FDA顾问团称：总体而言对Enbrel的Ae报告比Remic
Because they are different, adverse events with one should not necessarily be expected for the other, said Miles Braun, director of the Division of Epidemiology in the FDA's Center for Biologics Evaluation and Research. When approved, both Enbrel and Remicade had precautions on infection risks in their labeling. Once on the market, infections, including TB, were reported to the FDA's MedWatch database, along with reports on multiple sclerosis, intestinal perforation, and malignancies, including aplastic anemia and lymphoma.
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In the years since approval, warnings have been added to both products' labels, with some events more clearly associated with Remicade and others with Enbrel. Remicade's new label will indicate that patients should be tested for TB before starting therapy and that the drug has been associated with opportunistic infections, sometimes fatal, including histoplasmosis, listeriosis, and pneumocystic carinii pneumonia.
Remicade has been associated more with TB, with 92 cases reported, according to the FDA. More than half were in Europe, and 77% were taking concomitant immunosuppressive therapy, a potential risk factor, noted FDA medical reviewer Jong-Hoon Lee. The reviewer estimated a TB incidence of 24 per 100,000 in the US for RA patients taking Remicade, and only 6 per 100,000 among RA patients in general.
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Jerry Boscia, vice president of clinical R&D for Centocor, said Remicade patients might be at higher risk for getting TB because they are also receiving methotrexate and immunosuppressive agents. He also said the data suggest that many of those who got TB did so early in Remicade therapy, indicating that the drug may have stimulated a latent infection.
He said TB risk is manageable as long as patients are tested for infection before starting therapy.
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Remicade was also associated with other infections. FDA had nine reports of histoplasmosis, 11 of listeriosis, and 10 of pneumocystic carinii pneumonia, said Lee. The new label for the drug states that in regions in which histoplasmosis is endemic, benefits and risks should be carefully weighed before starting Remicade.
FDA medical reviewer Jeffrey Siegel cited 14 cases of opportunistic infections reported for Enbrel patients, including 5 cases of pneumocystic carinii pneumonia. Four were taking concomitant methotrexate or corticosteroids, which he said might have increased infection risk.
, 百拇医药
Enbrel has been more closely associated than Remicade with new onset of multiple sclerosis, with 17 cases reported to the FDA so far. The company said an expert neurological panel it convened had found no positive link between Enbrel and MS, but had urged Immunex to closely monitor all reports.
There have been 18 cases of lymphoma reported to the agency for Enbrel, compared with 10 for Remicade. But Siegel said that the reported rate for both drugs--about 9 per 100,000--seems to be the same as that in the general population. However, he pointed out that there is underreporting to the FDA on all adverse events.
, 百拇医药
Both Immunex and Centocor, which is a Johnson & Johnson company, plan several prospective studies to further evaluate causes and incidence of infections and malignancies, and have also started registries to track patients taking their products. And both firms said they have hotlines for patients and physicians to report suspected adverse events.
The advisory panel on Friday commended the FDA and the manufacturers on their adverse event collection efforts and urged continued surveillance., http://www.100md.com
, http://www.100md.com
In the years since approval, warnings have been added to both products' labels, with some events more clearly associated with Remicade and others with Enbrel. Remicade's new label will indicate that patients should be tested for TB before starting therapy and that the drug has been associated with opportunistic infections, sometimes fatal, including histoplasmosis, listeriosis, and pneumocystic carinii pneumonia.
Remicade has been associated more with TB, with 92 cases reported, according to the FDA. More than half were in Europe, and 77% were taking concomitant immunosuppressive therapy, a potential risk factor, noted FDA medical reviewer Jong-Hoon Lee. The reviewer estimated a TB incidence of 24 per 100,000 in the US for RA patients taking Remicade, and only 6 per 100,000 among RA patients in general.
, 百拇医药
Jerry Boscia, vice president of clinical R&D for Centocor, said Remicade patients might be at higher risk for getting TB because they are also receiving methotrexate and immunosuppressive agents. He also said the data suggest that many of those who got TB did so early in Remicade therapy, indicating that the drug may have stimulated a latent infection.
He said TB risk is manageable as long as patients are tested for infection before starting therapy.
, http://www.100md.com
Remicade was also associated with other infections. FDA had nine reports of histoplasmosis, 11 of listeriosis, and 10 of pneumocystic carinii pneumonia, said Lee. The new label for the drug states that in regions in which histoplasmosis is endemic, benefits and risks should be carefully weighed before starting Remicade.
FDA medical reviewer Jeffrey Siegel cited 14 cases of opportunistic infections reported for Enbrel patients, including 5 cases of pneumocystic carinii pneumonia. Four were taking concomitant methotrexate or corticosteroids, which he said might have increased infection risk.
, 百拇医药
Enbrel has been more closely associated than Remicade with new onset of multiple sclerosis, with 17 cases reported to the FDA so far. The company said an expert neurological panel it convened had found no positive link between Enbrel and MS, but had urged Immunex to closely monitor all reports.
There have been 18 cases of lymphoma reported to the agency for Enbrel, compared with 10 for Remicade. But Siegel said that the reported rate for both drugs--about 9 per 100,000--seems to be the same as that in the general population. However, he pointed out that there is underreporting to the FDA on all adverse events.
, 百拇医药
Both Immunex and Centocor, which is a Johnson & Johnson company, plan several prospective studies to further evaluate causes and incidence of infections and malignancies, and have also started registries to track patients taking their products. And both firms said they have hotlines for patients and physicians to report suspected adverse events.
The advisory panel on Friday commended the FDA and the manufacturers on their adverse event collection efforts and urged continued surveillance., http://www.100md.com