Switching patients with inflammatory arthritis from Etanercept (Enbrel®) to the biosimilar drug, SB4 (Benepali®): A single-centre retrospective observational study in the UK and a review of the literature

Madenidou, Anastasia-Vasiliki; Jeffries, Andrew; Varughese, Sneha; Jones, Stephen R.; Sari-Kouzel, H; Veevers, Helen; Rao, Chandini

doi:10.31138/mjr.30.1.69

Cited by 13 publications

(9 citation statements)

References 6 publications

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“…In a small study in the Netherlands ( n = 69 switchers), the retention rate for SB4 was 75% [42]. In a UK study ( n = 72 switchers) retention rate was 73.6%; the main reasons for SB4 discontinuation were loss of effect (58%) and AEs (32%); withdrawal in patients with RA was associated with duration on reference ETN (odds ratio 1.43 [95% CI 1.02–2.00]) [46]. The authors highlighted the fact that there was no significant change in disease activity for SpA and PsA, and the loss of effect in RA was due to subjective measures except for CRP, suggesting that there were reasons for withdrawal not detected by the study.…”

Section: Resultsmentioning

confidence: 99%

“…Three small studies reported in congress abstracts found AEs to be the most frequent reason for back-switching, accounting for 58% (7/12) [42], 60% (6/10) [48] and 62.5% (6/8) [36] of back-switching, respectively (Table S1). Four congress abstracts reported ineffectiveness rather than AEs as the main reason for back-switching, accounting for 50% (7/14) [37], 80% (4/5) [39], 61% (11/18) [47] and 58% (11/19) [46] of back-switching, respectively (Table S1). In the last of these studies, the observed lack of effect was mainly subjective (see switching outcomes section above).…”

Section: Resultsmentioning

confidence: 99%

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

et al. 2019

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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.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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

et al. 2019

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“…The switchback rate varied widely between studies, with 1–72% of patients switching back after biosimilar failure either due to loss of efficacy, AEs, assumed nocebo effect, or subjective reasons. Only 24 studies reported outcomes following the switchback with the majority of patients (50–100%) regaining disease control following reinstitution of the originator treatment [ 58 , 68 , 70 , 104 , 107 , 109 , 115 , 118 – 120 , 123 , 124 , 128 , 129 , 133 , 134 , 138 – 140 , 143 – 146 , 148 ]. However, most of these studies do not provide an objective, blinded assessment of treatment failure after the switch or regaining response after switchback, and therefore it is important to note that there is a potential for bias in these studies.…”

Section: Switchback (Scenario 3)mentioning

confidence: 99%

“…Pharmacovigilance concerns also exist, particularly in those cases in which switchbacks happen relatively quickly after the initial switch, making it difficult to distinguish to which product an AE should be attributed. Patient-reported problems, such as more pain or injection/infusion reactions, and issues with delivery devices, were reported in 12 studies following a non-medical switch, often leading to a switchback to the originator [ 102 , 110 , 111 , 113 – 115 , 121 , 122 , 128 , 134 , 140 , 142 ]. However, this evidence is based on a limited number of RW studies not powered to investigate differences in injection/infusion reactions or issues with the delivery device after a switch, and it was not disclosed whether patients were adequately educated on the use of the new device.…”

Section: Switchback (Scenario 3)mentioning

confidence: 99%

The Challenges of Switching Therapies in an Evolving Multiple Biosimilars Landscape: A Narrative Review of Current Evidence

Feagan

Marabani

et al. 2020

Adv Ther

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With the increasing availability of biosimilars, the practice of switching therapies for non-medical reasons between an originator biologic and an analogous biosimilar has become more common. The evidence to support this practice mostly comes from single-switch randomized controlled trials (RCTs) and real-world (RW) evidence studies. However, as more biosimilars of the same originator enter the market, multiple switching events between originators and biosimilars is becoming a reality, despite limited evidence to support the efficacy and safety of such practice. Some countries have established guidelines, policies, or laws related to interchangeability and/or automatic substitution, whereas others have left these practices unregulated or controlled by other components of the healthcare system. Collectively, guidelines on single non-medical switching are often vague, with even less focus given to multiple non-medical switching, leaving this practice mostly unregulated. This narrative review will first discuss the current regulatory perspectives on non-medical switching and challenges associated with switching therapies, particularly with the availability of multiple biosimilars. We will then review the current evidence from RCTs and RW studies in the light of three different multiple-switch scenarios currently taking place in clinical practice: switching between an originator and a single biosimilar, switching between biosimilars of the same originator, and the clinical practice of switching back to the originator (i.e., switchbacks) after a failure of the initial non-medical switch to the analogous biosimilar.

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“…The proportion of patients who switch back to their original treatment ("back-switch" proportion) ranged from a low 1% 43 to a quarter of the patients (26%). 63 Elucidating the reasons underlying this difference is of interest to promote an agreeable switching experience for the patients, thereby minimizing the risk of performing additional switches. This is of particular importance, not just from a cost perspective, but also since payer-mandated switches from originator to biosimilar treatments are being implemented by various healthcare authorities.…”

Section: Discussionmentioning

confidence: 99%

Real-World Patient Experience of Switching Biologic Treatment in Inflammatory Arthritis and Ulcerative Colitis – A Systematic Literature Review

Luttropp¹,

Dalén²,

Svedbom³

et al. 2020

PPA

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Purpose: To obtain an up-to-date overview of the measurement of patient experience of switching biologic treatment in patients with inflammatory arthritis (IA) or ulcerative colitis (UC). Secondary objectives included summarizing the types of patient-reported outcomes (PROs) used (if any), and related findings; and summarizing medical and non-medical reasons for treatment switch and/or discontinuation. Methods: A systematic literature review (SLR) was performed, searching Medline and Embase for relevant publications. Results: In total, 70 relevant publications were identified. While the majority of these reported reasons for switching and/or discontinuing treatment, only four provided information explicitly regarding patient-reported experience of switching biologic treatment. All four utilized ranking tools to assess patient experience of switching biologic treatment. The most common reason for switching and/or discontinuing treatment was loss of efficacy, while the least common reason was patient preference. Conclusion: Although the number of available treatments in IA and UC have increased, there is a sparsity of information regarding patient-reported experience of switching biologic treatment. Further research regarding patient preference and/or experience would benefit this therapeutic area and help guide treatment choices.

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Switching patients with inflammatory arthritis from Etanercept (Enbrel^®) to the biosimilar drug, SB4 (Benepali^®): A single-centre retrospective observational study in the UK and a review of the literature

Cited by 13 publications

References 6 publications

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

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

The Challenges of Switching Therapies in an Evolving Multiple Biosimilars Landscape: A Narrative Review of Current Evidence

<p>Real-World Patient Experience of Switching Biologic Treatment in Inflammatory Arthritis and Ulcerative Colitis – A Systematic Literature Review</p>

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