Long-term effectiveness and safety of switching from originator to biosimilar infliximab in patients with Behçet’s disease

Excerpt

Behçet’s disease (BD) is a chronic multisystem inflammatory disorder clinically characterized by the “triple symptom complex,” consisting of recurrent oral aphthosis, genital ulcers, and chronic relapsing bilateral uveitis [1]. Besides this classical clinical pattern, other organs and systems including gastrointestinal tract, musculoskeletal, cardiovascular, and central nervous system may also be involved [2, 3]. The management of BD is often challenging due to its protean clinical features, therefore treatment should be individualized to each patient according to the type and severity of organ involvement [4]. The effectiveness of tumor necrosis factor (TNF) blockers, especially the monoclonal antibody anti-TNF-a infliximab (IFX), for all severe BD manifestations resistant to conventional therapy, has pointed out the critical role of this cytokine in its pathogenesis [5‐8]. However, the impending patent expiration and the relatively high costs of anti-TNF agents, have paved the way for biosimilar drugs development, the first of which has been the biosimilar IFX CT-P13. The efficacy and safety of biosimilar IFX has been evaluated in different inflammatory conditions, and approved for all indications of the reference product in several countries [9]. In spite of this, it is still debated whether the biosimilar IFX performs equally to the originator when patients treated with reference IFX are switched to biosimilar in routine care, as small differences in immunogenicity might influence tolerability and outcomes [10]. For this reason, biosimilars remain a hot topic in rheumatology, and some physicians are cautious about their application in clinical practice. To the best of our knowledge, there are scanty data on biosimilar IFX employment in BD [11], some of them with conflicting results, advising caution with regard to the automatic replacement of reference IFX in sustained remission patients [12]. Based on a retrospective chart survey, in the present study we report our experience with biosimilar IFX CT-P13 in patients affected by BD, who were switched from originator IFX. …