Infliximab in severe ulcerative colitis: short-term results of different infusion regimens and long-term follow-up
TL;DR: Severe ulcerative colitis is a life‐threatening disorder, despite i.v. glucocorticoids treatment, and infliximab has been proposed as a safe rescue therapy.
Abstract: Background Severe ulcerative colitis is a life-threatening disorder, despite i.v. glucocorticoids treatment. Infliximab has been proposed as a safe rescue therapy. Aim To evaluate short- and long-term effectiveness and safety of infliximab in severe refractory ulcerative colitis. Methods Eighty-three patients with severe ulcerative colitis (i.v. glucocorticoids treatment-refractory) were treated with infliximab in 10 Italian Gastroenterology Units. Patients underwent one or more infusions according to the choice of treating physicians. Short-term outcome was colectomy/death 2 months after the first infusion. Long-term outcome was survival free from colectomy. Safety data were recorded. Results Twelve patients (15%) underwent colectomy within 2 months. One died of Legionella pneumophila infection 12 days after infliximab. Early colectomy rates were higher in patients receiving one infusion (9/26), compared with those receiving two/more infusions (3/57, P = 0.001, OR = 9.53). Seventy patients who survived colectomy and did not experience any fatal complications were followed-up for a median time of 23 months; 58 patients avoided colectomy during the follow-up. Forty-two patients were maintained on immunosuppressive drugs. No clinical features were associated with outcomes. Conclusions Infliximab is an effective and relatively safe therapy to avoid colectomy and maintain long-term remission for patients with severe refractory ulcerative colitis. In the short term, two or more infusions seem to be more effective than one single infusion.
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TL;DR: Guidelines for clinical practice are aimed to indicate preferred approaches to medical problems as established by scientifically valid research, and are applicable to all physicians who address the subject regardless of specialty training or interests.
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TL;DR: It is scarcely an exaggeration to say that the recently issued preliminary report on the census of 1931 is one of the most sensational documents which has appeared for years, and that he who reads it intelligently will understand what is meant by saying that civilisation is in the melting pot.
Abstract: QUITE apart from the academic consideration that vital and medical statistics now form an obligatory part of the education of students seeking the University of London's diploma in public health, the demand for information about the methods of vital and medical statistics is increasing. The most casual reader of the newspapers is now aware that population problems are of serious practical importance and that the publications of the General Register Office cannot be ignored. It is scarcely an exaggeration to say that the recently issued preliminary report on the census of 1931 is one of the most sensational documents which has appeared for years, and that he who reads it intelligently will understand what is meant by saying that civilisation is in the melting pot. An Introduction to Medical Statistics. By Hilda M. Woods William T. Russell. Pp. x + 125. (London: P. S. King and Son, Ltd., 1931.) 7s. 6d.
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TL;DR: The most widely used index for severe UC remains that of Truelove and Witts3: any patient who has a bloody stool frequency ≥ 6/day and a tachycardia (> 90 bpm), or temperature > 37.8 °C, or anaemia (haemoglobin 30 mm/h) has severe ulcerative colitis (Table 1.3) as mentioned in this paper.
1,318 citations
University of Porto1, The Catholic University of America2, Sheba Medical Center3, Rambam Health Care Campus4, University of Palermo5, Boston Children's Hospital6, University College Dublin7, University of Barcelona8, Western General Hospital9, Guy's and St Thomas' NHS Foundation Trust10, McMaster University11, Université de Montréal12, Mount Sinai Hospital13
TL;DR: The treatment of inflammatory bowel disease has been revolutionised over the past decade by the increasing use of immunomodulators, mainly azathioprine/6-mercaptopurine and methotrexate, together with the advent of biological therapy.
1,150 citations
01 Jan 2012
TL;DR: In this article, the authors presented a study of Gastroenterology at the University of Toronto and University of Leuven (Belgium) with the aim of identifying the cause of colorectal cancer.
