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Title: Rituximab Provides Effective Rescue Treatment for Patients With Refractory Immune Thrombocytopenia Purpura: Presented at NHL

"Rituximab Provides Effective Rescue Treatment for Patients With Refractory Immune Thrombocytopenia Purpura: Presented at NHL"

By Chris Berrie PRAGUE, CZECH REPUBLIC -- September 14, 2004 -- Rituximab represents a rescue treatment for patients with refractory immune thrombocytopenia purpura (ITP), according to a Spanish multicentre retrospective study presented here September 12th at The Role of Immunotherapy in NHL: Optimising Treatment Outcomes, sponsored by Roche. Clinical Investigator Jorge Gayoso, PhD, haematology department, Clinica Puerta de Hierro, Madrid, Spain, introduced the study on behalf of clinical chief and coordinator Jose Rafael Cabrera, MD, and the whole author group of this Multi-Institutional Retrospective Study. "In the present study, we have evaluated the effectiveness of rituximab in the treatment of refractory patients diagnostic for ITP," Dr. Gayoso said. The data were collected to March 2004 through completion of clinical characteristics and response questionnaires that were received from the physicians of 99 patients in 43 centres. Among the 92 evaluable patients, platelet counts were below 30x 10[⁶/L, median age at diagnosis was 54 years (range 4-98), and 56% were women. Overall, 55% had idiopathic ITP, 14% had ITP associated with B-cell chronic lymphocytic leukaemia, 9% had autoimmune disease, and 3% had lymphoma; 12% had a range of other diseases.

Prior to rituximab administration, the patients received several treatment schemes, including corticosteroids (98%), intravenous immunoglobulin (88%) and cyclophosphamide (26%). Those that had received more than 3 lines of treatment (85%) were classified as heavily pretreated. Splenectomies had been performed on 52%.

Median time from diagnosis to rituximab treatment was 31 months, and overall median platelet count before rituximab was 8x 10⁶/L, with 66% having a platelet count below 10x 10⁶/L. Almost all patients (87%) received the standard dosing of rituximab (4x 375 mg/m²/week), with 37% receiving it in combination with other treatments.

Standard response criteria were defined according to platelet counts: complete >100x 10⁶/L; partial, 50-100x 10⁶/L; minimal 30-50x 10⁶/L.

The 55% overall response rate comprised 46% in complete response (CR) and 9% in partial response (PR), with 40% nonresponders. Dr. Gayoso noted that 40% of responders were seen in the first week of treatment, although maximum responses were achieved after a median of 5 weeks. The median platelet count at maximum response was 141x 10⁶/L (P <.001, analysis of variance).

The nonsplenectomised patients showed a significantly better response rate (CR+PR) than those who were splenectomised (68% vs 42%; P =.018), although this significance was lost in the maintained response rates (36% vs 33%). Heavily pretreated patients showed a worse response rate than the rest of patients (55% vs 77%, respectively; P =.012). However, no differences were seen between patients who had received rituximab alone and those with rituximab combinations, both for CR (44% vs 47%) and for maintained response (34% vs 36%). Similarly, age and gender did not affect the responses to rituximab.

Overall, after median monitoring of 9 months, 32% of patients maintained their CR, which did not vary significantly according to the associated diseases (P =.88). Rituximab was also well tolerated, with 2 episodes of fever following infusion, and 2 reports of skin eruptions.

"These results suggest that rituximab can be considered as a rescue treatment in patients with refractory ITP, with an excellent tolerance supplied," Dr. Gayoso concluded. However, he also stressed the need for further studies to establish the real role of rituximab in this setting.

[Presentation title: Treatment of Refractory Immune Thrombocytopaenic Purpura With Rituximab. Abstract 548]

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