Real-World Evidence on Etanercept Biosimilar SB4 in Etanercept-Naïve or Switching Patients: A Systematic Review

Abstract

Introduction In 2016, SB4 (Benepali ® ) became the first etanercept (ETN) biosimilar to obtain marketing authorisation in Europe. Despite robust analytical and clinical comparisons, outstanding questions remain on SB4 use in routine practice. Methods A systematic search for publications on real-world evidence of SB4 effectiveness, safety and drug survival was undertaken using search terms (SB4 OR Benepali OR biosimilar etanercept OR innovator etanercept) in the BIOSIS ® Toxicology, BIOSIS Previews ® , Embase ® and MEDLINE ® databases up to 17 January 2019. Results Of 959 articles identified, eight journal articles, two journal letters and 23 congress abstracts were selected on criteria of original real-world evidence with a clinical focus. As expected with real-world evidence, quality scoring showed that the evidence had high external validity but lower internal validity. A total of 13,552 patients were described across nine European countries and all approved SB4 indications: 2499 were ETN-naïve and 11,053 switched from reference ETN to SB4 (switchers). Switch acceptance rates (a combination of clinicians offering and patients accepting initiation on SB4) ranged between 51.6% and 99.0%; patient support programmes positively contributed to acceptance. Disease activity was generally similar pre- and post-switch (typically 3-month timeframe). Retention rates across studies were at least 75% (up to 12 months follow-up). No new safety signals were identified. Differences in discontinuation rates versus historic controls reported in some studies may have been influenced by differences in treatment practices, lack of clinician confidence and nocebo effects. Conclusion Nearly 2500 ETN-naïve patients have been initiated on SB4 and outcomes are similar to those patients receiving reference ETN. Overall this systematic review of real-world evidence provides additional reassurance that SB4 is as effective and safe as reference ETN in both switched and naïve patients. Funding Biogen International GmbH. Electronic Supplementary Material The online version of this article (10.1007/s40744-019-00169-4) contains supplementary material, which is available to authorized users.

Rheumatic Diseases and Biosimilars: Evidence about Switch from Originators to Biosimilars in the Real Life

“…Globally, acceptance rates ranged between 51.6% and 99.0%.The RABBIT registry confirmed the data of the registration study reporting lower rates of site reaction in patients treated with SB4 vs. the originator [61]. Differences in treatment practices, lack of clinician confidence with the drug andnocebo effects could have influenced this report [62].…”

The switch from etanercept originator to SB4: data from a real-life experience on tolerability and persistence on treatment in joint inflammatory diseases

“…Similarly, the BIO-SPAN study reached discontinuation rates of 10% in ETN/SB4 switched patients at 6 months, 22 while the cumulative persistence was around 75% at 12 months in a recent systematic review on 11053 ETN/SB4 switching patients. 23 When compared with those significantly larger populations, our patients showed a higher treatment persistence at 6- and 12-month evaluations and first results at 18 months, despite the fact that a direct comparison cannot be made.…”

“…Comparable results were also reported by Ebbers et al . 23 When considering AEs in detail, still the DANBIO registry reports that, in particular, a prevalence of joint disease flares after 3 months from switching ranged from 5% to 24% of patients, according to different disease specific definitions. 17 These data regarding disease flares are in line with our population, in which any extent of clinically defined disease flare (including joint, but also cutaneous, ocular and intestinal) was recorded in 35 (15.9%) over a longer follow-up, based on both physician and patient evaluation.…”

Multi-modal Imaging in Etanercept-induced Uveitis: A Case Series

“…The equivalence studies for both new agents did not identify any significant increase in the incidence of ocular inflammation [14]. Additionally, abstract data for Erelzi and real-world data for Benepali studies showed no new safety signals compared to reference agents [15,16]. Furthermore, switching to anti-TNF alpha biosimilars used to treat uveitis specifically demonstrated no statistically significant difference in the rate of uveitis flares [17].…”