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Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results

JS. Smolen, JY. Choe, N. Prodanovic, J. Niebrzydowski, I. Staykov, E. Dokoupilova, A. Baranauskaite, R. Yatsyshyn, M. Mekic, W. Porawska, H. Ciferska, K. Jedrychowicz-Rosiak, A. Zielinska, J. Choi, YH. Rho,

. 2017 ; 56 (10) : 1771-1779.

Language English Country Great Britain

Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc18016317

Objectives: SB2 is a biosimilar to the reference infliximab (INF). Similar efficacy, safety and immunogenicity between SB2 and INF up to 30 weeks were previously reported. This report investigates such clinical similarity up to 54 weeks, including structural joint damage. Methods: In this phase III, double-blind, parallel-group, multicentre study, patients with moderate to severe RA despite MTX were randomized (1:1) to receive 3 mg/kg of either SB2 or INF at 0, 2, 6 and every 8 weeks thereafter. Dose escalation by 1.5 mg/kg up to a maximum dose of 7.5 mg/kg was allowed after week 30. Efficacy, safety and immunogenicity were measured at each visit up to week 54. Radiographic damage evaluated by modified total Sharp score was measured at baseline and week 54. Results: A total of 584 patients were randomized to receive SB2 (n = 291) or INF (n = 293). The rate of radiographic progression was comparable between SB2 and INF (mean modified total Sharp score difference: SB2, 0.38; INF, 0.37) at 1 year. ACR responses, 28-joint DAS, Clinical Disease Activity Index and Simplified Disease Activity Index were comparable between SB2 and INF up to week 54. The incidence of treatment-emergent adverse events and anti-drug antibodies were comparable between treatment groups. Such comparable trends of efficacy, safety and immunogenicity were consistent from baseline up to 54 weeks. The pattern of dose increment was also comparable between SB2 and INF. Conclusion: SB2 maintained similar efficacy, safety and immunogenicity with INF up to 54 weeks in patients with moderate to severe RA. Radiographic progression was comparable at 1 year. Trial registration: ClinicalTrials.gov (http://clinicaltrials.gov; NCT01936181) and EudraCT (https://www.clinicaltrialsregister.eu; 2012-005733-37).

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$a Choe, Jung-Yoon $u Division of Rheumatology, Daegu Catholic University Medical Center, Daegu, South Korea.
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$a Prodanovic, Nenad $u Department of Rheumatology and Clinical Immunology, Clinical Center Banja Luka, Banja Luka, Bosnia and Herzegovina.
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$a Niebrzydowski, Jaroslaw $u Divison of Rheumatology, Medica Pro Familia, Gdynia, Poland.
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$a Staykov, Ivan $u Divison of Rheumatology, MHAT "Dr. Ivan Seliminski", Sliven, AD, Bulgaria.
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$a Dokoupilova, Eva $u Divison of Rheumatology, MEDICAL PLUS s.r.o, Uherske Hradiste, Czech Republic.
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$a Baranauskaite, Asta $u Division of Rheumatology, Lithuanian University of Health Sciences, Kaunas, Lithuania.
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$a Mekic, Mevludin $u Department of Health, Diseases and Rheumatism, University Clinic Centre Sarajevo, Sarajevo, Bosnia and Herzegovina.
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$a Porawska, Wieskawa $u Division of Rheumatology, Poznanski Osrodek Medyczny NOVAMED, Poznan, Poland.
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$a Ciferska, Hana $u Division of Rheumatology, Revmatologicky ustav, Praha, Czech Republic.
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$a Jedrychowicz-Rosiak, Krystyna $u Divison of Rheumatology, MCBK S.C., Grodzisk Mazowiecki.
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$a Zielinska, Agnieszka $u Divison of Rheumatology, Medica Pro Familia, Warszawa, Poland.
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