Prevalence of nephrogenic systemic fibrosis in renal insufficiency patients: results of the FINEST study.
OBJECTIVE
Nephrogenic systemic fibrosis (NSF) is characterized by widespread tissue fibrosis, mainly affecting the skin. Gadolinium chelates have been implicated in the onset of NSF in patients with renal impairment (RI). The FINEST study (FIbrose Néphrogénique SysTémique) was designed to determine the prevalence of NSF after magnetic resonance imaging (MRI) in French RI patients.


METHODS
We studied all patients with RI who had at least one MRI examination during a one-year period, with or without gadolinium chelate administration. Data were collected retrospectively from 9 Nephrology Departments in France, and included sex, age, renal function, type of gadolinium administered, and subsequent cutaneous disorders. If a patient presented a cutaneous disorder, a skin biopsy was performed to confirm the diagnostic.


RESULTS
The 308 eligible patients had a mean age of 59.9 years, 59% were men, and 54% had stage 5 RI. 75% of those 308 patients received a Gadolinium chelate. Among those patients who received a gadolinium chelate, 76% received gadoterate, 20% gadopentetate, 3% gadodiamide and 1% gadobenate. No cutaneous disorders were recorded after MRI.


CONCLUSIONS
These results confirm that NSF is a rare disease. Based on a reported frequency, approximately 3.5% in patients with glomerular filtration rate <30ml/min/1.73m(2)), some cases should have been observed in our study which included 308 patients. Most patients received gadoterate, a macrocyclic gadolinium chelate for which no case of NSF has been observed worldwide. This suggests that more stable macrocyclic agents may be less likely to induce NSF.
Janus
Nicolas
N
Department of Nephrology, Pitié-Salpêtrière Hospital, 83 boulevard de l'Hôpital, 75013 Paris, France. nicolas.janus@psl.aphp.fr
Launay-Vacher
Vincent
V
Karie
Svetlana
S
Clement
Olivier
O
Ledneva
Elena
E
Frances
Camille
C
Choukroun
Gabriel
G
Deray
Gilbert
G
D015897:Comorbidity; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D054989:Nephrogenic Fibrosing Dermopathy / Q000175:diagnosis* / Q000453:epidemiology*; D015995:Prevalence; D051437:Renal Insufficiency / Q000175:diagnosis* / Q000453:epidemiology*; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors; D012680:Sensitivity and Specificity