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1.
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
2.
Scand J Gastroenterol ; 51(2): 186-95, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26200929

RESUMO

OBJECTIVE: To describe clinical practice with infliximab (IFX) in ulcerative colitis (UC); identification of predictive factors for IFX treatment discontinuation due to insufficient response and for colectomy. MATERIAL AND METHODS: Retrospective, multicentric and observational study including every UC IFX-treated patient in 10 Spanish hospitals. Variables analyzed: epidemiological data; variables for poor prognosis; IFX prior treatments; characteristics of the IFX treatment; time from the UC diagnosis to induction with IFX; time from induction to colectomy or until data collection. Predictive and protective factors for IFX discontinuation due to lack of response and for colectomy were analyzed with binary logistic regression and Cox analysis. RESULTS: Follow-up time from induction with IFX to the collection of data or colectomy: 36.7 ± 25.7 months. Prior treatment with immunomodulator medications (IMM): 79%; IFX + immunosuppressant therapy: 77%; discontinuation of IFX: 26%, colectomy 16%. Independent predictive or protective factors for IFX discontinuation: IMM resistance (OR: 2.9, p = 0.022, 95% CI: 1.2-7.2), prior use of leukocytapheresis (OR: 3.3, p = 0.024, 95% CI: 1.1-9.4), IFX + IMM therapy (OR: 0.3, p = 0.022, 95% CI: 0.1-0.9, and HR: 0.4, p = 0.006, 95% CI: 0.2-0.8) and corticosteroid use in induction (HR: 1.9, p = 0.049, 95% CI: 1.0-3.8). Independent predictive or protective factors for colectomy: Use of leukocytapheresis (OR: 3.0, p = 0.036, 95% CI: 1.1-8.4), IFX + IMM therapy (OR: 0.3, p = 0.022, 95% CI: 0.1-0.8, and HR: 0.3, p = 0.011, 95% CI: 0.1-0.8) and severe cortico-resistant flare-up (HR: 2.5, p = 0.032, 95% CI: 1.1-5.9). CONCLUSIONS: Prior use of IMM and leukocytapheresis, the use of corticosteroids in induction and a severe cortico-resistant flare predict a worse response to IFX and the need for colectomy. Combination therapy is a protective factor for both.


Assuntos
Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/cirurgia , Fármacos Gastrointestinais/uso terapêutico , Infliximab/uso terapêutico , Corticosteroides/uso terapêutico , Adulto , Azatioprina/uso terapêutico , Inibidores de Calcineurina/uso terapêutico , Colectomia , Progressão da Doença , Resistência a Medicamentos , Quimioterapia Combinada , Feminino , Humanos , Imunossupressores/uso terapêutico , Quimioterapia de Indução/métodos , Leucaférese , Quimioterapia de Manutenção/métodos , Masculino , Mercaptopurina/uso terapêutico , Pessoa de Meia-Idade , Prognóstico , Fatores de Proteção , Estudos Retrospectivos , Fatores de Risco , Falha de Tratamento
3.
Rev Esp Enferm Dig ; 107(9): 527-33, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26334458

RESUMO

INTRODUCTION: Infliximab (IFX) therapy intensification in ulcerative colitis (UC) is more common than established in pivotal studies. OBJECTIVES: To establish the frequency and form of intensification for UC in clinical practice, as well as predictors, and to compare outcomes between intensified and non-intensified treatment. METHODS: A retrospective study of 10 hospitals and 144 patients with response to infliximab (IFX) induction. Predictive variables for intensification were analyzed using a Cox regression analysis. Outcome, loss of response to IFX, and colectomy were compared between intensified and non-intensified therapy. RESULTS: Follow-up time from induction to data collection: 38 months [interquartile range (IQR), 20-62]. Time on IFX therapy: 24 months (IQR, 10-44). In all, 37% of patients required intensification. Interval was shortened for 36 patients, dose was increased for 7, and 10 subjects received both. Concurrent thiopurine immunosuppressants (IMM) and IFX initiation was an independent predictor of intensification [Hazard ratio, 0.034; p, 0.006; CI, 0.003-0.371]. In patients on intensified therapy IFX discontinuation for loss of response (30.4% vs. 10.2%; p, 0.002), steroid reintroduction (35% vs. 18%; p, 0.018), and colectomy (22% vs. 6.4%; p, 0.011) were more common. Of patients on intensification, 17% returned to receiving 5 mg/kg every 8 weeks. CONCLUSIONS: Intensification is common and occasionally reversible. IMM initiation at the time of induction with IFX predictsnon-intensification. Intensification, while effective, is associated with poorer outcome.


