*ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.1
Pediatric Patients
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Adults and Adolescents
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Previously Untreated Patients (PUPs)
Pediatric Patients Aged 1-11 years
| Median overall ABR with ALPROLIX prophylaxis1 | |
| Patients aged 1 to 5 years: 1.09 (0-2.9) | Patients aged 6-11 years: 2.13 (0-4.17) |
| Median joint ABR with ALPROLIX prophylaxis1 | |
|
Patients aged 1 to 5 years: | Patients aged 6-11 years: 1.06 (0-2.09) |
| Median AsBR of ZERO1 | |
|
Patients aged 1 to 5 years: | Patients aged 6-11 years: 0 (0-2.09) |
| Media joint AsBR of ZERO2 | |
|
Patients aged 1 to 5 years: | Patients aged 6-11 years: 0 (0-1) |
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. All 30 patients were treated with ALPROLIX on an individualized prophylactic regimen. Fifteen patients were 1 to 5 years of age; 15 patients were 6 to 11 years of age.1
ALPROLIX is a flexible factor IX product for all dosing scenarios1
ALPROLIX has an established safety profile1
Adults and adolescents aged ≥12 years
ALPROLIX prophylaxis offers effective bleed protection* with tomorrow in mind
| Median overall ABR with ALPROLIX prophylaxis1 | |
| Interval-adjusted prophylaxis: 1.38 (0-3.43) | Weekly prophylaxis: 2.95 (1.01-4.35) |
| Median AsBR of ≤1 with ALPROLIX prophylaxis1 | |
| Interval-adjusted prophylaxis: 0.88 (0-2.3) | Weekly prophylaxis: 1.04 (0-2.19) |
Joint bleed protection* today for what tomorrow may bring
| Median joint ABR with ALPROLIX prophylaxis1 | |
| Interval-adjusted prophylaxis: 0.36 (0-3.24) | Weekly prophylaxis: 1.11 (0-4.01) |
| Median joint AsBR of ≤13 | |
| Interval-adjusted prophylaxis: 0 (0-1.7) | Weekly prophylaxis: 1 (0-2.1) |
*ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.1
Target joint resolution with ALPROLIX
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of adult and adolescent patients in B-YOND achieved target joint resolution4
- Target joints were resolved in 37/37 patients who had target joints at baseline in B-LONG4
- In our study, a target joint was defined as a major joint with ≥3 bleeding episodes in a consecutive 3-month period4,5
- Prior to enrollment in B-LONG, patients were on either an on-demand or prophylactic standard half-life (SHL) treatment regimen4
- In our study, target joint resolution was defined based on the ISTH subcommittee, which defines target joint resolution as ≤2 spontaneous bleeds in the target joint over 12 months4,5
- Patients had ≥12 months of consecutive follow-up and did not undergo joint surgery within 12 months of the start of follow-up4,5
Clinical trial information
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
B-YOND was an extension trial that studied the long-term safety and efficacy of ALPROLIX in 120 adult, adolescent, and pediatric patients previously treated in Kids B-LONG or B-LONG. The study included a fixed-interval arm (n=74), a fixed-dose arm (n=36), a modified prophylaxis arm (n=17), and an episodic (on-demand) arm (n=15).6
ALPROLIX is a flexible factor IX product for all dosing scenarios1
ALPROLIX has an established safety profile1
Previously untreated patients (PUPs) aged <18 years
| ALPROLIX prophylaxis offers protection* for PUPs today and tomorrow7 | |
| Median overall ABR: 1.24 (0-2.49) | Median traumatic ABR: 0.91 (0-1.8) |
| Spontaneous bleed rates of ZERO7 | |
| Median AsBR: 0 (0-0) | Median joint AsBR: 0 (0-0) |
*ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.1
Clinical trial information
PUPs B-LONG was a phase 3 open-label study that investigated the safety and efficacy of ALPROLIX in 33 previously untreated patients with moderate or severe hemophilia B (≤2% endogenous factor IX activity). Twenty-eight patients completed the study in the prophylaxis arm and 5 patients completed the study in the on-demand arm. At enrollment, the median age was 0.6 years (range: 0.1-2 years).7
Indication
ABR=annualized bleed rate; AsBR=annualized spontaneous bleed rate.
References: 1. ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc. 2. Fischer K, Kulkarni R, Nolan B, et al. Recombinant factor IX Fc fusion protein in children with haemophilia B (Kids B-LONG): results from a multicentre, non-randomised phase 3 study. Lancet Haematol. 2017;4(2):e75-e82. 3. Powell JS, Pasi KJ, Ragni MV, et al. Phase 3 study of recombinant factor IX Fc fusion protein in hemophilia B. N Engl J Med. 2013;369(24):2313-2323. 4. Data on file. Waltham, MA; Bioverativ Therapeutics Inc. 5. Blanchette VS, Key NS, Ljung LR, et al. Definitions in hemophilia: communication from the SSC of the ISTH. J Thromb Haemost. 2014;12(11):1935-1939. 6. Pasi KJ, Fischer K, Ragni M, et al. Long-term safety and sustained efficacy for up to 5 years of treatment with recombinant factor IX Fc fusion protein in subjects with haemophilia B: results from the B-YOND extension study. Haemophilia. 2020;26(6):e262-e271. 7. 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.
