Enhancing treatment success in inflammatory bowel disease: Optimising the use of anti-TNF agents and utilising their biosimilars in clinical practice

Abstract

Anti-tumour necrosis factor (TNF) agents such as infliximab and adalimumab have greatly altered the treatment landscape in inflammatory bowel disease (IBD). However, there are remaining unmet needs and opportunities to optimise their use. Recent data suggest that proactive therapeutic drug monitoring may lead to more efficient usage of these agents, with potential for higher rates of corticosteroid-free clinical remission than with reactive monitoring. Expanded application of faecal calprotectin measurements may also be valuable, given the ease of use of the assay and its proven effectiveness as a diagnostic tool and predictor of relapse risk. From a practical viewpoint, improved multidisciplinary working may be essential to optimise patient care, with IBD nurse specialists playing an increasingly central role within this model. Finally, the availability of biosimilars of the anti-TNF agents allow drug costs to be reduced without compromising safety or efficacy-thereby providing opportunities to improve accessibility. Alongside extensive data on originator to biosimilar infliximab switch, new studies are beginning to demonstrate the safety of biosimilar to biosimilar switch, as well as adalimumab biosimilar transitions. The risk of a nocebo effect when switching to a biosimilar can be reduced through improved patient education and preparation.

Informing Patients about Biosimilar Medicines: The Role of European Patient Associations

“…This should include the thorough regulatory evaluation process of EMA that assures the same clinical efficacy and safety between the original and biosimilar product. The potential benefits of biosimilars can also be considered, albeit in understandable language and as direct benefits (i.e., increase in access to necessary medicines or access to treatments at an earlier disease stage) [8,54,76]. However, it should be avoided that the impression is created that the patient is treated with biosimilars only for the sake of cost savings.…”

Biosimilar Uptake: The Importance of Healthcare Provider Education

“…A second approach is for clinicians to integrate biosimilars as part of a more comprehensive treatment strategy. For example, therapeutic drug monitoring (i.e., checking serum drug levels to guide future decisions), biomarker monitoring (i.e., to predict relapse risk and provide an objective measure of disease activity), and multidisciplinary working (i.e., bringing together diagnostic/treatment input from all providers involved in treatment of a given patient) have all been offered as examples of how biosimilars treatment can be enhanced to improve outcomes [ 37 ]. Any approaches that enhance outcomes will build clinician confidence in the efficacy of biosimilars, which will impact uptake; all the better if such approaches come from fellow clinicians, who are clearly a trusted source of information for each other.…”

Switching from IFX originator to biosimilar CT-P13 does not impact effectiveness,safety and immunogenicity in a large cohort of IBD patients

“…The definition of steroid-free clinical remission based on PRO2 allows a more comprehensive perception of patients' insight and avoid physicians' interpretation of data 41 . Anxiety associated with a perceived "change of therapy" might be held responsible for the observed symptomatic worsening 5 . Accordingly, the relation between patients and health-care providers is crucial for the management of the nocebo effect.…”

“…Biological drugs have significantly contributed to improve IBD management and patients 'quality of life, but have induced a significant increase in healthcare costs, resulting as the main driver of treatment-related expenses 3,4 . The advent of anti TNF-α biosimilars, after expiration of originators' patents, resulted in considerable cost-savings and increased patients' access to these drugs 5 .…”