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Peak concentrations of ustekinumab after intravenous induction therapy identify patients with Crohn's disease likely to achieve endoscopic and biochemical remissionHanžel, Jurij ...Background & Aims: Little is known about the relationship between ustekinumab exposure during the first 2 weeks of treatment and outcomes of patients with Crohn's disease (CD). We investigated the ... relationship between serum concentrations of ustekinumab during the first 2 weeks of treatment and endoscopic and biochemical remission in patients with CD. Methods: In a prospective observational study, we measured concentrations of ustekinumab in serum samples from 41 consecutive patients who started treatment with ustekinumab (approximately 6 mg/kg, intravenously, then 90 mg every 8 weeks), due to endoscopic markers of active CD, at a single center from October 2017 through January 2019. We measured ustekinumab exposure parameters during the first 2 weeks (peak concentration measured immediately after intravenous infusion, week 2 concentration, and area under the curve through week 2). We investigated the correlation between these parameters and endoscopic remission (simple endoscopic score for CD scores of 3 or less without ulceration, assessed centrally) and biochemical remission (level of fecal calprotectin below 100 mg/kg) using the Mann-Whitney U test. Results: Endoscopic remission was achieved in 10 patients (24.4%) at week 24; biochemical remission was achieved in 17 patients (41.5%) at week 8, 17 patients (41.5%) at week 16, and 21 patients (51.2%) at week 24. Peak concentrations associated with endoscopic remission (area under the receiver operating characteristic curve, 0.717; 95% CI, 0.517-0.916); 6/13 patients (46%) with peak concentrations above 105 [micro]g/mL (upper tercile) achieved endoscopic remission, compared to only 1/14 patients (7%) with peak concentrations below 88 [micro]g/mL (lower tercile). All exposure parameters during the first 2 weeks were associated with biochemical remission. There was no significant difference between the associations of peak concentrations, week-2 concentrations, area under the curve through week 2, or later exposure measures (at weeks 4 and 8) with biochemical or endoscopic remission. Conclusions: In a prospective study, we found that serum concentrations of ustekinumab as early as 1 hour after intravenous infusion might be used to identify patients with CD most likely to achieve endoscopic remission. This early measurement might be used to optimize treatment of CD. Grant support: This work was financially supported by the Slovenian Research Agency (ARRS Grant P1-0189)Vir: Clinical gastroenterology and hepatology. - ISSN 1542-3565 (Vol. 19, iss. 1, 2021, str. 111-118)Vrsta gradiva - članek, sestavni del ; neleposlovje za odrasleLeto - 2021Jezik - angleškiCOBISS.SI-ID - 4890993
Avtor
Hanžel, Jurij |
Zdovc, Jurij, farmacija |
Kurent, Tina, dr. med. |
Sever, Nejc, dr. med. |
Javornik, Katarina |
Tuta, Katja, štud. med. |
Koželj, Matic |
Smrekar, Nataša, 1967- |
Novak, Gregor, dr. med., 1984- |
Štabuc, Borut |
Dressen, Erwin |
Thomas, Debby |
Vovk, Tomaž, 1972- |
Grabnar, Iztok |
Drobne, David
Teme
Crohnova bolezen |
Črevesje |
pharmacokinetics |
therapeutic drug monitoring |
inflammatory bowels diseases |
prognostic factor |
črevesne bolezni |
vnetja |
ustekinumab
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vir: Clinical gastroenterology and hepatology. - ISSN 1542-3565 (Vol. 19, iss. 1, 2021, str. 111-118)
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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Povezave do osebnih bibliografij avtorjev | Povezave do podatkov o raziskovalcih v sistemu SICRIS |
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Hanžel, Jurij | 54194 |
Zdovc, Jurij, farmacija | 51148 |
Kurent, Tina, dr. med. | ![]() |
Sever, Nejc, dr. med. | ![]() |
Javornik, Katarina | ![]() |
Tuta, Katja, štud. med. | ![]() |
Koželj, Matic | 38330 |
Smrekar, Nataša, 1967- | 17902 |
Novak, Gregor, dr. med., 1984- | 38328 |
Štabuc, Borut | 11949 |
Dressen, Erwin | ![]() |
Thomas, Debby | ![]() |
Vovk, Tomaž, 1972- | 18155 |
Grabnar, Iztok | 16107 |
Drobne, David | 38327 |
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