G. Lopalco, V. Venerito, L. Cantarini
Oct 25, 2018
Internal and Emergency Medicine
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 . 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 . 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 . 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 . 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 , some of them with conflicting results, advising caution with regard to the automatic replacement of reference IFX in sustained remission patients . 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. Thirteen patients diagnosed with BD according to the International Study Group criteria or the International Criteria for BD initially treated with originator IFX were switched to biosimilar IFX CT-P13 from March 1st 2017 to May 31st 2017. Retrieved data including gender, ethnicity, age at diagnosis, HLA-B51 haplotype, clinical manifestations for which originator IFX was started, as well as age and concomitant immunosuppressive drugs at switch were collected (Table 1). The study was approved by the local ethics committee according to the Declaration of Helsinki principles. After obtaining informed consent from all patients, originator IFX was replaced with biosimilar CT-P13 at a dosage of 5 mg/kg every 8 weeks. Clinical assessment was done at the last follow-up visit under originator IFX, subsequently after starting biosimilar, every 3 months, and in case of disease relapse, during a whole follow-up period of 12 months. To assess disease activity accurately, the BD current activity form (BDCAF) was used at each examination during the treatment. BDCAF is a tool for the assessment of BD activity, which scores the history of clinical features including mucocutaneous lesions, joint, blood vessel, gastrointestinal, eye involvement, and central nervous system complications, which present over the 4 weeks prior to the day of assessment. The occurrence of adverse events was Giuseppe Lopalco and Vincenzo Venerito equally contributed to this work.