-
Je něco špatně v tomto záznamu ?
Infliximab biosimilar CT-P13 therapy is effective in maintaining endoscopic remission in ulcerative colitis - results from multicenter observational cohort
A. Bálint, M. Rutka, M. Kolar, M. Bortlik, D. Duricova, V. Hruba, M. Lukas, K. Mitrova, K. Malickova, M. Lukas, Z. Szepes, F. Nagy, K. Palatka, S. Lovas, Z. Végh, Z. Kürti, Á. Csontos, P. Miheller, T. Nyári, R. Bor, Á. Milassin, A. Fábián, K....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, multicentrická studie, pozorovací studie, práce podpořená grantem
- MeSH
- biosimilární léčivé přípravky terapeutické užití MeSH
- dospělí MeSH
- gastrointestinální endoskopie MeSH
- gastrointestinální látky terapeutické užití MeSH
- hojení ran účinky léků MeSH
- indukce remise MeSH
- infliximab terapeutické užití MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- monoklonální protilátky terapeutické užití MeSH
- senioři MeSH
- střevní sliznice účinky léků patologie MeSH
- ulcerózní kolitida diagnóza farmakoterapie patologie 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
- multicentrická studie MeSH
- pozorovací studie MeSH
- práce podpořená grantem MeSH
BACKGROUND: CT-P13, the first biosimilar monoclonal antibody to infliximab (IFX), has previously been confirmed to be efficacious in inducing mucosal healing in ulcerative colitis (UC) patients. The aim of this study was to evaluate the efficacy of CT-P13 therapy in maintaining mucosal healing in UC. METHODS: CT-P13 trough levels, antibody positivity, serum inflammatory markers as CRP level, fecal calprotectin at weeks 14 and 54, concomitant steroid and azathioprine therapy at the time of induction therapy and at weeks 14 and 54, previous use of anti TNF drug and the need of dose intensification as possible predictive factors for mucosal healing at week 54 were evaluated in this prospective study. RESULTS: 61 patients had already completed the 54-week treatment period. Mucosal healing was shown in 65.5 % and 62.1 %, complete mucosal healing was present in 31% and 38 % at week 14 and 54, respectively. The median values of CRP, leukocytes, thrombocytes, and albumin showed significant difference between baseline and week 54. Serum antibody positivity was proved in 6.5 % and 19.7 % of cases at week 14 and 54, respectively. CONCLUSION: Our study confirmed the long-term efficacy of CT-P13 therapy on mucosal healing in UC.
1st Department of Medicine University of Szeged Szeged Hungary
b IBD Clinical and Research Centre Prague Czech Republic
h 1st Department of Internal Medicine Semmelweis University Budapest Hungary
i 2nd Department of Internal Medicine Semmelweis University Budapest Hungary
j Department of Medical Physics and Informatics University of Szeged Szeged Hungary
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc19028178
- 003
- CZ-PrNML
- 005
- 20190823120427.0
- 007
- ta
- 008
- 190813s2018 enk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1080/14712598.2018.1530758 $2 doi
- 035 __
- $a (PubMed)30277084
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a enk
- 100 1_
- $a Bálint, Anita $u a 1st Department of Medicine , University of Szeged , Szeged , Hungary.
- 245 10
- $a Infliximab biosimilar CT-P13 therapy is effective in maintaining endoscopic remission in ulcerative colitis - results from multicenter observational cohort / $c A. Bálint, M. Rutka, M. Kolar, M. Bortlik, D. Duricova, V. Hruba, M. Lukas, K. Mitrova, K. Malickova, M. Lukas, Z. Szepes, F. Nagy, K. Palatka, S. Lovas, Z. Végh, Z. Kürti, Á. Csontos, P. Miheller, T. Nyári, R. Bor, Á. Milassin, A. Fábián, K. Szántó, PL. Lakatos, T. Molnár, K. Farkas,
- 520 9_
- $a BACKGROUND: CT-P13, the first biosimilar monoclonal antibody to infliximab (IFX), has previously been confirmed to be efficacious in inducing mucosal healing in ulcerative colitis (UC) patients. The aim of this study was to evaluate the efficacy of CT-P13 therapy in maintaining mucosal healing in UC. METHODS: CT-P13 trough levels, antibody positivity, serum inflammatory markers as CRP level, fecal calprotectin at weeks 14 and 54, concomitant steroid and azathioprine therapy at the time of induction therapy and at weeks 14 and 54, previous use of anti TNF drug and the need of dose intensification as possible predictive factors for mucosal healing at week 54 were evaluated in this prospective study. RESULTS: 61 patients had already completed the 54-week treatment period. Mucosal healing was shown in 65.5 % and 62.1 %, complete mucosal healing was present in 31% and 38 % at week 14 and 54, respectively. The median values of CRP, leukocytes, thrombocytes, and albumin showed significant difference between baseline and week 54. Serum antibody positivity was proved in 6.5 % and 19.7 % of cases at week 14 and 54, respectively. CONCLUSION: Our study confirmed the long-term efficacy of CT-P13 therapy on mucosal healing in UC.
