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1.
Inflamm Bowel Dis ; 2019 Aug 29.
Artigo em Inglês | MEDLINE | ID: mdl-31504569

RESUMO

BACKGROUND: The effectiveness of the switch to another anti-tumor necrosis factor (anti-TNF) agent is not known. The aim of this study was to analyze the effectiveness and safety of treatment with a second and third anti-TNF drug after intolerance to or failure of a previous anti-TNF agent in inflammatory bowel disease (IBD) patients. METHODS: We included patients diagnosed with IBD from the ENEIDA registry who received another anti-TNF after intolerance to or failure of a prior anti-TNF agent. RESULTS: A total of 1122 patients were included. In the short term, remission was achieved in 55% of the patients with the second anti-TNF. The incidence of loss of response was 19% per patient-year with the second anti-TNF. Combination therapy (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.8-3; P < 0.0001) and ulcerative colitis vs Crohn's disease (HR, 1.6; 95% CI, 1.1-2.1; P = 0.005) were associated with a higher probability of loss of response. Fifteen percent of the patients had adverse events, and 10% had to discontinue the second anti-TNF. Of the 71 patients who received a third anti-TNF, 55% achieved remission. The incidence of loss of response was 22% per patient-year with a third anti-TNF. Adverse events occurred in 7 patients (11%), but only 1 stopped the drug. CONCLUSIONS: Approximately half of the patients who received a second anti-TNF achieved remission; nevertheless, a significant proportion of them subsequently lost response. Combination therapy and type of IBD were associated with loss of response. Remission was achieved in almost 50% of patients who received a third anti-TNF; nevertheless, a significant proportion of them subsequently lost response.

2.
Therap Adv Gastroenterol ; 12: 1756284819847034, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31205485

RESUMO

Background: Inflammatory bowel disease (IBD) is associated with a considerable burden to the patient and society. However, current data on IBD incidence and burden are limited because of the paucity of nationwide epidemiological studies, heterogeneous designs, and a low number of participating centers and sample size. The EpidemIBD study is a large-scale investigation to provide an accurate assessment of the incidence of IBD in Spain, as well as treatment patterns and outcomes. Methods: This multicenter, population-based incidence cohort study included patients aged >18 years with IBD (Crohn's disease, ulcerative colitis, or unclassified IBD) diagnosed during 2017 in 108 hospitals in Spain, covering 50% of the Spanish population. Each participating patient will attend 10 clinic visits during 5 years of follow up. Demographic data, IBD characteristics and family history, complications, treatments, surgeries, and hospital admissions will be recorded. Results: The EpidemIBD study is the first large-scale nationwide study to investigate the incidence of IBD in Spain. Enrollment is now completed and 3627 patients are currently being followed up. Conclusions: The study has been designed to overcome many of the limitations of previous European studies into IBD incidence by prospectively recruiting a large number of patients from all regions of Spain. In addition to epidemiological information about the burden of IBD, the 5-year follow-up period will also provide information on treatment patterns, and the natural history and financial burden of IBD.

3.
Dig Liver Dis ; 2019 Dec 28.
Artigo em Inglês | MEDLINE | ID: mdl-31892506

RESUMO

BACKGROUND: Tumor necrosis factor-α (TNF-α) is involved in inducing inflammatory anemia. The potential effect of anti-TNF-α agents on anemia in inflammatory bowel diseases (IBD) is still unknown. METHODS: Analytical data and disease characteristics from 362 IBD patients [271 CD/91UC) treated with anti-TNF-α drugs were retrospectively collected. Effects on disease activity, blood markers and prevalence of anemia were assessed after 6 and 12 months of therapy. RESULTS: 29.3% patients presented anemia at baseline, and significantly reduced to 14.4% and 7.8% after 6 and 12 months of therapy, respectively. Mean ±â€¯SD Hb levels increased significantly at month 6, and this increase was sustained at 12 months. Serum markers of iron metabolism increased significantly compared to baseline, as disease activity measured by C-reactive protein (CRP) was reduced. All these effects were observed independently for CD and UC, and were independent of iron supplementation during treatment. Anemia at baseline (OR 4.09; 95%CI 1.98-8.45) and elevated CRP (OR 3.45; 95CI 1.29-9.22) were independently associated with risk of persistent anemia, as well as iron replacement during therapy (OR 4.36; 95%CI 2.07-9.16). CONCLUSIONS: Controlling disease activity with anti-TNF- α therapy significantly and independently associated with resolution of anemia in IBD, with no relevant role for iron replacement therapy.

