Multicentre, randomized, open-label study of on-demand treatment with two prophylaxis regimens of recombinant coagulation factor IX in haemophilia B subjects
Summary Few randomized studies have reported on the use of factor IX (FIX) for secondary prophylaxis in haemophilia B patients. This study aimed to evaluate the efficacy and safety of two secondary prophylaxis regimens of recombinant coagulation FIX, nonacog alfa, compared with on‐demand therapy. Ma...
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| Published in | Haemophilia : the official journal of the World Federation of Hemophilia Vol. 20; no. 3; pp. 398 - 406 |
|---|---|
| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Blackwell Publishing Ltd
01.05.2014
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1351-8216 1365-2516 1365-2516 |
| DOI | 10.1111/hae.12344 |
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| Abstract | Summary
Few randomized studies have reported on the use of factor IX (FIX) for secondary prophylaxis in haemophilia B patients. This study aimed to evaluate the efficacy and safety of two secondary prophylaxis regimens of recombinant coagulation FIX, nonacog alfa, compared with on‐demand therapy. Male subjects aged 6–65 years with severe or moderately severe haemophilia B (FIX:C ≤ 2, n = 50) and ≥12 bleeding episodes (including ≥6 haemarthroses episodes) within 12 months of study participation were enrolled in this multicentre, randomized, open‐label, four‐period crossover trial. The primary measure was the annualized bleeding rate (ABR) of two prophylactic regimens vs. on‐demand therapy. In the intent‐to‐treat group, mean ABR values were 35.1, 2.6 and 4.6 for the first on‐demand period, the 50 IU kg−1 twice‐weekly period, and the 100 IU kg−1 once‐weekly period respectively. Differences in ABR between the first on‐demand period and both prophylaxis regimens were significant (P < 0.0001); no significant differences were observed between prophylaxis regimens (P = 0.22). Seven serious adverse events occurred in five subjects, none related to study drug. Results demonstrated that secondary prophylaxis therapy with nonacog alfa 50 IU kg−1 twice weekly or 100 IU kg−1 once weekly reduced ABR by 89.4% relative to on‐demand treatment. Both prophylaxis regimens demonstrated favourable safety profiles in subjects with haemophilia B. |
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| AbstractList | Few randomized studies have reported on the use of factor IX (FIX) for secondary prophylaxis in haemophilia B patients. This study aimed to evaluate the efficacy and safety of two secondary prophylaxis regimens of recombinant coagulation FIX, nonacog alfa, compared with on-demand therapy. Male subjects aged 6-65 years with severe or moderately severe haemophilia B (FIX:C less than or equal to 2, n = 50) and greater than or equal to 12 bleeding episodes (including greater than or equal to 6 haemarthroses episodes) within 12 months of study participation were enrolled in this multicentre, randomized, open-label, four-period crossover trial. The primary measure was the annualized bleeding rate (ABR) of two prophylactic regimens vs. on-demand therapy. In the intent-to-treat group, mean ABR values were 35.1, 2.6 and 4.6 for the first on-demand period, the 50 IU kg-1 twice-weekly period, and the 100 IU kg-1 once-weekly period respectively. Differences in ABR between the first on-demand period and both prophylaxis regimens were significant (P<0.0001); no significant differences were observed between prophylaxis regimens (P =0.22). Seven serious adverse events occurred in five subjects, none related to study drug. Results demonstrated that secondary prophylaxis therapy with nonacog alfa 50 IU kg-1 twice weekly or 100 IU kg-1 once weekly reduced ABR by 89.4% relative to on-demand treatment. Both prophylaxis regimens demonstrated favourable safety profiles in subjects