ALPROLIX® offers acute bleed control your on-demand patients can trust, no matter their age1
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Most bleeding episodes resolved with just 1 infusion1-3: | ||
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Kids B-LONG: Aged 1-11 years |
B-LONG: Aged ≥12 years |
PUPs B-LONG: Aged <18 years |
| Response to first infusion was rated as excellent or good,* with abrupt or definite pain relief and/or improvement in signs of bleeding1,2,4: | ||
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Kids B-LONG: Aged 1-11 years |
B-LONG: Aged ≥12 years |
PUPs B-LONG: Aged <18 years |
In B-LONG, the median overall ABR for adults and adolescents treated on-demand was1: 17.69 (10.77-23.24)
*Seven first injections for bleeding episodes in children were not evaluated for response and are excluded from this analysis.1
Excellent response was defined as abrupt pain relief and/or improvement in signs of bleeding. Good response was defined as definite pain relief and/or improvement in signs of bleeding but possibly requiring another injection in 1-2 days.1,4
Clinical trial information
Kids B-LONG was a phase 3 open-label study that investigated the safety and efficacy of ALPROLIX in 30 previously treated pediatric patients with severe hemophilia B. Fifteen patients were 1 to 5 years of age; 15 patients were 6 to 11 years of age.1
B-LONG was a phase 3 open-label study that investigated the safety and efficacy of ALPROLIX in 123 previously treated adult and adolescent patients aged ≥12 years with severe hemophilia B. The study included a fixed-interval (weekly) arm (n=63), a fixed-dose (interval-adjusted) arm (n=29), an episodic (on-demand) arm (n=27), and a surgical arm (n=12).1
PUPs B-LONG was a phase 3 open-label study that investigated the safety and efficacy of ALPROLIX in 33 PUPs aged <18 years with moderate or severe hemophilia B (≤2% endogenous factor IX activity). At enrollment, the median age was 0.6 years (range: 0.1-2 years).3
ABR=annualized bleed rate; PUP=previously untreated patient.
Pediatric and adult/adolescent dosing targets for on-demand treatment and control of bleeding episodes1
ALPROLIX prophylaxis offers bleed and joint bleed protection1†
†ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.1
Indication
References: 1. ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc. 2. Nolan B, Klukowska A, Shapiro A, et al. Final results of PUPs B-LONG study: evaluating safety and efficacy of rFIXFc in previously untreated patients with hemophilia B. Poster presented at: The 28th Congress of the International Society on Thrombosis and Haemostasis (ISTH); July 12-14, 2020; Virtual. 3. Data on file. Waltham, MA: Bioverativ Therapeutics Inc. 4. Study to determine the safety and efficacy of rFIXFc in previously untreated males with severe hemophilia B (PUPs B-LONG). ClinicalTrials.gov identifier: NCT02234310. https://clinicaltrials.gov/ct2/show/NCT02234310. Updated March 25, 2022. Accessed October 26, 2022.
