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Prepublished online as a Blood First Edition Paper on January 16, 2003; DOI 10.1182/blood-2002-11-3547.
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Blood, 15 May 2003, Vol. 101, No. 10, pp. 3857-3861
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Rituximab for the treatment of refractory autoimmune hemolytic
anemia in children
Marco Zecca,
Bruno Nobili,
Ugo Ramenghi,
Silverio Perrotta,
Giovanni Amendola,
Pasquale Rosito,
Momcilo Jankovic,
Paolo Pierani,
Piero De
Stefano,
Mario Regazzi Bonora, and
Franco Locatelli
From the Oncoematologia Pediatrica, IRCCS Policlinico
San Matteo, Pavia, Italy; Clinica Pediatrica I, Seconda
Università degli Studi, Napoli, Italy; Clinica
Pediatrica, Università di Torino, Ospedale Regina Margherita,
Torino, Italy; Ematologia-Oncologia Pediatrica, Ospedale
di Nocera Inferiore, Italy; Clinica Pediatrica,
Università di Bologna, Policlinico Sant'Orsola, Bologna,
Italy; Clinica Pediatrica, Università di Milano
Bicocca, Nuovo Ospedale San Gerardo, Monza, Italy; Clinica
Pediatrica, Università di Ancona, Italy; and
Farmacologia Clinica, IRCCS Policlinico San Matteo, Pavia,
Italy.
Autoimmune hemolytic anemia (AIHA) in children is sometimes
characterized by a severe course, requiring prolonged administration of
immunosuppressive therapy. Rituximab is able to cause selective in vivo
destruction of B lymphocytes, with abrogation of antibody production.
In a prospective study, we have evaluated the use of rituximab for the
treatment of AIHA resistant to conventional treatment. Fifteen children
with AIHA were given rituximab, 375 mg/m2/dose for a median
of 3 weekly doses. All patients had previously received 2 or more
courses of immunosuppressive therapy; 2 patients had undergone
splenectomy. After completing treatment, all children received
intravenous immunoglobulin for 6 months. Treatment was well tolerated.
With a median follow-up of 13 months, 13 patients (87%) responded,
whereas 2 patients did not show any improvement. Median hemoglobin
levels increased from 7.7 g/dL to a 2-month posttreatment level of 11.8 g/dL (P < .001). Median absolute reticulocyte counts
decreased from 236 to 109 × 109/L
(P < .01). An increase in platelet count was observed in
patients with concomitant thrombocytopenia (Evans syndrome). Three
responder patients had relapse, 7, 8, and 10 months after rituximab
infusion, respectively. All 3 children received a second course of
rituximab, again achieving disease remission. Our data indicate that
rituximab is both safe and effective in reducing or even abolishing
hemolysis in children with AIHA and that a sustained response can be
achieved in the majority of cases. Disease may recur, but a second
treatment course may be successful in controlling the disease.
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