with haemophilia B. Summary Few randomized studies have reported on the use of factor IX (FIX) for secondary prophylaxis in haemophilia B patients. This study aimed to evaluate the efficacy and safety of two secondary prophylaxis regimens of recombinant coagulation FIX, nonacog alfa, compared with on‐demand therapy. Male subjects aged 6–65 years with severe or moderately severe haemophilia B (FIX:C ≤ 2, n = 50) and ≥12 bleeding episodes (including ≥6 haemarthroses episodes) within 12 months of study participation were enrolled in this multicentre, randomized, open‐label, four‐period crossover trial. The primary measure was the annualized bleeding rate (ABR) of two prophylactic regimens vs. on‐demand therapy. In the intent‐to‐treat group, mean ABR values were 35.1, 2.6 and 4.6 for the first on‐demand period, the 50 IU kg−1 twice‐weekly period, and the 100 IU kg−1 once‐weekly period respectively. Differences in ABR between the first on‐demand period and both prophylaxis regimens were significant (P < 0.0001); no significant differences were observed between prophylaxis regimens (P = 0.22). Seven serious adverse events occurred in five subjects, none related to study drug. Results demonstrated that secondary prophylaxis therapy with nonacog alfa 50 IU kg−1 twice weekly or 100 IU kg−1 once weekly reduced ABR by 89.4% relative to on‐demand treatment. Both prophylaxis regimens demonstrated favourable safety profiles in subjects with haemophilia B. Few randomized studies have reported on the use of factor IX (FIX) for secondary prophylaxis in haemophilia B patients. This study aimed to evaluate the efficacy and safety of two secondary prophylaxis regimens of recombinant coagulation FIX, nonacog alfa, compared with on-demand therapy. Male subjects aged 6-65 years with severe or moderately severe haemophilia B (FIX:C ≤ 2, n = 50) and ≥12 bleeding episodes (including ≥6 haemarthroses episodes) within 12 months of study participation were enrolled in this multicentre, randomized, open-label, four-period crossover trial. The primary measure was the annualized bleeding rate (ABR) of two prophylactic regimens vs. on-demand therapy. In the intent-to-treat group, mean ABR values were 35.1, 2.6 and 4.6 for the first on-demand period, the 50 IU kg(-1) twice-weekly period, and the 100 IU kg(-1) once-weekly period respectively. Differences in ABR between the first on-demand period and both prophylaxis regimens were significant (P < 0.0001); no significant differences were observed between prophylaxis regimens (P = 0.22). Seven serious adverse events occurred in five subjects, none related to study drug. Results demonstrated that secondary prophylaxis therapy with nonacog alfa 50 IU kg(-1) twice weekly or 100 IU kg(-1) once weekly reduced ABR by 89.4% relative to on-demand treatment. Both prophylaxis regimens demonstrated favourable safety profiles in subjects with haemophilia B.Few randomized studies have reported on the use of factor IX (FIX) for secondary prophylaxis in haemophilia B patients. This study aimed to evaluate the efficacy and safety of two secondary prophylaxis regimens of recombinant coagulation FIX, nonacog alfa, compared with on-demand therapy. Male subjects aged 6-65 years with severe or moderately severe haemophilia B (FIX:C ≤ 2, n = 50) and ≥12 bleeding episodes (including ≥6 haemarthroses episodes) within 12 months of study participation were enrolled in this multicentre, randomized, open-label, four-period crossover trial. The primary measure was the annualized bleeding rate (ABR) of two prophylactic regimens vs. on-demand therapy. In the intent-to-treat group, mean ABR values were 35.1, 2.6 and 4.6 for the first on-demand period, the 50 IU kg(-1) twice-weekly period, and the 100 IU kg(-1) once-weekly period respectively. Differences in ABR between the first on-demand period and both prophylaxis regimens were significant (P < 0.0001); no