4.
Eur J Gastroenterol Hepatol ; 30(12): 1521-1527, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30303822

RESUMO

BACKGROUND: Fecal calprotectin (FC) is a widely used noninvasive marker of gut inflammation that is associated with endoscopic severity in Crohn's disease (CD). However, FC has been inconsistent in predicting postoperative recurrence of CD, and its utility in the postoperative setting remains unclear. MATERIALS AND METHODS: Blood and fecal samples were collected in consecutively recruited patients with CD who had undergone ileocolonic resection and required a colonoscopy to assess postoperative recurrence, as defined by the Rutgeerts score (RS). RESULTS: A total of 86 patients were prospectively recruited at five centers. Overall, 49 (57%) had CD recurrence (RS≥i2). FC concentrations trended to increase with RS severity; FC median (interquartile range) was significantly higher in patients with endoscopic recurrence than those in endoscopic remission [172.5 (75-375) vs. 75 (36.5-180.5) µg/g, respectively]. The same occurred for C-reactive protein (CRP) [0.5 (0.1-0.95) vs. 0.1 (0.02-0.27)] mg/dl and the Harvey-Bradshaw index (HBI) [4 (2-7) vs. 1 (0-3.5)]. The three variables significantly correlated. The area under the curve to discriminate between patients in endoscopic remission and recurrence was 0.698 for FC, with 62 µg/g being the optimal cut-off point. This indicated FC would have 85.7% sensitivity and 45.9% specificity in detecting any recurrence, having positive predictive value and negative predictive value of 67.7 and 70.8%, respectively. Area under the curve for CRP and HBI were both 0.710. The combination of CRP and HBI provided a positive predictive value 95.7 and a diagnostic odds ratio of 30.8. CONCLUSION: FC is not better than CRP combined with HBI to predict endoscopic postoperative recurrence of CD.


Assuntos
Proteína C-Reativa/metabolismo , Doença de Crohn/diagnóstico , Fezes/química , Complexo Antígeno L1 Leucocitário/metabolismo , Adulto , Biomarcadores/metabolismo , Colectomia , Colonoscopia , Doença de Crohn/cirurgia , Estudos Transversais , Feminino , Humanos , Íleo/cirurgia , Masculino , Pessoa de Meia-Idade , Cuidados Pós-Operatórios/métodos , Período Pós-Operatório , Valor Preditivo dos Testes , Estudos Prospectivos , Recidiva , Indução de Remissão , Índice de Gravidade de Doença
5.
Aliment Pharmacol Ther ; 48(8): 839-851, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30281832

