בהודעה לעיתונות מדווחת חברת אוונטיס פרמצ’ שהתכשיר Arava שלו התווייה מאושרת לדלקת פרקים שגרונית (RA ) מאז 1998, הוכיח יעילות קלינית בטיפול בדלקת פרקים פסוריאטית (PsA ), ואושרה ע”י ה-EU להתוויה זו. Arava הוא הטיפול הפומי הראשון המאושר מקבוצת ה-DMARD לאינדיקציה זו.
האישור להתוויה ניתן בעקבות מחקר ה-TOPAS שבו הוכחה יעילות גבוהה לטיפול זה. ע”פ הודעכת אוונטיס התכשיר הוכיח גם יחס עלות/תועלת מצויין בטיפול זה, דבר שהופך את ה-Arava , לדברי החברה למועמד מרכזי לטיפול ב-PsA .
הנה לשון ההודעה כפי שהועברה אלינו ע”י אוונטיס:
The proven treatment of rheumatoid arthritis, marketed since 1998, also demonstrated efficacy in psoriatic arthritis. Arava is the first oral disease modifying anti-rheumatic drug (DMARD) therapy approved in this indication by the European Commission.
Aventis Europe Press Release
Strasbourg, France, June 23, 2004 Aventis today announced that the European Commission approved a new indication for Arava (leflunomide): the treatment of adult patients with active psoriatic arthritis (PsA).
Results of clinical studies (pivotal study: TOPAS) demonstrate Arava alone provides decisive advantages in the treatment of PsA: The product is highly effective in moderating joint and skin symptoms and therefore significantly improves patients quality of life. explains Gilles Brisson, Head of Aventis Europe, Moreover the product is well tolerated, easy to use, due to its oral administration route, and cost-effective. These characteristics, make Arava a major treatment option for patients with PsA.
Psoriatic arthritis is a potentially disabling inflammatory disease that affects up to 30% of patients with psoriasis, a skin condition found in about 13% of the population. PsA is most probably under diagnosed; therefore the true prevalence may be higher. PsA is associated with significant disability, reducing quality of life and increased mortality. Approved and effective treatment options for patients with PsA are limited. Classic agents used to treat joint symptoms often do little to improve skin lesions and vice versa.
PsA and psoriasis are accompanied by a significant disease burden, affecting both health-related and emotional aspects of a patients life. Accordingly, improving quality of life is a critical goal for therapeutic agents used to treat PsA. Arava demonstrated significant improvements compared to placebo both in functional status and in skin-related quality of life. The Dermatological Life Quality Index in Arava patients lead to an improvement of skin related quality of life of 24% as compared to the index for psoriatic patients in general.
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