{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T12:44:21Z","timestamp":1790772261105,"version":"4.1.0"},"reference-count":32,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2023,10,24]],"date-time":"2023-10-24T00:00:00Z","timestamp":1698105600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004326","name":"Bayer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["European J of Haematology"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To assess effectiveness and safety of damoctocog alfa pegol in interim analyses of the ongoing real\u2010world hemophilia A HEM\u2010POWR study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>HEM\u2010POWR (NCT03932201) is a multinational Phase 4 prospective observational study. The primary objective was annualized bleeding rate (ABR) in previously treated patients (PTPs) with hemophilia A. Secondary objectives included adverse events and number of affected joints.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At data cut\u2010off (August 17, 2022), the safety analysis set included 268 patients and the full analysis set (FAS) included 161 patients. The most common dosing regimen during observation period was prophylaxis (FAS\u2009=\u2009158\/161, 98.1%) every 3\u20134\u2009days (twice weekly; FAS\u2009=\u200978\/158, 49.4%) and a median (min, max) infusion dose of 37.5 (10, 72) IU\/kg. PTPs receiving prophylactic damoctocog alfa pegol have fewer infusions compared with prior treatment. Median total ABR (Q1, Q3) was 0.0 (0.0, 1.8) and mean total ABR (SD) was 2.4 (8.2). The proportion of patients with no affected joints increased between initial visit and follow\u2010up. No FVIII inhibitors, treatment\u2010related adverse events, or deaths were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Damoctocog alfa pegol shows effectiveness and acceptable safety, as well as consistent utilization, in real\u2010world PTPs with hemophilia A, including in patients with non\u2010severe hemophilia and those with a history of inhibitors. Please see video for a summary of this study.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/ejh.14114","type":"journal-article","created":{"date-parts":[[2023,10,25]],"date-time":"2023-10-25T00:17:45Z","timestamp":1698193065000},"page":"286-295","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Interim analyses of the multinational real\u2010world prospective cohort\n                    <scp>HEM\u2010POWR<\/scp>\n                    study evaluating the effectiveness and safety of damoctocog alfa pegol in patients with hemophilia A"],"prefix":"10.1111","volume":"112","author":[{"given":"Mark T.","family":"Reding","sequence":"first","affiliation":[{"name":"Center for Bleeding and Clotting Disorders University of Minnesota Medical Center  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Teresa","family":"\u00c1lvarez\u2010Rom\u00e1n","sequence":"additional","affiliation":[{"name":"Thrombosis and Haemostasis Unit Hospital Universitario La Paz  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giancarlo","family":"Castaman","sequence":"additional","affiliation":[{"name":"Department of Oncology, Center for Bleeding Disorders and Coagulation Careggi University Hospital  Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maissaa","family":"Janbain","sequence":"additional","affiliation":[{"name":"Deming Department of Internal Medicine, Section of Hematology and Medical Oncology Tulane School of Medicine  New Orleans Louisiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadashi","family":"Matsushita","sequence":"additional","affiliation":[{"name":"Department of Transfusion Medicine Nagoya University Hospital  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karina","family":"Meijer","sequence":"additional","affiliation":[{"name":"Department of Hematology University Medical Center Groningen  Groningen Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathrin","family":"Schmidt","sequence":"additional","affiliation":[{"name":"OS Operations Bayer  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes","family":"Oldenburg","sequence":"additional","affiliation":[{"name":"Institute of Experimental Hematology and Transfusion Medicine, University Hospital Bonn, Medical Faculty University of Bonn  Bonn Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,10,24]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)61139-2"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.12887"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14046"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.18553\/jmcp.2020.20199"},{"issue":"2","key":"e_1_2_11_6_1","article-title":"Predicted FVIII consumption of BAY 94\u20139027 compared with standard\u2010and extended\u2010half\u2010life FVIII products in patients with severe hemophilia A [abstract]","volume":"5","author":"Solms ASA","year":"2021","journal-title":"Res Pract Thromb Haemost"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2516.9.s1.17.x"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2009-11-254755"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.12506"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13853"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.thromres.2019.08.023"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.13597"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13982"},{"key":"e_1_2_11_14_1","unstructured":"European Medicines Agency (EMA).Damoctocog alfa pegol (jivi): EU summary of product characteristics.2018https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/jivi-epar-product-information_en.pdf. 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