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Biosimilars
Optimising anti-TNF treatment using biosimilars
Declaration of sponsorship Biogen

Making decisions about anti-TNF biosimilars

Declaration of sponsorship Biogen
Read time: 10 mins
Last updated:13th Dec 2022
Published:12th Feb 2020
In this Section

Shared decision-making between health care professionals and patients

Shared decision-making (SDM) between health care professionals (HCP) and patients, as opposed to HCPs making decisions on behalf of patients without proper information and consent, is supported by a growing base of evidence, across a range of therapy areas from rheumatologic disease to cancer1.  How can SDM boost treatment adherence and persistence for biologics and/or biosimilars?

Studies show that when patients have an active involvement in treatment decisions and are more educated about their treatment they will elect for more conservative treatment options2. Patients who adhere to their treatments are three times more likely to achieve desired outcomes, such as improved quality of life and better functional capacity, than nonadherent patients3. 

Adherence is the extent to which a patient takes a medication as prescribed by his or her HCP, and is usually reported as medication possession ratio, or percentage of days covered4 

When HCPs and patients engage in SDM there is a greater likelihood of adherence for patients, often with the added bonus of reduced health care costs3. Health care costs attributable to nonadherence annually in the US are estimated to be $100–$300 billion per year (2014 data)4.

In a 2021 cohort study of 1,655 Medicare beneficiaries at high risk of hospitalisation, and high-need resource use, the population-adjusted prevalence of cost-related medication nonadherence (CRN) was 53.6%; 28.4% of those who reported CRN at least once, had persistent CRN during the 15-month study period. Younger age, worse self-reported health, and depression, were associated with increased chance of persistent CRN. This result indicates that CRN is prevalent, moderately persistent, and variable in the Medicare population, despite coverage by insurance.

Implementation of shared decision-making in clinical practice

Treatment decisions for chronic conditions are inherently challenging as they occur over time and may need to be revisited6. However, SDM is only implemented in less than 50% of decisions on biologics in inflammatory bowel disease (IBD)6. IBD, including ulcerative colitis (UC) and Crohn’s disease (CD), develop in relatively young patients (approximately 25% of patients with IBD present before age 20 years)7. A recent real-world evidence (RWE) study in 5,612 patients with CD and 3,533 patients with UC demonstrated that less than half of the patients continued using their initial biologic treatment after 1 year (overall mean persistence rate of 48.48% in CD cohort; 44.78% in UC cohort)8. In the same study, the persistence rate for patients on different biologics ranged from 34.6% to 50.9% for CD, and 32.5% to 64.8% for UC8.

Benefits of shared decision-making for patients

SDM can be used to inform patients that equivalent outcomes that have been observed between originator biologics and biosimilars support the idea that, in a carefully managed environment, patients can switch between treatments9,10. Patients are often unfamiliar with biosimilars, and may express concerns about the safety and efficacy of treatment when asked to switch from a reference biologic. It is important to provide patients with evidence-based information to support a switch11,12. 

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How biosimilars are changing exit strategies with anti-TNF therapy

 

In this short video, Professor Thomas Dörner (Charité University Hospitals, Berlin, Germany) summarises treating patients with minimal disease levels, including the benefits and drawbacks of early treatment, tapering down treatment, and treatment discontinuation in patients with minimal disease levels or remission.

Tumour necrosis factor alpha inhibitor biosimilars

More tumour necrosis factor alpha inhibitor (anti-TNF) biosimilars available on the market represent increasing treatment options for patients and potentially improved rates of remission. Healthcare professionals (HCP) are starting to re-evaluate the need of applying exit strategies for anti-TNF therapy with the reduced costs of these treatments, following the advent of biosimilars.

For each major class of treatment used alone or in combination, there is a risk of relapse following dose reduction or stopping of treatment26. Generally, patients in clinical, biochemical and endoscopic remission have an increased chance of maintaining health when treatments are stopped26. Whether or not to stop a treatment depends on each individual patient and SDM with the patient should take place26.  

The risks, benefits, and timing of stopping anti-TNF treatment for inflammatory bowel disease (IBD) when patients are in stable remission on therapy, remain a topic of discussion27. In a meta-analysis of 27 studies evaluating discontinuation of anti-TNF therapies in patients with IBD, the overall risk of relapse after discontinuation of anti-TNF therapy was 44% for Crohn’s disease (CD) [95% CI 36–51%; 912 patients] and 38% for ulcerative colitis (UC) [23–52%; 266 patients] over the course of a year28. When anti-TNF treatment was stopped based exclusively on achievement of clinical remission, 42% of patients with CD relapsed during the following year. However, if patients discontinued anti-TNF therapy after achieving not only clinical but also endoscopic remission, the relapse rate at 1 year decreased to 26%28.

Biosimilars and exit strategies for anti-TNF therapies

The availability of biosimilars is causing an revaluation of the current guidelines on exit strategies for anti-TNF therapies. For instance, a single-centre retrospective analysis of 30 patients with IBD, found low relapse rates in patients with CD and UC who discontinued treatment with infliximab after achieving sustained remission31. Patients’ mean length of infliximab treatment before discontinuation was 38.5 months31. At 24 months after discontinuation, 91% of the 22 patients with available data remained in clinical remission31,32. After stopping infliximab, 50% of patients took no other medications for their IBD31. In total, 13.3% of patients had relapsed, and restarted biologic therapy. A cost analysis showed that discontinuing infliximab saved the hospital the equivalent of €379,351.56 over the study period31. The study demonstrated that discontinuing infliximab in patients with sustained remission was safe and cost-effective31.

A real-world study assessing the persistence of biologic therapies in UC and CD in patients independent of prior biologic experience, found that the sustainability of biologic treatment was less in UC than in CD patients, and not strongly determined by prior biologic exposure. These findings suggest the need for new non-biologic/small molecules to demonstrate their relative sustainability as IBD therapies (Figure 3)33.

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