FRI0128 A Phase III Randomised, Double-Blind Clinical Study Comparing SB4, An Etanercept Biosimilar, With Etanercept Reference Product (Enbrel®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (24-Week Results)

2015 ◽  
Vol 74 (Suppl 2) ◽  
pp. 467.2-468 ◽  
Author(s):  
J. Vencovský ◽  
A. Sylwestrzak ◽  
P. Leszczyński ◽  
W. Porawska ◽  
A. Baranauskaite ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Study ◽  
Reference Product ◽  
Methotrexate Therapy ◽  
Phase Iii ◽  
Severe Rheumatoid Arthritis ◽  
Double Blind

scholarly journals A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy

2015 ◽  
Vol 76 (1) ◽  
pp. 58-64 ◽  
Author(s):  
Jung-Yoon Choe ◽  
Nenad Prodanovic ◽  
Jaroslaw Niebrzydowski ◽  
Ivan Staykov ◽  
Eva Dokoupilova ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Reference Product ◽  
Methotrexate Therapy ◽  
Phase Iii ◽  
Severe Rheumatoid Arthritis ◽  
Double Blind ◽  
Acr20 Response ◽  
American College Of Rheumatology ◽  
Registration Number ◽  
Adjusted Rate

ObjectivesTo compare the efficacy, safety, immunogenicity and pharmacokinetics (PK) of SB2 to the infliximab reference product (INF) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy.MethodsThis is a phase III, randomised, double-blind, multinational, multicentre parallel group study. Patients with moderate to severe RA despite methotrexate therapy were randomised in a 1:1 ratio to receive either SB2 or INF of 3 mg/kg. The primary end point was the American College of Rheumatology 20% (ACR20) response at week 30. Inclusion of the 95% CI of the ACR20 response difference within a ±15% margin was required for equivalence.Results584 subjects were randomised into SB2 (N=291; 290 analysed) or INF (N=293). The ACR20 response at week 30 in the per-protocol set was 64.1% in SB2 versus 66.0% in INF. The adjusted rate difference was −1.88% (95% CI −10.26% to 6.51%), which was within the predefined equivalence margin. Other efficacy outcomes such as ACR50/70, disease activity score measured by 28 joints and European League against Rheumatism response were similar between SB2 and INF. The incidence of treatment-emergent adverse events was comparable (57.6% in SB2 vs 58.0% in INF) as well as the incidence of antidrug antibodies (ADA) to infliximab up to week 30 (55.1% in SB2 vs 49.7% in INF). The PK profile was similar between SB2 and INF. Efficacy, safety and PK by ADA subgroup were comparable between SB2 and INF.ConclusionsSB2 was equivalent to INF in terms of ACR20 response at week 30. SB2 was well tolerated with a comparable safety profile, immunogenicity and PK to INF.Trial registration numberNCT01936181.

scholarly journals Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis

2020 ◽  
Vol 39 (11) ◽  
pp. 3341-3352
Author(s):  
Gerd Burmester ◽  
Edit Drescher ◽  
Pawel Hrycaj ◽  
David Chien ◽  
Zhiying Pan ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Reference Product ◽  
Tumor Necrosis Factor Inhibitor ◽  
Similar Efficacy ◽  
Double Blind Study ◽  
Inadequate Response ◽  
Severe Rheumatoid Arthritis ◽  
Double Blind ◽  
Single Transition ◽  
Anti Cd20

Abstract Background/objectives ABP 798 is a proposed biosimilar to the originator biologic rituximab, an anti-CD20 monoclonal antibody. This comparative clinical study evaluated the pharmacokinetics (PK), safety, and efficacy of ABP 798 versus rituximab reference product (RP) in patients with moderate-to-severe rheumatoid arthritis (RA). Methods Adults with moderate-to-severe RA with an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs including 1 or more tumor necrosis factor inhibitor therapies (n = 311) received ABP 798, US-sourced rituximab RP (rituximab US), or EU-sourced rituximab RP (rituximab EU) (1000 mg, 2 weeks apart). At week 24, ABP 798- or rituximab EU-treated subjects received a second dose of the same treatment, while rituximab US-treated subjects transitioned to receive ABP 798. The key efficacy endpoint was DAS28-CRP change from baseline at week 24. Other efficacy endpoints included DAS28-CRP at other time points; ACR20, ACR50, and ACR70 criteria; and hybrid ACR. The rituximab RP groups were pooled for all efficacy endpoints since PK equivalence had been established between rituximab US and rituximab EU. Results Clinical equivalence between ABP 798 and rituximab RP was established as the 90% confidence interval for DAS28-CRP change from baseline at week 24 fell within the prespecified equivalence margin (− 0.6, 0.6). Safety and immunogenicity profiles of ABP 798 were comparable across treatment groups and not affected by single transition from RP to ABP 798. Conclusions Clinical equivalence in terms of efficacy, safety, and immunogenicity was established between ABP 798 and rituximab RP in this comparative clinical trial in patients with moderate-to-severe RA. Key Points• ABP 798 provided similar efficacy as rituximab reference product (RP) in patients with moderate-severe rheumatoid arthritis.• The safety and immunogenicity profiles for ABP 798 were similar to those for the rituximab RP.• The single transition from rituximab RP to ABP 798 did not show differences in efficacy, safety, or immunogenicity.

scholarly journals Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to methotrexate

2017 ◽  
Vol 77 (4) ◽  
pp. 488-494 ◽  
Author(s):  
Hiroaki Matsuno ◽  
Masato Tomomitsu ◽  
Atsushi Hagino ◽  
Seonghye Shin ◽  
Jiyoon Lee ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Active Rheumatoid Arthritis ◽  
Reference Product ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acr20 Response ◽  
American College Of Rheumatology ◽  
Parallel Group ◽  
Registration Number

ObjectiveTo evaluate the similarities between LBEC0101 (etanercept biosimilar) and the etanercept reference product (ETN-RP) in terms of efficacy and safety, including immunogenicity, in patients with active rheumatoid arthritis despite methotrexate treatment.MethodsThis phase III, multicentre, randomised, double-blind, parallel-group, 54-week study was conducted in Japan and Korea. The primary efficacy endpoint was the change from baseline in the disease activity score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) at week 24. American College of Rheumatology 20% (ACR20) response rate, adverse events (AEs), pharmacokinetics and development of antidrug antibodies (ADAs) were also evaluated.ResultsIn total, 374 patients were randomised to LBEC0101 (n=187) or ETN-RP (n=187). The least squares mean changes from baseline in DAS28-ESR at week 24 in the per-protocol set were −3.01 (95% CI −3.198 to −2.820) in the LBEC0101 group and −2.86 (95% CI −3.051 to −2.667) in the ETN-RP group. The estimated between-group difference was −0.15 and its 95% CI was −0.377 to 0.078, which was within the prespecified equivalence margin of −0.6 to 0.6. ACR20 response rates at week 24 were similar between the groups (LBEC0101 93.3% vs ETN-RP 86.7%). The incidence of AEs up to week 54 was comparable between the groups (LBEC0101 92.0% vs ETN-RP 92.5%), although fewer patients in the LBEC0101 group (1.6%) than the ETN-RP group (9.6%) developed ADAs.ConclusionThe clinical efficacy of LBEC0101 was equivalent to that of ETN-RP. LBEC0101 was well tolerated and had a comparable safety profile to ETN-RP.Trial registration numberNCT02357069.

Sign in / Sign up

Export Citation Format

Share Document