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    Home > Active Ingredient News > Drugs Articles > NEJM: GSK anti-inflammatory drug nucala has a significant effect on eosinophilic granulomatous vasculitis (egpa)

    NEJM: GSK anti-inflammatory drug nucala has a significant effect on eosinophilic granulomatous vasculitis (egpa)

    • Last Update: 2017-05-22
    • Source: Internet
    • Author: User
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    Source: CFDA 2017-05-22 GSK, a British pharmaceutical giant, recently announced that the positive data of a key phase III clinical study (mea115921) on the treatment of recurrent and refractory eosinophilic granulomatous vasculitis (egpa) with anti-IL-5 monoclonal anti-inflammatory drug nucala (mepolizumab) has been published online in the New England Journal of Medicine (NEJM) GSK, a British pharmaceutical giant, recently announced that the positive data of a key phase III clinical study (mea115921) on the treatment of recurrent and refractory eosinophilic granulomatous vasculitis (egpa) with anti-IL-5 monoclonal anti-inflammatory drug nucala (mepolizumab) has been published online in the New England Journal of Medicine (NEJM) The study was carried out by GlaxoSmithKline in collaboration with the National Institute of allergy and infectious diseases (NIAID), a subsidiary of the National Institutes of Health (NIH) It is the first randomized, double-blind, placebo-controlled study ever conducted among egpa patients A total of 136 patients with recurrent or refractory egpa undergoing standard care (including background corticosteroid therapy [with or without immunosuppression therapy]) were enrolled in the study The purpose of the study was to investigate the efficacy and safety of 300 mg of mepolizumab (once every 4 weeks, subcutaneous injection) compared with placebo during the 52 week treatment period The common primary end point of the study was the total duration of remission and the proportion of patients who achieved sustained remission In addition, the study included six secondary endpoints to assess relapse, remission, and glucocorticoid use, all of which were considered clinically relevant for egpa patients The data showed that the study reached the common primary endpoint and all secondary endpoints The detailed data are as follows: (1) during the 52 week treatment period, mepolizumab group achieved significantly longer cumulative remission time compared with placebo group (remission defined as prednisolone / prednisone dose ≤ 4mg / day, Birmingham vasculitis score [bvas] = 0) (2) The proportion of patients who achieved continuous remission for at least 24 weeks in the mepolizumab group was significantly higher than that in the placebo group (28% [22 / 68] vs 3% [2 / 68], P < 0.001); (3) the proportion of patients who achieved remission at 36 and 48 weeks in the mepolizumab group was significantly higher than that in the placebo group (32% [22 / 68] vs 3% [2 / 68], P < 0.001); (4) The proportion of patients who achieved remission in the first 24 weeks and maintained remission until the 52nd week was significantly higher in the mepolizumab group than in the placebo group (19% vs 1%, P = 0.007) (5) Within 52 weeks of treatment, the time of the first recurrence event was significantly delayed in the mepolizumab group (P < 0.001), and the time of the first major recurrence event was significantly delayed in the mepolizumab group (P = 0.042) (6) During the 48-52 weeks of treatment, the mean dose of prednisolone / prednisone in mepolizumab group was significantly reduced, and the proportion of patients whose dose was reduced to ≤ 4mg / day was significantly higher (44% vs 7%, P < 0.001) (7) The proportion of patients who did not meet the remission goals defined by the study was significantly lower in the mepolizumab group (47% vs 81%) (8) In terms of the annual recurrence rate, about half of the patients in the mepolizumab group relapsed, but the annual recurrence rate was 50% lower than that in the placebo group (1.14% vs 2.27%) (9) In terms of safety, there was no significant difference in the incidence of treatment-related adverse events between the mepolizumab group and placebo group (97% vs 94%) The overall situation of adverse events was similar to the previous study, and no new safety signals were observed The incidence of serious adverse events in the mepolizumab group was lower than that in the placebo group (18% vs 26%), and the most common serious adverse event was the deterioration or aggravation of asthma (3% vs 6%) The incidence of mepolizumab was higher than that of placebo group One patient in the mepolizumab group died and was not considered to be related to the study medication EPGA, known as church Strauss syndrome, is a rare systemic inflammatory disease characterized by extensive inflammation of the inner wall of small blood vessels (vasculitis), which can involve multiple organs, including the heart, lung, skin, gastrointestinal tract, kidney and nervous system Clinically, one of the main goals of egpa treatment is to induce and maintain remission while reducing the use of glucocorticoids and other immunosuppressive therapies Mepolizumab (mepolizumab) is a humanized monoclonal antibody, which specifically targets interleukin-5 (IL-5) IL-5 is a kind of cytokines, which can regulate the growth, activation and survival of eosinophils (leukocytes), and provide important signals for the migration of eosinophils from bone marrow to lung and other organs Nucala binds to human IL-5 and blocks the binding of IL-5 to eosinophil surface receptors In this way, inhibiting the binding of IL-5 to receptor can reduce the level of eosinophils in blood, tissue and sputum, which in turn can reduce the inflammation mediated by eosinophils At present, mepolizumab is in a number of clinical projects to investigate the treatment of chronic obstructive pulmonary disease, severe eosinophilic asthma, eosinophilic granulomatous polyangitis (egpa) In the United States and the European Union, mepolizumab was approved at the end of 2015 as an additional therapy for patients with severe refractory eosinophilic asthma under the brand name of nucala This approval makes nucala the first biotherapy targeting interleukin-5 (IL-5) in the world and the first IL-5 monoclonal antibody approved for the treatment of severe eosinophilic asthma.
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