RESUMO

BACKGROUND: Effectiveness of vedolizumab in real world clinical practice is unknown. AIM: To evaluate the short and long-term effectiveness of vedolizumab in patients with inflammatory bowel disease (IBD). METHODS: Patients who received at least 1 induction dose of vedolizumab were included. Effectiveness was defined based on Harvey-Bradshaw index (HBI) in Crohn's disease (CD) and Partial Mayo Score (PMS) in ulcerative colitis (UC). Short-term response was assessed at week 14. Variables associated with short-term remission were identified by logistic regression analysis. The Kaplan-Meier method was used to evaluate the long-term durability of vedolizumab treatment. Cox model was used to identify factors associated with discontinuation of treatment and loss of response. RESULTS: 521 patients were included (median follow-up 10 months [interquartile range 5-18 months]). At week 14, 46.8% had remission and 15.7% clinical response. CD (vs UC), previous surgery, higher CRP concentration and disease severity at baseline were significantly associated with impaired response. The rate of vedolizumab discontinuation was 37% per patient-year of follow-up (27.6% in UC and 45.3% in CD, P < 0.01). CD (vs UC), anaemia at baseline, steroids during induction and CRP concentration were associated with lower durability of treatment. Seven per cent of patients developed adverse events, infections being the most frequent. CONCLUSIONS: Over 60% of IBD patients respond to vedolizumab. Many patients discontinue treatment over time. CD and disease burden impair both short- and long-term response. Vedolizumab seems to be safe in clinical practice.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Fármacos Gastrointestinais/uso terapêutico , Doenças Inflamatórias Intestinais/diagnóstico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Sistema de Registros , Adulto , Anticorpos Monoclonais Humanizados/efeitos adversos , Colite Ulcerativa/diagnóstico , Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/epidemiologia , Doenças Transmissíveis/induzido quimicamente , Doenças Transmissíveis/diagnóstico , Doenças Transmissíveis/epidemiologia , Doença de Crohn/diagnóstico , Doença de Crohn/tratamento farmacológico , Doença de Crohn/epidemiologia , Feminino , Seguimentos , Fármacos Gastrointestinais/efeitos adversos , Humanos , Doenças Inflamatórias Intestinais/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Indução de Remissão , Espanha/epidemiologia , Resultado do Tratamento
6.
Dig Liver Dis ; 49(4): 405-411, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28096058

RESUMO

BACKGROUND: The prevalence, characteristic and determinants of anemia, at the time of inflammatory bowel disease (IBD) diagnosis have yet to be fully elucidated. METHODS: Retrospective cross-sectional study. Analytical data and disease characteristics obtained upon diagnosis of 1278 IBD patients [Crohn's disease/ulcerative colitis (CD/UC): 718/560] were collected. RESULTS: Anemia was present in 41.2% of patients at diagnosis (47% and 33.8% of CD and UC patients, respectively; p<0.001), being severe in 5.5%. Iron deficiency anemia represented 69.6% of cases, with no differences between CD and UC. Female sex was the strongest risk factor for anemia in both CD and UC (OR 7.11; 95%CI 4.18-12.10 and 6.55; 95%CI 3.39-12.63, respectively), followed by elevated (≥2mg/dL) C-reactive protein (OR 4.08; 95%CI 2.39-6.97 and 4.58; 95%CI 2.26-9.27, respectively). Current smoking was a risk factor for anemia in CD (OR 2.23; 95%CI 1.24-4.02), but a protective one in UC (OR 0.36; 95%CI 0.14-0.92). A penetrating CD behavior increased the risk of anemia (OR 3.34; 95%CI 1.36-8.21); in UC, anemia increased with disease extension (E2+E3) (OR 1.80; 95%CI 1.13-2.86). CONCLUSIONS: Female sex and disease activity are major determinants of anemia at IBD diagnosis. Anemia is associated with disease behavior in CD and with disease extension in UC.


Assuntos
Anemia/epidemiologia , Colite Ulcerativa/complicações , Doença de Crohn/complicações , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Proteína C-Reativa/análise , Estudos Transversais , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Distribuição por Sexo , Espanha , Adulto Jovem
7.
Inflamm Bowel Dis ; 22(4): 894-901, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26933750

