Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies.

Autor: Sun B; Viatris Inc, 1000 Mylan Boulevard, Canonsburg, PA, 15317, USA. Bin.Sun@viatris.com., Sengupta N; Biocon Research Limited, 20th KM, Hosur Road, Electronic City, 560100, Bangalore, India., Rao A; Biocon Research Limited, 20th KM, Hosur Road, Electronic City, 560100, Bangalore, India., Donnelly C; Viatris Inc, 1000 Mylan Boulevard, Canonsburg, PA, 15317, USA., Waichale V; Biocon Research Limited, 20th KM, Hosur Road, Electronic City, 560100, Bangalore, India.; Agilex Biolabs, SA, Thebarton, Australia., Roy AS; Biocon Research Limited, 20th KM, Hosur Road, Electronic City, 560100, Bangalore, India.; Cliantha Research Limited, Ahmedabad, India., Ramaswamy S; Biocon Research Limited, 20th KM, Hosur Road, Electronic City, 560100, Bangalore, India., Pathak D; Biocon Research Limited, 20th KM, Hosur Road, Electronic City, 560100, Bangalore, India.; Altasciences, QC, Laval, Canada., Bowsher RR; B2S Life Sciences, 97 East Monroe Street, Franklin, IN, 46131, USA., Raiter Y; Viatris Inc, 1000 Mylan Boulevard, Canonsburg, PA, 15317, USA., Aubonnet P; Viatris Inc, Turmstrasse 24, Tower 4, 6312, Steinhausen, Switzerland., Barve A; Viatris Inc, 1000 Mylan Boulevard, Canonsburg, PA, 15317, USA.
Jazyk: angličtina
Zdroj: BMC endocrine disorders [BMC Endocr Disord] 2021 Jun 26; Vol. 21 (1), pp. 129. Date of Electronic Publication: 2021 Jun 26.
DOI: 10.1186/s12902-021-00797-4
Abstrakt: Background: MYL-1501D is a proposed biosimilar to insulin glargine. The noninferiority of MYL-1501D was demonstrated in patients with type 1 diabetes and type 2 diabetes in 2 phase 3 trials. Immunogenicity of MYL-1501D and reference insulin glargine was examined in both studies.
Methods: INSTRIDE 1 and INSTRIDE 2 were multicenter, open-label, randomized, parallel-group studies. In INSTRIDE 1, patients with type 1 diabetes received MYL-1501D or insulin glargine over a 52-week period. In INSTRIDE 2, patients with type 2 diabetes treated with oral antidiabetic drugs, insulin naive or not, received MYL-1501D or reference insulin glargine over a 24-week period. Incidence rates and change from baseline in relative levels of antidrug antibodies (ADA) and anti-host cell protein (anti-HCP) antibodies in both treatment groups were determined by a radioimmunoprecipitation assay and a bridging immunoassay, respectively. Results were analyzed using a mixed-effects model (INSTRIDE 1) or a nonparametric Wilcoxon rank sum test (INSTRIDE 2).
Results: Total enrollment was 558 patients in INSTRIDE 1 and 560 patients in INSTRIDE 2. The incidence of total and cross-reactive ADA was comparable between treatment groups in INSTRIDE 1 and INSTRIDE 2 (P > 0.05 for both). A similar proportion of patients had anti-HCP antibodies in both treatment groups in INSTRIDE 1 at week 52 (MYL-1501D, 93.9 %; reference insulin glargine, 89.6 %; P = 0.213) and in INSTRIDE 2 at week 24 (MYL-1501D, 87.3 %; reference insulin glargine, 86.9 %; P > 0.999).
Conclusions: In INSTRIDE 1 and INSTRIDE 2, similar immunogenicity profiles were observed for MYL-1501D and reference insulin glargine in patients with type 1 diabetes and type 2 diabetes, respectively.
Trial Registration: ClinicalTrials.gov, INSTRIDE 1 ( NCT02227862 ; date of registration, August 28, 2014); INSTRIDE 2 ( NCT02227875 ; date of registration, August 28, 2014).
Databáze: MEDLINE
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