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Biomedical subjects

Chinyu Su

Publications and source records attributed to Chinyu Su.

9 recordsLinked to original sources
PubMed2006

Outcomes of placebo therapy in inflammatory bowel disease.

Placebo is important in assessing drug response, particularly in diseases characterized by spontaneous periods of acute exacerbation and quiescence. Randomized, placebo-controlled trials are the most objective means of evaluating drug efficacy, although the conduct of such clinical trials may not always be practical or ethical in all disease states. In inflammatory bowel disease (IBD), most patients experience intermittent episodes of active disease alternating with variable periods of remission. Thus, development of new medical therapies for IBD requires proof of superiority to placebo or alternative therapies. In this regard, knowledge of the outcomes of patients receiving placebo therapy and their influencing factors is important for proper study design and meaningful results. Such knowledge also is essential for interpreting results of open-label studies often necessary before randomized controlled trials can be conducted. In addition, the disease course of placebo-treated patients in clinical trials of IBD serves as an approximation of the natural history of these patients. The knowledge of placebo response in these patients provides clinicians with an important piece of information in prognosticating and making management decisions. This review presents our current knowledge of placebo therapy in IBD. Specifically, the existing literature on the outcomes and predictors of outcomes in patients receiving placebo therapy in clinical trials of IBD is reviewed.

Anti-Inflammatory Agents↗
PubMed2006

The effect of anti-TNF-alpha therapy on spinal bone mineral density in patients with Crohn's disease.

Proinflammatory cytokines, including tumor necrosis factor-alpha (TNF-alpha) might be, at least partially, responsible for the development of osteopenia or osteoporosis in Crohn's disease. We investigated whether anti-TNF therapy for Crohn's disease could have any skeletal impact. Therefore, we studied the effects of infliximab, a monoclonal antibody against TNF-alpha with and without bisphosphonates, on spinal bone mineral density (BMD). The effect of corticosteroids was also analyzed. A retrospective cohort analysis was performed on 61 patients with Crohn's disease and low BMD by serial DXA scans. Twenty-three patients were on infliximab and 36 patients were on bisphosphonates. Mean duration between DXA scans was 2.2 +/- 0.99 years. After controlling for corticosteroid use, patients with concurrent infliximab and bisphosphonate treatment exhibited a greater increase in BMD compared to those on bisphosphonates alone (+6.7%/year vs. +4.46%/year, P= 0.045); corticosteroids inhibited this effect (P= 0.025). However, infliximab alone had no effects on BMD. Patients receiving bisphosphonates showed a significant increase in lumbar spine BMD compared to those not on bisphosphonates (+3.97% change in T score/year vs. -3.68%/year, P < 0.0001). Concurrent corticosteroid use significantly inhibited this effect (+2.15%/year vs. +4.97%/year, P= 0.0014). Concurrent infliximab use may confer an additional benefit to that already documented for bisphosphonate use alone; bisphosphonates are beneficial in the treatment of low BMD in patients with Crohn's disease, though corticosteroids may partially inhibit this effect.

Antibodies, Monoclonal↗
PubMed2005

Are there predictors of Remicade treatment success or failure?

Infliximab (Remicade) is an antitumor necrosis factor (TNF) therapy effective in both induction and maintenance of remission in Crohn's disease. Identifying predictors of response or relapse to infliximab is important given the potential toxicities and cost of this therapy. Currently available data suggest that concurrent immunosuppressant therapy, certain clinical characteristics, biological and immunological markers, and gene polymorphism may correlate with response to infliximab. However, no single variable has been consistently shown or definitely proven in studies to be a predictor of response to infliximab to be of practical value in current clinical practice. Data from the literature in these areas are reviewed in this article, pointing to the need for additional research in this topic.

Antibodies, Monoclonal↗
PubMed2004

Treatment of inflammatory bowel disease with azathioprine and 6-mercaptopurine.

