e55 Analysis of rheumatoid arthritis patients who failed the switch from originator etanercept to biosimilar etanercept in Croydon

Patel, Dimil; Ahmed, Talat; Levy, Sarah; Rajak, Rizwan; Sathananthan, Rosh; Horwood, Natalie

doi:10.1093/rheumatology/key075.596

Cited by 4 publications

(3 citation statements)

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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%

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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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Section: Switchback (Scenario 3)mentioning

confidence: 99%

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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“…Study characteristics are described in Supplementary Table 6. 28 studies were performed in patients with IA; 18,19,26-28,30-36,47,49-51,55-57, 59-63,67,79,80,83 25 in patients with RA; 7,16,17,23,24,37,39,40,[42][43][44][45]53,54,58,66,68,70,[73][74][75][76][77][78]84 5 in patients with AS; 21,25,46,48,65 4 in patients with PsA; 41,64,71,81 4 in patients with UC; 22,69,72,82 2 in patients with IBD (with results reported separately for UC); 38,52 and one in patients with SpA. 29 Most studies were retrospective (n=37), while 28 were prospective and one was cross-sectional.…”

Section: Study Characteristicsmentioning

confidence: 99%

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

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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Nonmedical Switching From Originators to Biosimilars: Does the Nocebo Effect Explain Treatment Failures and Adverse Events in Rheumatology and Gastroenterology?

Fleischmann

Jairath

Mysler³

et al. 2020

Rheumatol Ther

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The act of nonmedical switching, defined as switching stable patients who are generally doing well with their current therapy from an originator biologic to its biosimilar, has been endorsed as a reasonable treatment strategy. The safety and efficacy of nonmedical switching have been evaluated in randomized controlled and real-world evidence studies, which have demonstrated that although many patients maintain treatment response after the switch, some patients experience therapy failure, resulting in therapy discontinuation. It has been postulated that the vast majority, if not all, of these treatment failures result from a ''nocebo effect'', defined as patients' negative expectations toward the therapy change. Reports suggest that the risk of a nocebo effect is higher following a mandated nonmedical switch. Although the nocebo effect is a well-recognized phenomenon in pain studies, evidence is limited in immune-mediated diseases primarily because it is difficult to quantify, especially retrospectively. In spite of this, numerous biosimilar studies in patients with immunemediated diseases have concluded that nonmedical switching failures are due to a nocebo effect. The objective of this narrative review was to explore the reasons for nonmedical switch failure or discontinuation and the role of the nocebo effect among patients with inflammatory rheumatic and gastrointestinal diseases who switched from an originator biologic to its biosimilar.

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e55 Analysis of rheumatoid arthritis patients who failed the switch from originator etanercept to biosimilar etanercept in Croydon

Cited by 4 publications

References 0 publications

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

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>

Nonmedical Switching From Originators to Biosimilars: Does the Nocebo Effect Explain Treatment Failures and Adverse Events in Rheumatology and Gastroenterology?

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