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Ustekinumab concentrations shortly after escalation to monthly dosing may identify endoscopic remission in refractory Crohn's disease [Elektronski vir]Hanžel, Jurij ...Objectives: Some patients with Crohn’s disease do not achieve remission with the approved maintenance dosing of ustekinumab every 8 weeks, possibly due to insufficient drug exposure. We aimed to ... study the exposure-response relationship for endoscopic remission and biomarker normalization with ustekinumab dose escalation to every 4 weeks. Methods: Out of 135 consecutive patients, 44 with active Crohn’s disease despite standard maintenance dosing [at least one of C-reactive protein (CRP) >5 mg/L, fecal calprotectin >100 mg/kg, simple endoscopic score (SES) for Crohn’s disease >3] underwent dose escalation to every 4 weeks. Subsequent endoscopic remission (SES-CD ≤3 without ulceration) and biomarker normalization were compared against ustekinumab concentrations. Results: Dose escalation led to endoscopic remission in 28.6% (8/28), CRP normalization 29.2% (7/24) and fecal calprotectin normalization 51.7% (15/29) of patients. Ustekinumab concentrations after escalation were higher in patients with endoscopic remission (6.90 vs. 4.29 mg/L; P = 0.025) and fecal calprotectin normalization (6.65 vs. 3.74 mg/L; P = 0.001). A threshold of 6.00 mg/L identified endoscopic remission [area under the receiver operating curve (AUROC): 0.775; 95% confidence interval (CI), 0.551–0.999), a threshold of 4.40 mg/L (AUROC 0.755; 95% CI, 0.545–0.964) two months after escalation identified patients with fecal calprotectin normalization at the end of follow-up. Concentrations <3.5 mg/L after escalation precluded endoscopic remission or biomarker normalization. Conclusion: Endoscopic remission was associated with higher ustekinumab concentrations after dose escalation. Patients with concentrations <3.5 mg/L after dose escalation are unlikely to achieve endoscopic remission or biomarker normalization.Source: European journal of gastroenterology & hepatology [Elektronski vir]. - ISSN 1473-5687 (Vol. 33, 2021, str. e831-e836)Type of material - e-article ; adult, seriousPublish date - 2021Language - englishCOBISS.SI-ID - 76342787
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Database name | Field | Year |
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Links to authors' personal bibliographies | Links to information on researchers in the SICRIS system |
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Hanžel, Jurij | 54194 |
Koželj, Matic, dr. med. | 38330 |
Špes, Ana, dr. med., 1998- | ![]() |
Kurent, Tina, dr. med. | ![]() |
Sever, Nejc, dr. med. | ![]() |
Zdovc, Jurij, farmacija | 51148 |
Smrekar, Nataša, 1967- | 17902 |
Novak, Gregor, medicina, 1984- | 38328 |
Štabuc, Borut | 11949 |
Grabnar, Iztok | 16107 |
Drobne, David, 1978- | 38327 |
Source: Personal bibliographies
and: SICRIS
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