Anti-tumor necrosis factor agents in psoriasis: addressing key challenges using biosimilars.

INTRODUCTION: Anti-tumor necrosis factor agents are key treatment options in moderate-severe psoriasis. The advent of multiple biosimilars of these drugs provides a major opportunity to address this particular factor by helping to reduce costs. Reduced cost can help improve undertreatment, which is one of the challenges in treating moderate-severe psoriasis. There is now a wealth of real-world evidence demonstrating that patients with psoriasis can be initiated on - or transitioned to - an anti-TNF biosimilar without detrimental effects on overall safety and efficacy. Furthermore, recent results suggest that patients can be switched between different biosimilar versions of the same anti-TNF agent without any compromise in outcomes. AREAS COVERED: In this review, we summarized the role of anti-TNFs in psoriasis, health economic aspects of anti-TNF biosimilars, and their real-world data in clinical practice and registries. EXPERT OPINION: The introduction and competition of anti-TNF biosimilars reduced the cost of biologics and accumulated real-world data support efficacy and safety of anti-TNF biosimilars for psoriasis treatment. Although IL-17 and IL-23 inhibitors show better efficacy in psoriasis patients, long-term efficacy and safety data of anti-TNF and cost-effectiveness of anti-TNF biosimilars may play an important role to increase patient access to biologics through greater adoption of biosimilars.

Treatment journey in rheumatoid arthritis with biosimilars: from better access to good disease control through cost savings and prevention of nocebo effects.

Early diagnosis and treatment of rheumatoid arthritis (RA) are of critical importance to halt the progression of the disease. Optimal use of advanced imaging techniques or biomarkers may facilitate early diagnosis of RA. Even though many disease-modifying anti-rheumatic drugs (DMARDs) are available for RA treatment, biological DMARDs (bDMARDs) offer expanding therapeutic options and good outcomes in patients with RA who do not have a sufficient response to conventional synthetic DMARDs. However, high costs of bDMARDs have limited patient access to optimised disease management and increased the cost burden for healthcare systems. The advent of biosimilars led to significant cost savings driven by price competition among the reference products, which could be beneficial for healthcare systems. Healthcare provider (HCP)-patient communication and informed shared decision-making are crucial to prevent the occurrence of a nocebo effect, which results from negative perceptions that patients may have and could lead to less effective outcomes. Research has demonstrated that effective communication between HCPs and patients utilising positive framing can improve acceptance by patients to be initiated on or switched to a biosimilar and can help to integrate biosimilars into routine clinical practice to maximise benefits for patients with RA.

Unlocking the Value of Anti-TNF Biosimilars: Reducing Disease Burden and Improving Outcomes in Chronic Immune-Mediated Inflammatory Diseases: A Narrative Review.

Immune-mediated inflammatory diseases (IMIDs) are chronic conditions that create a significant disease burden on millions of patients while adding a major financial burden to societies and healthcare systems. The introduction of biologic medicines has contributed majorly to improving the clinical outcomes of IMIDs and as such these modalities have gained first- or second-line positions in a wide range of treatment guidelines from different international clinical societies. However, the high cost of these biologics traditionally limited their accessibility and delayed their initiation, leaving millions of patients with unmet medical needs for a more affordable and sustainable solution. The introduction of cost-efficient biosimilar anti-TNFs within Europe since 2013 has allowed more patients with IMIDs to access biologic therapies earlier and for longer, potentially altering the course of the disease into a milder phenotype and reducing the long-term disease burden. This review provides the latest evidence for the impact of biosimilars on patient outcomes and demonstrates their clinical value beyond a reduction in price.

Correction to: Unlocking the Value of Anti-TNF Biosimilars: Reducing Disease Burden and Improving Outcomes in Chronic Immune-Mediated Inflammatory Diseases: A Narrative Review.

In the original article, under the "Access to treatment" heading.

Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience.

Tumor necrosis factor (TNF) inhibitors account for a large proportion of drugs used to treat psoriasis and are indicated first-line options in certain settings. Several biosimilar drugs based on the anti-TNF agents adalimumab, infliximab, and etanercept are now available for use in patients with psoriasis. The favorable cost differential of biosimilars is expected to improve access to biologic therapy for biologic-naive psoriasis patients, who are often undertreated. Also, substantial cost savings can be made if patients are switched to biosimilars. To date, most clinical testing of anti-TNF biosimilars approved for use in psoriasis has been performed in patients with rheumatoid arthritis, and the results extrapolated to psoriasis. Although this may initially raise concerns for clinicians looking to start their psoriasis patients on biologic treatment with a biosimilar or switch from an original biologic to a biosimilar, the process of extrapolation is tightly regulated and scientifically justified. Furthermore, available real-world evidence of the safety and efficacy of anti-TNF agents in patients with psoriasis complements clinical trial data in patients with rheumatoid arthritis. When equipped with the appropriate knowledge, clinicians should have confidence to use biosimilars for the treatment of psoriasis.

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

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.

