| Autor: |
Vacchi C; Rheumatology Unit, University of Modena and Reggio Emilia, Modena, Italy.; Clinical and Experimental Medicine PhD Program, University of Modena and Reggio Emilia, Modena, Italy., Visentini M; Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy., Gragnani L; Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy., Fraticelli P; Department of Internal Medicine, Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona, Ancona, Italy., Tavoni A; Clinical Immunology Unit, University Hospital of Pisa, Pisa, Italy., Filippini D; Rheumatology Unit, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy., Saccardo F; Presidio Ospedaliero Di Saronno, ASST Della Valle Olona, Saronno, Italy., Lauletta G; Department of Biomedical Sciences and Human Oncology, University of Bari 'Aldo Moro', Bari, Italy., Colantuono S; Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy., Atzeni F; Rheumatology Unit, University of Messina, Messina, Italy., Pioltelli P; Hematology Unit, AO San Gerardo, Università Di Milano-Bicocca, Monza, Italy., Manfredi A; Rheumatology Unit, University of Modena and Reggio Emilia, Modena, Italy., Casato M; Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy., Zignego AL; Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy., Monti G; Presidio Ospedaliero Di Saronno, ASST Della Valle Olona, Saronno, Italy., Pietrogrande M; Department of Health Sciences, University of Milan, Milan, Italy., Galli M; Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy., Sebastiani M; Rheumatology Unit, University of Modena and Reggio Emilia, Modena, Italy. marco.sebastiani@unimore.it. |
| Abstrakt: |
Rituximab (RTX) represents a milestone in the treatment of mixed cryoglobulinemic vasculitis (MCV). Despite usually well-tolerated, RTX may induce different types of adverse drug reactions, including exacerbation of vasculitis. Recently, RTX biosimilar CT-P10 has been approved in Europe for the treatment of rheumatoid arthritis, but no data are available about effectiveness and safety of CT-P10 in the treatment of MCV. In this multicenter open-label study, we analyzed the safety of CT-P10 in patients with MCV treated in first-line or after a shift by RTX originator. Fifty-one consecutive MCV patients (females/males 35/16, median age 68 years, median disease duration 42 months, 51% HCV positive) were included in the study between July and December 2018 and were treated with CT-P10 (group 1). Safety and effectiveness of CT-P10 were compared with a retrospective group (group 2) including 75 consecutive patients treated with RTX originator between July 2017 and July 2018. Thirty-six patients were treated with CT-P10 for the first time, while the other 15 switched from RTX originator. RTX was administrated with high or dosage schemes (375 mg/m 2 four times a week apart/1000 mg twice one week apart or 250 mg/m 2 twice one week apart). During a month period after the last infusion, 13/51 adverse events (AE) were observed in group 1 and 17/75 in group 2 (p not significant). Among them, 7/13 and 6/17 (in group 1 and 2, respectively) could be considered immune-mediated AE (p not significant). At univariate analysis patients with IM-AE were more frequently males (p = 0.04) and with a lower disease duration (p = 0.03), but both the parameters were not significant at logistic regression. About clinical response after 6 months by the end of the treatment, no differences were observed between patients treated with originator and CT-P10 regarding the response to the therapy. No differences were observed in safety and effectiveness between patients naïve at RTX or switching from originator. Despite the higher prevalence of immune-mediated AE among patients treated with CT-P10 than originator, we have observed no significant differences between the 2 groups. The use of a low-dosage regimen is more common in group 1 than in group 2, representing a possible bias of the study, possibly influencing the appearance of AE. Considering the cost/efficacy ratio of biosimilars, their use could be helpful to treat a large number of MCV patients with an effectiveness and safety comparable to originator. Multicenter studies including a large number of patients and the new RTX biosimilars could be useful to fully elucidate the possible risk of immune-mediated adverse events with biosimilar drugs. Considering the cost/efficacy ratio of CT-P10, its use could help to treat a large number of MCV patients with an effectiveness and safety comparable to originator. |
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