Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie
PubMed
28584187
PubMed Central
PMC5629940
DOI
10.1136/annrheumdis-2016-210459
PII: S0003-4967(24)19787-7
Knihovny.cz E-zdroje
- Klíčová slova
- DMARDs (biologic), TNF-alpha, anti-TNF, inflammation, rheumatoid arthritis,
- MeSH
- adalimumab škodlivé účinky terapeutické užití MeSH
- antirevmatika škodlivé účinky farmakokinetika terapeutické užití MeSH
- biosimilární léčivé přípravky škodlivé účinky farmakokinetika terapeutické užití MeSH
- C-reaktivní protein metabolismus MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- protilátky krev MeSH
- revmatoidní artritida krev farmakoterapie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- stupeň závažnosti nemoci MeSH
- terapeutická ekvivalence MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- adalimumab MeSH
- antirevmatika MeSH
- biosimilární léčivé přípravky MeSH
- C-reaktivní protein MeSH
- protilátky MeSH
OBJECTIVES: ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. METHODS: In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at week 24. Primary hypothesis that the treatments were equivalent would be confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies were assessed to determine immunogenicity. RESULTS: A total of 526 patients were randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were similar. There were no clinically meaningful differences in AEs and laboratory abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients tested positive for binding antidrug antibodies. CONCLUSIONS: Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. TRIAL REGISTRATION NUMBER: NCT01970475; Results.
Advanced Arthritis Care and Research Scottsdale Arizona USA
Amgen Inc Thousand Oaks California USA
Arthritis and Rheumatism Associates Wheaton Maryland USA
Instituto de Investigación Hospital 12 de Octubre Universidad Complutense de Madrid Madrid Spain
Metroplex Clinical Research Center Dallas Texas USA
Na Slupi 4 Praha 2 Praha Czech Republic
RANA Clinical Research Center Huntsville Alabama USA
Stanford University School of Medicine Palo Alto California USA
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Effect of treatment with original or biosimilar adalimumab on SARS-CoV2 vaccination antibody titers
ClinicalTrials.gov
NCT01970475
