*Internal Medicine and Gastroenterology Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy †IBD Center, Gastroenterology, IRCCS Humanitas, Milan, Italy ‡General Surgery Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy.
Up to 20% of patients with ulcerative colitis (UC) become steroid-dependent during their course. Thiopurines are recommended in steroid-dependent UC, but their efficacy is debated. Data exploring the use of infliximab in these patients are scarce. Aims of this study were to evaluate the effectiveness of infliximab in steroid-dependent UC and identify predictors of steroid-free remission, mucosal healing (MH), and colectomy.
Steroid-dependent UC patients were enrolled and intentionally treated with infliximab. The prospectively designed analyses evaluated (1) steroid-free clinical remission at 6 and 12 months, (2) steroid-free clinical remission and MH at 12 months, and (3) colectomy within 12 months.
One hundred and twenty-six active steroid-dependent UC patients were studied. Of the 126 patients, 36 patients were retrospectively included and 90 patients prospectively enrolled. Steroid-free remission was 53% and 47% at 6 and 12 months, respectively. Predictors of steroid-free remission at 6 and 12 months were thiopurine-naive status (hazard ratio [HR], 2.5 and HR, 2.8, respectively) and combination therapy (HR, 2.1 and HR, 2.2, respectively). At 12 months, 32% were in steroid-free remission and MH. Thiopurine-naive status predicted steroid-free remission and MH (odds ratio, 3.6). C-reactive protein drop to normal after infliximab induction was predictive of steroid-free remission at 6 (HR, 5.9) and 12 months (HR, 4.6) and steroid-free remission and MH at 12 months (odds ratio, 6.0). Twelve patients underwent colectomy after a median of 4.7 months. Steroid sparing significantly reduced the risk of colectomy within 12 months (HR, 0.14).
Infliximab seems effective in steroid-dependent UC. Thiopurine-naive status and combination therapy significantly increase the rate of steroid-free remission up to 12 months.
"If symptoms persist or patients are unable to stop steroids after 12 weeks of starting thiopurines, anti-TNFα agents should be started.10 Finally, induction and scheduled maintenance treatment with infliximab has been recently reported to be effective for inducing steroid-free clinical remission and mucosal healing at 1 year, in both thiopurine-naïve and experienced, corticosteroid-dependent, ulcerative colitis patients.11 "
[Show abstract][Hide abstract] ABSTRACT: The treatment of ulcerative colitis has changed over the last decade, with the introduction of biological drugs. This article reviews the currently available therapies for ulcerative colitis and the specific use of these therapies in the management of patients in different settings, particularly the difficult-to-treat patients. The focus of this review is on adalimumab, which has recently obtained approval by the European Medicines Agency and the US Food and Drug Administration, for use in treating adult patients with moderate-to-severe, active ulcerative colitis, who are refractory, intolerant, or who have contraindications to conventional therapy, including corticosteroids and thiopurines. Since the results emerging from the pivotal trials have been subject to some debate, the aim of this review was to summarize all available data on the use of adalimumab in ulcerative colitis, focusing also on a retrospective series of real-life experiences. Taken together, the current evidence indicates that adalimumab is effective for the treatment of patients with different types of ulcerative colitis, including biologically naïve and difficult-to-treat patients.
Drug Design, Development and Therapy 04/2013; 7:289-96. DOI:10.2147/DDDT.S33197 · 3.03 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Until recently, the management of ulcerative colitis (UC) consisted of the stepwise use of mesalazine, corticosteroids and immunomodulators, or consideration of surgery. Anti-tumour necrosis factor (TNF) agents are recent additions to the UC-treatment algorithm.
To provide clinicians with a review of the role of anti-TNFs in UC, discussing how the drug(s) were used in the past, their current use and to determine their future role.
The scientific literature was reviewed to evaluate data on the use of anti-TNFs in UC.
In this review, we report how the management of UC has changed with the availability of anti-TNFs. The results from landmark anti-TNF trials have impacted clinical practice, leading to a readjustment of treatment goals. In addition, experience from clinical trials and local real-life cohorts have helped to clarify some misunderstandings in the management of UC. New anti-TNFs are on the horizon but questions still remain on the future role of anti-TNFs with regard to impact on disability, digestive damage and the possible development of risk matrices. Experiences from the use of anti-TNFs in Crohn's disease (for example, combination therapy and early treatment) now need to be addressed in UC.
The use of anti-TNFs in the management of UC has matured rapidly. Clinical experience has helped shape the current role of anti-TNFs, but more clinical research is needed to optimise their future role.
[Show abstract][Hide abstract] ABSTRACT: The effectiveness of adalimumab in the treatment of ulcerative colitis is under debate. Although controlled trials have shown that adalimumab is significantly better than placebo, the absolute clinical benefit is modest. We report data on the effectiveness of adalimumab in a cohort of ulcerative colitis patients treated in 22 Italian centres.
Digestive and Liver Disease 05/2013; DOI:10.1016/j.dld.2013.03.018 · 2.96 Impact Factor
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