Real-World Evidence on Etanercept Biosimilar SB4 in Etanercept-Naïve or Switching Patients: A Systematic Review.

INTRODUCTION: In 2016, SB4 (Benepali®) became the first etanercept (ETN) biosimilar to obtain marketing authorisation in Europe. Despite robust analytical and clinical comparisons, outstanding questions remain on SB4 use in routine practice. METHODS: A systematic search for publications on real-world evidence of SB4 effectiveness, safety and drug survival was undertaken using search terms (SB4 OR Benepali OR biosimilar etanercept OR innovator etanercept) in the BIOSIS® Toxicology, BIOSIS Previews®, Embase® and MEDLINE® databases up to 17 January 2019. RESULTS: Of 959 articles identified, eight journal articles, two journal letters and 23 congress abstracts were selected on criteria of original real-world evidence with a clinical focus. As expected with real-world evidence, quality scoring showed that the evidence had high external validity but lower internal validity. A total of 13,552 patients were described across nine European countries and all approved SB4 indications: 2499 were ETN-naïve and 11,053 switched from reference ETN to SB4 (switchers). Switch acceptance rates (a combination of clinicians offering and patients accepting initiation on SB4) ranged between 51.6% and 99.0%; patient support programmes positively contributed to acceptance. Disease activity was generally similar pre- and post-switch (typically 3-month timeframe). Retention rates across studies were at least 75% (up to 12 months follow-up). No new safety signals were identified. Differences in discontinuation rates versus historic controls reported in some studies may have been influenced by differences in treatment practices, lack of clinician confidence and nocebo effects. CONCLUSION: Nearly 2500 ETN-naïve patients have been initiated on SB4 and outcomes are similar to those patients receiving reference ETN. Overall this systematic review of real-world evidence provides additional reassurance that SB4 is as effective and safe as reference ETN in both switched and naïve patients. FUNDING: Biogen International GmbH.

Anti-TNF biosimilars in Crohn's Disease: a patient-centric interdisciplinary approach.

Introduction: The purpose of this review is to highlight the role of biosimilars in early treatment in IBD and introduce ways to facilitate a patient-centric switching process through multidisciplinary approach. Areas covered: We summarize existing scientific literature related to the role of biosimilars in inflammatory bowel disease in terms of early treatment and cost-saving and implementing switching process. Expert opinion: Use of anti-TNF biosimilars in patients has the potential for large drug-acquisition cost-saving, which can be reinvested into early treatment. Managed switched programs for adalimumab can add further benefits in the future.

Correction to: To See or NOsee: The Debate on the Nocebo Effect and Optimizing the Use of Biosimilars.

The article "To See or NOsee: The Debate on the Nocebo Effect and Optimizing the Use of Biosimilars", written by Mourad F. Rezk and Burkhard Pieper was originally published electronically on the publisher's internet portal (currently SpringerLink) on June 5, 2018 without open access.

To See or NOsee: The Debate on the Nocebo Effect and Optimizing the Use of Biosimilars.

In addition to the general clinical benefit offered, biosimilars may not only generate savings for healthcare budgets but also improve patient access to biologic products. Since the first biosimilar was approved in Europe in 2006, a further 36 different biosimilar drugs have been approved for several indications. Despite the wealth of experience gained and the reported data supporting the use of biosimilars, both in naïve and biologic-experienced patients, some healthcare professionals continue to express doubt regarding the rigorous approval process for biosimilars and uncertainty with how to incorporate them into daily clinical practice. These opinions can be transferred to patients through poor or lack of communication, meaning that patients may lack confidence in treatment quality and, as a result, be susceptible to the nocebo effect. At the 2017 American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting, during a debate the question was asked as to whether the nocebo effect was in fact being used to describe "any result you don't agree with". Here, we detail that the nocebo effect has been demonstrated in a number of clinical trials, and that this effect may negatively affect acceptance in patients switching from an originator product to a biosimilar. Awareness of the potential for the nocebo effect and adoption of enhanced communication techniques may be useful in mitigating the nocebo effect. Effective healthcare professional-patient dialogue is key in transferring confidence to the patient, and has been shown to reduce nocebo effects in patients when switching from an originator to a biosimilar. FUNDING: Biogen International GmbH.

Treatment Outcomes with Biosimilars: Be Aware of the Nocebo Effect.

Over the years, biologic agents have proven their importance in the management of chronic autoimmune diseases, such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Biosimilars, which are biologic medicines, are highly similar to approved biologic medicines, and are comprehensively developed and rigorously tested to ensure efficacy and safety are similar to the reference product. A broader armamentarium of biosimilars is expected to improve patients' access to safe and effective biologic medicines, thus offering benefits to healthcare systems around the globe. Here we consider the factors that may compromise the benefits of biosimilars being realized, including patient and physician perception of biosimilars, and an often overlooked factor, the nocebo effect, which is re-emerging with the widespread adoption of biosimilar medicines. We have also described a variety of strategies and recommendations that could help limit the nocebo effect. FUNDING: Biogen.