FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2920241918> ?p ?o ?g. }

• W2920241918 endingPage "1192" @default.
• W2920241918 startingPage "1192" @default.
• W2920241918 abstract "Abstract Introduction: Prophylactic replacement of coagulation factor VIII (FVIII) is the standard of care in hemophilia A, given its natural mechanism of action, strict homeostatic regulation, and consistent safety profile. Recombinant FVIII Fc fusion protein (rFVIIIFc) is an extended half-life therapy that demonstrated safety and efficacy in previously treated pediatric, adolescent, and adult subjects with severe hemophilia A in the Phase 3 A-LONG and Kids A-LONG trials (NCT01181128 and NCT01458106, respectively) (Young et al, J Thromb Haemostas, 2015; Mahlangu et al, Blood, 2014). Herein, the final results are reported from ASPIRE (NCT01454739), the long-term extension trial of those 2 studies. Methods: This was an open-label, multicenter, long-term trial of previously treated subjects of all ages with severe hemophilia A. Subjects received 1 of the 4 following regimens: individualized prophylaxis (IP; rFVIIIFc 25‒60 IU/kg every 3-5 days, or twice weekly), weekly prophylaxis (WP; rFVIIIFc 65 IU/kg every 7 days), modified prophylaxis (MP; personalized dosing), or episodic treatment (ET; on-demand dosing based on bleeding episodes). Subjects <12 years of age were eligible for only IP or MP. Investigators could switch a subject's treatment group at any time; therefore, each subject may appear in >1 treatment group. The primary endpoint was development of inhibitors. Secondary endpoints included annualized bleeding rates (ABRs), joint ABRs, spontaneous joint ABRs, exposure days (ED), and factor consumption. Descriptive statistics were used for analysis. Analyses were performed separately based on parent study. Results: A total of 211 subjects (150 were from A-LONG and 61 were from Kids A-LONG) enrolled in ASPIRE, and 186 subjects (132 from A-LONG and 54 from Kids A-LONG) completed the study. Subjects from Kids A-LONG had a median (range) age of 6.0 (2-12) years. Of the subjects from the A-LONG study enrolled to ASPIRE, the median (range) age was 31.0 (13-66) years. Most subjects received IP regardless of parent study (Kids A-LONG: IP [n=59], MP [n=3]; A-LONG: IP [n=110], WP [n=27], MP [n=21], ET [n=13]). No inhibitors were observed throughout the study, and the overall safety profile of rFVIIIFc was consistent with the parent studies and prior interim analyses. ABRs remained low throughout the entirety of ASPIRE in subjects prescribed IP (Table 1). For subjects from the Kids A-LONG study, the median (range) number of ED during ASPIRE was 332.0 (18.0-467.0) days. Total median (range) treatment duration was 166.6 (14.4-203.0) weeks. The median (range) number of ED for A-LONG subjects was 267.5 (8.0-660.0) days. Total median treatment duration was 201.4 (5.1-274.6) weeks. Overall, the median (range) duration of treatment with rFVIIIFc was 4.1 (0.4, 5.9) years. From the end of the parent study to the end of ASPIRE, the rFVIIIFc dosing interval increased for 6.6% and 21.1% of subjects from Kids A-LONG and A-LONG, respectively (Table 2). There was no change in median weekly factor consumption from the end of either parent study to the end of ASPIRE. For subjects from Kids A-LONG, the median (IQR) was 0.0 (0.0‒3.2), while the median (IQR) for those from A-LONG was 0.0 (0.0‒0.0). Conclusions: Throughout up to 4 years of treatment with rFVIIIFc in the ASPIRE extension study, no inhibitors were reported, and low ABRs and extended dosing intervals were sustained. These data are consistent with the well-characterized safety profile and durable efficacy of rFVIIIFc prophylaxis in previously treated subjects of all ages with hemophilia A. Disclosures Nolan: Bayer: Research Funding; CSL Behring: Research Funding; Sobi: Research Funding. Mahlangu:Sanofi: Research Funding, Speakers Bureau; Roche: Consultancy, Research Funding, Speakers Bureau; Alnylam: Consultancy, Research Funding, Speakers Bureau; Bayer: Research Funding; Biogen: Research Funding, Speakers Bureau; Chugai: Consultancy; Catalyst Biosciences: Consultancy, Research Funding; Amgen: Consultancy; Biomarin: Research Funding, Speakers Bureau; CSL Behring: Consultancy, Research Funding, Speakers Bureau; NovoNordisk: Consultancy, Research Funding, Speakers Bureau; LFB: Consultancy; Shire: Consultancy, Research Funding, Speakers Bureau; Sobi: Research Funding, Speakers Bureau; Spark: Consultancy, Research Funding. Young:Bayer: Consultancy; Bioverativ: Consultancy, Honoraria; Kedrion: Consultancy; Novo Nordisk: Consultancy, Honoraria; CSL Behring: Consultancy, Honoraria; Genentech/Roche: Consultancy, Honoraria; Shire: Consultancy, Honoraria. Konkle:Sangamo: Research Funding; Gilead: Consultancy; Spark: Consultancy, Research Funding; BioMarin: Consultancy; CSL Behring: Consultancy; Genentech: Consultancy; Bioverativ: Research Funding; Pfizer: Research Funding; Shire: Research Funding. Pasi:Shire: Speakers Bureau; Alnylam: Honoraria, Research Funding; Bayer: Speakers Bureau; Octapharma: Honoraria; Pfizer: Speakers Bureau; Biomarin: Honoraria, Research Funding; Sobi: Honoraria; Bioverativ: Honoraria, Research Funding; NovoNordisk: Speakers Bureau; Catalyst Bio: Honoraria; Apcintex: Honoraria. Oldenburg:Novo Nordisk: Honoraria, Research Funding; Chugai: Honoraria, Research Funding; Roche: Honoraria, Research Funding; Biotest: Honoraria, Research Funding; Biogen: Honoraria, Research Funding; Shire: Honoraria, Research Funding; Grifols: Honoraria, Research Funding; Bayer: Consultancy, Honoraria, Research Funding; Octapharma: Honoraria, Research Funding; CSL Behring: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Swedish Orphan Biovitrum: Honoraria, Research Funding. Nogami:Chugai Pharmaceutical Co., Ltd: Consultancy, Membership on an entity's Board of Directors or advisory committees, Patents & Royalties: Anti-FIXa/X bispecific antibodies , Research Funding, Speakers Bureau. Tripkovic:Sobi: Employment. Rudin:Bioverativ: Employment, Equity Ownership." @default.
