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Natural interferon-alpha versus its combination with 6-methyl- prednisolone
in the therapy of type II mixed cryoglobulinemia: a long- term, randomized,
controlled study
F Dammacco, D Sansonno, JH Han, V Shyamala, V Cornacchiulo, AR Iacobelli, G Lauletta and R Rizzi
Department of Biomedical Sciences, University of Bari Medical School,
Italy.
Type II mixed cryoglobulinemia (MC) is an often progressive vasculitis
characterized by circulating cold-precipitable proteins that usually
consists of polyclonal IgG and monoclonal IgM kappa with rheumatoid factor
(RF) activity. Its etiology is unknown, although recent evidence strongly
suggests that hepatitis C virus (HCV) plays a major role. Plasmapheresis,
corticosteroids, and cytotoxic drugs have been used in the therapy of MC
patients. Recently, favorable results with recombinant interferon-alpha
(rIFN alpha) have been reported. To further assess its effectiveness, we
studied the effects of natural human interferon-alpha (nIFN alpha), alone
and in combination with 6- methyl-prednisolone (PDN), in a prospective,
randomized, controlled trial in patients with symptomatic MC. Sixty-five
patients were enrolled onto the trial, 52 (80%) of whom presented serum
anti-HCV antibodies and specific genomic RNA sequences. Fifteen patients
received nIFN alpha (3 MU) intramuscularly (IM) three times weekly, whereas
17 patients also received 16 mg/d of PDN orally on non-IFN days. Moreover,
18 patients received 16 mg/d of PDN only, and 15 were untreated. Treatment
was discontinued after 1 year and patients were monitored for 8 to 17
months (mean, 13). A complete response was achieved in eight of 15 patients
(53.3%) treated with nIFN alpha and nine of 17 (52.9%) treated with nIFN
alpha plus PDN, as compared with three of 18 patients (16.7%) who received
PDN only (P < .05) and one of 15 (6.7%) untreated controls (P < .01).
Partial response occurred in two of 15 (13.3%) patients treated with nIFN
alpha, three of 17 (17.6%) who received nIFN alpha plus PDN, one of 18
(5.5%) who received PDN only, and one of 15 (6.7%) controls. A complete
response in six patients (66.7%) was achieved within 3 months in the group
that received nIFN alpha plus PDN, as compared with two patients (25%) of
those who received nIFN alpha alone (P < .02). In anti-HCV-positive
patients, the clinical response occurred in step with reduced or
undetectable levels of HCV RNA and transaminase normalization.
Quantification of circulating HCV RNA represented a good predictive
response marker. The probability of relapse within 3 months after treatment
was 100% (three of three patients) and 75% (six of eight patients),
respectively, in patients who received PDN alone or nIFN alpha alone as
compared with none of those who received nIFN alpha plus PDN (P <
.001).(ABSTRACT TRUNCATED AT 250 WORDS)
Volume 84,
Issue 10,
pp. 3336-3343,
11/15/1994
Copyright © 1994 by The American Society of Hematology
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