Comparison of injection-site reactions between the etanercept biosimilar SB4 and the reference etanercept in patients with rheumatoid arthritis from a phase III study

Girolomoni, Giampiero; Feldman, Steven R.; Emery, Paul; Ghil, Jeehoon; Keum, Jung Won; Cheong, Soo Yeon; Hong, E.

doi:10.1111/bjd.16032

Cited by 31 publications

(19 citation statements)

References 6 publications

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“…It was hypothesized that this could be beneficial in terms of safety and immunogenicity (35). In line with this hypothesis, equivalent efficacy was demonstrated for SB4 and etanercept reference product in relation to the American College of Rheumatology (ACR) 20 response at 24 weeks in a phase III trial of patients with rheumatoid arthritis, but SB4 was associated with significantly fewer injection-site reactions up to week 52, and less immunogenicity than the reference product (40,41). These findings emphasize the importance of publishing biosimilar quality data to better understand biosimilar clinical trial data.…”

Section: Demonstrating Anti-tnf Biosimilaritymentioning

confidence: 95%

Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience

Barker

Girolomoni

Egeberg

et al. 2019

Journal of Dermatological Treatment

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Tumor necrosis factor (TNF) inhibitors account for a large proportion of drugs used to treat psoriasis and are indicated first-line options in certain settings. Several biosimilar drugs based on the anti-TNF agents adalimumab, infliximab, and etanercept are now available for use in patients with psoriasis. The favorable cost differential of biosimilars is expected to improve access to biologic therapy for biologic-naive psoriasis patients, who are often undertreated. Also, substantial cost savings can be made if patients are switched to biosimilars. To date, most clinical testing of anti-TNF biosimilars approved for use in psoriasis has been performed in patients with rheumatoid arthritis, and the results extrapolated to psoriasis. Although this may initially raise concerns for clinicians looking to start their psoriasis patients on biologic treatment with a biosimilar or switch from an original biologic to a biosimilar, the process of extrapolation is tightly regulated and scientifically justified. Furthermore, available real-world evidence of the safety and efficacy of anti-TNF agents in patients with psoriasis complements clinical trial data in patients with rheumatoid arthritis. When equipped with the appropriate knowledge, clinicians should have confidence to use biosimilars for the treatment of psoriasis.

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Section: Demonstrating Anti-tnf Biosimilaritymentioning

confidence: 95%

Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience

Barker

Girolomoni

Egeberg

et al. 2019

Journal of Dermatological Treatment

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“… 12 In another phase III clinical trial, SB4 was proven to be less associated with injection site reactions and also to have less immunogenic power than ETN in RA patients. 13 With this background, switching from originator bDMARD to biosimilar has become part of clinical practice, despite geographical differences: in fact, while common in European countries, the practice of switching from originator to biosimilar product is confined to a very small minority of cases in other regions, such as the USA, possibly due to the differences in healthcare systems. 14 This is particularly true for the non-medical switching (NMS), performed for non-medical reasons (mostly economic), which has raised several concerns from both physicians and patients.…”

Section: Introductionmentioning

confidence: 99%

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

Bruni

Gentileschi

Pacini

et al. 2020

Therapeutic Advances in Musculoskeletal

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Aims: Switching from originator to biosimilar is part of current practice in inflammatory rheumatic musculoskeletal diseases (iRMDs) such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondylarthritis (axSpA), with evidences derived from both etanercept (ETN) to SB4-switching randomized controlled trials and real-life registries. We investigated the safety and treatment persistence of ETN/SB4 in a multi-iRMD cohort derived from two rheumatology departments in our region. Methods: Adult patients with iRMDs, treated with ETN for at least 6 months and switched to SB4 in stable clinical condition, were eligible for this retrospective evaluation. Retrospective data on adverse events, loss of efficacy and persistence on treatment were collected until latest available follow-up. Results: A total of 220 patients (85 RA, 81 PsA, 33 axSpA, 14 juvenile idiopathic arthritis and seven other conditions; 142 females, mean age 58 ± 7 years, disease duration 12 ± 4 years, ETN duration 7 ± 4 years) were enrolled, with median follow-up of 12.1 (9.7–15.8) months. A total of 50 patients (22.7%) presented with at least one adverse event, with 36 (16.4%) disease flares and 30 (13.6%: 11 for safety and 19 loss of efficacy) SB4 withdrawals. Cumulative SB4 treatment persistence was 99.1%, 88.6% and 64.6% at 6, 12 and 18 months respectively. Back-switch to ETN was performed in 17/30 cases, the remaining cases were managed with change of biologic disease modifying or conventional synthetic anti-rheumatic drug. Age was the only significant predictor of SB4 interruption at 6 months. Conclusion: Our real-life data confirm the safety profile of switching from ETN to SB4, with slightly higher treatment persistence rates compared with other real-life registries.

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“…The difference observed in ADA incidence is likely not attributable to the assay system as both systems (using labeled ETN-RP and LBEC0101) produced similar results [39]. Interestingly, previous studies comparing etanercept biosimilars, SB4 and GP2015, with the ETN-RP have also reported unexplained lower incidences of injection site reactions and ADAs with the biosimilars compared to the ETN-RP [43,45,46]. It has been proposed that differences in the composition and container closure system between SB4 and ENT-RPfor instance, the lack of latex in the needle shield in SB4may account for the lower frequency of injection site reactions reported for patients treated with SB4 [28,46].…”

Section: Safety and Tolerabilitymentioning

confidence: 71%

“…Interestingly, previous studies comparing etanercept biosimilars, SB4 and GP2015, with the ETN-RP have also reported unexplained lower incidences of injection site reactions and ADAs with the biosimilars compared to the ETN-RP [43,45,46]. It has been proposed that differences in the composition and container closure system between SB4 and ENT-RPfor instance, the lack of latex in the needle shield in SB4may account for the lower frequency of injection site reactions reported for patients treated with SB4 [28,46]. Indeed, immunogenicity may be affected by factors such as aggregates and impurities in the product, and the container closure system [39], but further investigation is required to fully explain the differences in incidences of injection site reactions and ADAs between LBEC0101 and the ETN-RP.…”

Section: Safety and Tolerabilitymentioning

confidence: 97%

LBEC0101, an etanercept biosimilar for the treatment of rheumatoid arthritis

Song

Park

Kim

2019

Expert Opinion on Biological Therapy

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Comparison of injection-site reactions between the etanercept biosimilar SB4 and the reference etanercept in patients with rheumatoid arthritis from a phase III study

Cited by 31 publications

References 6 publications

Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience

Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience

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

LBEC0101, an etanercept biosimilar for the treatment of rheumatoid arthritis

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