Assuntos
Colite Ulcerativa/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Infliximab/uso terapêutico , Adulto , Colectomia , Colite Ulcerativa/cirurgia , Feminino , Seguimentos , Humanos , Infliximab/administração & dosagem , Infliximab/efeitos adversos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Esteroides/administração & dosagem , Esteroides/uso terapêutico , Resultado do Tratamento
4.
Rev. esp. enferm. dig ; 107(9): 527-533, sept. 2015. tab, ilus
Artigo em Espanhol | IBECS | ID: ibc-140748

RESUMO

Introducción: la intensificación del tratamiento con infliximab (IFX) en la colitis ulcerosa (CU) es más frecuente de lo establecido en estudios pivotales. Objetivos: establecer la frecuencia y forma con la que intensificamos en CU en práctica clínica, los factores predictores y comparar la evolución entre los pacientes con tratamiento intensificado y no intensificado. Métodos: estudio retrospectivo de 10 hospitales y 144 pacientes con respuesta a la inducción con IFX. Se analizaron variables predictoras de la intensificación con análisis de regresión de Cox. Se comparó la evolución, pérdida de respuesta a IFX y colectomía según tratamiento intensificado o no intensificado. Resultados: tiempo de seguimiento desde la inducción hasta la recogida de datos: 38 meses [rango intercuartil (RIC) 20-62]. Tiempo de tratamiento con IFX: 24 meses (RIC, 10-44). El 37% de los pacientes requirió intensificación. Se acortó el intervalo en 36 pacientes, se aumentó la dosis en 7, ambas en 10. La introducción simultánea de inmunosupresores tiopurínicos (INM) e IFX predijo la intensificación de forma independiente [Hazard ratio (HR) 0,034 p 0,006 IC 0,003-0,371]. En los pacientes con tratamiento intensificado fue más frecuente la suspensión de IFX por pérdida de respuesta (30,4% vs. 10,2% p 0,002), la reintroducción de corticoides (35% vs. 18%, p 0,018) y la colectomía (22% vs. 6,4% p 0,011). El 17% de los pacientes intensificados volvió a recibir 5 mg/kg cada 8 semanas. Conclusiones: la intensificación es frecuente y en ocasiones reversible. La introducción del INM en el momento de la inducción con IFX predice la no intensificación. La intensificación, aunque eficaz, se asocia a una peor evolución (AU)


Introduction: Infliximab (IFX) therapy intensification in ulcerative colitis (UC) is more common than established in pivotal studies. Objectives: To establish the frequency and form of intensification for UC in clinical practice, as well as predictors, and to compare outcomes between intensified and non-intensified treatment. Methods: A retrospective study of 10 hospitals and 144 patients with response to infliximab (IFX) induction. Predictive variables for intensification were analyzed using a Cox regression analysis. Outcome, loss of response to IFX, and colectomy were compared between intensified and non-intensified therapy. Results: Follow-up time from induction to data collection: 38 months [interquartile range (IQR), 20-62]. Time on IFX therapy: 24 months (IQR, 10-44). In all, 37% of patients required intensification. Interval was shortened for 36 patients, dose was increased for 7, and 10 subjects received both. Concurrent thiopurine immunosuppressants (IMM) and IFX initiation was an independent predictor of intensification [Hazard ratio, 0.034; p, 0.006; CI, 0.003-0.371]. In patients on intensified therapy IFX discontinuation for loss of response (30.4% vs. 10.2%; p, 0.002), steroid reintroduction (35% vs. 18%; p, 0.018), and colectomy (22% vs. 6.4%; p, 0.011) were more common. Of patients on intensification, 17% returned to receiving 5 mg/kg every 8 weeks. Conclusions: Intensification is common and occasionally reversible. IMM initiation at the time of induction with IFX predicts non-intensification. Intensification, while effective, is associated with poorer outcome (AU)


