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1.
N Engl J Med ; 388(13): 1191-1200, 2023 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-36988594

RESUMO

BACKGROUND: Approximately half the patients with ulcerative colitis who undergo restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) will subsequently have pouchitis, and among those patients, one fifth will have chronic pouchitis. METHODS: We conducted a phase 4, double-blind, randomized trial to evaluate vedolizumab in adult patients in whom chronic pouchitis had developed after undergoing IPAA for ulcerative colitis. Patients were assigned (in a 1:1 ratio) to receive vedolizumab intravenously at a dose of 300 mg or placebo on day 1 and at weeks 2, 6, 14, 22, and 30. All the patients received concomitant ciprofloxacin from weeks 1 to 4. The primary end point was modified Pouchitis Disease Activity Index (mPDAI)-defined remission (an mPDAI score of ≤4 and a reduction from baseline of ≥2 points in the mPDAI total score; scores range from 0 to 12, with higher scores indicating more severe pouchitis) at week 14. The mPDAI is based on clinical symptoms and endoscopic findings. Other efficacy end points included mPDAI-defined remission at week 34, mPDAI-defined response (a reduction from baseline of ≥2 points in the mPDAI score) at weeks 14 and 34, and PDAI-defined remission (a PDAI score of ≤6 and a reduction from baseline of ≥3 points; scores range from 0 to 18, with higher scores indicating more severe pouchitis) at weeks 14 and 34. The PDAI is based on clinical symptoms, endoscopic findings, and histologic findings. RESULTS: Among the 102 patients who underwent randomization, the incidence of mPDAI-defined remission at week 14 was 31% (16 of 51 patients) with vedolizumab and 10% (5 of 51 patients) with placebo (difference, 21 percentage points; 95% confidence interval [CI], 5 to 38; P = 0.01). Differences in favor of vedolizumab over placebo were also seen with respect to mPDAI-defined remission at week 34 (difference, 17 percentage points; 95% CI, 0 to 35), mPDAI-defined response at week 14 (difference, 30 percentage points; 95% CI, 8 to 48) and at week 34 (difference, 22 percentage points; 95% CI, 2 to 40), and PDAI-defined remission at week 14 (difference, 25 percentage points; 95% CI, 8 to 41) and at week 34 (difference, 19 percentage points; 95% CI, 2 to 37). Serious adverse events occurred in 3 of 51 patients (6%) in the vedolizumab group and in 4 of 51 patients (8%) in the placebo group. CONCLUSIONS: Treatment with vedolizumab was more effective than placebo in inducing remission in patients who had chronic pouchitis after undergoing IPAA for ulcerative colitis. (Funded by Takeda; EARNEST ClinicalTrials.gov number, NCT02790138; EudraCT number, 2015-003472-78.).


Assuntos
Colite Ulcerativa , Fármacos Gastrointestinais , Pouchite , Proctocolectomia Restauradora , Adulto , Humanos , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/uso terapêutico , Ciprofloxacina/administração & dosagem , Ciprofloxacina/uso terapêutico , Colite Ulcerativa/complicações , Colite Ulcerativa/cirurgia , Pouchite/tratamento farmacológico , Pouchite/etiologia , Doença Crônica , Fármacos Gastrointestinais/administração & dosagem , Fármacos Gastrointestinais/uso terapêutico , Proctocolectomia Restauradora/efeitos adversos , Método Duplo-Cego , Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Administração Intravenosa , Quimioterapia Combinada
2.
Intest Res ; 17(1): 45-53, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30449081

RESUMO

Great strides have been achieved in the development of quality-of-care measures and standards for inflammatory bowel disease (IBD) over the last decade. The central structural component of care in IBD revolves around the multidisciplinary team, which should be equipped with the necessary resources to operate and implement decisions. Process measures have been defined by interest groups and can be adapted into process tools for the delivery of care for various patient subgroups and clinical scenarios. The emerging treat-to-target approach to IBD management may be used to achieve optimal long-term and holistic patient-centred outcomes, such as survival, control of inflammation and disease progression, symptomatic remission, quality of life and complications. Other important quality-of-care outcome measures for IBD include disutility of care, healthcare utilization and other patient-reported outcomes such as nutritional status and impact of fistulae. The current challenge for healthcare providers and health systems is the integration of quality-of-care structures and processes into clinical practice, and the consistent delivery of updated evidence-based quality IBD care to various patient populations by individual health care providers. Finally, the awareness and appreciation for quality of care in IBD is increasing in Asia, and Asian healthcare institutions should be encouraged to take the lead in improving the quality of care in IBD.

