Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
29042358
PubMed Central
PMC5867419
DOI
10.1136/annrheumdis-2017-211741
PII: S0003-4967(24)00999-3
Knihovny.cz E-zdroje
- Klíčová slova
- anti-tnf, dmards (biologic), rheumatoid arthritis, tnf-alpha, treatment,
- MeSH
- antirevmatika aplikace a dávkování škodlivé účinky MeSH
- biosimilární léčivé přípravky aplikace a dávkování škodlivé účinky MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- infliximab aplikace a dávkování škodlivé účinky imunologie MeSH
- kombinovaná farmakoterapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- methotrexát terapeutické užití MeSH
- mladiství MeSH
- mladý dospělý MeSH
- protilátky krev MeSH
- revmatoidní artritida farmakoterapie imunologie MeSH
- senioři MeSH
- stupeň závažnosti nemoci MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- antirevmatika MeSH
- biosimilární léčivé přípravky MeSH
- infliximab MeSH
- methotrexát MeSH
- protilátky MeSH
OBJECTIVES: Efficacy, safety and immunogenicity results from the phase III study of SB2, a biosimilar of reference infliximab (INF), were previously reported through 54 weeks. This transition period compared results in patients with rheumatoid arthritis (RA) who switched from INF to SB2 with those in patients who maintained treatment with INF or SB2. METHODS: Patients with moderate to severe RA despite methotrexate treatment were randomised (1:1) to receive SB2 or INF at weeks 0, 2 and 6 and every 8 weeks thereafter until week 46. At week 54, patients previously receiving INF were rerandomised (1:1) to switch to SB2 (INF/SB2 (n=94)) or to continue on INF (INF/INF (n=101)) up to week 70. Patients previously receiving SB2 continued on SB2 (SB2/SB2 (n=201)) up to week 70. Efficacy, safety and immunogenicity were assessed up to week 78. RESULTS: Efficacy was sustained and comparable across treatment groups. American College of Rheumatology (ACR) 20 responses between weeks 54 and 78 ranged from 63.5% to 72.3% with INF/SB2, 66.3%%-69.4% with INF/INF and 65.6%-68.3% with SB2/SB2. Treatment-emergent adverse events during this time occurred in 36.2%, 35.6% and 40.3%, respectively, and infusion-related reactions in 3.2%, 2.0% and 3.5%. Among patients who were negative for antidrug antibodies (ADA) up to week 54, newly developed ADAs were reported in 14.6%, 14.9% and 14.1% of the INF/SB2, INF/INF and SB2/SB2 groups, respectively. CONCLUSIONS: The efficacy, safety and immunogenicity profiles remained comparable among the INF/SB2, INF/INF and SB2/SB2 groups up to week 78, with no treatment-emergent issues or clinically relevant immunogenicity after switching from INF to SB2. TRIAL REGISTRATION NUMBER: NCT01936181; EudraCT number: 2012-005733-37.
Department of Internal Medicine Catholic University of Daegu School of Medicine Daegu South Korea
Department of Rheumatology Lithuanian University of Health Sciences Kaunas Lithuania
Department of Rheumatology Medical University of Vienna Vienna Austria
Faculty of Pharmacy University of Veterinary and Pharmaceutical Sciences Brno Czech Republic
Internal Medicine 1 Department SHEI Ivano Frankivsk NMU Ivano Frankivsk Ukraine
MCBK S C GrodziskMazowiecki Poland
Medica Pro Familia Gdynia Poland
Medica Pro Familia Sp z o o Spolka Komandytowo Akcyjna Warsaw Poland
Medical Plus sro Uherske Hradiste Czech Republic
Poznanski Osrodek Medyczny Novamed Poznan Poland
Samsung Bioepis Co Ltd Incheon Korea
University Clinic Centre Sarajevo Sarajevo Bosnia and Herzegovina
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ClinicalTrials.gov
NCT01936181
