Background: The occurrence or recurrence of autoimmune diseases or of autoa
ntibodies (autoAb) has been reported during type I interferon (IFN) treatme
nt. Objective: To define the frequency of thyroid and liver dysfunction and
of autoimmunity during IFN-beta 1b (IFNB) treatment of MS. Methods: Prospe
ctive 1-year multicenter follow-up of 156 patients with MS recruited by 18
centers was conducted. Thyroid-stimulating hormone and anti-thyroid autoAb
were measured by an immunoradiometric method, thyroid hormones by chromatog
raphic assay, and non-organ-specific autoAb by indirect immunofluorescence.
Tests were repeated every 3 months. The probability of having liver, thyro
id, or autoAb alterations was analyzed longitudinally with the generalized
estimating equations (GEE) method. Results: Thyroid dysfunction was observe
d in 5.3% of cases at baseline and 8.3% de novo during IFNB treatment. GEE
analysis showed that the probability of having thyroid alteration did not c
hange significantly during treatment compared with baseline. Liver alterati
on was observed in 4.6% of cases at baseline and 37.5% de novo during IFNB
treatment (p < 0.0001). GEE analysis showed that the probability of having
liver alteration was higher (p < 0.002) at months 3 and 6 compared with bas
eline, returning to values similar to baseline by month 9. AutoAb were dete
cted in 16.1% of patients at baseline and in 20% during IFNB. GEE analysis
showed that the probability of having autoAb did not change significantly d
uring treatment compared with baseline. Thyroid or liver alteration or auto
Ab occurring de novo during IFNB were usually transient. Conclusions: Diffe
rently from the frequency of liver function alteration (which significantly
increased during the first months of IFNB treatment, suggesting a probable
causal relationship with IFNB), the frequency of thyroid dysfunction or of
autoimmunity showed random and insignificant changes over time, probably n
ot related to IFNB treatment.