scholarly journals Patient Adherence and Efficacy of Certolizumab Pegol in the Management of Crohn's Disease

2012 ◽  
Vol 5 ◽  
pp. CGast.S7613 ◽  
Author(s):  
Wojciech Blonski ◽  
Anna M. Buchner ◽  
Gary R. Lichtenstein
Keyword(s):  
Tumor Necrosis ◽  
Maintenance Treatment ◽  
Patient Adherence ◽  
Certolizumab Pegol ◽  
Controlled Trials ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Us ◽  
Necrosis Factor ◽  
Adherence To Therapy

Treatment with Anti-Tumor Necrosis Factor (anti-TNF) therapy has become a mainstay of therapy for patients with CD who are unresponsive to conventional medical management. Currently there are three anti-TNFα antibodies that have been approved by the US Food and Drug Administration for the treatment of CD, namely infliximab, adalimumab and certolizumab pegol (CZP). Several double blind placebo controlled trials determined that CZP is effective as induction and maintenance treatment in adult patients with CD regardless of their prior exposure to other anti-TNFα antibodies. This review discusses the efficacy of CZP and adherence to therapy with anti-TNFα antibodies in patients with CD.

scholarly journals Randomized, Double-blind, Placebo-controlled, Dose-response, and Preclinical Safety Study of Transforaminal Epidural Etanercept for the Treatment of Sciatica

2009 ◽  
Vol 110 (5) ◽  
pp. 1116-1126 ◽  
Author(s):  
Steven P. Cohen ◽  
Nikolai Bogduk ◽  
Anthony Dragovich ◽  
Chester C. Buckenmaier ◽  
Scott Griffith ◽  
...  
Keyword(s):  
Tumor Necrosis Factor ◽  
Dose Response ◽  
Tumor Necrosis ◽  
Saline Group ◽  
Controlled Study ◽  
Safety Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Lumbosacral Radiculopathy ◽  
Necrosis Factor

Background Recent evidence implicates the inflammatory cytokine tumor necrosis factor as a major cause of radiculopathy. Yet, whereas open-label studies with systemically delivered tumor necrosis factor inhibitors have yielded positive results, a placebo-controlled study failed to demonstrate efficacy. One variable that may have contributed to poor outcomes is low drug levels at the site of nerve inflammation. To date, no studies have evaluated the efficacy or safety of epidurally administered anti-tumor necrosis factor agents. Methods A double-blind, placebo-controlled, dose-response study was conducted to evaluate an epidural tumor necrosis factor inhibitor. Twenty-four patients with subacute lumbosacral radiculopathy were randomly assigned to receive two transforaminal epidural injections of 2, 4, or 6 mg of entanercept 2 weeks apart in successive groups of eight. In each group, two patients received epidural saline. A parallel epidural canine safety study was conducted using the same injection doses and paradigm as in the clinical study. Results The animal and human safety studies revealed no behavioral, neurologic, or histologic evidence of drug-related toxicity. In the clinical arm, significant improvements in leg and back pain were collectively noted for the etanercept-treated patients, but not for the saline group, one month after treatment. One patient in the saline group (17%), six patients in the 2-mg group (100%), and four patients each in the 4-mg and 6-mg groups (67%) reported at least 50% reduction in leg pain and a positive global perceived effect one month after treatment. Six months after treatment, the beneficial effects persisted in all but one patient. Conclusion Epidural entanercept holds promise as a treatment for lumbosacral radiculopathy.

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