6-Mercaptopurine and azathioprine have become important therapeutic options for patients with inflammatory bowel disease (IBD). Although accumulating data in the literature have supported the use of these immunomodulators in the management of IBD, marked variation exists in the pattern of clinical practice regarding azathioprine or 6-mercaptopurine therapy in patients with IBD. This article provides a critical review of the data on the clinical efficacy and toxicities of 6-mercaptopurine and azathioprine in the management of IBD. Emerging literature on the potential application of pharmacogenetic testing and metabolite monitoring are also discussed.

Azathioprine↗
PubMed2004

A meta-analysis of the placebo rates of remission and response in clinical trials of active Crohn's disease.

BACKGROUND & AIMS: Placebo-controlled, randomized clinical trials (PC-RCTs) are commonly used to assess therapies for Crohn's disease (CD). Knowledge of the placebo rates of remission and response and understanding of design factors that influence these rates is important for designing future clinical trials evaluating pharmacotherapy of CD. The aims of this study were to estimate rates of remission and response in patients with active CD receiving placebo and to identify factors influencing these rates. METHODS: We performed a systematic review and meta-analysis of PC-RCTs evaluating therapies for active CD identified from MEDLINE from 1966 to 2001. RESULTS: The pooled estimates of the placebo rates of remission and response were 18% (95% confidence interval, 14%-24%; range, 0%-50%) and 19% (95% confidence interval, 13%-28%; range, 0%-46%), respectively, both with significant heterogeneity among studies (P < 0.01 for remission, P < 0.03 for response). In multivariate models, study duration, number of study visits, and entry Crohn's Disease Activity Index score were important predictors of the placebo remission rate, with study duration the most important. However, no single factor could account for all of the heterogeneity. Factors that influence the placebo response rates were similar to those affecting the placebo remission rates. The absolute benefit of active treatment beyond placebo was generally larger when outcome was measured by response than remission. CONCLUSIONS: Placebo remission and response rates in PC-RCTs for active CD are variable. Study duration, number of study visits, and disease severity at entry have a large influence on placebo remission rates.

Controlled Clinical Trials as Topic↗
PubMed2002

Recent developments in inflammatory bowel disease.

The evolving medical armamentarium holds promise for more precise and effective therapies for IBD. The experience with anti-TNF therapy, particularly infliximab, illustrates the potential efficacy of therapies targeted at specific mediators or pathways involved in the pathogenesis. Advances in molecular technology have enabled the development of novel and potentially effective targeted therapies. Equally important is the increasing scientific understanding of the pathogenesis of IBD, which will likely improve the ability to stratify disease and to select therapies based on genotypic, immunologic, and phenotypic profiles in the future.

Adjuvants, Immunologic↗
PubMed2002

Efficacy of anti-tumor necrosis factor therapy in patients with ulcerative colitis.

OBJECTIVES: Tumor necrosis factor-alpha (TNF-alpha) is an important cytokine involved in the pathogenesis of inflammatory bowel disease. The monoclonal antibody to TNF-alpha, infliximab, is effective in treating Crohn's disease. Preclinical studies suggest the importance of TNF-alpha in treating ulcerative colitis (UC). We report the effectiveness of infliximab for UC and examine factors predictive of response to medication. METHODS: Data from all UC patients receiving infliximab at four institutions were analyzed. Disease activity was determined by the Disease Activity Index. RESULTS: A total of 27 patients with active UC received inpatient (37%) and outpatient (63%) infliximab as single (52%) or multiple (two to 15) infusions (48%). Twelve patients (44%) achieved remission and six patients (22%) had partial response. Nine patients had no response; five subsequently underwent total colectomy. The median time to achieve response and remission was 4 days and the median duration 8 wk. Nine of the 18 patients who responded experienced 19 relapses; 18 of these relapses (95%) were successfully treated with repeat infusions. Steroid-refractory patients were less likely to respond to infliximab therapy than were steroid-responsive patients (33% vs 83%; p = 0.026). No other factors were predictive of response to infliximab. Two patients developed serious adverse events, including death in one case. CONCLUSIONS: Preliminary evidence suggest effectiveness of infliximab in the treatment of UC, including medically refractory severe disease. Individuals who are refractory to corticosteroids, however, may be unlikely to respond to infliximab. A randomized controlled trial is necessary to further investigate the efficacy of infliximab in patients with UC.

Adult↗