significant differences were observed between prophylaxis regimens (P = 0.22). Seven serious adverse events occurred in five subjects, none related to study drug. Results demonstrated that secondary prophylaxis therapy with nonacog alfa 50 IU kg(-1) twice weekly or 100 IU kg(-1) once weekly reduced ABR by 89.4% relative to on-demand treatment. Both prophylaxis regimens demonstrated favourable safety profiles in subjects with haemophilia B. Few randomized studies have reported on the use of factor IX (FIX) for secondary prophylaxis in haemophilia B patients. This study aimed to evaluate the efficacy and safety of two secondary prophylaxis regimens of recombinant coagulation FIX, nonacog alfa, compared with on-demand therapy. Male subjects aged 6-65 years with severe or moderately severe haemophilia B (FIX:C ≤ 2, n = 50) and ≥12 bleeding episodes (including ≥6 haemarthroses episodes) within 12 months of study participation were enrolled in this multicentre, randomized, open-label, four-period crossover trial. The primary measure was the annualized bleeding rate (ABR) of two prophylactic regimens vs. on-demand therapy. In the intent-to-treat group, mean ABR values were 35.1, 2.6 and 4.6 for the first on-demand period, the 50 IU kg(-1) twice-weekly period, and the 100 IU kg(-1) once-weekly period respectively. Differences in ABR between the first on-demand period and both prophylaxis regimens were significant (P < 0.0001); no significant differences were observed between prophylaxis regimens (P = 0.22). Seven serious adverse events occurred in five subjects, none related to study drug. Results demonstrated that secondary prophylaxis therapy with nonacog alfa 50 IU kg(-1) twice weekly or 100 IU kg(-1) once weekly reduced ABR by 89.4% relative to on-demand treatment. Both prophylaxis regimens demonstrated favourable safety profiles in subjects with haemophilia B. Few randomized studies have reported on the use of factor IX ( FIX ) for secondary prophylaxis in haemophilia B patients. This study aimed to evaluate the efficacy and safety of two secondary prophylaxis regimens of recombinant coagulation FIX , nonacog alfa, compared with on‐demand therapy. Male subjects aged 6–65 years with severe or moderately severe haemophilia B ( FIX :C ≤ 2, n = 50) and ≥12 bleeding episodes (including ≥6 haemarthroses episodes) within 12 months of study participation were enrolled in this multicentre, randomized, open‐label, four‐period crossover trial. The primary measure was the annualized bleeding rate ( ABR ) of two prophylactic regimens vs. on‐demand therapy. In the intent‐to‐treat group, mean ABR values were 35.1, 2.6 and 4.6 for the first on‐demand period, the 50 IU kg −1 twice‐weekly period, and the 100 IU kg −1 once‐weekly period respectively. Differences in ABR between the first on‐demand period and both prophylaxis regimens were significant ( P < 0.0001); no significant differences were observed between prophylaxis regimens ( P = 0.22). Seven serious adverse events occurred in five subjects, none related to study drug. Results demonstrated that secondary prophylaxis therapy with nonacog alfa 50 IU kg −1 twice weekly or 100 IU kg −1 once weekly reduced ABR by 89.4% relative to on‐demand treatment. Both prophylaxis regimens demonstrated favourable safety profiles in subjects with haemophilia B. |
| Author | Valentino, L. A. Rusen, L. Rendo, P. Smith, L. M. Elezovic, I. Korth-Bradley, J. M. |
