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

Abstract

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.

Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2016 update of the EULAR recommendations for the management of rheumatoid arthritis

“…IFX CT-P13 also demonstrated clinical efficacy in another RCT of MTX-IR RA 46. Efficacy was also formally proven in placebo-controlled RCTs with the ADA bsDMARDs ABP50147 and SB5,48 with the ETN bsDMARDs HD20349 and SB4,50 with the IFX bsDMARD SB251 and with the RTX bsDMARD BCD-020 52…”

The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis

“…1): screening, treatment period 1 (weeks 0-12), treatment period 2 (weeks [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] and an extension phase (weeks 31-52). In treatment period 1, patients were randomized 1 : 1 to self-administer 50 mg GP2015 or 50 mg ETN (Enbrel â ; Amgen Inc., Thousand Oaks, CA, U.S.A.; European Union authorized) twice weekly, subcutaneously.…”

“…17,18 Other biosimilar studies have also reported higher response rates for the primary efficacy parameter compared with the pivotal studies for the originator product. 21,[26][27][28] Moreover, the EGALITY study was designed to establish similarity between GP2015 and ETN …”

Position of Scientific Oncological Societies Towards Biosimilar Antibodies

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