Innovator Infliximab Research Articles

Su1025 - Cost-Effectiveness of Infliximab's Biosimilar CT-P13 Compared to Innovator Infliximab for the Management of Crohn's Disease

Su1025 - Cost-Effectiveness of Infliximab's Biosimilar CT-P13 Compared to Innovator Infliximab for the Management of Crohn's Disease

DOP061 Phase III randomised, double-blind, controlled trial to compare biosimilar infliximab (CT-P13) with innovator infliximab in patients with active Crohn's disease: early efficacy and safety results

DOP061 Phase III randomised, double-blind, controlled trial to compare biosimilar infliximab (CT-P13) with innovator infliximab in patients with active Crohn's disease: early efficacy and safety results

Comparative efficacy and safety of infliximab biosimilar (BCD-055) and innovator infliximab in patients with ankylosing spondylitis (results of international, multiple-center, double-blind phase I and phase III clinical studies)

This article presents results from two clinical trials of infliximab biosimilar, BCD-055, including comparative data on the pharmacokinetics (PK), efficacy and safety of BCD-055 and innovator infliximab (IFX) in patients with ankylosing spondylitis (AS). Objective : The purpose of phase I clinical study ASART-1 was to evaluate the pharmacokinetic and safety profile of BCD-055 and to prove its equivalence with Remicade®, phase III study ASART-2 was conducted to evaluate the efficacy and tolerability of BCD-055 in comparison with Remicade® in patients with active AS. Patients and methods : Both studies were conducted as international multi-center randomized double-blind studies in direct comparison with innovator IFX. Inclusion and exclusion criteria, main examination methods, and drug regimens were the same in both trials. A total of 199 patients were enrolled in the studies. After the screening, the 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 at 0, 2, 6 and then every 8 weeks (up to week 54). The primary endpoint for PK profile evaluation was the area under the concentration-time curve (AUC(0-tau)), maximum serum concentration of infliximab at steady state Cmax,ss. Efficacy was assessed by achieving ASAS20 at week 30, the endpoints for safety profile were the incidence of adverse events and serious adverse events during the maintenance-dosing phase and withdrawals from the study due to the safety reasons. Results : A total of 81 patients (ASART-1 study) were included in PK analysis, 199 patients were in efficacy and safety analysis. AUC(0-tau) value were 25,420,996.25±11,635,015.74 (ng/ml) Cmax,ss for BCD-055 and 26,114,705.71±12,102,376.9 (ng/ml)⋅h for INF innovator (p>0.05). Cmax,ss for BCD-055/Remicade® was 122,752 [99,401–151,553] ng/ml and 119,844 [98,120–132,772] ng/ml, respectively (p>0.05). ASAS20 was achieved at week 30 by 81.30% of the patients in the BCD-055 group, and 67.74% in the INF innovator group (p=0.061). The analysis of secondary endpoints (BASDAI, BASMI, BASFI, MASES, quality of life, chest excursion, and number of pathologically changed joints) showed no difference between the biosimilar and innovator groups. BCD-055 and innovator IFX showed highly similar safety profiles in both studies without cases of unexpected toxicity. The rates of AEs were equivalent for both drugs and were 48.48% and 58.21% of patients in the BCD-055 and Remicade®, respectively. Conclusion : BCD-055 is found to be equivalent in terms of PK, and showed the similarity in efficacy and safety profile compared with innovator IFX in patients with active AS.

Safety and efficacy of CT-P13 in Japanese patients with rheumatoid arthritis in an extension phase or after switching from infliximab

Objectives: This study aimed to evaluate the safety of CT-P13 in patients with rheumatoid arthritis (RA) during long-term treatment or after switching from innovator infliximab (IFX).Methods: Patients who completed 54 weeks of treatment in a phase I/II study (PI/II) received CT-P13 at an initial dose of 3 mg/kg at Week 62, with dose increases permitted up to 10 mg/kg. The primary endpoint was adverse event (AE) incidence.Results: Thirty-four of 38 patients in the maintenance group and 29 of 33 in the switch group reported at least one AE. Safety profiles in both groups were similar to those in PI/II. Eleven of 28 patients who were positive for anti-drug antibodies (ADA) at Week 62 discontinued the study before Week 110. Forty-one of 43 ADA-negative patients remained negative, and 10 of 28 ADA-positive patients became negative during the study. The mean DAS28 (ESR) at Week 134 was 3.166 in the maintenance group and 3.955 in the switch group.Conclusions: CT-P13 was well tolerated in patients who maintained the treatment after 54 weeks and in patients who switched to CT-P13 after 54 weeks of IFX treatment. The study also demonstrated a stable clinical efficacy of CT-P13 in RA patients.

Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study.

