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Low immunogenicity but reduced bioavailability of an interferon beta-1a biosimilar compared with its biological parent: results of MATRIX, a cross-sectional, multicenter phase 4 study

Authors Cuevas C, Deisenhammer F, You X, Scolnik M, Buffels R, Sperling B, Flores-Ramírez F, Macías-Islas M, Sauri-Suárez S

Received 30 January 2015

Accepted for publication 3 June 2015

Published 15 September 2015 Volume 2015:5 Pages 75—81


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Editor who approved publication: Professor Shein-Chung Chow

Carlos Cuevas,1 Florian Deisenhammer,2 Xiaojun You,3 Mariano Scolnik,4 Regine Buffels,3 Bjørn Sperling,3 Francisco Flores-Ramírez,5 Miguel Macías-Islas,6 Sergio Sauri-Suárez7

On behalf of the MATRIX Investigator Group

1Specialty Hospital, Department of Neurology, National Medical Center Siglo XXI, Mexican Institute of Social Security, Mexico City, Mexico; 2Department of Neurology, University of Innsbruck, Innsbruck, Austria; 3Biogen, Cambridge, MA, USA; 4Biogen, Argentina, Buenos Aires, Argentina; 5Department of Internal Medicine–Neurology, Hospital Regional ISSSTE Monterrey, Monterrey, 6University Center for Health Sciences, University of Guadalajara, Guadalajara, 7Internal Medicine/Department of Neurology, National Medical Center, Mexico City, Mexico

Abstract: MATRIX (Measuring neutralizing Antibodies in patients TReated with Interferon beta-1a IM in MeXico) was primarily a cross-sectional phase 4 study of patients with relapsing multiple sclerosis (RMS) that evaluated neutralizing antibody (NAb) frequency in Mexican and Colombian patients treated with intramuscular interferon (IFN) beta-1a in the form of Avonex® or the biosimilar drug Jumtab®. A secondary long-term retrospective observational evaluation of safety, tolerability, and relapses was also performed for patients in each arm of the study. In the cross-sectional portion of the study, patients with multiple sclerosis who had been treated with once-weekly Avonex (n=36) or Jumtab (n=29) self-injections as their first and only disease-modifying therapy for 1–3 years were retrospectively identified. The primary and secondary endpoints were proportion of patients with NAb levels >100 tenfold reduction units (TRU) and >20 TRU. The biological response to IFN beta-1a injections was assessed by change in serum neopterin levels and by pre- versus post-dose concentration difference. Safety, tolerability, and relapse-related information were also retrospectively assessed. No patients developed NAb levels >100 TRU. Neopterin levels were significantly higher relative to baseline with Avonex than with Jumtab. Supporting this result, flu-like symptoms were reported in a greater proportion of Avonex-treated than Jumtab-treated patients. No unexpected adverse events or significant differences in relapses were observed. In conclusion, Avonex and Jumtab exhibited minimal immunogenicity; Jumtab was associated with significantly lower neopterin activation and flu-like symptom frequency compared with Avonex, suggesting less IFN bioactivity with Jumtab.

Keywords: multiple sclerosis, neutralizing antibodies, flu-like symptoms, neopterin, follow-on biologics, biosimilars

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