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Results of the 30-week Phase III clinical trial for Remicade, the first monoclonal antibody being studied for use in treating rheumatoid arthritis, show a reduction in signs and symptoms of the condition by 52% in patients receiving the drug compared to 20% of those on placebo. Remicade is produced by San Diego-based Centocor.
All patients in the study had advanced disease. Those who received the 3 mg/kg infusion every eight weeks experienced comparable benefits to patients who received higher doses of the drug as measured by ACR 20, a standard assessment of disease activity and a primary endpoint of the study. ACR 20 represents a 20% reduction in the number of tender and swollen joint counts, as well as other criteria including physician and patient global assessments and a laboratory marker of inflammation and pain. Two other key assessments, ACR 50 and ACR 70, represent 50% and 70% reductions in these same benchmarks, respectively.
The study involved 428 patients in 34 clinical sites in North America and Europe. Patients were randomized to one of the following treatments: placebo and methotrexate infusion every four weeks; 3 mg/kg of Remicade and methotrexate infused every four weeks; 3 mg/kg of Remicade and methotrexate infused every eight weeks; 10 mg/kg of Remicade and methotrexate infused every four weeks; 10 mg/kg of Remicade and methotrexate infused every eight weeks.
The three mg/kg infusion every eight weeks provided optimal results in the trial, although consistent benefits were seen in all patient groups treated with Remicade compared to placebo. The majority of patients responding to treatment did so within two weeks of infusion, and virtually all responding patients (approximately 90%) did so within six weeks.
The most common adverse events included upper respiratory tract infection, headache, nausea, sinusitis, rash, and cough. There was no increased incidence of serious adverse events (11% with Remicade vs. 16% with placebo), or serious infections (4% with Remicade vs. 6% with placebo).
The trial will continue for another 18 months to evaluate the long-term use of Remicade in patients with rheumatoid arthritis. For additional information about Centocor and its products, visit their Web site, www.centocor.com.
Baton Rouge, LA-based Amedisys recently announced the completion of its acquisition of Columbia/HCA Home Care Operations in Alabama, Georgia, Louisiana, North Carolina, Oklahoma, and Tennessee. The $24 million agreement is expected to increase Amedisys annual home care revenues by $100 million to approximately $120 million.
A novel polymer coating from Rochester, NY-based STS Biopolymers has been shown to increase the ultrasound visibility of devices covered with the coating. The Echo-Coat surface coating increased image brightness by up to 10 times at angles up to 60 degrees. The coating is anticipated to enhance the visibility of biopsy and amniocentesis needles, stents, shunts, pacemaker leads, catheters, and guidewires.
Echo-Coat coatings are biocompatible and remain firmly attached to device surfaces. Devices treated with the coating can be sterilized and sorted for lengthy periods of time. For more information, visit the company’s Web site at www.stsduotek.com.
Boca Raton, FL-based biopharmaceutical company NABI recently filed an expanded access for its reformulated Hepatitis B Immune Globulin drug (human) for use in preventing reinfection of transplanted livers in chronic hepatitis B patients. The FDA’s expanded access program makes experimental drugs for use in treating life-threatening diseases such as hepatitis B more widely available to severely ill patients.
Recent studies conducted by clinicians at six transplant centers showed the drug provides the protective levels of antibody necessary to protect each patient’s new liver against recurrent hepatitis B disease. NABI Hepatitis B Immune Globulin was also well tolerated and could be infused over a short interval.
For additional information, visit the company’s Web site, www.nabi.com.
Skokie, IL-based Sabratek Corp. recently halted distribution of its Rocap flush product line following discussions with the Food and Drug Administration regarding the status of Rocap’s 510k submission filed in mid-1997. The halt in shipping is not the result of any quality, safety, or effectiveness problems with the product. It is uncertain when Sabratek will be able to resume shipments.