A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial
PubMed
26150601
PubMed Central
PMC5264222
DOI
10.1136/annrheumdis-2015-207588
PII: S0003-4967(24)01574-7
Knihovny.cz E-resources
- Keywords
- Anti-TNF *, DMARDs (biologic) *, Rheumatoid Arthritis *,
- MeSH
- Antirheumatic Agents adverse effects immunology pharmacokinetics therapeutic use MeSH
- Biosimilar Pharmaceuticals adverse effects pharmacokinetics therapeutic use MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Etanercept adverse effects immunology pharmacokinetics therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Methotrexate therapeutic use MeSH
- Antibodies blood MeSH
- Arthritis, Rheumatoid drug therapy MeSH
- Aged MeSH
- Therapeutic Equivalency MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Names of Substances
- Antirheumatic Agents MeSH
- Biosimilar Pharmaceuticals MeSH
- Etanercept MeSH
- Methotrexate MeSH
- Antibodies MeSH
OBJECTIVES: To compare the efficacy and safety of SB4 (an etanercept biosimilar) with reference product etanercept (ETN) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. METHODS: This is a phase III, randomised, double-blind, parallel-group, multicentre study with a 24-week primary endpoint. Patients with moderate to severe RA despite MTX treatment were randomised to receive weekly dose of 50 mg of subcutaneous SB4 or ETN. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 24. Other efficacy endpoints as well as safety, immunogenicity and pharmacokinetic parameters were also measured. RESULTS: 596 patients were randomised to either SB4 (N=299) or ETN (N=297). The ACR20 response rate at week 24 in the per-protocol set was 78.1% for SB4 and 80.3% for ETN. The 95% CI of the adjusted treatment difference was -9.41% to 4.98%, which is completely contained within the predefined equivalence margin of -15% to 15%, indicating therapeutic equivalence between SB4 and ETN. Other efficacy endpoints and pharmacokinetic endpoints were comparable. The incidence of treatment-emergent adverse events was comparable (55.2% vs 58.2%), and the incidence of antidrug antibody development up to week 24 was lower in SB4 compared with ETN (0.7% vs 13.1%). CONCLUSIONS: SB4 was shown to be equivalent with ETN in terms of efficacy at week 24. SB4 was well tolerated with a lower immunogenicity profile. The safety profile of SB4 was comparable with that of ETN. TRIAL REGISTRATION NUMBERS: NCT01895309, EudraCT 2012-005026-30.
Institute of Rheumatology Prague Czech Republic
Kharkiv Medical Academy of Postgraduate Education Kharkiv Ukraine
Klaipeda University Hospital Klaipeda Lithuania
Lithuanian University of Health Sciences Kaunas Lithuania
M 5 Sklifosovskyi Poltava Regional Clinical Hospital Poltava Ukraine
Medicome Sp z o o Oswiecim Poland
NIHR Leeds Musculoskeletal Biomedical Research Unit Leeds Teaching Hospitals NHS Trust Leeds UK
NZOZ Medica Pro Familia Sp z o o Warsaw Poland
Poznan University of Medical Sciences Poznan Poland
Poznanski Osrodek Medyczny NOVAMED Pultusk Poland
Samsung Bioepis Co Ltd Incheon Republic of Korea
Unidad de Atención Medica e Investigación en Salud Yucatán México
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NCT01895309
