Does Similarity Breed Contempt? A Review of the Use of Biosimilars in Inflammatory Bowel Disease

Bhat, Shubha; Limdi, Jimmy K.; Cross, Raymond K.; Farraye, Francis A.

doi:10.1007/s10620-021-07114-y

Cited by 13 publications

(10 citation statements)

References 40 publications

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“… 76 Because biosimilars withdrawal was closely associated with non-specific complaints, several authors suggest that the nocebo effect is probably the best explanation for biosimilar’s discontinuation. 12 , 37 , 77 , 78 The nocebo effect is the worsening of symptom induction by pharmacological or non-pharmacological treatments. 20 , 79 The nocebo responses may result from patients’ negative expectations and not the pharmacologic action of the biosimilar itself.…”

Section: Resultsmentioning

confidence: 99%

“… 35 Biosimilar uptake can be influenced by patient-related factors, including refusal to change or negative perceptions. 6 , 36 , 37 Patients satisfied with RA control or confident with their current treatment did not perceive a need to change their treatment, which may risk losing the currently acceptable health state or fearing new side effects. 38 , 39 …”

Section: Introductionmentioning

confidence: 99%

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Patient-Reported Outcomes in Rheumatoid Arthritis: A Key Consideration for Evaluating Biosimilar Uptake?

Horta-Baas¹

2022

PROM

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Purpose This review aims to provide an overview of the impact of TNFis biosimilars, with marketing authorization, in patient-reported outcome measures (PROMs) scores and explore how PROMs endpoints might add value in biosimilars uptake in RA patients. Patients and Methods A comprehensive search of Medline, Scopus, Lilacs, and CINAHL databases was performed for papers published between January 2012 and December 2021. For inclusion, studies had to be prospective, published in a peer-reviewed journal, published in English or Spanish language; studies using PROMs as an outcome measure. After screening title and abstracts and assessing the remaining full texts fulfilling the inclusion criteria, 31 papers were used in this narrative review. Results PROMs were used as secondary outcomes in included studies. The most frequently employed domains to assess biosimilar efficacy include physical function, patient global assessment (PtGA), health-related quality of life (HRQoL), and fatigue. The results of randomized clinical trials uniformly showed that mean change in PROMs scores is comparable between biosimilar and reference biologic treatment groups. However, open-label and real-world studies revealed high rates of discontinuation of therapy, mainly for subjective worsening of disease activity or non-specific adverse events. Even without objective clinical evidence of inflammation, patients who are considered to have active disease (higher scores on PtGA) have higher discontinuation rates of biosimilars. The available information suggests that the nocebo effect is the most likely cause for the discontinuation of biosimilars. Conclusion There is scarce literature surrounding the impact of biosimilars in PROMs, especially in open-label studies. In real-life studies, biosimilars have a higher discontinuation rate than reference products. TNFis biosimilars treatment efficacy in RA depends on disease activity and other factors such as PtGA and fatigue. The nocebo effect is the best explanation for biosimilar’s discontinuation.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Patient-Reported Outcomes in Rheumatoid Arthritis: A Key Consideration for Evaluating Biosimilar Uptake?

Horta-Baas¹

2022

PROM

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“…85 The use of biosimilars provides several advantages including easing the economic burden of anti-TNF treatment, increasing access to anti-TNF therapy, thereby allowing earlier access to treatment, and availability of assays for measuring drug concentrations to optimise patient care. 87 This paves the way for reducing complications and functional disability associated with IBD. 86 In 2021, Schreiber et al conducted an open-label study investigating the use of subcutaneous IFX biosimilar compared to its intravenous route.…”

Section: Biosimilarsmentioning

confidence: 99%

A review of the therapeutic management of Crohn’s disease

Kumar

Cole

Segal

et al. 2022

Therap Adv Gastroenterol

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Crohn’s disease is a chronic inflammatory, relapsing-remitting, and progressive gastrointestinal disorder with an often-negative impact on the physical, emotional, and psychological well-being. Over the past two decades, the medical compendium for the treatment of Crohn’s disease has increased significantly, enabling treatment beyond symptoms. Indeed, early and timely use of effective medical therapy has been reflected by improved outcomes with reduction in surgery and ability to achieve clinical and endoscopic remission, reduce corticosteroid dependance, and prevent long-term complications in more patients. In this review, we discuss the key milestones in the medical management of Crohn’s disease.

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“…Like other biosimilars, adalimumab-adbm has the potential to generate price competition among products, thereby (1) driving down medication and possibly insurance-related costs (eg, premiums), and (2) increasing patient access to treatment, permitting for earlier use of therapies traditionally deemed to be expensive. 25 However, as an interchangeable biosimilar, adalimumab-adbm could have a greater impact on patient care and health systems, as interchangeability status (subject to state pharmacy laws) permits adalimumab-adbm to be substituted and dispensed in place of the prescribed reference product without consulting the prescribing provider. 7 This step reduces some of the existing barriers to biosimilar adoption and use, including formulary limitations and provider/patient reservations.…”

Section: Relevance To Patient Care and Clinical Practicementioning

confidence: 99%

Adalimumab-Adbm: The First Interchangeable Biosimilar for the Treatment of Inflammatory Diseases

et al. 2022

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Objective The objective of the study was to review the pharmacologic and clinical profile of adalimumab-adbm (BI 695501), the first interchangeable biosimilar for treatment of inflammatory diseases. Data Sources A PubMed search was conducted from inception to December 2021 using the keywords BI 695501 and adalimumab-adbm. Information was also obtained from published abstracts and package inserts. Study Selection and Data Extraction Phase 1, 2 and 3 studies plus relevant literature on adalimumab-adbm pharmacologic and clinical profile were reviewed. Data Synthesis: Adalimumab-adbm approval was based on a series of phase 3 VOLTAIRE trials, which evaluated the biosimilar’s efficacy and safety in the treatment of moderate to severe Crohn’s disease, rheumatoid arthritis, and psoriasis. Interchangeability status was granted based on data from the VOLTAIRE-X trial. The VOLTAIRE and VOLTAIRE-X studies demonstrated comparable efficacy and safety between adalimumab-adbm and reference adalimumab. Common adverse events included infections and injection site reactions. Similar to reference adalimumab, adalimumab-adbm contains black box warnings related to serious infections and malignancy. Relevance to Patient Care and Clinical Practice Adalimumab-adbm is the first interchangeable biosimilar to be approved for inflammatory diseases and has the potential to improve patient access to treatment while decreasing medication-related costs. However, it will not be commercially available for patient use until 2023 and its adoption into clinical practice may face potential barriers seen with other biosimilars. Conclusion As an interchangeable biosimilar with comparable efficacy and safety to reference adalimumab, adalimumab-adbm is an important advance toward cost-effective management of inflammatory diseases.

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Does Similarity Breed Contempt? A Review of the Use of Biosimilars in Inflammatory Bowel Disease

Cited by 13 publications

References 40 publications

Patient-Reported Outcomes in Rheumatoid Arthritis: A Key Consideration for Evaluating Biosimilar Uptake?

Patient-Reported Outcomes in Rheumatoid Arthritis: A Key Consideration for Evaluating Biosimilar Uptake?

A review of the therapeutic management of Crohn’s disease

Adalimumab-Adbm: The First Interchangeable Biosimilar for the Treatment of Inflammatory Diseases

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