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Optimising anti-TNF treatment using biosimilars
Declaration of sponsorship Biogen

Decision Making

Declaration of sponsorship Biogen
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Shared decision making (SDM) between physicians 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 cancer.1 So, 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 options.2 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 patients.3 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 costs.3 Health care costs attributable to nonadherence annually in the United States are estimated to be $100–$300 billion per year.4

Treatment decisions for chronic conditions are inherently challenging as they occur over time and may need to be revisited.5 However, SDM is only implemented in less than 50% of decisions on biologics in inflammatory bowel disease (IBD).5 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).6 A recent 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).7 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 UC.7

SDM can be used to inform patients that equivalent outcomes have been observed between originator biologics and biosimilars supporting the idea that, in a carefully managed environment, patients can switch between treatments.8–9 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 therefore important to provide them with evidence-based information to support such a switch.10,11 An example of the benefits of SDM is the switching programme between reference infliximab and biosimilar infliximab that was conducted in 143 patients with IBD in one UK hospital.8 The programme was conducted in a carefully managed environment using SDM and found that there was no significant difference in drug persistence between the cohort who switched to biosimilar infliximab versus the cohort treated with reference infliximab in the year before the switch.8 The IBD-specialist nurses supporting patients during the switch with care and information about their treatment may have contributed to significant improvements in patient-reported outcomes as an example of the utility of SDM.8,11

There are a number of factors that seem to determine acceptance of biosimilars and emphasise the importance of conversation between patient and HCP. When a switch from an originator product to a biosimilar is proposed by HCPs used to offering the switch and that provide positive information on biosimilars, acceptance of the switch increases.12 Providing patients with written information on switching to biosimilars improves acceptance rates.12 Furthermore, having the option to switch back if patients considered that tolerance or efficacy was not deemed equivalent also contributed to increased acceptance rates.12

Biogen_Biosimilars_Bucket4_Fig1__B69CAC6D-08C0-43AE-BAAC7DAEABFB504F.png

Figure 1, Survival curve showing drug persistence in relation to reference infliximab in all patients treated with reference infliximab (from April 2014 to March 2015), and in relation to biosimilar infliximab CT-P13 in patients switched from reference infliximab (between April 2014 and March 2015) at University Hospital Southampton.8,11

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How biosimilars are changing exit strategies with anti-TNF therapy

The increasing numbers of anti-TNF biosimilars available on the market represent increasing treatment options for patients and potentially improved rates of remission. HCPs 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 treatment.22 Generally, patients in clinical, biochemical and endoscopic remission have an increased chance of maintaining health when treatments are stopped.22 Whether or not to stop a treatment depends on each individual patient and SDM with the patient should take place.22 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 discussion.23 In a recent 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 year.24 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%.24

The availability of biosimilars is causing a reevaluation 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 among patients with CD and UC who discontinued treatment with infliximab after achieving sustained remission.25 Patients’ mean length of infliximab treatment before discontinuation was 38.5 months.25 At 24 months after discontinuation, 91% of the 22 patients with available data remained in clinical remission.25 After stopping infliximab, 50% of patients took no other medications for their IBD.25 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 €379351.56 over the study period.25 The study demonstrated that discontinuing infliximab in patients with sustained remission was safe and cost-effective.25,26

Biogen_Biosimilars_Bucket4_Fig2a__94963F34-4C9F-4E88-833AD27986D6B635.png

Biogen_Biosimilars_Bucket4_Fig2b__FD1386D2-7EDA-4071-A6DF097E04D9A4BD.png

Figure 3, median time to discontinuation between biologic naïve and biologic experienced patients with UC and CD.27

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References

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