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Prepublished online as a Blood First Edition Paper on December 27, 2002; DOI 10.1182/blood-2002-10-3162.
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Blood, 15 May 2003, Vol. 101, No. 10, pp. 3818-3826
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Monoclonal antibody treatment of mixed cryoglobulinemia
resistant to interferon  with an anti-CD20
Domenico Sansonno,
Valli De
Re,
Gianfranco Lauletta,
Felicia Anna Tucci,
Mauro Boiocchi, and
Franco Dammacco
From the Department of Biomedical Sciences and Human
Oncology, Section of Internal Medicine and Clinical Oncology,
University of Bari Medical School, Bari, Italy, and Division of
Experimental Oncology I, Centro di Riferimento Oncologico, Aviano
(Pordenone), Italy.
A controlled study has been carried out to assess the efficacy of
rituximab, a chimeric antibody that binds to the B-cell surface antigen
CD20, in 20 patients with mixed cryoglobulinemia (MC) and hepatitis C
virus (HCV)-positive chronic active liver disease, resistant to
interferon  (IFN-) therapy. They received an intravenous infusion
of 375 mg/m2 rituximab once a week for 4 consecutive weeks.
Infusion of rituximab had a good safety profile and no severe side
effects were reported. Sixteen patients (80%) showed a complete
response (CR), characterized by rapid improvement of clinical signs
(disappearance of purpura and weakness arthralgia and improvement of
peripheral neuropathy), and decline of cryocrit. CR was associated with
a significant reduction of rheumatoid factor (RF) activity and anti-HCV
antibody titers. Decline of IgG anti-HCV titers in the cryoprecipitates was usually associated with a favorable response
(r = 0.81; P < .005). No differences in
the dynamics of B-cell depletion and recovery were found between
responders and nonresponders. Molecular monitoring of the B-cell
response revealed disappearance/deletion of peripheral clones in the
responders and great stability in the nonresponders. Rituximab had a
deep impact on hepatitis C viremia; HCV RNA increased approximately
twice the baseline levels in the responders, whereas it remained much
the same in the nonresponders. Twelve (75%) of 16 responders
remained in remission throughout the follow-up. The results indicate
that rituximab has clinical and biologic activity in patients with
HCV+ MC. However, in view of the increased viremia in the
responders, additional modes of application and combination of
rituximab with other agents need to be investigated.
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