- 650 _2
- $a mladiství $7 D000293
- 650 _2
- $a dospělí $7 D000328
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a monoklonální protilátky $x terapeutické užití $7 D000911
- 650 _2
- $a biosimilární léčivé přípravky $x terapeutické užití $7 D059451
- 650 _2
- $a kohortové studie $7 D015331
- 650 _2
- $a ulcerózní kolitida $x diagnóza $x farmakoterapie $x patologie $7 D003093
- 650 _2
- $a gastrointestinální endoskopie $7 D016099
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a gastrointestinální látky $x terapeutické užití $7 D005765
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a infliximab $x terapeutické užití $7 D000069285
- 650 _2
- $a střevní sliznice $x účinky léků $x patologie $7 D007413
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a indukce remise $7 D012074
- 650 _2
- $a výsledek terapie $7 D016896
- 650 _2
- $a hojení ran $x účinky léků $7 D014945
- 650 _2
- $a mladý dospělý $7 D055815
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a pozorovací studie $7 D064888
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a Rutka, Mariann $u a 1st Department of Medicine , University of Szeged , Szeged , Hungary.
- 700 1_
- $a Kolar, Martin $u b IBD Clinical and Research Centre , Prague , Czech Republic. c 1st Medical Faculty , Charles University , Prague , Czech Republic.
- 700 1_
- $a Bortlik, Martin $u b IBD Clinical and Research Centre , Prague , Czech Republic. d Department of Internal Medicine , Military Hospital, Charles University , Prague , Czech Republic.
- 700 1_
- $a Duricova, Dana $u b IBD Clinical and Research Centre , Prague , Czech Republic. e Institute of Pharmacology, 1st Medical Faculty , Charles University , Prague , Czech Republic.
- 700 1_
- $a Hruba, Veronika $u b IBD Clinical and Research Centre , Prague , Czech Republic.
- 700 1_
- $a Lukas, Martin $u b IBD Clinical and Research Centre , Prague , Czech Republic.
- 700 1_
- $a Mitrova, Katarina $u b IBD Clinical and Research Centre , Prague , Czech Republic. f Department of Paediatrics, Faculty Hospital Motol, 2nd Medical Faculty , Charles University , Prague , Czech Republic.
- 700 1_
- $a Malickova, Karin $u b IBD Clinical and Research Centre , Prague , Czech Republic. f Department of Paediatrics, Faculty Hospital Motol, 2nd Medical Faculty , Charles University , Prague , Czech Republic.
- 700 1_
- $a Lukas, Milan $u b IBD Clinical and Research Centre , Prague , Czech Republic.
- 700 1_
- $a Szepes, Zoltán $u a 1st Department of Medicine , University of Szeged , Szeged , Hungary.
- 700 1_
- $a Nagy, Ferenc $u a 1st Department of Medicine , University of Szeged , Szeged , Hungary.
- 700 1_
- $a Palatka, Károly $u g Institute of Medicine, Department of Gastroenterology , University of Debrecen, Clinical Center , Debrecen , Hungary.
- 700 1_
- $a Lovas, Szilvia $u g Institute of Medicine, Department of Gastroenterology , University of Debrecen, Clinical Center , Debrecen , Hungary.
- 700 1_
- $a Végh, Zsuzsanna $u h First Department of Internal Medicine , Semmelweis University , Budapest , Hungary.
- 700 1_
- $a Kürti, Zsuzsanna $u h First Department of Internal Medicine , Semmelweis University , Budapest , Hungary.
- 700 1_
- $a Csontos, Ágnes $u i Second Department of Internal Medicine , Semmelweis University , Budapest , Hungary.
- 700 1_
- $a Miheller, Pál $u i Second Department of Internal Medicine , Semmelweis University , Budapest , Hungary.
- 700 1_
- $a Nyári, Tibor $u j Department of Medical Physics and Informatics , University of Szeged , Szeged , Hungary.
- 700 1_
- $a Bor, Renáta $u a 1st Department of Medicine , University of Szeged , Szeged , Hungary.
- 700 1_
- $a Milassin, Ágnes $u a 1st Department of Medicine , University of Szeged , Szeged , Hungary.
- 700 1_
- $a Fábián, Anna $u a 1st Department of Medicine , University of Szeged , Szeged , Hungary.
- 700 1_
- $a Szántó, Kata $u a 1st Department of Medicine , University of Szeged , Szeged , Hungary.
- 700 1_
- $a Lakatos, Péter L $u h First Department of Internal Medicine , Semmelweis University , Budapest , Hungary.
- 700 1_
- $a Molnár, Tamás $u a 1st Department of Medicine , University of Szeged , Szeged , Hungary.
- 700 1_
- $a Farkas, Klaudia $u a 1st Department of Medicine , University of Szeged , Szeged , Hungary.
- 773 0_
- $w MED00181398 $t Expert opinion on biological therapy $x 1744-7682 $g Roč. 18, č. 11 (2018), s. 1181-1187
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/30277084 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20190813 $b ABA008
- 991 __
- $a 20190823120641 $b ABA008
- 999 __
- $a ok $b bmc $g 1433327 $s 1066638
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2018 $b 18 $c 11 $d 1181-1187 $e 20181009 $i 1744-7682 $m Expert opinion on biological therapy $n Expert Opin Biol Ther $x MED00181398
- LZP __
- $a Pubmed-20190813
