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Olumiant ® (baricitinib) tabletter
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The recommended dose is 2 mg once daily in patients with creatinine clearance between 30 and 60 mL/min. Baricitinib is not recommended for use in patients with creatinine clearance < 30 mL/min.1
In phase 3 studies, patients with an eGFR ≥40 and <60 mL/min/1.73 m2
Patients were excluded from the phase 3 studies if they had an eGFR <40 mL/min/1.73m2 calculated based on the most recent available serum creatinine using the MDRD method.2
Renal impairment subgroups were defined using the eGFR ranges from the National Kidney Foundation Clinical Practice Guidelines for Chronic Kidney Disease. Subgroups by baseline eGFR included
Subgroup analyses were performed in BARI-treated patients using the renal function subgroup of none (n=1552), mild (n=1446), and moderate (n=175) dysfunction. Compared to patients with no renal impairment, patients with mild or moderate renal impairment had higher numerical EAIRs of
Placebo-controlled analyses do not suggest any clinically meaningful differences between BARI and placebo by baseline renal function.2
Renal elimination is the principal mechanism for baricitinib’s clearance through glomerular filtration and active secretion via
In a clinical pharmacology study, approximately 75 % of the administered dose was eliminated in the urine, while about 20 % of the dose was eliminated in the faeces.1
Baricitinib was excreted predominately as unchanged drug in urine (69%) and feces (15%).2
Baricitinib exposure was evaluated in patients with mild, moderate, and severe renal impairment, including ESRD requiring hemodialysis, compared with healthy subjects with normal renal function.2
The dose-normalized geometric mean ratios of BARI exposure (AUC) relative to healthy subjects from each of the renally-impaired cohorts were
The mean terminal half-life by subgroup was
These results suggest that renal impairment significantly affects exposure to BARI, leading to increased exposure with decreasing renal function. Baricitinib does appear to be dialyzable.2
In rheumatoid arthritis, baricitinib induced a mean increase in serum creatinine levels of 3.8 µmol/L after two weeks of treatment, as compared to placebo, which remained stable thereafter during up to 104 weeks of treatment. This may be due to inhibition of creatinine secretion by baricitinib in the renal tubules.1
Consequently, estimates of the glomerular filtration rate based on serum creatinine may be slightly reduced, without actual loss of renal function or the occurrence of renal adverse events.1
Renal function was found to significantly affect baricitinib exposure.1
1Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002;39(2 suppl 1):S1-S266.
AUC = area under the concentration-time curve
BARI = baricitinib
EAIR = exposure-adjusted incidence rate
ESRD = end-stage renal disease
eGFR = estimated glomerular filtration rate
MDRD = Modification of Diet in Renal Disease
SAE = serious adverse event
TEAE = treatment-emergent adverse event
Datum fӧr senaste ӧversyn 2018 M09 26