| Author_xml | – sequence: 1 givenname: L. A. surname: Valentino fullname: Valentino, L. A. email: lvalentino@rush.edu organization: Rush University Medical Center, IL, Chicago, USA – sequence: 2 givenname: L. surname: Rusen fullname: Rusen, L. organization: Institutul National de Hematologie Transfuzionala, Bucharest, Romania – sequence: 3 givenname: I. surname: Elezovic fullname: Elezovic, I. organization: Medical Faculty, Clinic of Haematology, University of Belgrade, Clinical Center of Serbia, Belgrade, Serbia – sequence: 4 givenname: L. M. surname: Smith fullname: Smith, L. M. organization: Pfizer Inc, PA, Collegeville, USA – sequence: 5 givenname: J. M. surname: Korth-Bradley fullname: Korth-Bradley, J. M. organization: Pfizer Inc, PA, Collegeville, USA – sequence: 6 givenname: P. surname: Rendo fullname: Rendo, P. organization: Pfizer Inc, PA, Collegeville, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/24418368$$D View this record in MEDLINE/PubMed |
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| References_xml | – reference: Roth DA, Kessler CM, Pasi KJ, Rup B, Courter SG, Tubridy KL. Human recombinant factor IX: safety and efficacy studies in hemophilia B patients previously treated with plasma-derived factor IX concentrates. Blood 2001; 98: 3600-6. – reference: Aznar JA, Lucia JF, Abad-Franch L et al. Focusing on haemophilia B: prophylaxis in Spanish patients. Haemophilia 2011; 17: 542-3. – reference: Nilsson IM, Berntorp E, Lofqvist T, Pettersson H. Twenty-five years' experience of prophylactic treatment in severe haemophilia A and B. J Intern Med 1992; 232: 25-32. – reference: Bjorkman S. A commentary on the differences in pharmacokinetics between recombinant and plasma-derived factor IX and their implications for dosing. Haemophilia 2011; 17: 179-84. – reference: Valentino LA. Secondary prophylaxis therapy: what are the benefits, limitations and unknowns? Haemophilia 2004; 10: 147-57. – reference: Srivastava A, Brewer AK, Mauser-Bunschoten EP et al. Guidelines for the management of hemophilia. Haemophilia 2013; 19: e1-47. – reference: Santagostino E. Prophylaxis in haemophilia B patients: unresolved issues and pharmacoeconomic implications. Haemophilia 2010; 16(Suppl. 6): 13-7. – reference: Lambert T, Recht M, Valentino LA et al. Reformulated BeneFix: efficacy and safety in previously treated patients with moderately severe to severe haemophilia B. Haemophilia 2007; 13: 233-43. – reference: Morfini M, Mannucci PM, Mariani G et al. Evaluation of prophylactic replacement therapy in haemophilia B. Scand J Haematol 1976; 16: 41-7. – reference: Tagliaferri A, Rivolta GF, Rossetti G, Pattacini C, Gandini G, Franchini M. Experience of secondary prophylaxis in 20 adolescent and adult Italian hemophiliacs. Thromb Haemost 2006; 96: 542-3. – reference: Rocca A, Pizzinelli S, Oliovecchio E, Santagostino E, Rocino A, Iorio A. Replacement therapy with recombinant factor IX. A multicentre evaluation of current dosing practices in Italy. Blood Transfus 2011; 9: 60-9. – reference: Biss TT, Chan AK, Blanchette VS, Iwenofu LN, Mclimont M, Carcao MD. The use of prophylaxis in 2663 children and adults with haemophilia: results of the 2006 Canadian national haemophilia prophylaxis survey. Haemophilia 2008; 14: 923-30. – reference: Khawaji M, Astermark J, Berntorp E. Lifelong prophylaxis in a large cohort of adult patients with severe haemophilia: a beneficial effect on orthopaedic outcome and quality of life. Eur J Haematol 2012; 88: 329-35. – reference: Kisker CT, Eisberg A, Schwartz B. Prophylaxis in factor IX deficiency product and patient variation. Haemophilia 2003; 9: 279-84. – reference: Lofqvist T, Nilsson IM, Berntorp E, Pettersson H. Haemophilia prophylaxis in young patients-a long-term follow-up. J Intern Med 1997; 241: 395-400. – reference: Stobart K, Iorio A, Wu JK. Clotting factor concentrates given to prevent bleeding and bleeding-related complications in people with hemophilia A or B. Cochrane Database Syst Rev 2006; 2: CD003429. – reference: Shapiro AD, Di Paola J, Cohen A et al. The safety and efficacy of recombinant human blood coagulation factor IX in previously untreated patients with severe or moderately severe hemophilia B. Blood 2005; 105: 518-25. – reference: Chang HH, Yang YL, Hung MH, Tsay W, Shen MC. Pharmacokinetic study of recombinant human factor IX in previously