In a nutshell
The authors compared the effectiveness and safety of SB4, a biological variant of etanercept (Enbrel), to etanercept alone in patients with rheumatoid arthritis (RA).
Some background
In RA, high levels of immune system protein are generated, which causes inflammation. This can lead to chronic pain. Methotrexate (Trexall) is one of the most commonly used drugs in the treatment of RA. Etanercept is an alternative treatment approved for RA. It blocks specific parts of the immune system that play a key role in RA inflammation.
SB4 is a biosimilar of etanercept. A biosimilar is a medicinal product highly similar to an already approved biological product, known as a reference product (etanercept in this case), in terms of safety and function.
Understanding the safety and effectiveness of SB4 is critical in making it a useful and effective treatment option in RA.
Methods & findings
The authors aimed to compare the safety and effectiveness of SB4 to that of etanercept.
596 RA patients were included in this study. All patients had moderate to severe RA despite treatment with methotrexate. 299 patients received SB4 and 297 patients received etanercept injections. Patients were evaluated for ACR20 response and safety, among others, after 24 weeks of treatment. ACR20 (American College of Rheumatology) response measured 20% improvements in swollen or tender joints after treatment.
78.1% of patients treated with SB4 achieved ACR20. This was compared to 80.3% of patients treated with etanercept. The occurrence of treatment-related side effects was 55.2% in the SB4 group. Side effects included upper infection in the nose, sinuses or lungs (7%) and increases in liver enzymes (5%). For the etanercept group, the occurrence of side effects was 58.2%. These included rashes at injection sites (11.1%), infection in the nose, sinuses or lungs (5.1%) and inflammation of the throat and nasal passage (5.1%).
Immunogenicity of SB4 and etanercept was also measured. Immunogenicity measured the ability of a substance to start an immune response in the body. 2 patients (0.7%) in SB4 group and 39 patients (13.1%) in the etanercept group experienced immunogenic responses.
The bottom line
The authors concluded that the safety and effectiveness of SB4 was similar to that of etanercept in the treatment of moderate to severe RA.
Published By :
Annals of the rheumatic diseases
Date :
Jul 06, 2015