Abstract: ,2,3Department of Medicine 1, Agaplesion Markus Hospital, Wilhelm-Epstein-Str. 4, D-60431 Frankfurt/Main, GermanyDivision of Gastroenterology, Department of Medicine, MtSinai Hospital and University Health Network;University of Toronto, 600 University Avenue, Toronto, ON, Canada M5G 1X5 and University of Leuven, BelgiumReceived 26 August 2012; accepted 3 September 2012KEYWORDS
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TL;DR: Patients with moderate-to-severe active ulcerative colitis treated with infliximab at weeks 0, 2, and 6 and every eight weeks thereafter were more likely to have a clinical response at weeks 8, 30, and 54 than were those receiving placebo.
Abstract: Background Infliximab, a chimeric monoclonal antibody directed against tumor necrosis factor α, is an established treatment for Crohn's disease but not ulcerative colitis. Methods Two randomized, double-blind, placebo-controlled studies — the Active Ulcerative Colitis Trials 1 and 2 (ACT 1 and ACT 2, respectively) — evaluated the efficacy of infliximab for induction and maintenance therapy in adults with ulcerative colitis. In each study, 364 patients with moderate-to-severe active ulcerative colitis despite treatment with concurrent medications received placebo or infliximab (5 mg or 10 mg per kilogram of body weight) intravenously at weeks 0, 2, and 6 and then every eight weeks through week 46 (in ACT 1) or week 22 (in ACT 2). Patients were followed for 54 weeks in ACT 1 and 30 weeks in ACT 2. Results In ACT 1, 69 percent of patients who received 5 mg of infliximab and 61 percent of those who received 10 mg had a clinical response at week 8, as compared with 37 percent of those who received placebo (P<0...
3,345 citations
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TL;DR: Findings, i.e. that as-needed AO provided for a period of 3 months had no effect on quality of life and walked distance, are against the stream of current guidelines.
Abstract: I. Garcia-Talavera's reaction to the results of our trial of ambulatory oxygen (AO) in oxygen-dependent chronic obstructive pulmonary disease (COPD) is of no surprise to us. We realise that our findings, i.e. that as-needed AO provided for a period of 3 months had no effect on quality of life and walked distance 1, are against the stream of current guidelines ( i.e. that active patients receiving long-term oxygen therapy should have both stationary and mobile systems of oxygen delivery) 2 …
3,097 citations
Book•
23 Nov 1987
TL;DR: The design of experiments, analysis of the means of small samples using the t-c Distribution, and selection of the statistical method for clinical measurement and the structure of human populations are reviewed.
Abstract: Introduction The design of experiments Sampling and observational studies Summarizing data Presenting data Probability The Normal Distribution Estimation, standard error, and confidence intervals Significance tests Analysis of the means of small samples using the t-c Distribution Choosing the statistical method Clinical measurement Mortality statistics and the structure of human populations Solutions to exercises.
2,245 citations
TL;DR: Intravenous cyclosporine therapy is rapidly effective for patients with severe corticosteroid-resistant ulcerative colitis.
Abstract: Background There has been no new effective drug therapy for patients with severe ulcerative colitis since corticosteroids were introduced almost 40 years ago. In an uncontrolled study, 80 percent of 32 patients with active ulcerative colitis refractory to corticosteroid therapy had a response to cyclosporine therapy. Methods We conducted a randomized, double-blind, controlled trial in which cyclosporine (4 mg per kilogram of body weight per day) or placebo was administered by continuous intravenous infusion to 20 patients with severe ulcerative colitis whose condition had not improved after at least seven days of intravenous corticosteroid therapy. A response to therapy was defined as an improvement in a numerical symptom score (0 indicated no symptoms, and 21 severe symptoms) leading to discharge from the hospital and treatment with oral medications. Failure to respond to therapy resulted in colectomy, but some patients in the placebo group who had no response and no urgent need for surgery were subseque...
1,589 citations