Elocta and Alprolix can provide perioperative haemostatic control across a wide spectrum of surgeries

Sobi and Sanofi will present data demonstrating that Elocta (efmoroctocog alfa) and Alprolix (eftrenonacog alfa) can provide perioperative haemostatic control across a wide spectrum of major and minor surgeries in subjects of all ages with severe haemophilia A and B respectively . The presentation will take place at the World Federation of Hemophilia’s 16th International Musculoskeletal Congress (MSK) 10-12 May 2019, in Madrid, Spain.

One of the major complications for people living with haemophilia is recurrent bleeding into joints and subsequent deteriorating joint health. Joint surgery and rehabilitation of damaged joints can improve the quality of life for these patients. However, people with haemophilia are at risk during surgical procedures due to the increased risk of bleeding during the procedure and the reduced clotting of the blood which characterises haemophilia. It is possible to minimise blood loss during surgery by treating patients with an individualised and optimal factor replacement therapy to control the haemostasis. The risk of bleeding in a haemophilia patient is inversely proportional to the factor level activity in the blood and treatment guidelines recommend monitoring factor levels post-surgery.

“Orthopaedic surgery is common in haemophilia since a large majority of haemophilia patients experience joint damage due to suboptimal levels of protection, leading to reoccurring bleeding in the joints,” says Armin Reininger, Head of Scientific and Medical Affairs at Sobi. “Therefore, it is of great importance to offer an individualised prophylactic treatment to reduce the need for and occurrence of surgery as well as an optimal and measurable factor treatment during surgery. Furthermore, to maintain joint health, it is important to reduce pain and increase mobility of patients so that they can fully participate in everyday life”

The data presented at MSK support the use of individualised treatment with rFVIIIFc (efmoroctocog alfa) and rFIXFc (eftrenonacog alfa) to provide perioperative haemostatic control across a wide spectrum of major and minor surgeries in subjects of all ages with severe haemophilia A and B respectively. Most major procedures required one injection to maintain haemostasis during surgery, and all haemostatic responses were assessed as excellent or good by the investigator/surgeon. Both treatments were well tolerated.

Results from the studies : The data present final pooled post-hoc analysis of A-LONG, Kids A-LONG and ASPIRE subjects who underwent surgery and were treated with an investigator-determined rFVIIIFc regimen as well as the final pooled post-hoc analysis of B-LONG, Kids B-LONG and B-YOND subjects treated with investigator-determined rFIXFc regimens during major and minor surgery. Forty-six major and 90 minor surgeries were performed on respectively 32 and 70 subjects with haemophilia A. rFVIIIFc was administered on the day of surgery for 44 major (including 33 orthopaedic surgeries) and 84 minor procedures. Most major (87 per cent) and minor (89 per cent) surgeries required ?1 injection of rFVIIIFc (including loading dose) to maintain haemostasis during surgery. All haemostatic responses (where available) were assessed as excellent (major surgery: 93 per cent; minor surgery: 85 per cent) or good.

No adverse events were deemed related to rFVIIIFc treatment. Thirty-five major and 62 minor surgeries were performed on respectively 22 and 37 subjects with haemophilia B. rFIXFc was administered on the day of surgery for 35 major (including 24 orthopaedic procedures) and 55 minor procedures. Most major (82.9 per cent) and minor (87.1 per cent) surgeries required ?1 injection of rFIXFc (including the loading dose) to maintain perioperative haemostasis. Haemostatic responses were assessed as excellent/good for all major surgeries and 95 per cent of minor surgeries. No adverse events were deemed related to rFIXFc treatment.

The safety and efficacy of prophylactic rFVIIIFc (efmoroctocog alfa) regimens in patients with severe haemophilia A has been demonstrated by the A-LONG, Kids A-LONG, and the ASPIRE extension phase 3 studies. The safety and efficacy of rFIXFc (eftrenonacog alfa) prophylaxis has been demonstrated in patients with severe haemophilia B in the B-LONG and Kids B-LONG phase 3 trials and the B-YOND extension studies.

Abstracts : Poster P-03: "Recombinant Factor IX Fc Fusion Protein (rFIXFc) for Perioperative Haemostatic Management in Severe Haemophilia B"-Poster P-14: Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) Efficacy for Perioperative Haemostatic Management in Severe Haemophilia A.