52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis

Abstract

ObjectiveTo compare the 52-week efficacy and safety of SB4 [an etanercept biosimilar] with reference etanercept (ETN) in patients with active RA.MethodsIn a phase 3, randomized, double-blind, multicentre study, patients with moderate to severe RA despite MTX treatment were randomized to receive 50 mg/week of s.c. SB4 or ETN up to week 52. Efficacy assessments included ACR response rates, 28-joint DAS, Simplified and Clinical Disease Activity Indices and changes in the modified total Sharp score (mTSS). Safety and immunogenicity were also evaluated.ResultsA total of 596 patients were randomized to receive either SB4 (n = 299) or ETN (n = 297) and 505 (84.7%) patients completed 52 weeks of the study. At week 52, the ACR20 response rates in the per-protocol set were comparable between SB4 (80.8%) and ETN (81.5%). All efficacy results were comparable between the two groups and they were maintained up to week 52. Radiographic progression was also comparable and the change from baseline in the mTSS was 0.45 for SB4 and 0.74 for ETN. The safety profile of SB4 was similar to that of ETN and the incidence of anti-drug antibody development up to week 52 was 1.0 and 13.2% in the SB4 and ETN groups, respectively.ConclusionEfficacy including radiographic progression was comparable between SB4 and ETN up to week 52. SB4 was well tolerated and had a similar safety profile to that of ETN.Trial registration numberClinicalTrials.gov NCT01895309, EudraCT 2012-005026-30

Naringin Protects Against Cartilage Destruction in Osteoarthritis Through Repression of NF-κB Signaling Pathway

“…TNF-α is wellestablished in arthritis, and anti-TNF agents have been extensively studied for therapy of inflammatory arthritis as well as osteoarthritis [18,19]. TNF-α enhances expression of MMPs and ADAMTS [8,20,21], and these increased proteases in turn cause exaggerated degradation of cartilage matrix including cartilage oligomeric matrix protein, Col II, and Aggrecan, which promotes progression of OA [22,23].…”

Comparison of injection-site reactions between the etanercept biosimilar SB4 and the reference etanercept in patients with rheumatoid arthritis from a phase III study

“…Immunogenicity was reported in patients with available assessment results, and patients were regarded as having a positive ADA status if they tested positive for ADAs at least once up to week 52. Incidence of ADA development was lower with SB4 than with ETN: 1·0% (three of 299) vs. 13·1% (39 of 297), respectively; P < 0·001 . The occurrence, description and severity of ISRs were analysed within subgroups based on the presence of ADAs.…”

Focus on biosimilar etanercept &ndash; bioequivalence and interchangeability

“…At 52 weeks, structural radiological damage was also evaluated using the van der Heijde modified Total Sharpe Score. SB4 and re-ETN had similar results with a score variation from baseline of 0.45 and 0.74 29. In the study extension, of 245 patients who had completed 52 weeks, 126 continued SB4 and 119 switched from re-ETN to SB4 for 48 weeks.…”

“…The benefits of SB4 and re-ETN were maintained at 52 weeks of treatment 29. Despite the different response in the ACR70, the EMA concluded that there was sufficient evidence for the biosimilarity relationship 16.…”