Biosimilar therapies in inflammatory bowel disease: should we care about patient profile?

Biosimilars represent a great opportunity to treat patients with inflammatory bowel disease (IBD) at a lower cost, especially in the long term. Recent data from real-life cohort studies show that infliximab biosimilar may not differ from the originator in terms of efficacy, safety, and immunogenicity, both in adult and pediatric IBD populations. Long-term data are still needed to confirm these preliminary observations. We briefly discuss the recent data available on infliximab biosimilars in IBD, proposing the best patient profile to be eligible for the use of biosimilars in the next future. In the last two decades, monoclonal antibodies (mAbs), also known as biological agents, have brought a revolution in the management of IBD, such as Crohn’s disease (CD) and ulcerative colitis (UC), in terms of controlling disease symptoms, healing mucosal lesions, and reducing the IBD-related hospitalization and surgery rates [1,2]. Costs derived from the use of mAbs account for the 15% of all costs related to IBD in the first year [3], and they are expected to increase in the next future, also considering that up to 50% of patients achieving deep remission with mAbs would need to continue biological agents over time. The recent development of mAb biosimilars represents a great opportunity for the management of IBD, theoretically offering the same clinical efficacy with significantly high health-care resource sparing effects. Recently, two biosimilars of infliximab are available in the European Union. Since their approval by the European Medicine Agency, there has been a strong debate on the lack of data in IBD deriving from clinical studies [4–6]. Actually, the approval of biosimilars in IBD was based on data coming from two randomized controlled trials conducted on subjects with rheumatoid arthritis and ankylosing spondylitis, and prolonged up to 2 years [7–10], showing no clinical differences in terms of efficacy, safety, and immunogenicity, both in subjects naïve to infliximab and in those switched from the infliximab originator to the infliximab biosimilar. Between 2013 and 2014, the European Crohn’s Colitis Organization and some national IBD societies published their position papers, focusing on the need for clinical data in IBD, the need for more solid data concerning safety and immunogenicity in the long term, and expressing their concerns about the automatic substitution by a different person from the prescribing physician, and the same International Non-proprietary Name given to all the infliximab molecules (originator and biosimilars) [4–6,11]. More recently, preliminary data are coming from real-life cohort studies across different countries that may support the bioequivalence of infliximab biosimilars in IBD, as well as in rheumatology and dermatology [12–14]. Gecse et al. conducted a prospective observational multicenter nationwide cohort study across Hungary on 90 consecutive IBD patients (57 CD and 33 UC subjects) treated by infliximab biosimilar for a median time of 108 weeks for CD and 54 weeks for UC. They found a significant decrease in the clinical activity index and C-reactive protein (CRP) in the whole study population, and only four allergic reactions in subjects previously exposed to infliximab. Similar preliminary results come from the large prospective study ongoing in Norway (the NOR-SWITCH study) [15]. Data from 46 CD and 32 UC patients showed a statistically significant reduction in disease activity, fecal calprotectin, and CRP at week 14. Twenty-two patients (8 UC and 14 CD) were previously treated with other biologics. After the induction phase, 76% (32/42) of CD subjects were in clinical remission (HBI score ≤4), as well as 56% (18/32) of UC subjects. These preliminary data show that probably no differences may be expected from biosimilars of infliximab EXPERT REVIEW OF CLINICAL IMMUNOLOGY, 2016 VOL. 12, NO. 4, 361–363 http://dx.doi. org/10.1586/1744666X.2016. 1141050