Inhibitor development, safety and efficacy of Advate® among previously treated patients with hemophilia A in a postmarketing surveillance in Japan

Taki, Masashi; Fukutake, Katsuyuki; Matsushita, Tadashi; Nogami, Keiji; Shima, Midori; Yoshioka, Akira; Takamatsu, Junki; Arai, Morio; Uchikawa, Haruhiko; Engl, Werner; Shirahata, Akira

doi:10.1007/s12185-018-02574-x

Cited by 7 publications

(3 citation statements)

References 22 publications

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“…be elevated in a postmarketing surveillance study of patients previously treated with antihaemophilic factor (recombinant). 22 During the first week after surgery, a decrease in IR and an increase in CL were observed in the current study, although the limited data available prevent meaningful analysis and interpretation of these results, which should be considered in the context of varying results reported in the literature. Although Batorova and…”

Section: Discussionmentioning

confidence: 54%

“…In the separate study of the present study drug (Négrier et al mentioned above), surgical patients previously treated with antihaemophilic factor (recombinant) did not develop FVIII inhibitors 13 . In addition, the risk of inhibitors was not found to be elevated in a postmarketing surveillance study of patients previously treated with antihaemophilic factor (recombinant) 22 …”

Section: Discussionmentioning

confidence: 98%

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Results of a randomized phase III/IV trial comparing intermittent bolus versus continuous infusion of antihaemophilic factor (recombinant) in adults with severe or moderately severe haemophilia A undergoing major orthopaedic surgery

et al. 2021

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Introduction In patients with haemophilia A undergoing surgery, factor VIII (FVIII) replacement therapy by continuous infusion (CI) may offer an alternative to bolus infusion (BI). Aim To compare the perioperative haemostatic efficacy and safety of antihaemophilic factor (recombinant) (ADVATE®; Baxalta US Inc., a Takeda company, Lexington, MA, USA) CI or BI administration. Methods In this multicentre, phase III/IV, controlled study (NCT00357656), 60 previously treated adult patients with severe or moderately severe disease undergoing elective unilateral major orthopaedic surgery (knee replacement, n = 48; hip surgery, n = 4; other, n = 8) requiring drain placement were randomized to receive antihaemophilic factor (recombinant) CI (n = 29) or BI (n = 31) through postoperative day 7. Primary outcome measure was cumulative packed red blood cell (PRBC)/blood volume in the drainage fluid within 24 h after surgery, used to establish non‐inferiority of CI to BI. Results CI:BI ratio of cumulative PRBC volume in the 24‐h drainage fluid was 0.92 (p‐value <.001 for non‐inferiority; 95% confidence interval, 0.82–1.05). Total antihaemophilic factor (recombinant) dose per kg body weight received in the combined trans‐ and postoperative periods was similar with CI and BI to maintain targeted FVIII levels during/after surgery. Treatment‐related adverse events (AEs) were reported in five patients treated by CI (eight events) and five treated by BI (six events), including two serious AEs in each arm. Conclusion CI administration of antihaemophilic factor (recombinant) is a viable alternative to BI in patients with haemophilia A undergoing major orthopaedic surgery, providing comparable efficacy and safety.

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Section: Discussionmentioning

confidence: 54%

Section: Discussionmentioning

confidence: 98%

Results of a randomized phase III/IV trial comparing intermittent bolus versus continuous infusion of antihaemophilic factor (recombinant) in adults with severe or moderately severe haemophilia A undergoing major orthopaedic surgery

et al. 2021

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“…The mass had first been noticed 6 months prior to his presentation and treated as olecranon bursitis. During this time, haematology had switched his recombinant factor VIII replacement a few months prior to presentation in March 2008 from Recombinate to Advate in order to allow infusions with fewer vials and additional bleeding prophylaxis to facilitate more physical therapy for his elbows 5 6. However, due to increasing size of the mass over time despite adequate factor levels and with the emergence of ulnar nerve paresthesias with development of subjective weakness and clumsiness with intrinsic hand function, the patient was referred to orthopaedic surgery for evaluation of the mass and workup of his ulnar nerve symptoms.…”

Section: Case Presentationmentioning

confidence: 99%

Unusual olecranon mass with ulnar nerve compressive neuropathy caused by a haemophilic pseudotumour

Yeung

Blazar²

2019

BMJ Case Rep

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A 55-year-old man with a history of haemophilia A and bilateral haemophilic arthropathy of the elbows presented with an enlarging left elbow mass and worsening paresthesias in the ulnar distribution of the left hand. The mass, originally thought to be olecranon bursitis and treated as such, was found to be due to a haemophilic pseudotumour. The patient underwent successful excision of the haemophilic pseudotumour with concomitant ulnar nerve decompression and had sustained resolution of the pseudotumour and symptoms at 10 years of follow-up. This case demonstrates the need for consideration of haemophilic pseudotumour in the differential diagnosis for olecranon masses and cubital tunnel compressive neuropathy in patients with haemophilia, and highlights the viability of surgical excision as a therapeutic option for the treatment of haemophilic pseudotumours in the elbow.

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Octocog-α

2019

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Inhibitor development, safety and efficacy of Advate® among previously treated patients with hemophilia A in a postmarketing surveillance in Japan

Cited by 7 publications

References 22 publications

Results of a randomized phase III/IV trial comparing intermittent bolus versus continuous infusion of antihaemophilic factor (recombinant) in adults with severe or moderately severe haemophilia A undergoing major orthopaedic surgery

Results of a randomized phase III/IV trial comparing intermittent bolus versus continuous infusion of antihaemophilic factor (recombinant) in adults with severe or moderately severe haemophilia A undergoing major orthopaedic surgery

Unusual olecranon mass with ulnar nerve compressive neuropathy caused by a haemophilic pseudotumour

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