A prospective evaluation of dermatological side-effects during alpha-interferon therapy for chronic viral hepatitis

Objective Alpha-interferon therapy may occasionally account for immune-medi ated phenomena, This study was conducted in an attempt to investigate the i ncidence of the development of immune-mediated dermatological diseases duri ng alpha-interferon therapy in patients with chronic viral hepatitis. The l atter has not been evaluated prospectively, whereas most of the previous st udies examined small numbers of interferon treated patients or consisted of case reports. Design A prospective case-control study. Setting A tertiary referral centre. Participants One hundred and twenty consecutive patients with chronic viral hepatitis (67 with hepatitis B, 45 with hepatitis C, six with both hepatit is viruses, and two with delta hepatitis) were evaluated during a course of alpha-interferon therapy. In addition, 120 consecutive patients with chron ic liver diseases (disease control group), who had never received alpha-int erferon therapy, were evaluated during the period of the study (at least fo r 12 months). Interventions Recombinant alpha-interferon at a dose of 4.5 or 5 million un its subcutaneously (s.c.) three times per week for 6 to 12 months was admin istered to patients with hepatitis B. The patients with chronic hepatitis C were treated with 3 million units s.c. three times per week for 12 to 18 m onths. The patients with chronic hepatitis B and C infections received 4.5 million units for 6 months, and then 3 million units for an additional 6 to 12 months. Finally, the patients with chronic delta hepatitis received 5 m illion units for 1 year or more. Main outcome measures To assess prospectively the incidence of these dermat ological disorders during alpha-interferon therapy and to estimate if there is any relationship between their development and the clinical, laboratory or other characteristics of the patients with chronic hepatitis. Results Three to 6 months after the initiation of alpha-interferon three pa tients with chronic viral hepatitis (two with hepatitis C and one with hepa titis B) developed lichen planus, whereas one patient with hepatitis C deve loped relapsing aphthous stomatitis. The development of these disorders was significantly associated only with the presence of antinuclear antibodies before the initiation of alpha-interferon (P = 0.000000). None of the patie nts from the disease control group had such a manifestation during the foll ow-up. Lichen planus resolved after the end of therapy in all of them. In c ontrast, therapy was discontinued in the patient who developed aphthous sto matitis, owing to the painful lesions. Conclusions This study demonstrated that alpha-interferon may rarely (3.3%) induce immune-mediated dermatological disorders, especially lichen planus. The development of these disorders may reflect a subclinical or covert aut oimmune background of patients, as suggested by the presence, although in l ow titres, of antinuclear antibodies. However, when lichen planus developed , it was mild, did not require the discontinuation of therapy and resolved after alpha-interferon administration had ceased. Eur J Gastroenterol Hepat ol 10:933-939 (C) 1998 Lippincott Williams & Wilkins.