19 research outputs found
Rapid And Durable Responses With The Syk/Jak Inhibitor Cerdulatinib In A Phase 2 Study In Relapsed/Refractory Follicular Lymphoma—Alone Or In Combination With Rituximab
Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/149541/1/hon30_2629.pd
199 Efficacy and Safety With Andexanet Alfa in Traumatic Intracranial Hemorrhage: An ANNEXA-4 Substudy
Autosomal recessive chronic granulomatous disease caused by novel mutations in NCF-2 , the gene encoding the p67- phox component of phagocyte NADPH oxidase
Autosomal recessive chronic granulomatous disease caused by novel mutations in NCF-2, the gene encoding the p67-phox component of phagocyte NADPH oxidase
Solubilization of the NADPH-Oxidase from Bone Marrow Derived Macrophages by Dialkylphospholipid and Purification by HPLC-Anion Exchange Chromatography
Myeloid haemopoietic cells of patients with chronic granulomatous disease are relatively resistant to TNF
Hemostatic Efficacy and Anti-FXa (Factor Xa) Reversal With Andexanet Alfa in Intracranial Hemorrhage: ANNEXA-4 Substudy
BACKGROUND AND PURPOSE: Andexanet alfa is a recombinant modified human FXa (factor Xa) developed to reverse FXa inhibition from anticoagulants. Hemostatic efficacy and reversal of anti-FXa activity with andexanet were assessed in patients from the ANNEXA-4 study (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of FXa Inhibitors) with intracranial hemorrhage (ICrH). METHODS: ANNEXA-4 was a single-arm study evaluating andexanet in patients presenting with major bleeding ≤18 hours after taking an FXa inhibitor. Patients received a bolus plus 2-hour infusion of andexanet. Brain imaging in patients with ICrH was performed at baseline and at 1 and 12 hours postandexanet infusion. Coprimary efficacy outcomes were change in anti-FXa activity and hemostatic efficacy at 12 hours (excellent/good efficacy defined as ≤35% increase in hemorrhage volume/thickness). Safety outcomes included occurrence of thrombotic events and death at 30 days. RESULTS: A total of 227 patients with ICrH were included in the safety population (51.5% male; mean age 79.3 years) and 171 in the efficacy population (99 spontaneous and 72 traumatic bleeds). In efficacy evaluable patients, excellent/good hemostasis 12 hours postandexanet occurred in 77 out of 98 (78.6%) and in 58 out of 70 (82.9%) patients with spontaneous and traumatic bleeding, respectively. In the subanalysis by FXa inhibitor treatment group in the efficacy population, median of percent change in anti-FXa from baseline to nadir showed a decrease of 93.8% for apixaban-treated patients (n=99) and by 92.6% for rivaroxaban-treated patients (n=59). Within 30 days, death occurred in 34 out of 227 (15.0%) patients and thrombotic events occurred in 21 out of 227 (9.3%) patients (safety population). CONCLUSIONS: Andexanet reduced anti-FXa activity in FXa inhibitor-treated patients with ICrH, with a high rate of hemostatic efficacy. Andexanet may substantially benefit patients with ICrH, the most serious complication of anticoagulation. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02329327