Anti-tumor necrosis factor agents in psoriasis: addressing key challenges using biosimilars

Prignano, Francesca; Choi, Jaeyun; Pieper, Burkhard; Iversen, Lars

doi:10.1080/14712598.2020.1812576

Cited by 10 publications

(7 citation statements)

References 32 publications

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“…15,20 The gradual accumulation and analysis of longterm data on the use of biosimilars may help to increase the confidence of clinicians to advocate their use. 25,57 It is also important for clinicians to understand the development and approval process for biosimilars in order to provide the best cost-effective access to care for their patients. 25,57 For example, clinicians should understand that biosimilar products are approved on their 'sameness' to a reference product, not through the recreation of trials performed for the reference product.…”

Section: Discussionmentioning

confidence: 99%

“…25,57 It is also important for clinicians to understand the development and approval process for biosimilars in order to provide the best cost-effective access to care for their patients. 25,57 For example, clinicians should understand that biosimilar products are approved on their 'sameness' to a reference product, not through the recreation of trials performed for the reference product. This sameness is performed in the setting most sensitive to detect any differences, which may not be the setting for the major indication of the product.…”

Section: Discussionmentioning

confidence: 99%

“…Since the first biosimilars were approved, many studies have assessed the safety and efficacy of switching from the reference products. 25 A systematic review of 90 studies in 2018 reported that the vast majority of studies did not observe differences in safety, efficacy, or immunogenicity between biosimilars and the associated reference products, indicating that the benefitrisk profile is unchanged when switching to a biosimilar. 26 Some of the most recent real-world studies conducted in this field, published over the past 18 months, are summarised below.…”

Section: Real-world Studies Of Anti-tnf Biosimilars In Immune-mediate...mentioning

confidence: 99%

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The Rise of Anti-TNF Biosimilars: Guidelines, Real-World Evidence, and Challenges to Acceptance

Humphry¹

2022

EMJ Gastroenterol

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The over-production of TNF-α can lead to chronic inflammation and organ damage in immune-mediated inflammatory diseases (IMID), such as rheumatoid arthritis (RA), axial spondyloarthritis, psoriasis, and inflammatory bowel disease (IBD). Anti-TNF therapy is generally considered to be an effective, well-tolerated treatment option for the management of chronic inflammation in these conditions. Over the past decade, patents for the original reference anti-TNF agents have expired, permitting the development of anti-TNF products that are biologically similar, termed ‘biosimilar’, to the original reference product. Differences in the approval process mean that biosimilars are often available to healthcare services at a considerably lower cost compared with the reference products, providing an opportunity to improve patient access to the benefits of anti-TNF therapy. However, despite the spreading use of biosimilars across healthcare services, some clinicians remain reluctant to prescribe them. The gradual accumulation of long-term data on the real-world use of biosimilars, and an improved understanding of the development and approval process for these products, may help to increase clinicians’ confidence to increase usage of biosimilars. This mini review summarises the current status of anti-TNF biosimilars in clinical practice, including the requirements for regulatory approval, real-word evidence for their equivalence to novel anti-TNFs, guidelines for their use, and challenges to their acceptance by both clinicians and patients.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Real-world Studies Of Anti-tnf Biosimilars In Immune-mediate...mentioning

confidence: 99%

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The Rise of Anti-TNF Biosimilars: Guidelines, Real-World Evidence, and Challenges to Acceptance

Humphry¹

2022

EMJ Gastroenterol

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“…The study used efficacy criteria and measures that were already applied in other large-scale clinical trials with systemic medications for the treatment of psoriasis [ 23 , 24 ]. The primary endpoint, PASI 75 response at week 16, was shown to be equivalent for BCD-057 and iADA: the 95% CIs for treatment difference were within the predefined margins for equivalence of ±15%.…”

Section: Discussionmentioning

confidence: 99%

Long-term data on the proposed adalimumab biosimilar BCD-057 in patients with moderate to severe psoriasis: A randomized controlled trial

