THU0146 Impact of anti-Drug Antibodies on Efficacy and Safety Up To Week 24 from A Phase III Study Comparing SB5 (An Adalimumab Biosimilar) with Adalimumab Reference Product in Patients with Moderate To Severe Rheumatoid Arthritis despite Methotrexate Therapy

2016 ◽  
Vol 75 (Suppl 2) ◽  
pp. 234.2-234
Author(s):  
M.C. Genovese ◽  
M. Weinblatt ◽  
E. Keystone ◽  
A. Baranauskaite ◽  
S.Y. Cheong ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Reference Product ◽  
Methotrexate Therapy ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Severe Rheumatoid Arthritis ◽  
Phase Iii Study

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.

Sign in / Sign up

Export Citation Format

Share Document