פרוליה ותופעות לוואי לאישה בת 92

שלום,
אישה בת 92 אמורה להתחיל טיפול בפרוליה. בעבר היא סבלה 3 פעמים מדלקות בלבלב. קראתי שאנשים עם נטייה כזו עלולים לסבול מתופעת לוואי זו . האם רצוי להימנע מטיפול בפרוליה?

Tom Brody, in FDA's Drug Review Process and the Package Label, 2018

iii Denosumab (Osteoporosis in Postmenopausal Women) BLA 125-320
The relatedness analysis attributed the AEs to the concomitant disease of pancreatitis

Denosumab is an antibody for treating osteoporosis, the antibody that binds to RANKL (RANK ligand). FDA’s relatedness analysis concerned the AEs of pancreatitis and dermatological AEs. FDA’s relatedness analysis of pancreatitis established that this AE was not due to denosumab but was instead due to the fact that the study subjects were already at risk for pancreatitis. For help in relatedness analysis, the Sponsor chose to consult a team of experts (FDA’s Division of Dermatology and Dental Products).

Regarding pancreatitis, FDA’s Medical Review observed, “Pancreatitis. In trial 20030216, there was an imbalance in events of pancreatitis in subjects randomized to denosumab. A total of 4 subjects in the placebo group, and 8 subjects in the denosumab group reported an event of pancreatitis. … [m]any of these subjects had underlying risk factors for pancreatitis … [t]he temporal relationship between duration of denosumab exposure and the development of pancreatitis is highly variable. In addition, most cases in the denosumab group were confounded by prior episodes of pancreatitis or risk factors for the development of pancreatitis.78

תודה.