RESUMO

BACKGROUND: Psoriasis induced by anti-tumor necrosis factor-α (TNF) therapy has been described as a paradoxical side effect. AIM: To determine the incidence, clinical characteristics, and management of psoriasis induced by anti-TNF therapy in a large nationwide cohort of inflammatory bowel disease patients. METHODS: Patients with inflammatory bowel disease were identified from the Spanish prospectively maintained Estudio Nacional en Enfermedad Inflamatoria Intestinal sobre Determinantes genéticos y Ambientales registry of Grupo Español de Trabajo en Enfermedad de Croh y Colitis Ulcerosa. Patients who developed psoriasis by anti-TNF drugs were the cases, whereas patients treated with anti-TNFs without psoriasis were controls. Cox regression analysis was performed to identify predictive factors. RESULTS: Anti-TNF-induced psoriasis was reported in 125 of 7415 patients treated with anti-TNFs (1.7%; 95% CI, 1.4-2). The incidence rate of psoriasis is 0.5% (95% CI, 0.4-0.6) per patient-year. In the multivariate analysis, the female sex (HR 1.9; 95% CI, 1.3-2.9) and being a smoker/former smoker (HR 2.1; 95% CI, 1.4-3.3) were associated with an increased risk of psoriasis. The age at start of anti-TNF therapy, type of inflammatory bowel disease, Montreal Classification, and first anti-TNF drug used were not associated with the risk of psoriasis. Topical steroids were the most frequent treatment (70%), achieving clinical response in 78% of patients. Patients switching to another anti-TNF agent resulted in 60% presenting recurrence of psoriasis. In 45 patients (37%), the anti-TNF therapy had to be definitely withdrawn. CONCLUSIONS: The incidence rate of psoriasis induced by anti-TNF therapy is higher in women and in smokers/former smokers. In most patients, skin lesions were controlled with topical steroids. More than half of patients switching to another anti-TNF agent had recurrence of psoriasis. In most patients, the anti-TNF therapy could be maintained.


Assuntos
Adalimumab/efeitos adversos , Colite Ulcerativa/tratamento farmacológico , Doença de Crohn/tratamento farmacológico , Infliximab/efeitos adversos , Psoríase/epidemiologia , Psoríase/prevenção & controle , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adolescente , Adulto , Anti-Inflamatórios/efeitos adversos , Estudos de Casos e Controles , Estudos de Coortes , Feminino , Seguimentos , Fármacos Gastrointestinais/efeitos adversos , Humanos , Incidência , Masculino , Prognóstico , Psoríase/patologia , Espanha/epidemiologia , Suspensão de Tratamento
8.
Eur J Gastroenterol Hepatol ; 26(12): 1399-407, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25341061

RESUMO

BACKGROUND AND AIM: A growing incidence of inflammatory bowel disease (IBD) has been reported recently in southern Europe, with records of pediatric cases confirming these tendencies in Spain. Data on adult populations, however, have not been provided for over 10 years and need to be updated. PATIENTS AND METHODS: A multicenter retrospective registry of all adult patients with a diagnosis of IBD, including both Crohn's disease (CD) and ulcerative colitis (UC), attending five public hospitals covering a population of 514 368 inhabitants, was assessed. RESULTS: In 2012, the prevalence of CD and UC in adults was 137.17/100 000 inhabitants (95% confidence interval 114-160) and 99.84/100 000 inhabitants (95% confidence interval 79-119), respectively. The mean incidence rate during the period 2000-2012 of CD and UC was 8.9 and 5.6/100 000 inhabitants per year, respectively. Most of our patients (75.55%) had been diagnosed during the last 13 years. CD affected both sexes equally; a trend toward a progressive increase in the age at diagnosis, ileal location, and inflammatory behavior was documented for CD patients. In contrast, UC affected male patients with a higher frequency (57.8%; P=0.015), specifically those older than 40 years of age. Age at UC onset tended to increase progressively from 2000 to 2012 (P<0.001), but the extension on the disease remained unchanged. CONCLUSION: IBD is a highly prevalent disorder in our region, reaching the incidence of CD similar to the figures provided for Northern Europe. Changes in IBD localization, behavior, and age at diagnosis were documented during the period 2000-2012.


Assuntos
Colite Ulcerativa/epidemiologia , Doença de Crohn/epidemiologia , Adolescente , Adulto , Distribuição por Idade , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Colite Ulcerativa/diagnóstico , Colite Ulcerativa/terapia , Doença de Crohn/diagnóstico , Doença de Crohn/terapia , Feminino , Hospitais Públicos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Prevalência , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Distribuição por Sexo , Fatores Sexuais , Espanha/epidemiologia , Fatores de Tempo , Adulto Jovem
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