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Background: There is little information regarding the potential of interferon beta (IFNβ) to induce or exacerbate autoimmune disease. Existing data from unco ntrolled studies are contradictory and do not differentiate between autoimmune d ysfunction, which is frequent in patients with multiple sclerosis (MS), and unto ward drug effects. Objective: To evaluate the impact of IFNβ.on hepatic, thyroi d, and other markers of autoimmunity using data from the European placebo-contr olled double-blind, multicenter study of IFNβ-1b in patients with secondary p rogressive MS (SPMS). Methods: Serum samples obtained at baseline and at 6-mont h intervals for 24 months were analyzed for the following autoantibodies (AAbs): antinuclear (ANA), antimitochondrial (AMA), smooth muscle (SMA), liver kidney m icrosome (LKM), thyroid microsome (TPO), and human thyroglobulin (TG). AAb statu s at baseline and during treatment was related to respective laboratory and clin ical deviations. Results: The analysis of AAb data included 355 patients receivi ng IFNβ-1b and 353 receiving placebo. There was no difference between treatmen t groups in de novo AAb positivity. A greater proportion of women were AAb posit ive at baseline and during treatment. No association was found between liver enz yme elevations and ANA, AMA, or SMA antibody formation in either treatment group . Laboratory-based thyroid alterations during the study were significantly rela ted to TG/TPO status at baseline but were not associated with IFNβ-1b treatmen t. Adverse events possibly indicative of other diseases with autoimmune links we re not associated with respective AAb status. Conclusion: Interferon beta-1b tr eatment did not induce autoantibody formation in this population of patients wit h secondary progressive multiple sclerosis.
Background: There is little information regarding the potential of interferon beta (IFNβ) to induce or exacerbate autoimmune disease. Existing data from unco ntrolled studies are contradictory and do not differentiate between autoimmune d ysfunction, which is frequent in patients with multiple sclerosis (MS) , and unto ward drug effects. Objective: To evaluate the impact of IFNβ. on hepatic, thyroi d, and other markers of autoimmunity using data from the European placebo-contr olled double-blind, multicenter study of IFNβ-1b in patients with secondary Methods: Serum samples obtained at baseline and at 6-mont h intervals for 24 months were analyzed for the following autoantibodies (AAbs): antinuclear (ANA), antimitochondrial (AMA), smooth muscle (SMA) liver kidney m icrosome (LKM), thyroid microsome (TPO), and human thyroglobulin (TG). AAb statu s at baseline and during treatment was related to each laboratory and clinical deviations. Results: The analys There was no difference between treatmen t groups in de novo AAb positivity. A greater proportion of women were AAb posit ive at baseline and during treatment. No association was found between liver enz yme elevations and ANA, AMA, or SMA antibody formation in either treatment group. Laboratory-based thyroid alterations during the study were significantly rela ted to TG / TPO status at baseline but were not associated with IFNβ-1b treatmen t. Adverse events likely indicative of other diseases with autoimmune links we re not associated with corresponding AAb status. Conclusion: Interferon beta-1b tr eatment did not induce autoantibody formation in this population of patients wit h secondary progressive multiple sclerosis.