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Blood, 15 April 2004, Vol. 103, No. 8, pp. 2925-2928.
Prepublished online as a Blood First Edition Paper on December 30, 2003; DOI 10.1182/blood-2003-10-3597.
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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Rituximab for primary chronic cold agglutinin disease: a prospective study of 37 courses of therapy in 27 patients
Sigbjørn Berentsen,
Elling Ulvestad,
Bjørn Tore Gjertsen,
Henrik Hjorth-Hansen,
Ruth Langholm,
Håvar Knutsen,
Waleed Ghanima,
Fuad Victor Shammas, and
Geir E. Tjønnfjord
From the Department of Medicine, Haugesund Hospital, and the University of Bergen; Department of Microbiology and Immunology, Gade Institute, Haukeland University Hospital, Bergen; Department of Medicine, Haukeland University Hospital, Bergen; Department of Medicine, St Olav University Hospital, Trondheim; Department of Pathology, Norwegian Radium Hospital, Oslo; Department of Medicine, Akershus University Hospital, Lørenskog; Department of Medicine, Østfold Hospital Fredrikstad; Department of Hematology and Oncology, Rogaland Central Hospital, Stavanger; and Department of Medicine, National Hospital, Oslo, Norway.
Conventional therapies for primary chronic cold agglutinin disease (CAD) are ineffective, but remissions after treatment with the anti-CD20 antibody rituximab have been described in a small, prospective trial and in some case reports. In this study we report on 37 courses of rituximab administered prospectively to 27 patients. Fourteen of 27 patients responded to their first course of rituximab, and 6 of 10 responded to re-treatment. In both groups combined, responses were achieved after 20 of 37 courses, giving an overall response rate of 54%. We observed 1 complete and 19 partial responses. Two nonresponders and 3 patients who experienced relapse received second-line therapy with interferon- combined with a new course of rituximab, and 1 nonresponder and 2 patients who experienced relapse achieved partial responses. Responders achieved a median increase in hemoglobin levels of 40 g/L (4 g/dL). Median time to response was 1.5 months, and median observed response duration was 11 months. We conclude that rituximab is an effective and well-tolerated therapy for CAD. Histologic and flow cytometric findings suggest that some of the effect may be mediated by mechanisms other than the elimination of clonal lymphocytes. We were unable to predict responses from the hematologic, immunologic, or histologic parameters before therapy. (Blood. 2004;103:2925-2928)
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