Assuntos
Adulto , Feminino , Humanos , Masculino , Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/prevenção & controle , Colectomia/métodos , Colectomia , Corticosteroides/uso terapêutico , Estudos Retrospectivos , Análise de Regressão , Receptores do Fator de Necrose Tumoral/uso terapêutico , Análise Multivariada
5.
J Crohns Colitis ; 9(5): 382-9, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25740813

RESUMO

BACKGROUND AND AIMS: Cerebrovascular accidents [CVA] have rarely been reported in inflammatory bowel disease [IBD] patients treated with anti-tumour necrosis alpha [anti-TNF alpha] agents. Our aim here was to describe the clinical course of CVA in these patients. METHODS: This was a European Crohn's and Colitis Organisation [ECCO] retrospective observational study, performed as part of the CONFER [COllaborative Network For Exceptionally Rare case reports] project. A call to all ECCO members was made to report on IBD patients afflicted with CVA during treatment with anti-TNF alpha agents. Clinical data were recorded in a standardised case report form and analysed for event association with anti-TNF alpha treatment. RESULTS: A total of 19 patients were identified from 16 centres: 14 had Crohn's disease, four ulcerative colitis and one IBD colitis unclassified [median age at diagnosis: 38.0 years, range: 18.6-62.5]. Patients received anti-TNF alpha for a median duration of 11.8 months [range: 0-62] at CVA onset; seven had previously been treated with at least one other anti-TNF alpha agent. Complete neurological recovery was observed in 16 patients. Anti-TNF alpha was discontinued in 16/19 patients. However, recurrent CVA or neurological deterioration was not observed in any of the 11 patients who received anti-TNF alpha after CVA [eight resumed after temporary cessation, three continued without interruption] for a median follow-up of 39.8 months [range: 5.6-98.2]. CONCLUSION: These preliminary findings do not unequivocally indicate a causal role of anti-TNF alpha in CVA complicating IBD. Resuming or continuing anti-TNF alpha in IBD patients with CVA may be feasible and safe in selected cases, but careful weighing of IBD activity versus neurological status is prudent.


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Transtornos Cerebrovasculares/etiologia , Colite Ulcerativa/tratamento farmacológico , Doença de Crohn/tratamento farmacológico , Imunossupressores/uso terapêutico , Doenças Raras/etiologia , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adalimumab/uso terapêutico , Adulto , Azatioprina/uso terapêutico , Transtornos Cerebrovasculares/diagnóstico , Certolizumab Pegol/uso terapêutico , Colite Ulcerativa/complicações , Doença de Crohn/complicações , Quimioterapia Combinada , Feminino , Humanos , Infliximab/uso terapêutico , Masculino , Metotrexato/uso terapêutico , Pessoa de Meia-Idade , Doenças Raras/diagnóstico , Retratamento , Estudos Retrospectivos , Adulto Jovem
6.
Gastroenterol. hepatol. (Ed. impr.) ; 34(6): 379-384, jun. - jul. 2011.
Artigo em Espanhol | IBECS | ID: ibc-92943

RESUMO

Objetivos Evaluar la prevalencia de osteopenia y osteoporosis en pacientes con enfermedad inflamatoria intestinal (EII) y estudiar los diversos factores que influyen en su patogenia.MétodosSe incluyeron 100 pacientes consecutivos con EII (57 mujeres, edad media 41 años), recogiéndose datos acerca de sus hábitos de vida, características de su enfermedad y empleo de fármacos (principalmente corticoides). Se realizaron determinaciones analíticas incluyendo marcadores bioquímicos de recambio óseo y se determinó la presencia de osteoporosis u osteopenia mediante densitometría ósea (DXA) total de cadera y columna lumbar.ResultadosLos porcentajes de osteopenia oscilaron entre el 37% (evaluada mediante el t-score de DXA columna lumbar) y el 39% (t-score DXA cadera). Por su parte, la presencia de osteoporosis se situó entre el 2% (t-score DXA cadera) y el 15% (t-score DXA columna lumbar). El análisis multivariante demostró que la enfermedad de Crohn (vs. colitis ulcerosa; odds ratio 2,9, IC 95% 1-8,7) y el número de brotes ajustado por la dosis total acumulada de corticoides (n.° de brotes ≥ 3: odds ratio 8,7; IC 95% 1,6-45) se asociaba con una mayor frecuencia de osteopenia/osteoporosis. Ninguna de las variables analíticas se correlacionó con las alteraciones de la densidad mineral ósea.ConclusionesExiste una mayor prevalencia de osteopenia/osteoporosis en los pacientes con EII (fundamentalmente con enfermedad de Crohn) con respecto a la población general. La propia actividad inflamatoria de la enfermedad, más que la dosis de corticoides per se, parece relacionarse con la alteración del metabolismo óseo. Los marcadores bioquímicos de resorción y osteoformación no presentaron correlación con la presencia de osteopenia y osteoporosis (AU)


