Novartis Tries to Re-assure Elidel Users
Novartis AG said Monday that data from a long-term study of adult and pediatric patients with atopic dermatitis showed that the company's Elidel cream provided sustained control of symptoms associated with eczema. Richard Langley, Assistant Professor, Director of Research, Division of Dermatology, Dalhousie University, Canada, said, "This study provides encouraging news because one of the most unsettling aspects of eczema is the unpredictability of the condition.
What this study shows is that using Elidel to treat a flare-up at the onset of such symptoms as tingling or itching may enable patients to control flares and better manage their condition long-term." The objective of the multinational study was to evaluate the long-term safety and effectiveness of Elidel in pediatric and adult patients with eczema of any severity, who had previously completed a six-month 947-patient core study.
The extension study included 368 of those patients who remained in the study and were treated for up to 18 months. During the extension phase of the study, Elidel was incorporated as needed into patients' daily treatment routines - any time signs or symptoms returned, patients resumed twice-daily treatment, in effort to prevent progression.
In the core study, 79.6 percent of patients who had used Elidel twice daily experienced relief from the itching associated with mild to moderate eczema. These results were sustained for an additional six months in 75.3 percent of the patients who continued to be monitored in the extension study.
Novartis said also said that importantly, the quantity of Elidel used during the course of the study decreased from 3.3 grams per day at the end of the core study to 2.5 grams per day six months later, particularly in those patients who had the most severe eczema at the start of the study. The company said more than 75 percent of patients continued to rate their disease control as either "complete" or "good" at the end of the extension study. There were no unexpected safety findings.
The most common adverse events, occurring in 5 percent of patients or more, were infections, respiratory disorders, application-site conditions and headache. The overall incidence of viral infections was less than 1 percent, and treatment-related herpes simplex occurred in 4 patients or 1.1 percent of the study group.
Novartis noted that the incidence of adverse events decreased from the end of the core study to the end of the extension study. Currently, eczema affects up to 17 percent of the U.S. population.
Eczema is a term used to describe patchy, red, dry itchy and scaly skin, which, when severe, can bleed and/or crust over. Novartis' Elidel uses pimecrolimus, which is derived from a natural substance produced by the fungus Streptomyces hygroscopicus var. ascomyceticus, to selectively block the production and release of cytokines from T-cells. These cytokines in the skin cause the inflammation, redness and itching associated with eczema.
What this study shows is that using Elidel to treat a flare-up at the onset of such symptoms as tingling or itching may enable patients to control flares and better manage their condition long-term." The objective of the multinational study was to evaluate the long-term safety and effectiveness of Elidel in pediatric and adult patients with eczema of any severity, who had previously completed a six-month 947-patient core study.
The extension study included 368 of those patients who remained in the study and were treated for up to 18 months. During the extension phase of the study, Elidel was incorporated as needed into patients' daily treatment routines - any time signs or symptoms returned, patients resumed twice-daily treatment, in effort to prevent progression.
In the core study, 79.6 percent of patients who had used Elidel twice daily experienced relief from the itching associated with mild to moderate eczema. These results were sustained for an additional six months in 75.3 percent of the patients who continued to be monitored in the extension study.
Novartis said also said that importantly, the quantity of Elidel used during the course of the study decreased from 3.3 grams per day at the end of the core study to 2.5 grams per day six months later, particularly in those patients who had the most severe eczema at the start of the study. The company said more than 75 percent of patients continued to rate their disease control as either "complete" or "good" at the end of the extension study. There were no unexpected safety findings.
The most common adverse events, occurring in 5 percent of patients or more, were infections, respiratory disorders, application-site conditions and headache. The overall incidence of viral infections was less than 1 percent, and treatment-related herpes simplex occurred in 4 patients or 1.1 percent of the study group.
Novartis noted that the incidence of adverse events decreased from the end of the core study to the end of the extension study. Currently, eczema affects up to 17 percent of the U.S. population.
Eczema is a term used to describe patchy, red, dry itchy and scaly skin, which, when severe, can bleed and/or crust over. Novartis' Elidel uses pimecrolimus, which is derived from a natural substance produced by the fungus Streptomyces hygroscopicus var. ascomyceticus, to selectively block the production and release of cytokines from T-cells. These cytokines in the skin cause the inflammation, redness and itching associated with eczema.
posted by Madison @ 9:15 AM
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