Effects of two different alpha-interferon regimens on clinical and virological findings in mixed cryoglobulinemia

C. Mazzaro, T. Lacchin, M. Moretti, P. Tulissi, O. Manazzone, R. Colle, G. Pozzato

Research output: Contribution to journalArticle

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Abstract

Objective. As previous studies have shown a good response of mixed cryoglobulinemia (MC) to alpha-interferon (IFN) therapy, we investigated the efficacy and tolerability of two IFN regimens in a group of 36 patients affected by MC. Methods. The patients, diagnosed on the basis of standard clinical and laboratory criteria, were randomly divided into 2 groups: group A (18 cases) received alpha2b-IFN3 M.U. thrice a week for six months, while group B (18 cases) received alpha2b-IFN thrice a week for 1 year. The patients were followed for six months after the end of therapy. Liver function tests, cryoglobulin determinations and a clinical examination were performed each month. HCV serology and HCV-RNA detection by PCR were performed before therapy and at the end of the follow-up period. Results. The two study groups were comparable in age, male/female ratio, purpura score, cryoglobulin level, mean ALT serum activity and liver histology. 32 patients (89%) were positive for anti-HCV antibodies and 29 (81%) for HCV-RNA. During therapy all patients showed a significant (p <0.001) decrease in their cryoglobulin level as well as improvement (p <0.05) in their purpura score. In group A, five patients (28%) showed normalized ALT, but three later relapsed. In group B seven patients (39%) responded to treatment but three relapsed after suspension of the drug. Two patients from group B developed severe side effects (hypothyroidism and depression) and therapy was discontinued after 9 and 11 months, respectively. In all the non-responders and relapsed patients, purpura, ALT, and cryoglobulins rose to pretreatment levels within a few months. At the end of follow-up, two patients from group A (11%) and four in group B (22%) had achieved complete remission. Conclusion. This study indicates that IFN is useful in MC and that viral replication can be considered the target of the therapy. Despite the absence of a statistical difference in the response rate between the two regimens (due to the low number of subjects), the one-year therapy course seemed to show a better efficacy, although associated with higher toxicity.

Original languageEnglish
JournalClinical and Experimental Rheumatology
Volume13
Issue numberSUPPL. 13
Publication statusPublished - 1995

Fingerprint

Cryoglobulinemia
Interferon-alpha
Cryoglobulins
Purpura
Interferons
Therapeutics
RNA
Hepatitis C Antibodies
Liver Function Tests
Serology
Hypothyroidism
Suspensions
Histology

Keywords

  • alpha-interferon
  • hepatitis C virus
  • mixed cryoglobulinemia

ASJC Scopus subject areas

  • Rheumatology
  • Immunology

Cite this

Mazzaro, C., Lacchin, T., Moretti, M., Tulissi, P., Manazzone, O., Colle, R., & Pozzato, G. (1995). Effects of two different alpha-interferon regimens on clinical and virological findings in mixed cryoglobulinemia. Clinical and Experimental Rheumatology, 13(SUPPL. 13).

Effects of two different alpha-interferon regimens on clinical and virological findings in mixed cryoglobulinemia. / Mazzaro, C.; Lacchin, T.; Moretti, M.; Tulissi, P.; Manazzone, O.; Colle, R.; Pozzato, G.

In: Clinical and Experimental Rheumatology, Vol. 13, No. SUPPL. 13, 1995.

Research output: Contribution to journalArticle

Mazzaro, C, Lacchin, T, Moretti, M, Tulissi, P, Manazzone, O, Colle, R & Pozzato, G 1995, 'Effects of two different alpha-interferon regimens on clinical and virological findings in mixed cryoglobulinemia', Clinical and Experimental Rheumatology, vol. 13, no. SUPPL. 13.
Mazzaro, C. ; Lacchin, T. ; Moretti, M. ; Tulissi, P. ; Manazzone, O. ; Colle, R. ; Pozzato, G. / Effects of two different alpha-interferon regimens on clinical and virological findings in mixed cryoglobulinemia. In: Clinical and Experimental Rheumatology. 1995 ; Vol. 13, No. SUPPL. 13.
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abstract = "Objective. As previous studies have shown a good response of mixed cryoglobulinemia (MC) to alpha-interferon (IFN) therapy, we investigated the efficacy and tolerability of two IFN regimens in a group of 36 patients affected by MC. Methods. The patients, diagnosed on the basis of standard clinical and laboratory criteria, were randomly divided into 2 groups: group A (18 cases) received alpha2b-IFN3 M.U. thrice a week for six months, while group B (18 cases) received alpha2b-IFN thrice a week for 1 year. The patients were followed for six months after the end of therapy. Liver function tests, cryoglobulin determinations and a clinical examination were performed each month. HCV serology and HCV-RNA detection by PCR were performed before therapy and at the end of the follow-up period. Results. The two study groups were comparable in age, male/female ratio, purpura score, cryoglobulin level, mean ALT serum activity and liver histology. 32 patients (89{\%}) were positive for anti-HCV antibodies and 29 (81{\%}) for HCV-RNA. During therapy all patients showed a significant (p <0.001) decrease in their cryoglobulin level as well as improvement (p <0.05) in their purpura score. In group A, five patients (28{\%}) showed normalized ALT, but three later relapsed. In group B seven patients (39{\%}) responded to treatment but three relapsed after suspension of the drug. Two patients from group B developed severe side effects (hypothyroidism and depression) and therapy was discontinued after 9 and 11 months, respectively. In all the non-responders and relapsed patients, purpura, ALT, and cryoglobulins rose to pretreatment levels within a few months. At the end of follow-up, two patients from group A (11{\%}) and four in group B (22{\%}) had achieved complete remission. Conclusion. This study indicates that IFN is useful in MC and that viral replication can be considered the target of the therapy. Despite the absence of a statistical difference in the response rate between the two regimens (due to the low number of subjects), the one-year therapy course seemed to show a better efficacy, although associated with higher toxicity.",
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T1 - Effects of two different alpha-interferon regimens on clinical and virological findings in mixed cryoglobulinemia

