Infliximab for acute severe ulcerative colitis: A randomized pilot study in non steroid refractory patients

Ochsenkühn, Thomas; Sackmann, Michael; Goeke, Burkhard

doi:10.1016/s0016-5085(03)80304-9

Cited by 44 publications

(57 citation statements)

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“…Five randomised double blind studies have compared infliximab with placebo for the treatment of UC [15][16][17][18] with two further randomised studies comparing infliximab with steroids [25,26] . Despite significant heterogeneity in the study populations and trial designs used, all but one study demonstrated a significant improvement in the disease treated with infliximab compared to placebo [16] .…”

Section: Discussionmentioning

confidence: 99%

The use of infliximab in the prevention and delay of colectomy in severe steroid dependant and refractory ulcerative colitis

Willert¹,

Lawrance²

2008

WJG

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AIM: To determine if infliximab can prevent or delay surgery in refractory ulcerative colitis (UC). METHODS:UC patients who failed to have their disease controlled with conventional therapies and were to undergo colectomy if infliximab failed to induce a clinical improvement were reviewed. Patients were primarily treated with a single 5 mg/kg infliximab dose. The Colitis Activity Index (CAI) was used to determine response and remission. Data of 8 wk response and colectomy rates at 6 mo and 12 mo were collected. RESULTS:Fifteen patients were included, 7 with UC unresponsive or intolerant to Ⅳ hydrocortisone, and 8 with active disease despite oral steroids (all but one with therapeutic dosage and duration of immunomodulation). All the Ⅳ hydrocortisone-resistant/intolerant patients had been on azathioprine/6-MP < 8 wk. At 8 wk, infliximab induced a response in 86.7% (13/15) with 40% in remission (6/15). Within 6 mo of treatment 26.7% (4/15) had undergone colectomy and surgery was avoided in 46.6% (7/15) at 12 mo. The colectomy rate at 12 mo in those on immunomodulatory therapy < 8 wk at time of infliximab was 12.5% (1/8) compared with 100% (7/7) in patients who were on long-term maintenance immunomodulators (P < 0.02). CONCLUSION:Infliximab prevented colectomy due to active disease in immunomodulatory-naïve, refractory UC patients comparable to the use of Cyclosporine. In patients, however, on effective dosage and duration of immunomodulation at time of infliximab therapy colectomy was not avoided.

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Section: Discussionmentioning

confidence: 99%

The use of infliximab in the prevention and delay of colectomy in severe steroid dependant and refractory ulcerative colitis

Willert¹,

Lawrance²

2008

WJG

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“…[20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38] All 20 studies reported a mean age. The composite mean age was 39.2 years with a mean range of 36.2 to 44 years.…”

Section: Biological Agentsmentioning

confidence: 99%

“…Based on the age range data alone, 2 studies did not include elderly patients. 20,26 There were a total of 14 studies in which the estimated number of elderly patients could be calculated by adding 1 or 2 SD to the mean age, whichever provided the closest estimate to an elderly age. Using this method, approximately 16% of the study population had a mean age of 53.4 years (mean of 'mean plus 1 SD') or older.…”

Section: Biological Agentsmentioning

confidence: 99%

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Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

Baggenstos

Hanson²,

Shaukat

2013

Clinical Medicine Insights: Geriatrics

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Ulcerative colitis (UC) is increasingly recognized as a disease affecting the elderly. Approximately 10%-30% of the UC population is over the age of 60 years. Additionally, younger patients with UC are aging and thus comprise a second group of elderly IBD patients. To date, there have been no clinical trials that have evaluated treatment efficacy of UC in the elderly population. The aim of our study was to conduct a systematic review of all randomized controlled trials (RCTs) addressing treatment outcome in UC; we also sought to identify the elderly population, defined as age 60 years or older, represented in these studies, to see if pooled data would lead to meaningful conclusions regarding treatment efficacy and safety profile in the elderly. A search of the MEDLINE database via PubMed and the EMBASE database via Scopus was performed to identify all RCTs evaluating medical therapy for UC in humans, published within the English language through September 2012. Studies were grouped into three categories: biological agent (BA) therapy; immunosuppressant (IS) therapy; and 5-aminosalicylic acid (5-ASA) therapy. To estimate the number of elderly patients in each study, mean age plus 1 and 2 standard deviations (SD) was calculated to find the closest approximation to age 60. Of 876 studies, 112 RCTs were included in the final analysis-20 studies for BA, 20 for IS, and 72 for 5-ASA agents. While nearly all studies reported either a mean or median age, only 38% additionally reported the SD and age range. The mean composite age was 39.2 years for the BA studies, 38.5 years for the IS studies, and 42.8 years for the 5-ASA studies, consistent with a young middle-aged patient. We estimated that no more than 16% of patients per study would have qualified as elderly, and in most cases a much smaller percentage (,8%). Additionally, there were no BA or IS RCTs that reported results by age subgroup analysis. Four studies in the 5-ASA group report age-specific analyses and showed no difference in treatment efficacy by age. None of the 112 RCTs reported age sub-analyses of safety, tolerability, adverse events, or withdrawal rates. There is insufficient evidence to evaluate efficacy of treatment and adverse events from treatment for UC in the elderly. With the rising number of elderly patients with UC, there is a need for more clinical trials that specifically address UC treatment in this unique population.

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“…С развитием технологии синтеза моноклональных антител стало возможным применение инфликсимаба (ИНФ) -антител к α-фактору некроза опухоли, эффек-тивность которого при ЯК продемонстрирована в ходе рандомизированных контролируемых испытаний [15][16][17] и подтверждена данными Кокрановского системати-ческого обзора [18]. Однако если в целом ИНФ в сочета-нии со стандартной терапией при ЯК позволяет избежать хирургического лечения почти у 90% пациентов в течение 1 года [19], то при ТО ЯК, резистентной к внутривенным ГКС, к хирургическому лечению, несмотря на введения ИНФ, приходится прибегать практически в 1 / 3 случаев [20][21][22].…”

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Long-term results of medical treatment in patients with a severe attack of ulcerative colitis

et al. 2015

Ter. arkh.

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Infliximab for acute severe ulcerative colitis: A randomized pilot study in non steroid refractory patients

Cited by 44 publications

References 0 publications

The use of infliximab in the prevention and delay of colectomy in severe steroid dependant and refractory ulcerative colitis

The use of infliximab in the prevention and delay of colectomy in severe steroid dependant and refractory ulcerative colitis

Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

Long-term results of medical treatment in patients with a severe attack of ulcerative colitis

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