Etanercept Biosimilar SDZ ETN Demonstrates Efficacy, Safety in Rheumatic Disease

Results of a multi-country, non-interventional study demonstrated the comparable safety and efficacy, as well as high treatment persistence of the etanercept biosimilar, SDZ ETN, in patients with rheumatic diseases compared with the reference product and other biosimilars, according to research published in Advances in Therapy.¹

To control symptoms, prevent structural damage, and maximize quality of life, patients must receive a timely diagnosis, initiate treatment, and exhibit treatment persistence. Previous research has proven anti-tumor necrosis factor (TNF) agents, such as etanercept, are an effective and safe way to treat rheumatic disease.²

“The higher estimated annual costs of anti-TNF drugs per treated patient limits their accessibility to patients,” wrote co-lead investigator Herbert Kellner, MD, head of the Department of Rheumatology at the Neuwittelsbach Hospital in Munich, Germany, and colleagues. “In this context, the introduction of biosimilars has gained considerable interest as they are more cost-effective and increase patient access to effective treatment options.”

The COMPACT study assessed the safety, efficacy, persistence, and patient-reported outcomes (PROs) in patients aged ≥18 years with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) who received SDZ ETN.

Patients were placed into categories based on their prior treatment status (A — D): those in clinical remission or with low disease activity during treatment with etanercept or etanercept biosimilars who switched to SDZ ETN (group A); those who were treated with non-etanercept targeted therapies who switched to SDZ ETN (group B); patients who were biologic-naïve who started SDZ ETN following conventional therapy failure (group C); or those with RA who were disease-modifying antirheumatic drug (DMARD)-naïve and considered suitable for biologic treatment initiation who began treatment with SDZ ETN (group D).

Remission was defined as a Disease Activity Score 28-joint count Erythrocyte Sedimentation Rate (DAS28-ESR) score of < 2.6 and low disease activity was categorized as a DAS28-ESR score between ≥ 2.6 to ≤ 3.2. Drug persistence, described as the time between recruitment until discontinuation of SDZ ETN, was the primary endpoint.

A total of 1466 patients were ultimately enrolled in the study, of which 844 (57.6%) were diagnosed with RA, 334 (22.8%) had axSpA, and 288 (19.6%) had PsA. Among the cohort, 572 patients were placed in group A, 171 were in group B, 713 were categorized as group C, and 10 patients with RA were in group D. The mean age was 54.4 years and 59.8% were female.

Patients received SDZ ETN treatment for an average of 138 days (range 1 — 841). During this observation period, 22.7% of patients discontinued the biosimilar within a 12-month span. Non-response (14.4%) and adverse events (7.9%) were reported as the main reasons for discontinuation.

Patients being treated with SDZ ETN had generally good treatment persistence at month 12, with discontinuation rates of 15.2% in group A, 25.7% in group B, and 27.8% in group C. As group D was comprised of a significantly smaller number of patients, persistence rates were difficult to interpret.

No significant differences were reported regarding the disease activity and PRO scores between baseline and the 12-month mark. Additionally, injection-site reactions were low across treatment arms and safety was comparable between groups. The most common adverse events were general disorders and administration site conditions (22.4%), infections and infestations (16.7%), musculoskeletal and connective tissue disorders (11.1%), and investigations (6.1%).

Investigators noted the descriptive nature of the analysis and using drug survival rates from enrollment as opposed to the beginning of treatment with SDZ ETN as limitations.

“These results may help both patients and healthcare providers with the application of routine-based SDZ ETN,” investigators concluded.

References

1. ^{Mease PJ, Bhutani MK, Hass S, Yi E, Hur P, Kim N. Comparison of clinical manifestations in rheumatoid arthritis vs. spondyloarthritis: a systematic literature review. Rheumatol Ther. 2022;9(2):331–78.}
2. ^{Schmalzing M, Kellner H, Askari A, et al. Real-World Effectiveness and Safety of SDZ ETN, an Etanercept Biosimilar, in Patients with Rheumatic Diseases: Final Results from Multi-Country COMPACT Study. Adv Ther. 2024;41(1):315-330. doi:10.1007/s12325-023-02706-8}