Biosimilars Report: Switching to Etanercept Biosimilar Doesn't Compromise Safety or Efficacy

June 10, 2019

A second study published in May on the safety and efficacy of biosimilars, shows that switching rheumatoid arthritis patients from etanercept (Enbrel, Amgen) to its biosimilar etanercept-szzs (Erelzi, Sandoz), does not affect efficacy, safety or immunogenicity of etanercept.

A second study published in May in Arthritis Research & Therapy on the safety and efficacy of biosimilars, shows that switching rheumatoid arthritis patients from etanercept (Enbrel, Amgen) to its biosimilar etanercept-szzs (Erelzi, Sandoz), does not affect efficacy, safety or immunogenicity of etanercept.

The study, conducted by Janusz Jaworski, M.D., Ph.D., of Poland, is based on the findings of the 48-week long EQUIRA, a phase three, double-blind study conducted in patients with moderate-to-severe rheumatoid arthritis who experienced an inadequate response to disease-modifying anti-rheumatic drugs, but had not yet tried a biologic.

“The advent of biosimilars has increased the possibility for switching between the reference medicine and its biosimilars, and this process is being evaluated in several countries. The 48-week results from the EQUIRA study demonstrates that switching patients from etanercept to etanercept-szzs did not impact the efficacy, safety, or immunogenicity of etanercept in patients with moderate-to-severe rheumatoid arthritis,” the authors wrote.

Etanercept is a TNF-inhibitor which is used to treat rheumatoid arthritis and other conditions. Previously, it was shown in the 24-week EQUIRA study, that etanercept and its biosimilar had comparable safety and efficacy in rheumatoid arthritis patients.

THE STUDY

The patients were randomized to receive 50 mg of etanercept or the biosimilar once-weekly for 24 weeks when patients with having at least a moderate response to the biosimilar continued with that treatment. Those in the biologic treatment group were switched to receive 50 mg the biosimilar for up to 48 weeks. These patients also received methotrexate at 10–25 mg each week and folic acid.

See next page:  The Results

THE RESULTS

The proportion of patients achieving DAS28-erythrocyte sedimentation rate and ACR20/50/70 were comparable between the group of patients continued on the biosimilar and those who were switched to the biosimilar. For those patients who continued on the biosimilar, 42.9 percent experienced at least one adverse event compared to 38 percent of the group who were switched to the biosimilar. After 24 weeks, no patient in the switch group developed anti-drug antibodies, but four in the continued group had “single event, very low titer, non-neutralizing ADAs detected.

“In addition, the results also support data on switching from other clinical trials in different indications. Future patient registry studies would help to further confirm the effect of switching on long-term efficacy, safety, and immunogenicity,” the authors wrote.

TAKE HOME POINTS

Previously in Rheumatology Network, we have reported on the real and potential benefits of introducing biosimilar drugs for treating inflammatory disease. As clinicians, any way we can improve access and facilitate regular adherence to therapeutic regimens is a worthwhile endeavor.

These results add to the conversation already started showing that we may be able to switch from a more costly originator medication to a biosimilar possibly saving our patients out of pocket expenses while promoting compliance and uninterrupted treatment.

  • For more news on etanercept from Rheumatology Network, click here.

REFERENCE:

Janusz Jaworski, Marco Matucci-Cerinic, Hendrik Schulze-Koops, et al.  Switch from reference etanercept to SDZ ETN, an etanercept biosimilar, does not impact efficacy, safety, and immunogenicity of etanercept in patients with moderate-to- severe rheumatoid arthritis: 48-week results from the phase III, randomized, double- blind EQUIRA study.  Arthritis Research & Therapy (2019) 21:130 https://doi.org/10.1186/s13075-019-1907-x