de tuinman schreef op 5 juni 2018 15:18:
In this study, the safety profile of upadacitinib was consistent with previously reported results from the other SELECT trials in rheumatoid arthritis.1-8 No new safety signals were detected.1
Through week 24, serious adverse events occurred in 5/6 percent of patients in the 15 mg/30 mg upadacitinib groups, respectively, compared to 4 percent in the methotrexate group.1 Serious infections occurred in 2/3 percent of patients in the 15 mg/30 mg upadacitinib groups, respectively, compared to 1 percent in the methotrexate group.1
There were six deaths through week 24, three of which were major adverse cardiovascular events (MACE) with one in each treatment group (methotrexate, 15 mg upadacitinib and 30 mg upadacitinib, respectively).1
There was one death in the 15 mg upadacitinib group due to metastatic malignant melanoma in a patient with a history of melanoma prior to study entry, and two deaths in the 30 mg upadacitinib group, one due to pneumonia and sepsis and another due to peritonitis.1 There were four MACE, including the three fatal events mentioned above.1 One additional non-fatal MACE in the 30 mg upadacitinib group was reported.1 There were two cases of adjudicated venous thromboembolic events (VTE) in the study, one pulmonary embolism in the methotrexate group, one deep vein thrombosis in the 30 mg upadacitinib group and none in the 15 mg upadacitinib group.1
To date, across the SELECT rheumatoid arthritis program (with more than 3,300 patient years of exposure to upadacitinib) t
he rates of VTEs in both the placebo-controlled and extension periods remain consistent with the background rate in the rheumatoid arthritis patient population.1-5,23-25Als ik dit lees denk ik, wat is Upa voor een troep. Maar de studie is natuurlijk over een enorme hoeveelheid mensen.
Heeft iemand hier meer kennis van? Zijn dit acceptabele uitslagen voor Upa?