22 research outputs found
Review article: efficacy of infliximab in Crohn’s disease - induction and maintenance of remission
A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alfa for Crohn's disease
interior, roof insulation (thin insulation foam roll installed underneath roof using GI wire), at the BACIP offices, Gilgit, Pakistan, 200
A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alfa for Crohn's disease
Infliximab for the treatment of fistulas in patients with Crohn's disease
Enterocutaneous fistulas are a serious complication of Crohn's disease and are difficult to treat. Infliximab, a chimeric monoclonal antibody to tumor necrosis factor alpha, has recently been developed as a treatment for Crohn's disease. We conducted a randomized, multicenter, double-blind, placebo-controlled trial of infliximab for the treatment of fistulas in patients with Crohn's disease. The study included 94 adult patients who had draining abdominal or perianal fistulas of at least three months' duration as a complication of Crohn's disease. Patients were randomly assigned to receive one of three treatments: placebo (31 patients), 5 mg of infliximab per kilogram of body weight (31 patients), or 10 mg of infliximab per kilogram (32 patients); all three were to be administered intravenously at weeks 0, 2, and 6. The primary end point was a reduction of 50 percent or more from base line in the number of draining fistulas observed at two or more consecutive study visits. A secondary end point was the closure of all fistulas. Sixty-eight percent of the patients who received 5 mg of infliximab per kilogram and 56 percent of those who received 10 mg per kilogram achieved the primary end point, as compared with 26 percent of the patients in the placebo group (P=0.002 and P=0.02, respectively). In addition, 55 percent of the patients assigned to receive 5 mg of infliximab per kilogram and 38 percent of those assigned to 10 mg per kilogram had closure of all fistulas, as compared with 13 percent of the patients assigned to placebo (P=0.001 and P=0.04, respectively). The median length of time during which the fistulas remained closed was three months. More than 60 percent of patients in all the groups had adverse events. For patients treated with infliximab, the most common were headache, abscess, upper respiratory tract infection, and fatigue. Infliximab is an efficacious treatment for fistulas in patients with Crohn's diseas
943d A Phase 2/3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Subcutaneous Golimumab Induction Therapy in Patients with Moderately to Severely Active Ulcerative Colitis: PURSUIT SC
Efficacy and Safety of Adalimumab in Crohn's Disease
Adalimumab (ADA) is a subcutaneously (SC) self-administered fully human Ig G1
monoclonal antibody directed against tumor necrosis factor alpha (TNFce). In the
CLASSIC dose-ranging trial, ADA was superior to placebo for inducing remission
in patients with moderate-to-severe Crohn's disease (CD) naive to
TNFa inhibitor therapy. In CLASSIC II, patients in remission following CLASSIC I
maintained remission for up to 56 weeks while on ADA. In CHARM, approximately
40% of the 499 patients with moderate-to-severe CD who responded to ADA,
maintained remission at 26 and 52 weeks, thus confirming long-term efficacy. ADA
demonstrated steroid-sparing properties, beneficial effects in patients with
perianal fistulas, and decreases in rates of hospitalization and surgery.
Sub-group analyses demonstrated similar remission rates irrespective of
concomitant immunosuppressive use or previous exposure to other TNFa inhibitor
therapy. In the GAIN trial, 325 patients who had either lost response or become
intolerant to infliximab (IFX) were randomized to recieve ADA induction therapy
or placebo. In this difficult-to-treat patient population, 21% achieved
remission and half demonstrated clinical benefit from ADA induction therapy.
Injection site reactions may occur with SC ADA (2-5% of patients), which are
generally less dramatic in nature than infusion reactions experienced with
intravenous IFX. Immunogenicity occurs with all monoclonal antibodies; however,
in the CD development program anti-ADA antibodies were detected at low rates
(0.7 and 2.6% of patients in the CLASSIC I and CLASSIC II studies,
respectively). Based on robust short- and long-term efficacy data from large
randomized controlled trials and a favorable safety signal, ADA has become a key
addition to the therapeutic armamentarium in the treatment of moderate-to-severe
CD