Objective. To conduct a long-term, prospective, randomized controlled trial evaluating rituximab (RTX) therapy for severe mixed cryoglobulinemia or cryoglobulinemic vasculitis (CV).Methods. Fifty-nine patients with CV and related skin ulcers, active glomerulonephritis, or refractory peripheral neuropathy were enrolled. In CV patients who also had hepatitis C virus (HCV) infection, treatment of the HCV infection with antiviral agents had previously failed or was not indicated. Patients were randomized to the non-RTX group (to receive conventional treatment, consisting of 1 of the following 3: glucocorticoids; azathioprine or cyclophosphamide; or plasmapheresis) or the RTX group (to receive 2 infusions of 1 gm each, with a lowering of the glucocorticoid dosage when possible, and with a second course of RTX at relapse). Patients in the non-RTX group who did not respond to treatment could be switched to the RTX group. Study duration was 24 months.Results. Survival of treatment at 12 months (i.e., the proportion of patients who continued taking their initial therapy), the primary end point, was statistically higher in the RTX group (64.3% versus 3.5% [P < 0.0001]), as well as at 3 months (92.9% versus 13.8% [P < 0.0001]), 6 months (71.4% versus 3.5% [P < 0.0001]), and 24 months (60.7% versus 3.5% [P < 0.0001]). The Birmingham Vasculitis Activity Score decreased only after treatment with RTX (from a mean ؎ SD of 11.9 ؎ 5.4 at baseline to 7.1 ؎ 5.7 at month 2; P < 0.001) up to month 24 (4.4 ؎ 4.6; P < 0.0001). RTX appeared to be superior therapy for all 3 target organ manifestations, and it was as effective as conventional therapy. The median duration of response to RTX was 18 months. Overall, RTX treatment was well tolerated.Conclusion. RTX monotherapy represents a very good option for severe CV and can be maintained over the long term in most patients.Mixed cryoglobulinemia, which is also known as cryoglobulinemic syndrome or cryoglobulinemic vasculitis (CV), is a systemic vasculitis that is primarily mediated by immune complexes and is associated with hepatitis C virus (HCV) infection and B cell lymphoproliferation (1-5). HCV infection might be crucial for
Objective: In this study we performed single-cell analysis of the intracellular cytokine expression in peripheral CD4+ and CD8 + lymphocytes from patients with Hashimoto's thyroiditis (HT) to investigate the type-1 response separately for the two lymphocyte sub-populations. Design and methods: Twenty-nine patients affected by HT and 20 healthy subjects, matched for sex and age, were enrolled. After the analysis of the lymphocyte sub-populations, the intracellular content of interferon-g (IFN-g) in phorbolmyristate acetate (PMA)-stimulated CD4 + and CD8 + lymphocytes was assayed. Moreover, the CD4 + lymphocytes were also evaluated for the intracellular expression of IL-4. Results: No significant differences in CD3 + , CD4 + and CD8 + lymphocytes were found between HT patients and control subjects. However, the HT patients showed higher numbers of CD4 + IFN-g + , CD4+ IL-4 + and CD8 + IFN-g + ðt-test; P # 0:001Þ cells than the control subjects. Analysing the intracellular expression of IFN-g and IL-4 in relation to thyroid function, we found that the euthyroid patients (18 cases) showed more expression of IL-4 in CD4 + lymphocytes than the control subjects, without any significant modification of IFN-g expression in CD4+ and CD8 + lymphocytes. However, the hypothyroid patients (11 cases) showed an increase of IFN-g expression in both CD4 + and CD8 + lymphocytes with respect to the control subjects and the euthyroid patients. Moreover, the expression of IL-4 in CD4 + cells from hypothyroid patients was significantly lower than that seen in the euthyroid cases and comparable to that found in the control subjects. Conclusions: Our study has demonstrated that the peripheral CD4 + and CD8 + T lymphocytes from the HT patients show a type-1 activation strictly correlated to the occurrence of hypothyroidism. Further studies will be needed to clarify the exact role of peripheral lymphocytes in HT and whether they could provide a reliable marker of thyroid immune involvement.
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