Slovenský hematolologický portál - Rituximab therapy in adult patients with relapsed or refractory ITP

Rituximab therapy in adult patients with relapsed or refractory immune thrombocytopenic purpura: long-term follow-up results

Marta Medeot1, Francesco Zaja1, Nicola Vianelli2, Marta Battista1, Michele Baccarani2, Francesca Patriarca1, Franca Soldano3, Miriam Isola3, Stefano De Luca1, Renato Fanin1

1Clinica Ematologica, DIRM, University of Udine, Udine, Italy; 2Istituto di Ematologia ed Oncologia Medica L. e A. Seragnoli, Bologna, Italy; 3Istituto di Statistica, DIRM, University of Udine, Udine, Italy

European Journal of Haematology 2008 81 (165-169)

Correspondence Francesco Zaja, MD, Clinica Ematologica, University of Udine, P.zza S. Maria della Misericordia, 33100 Udine, Italy. Tel: +39 432 559604; Fax: +39 432 559661; e-mail: zaja.francesco@aoud.sanita.fvg.it

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Abstract
Objective: To evaluate the long-term activity and toxicity profile of rituximab in adult patients with idiopathic immune thrombocytopenic purpura (ITP). Patients and methods: Twenty-six patients with active and symptomatic ITP relapsed or refractory received weekly infusions of rituximab 375 mg⁄m2 for 4 wk. Median time from diagnosis to rituximab was 34.5 months. The following parameters of efficacy and toxicity were considered: complete response (CR) and partial response (PR), relapse rate, relapse-free survival (RFS), therapy - free survival (TFS), short- and long-term toxicity.
Results: CR and PR were 14 ⁄ 26 (54%) and 4 ⁄ 26 (15%), respectively. Median time of observation was 56.5 months (range 39-77). Nine of the 18 responding patients relapsed after a median of 21 months (range 8-66); 9 ⁄ 26 patients (35%) maintained the response, with a median follow-up of 57 months (range 39-69), and 11 ⁄ 26 (42%) did not necessitate further therapy; estimated 5 yr RFS and TFS were 61% and 72%, respectively. Younger age and shorter interval from diagnosis to rituximab appeared indicators of better outcome. Rituximab administration was associated with two episodes of short-term toxicity, with one case of serum sickness syndrome; no infectious or other significant long-term complications were documented.
Conclusion: Rituximab therapy may achieve long-lasting remission in nearly one-third of patients with relapsed or refractory ITP, with a good safety profile.

Key words immune thrombocytopenic purpura; rituximab; long-term activity

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