Objectives To evaluate the prevalence of osteopenia and osteoporosis in patients with inflammatory bowel disease (IBD) and to study the factors involved in their pathogenesis.MethodsOne hundred consecutive patients with IBD (57 women, mean age 41 years) were included in this study. Data were collected about their life habits, disease characteristics of medication use (mainly corticosteroids). Bone turnover markers were analyzed and the presence of osteoporosis or osteopenia was assessed with total hip and lumbar spine bone densitometry (DXA).ResultsOsteopenia percentages ranged from 37% (t-score measured by lumbar spine DXA) to 39% (hip DXA t-score). The prevalence of osteoporosis ranged from 2% (t-score measured by hip DXA) to 15% (lumbar spine DXA t-score). In the multivariate analysis, diagnosis of Crohn's disease (vs. ulcerative colitis; odds ratio 2.9, 95% CI 1-8.7) and the number of flares controlled by the cumulative dose of steroids (number of flares ≥3: odds ratio 8.7; 95%CI 1.6-45) were associated with a higher risk of osteopenia/osteoporosis. None of the analytical parameters significantly correlated with bone mineral density values.ConclusionsThe prevalence of osteopenia/osteoporosis is higher in patients with IBD (mainly those with Crohn's disease) than in the general population. Changes in bone metabolism seem to be more closely related to the inflammatory activity of IBD than to the steroid dose per se. Bone turnover markers did not correlate with the presence of osteopenia and osteoporosis (AU)


Assuntos
Humanos , Doenças Inflamatórias Intestinais/complicações , Osteoporose/epidemiologia , Doenças Ósseas Metabólicas/epidemiologia , Corticosteroides/uso terapêutico , Densitometria , Desmineralização Patológica Óssea/etiologia , Doença de Crohn/fisiopatologia , Colite Ulcerativa/fisiopatologia
7.
Gastroenterol Hepatol ; 34(6): 379-84, 2011.
Artigo em Espanhol | MEDLINE | ID: mdl-21664725

RESUMO

OBJECTIVES: To evaluate the prevalence of osteopenia and osteoporosis in patients with inflammatory bowel disease (IBD) and to study the factors involved in their pathogenesis. METHODS: One hundred consecutive patients with IBD (57 women, mean age 41 years) were included in this study. Data were collected about their life habits, disease characteristics of medication use (mainly corticosteroids). Bone turnover markers were analyzed and the presence of osteoporosis or osteopenia was assessed with total hip and lumbar spine bone densitometry (DXA). RESULTS: Osteopenia percentages ranged from 37% (t-score measured by lumbar spine DXA) to 39% (hip DXA t-score). The prevalence of osteoporosis ranged from 2% (t-score measured by hip DXA) to 15% (lumbar spine DXA t-score). In the multivariate analysis, diagnosis of Crohn's disease (vs. ulcerative colitis; odds ratio 2.9, 95% CI 1-8.7) and the number of flares controlled by the cumulative dose of steroids (number of flares ≥ 3: odds ratio 8.7; 95%CI 1.6-45) were associated with a higher risk of osteopenia/osteoporosis. None of the analytical parameters significantly correlated with bone mineral density values. CONCLUSIONS: The prevalence of osteopenia/osteoporosis is higher in patients with IBD (mainly those with Crohn's disease) than in the general population. Changes in bone metabolism seem to be more closely related to the inflammatory activity of IBD than to the steroid dose per se. Bone turnover markers did not correlate with the presence of osteopenia and osteoporosis.


