Background Infliximab (IFX) was one of the first genetically engineered biologics successfully applied for medical use in patients with active RA and patients with AS. Previous preclinical studies showed that BCD-055 is highly similar to innovator IFX.
Objectives This abstract presents results from three clinical trials of infliximab biosimilar, BCD-055, including comparative data on pharmacokinetics (PK), efficacy and safety in a variety of patient populations.
Methods All three studies were conducted as international multicenter randomized double-blind studies in direct comparison with innovator IFX. ASART-1 study (Phase 1, PK study) and ASART-2 study (Phase 3, efficacy and safety study) were conducted in patients with AS. After the screening patients were stratified by CRP and BASDAI score, randomized (1:1 ratio in ASART-1; 2:1 ratio in ASART-2) into 2 arms and received BCD-055 or innovator IFX at a dose 5 mg/kg IV on day 1 wk 0, 2, 6 and then every 8 wks (up to wk 54). LIRA study (Phase 3 study) was conducted in patients with active RA who were stratified by age and DAS28 score, randomized (2:1) into 2 arms and received BCD-055 or innovator IFX at a dose 3 mg/kg IV on day 1 wk 0, 2, 6 and then every 8 wks (up to wk 54).
Results A total of 91 patients were enrolled in ASART-1 study, 198 patients - in ASART-2 study and 195 patients - in LIRA study in Russia and Belarus.
PK characteristics were equivalent for BCD-055 and innovator IFX. After the single administration 90%CI for the ratio of geometric means for AUC0–336 was 86.40% – 110.09%, for Cmax – 82.70% – 109.83%. After multiple-dose administration 90%CI for the ratio of geometric means for AUC0-tau was 81.35% – 121.13%, for Cmax,ss – 90.16% – 117.32%.
Efficacy: BCD-055 is non-inferior to innovator IFX both in RA and AS patients: ACR20 at wk 14 was reached by 75.83% of patients in BCD-055 group and 74.19% in innovator IFX group (p=0.951, 95% CI for difference in proportion [-12.90%; 16.18%], margin -20%), ASAS20 at wk 30 - by 81.30% and 67.74% respectively (p=0.061, 95% CI for difference in proportion [-1.18%; 28.28%], margin -17.5%).
Safety: BCD-055 and innovator IFX showed highly similar safety profiles in all three studies without cases of unexpected toxicity. The rates of AEs were equivalent for both drugs and varied from 47% in patients with AS to 53% in patients with RA. Immunogenicity assessment didn't find any significant difference between BCD-055 and innovator IFX, anti-drug antibodies occurred at the same rate irrespectively to the group.
Conclusions BCD-055 is highly similar to innovator IFX in patients with active RA and in patients with AS in terms of efficacy, safety and PK.
Disclosure of Interest L. Denisov: None declared, I. Gordeev: None declared, V. Mazurov: None declared, A. Lila: None declared, E. Zonova: None declared, O. Nesmeyanova: None declared, E. Ilivanova: None declared, T. Plaksina: None declared, A. Eremeeva Employee of: JCS BIOCAD, A. Artemeva Employee of: JCS BIOCAD, E. Chernyaeva Employee of: JCS BIOCAD, R. Ivanov Employee of: JCS BIOCAD, S. Pimanov: None declared, E. Kunder: None declared, N. Soroka: None declared