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
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie
PubMed
26318384
PubMed Central
PMC5264229
DOI
10.1136/annrheumdis-2015-207764
PII: S0003-4967(24)01575-9
Knihovny.cz E-zdroje
- Klíčová slova
- Anti-TNF, DMARDs (biologic), Disease Activity, Rheumatoid Arthritis,
- MeSH
- antirevmatika škodlivé účinky farmakokinetika terapeutické užití MeSH
- biosimilární léčivé přípravky škodlivé účinky farmakokinetika terapeutické užití MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- infliximab škodlivé účinky imunologie farmakokinetika terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- methotrexát terapeutické užití MeSH
- protilátky krev MeSH
- revmatoidní artritida farmakoterapie MeSH
- senioři MeSH
- stupeň závažnosti nemoci MeSH
- terapeutická ekvivalence MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- antirevmatika MeSH
- biosimilární léčivé přípravky MeSH
- infliximab MeSH
- methotrexát MeSH
- protilátky MeSH
OBJECTIVES: To 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. METHODS: This 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. RESULTS: 584 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. CONCLUSIONS: SB2 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 NUMBER: NCT01936181.
Clinical Center Banja Luka Banja Luka Bosnia and Herzegovina
Department of Internal Medicine Catholic University of Daegu School of Medicine Daegu South Korea
Internal Medicine 1 Department Ivano Frankivsk National Medical University Ivano Frankivsk Ukraine
Lithuanian University of Health Sciences Kaunas Lithuania
MCBK S C Grodzisk Mazowiecki Poland
Medica Pro Familia Gdynia Poland
Medica Pro Familia Sp z o o Spolka Komandytowo Akcyjna Warszawa Poland
MEDICAL PLUS s r o Uherske Hradiste Czech Republic
Medical University of Vienna Vienna Austria
MHAT Dr Ivan Seliminski AD Sliven Bulgaria
Poznanski Osrodek Medyczny NOVAMED Poznan Poland
Samsung Bioepis Co Ltd Incheon Republic of Korea
University Clinic Centre Sarajevo Sarajevo Bosnia and Herzegovina
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ClinicalTrials.gov
NCT01936181