Biosimilar infliximab (INX) was recently approved by the European Medicine Agency for the treatment of rheumatoid arthritis, ankylosing spondylitis (AS), Crohn's disease, ulcerative colitis, psoriatic arthritis (PsA), and psoriasis on the grounds that its pharmacokinetics, safety, and efficacy were comparable to those of innovator INX. The aim of this study was to investigate the real-life efficacy, safety, and immunogenicity of switching from innovator to biosimilar INX in patients with spondyloarthritis (SpA). Forty-one patients attending three Italian rheumatology centres with a previous diagnosis of SpA and clinically inactive or moderate disease activity (ASDAS-CRP<2.1; 22 with AS, five with enteropathic arthritis, 10 with PsA, and four with undifferentiated SpA), who had been treated for more than 6months with innovator INX in accordance with the ASAS/EULAR guidelines, were switched to biosimilar INX for pharmaco-economic reasons (Tuscany Law No. 450 of 7 April 2015) and followed up for 6months. A record was kept of their BASDAI, BASFI, ASDAS-CRP, DAS28-CRP (in the presence of peripheral disease), MASES, VAS pain scores, the duration of morning stiffness, and adverse events (AEs). At the time of the switch, the patients had a median age of 50.9years (range 23-80), a median disease duration of 124.5months (range 14-372), and a median duration of treatment with innovator INX of 73.7months (range 6-144). After 6months of biosimilar INX therapy, there were no statistical differences in their median BASDAI (2.73±1.5 vs. 2.6±1.3, p=.27), BASFI (2.34±1.3 vs. 2.17±1.2, p=0.051), ASDAS-CRP (1.35±0.3 vs. 1.28±0.2, p=0.24), DAS28-CRP (2.66±0.67 vs. 2.67±0.35, p=0.92), MASES (0.35±0.7 vs. 0.17±0.4, p=0.08), or VAS pain scores (18±14.7 vs. 16.7±11.3, p=0.55), whereas the median duration of morning stiffness had significantly decreased (7.2±6.9 vs. 5.8±6, p=0.02). Furthermore, there was no change in circulating INX (4.22±2.89 vs 4.84±2.86μg/mL, p=0.80) or anti-INX antibody levels (27.76±17.13 vs 27.27±17.28ng/mL, p=0.98). The switch from innovator to biosimilar INX in this Italian multicentre SpA cohort was not associated with any statistically significance differences in efficacy, adverse events or anti-drug antibody level.

Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis

Objectives. To demonstrate the pharmacokinetic equivalence of CT-P13 and its innovator infliximab (IFX) in Japanese patients with rheumatoid arthritis (RA), and to compare the efficacy and safety of these drugs, administered for 54 weeks.Methods. In a randomized, double-blind, parallel-group, multicenter study, 3 mg/kg of CT-P13 or IFX, in combination with methotrexate (MTX) (6–16 mg/week), was administered for 54 weeks to Japanese active RA patients with an inadequate response to MTX, to demonstrate the pharmacokinetic equivalence, based on the area under the curve (AUCτ) (weeks 6–14) and Cmax (week 6) of these drugs, and to compare their efficacy and safety.Results. The CT-P13-to-IFX ratios (90% confidence intervals) of the geometric mean AUCτ and Cmax values in patients negative for antibodies to infliximab at week 14 were 111.62% (100.24–124.29%) and 104.09% (92.12–117.61%), respectively, demonstrating the pharmacokinetic equivalence of these drugs. In the full analysis set, CT-P13 and IFX showed comparable therapeutic effectiveness, as measured by the American College of Rheumatology, Disease Activity Score in 28 joints, the European League Against Rheumatism, and other efficacy criteria, at weeks 14 and 30. The incidence of adverse events was similar for these drugs.Conclusion. CT-P13 and IFX, administered at a dose of 3 mg/kg in combination with MTX to active RA patients, were pharmacokinetically equivalent and comparable in efficacy and safety.

THU0159 Disease Activity Assessment Using the DAS28, CDAI and SDAI and Effect of Anti-Drug Antibody on Clinical Response in a Randomized, Double-Blind, Comparative Trial of CT-P13 and Innovator Infliximab: Planetra Study

BackgroundCT-P13 is a biosimilar to innovator infliximab (INX) approved by the European Medicines Agency. From the PLANETRA, which is randomized, double-blind, active-controlled trial to assess efficacy and safety of CT-P13...

THU0158 Inhibition of Radiographic Progression and Its Association with Clinical Parameters in RA Patients Treated with CT-P13 and Innovator Infliximab in PLANETRA Study

BackgroundCT-P13 is a biosimilar of innovator infliximab (INX), approved by the European Medicines Agency in 2013. Clinical data up to 1 year from PLANETRA have been reported at EULAR 20131ObjectivesTo...

OP0157 Clinical Response of Disease Activity, Disability and Mobility Indices in Relation to Anti-Drug Antibody in the Planetas

BackgroundRecently, the European Medicines Agency approved a biosimilar to infliximab, CT-P13. Biosimilars are not only required to have biochemical and pharmacokinetics (PK) equivalence, but also must demonstrate similarity in their...

SAT0214 Statistical Evalution of Joint Damage Prgression in Patients with Rheumatoid Arthritis Treated with Infliximab or Biosimilar Infliximab (CT-P13) Anti-TNF Therapy: A Role of Sensitivity Analysis for Missing Data Evaluating Similarity

BackgroundBiosimilar infliximab (CT-P13) was the first monoclonal antibody biosimilar of innovator infliximab (INX) approved by the European Medicines Agency. In the PLANETRA study (1), patients with rheumatoid arthritis received 3...

FRI0281 The Rate of Positive Conversion in the Quantiferon-TB Gold Test over 2 Years among Patients Treated with CT-P13 or Innovator Infliximab in the Extension Studies of Planetas and Planetra

BackgroundLong-term treatment of anti-TNF agents in patients with immune mediated disease can increase the risk of active tuberculosis infection (ATBI) by reactivation of latent tuberculosis infection (LTBI) or de novo...

A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study

ObjectivesTo compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) and CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS).MethodsPhase 1 randomised, double-blind, multicentre, multinational,...

A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study

ObjectivesTo compare the efficacy and safety of innovator infliximab (INX) and CT-P13, an INX biosimilar, in active rheumatoid arthritis patients with inadequate response to methotrexate (MTX) treatment.MethodsPhase III randomised, double-blind,...