• W2920241918 created "2019-03-11" @default.
• W2920241918 creator A5004338432 @default.
• W2920241918 creator A5008757028 @default.
• W2920241918 creator A5014530935 @default.
• W2920241918 creator A5037461534 @default.
• W2920241918 creator A5039315652 @default.
• W2920241918 creator A5058639047 @default.
• W2920241918 creator A5069063909 @default.
• W2920241918 creator A5070826588 @default.
• W2920241918 creator A5079861916 @default.
• W2920241918 creator A5087552786 @default.
• W2920241918 date "2018-11-29" @default.
• W2920241918 modified "2023-09-29" @default.
• W2920241918 title "ASPIRE Final Results Confirm Established Safety and Sustained Efficacy for Up to 4 Years of Treatment With rFVIIIFc in Previously Treated Subjects With Severe Hemophilia A" @default.
• W2920241918 doi "https://doi.org/10.1182/blood-2018-99-118586" @default.
• W2920241918 hasPublicationYear "2018" @default.
• W2920241918 type Work @default.
• W2920241918 sameAs 2920241918 @default.
• W2920241918 citedByCount "5" @default.
• W2920241918 countsByYear W29202419182019 @default.
• W2920241918 countsByYear W29202419182020 @default.
• W2920241918 countsByYear W29202419182021 @default.
• W2920241918 crossrefType "journal-article" @default.
• W2920241918 hasAuthorship W2920241918A5004338432 @default.
• W2920241918 hasAuthorship W2920241918A5008757028 @default.
• W2920241918 hasAuthorship W2920241918A5014530935 @default.
• W2920241918 hasAuthorship W2920241918A5037461534 @default.
• W2920241918 hasAuthorship W2920241918A5039315652 @default.
• W2920241918 hasAuthorship W2920241918A5058639047 @default.
• W2920241918 hasAuthorship W2920241918A5069063909 @default.
• W2920241918 hasAuthorship W2920241918A5070826588 @default.
• W2920241918 hasAuthorship W2920241918A5079861916 @default.
• W2920241918 hasAuthorship W2920241918A5087552786 @default.
• W2920241918 hasBestOaLocation W29202419181 @default.
• W2920241918 hasConcept C126322002 @default.
• W2920241918 hasConcept C187212893 @default.
• W2920241918 hasConcept C197934379 @default.
• W2920241918 hasConcept C203092338 @default.
• W2920241918 hasConcept C2777288759 @default.
• W2920241918 hasConcept C535046627 @default.
• W2920241918 hasConcept C71924100 @default.
• W2920241918 hasConceptScore W2920241918C126322002 @default.
• W2920241918 hasConceptScore W2920241918C187212893 @default.
• W2920241918 hasConceptScore W2920241918C197934379 @default.
• W2920241918 hasConceptScore W2920241918C203092338 @default.
• W2920241918 hasConceptScore W2920241918C2777288759 @default.
• W2920241918 hasConceptScore W2920241918C535046627 @default.
• W2920241918 hasConceptScore W2920241918C71924100 @default.
• W2920241918 hasIssue "Supplement 1" @default.
• W2920241918 hasLocation W29202419181 @default.
• W2920241918 hasOpenAccess W2920241918 @default.
• W2920241918 hasPrimaryLocation W29202419181 @default.
• W2920241918 hasRelatedWork W1966541007 @default.
• W2920241918 hasRelatedWork W1994361489 @default.
• W2920241918 hasRelatedWork W2078175780 @default.
• W2920241918 hasRelatedWork W2087566648 @default.
• W2920241918 hasRelatedWork W2374781999 @default.
• W2920241918 hasRelatedWork W2409957712 @default.
• W2920241918 hasRelatedWork W2527805684 @default.
• W2920241918 hasRelatedWork W2947337648 @default.
• W2920241918 hasRelatedWork W3047195474 @default.
• W2920241918 hasRelatedWork W4322724425 @default.
• W2920241918 hasVolume "132" @default.
• W2920241918 isParatext "false" @default.
• W2920241918 isRetracted "false" @default.
• W2920241918 magId "2920241918" @default.
• W2920241918 workType "article" @default.