Infliximab or cyclosporine for acute severe ulcerative colitis: A retrospective analysis

Dean, Kathryn E.; Hikaka, Joanna; Huakau, John T; Walmsley, Russell

doi:10.1111/j.1440-1746.2011.06958.x

Cited by 42 publications

(37 citation statements)

References 32 publications

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“…Although both ciclosporin and infliximab were effective in steroid-resistant UC, results did not agree which drug was better. [32][33][34][35] One small retrospective study 34 of 38 patients with acute UC resistant to steroids showed a higher rate of colectomy in patients who received ciclosporin (63% and 68% at 3 and 12 months, respectively) than in those who received infliximab (21% and 37% at 3 and 12 months, respectively); there was no significant difference between groups in adverse events (AEs) or steroid dependence. A prospective study 36 found the colectomy-free rate at discharge, and at 3 and 12 months from admission, was significantly higher in patients who had infliximab as a rescue therapy (n = 45) compared with those who had ciclosporin (n = 38).…”

Section: Review Of Literaturementioning

confidence: 99%

“…We used the electronic search strategies checklist of the Cochrane Collaboration. 31 We identified nine observational studies and one RCT [32][33][34][35][36][37][38][39][40][41] that compared the efficacy and safety of ciclosporin with those of infliximab ( Table 1). Although both ciclosporin and infliximab were effective in steroid-resistant UC, results did not agree which drug was better.…”

Section: Review Of Literaturementioning

confidence: 99%

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Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT)

Williams

Alam

Alrubaiy

et al. 2016

Health Technol Assess

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BackgroundThe efficacy of infliximab and ciclosporin in treating severe ulcerative colitis (UC) is proven, but there has been no comparative evaluation of effectiveness.ObjectiveTo compare the clinical effectiveness and cost-effectiveness of infliximab and ciclosporin in treating steroid-resistant acute severe UC.MethodBetween May 2010 and February 2013 we recruited 270 participants from 52 hospitals in England, Scotland and Wales to an open-label parallel-group, pragmatic randomised trial. Consented patients admitted with severe colitis completed baseline quality-of-life questionnaires before receiving intravenous hydrocortisone. If they failed to respond within about 5 days, and met other inclusion criteria, we invited them to participate and used a web-based adaptive randomisation algorithm to allocate them in equal proportions between 5 mg/kg of intravenous infliximab at 0, 2 and 6 weeks or 2 mg/kg/day of intravenous ciclosporin for 7 days followed by 5.5 mg/kg/day of oral ciclosporin until 12 weeks from randomisation. Further treatment was at the discretion of physicians responsible for clinical management. The primary outcome was quality-adjusted survival (QAS): the area under the curve (AUC) of scores derived from Crohn’s and Ulcerative Colitis Questionnaires completed by participants at 3 and 6 months, and then 6-monthly over 1–3 years, more frequently after surgery. Secondary outcomes collected simultaneously included European Quality of Life-5 Dimensions (EQ-5D) scores and NHS resource use to estimate cost-effectiveness. Blinding was possible only for data analysts. We interviewed 20 trial participants and 23 participating professionals. Funded data collection finished in March 2014. Most participants consented to complete annual questionnaires and for us to analyse their routinely collected health data over 10 years.ResultsThe 135 participants in each group were well matched at baseline. In 121 participants analysed in each group, we found no significant difference between infliximab and ciclosporin in QAS [mean difference in AUC/day 0.0297 favouring ciclosporin, 95% confidence interval (CI) –0.0088 to 0.0682;p = 0.129]; EQ-5D scores (quality-adjusted life-year mean difference 0.021 favouring ciclosporin, 95% CI –0.032 to 0.096;p = 0.350); Short Form questionnaire-6 Dimensions scores (mean difference 0.0051 favouring ciclosporin, 95% CI –0.0250 to 0.0353;p = 0.737). There was no statistically significant difference in colectomy rates [odds ratio (OR) 1.350 favouring infliximab, 95% CI 0.832 to 2.188;p = 0.223]; numbers of serious adverse reactions (event ratio = 0.938 favouring ciclosporin, 95% CI 0.590 to 1.493;p = 0.788); participants with serious adverse reactions (OR 0.660 favouring ciclosporin, 95% CI 0.282 to 1.546;p = 0.338); numbers of serious adverse events (event ratio 1.075 favouring infliximab, 95% CI 0.603 to 1.917;p = 0.807); participants with serious adverse events (OR 0.999 favouring infliximab, 95% CI 0.473 to 2.114;p = 0.998); deaths (all three who died received infliximab;p = 0.247) or concomitant use of immunosuppressants. The lower cost of ciclosporin led to lower total NHS costs (mean difference –£5632, 95% CI –£8305 to –£2773;p < 0.001). Interviews highlighted the debilitating effect of UC; participants were more positive about infliximab than ciclosporin. Professionals reported advantages and disadvantages with both drugs, but nurses disliked the intravenous ciclosporin.ConclusionsTotal cost to the NHS was considerably higher for infliximab than ciclosporin. Nevertheless, there was no significant difference between the two drugs in clinical effectiveness, colectomy rates, incidence of SAEs or reactions, or mortality, when measured 1–3 years post treatment. To assess long-term outcome participants will be followed up for 10 years post randomisation, using questionnaires and routinely collected data. Further studies will be needed to evaluate the efficacy and effectiveness of new anti-tumour necrosis factor drugs and formulations of ciclosporin.Trial registrationCurrent Controlled Trials ISRCTN22663589.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 44. See the NIHR Journals Library website for further project information.

