Immanuel Medical Center

About: Immanuel Medical Center is a healthcare organization based out in Omaha, Nebraska, United States. It is known for research contribution in the topics: Randomized controlled trial & Population. The organization has 82 authors who have published 154 publications receiving 5875 citations.

Six‐month results of a double‐blind, placebo‐controlled trial of etanercept treatment in patients with active ankylosing spondylitis

Abstract: Objective There is increasing evidence that tumor necrosis factor α (TNFα) is centrally involved in the pathogenesis of ankylosing spondylitis (AS) and other spondylarthritides. This study was designed to investigate the efficacy of anti-TNFα therapy with etanercept, a 75-kd receptor fusion protein, in active AS. Methods This multicenter trial had 2 phases: an initial placebo-controlled period of 6 weeks' duration and an observational phase lasting 24 weeks. Thirty patients with active AS were included. They were randomized into 2 groups, which received either etanercept (25 mg twice weekly) (n = 14) or placebo (n = 16) for 6 weeks. Then both groups were treated with etanercept. Nonsteroidal antiinflammatory drug (NSAID) treatment could be continued, but disease-modifying antirheumatic drugs (DMARDs) and steroids had to be withdrawn prior to the study. All patients received etanercept for a total of 12 weeks and were followed up for at least 24 weeks. The Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index, Bath AS Metrology Index, pain level on a numeric rating scale, quality of life by the Short Form 36, and C-reactive protein (CRP) level were assessed. The primary outcome parameter was a ≥50% improvement in the BASDAI. Results Treatment with etanercept resulted in at least a 50% regression of disease activity in 57% of these patients at week 6, versus 6% of the placebo-treated patients (P = 0.004). After the placebo-treated patients switched to etanercept, 56% improved. The mean ± SD BASDAI improved from 6.5 ± 1.2 at baseline to 3.5 ± 1.9 at week 6 in the etanercept group, with no improvement in the placebo group (P = 0.003 between groups). Similarly, pain, function, mobility, and quality of life improved with etanercept but not with placebo at week 6 (P < 0.05). Mean CRP levels decreased significantly with etanercept but not with placebo (P = 0.001). There was ongoing improvement in all parameters in both groups until week 12 and week 18, respectively (i.e., throughout the period of etanercept treatment). Disease relapses occurred a mean ± SD of 6.2 ± 3.0 weeks after cessation of etanercept. No severe adverse events, including major infections, were observed during the trial. Conclusion This study shows that on a short-term basis (3 months), treatment with etanercept is clearly efficacious in patients with active AS who are receiving NSAID therapy but not DMARDs or steroids. After cessation of therapy, almost all patients experienced a relapse within a few weeks. Thus, it seems probable that etanercept must be administered continuously in most AS patients to achieve permanent inhibition of the inflammatory process.

Effects of yoga on mental and physical health: a short summary of reviews

Abstract: This report summarizes the current evidence on the effects of yoga interventions on various components of mental and physical health, by focussing on the evidence described in review articles. Collectively, these reviews suggest a number of areas where yoga may well be beneficial, but more research is required for virtually all of them to firmly establish such benefits. The heterogeneity among interventions and conditions studied has hampered the use of meta-analysis as an appropriate tool for summarizing the current literature. Nevertheless, there are some meta-analyses which indicate beneficial effects of yoga interventions, and there are several randomized clinical trials (RCT's) of relatively high quality indicating beneficial effects of yoga for pain-associated disability and mental health. Yoga may well be effective as a supportive adjunct to mitigate some medical conditions, but not yet a proven stand-alone, curative treatment. Larger-scale and more rigorous research with higher methodological quality and adequate control interventions is highly encouraged because yoga may have potential to be implemented as a beneficial supportive/adjunct treatment that is relatively cost-effective, may be practiced at least in part as a self-care behavioral treatment, provides a life-long behavioural skill, enhances self-efficacy and self-confidence and is often associated with additional positive side effects.

Long-term efficacy and safety of infliximab in the treatment of ankylosing spondylitis: an open, observational, extension study of a three-month, randomized, placebo-controlled trial.

Abstract: Objective Treatment of ankylosing spondylitis (AS) with infliximab, an anti–tumor necrosis factor α monoclonal antibody, was shown to be efficacious in patients with active disease during a 3-month treatment period. The purpose of this study was to evaluate the efficacy and safety of infliximab treatment of AS for a 1-year period. Methods This study was an open, observational, extension study of a 3-month, randomized, placebo-controlled trial. All patients who had tolerated infliximab (infliximab/infliximab group) or placebo (placebo/infliximab 12-week crossover group) therapy for 3 months entered the open extension trial (n = 65). Infliximab was administered at a dosage of 5 mg/kg every 6 weeks after the induction phase (weeks 0, 2, and 6). The primary end point was a 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Results At week 54, a total of 54 of the 69 patients (78%) continued to take infliximab. The intent-to-treat primary efficacy analysis at week 54 showed that 47% of patients in the infliximab/infliximab group (95% confidence interval 31–63) and 51% of the patients in the placebo/infliximab group (95% confidence interval 36–67) achieved 50% improvement in BASDAI scores. In the analysis of those who completed the study, the mean BASDAI scores improved between weeks 0 and 54 in both treatment groups: from 6.6 to 2.4 in the infliximab/infliximab group and from 6.3 to 2.6 in the placebo/infliximab group. The dosage of nonsteroidal antiinflammatory drugs was reduced in ∼70% of the patients. There were significant improvements in measures of functioning, metrologic parameters, and quality of life. Between weeks 12 and 54, a total of 4 patients had serious adverse events that were possibly related to infliximab and resulted in their discontinuing the study. Conclusion Infliximab therapy in AS patients resulted in a rapid and significant improvement in BASDAI scores (>50% improvement) and a durable response for 1 year. The safety profile of infliximab in AS was comparable to that observed in the postmarketing experience for the approved indications.