et al. 2022

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Introduction The objective of this study was to demonstrate that BCD-057 is similar to innovator adalimumab (iADA) in terms of efficacy, safety, and pharmacokinetics in steady state in the target population of patients with moderate to severe plaque psoriasis (NCT02762955). Methods Patients were randomized in 1:1 ratio to receive 80 mg of BCD-057 or iADA at week 0 and 40 mg thereafter every other week from week 1. At week 24 patients from iADA group were re-randomized (1:1) to continue iADA or to be switched to BCD-057. The primary efficacy endpoint was 75% improvement in Psoriasis Area and Severity Index from baseline (PASI 75), secondary endpoints included PASI percent improvement and relative change in affected Body Surface Area (BSA) from baseline at weeks 16, 24, 33, and 55. Safety was assessed through monitoring of adverse events (AEs) and antidrug antibodies. Pharmacokinetics was evaluated at steady state. Results Overall, 346 adult patients were included in the study (174/172 patients in BCD-057/iADA arms, respectively). At week 16 PASI 75 was achieved by 60.34% and 63.37% of patients in BCD-057 and iADA arms, respectively (p = 0.5622). Bounds of the calculated 95% confidence interval (CI) for the difference between PASI 75 responses in arms [-13.26%; 7.2%] fall within the equivalence margin [-15% to 15%] demonstrating equivalent efficacy of BCD-057 and iADA. At week 55 81.61%, 85.56%, and 80.49% of patients in BCD-057, iADA and iADA/BCD-057 arms achieved PASI 75. Comparison of the secondary endpoints did not show significant differences between arms. A comparable pharmacokinetics was shown at steady state. Safety profiles and proportions of patients with antidrug antibodies were similar between arms. The switch from the iADA to BCD-057 did not affect the immunogenicity profile. Conclusion Obtained data demonstrate that BCD-057 and iADA are highly similar in clinical efficacy, pharmacokinetics, safety, and immunogenicity in patients with moderate to severe plaque psoriasis.

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“…High-quality TNF-α inhibitor biosimilars have been providing a cheaper, yet effective option, therefore being suitable for prescription early in the patient care path [ 3 , 4 ]. The biological properties of biosimilars in terms of pharmacokinetic and pharmacodynamic features and immunogenicity are comparable to the originator [ 5 ]. The US Food and Drug Administration and/or the European Medicines Agency have so far approved several adalimumab biosimilars, including MSB11022 (Idacio), ABP501 (Amgevita), SB5 (Imraldi), BI695501 (Cyltezo), GP2017 (Hyrimoz), FKB327 (Hulio), PF06410293 (Amsparity/Abrilada), and CTP17 (Celltrion) [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

Real-Life Effectiveness of Adalimumab Biosimilars in Patients with Chronic Plaque Psoriasis

Bellinato

Gisondi

Mason

et al. 2022

Dermatol Ther (Heidelb)

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Introduction The real-life effectiveness of adalimumab biosimilars in patients with psoriasis has rarely been investigated. Objective To investigate drug survival of adalimumab biosimilars in patients with chronic plaque psoriasis and factors associated with its discontinuation. Methods We carried out a retrospective observational study including all consecutive patients with chronic plaque psoriasis who initiated adalimumab biosimilar MSB11022 (Idacio), ABP501 (Amgevita), or SB5 (Imraldi) between 1 January 2018 and 1 January 2021. The 1-year drug survival of adalimumab biosimilar and independent factors associated with its discontinuation were investigated. Cox regression models were fit to estimate adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs) for the risk of adalimumab discontinuation. A propensity score matching (PSM) model was adopted as sensitivity analysis. Results The study involved a total of 410 patients with follow-up of 549.84 person-years, 271 (66.1%) men, a mean (SD) age of 51.8 (14.5) years, and a baseline PASI of 14.54 (5.02). Among adalimumab biosimilars, 250 (61%) patients received MSB11022, 98 (24%) received ABP501, and 62 (15%) received SB5. Drug survival of adalimumab biosimilars at 1 year was 81.5% in the overall study population. Obesity was associated with increased risk of adalimumab discontinuation (HR = 2.01; 95% CI 1.33–3.03), whereas psoriatic arthritis (aHR = 0.32; 95% CI 0.16–0.64) and receiving adalimumab as first systemic treatment (aHR = 0.44; 95% CI 0.27–0.70) were associated with lower risk. Conclusion The real-life effectiveness of adalimumab biosimilars in patients with psoriasis is consistent with that previously reported for the originator. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-022-00732-y.

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Anti-tumor necrosis factor agents in psoriasis: addressing key challenges using biosimilars

Cited by 10 publications

References 32 publications

The Rise of Anti-TNF Biosimilars: Guidelines, Real-World Evidence, and Challenges to Acceptance

The Rise of Anti-TNF Biosimilars: Guidelines, Real-World Evidence, and Challenges to Acceptance

Long-term data on the proposed adalimumab biosimilar BCD-057 in patients with moderate to severe psoriasis: A randomized controlled trial

Real-Life Effectiveness of Adalimumab Biosimilars in Patients with Chronic Plaque Psoriasis

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