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Simoctocog alfa (Nuwiq) for hemophilia A: Overview

Simoctocog alfa (trade name: Nuwiq) has been approved since July 2014 for the treatment of hemophilia A. Hemophilia is an inherited disorder that affects the blood's ability to clot.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: February 16, 2015

Regular clotting factor replacement therapy to prevent joint disease in people with severe hemophilia A or B

Hemophilia A and B are X‐linked inherited bleeding disorders, in which the major clinical problem is repeated bleeding into joints. As this disorder progresses, joints become deformed and movement limited. Current therapy for treating and preventing bleeding includes plasma‐derived or recombinant clotting factor concentrates. This review includes six randomised controlled trials. Two compare the regular use of clotting factor concentrates to prevent joint bleeds with their use 'on demand'. Four compare different regimens of regular use in children and adults with hemophilia. It was clearly evident that preventative therapy, as intravenous infusion of factor concentrate repeated more times a week and started early in childhood was able to reduce joint deterioration as compared to treatment administered after bleeding occurred. This favourable effect is due to a consistent reduction in total bleeds and hemarthrosis (bleeding into joints) and leads to a significant improvement in quality of life. Preventative therapy is linked to an increased factor usage and cost of treatment. We found weaker evidence (due to lack of data) to show preventative therapy reduced joint deterioration when treatment is started after joint damage has been established. Further studies are needed to establish the best preventative regimen, i.e. for example starting time, dosage frequency, minimally effective dose.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2011

Treatments for acute bleeds in people with acquired hemophilia A

Acquired hemophilia A is a rare but severe bleeding disorder caused by the autoantibody directed against factor VIII (FVIII, a blood clotting protein) in patients with no previous history of a bleeding disorder. This bleeding disorder occurs more frequently in the elderly and may be associated with several other conditions, such as solid tumours, autoimmune diseases, or with drugs; it is also sometimes associated with pregnancy. However, in about half of the cases the causes are unknown. Bleeding occurs in the skin; mucous membranes; and muscles; with joint bleeds being unusual. Therapies for acquired hemophilia A include treatments to stop acute bleeds and to destroy the FVIII autoantibodies. Acute bleeds can be treated with recombinant activated FVII or activated prothrombin complex concentrate (aPCC). If these are unavailable, FVIII concentrates or 1‐desamino‐8‐D‐arginine‐vasopressin (DDAVP) fresh frozen plasma can be attempted; however, these last two options are not usually effective, and it is not known if one of these products is better than the other.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

Recombinant (non‐human) factor VIIa clotting factor concentrates versus plasma concentrates for acute bleeds in people with haemophilia and inhibitors

We wanted to find evidence on the effectiveness of recombinant factor VIIa (containing no human proteins) as compared to concentrates derived from plasma for treating acute bleeding episodes in people with haemophilia with inhibitors.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2015

Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia

The purpose of this review was to evaluate the evidence of effectiveness and safety for the use of recombinant factor VIIa (rFVIIa). This drug has been used in patients who are either at risk of major bleeding (e.g. because of planned high‐risk surgery), or who have uncontrolled bleeding (e.g. related to trauma). There have been many articles in the literature describing the off‐license use of this drug, which often suggest benefit. However, most of the publications are based on small numbers of patients (in case reports or case series) and may be affected by bias. Randomised controlled trials provide higher‐quality research findings and allow us to assess the evidence of drug effectiveness with more certainty.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Rituximab for treating inhibitors in people with inherited severe hemophilia

We reviewed the evidence available to see if rituximab is effective and safe when treating clotting factor inhibitors in people with severe hemophilia.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2015

Drugs assessed by IQWiG: Overview

Since early 2011, the added benefit of most medications containing new active ingredients must be assessed as soon as they enter the market in Germany. The most important results of the IQWiG reviews are summarized here.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: March 2, 2015

Systematic Reviews in PubMed

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