Assuntos
Doenças Ósseas Metabólicas/epidemiologia , Doenças Ósseas Metabólicas/etiologia , Doenças Inflamatórias Intestinais/complicações , Osteoporose/epidemiologia , Adulto , Estudos Transversais , Feminino , Humanos , Masculino , Osteoporose/etiologia , Prevalência
10.
J Clin Gastroenterol ; 40(2): 129-34, 2006 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-16394873

RESUMO

AIMS: 1) To review clinical and endoscopic variables in patients hospitalized for upper gastrointestinal bleeding (UGIB) due to peptic gastroduodenal lesions over a period of 3 years; 2) to identify factors associated with unfavorable evolution; and 3) to evaluate characteristics of patients discharged immediately after endoscopy. METHODS: A 3-year retrospective analysis of all UGIB episodes was performed. Patients with gastroduodenal ulcer or erosive gastritis/duodenitis at endoscopy were included. The prognostic value of several clinical, endoscopic, and analytical variables was assessed. Persistence or recurrence of bleeding, surgery, and mortality were considered as outcome variables (evolution was classified as "unfavorable" when any of these was observed). RESULTS: A total of 341 patients were identified, with a mean age of 62 years. Melena was the most frequent UGIB presentation (70%). Forty-five percent had associated diseases, and 45% were taking gastroerosive drugs. Duodenal ulcer was the most frequent cause of UGIB (48%), followed by gastric ulcer (32%). The evolution of UGIB was unfavorable in 7% of cases. Variables associated with unfavorable evolution in the multivariate analysis were: systolic blood pressure < or = 100 mm Hg, heart rate > or = 100 bpm, and a Forrest endoscopic classification of severe. Only 10% of patients were immediately discharged, with no subsequent complications. However, if predictive variables obtained in the multivariate analysis had been used, hospitalization could have been prevented in 115 patients (34%) without subsequent complications. CONCLUSIONS: A number of clinical and endoscopic variables (blood pressure, heart rate, and endoscopic stigmata of bleeding) with prognostic value have been identified. These are easy to obtain and apply in clinical practice and allow an accurate estimation of the evolution of UGIB. This diagnostic strategy identifies a relatively high proportion of UGIB patients who can be managed on an outpatient basis.


Assuntos
Assistência Ambulatorial/métodos , Úlcera Péptica Hemorrágica/terapia , Medição de Risco , Distribuição de Qui-Quadrado , Feminino , Gastroscopia , Humanos , Masculino , Pessoa de Meia-Idade , Úlcera Péptica Hemorrágica/diagnóstico , Prognóstico , Estudos Retrospectivos , Resultado do Tratamento
11.
Med Clin (Barc) ; 122(4): 134-5, 2004 Feb 07.
Artigo em Espanhol | MEDLINE | ID: mdl-14967094

RESUMO

BACKGROUND AND OBJECTIVE: We assessed the prevalence and diagnostic value of antineutrophil cytoplasmic antibodies (ANCA) with a perinuclear pattern (pANCA) in patients with Crohn's disease (CD) and ulcerative colitis (UC). PATIENTS AND METHOD: pANCA were determined by indirect immunofluorescence and positive results were confirmed by ELISA. RESULTS: We included 117 patients with CD, 72 with UC and 2 with indeterminate colitis. One CD patient (0.9%) and 6 with UC (8.3%) had a positive pANCA result. Sensitivity, specificity, positive and negative predictive value, and positive and negative likehood ratio of pANCA for a diagnosis of UC (vs CD) were 8%, 99%, 86%, 64%, 8 and 0.9, respectively, thus indicating the need to standardize the methodology. No differences were observed with regard to age, tobacco consumption, localization and extension of UC and need of immunosuppressive agents according to pANCA. CONCLUSIONS: In our setting, the prevalence of pANCA is very low (8%) in UC and exceptional (< 1%) in CD. As a result, pANCA sensitivity for a diagnosis of UC in patients with inflammatory bowel disease is also very low, yet the specificity is very high.


Assuntos
Anticorpos Anticitoplasma de Neutrófilos/sangue , Colite Ulcerativa/diagnóstico , Doença de Crohn/diagnóstico , Adulto , Colite Ulcerativa/sangue , Doença de Crohn/sangue , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência
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