Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study

Abstract

We evaluated the 3-year drug survival and efficacy of the biosimilar SB4/Benepali in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients, previously treated with etanercept (ETA). Drug survival rate was calculated using the Kaplan–Meier method and Cox proportional hazard models were developed to examine predictors of SB4 discontinuation. 236 patients (120 RA, 80 PsA and 36 AS), aged 60.7 ± 13.8 years and with an ETA duration of 4.1 ± 3.4 years were included. The 3-year retention rate for SB4 was 94.4%, 88% and 86% in AS, RA and PsA patients, respectively, with no difference between groups. Patients without comorbid disease had higher retention rates vs. patients with comorbid disease (90% vs. 60%, p < 0.0001). Disease activity, as measured by DAS28, DAPSA and BASDAI remained stable over the 3 years. Comorbid disease (hazard ratio; HR: 4.06, p < 0.0001) and HAQ at baseline (HR: 2.42, p = 0.0024) significantly increased the risk of SB4 discontinuation, while previous ETA duration was negatively associated with SB4 discontinuation (HR: 0.97, p = 0.0064). Forty-one (17.4%) patients left the study due to the interruption of the SB4 treatment, 31 (75.6%) discontinued due to inefficacy and 10 (24.4%) due to adverse events. This real-life study confirms the similar efficacy profile of ETA with long-term retention and a good safety profile in inflammatory arthritis patients.

Treatment with adalimumab in patients with chronic inflammatory rheumatic diseases: a study of treatment trajectories on a patient level in routine care

“…A recent study of patients with CIRD switching from ETA originator to ETA bsDMARD found that patients with longer previous duration on originator ETA had lower estimated risks of ETA bsDMARD withdrawal, as did RA patients in remission or with low disease activity, 35 both results are comparable to our findings.…”

Safety and Effectiveness of Etanercept Biosimilar SB4 for Rheumatic Diseases in South Korea: Real-World Post-marketing Surveillance Data

“…The high retention rate in this study (94.9%) was similar to that reported by a Swedish study (90%) at 6 months, which used real-world data of 143 patients at an outpatient rheumatology center who were switched from reference etanercept [20]. Retention rates in the 3-year drug survival study of switched patients with RA, AS and PsA were 88, 94.4, and 86%, respectively [19]. A retrospective evaluation of 220 patients (85 RA, 33 AS, 81 PsA and 14 with other conditions; median follow-up 12.1 months) who were switched from reference etanercept to SB4 showed retention rates of 99.1, 88.6, and 64.6% at 6, 12, and 18 months, respectively [21].…”

“…In a 3-year, real-world drug survival and efficacy study of SB4 in patients with RA (n = 120), AS (36) and PsA 80) and patients, who were previously treated with reference etanercept, DAS28 and BASDAI remained stable over the 3 years (median scores after 3 years vs. baseline 2.5 vs. 2.37 and 1.05 vs. 1, respectively) [19].…”

Differential retention of adalimumab and etanercept biosimilars compared to originator treatments: Results of a retrospective French multicenter study

“…Due to its retrospective nature, there were missing data, especially for disease activity, which was available only for 31.8% of patients, which did not allow us to analyze this point with precision. No sufficient data were available to evaluate comorbidities of patients, which is a known factor that impacts retention of treatments ( 69 – 71 ) and may be an explanation for some of our results. Another limit is the exclusion of patients who were under boDMARDs switched to bsDMARDs which could have limited the conclusions we could draw from the results.…”