treated patients with hemophilia B in Taiwan. J Formos Med Assoc 2007; 106: 281-7. – reference: Charlebois TS, O'Connell BD, Adamson SR et al. Viral safety of B-domain deleted recombinant factor VIII. Semin Hematol 2001; 38: 32-9. – reference: Monahan PE, Liesner R, Sullivan ST, Ramirez ME, Kelly P, Roth DA. Safety and efficacy of investigator-prescribed BeneFIX prophylaxis in children less than 6 years of age with severe haemophilia B. Haemophilia 2010; 16: 460-8. – reference: Collins PW, Fischer K, Morfini M, Blanchette VS, Bjorkman S. Implications of coagulation factor VIII and IX pharmacokinetics in the prophylactic treatment of haemophilia. Haemophilia 2011; 17: 2-10. – reference: White GC. Parachutes and prophylaxis: they both work! J Thromb Haemost 2006; 4: 1226-7. – reference: Tagliaferri A, Franchini M, Coppola A et al. Effects of secondary prophylaxis started in adolescent and adult haemophiliacs. Haemophilia 2008; 14: 945-51. – reference: Ewenstein BM, Joist JH, Shapiro AD et al. Pharmacokinetic analysis of plasma-derived and recombinant FIX concentrates in previously treated patients with moderate or severe hemophilia B. Transfusion (Paris) 2002; 42: 190-7. – year: 2011 – volume: 38 start-page: 32 year: 2001 end-page: 9 article-title: Viral safety of B‐domain deleted recombinant factor VIII publication-title: Semin Hematol – volume: 13 start-page: 233 year: 2007 end-page: 43 article-title: Reformulated BeneFix: efficacy and safety in previously treated patients with moderately severe to severe haemophilia B publication-title: Haemophilia – volume: 9 start-page: 60 year: 2011 end-page: 9 article-title: Replacement therapy with recombinant factor IX. A multicentre evaluation of current dosing practices in Italy publication-title: Blood Transfus – volume: 96 start-page: 542 year: 2006 end-page: 3 article-title: Experience of secondary prophylaxis in 20 adolescent and adult Italian hemophiliacs publication-title: Thromb Haemost – volume: 4 start-page: 1226 year: 2006 end-page: 7 article-title: Parachutes and prophylaxis: they both work! publication-title: J Thromb Haemost – year: 2005 – volume: 98 start-page: 3600 year: 2001 end-page: 6 article-title: Human recombinant factor IX: safety and efficacy studies in hemophilia B patients previously treated with plasma‐derived factor IX concentrates publication-title: Blood – volume: 2 start-page: CD003429 year: 2006 article-title: Clotting factor concentrates given to prevent bleeding and bleeding‐related complications in people with hemophilia A or B publication-title: Cochrane Database Syst Rev – volume: 16 start-page: 13 issue: Suppl. 6 year: 2010 end-page: 7 article-title: Prophylaxis in haemophilia B patients: unresolved issues and pharmacoeconomic implications publication-title: Haemophilia – volume: 9 start-page: 279 year: 2003 end-page: 84 article-title: Prophylaxis in factor IX deficiency product and patient variation publication-title: Haemophilia – year: 2007 – volume: 42 start-page: 190 year: 2002 end-page: 7 article-title: Pharmacokinetic analysis of plasma‐derived and recombinant FIX concentrates in previously treated patients with moderate or severe hemophilia B publication-title: Transfusion (Paris) – volume: 17 start-page: 179 year: 2011 end-page: 84 article-title: A commentary on the differences in pharmacokinetics between recombinant and plasma‐derived factor IX and their implications for dosing publication-title: Haemophilia – volume: 10 start-page: 147 year: 2004 end-page: 57 article-title: Secondary prophylaxis therapy: what are the benefits, limitations and unknowns? publication-title: Haemophilia – volume: 19 start-page: e1 year: 2013 end-page: 47 article-title: Guidelines for the management of hemophilia publication-title: Haemophilia – volume: 105 start-page: 518 year: 2005 end-page: 25 article-title: The safety and efficacy of recombinant human blood coagulation