Switching to an etanercept biosimilar – an investigation of the safety and efficacy profile

This study investigated if switching from etanercept (Enbrel) to a biosimilar of etanercept (SDZ-ETN) is safe and effective in patients with rheumatoid arthritis (RA).

They found that switching to SDZ-ETN from reference etanercept was safe and effective. 

Rheumatoid arthritis (RA) is a long-term inflammatory condition. Excessive inflammation leads to pain and swelling in the joints. The degeneration of joint tissue progresses over time. RA is treated with disease-modifying anti-rheumatic drugs (DMARDs). Biological DMARDs (bDMARDs) are drugs that target specific inflammatory chemicals. bDMARDs are an effective treatment for RA if patients do not respond well to conventional DMARDs (csDMARDs). One disadvantage of bDMARDs is the cost. 

Biosimilars are generic versions of biologic drugs. They are called biosimilar because they are not an exact copy of the reference drug. Etanercept (ETN) is a bDMARD that blocks tumor necrosis factor (TNF). A biosimilar of ETN has been developed. It is unclear if switching from original ETN to biosimilar ETN (SDZ-ETN) is safe and effective. 

This study included 376 patients with moderate-severe RA. Patients were randomly assigned to treatment with SDZ-ETN or ETN. Treatment was administered once weekly for 24 weeks. At week 24, patients in the ETN group were switched to ETN-SDZ. Treatment continued for up to week 48. All patients also received methotrexate and folic acid at a stable dose. Disease activity scale (DAS28-CRP) was used to measure RA symptoms. Side effects were also recorded. 

An improvement in DAS28-CRP scores was observed in both ETN and SDZ-ETN groups. Thus, ETN and SDZ-ETN were similarly effective at 24 weeks. The improvement in disease activity was maintained in patients that switched from ETN to SDZ-ETN. Side effects rates were similar in patients continuing or switched to SDZ-ETN. The most common side effects were the common cold and upper respiratory tract infections. 

The authors concluded that switching to SDZ-ETN from ETN was safe and effective in patients with RA.

This study was funded by Hexal AG, a Sandoz company, the manufacturer of SDZ-ETN.

If you have any concerns regarding RA please consult with your physician.