse was 19% and 17% per patient-year in Crohn's disease and ulcerative colitis patients, respectively. In both Crohn's disease and ulcerative colitis patients in deep remission, the incidence rate of relapse was 19% per patient-year. The treatment with adalimumab vs. infliximab (hazard ratio (HR)=1.29; 95% confidence interval (CI)=1.01-1.66), elective discontinuation of anti-TNFs (HR=1.90; 95% CI=1.07-3.37) or discontinuation because of adverse events (HR=2.33; 95% CI=1.27-2.02) vs. a top-down strategy, colonic localization (HR=1.51; 95% CI=1.13-2.02) vs. ileal, and stricturing behavior (HR=1.5; 95% CI=1.09-2.05) vs. inflammatory were associated with a higher risk of relapse in Crohn's disease patients, whereas treatment with immunomodulators after discontinuation (HR=0.67; 95% CI=0.51-0.87) and age (HR=0.98; 95% CI=0.97-0.99) were protective factors. None of the factors were predictive in ulcerative colitis patients. Retreatment of relapse with the same anti-TNF was effective (80% responded) and safe. CONCLUSIONS: The incidence rate of inflammatory bowel disease relapse after anti-TNF discontinuation is relevant. Some predictive factors of relapse after anti-TNF withdrawal have been identified. Retreatment with the same anti-TNF drug was effective and safe.


Subject(s)
Adalimumab/therapeutic use , Antirheumatic Agents/therapeutic use , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Deprescriptions , Immunologic Factors/therapeutic use , Infliximab/therapeutic use , Adolescent , Adult , Age Factors , Aged , Aged, 80 and over , Colitis, Ulcerative/physiopathology , Colon , Constriction, Pathologic , Crohn Disease/physiopathology , Disease Progression , Drug-Related Side Effects and Adverse Reactions , Female , Follow-Up Studies , Humans , Ileum , Incidence , Inflammatory Bowel Diseases/drug therapy , Male , Mesalamine/therapeutic use , Methotrexate/therapeutic use , Middle Aged , Proportional Hazards Models , Protective Factors , Recurrence , Remission Induction , Retreatment , Retrospective Studies , Risk Factors , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Young Adult
2.
J Crohns Colitis ; 10(10): 1186-93, 2016 Oct.
Article in English | MEDLINE | ID: mdl-26802085

ABSTRACT

BACKGROUND AND AIMS: Despite having adopted preventive measures, tuberculosis (TB) may still occur in patients with inflammatory bowel disease (IBD) treated with anti-tumour necrosis factor (anti-TNF). Data on the causes and characteristics of TB cases in this scenario are lacking. Our aim was to describe the characteristics of TB in anti-TNF-treated IBD patients after the publication of the Spanish TB prevention guidelines in IBD patients and to evaluate the safety of restarting anti-TNF after a TB diagnosis. METHODS: In this multicentre, retrospective, descriptive study, TB cases from Spanish hospitals were collected. Continuous variables were reported as mean and standard deviation or median and interquartile range. Categorical variables were described as absolute and relative frequencies and their confidence intervals when necessary. RESULTS: We collected 50 TB cases in anti-TNF-treated IBD patients, 60% male, median age 37.3 years (interquartile range [IQR] 30.4-47). Median latency between anti-TNF initiation and first TB symptoms was 155.5 days (IQR 88-301); 34% of TB cases were disseminated and 26% extrapulmonary. In 30 patients (60%), TB cases developed despite compliance with recommended preventive measures; *not performing 2-step TST (tuberculin skin test) was the main failure in compliance with recommendations. In 17 patients (34%) anti-TNF was restarted after a median of 13 months (IQR 7.1-17.3) and there were no cases of TB reactivation. CONCLUSIONS: Tuberculosis could still occur in anti-TNF-treated IBD patients despite compliance with recommended preventive measures. A significant number of cases developed when these recommendations were not followed. Restarting anti-TNF treatment in these patients seems to be safe.


Subject(s)
Adalimumab/therapeutic use , Guideline Adherence/statistics & numerical data , Immunosuppressive Agents/therapeutic use , Inflammatory Bowel Diseases/drug therapy , Infliximab/therapeutic use , Opportunistic Infections/prevention & control , Tuberculosis/prevention & control , Adult , Female , Follow-Up Studies , Humans , Inflammatory Bowel Diseases/complications , Male , Middle Aged , Opportunistic Infections/complications , Opportunistic Infections/diagnosis , Opportunistic Infections/epidemiology , Practice Guidelines as Topic , Retreatment , Retrospective Studies , Spain , Treatment Outcome , Tuberculin Test/statistics & numerical data , Tuberculosis/complications , Tuberculosis/diagnosis , Tuberculosis/epidemiology
3.
Gut ; 64(9): 1397-402, 2015 Sep.
Article in English | MEDLINE | ID: mdl-25516418

ABSTRACT

OBJECTIVE: Severe endoscopic lesions (SEL) in patients with colonic Crohn's disease (CD) have been linked to higher risk of colectomy. The aims of this study were to reassess the predictive value of colonoscopy compared against MRI for requirement of resection surgery in patients with CD and determine the influence of current therapeutic options. DESIGN: In this single-centre, observational, prospective, longitudinal study, patients with an established diagnosis of CD and suspected activity were included. After baseline assessment, including colonoscopy and MRI, patients were followed until resection surgery or the end of study. RESULTS: 112 patients were eligible for analysis. Ulcers were present in 94/112 (84%) of patients at colonoscopy (SELs in 51/112 (46%)) and stenosis in 38/112 (34%). MRI identified ulcers in 79/112 (71%) of patients, stenosis in 36/112 (32%) and intra-abdominal fistulae in 20/112 (18%). Surgical resection requirements (29/112 (26%)) were not associated with the presence of SELs at colonoscopy. The presence of stenosis (p<0.001) or intra-abdominal fistulae (p<0.001) at MRI correlated with a higher risk of surgery. In the multivariate analysis, perianal disease (OR 9 (2 to 39), p=0.003), stenosis (OR 3.4 (1 to 11), p=0.04) and fistulae at MRI (OR 10.6 (2 to 46), p=0.002) increased the risk of abdominal resection surgery, while months under immunomodulators (OR 0.94 (0.90 to 0.98), p=0.002) and/or antitumor necrosis factor (anti-TNF) therapy (OR 0.97 (0.94 to 1), p=0.04) during follow-up decreased this risk. CONCLUSIONS: Perianal disease, stenosis and/or intra-abdominal fistulae at MRI independently predict an increased risk of resection surgery in patients with CD, whereas immunosuppressants and/or anti-TNF therapy reduce such risk. Under current therapeutic strategies, the presence of SELs is not a predictor of resection surgery in patients with CD.


Subject(s)
Biological Products/therapeutic use , Colectomy/methods , Colonoscopy/methods , Crohn Disease/diagnosis , Crohn Disease/surgery , Magnetic Resonance Imaging/methods , Adult , Crohn Disease/drug therapy , Crohn Disease/mortality , Disease-Free Survival , Female , Follow-Up Studies , Humans , Kaplan-Meier Estimate , Longitudinal Studies , Male , Middle Aged , Multivariate Analysis , Predictive Value of Tests , Proportional Hazards Models , Prospective Studies , Risk Assessment , Severity of Illness Index , Spain , Survival Analysis , Treatment Outcome , Young Adult
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