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Section: Review Of Literaturementioning

confidence: 99%

Section: Review Of Literaturementioning

confidence: 99%

Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT)

Williams

Alam

Alrubaiy

et al. 2016

Health Technol Assess

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“…Longer term colectomy data suggest that infliximab may be superior to cyclosporine. 28,29 When to Stop Therapy A number of factors (e.g., cost, long-term safety, pregnancy, patient preference) may lead to cessation of TNF-a antagonist therapy. Louis et al 30 performed a prospective study to examine the risk of relapse after discontinuation of infliximab.…”

Section: Management Of Acute Severe Ulcerative Colitismentioning

confidence: 99%

Tumor Necrosis Factor-Alpha Antagonists Twenty Years Later

Akobeng

Sandborn

Bickston

et al. 2014

Inflammatory Bowel Diseases

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In 1998, the U.S. Food and Drug Administration granted regulatory approval to the first tumor necrosis factor-α antagonist, infliximab, for the treatment of moderately to severely active Crohn's disease. As of 2013, there were 3 additional tumor necrosis factor-α antagonists commercially available for the treatment of inflammatory bowel disease in the United States: adalimumab, certolizumab pegol, and golimumab. Despite a vast literature describing both clinical trial and clinical practice experience with these agents, there remain important questions regarding the efficacy and safety of tumor necrosis factor-α antagonists for the treatment of inflammatory bowel disease. These questions and the best available evidence to answer them were discussed during a Cochrane Collaboration session held at the 2013 Digestive Diseases Week annual meeting. This article reviews the data from that session.

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“…[46][47][48][49][50] Although the use of both CsA and IFX has been shown to be effective and safe as rescue therapy compared with placebo in acute severe UC, data regarding head-to-head comparison of CIs and anti-TNF-a agents are limited and based on retrospective observational studies. [51][52][53][54] Mocciaro et al 55 reviewed patients with severe steroid-refractory colitis who had been treated with intravenous CsA (2 mg/kg) or intravenous IFX (5 mg/kg). A total of 65 patients were included: 35 in the CsA group and 30 in the IFX group.…”

Section: Efficacy Of Tac In CDmentioning

confidence: 99%

Role in Calcineurin Inhibitors for Inflammatory Bowel Disease in the Biologics Era

Nakase

Yoshino

Matsuura

2014

Inflammatory Bowel Diseases

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Ulcerative colitis and Crohn's disease, which is the 2 major forms of inflammatory bowel disease, are chronic relapsing and remitting inflammatory disorder of the gastrointestinal tract. During the last 30 years, the therapy for patients with refractory inflammatory bowel diseases is still challenging despite the fact that morbidity and mortality rates have been obviously reduced. The conventional management with corticosteroids has been modified by the introduction of calcineurin inhibitors and biologics. In this review, we focus on role in calcineurin inhibitors for patients with inflammatory bowel disease in the currently clinical practice.

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Infliximab or cyclosporine for acute severe ulcerative colitis: A retrospective analysis

Abstract: Infliximab improved clinical outcomes compared to the previous use of intravenous cyclosporine in patients admitted with steroid-refractory acute severe UC.

Cited by 42 publications

References 32 publications

Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT)

Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT)

Tumor Necrosis Factor-Alpha Antagonists Twenty Years Later

Role in Calcineurin Inhibitors for Inflammatory Bowel Disease in the Biologics Era

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