factor IX in previously untreated patients with severe or moderately severe hemophilia B publication-title: Blood – volume: 16 start-page: 460 year: 2010 end-page: 8 article-title: Safety and efficacy of investigator‐prescribed BeneFIX prophylaxis in children less than 6 years of age with severe haemophilia B publication-title: Haemophilia – volume: 14 start-page: 923 year: 2008 end-page: 30 article-title: The use of prophylaxis in 2663 children and adults with haemophilia: results of the 2006 Canadian national haemophilia prophylaxis survey publication-title: Haemophilia – volume: 88 start-page: 329 year: 2012 end-page: 35 article-title: Lifelong prophylaxis in a large cohort of adult patients with severe haemophilia: a beneficial effect on orthopaedic outcome and quality of life publication-title: Eur J Haematol – year: 2002 – volume: 16 start-page: 41 year: 1976 end-page: 7 article-title: Evaluation of prophylactic replacement therapy in haemophilia B publication-title: Scand J Haematol – volume: 106 start-page: 281 year: 2007 end-page: 7 article-title: Pharmacokinetic study of recombinant human factor IX in previously treated patients with hemophilia B in Taiwan publication-title: J Formos Med Assoc – volume: 17 start-page: 542 year: 2011 end-page: 3 article-title: Focusing on haemophilia B: prophylaxis in Spanish patients publication-title: Haemophilia – volume: 17 start-page: 2 year: 2011 end-page: 10 article-title: Implications of coagulation factor VIII and IX pharmacokinetics in the prophylactic treatment of haemophilia publication-title: Haemophilia – volume: 232 start-page: 25 year: 1992 end-page: 32 article-title: Twenty‐five years' experience of prophylactic treatment in severe haemophilia A and B publication-title: J Intern Med – volume: 14 start-page: 945 year: 2008 end-page: 51 article-title: Effects of secondary prophylaxis started in adolescent and adult haemophiliacs publication-title: Haemophilia – volume: 241 start-page: 395 year: 1997 end-page: 400 article-title: Haemophilia prophylaxis in young patients–a long‐term follow‐up publication-title: J Intern Med – ident: e_1_2_11_27_1 doi: 10.1111/j.1365-2516.2003.00870.x – ident: e_1_2_11_2_1 – ident: e_1_2_11_17_1 doi: 10.1046/j.1365-2796.1997.130135000.x – ident: e_1_2_11_25_1 doi: 10.1111/j.1365-2516.2010.02431.x – ident: e_1_2_11_21_1 doi: 10.1111/j.1365-2516.2009.02162.x – ident: e_1_2_11_20_1 doi: 10.1111/j.1365-2516.2007.01458.x – ident: e_1_2_11_12_1 doi: 10.1160/TH06-06-0307 – ident: e_1_2_11_22_1 doi: 10.1046/j.1365-2516.2003.00751.x – ident: e_1_2_11_29_1 doi: 10.1111/j.1365-2516.2010.02301.x – ident: e_1_2_11_8_1 doi: 10.1111/j.1365-2516.2010.02412.x – ident: e_1_2_11_30_1 doi: 10.1111/j.1365-2516.2008.01791.x – volume: 9 start-page: 60 year: 2011 ident: e_1_2_11_6_1 article-title: Replacement therapy with recombinant factor IX. 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Few randomized studies have reported on the use of factor IX (FIX) for secondary prophylaxis in haemophilia B patients. This study aimed to evaluate... Few randomized studies have reported on the use of factor IX ( FIX ) for secondary prophylaxis in haemophilia B patients. This study aimed to evaluate the... Few randomized studies have reported on the use of factor IX (FIX) for secondary prophylaxis in haemophilia B patients. This study aimed to evaluate the... |
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| SubjectTerms | Adolescent Adult Aged Child Cross-Over Studies factor IX Factor IX - therapeutic use haemophilia B Hemophilia B - drug therapy Humans Male Middle Aged prophylaxis recombinant factor IX Recombinant Proteins - therapeutic use Young Adult |
| Title | Multicentre, randomized, open-label study of on-demand treatment with two prophylaxis regimens of recombinant coagulation factor IX in haemophilia B subjects |
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