3.
World J Gastroenterol ; 20(12): 3153-63, 2014 Mar 28.
Artigo em Inglês | MEDLINE | ID: mdl-24696601

RESUMO

Inflammatory bowel disease and Crohn's disease in particular, is a common cause of intestinal failure. Current therapeutic options include home parenteral nutrition and intestinal transplantation. For most patients, home intravenous therapy including parenteral nutrition, with a good probability of long-term survival, is the favoured choice. However, in selected patients, with specific features that may shorten survival or complicate home parenteral nutrition, intestinal transplantation presents a viable alternative. We present survival, complications, quality of life and economic considerations that currently influence individualised decision-making between home parenteral nutrition and intestinal transplantation.


Assuntos
Doenças Inflamatórias Intestinais/terapia , Intestino Delgado/transplante , Nutrição Parenteral no Domicílio , Cateterismo/efeitos adversos , Doença de Crohn/terapia , Humanos , Hepatopatias/complicações , Complicações Pós-Operatórias , Qualidade de Vida , Recidiva , Sepse , Resultado do Tratamento
4.
J Crohns Colitis ; 4(1): 63-101, 2010 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-21122490
5.
J Crohns Colitis ; 3(3): 168-74, 2009 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-21172266

RESUMO

INTRODUCTION: A previous randomised controlled trial has demonstrated that oral plus topical mesalazine enema is more effective than oral mesalazine alone for achieving clinical remission in mild-to-moderately active extensive ulcerative colitis (UC). To evaluate whether this strategy is cost-effective we conducted an economic evaluation comparing 1 g topical mesalazine in combination with 4 g oral mesalazine compared to 4 g mesalazine monotherapy in mild-to-moderately active UC. METHODS: The economic evaluation was based on the ability to achieve remission using changes from baseline in the ulcerative colitis disease activity instrument (UCDAI). A cost-utility analysis was used where the main outcome was quality-adjusted life years to reflect improved quality of life associated with achieving remission compared with active disease. A simulated Markov model with five health states was constructed to model cost and outcome changes over time: (1) active UC; (2) mesalazine-refractory active UC; (3) steroid-refractory active UC; (4) infliximab-responsive active UC; and (5) remission. To reflect parameter uncertainty in the cost-effectiveness analysis probabilistic sensitivity analysis (PSA) was conducted by varying relevant clinical parameters. RESULTS: Average treatment costs required to transition a patient from active UC to remission using oral and topical mesalazine compared with oral alone were £1812 and £2390, respectively. Improved remission rates attributed to oral and topical mesalazine resulted in moderate improvements in quality-adjusted life years (QALYs) compared to oral mesalazine alone. Disaggregation of medical costs indicated that medical consultations and diagnostic costs were similar for both treatment arms. An abbreviated analysis which considered costs up to steroid-refractory patients in subacute UC indicated that combination therapy offered a cost-savings of £285 over 16 weeks of therapy compared with monotherapy. CONCLUSIONS: The results indicate that the addition of 1 g topical mesalazine results in significant cost-savings and moderate quality of life improvements. We have also shown that irrespective of which treatment modality is used in steroid-refractory patients (eg, infliximab, azathioprine, ciclosporine) that topical mesalazine is cost-saving.

6.
Curr Opin Gastroenterol ; 24(4): 469-74, 2008 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-18622161

RESUMO

PURPOSE OF REVIEW: Advances in conventional therapy, novel targets and therapeutic goals are the highlights of treatment for ulcerative colitis in the last year. There have also been disappointments. This review summarizes the highs and lows, with an emphasis on strategy as opposed to seeking the newest treatment option. RECENT FINDINGS: In conventional therapy, once daily therapy for 5-aminosalicylic acid is generally sufficient. Furthermore, a new 5-aminosalicylic acid (mesalamine MMX) has been released that effectively induces and maintains remission. There have been reappraisals of immunomodulators and further evaluation of (yes, now conventional!) infliximab for ulcerative colitis. Opportunistic infections, long-term outcomes and the burden of disease are being characterized. New therapeutic targets included an antibody against T cells (anti-CD3), but trials on visilizumab for acute severe colitis have been suspended. T-cell costimulation, phosphatidylcholine to promote barrier function, new anti-tumour necrosis factor agents, B-cell (anti-CD20) depletion and complementary therapies represent new therapeutic horizons. International agreement is needed on activity indices, definitions of remission, therapeutic goals (including mucosal healing) and outcomes that matter to patients, so that trials can be compared. SUMMARY: Advances will take time to alter mainstream practice, but 2007-2008 is the year of organized strategies, with European, American and British guidelines on ulcerative colitis published or in press. These should be the platform for better outcomes for patients.


Assuntos
Colite Ulcerativa/terapia , Anti-Inflamatórios/uso terapêutico , Colectomia , Colite Ulcerativa/complicações , Colite Ulcerativa/patologia , Fármacos Gastrointestinais/uso terapêutico , Humanos , Fatores Imunológicos/uso terapêutico
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