-
Je něco špatně v tomto záznamu ?
Assessment of effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting for treatment of patients with active rheumatoid arthritis or ankylosing spondylitis
C. Codreanu, K. Šírová, K. Jarošová, A. Batalov,
Jazyk angličtina Země Velká Británie
Typ dokumentu časopisecké články, multicentrická studie, pozorovací studie
- MeSH
- ankylózující spondylitida * diagnóza farmakoterapie MeSH
- antirevmatika aplikace a dávkování škodlivé účinky MeSH
- biosimilární léčivé přípravky aplikace a dávkování škodlivé účinky MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- monitorování léčiv metody MeSH
- monoklonální protilátky * aplikace a dávkování škodlivé účinky MeSH
- náhrada léků * škodlivé účinky metody MeSH
- nežádoucí účinky léčiv diagnóza etiologie MeSH
- posouzení stavu pacienta MeSH
- revmatoidní artritida * diagnóza farmakoterapie MeSH
- senioři 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
- multicentrická studie MeSH
- pozorovací studie MeSH
- Geografické názvy
- Bulharsko MeSH
- Česká republika MeSH
- Rumunsko MeSH
OBJECTIVE: To assess the effectiveness and safety of infliximab biosimilar, CT-P13, administered in a real-life setting to adult patients with active rheumatoid arthritis (RA) or ankylosing spondylitis (AS). METHODS: This multi-center, non-interventional, observational study was conducted in Bulgaria, the Czech Republic, and Romania. A total of 151 patients with severe active RA (n = 81) or AS (n = 70) were enrolled and treated with CT-P13 for 24 weeks, according to current medical recommendations. Effectiveness was assessed using the 4-item Disease Activity Score 28 with C-reactive protein (DAS28-CRP) for RA patients, and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. Safety was assessed by withdrawals and adverse events (AEs). RESULTS: A total of 129 patients (RA: 67; AS: 62) were included in the effectiveness analysis. CT-P13 treatment significantly improved DAS28-CRP scores at 12 and 24 weeks (p = .0001 vs baseline for both timepoints) in patients with RA and BASDAI scores at 12 and 24 weeks (p = .0001 vs baseline for both timepoints) in patients with AS. CRP levels were significantly reduced at 12 and 24 weeks (p = .0001 vs baseline for both timepoints). Among 713 infusions, 34 AEs were reported (4.8% of infusions), of which 11 were considered related to CT-P13 treatment. Two of seven serious AEs were considered possibly (hepatocellular injury) or definitely (dyspnoea due to allergic infusion reaction) treatment-related. Eight patients discontinued CT-P13 due to AEs and four patients were withdrawn due to therapeutic failure. CONCLUSIONS: CT-P13 was effective and safe in a real-life setting in patients with active RA or AS.
b Revmatologie Revmatologie MU Dr Klara Sirova sro Ostrava Czech Republic
c Institute of Rheumatology Prague Czech Republic
Center for Rheumatic Diseases University of Medicine and Pharmacy Bucharest Romania
Rheumatology Medical University of Plovdiv UMHAT Kaspela Plovdiv Bulgaria
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc19045551
- 003
- CZ-PrNML
- 005
- 20200113143513.0
- 007
- ta
- 008
- 200109s2018 xxk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1080/03007995.2018.1441144 $2 doi
- 035 __
- $a (PubMed)29439591
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxk
- 100 1_
- $a Codreanu, Cătălin $u a Center for Rheumatic Diseases , University of Medicine and Pharmacy , Bucharest , Romania.
- 245 10
- $a Assessment of effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting for treatment of patients with active rheumatoid arthritis or ankylosing spondylitis / $c C. Codreanu, K. Šírová, K. Jarošová, A. Batalov,
- 520 9_
- $a OBJECTIVE: To assess the effectiveness and safety of infliximab biosimilar, CT-P13, administered in a real-life setting to adult patients with active rheumatoid arthritis (RA) or ankylosing spondylitis (AS). METHODS: This multi-center, non-interventional, observational study was conducted in Bulgaria, the Czech Republic, and Romania. A total of 151 patients with severe active RA (n = 81) or AS (n = 70) were enrolled and treated with CT-P13 for 24 weeks, according to current medical recommendations. Effectiveness was assessed using the 4-item Disease Activity Score 28 with C-reactive protein (DAS28-CRP) for RA patients, and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. Safety was assessed by withdrawals and adverse events (AEs). RESULTS: A total of 129 patients (RA: 67; AS: 62) were included in the effectiveness analysis. CT-P13 treatment significantly improved DAS28-CRP scores at 12 and 24 weeks (p = .0001 vs baseline for both timepoints) in patients with RA and BASDAI scores at 12 and 24 weeks (p = .0001 vs baseline for both timepoints) in patients with AS. CRP levels were significantly reduced at 12 and 24 weeks (p = .0001 vs baseline for both timepoints). Among 713 infusions, 34 AEs were reported (4.8% of infusions), of which 11 were considered related to CT-P13 treatment. Two of seven serious AEs were considered possibly (hepatocellular injury) or definitely (dyspnoea due to allergic infusion reaction) treatment-related. Eight patients discontinued CT-P13 due to AEs and four patients were withdrawn due to therapeutic failure. CONCLUSIONS: CT-P13 was effective and safe in a real-life setting in patients with active RA or AS.
- 650 _2
- $a dospělí $7 D000328
- 650 _2
- $a senioři $7 D000368
- 650 12
- $a monoklonální protilátky $x aplikace a dávkování $x škodlivé účinky $7 D000911
- 650 _2
- $a antirevmatika $x aplikace a dávkování $x škodlivé účinky $7 D018501
- 650 12
- $a revmatoidní artritida $x diagnóza $x farmakoterapie $7 D001172
- 650 _2
- $a biosimilární léčivé přípravky $x aplikace a dávkování $x škodlivé účinky $7 D059451
- 650 _2
- $a monitorování léčiv $x metody $7 D016903
- 650 12
- $a náhrada léků $x škodlivé účinky $x metody $7 D057915
- 650 _2
- $a nežádoucí účinky léčiv $x diagnóza $x etiologie $7 D064420
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a posouzení stavu pacienta $7 D062072
- 650 12
- $a ankylózující spondylitida $x diagnóza $x farmakoterapie $7 D013167
- 650 _2
- $a výsledek terapie $7 D016896
- 651 _2
- $a Bulharsko $7 D002031
- 651 _2
- $a Česká republika $7 D018153
- 651 _2
- $a Rumunsko $7 D012383
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a pozorovací studie $7 D064888
- 700 1_
- $a Šírová, Klára $u b Revmatologie , Revmatologie MU Dr. Klara Sirova, sro , Ostrava , Czech Republic.
- 700 1_
- $a Jarošová, Katerina $u c Institute of Rheumatology , Prague , Czech Republic.
- 700 1_
- $a Batalov, Anastas $u d Rheumatology , Medical University of Plovdiv, UMHAT "Kaspela" , Plovdiv , Bulgaria.
- 773 0_
- $w MED00009520 $t Current medical research and opinion $x 1473-4877 $g Roč. 34, č. 10 (2018), s. 1763-1769
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/29439591 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20200109 $b ABA008
- 991 __
- $a 20200113143845 $b ABA008
- 999 __
- $a ok $b bmc $g 1483819 $s 1084224
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2018 $b 34 $c 10 $d 1763-1769 $e 20180416 $i 1473-4877 $m Current medical research and opinion $n Curr Med Res Opin $x MED00009520
- LZP __
- $a Pubmed-20200109