AU - Mazzaro, C.

AU - Lacchin, T.

AU - Moretti, M.

AU - Tulissi, P.

AU - Manazzone, O.

AU - Colle, R.

AU - Pozzato, G.

PY - 1995

Y1 - 1995

N2 - Objective. As previous studies have shown a good response of mixed cryoglobulinemia (MC) to alpha-interferon (IFN) therapy, we investigated the efficacy and tolerability of two IFN regimens in a group of 36 patients affected by MC. Methods. The patients, diagnosed on the basis of standard clinical and laboratory criteria, were randomly divided into 2 groups: group A (18 cases) received alpha2b-IFN3 M.U. thrice a week for six months, while group B (18 cases) received alpha2b-IFN thrice a week for 1 year. The patients were followed for six months after the end of therapy. Liver function tests, cryoglobulin determinations and a clinical examination were performed each month. HCV serology and HCV-RNA detection by PCR were performed before therapy and at the end of the follow-up period. Results. The two study groups were comparable in age, male/female ratio, purpura score, cryoglobulin level, mean ALT serum activity and liver histology. 32 patients (89%) were positive for anti-HCV antibodies and 29 (81%) for HCV-RNA. During therapy all patients showed a significant (p <0.001) decrease in their cryoglobulin level as well as improvement (p <0.05) in their purpura score. In group A, five patients (28%) showed normalized ALT, but three later relapsed. In group B seven patients (39%) responded to treatment but three relapsed after suspension of the drug. Two patients from group B developed severe side effects (hypothyroidism and depression) and therapy was discontinued after 9 and 11 months, respectively. In all the non-responders and relapsed patients, purpura, ALT, and cryoglobulins rose to pretreatment levels within a few months. At the end of follow-up, two patients from group A (11%) and four in group B (22%) had achieved complete remission. Conclusion. This study indicates that IFN is useful in MC and that viral replication can be considered the target of the therapy. Despite the absence of a statistical difference in the response rate between the two regimens (due to the low number of subjects), the one-year therapy course seemed to show a better efficacy, although associated with higher toxicity.

AB - Objective. As previous studies have shown a good response of mixed cryoglobulinemia (MC) to alpha-interferon (IFN) therapy, we investigated the efficacy and tolerability of two IFN regimens in a group of 36 patients affected by MC. Methods. The patients, diagnosed on the basis of standard clinical and laboratory criteria, were randomly divided into 2 groups: group A (18 cases) received alpha2b-IFN3 M.U. thrice a week for six months, while group B (18 cases) received alpha2b-IFN thrice a week for 1 year. The patients were followed for six months after the end of therapy. Liver function tests, cryoglobulin determinations and a clinical examination were performed each month. HCV serology and HCV-RNA detection by PCR were performed before therapy and at the end of the follow-up period. Results. The two study groups were comparable in age, male/female ratio, purpura score, cryoglobulin level, mean ALT serum activity and liver histology. 32 patients (89%) were positive for anti-HCV antibodies and 29 (81%) for HCV-RNA. During therapy all patients showed a significant (p <0.001) decrease in their cryoglobulin level as well as improvement (p <0.05) in their purpura score. In group A, five patients (28%) showed normalized ALT, but three later relapsed. In group B seven patients (39%) responded to treatment but three relapsed after suspension of the drug. Two patients from group B developed severe side effects (hypothyroidism and depression) and therapy was discontinued after 9 and 11 months, respectively. In all the non-responders and relapsed patients, purpura, ALT, and cryoglobulins rose to pretreatment levels within a few months. At the end of follow-up, two patients from group A (11%) and four in group B (22%) had achieved complete remission. Conclusion. This study indicates that IFN is useful in MC and that viral replication can be considered the target of the therapy. Despite the absence of a statistical difference in the response rate between the two regimens (due to the low number of subjects), the one-year therapy course seemed to show a better efficacy, although associated with higher toxicity.

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