נוגדנים לטיפול באוסטאופורוזיס יעילים במניעת שברים בשלד העצמות

אוסטאופורוזיס, צפיפות נמוכה של סידן ברקמת העצם, היא בעיה שכיחה בעיקר בנשים בגיל הבלות ואחראית להופעת שברים בשלד העצמות. בארצות הברית 30% מהנשים בגיל הבלות סובלות מהמחלה ולפחות 40% מהן תפתחנה שברים במהלך חייהן. בגברים, שכיחות הבעיה והשברים נמוכה יותר (15-30%).

בעשור האחרון חל מהפך רבתי בטיפול באוסטאופורוזיס עם כניסתן של תרופות הבולמות את התהליכים שפוגעים בצפיפות העצם ואף תרופות הגורמות למהפך בצפיפות, ולו גם לפרק זמן מוגבל, ומשרות עליה בצפיפות.

לפני כשנה (26.9.16) העליתי פוסט שדן בנוגדנים המיוצרים על ידי חברת אמגן (Amgen), תחת השם רומוסוצומב, שבולמים את תהליך פירוק העצם ובנסויים ראשוניים בבני אדם צמצמו את הופעת השברים בחוליות עמוד השדרה ב 73%. השבוע פורסם בעיתון NEJM מחקר המשווה זה בצד זה את השפעת רומוסוצומב לתרופה אלנדרונאט שמאיטה גם היא את תהליך פירוק העצם (התרופה משווקת בארץ תחת השמות פוסלן, מקסיבון, טבענט ופוסאוונס). המחקר כלל 4093 נשים בגיל הבלות הסובלות מאוסטאופורוזיס ולקו בשברים בעצמות. הנשים חולקו לשתי קבוצות: קבוצה אחת טופלה במשך שנתיים באלנדרונאט בלבד והקבוצה השניה טופלה במשך שנה אחת ברומוסוצומב ובמשך שנה נוספת באלנדרונאט. שתי הקבוצות היו במעקב המחקר במשך 2.7 שנים. החוקרים מצאו כי בהשוואה לנשים שטופלו במשך שנתיים באלנדרונאט בלבד הסיכון לשברים בעמוד השדרה בנשים שטופלו ברומוסוצומב היה נמוך ב 48%, הסיכון לשברים שאינם בעמוד השדרה היה נמוך ב  19% והסיכון לשברים בצוואר הירך היה נמוך ב 38%. לעומת זאת, שכיחותם של אירועים קרדיווסקולריים (כמו למשל אוטמים בשריר הלב) היו שכיחים יותר בקבוצה שטופלה ברומוסוצומב. שאר תופעות הלוואי היו דומות בשתי הקבוצות.

לסיכום, נראה כי בנשים בגיל הבלות הסובלות מאוסטאופורוזיס ונמצאות בסיכון גבוה להתפתחות שברים בשלד (וסיכון נמוך להתפתחות מחלות קרדיווסקולריות) טיפול ברומוסוצומב במשך שנה מצמצם באופן משמעותי את הסיכון להופעת שברים בשלד.  נותר לברר אם רשות התרופות והמזון האמריקאית  תאשר את הטיפול ברומוסוצומב לטיפול באוסטאופורוזיס, מדוע רומוסוצומב מגדיל את הסיכון למחלות קרדיווסקולריות ומה תהיה עלות הטיפול.

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