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Rituximab Added to Dexamethasone Improves Sustained Response in Immune Thrombocytopenic Purpura: Presented at ASH

By Emma Hitt, PhD

SAN FRANCISCO -- December 8, 2008 -- Rituximab demonstrates efficacy in the treatment of previously untreated immune thrombocytopenic purpura (ITP), according to the findings of a phase 3 trial presented at American Society of Hematology (ASH) 50th Annual Meeting and Exposition.

"The long-term response to steroid treatment [in this disease] is frequently dismal," said Francesco Zaja, MD, University of Udine, Udine, Italy, presenting his research here on December 7. "Splenectomy is the standard salvage therapy, but nearly 10% of patients suffer postoperative or delayed infections, and no drugs are currently used for ITP."

Previous studies indicate that nearly 30% of patients have long-lasting response to rituximab. The current study sought to evaluate rituximab in previously untreated patients with ITP and a platelet count of <=20 x 10⁹/L.

Patients in this prospective study (n = 101) were randomised to receive dexamethasone 40 mg on days 1 to 4, either as monotherapy (n = 52) or with rituximab 375 mg/m² IV starting on day 7 once a week for 4 weeks (n = 49). Patients who failed to achieve a sustained response (platelet count >50 x 10⁹/L 6 months after the start of treatment) with dexamethasone alone could be rescued with dexamethasone plus rituximab. A total of 101 patients were included in the intent-to-treat (ITT) analysis, and 64 patients were included in a per-protocol analysis.

Addition of rituximab to dexamethasone showed significant improvement in the primary outcome of sustained response. Of the 101 patients in the ITT analysis, treatment with rituximab resulted in a sustained response in 63% of the patients compared to 36% in patients treated with dexamethasone alone (P = .004). Significant improvements in sustained response were also observed with rituximab compared with dexamethasone alone when higher platelet-level cut-offs were used: platelets >100 x 10⁹/L (P = .019) and platelets >100 x 10⁹/L (P = .029).

The per-protocol analysis also demonstrated a significant benefit with the addition of rituximab, with 39% and 85% of patients meeting the primary endpoint in the dexamethasone monotherapy and rituximab plus dexamethasone groups, respectively (P < .001).

The researchers identified no clinical or laboratory factors that could predict a sustained response, and serum levels of rituximab did not correlate with response. No treatment-related deaths were observed, although there was a mild increase in the incidence of severe adverse events in patients receiving the combination.

"The results of the study document the efficacy of rituximab in ITP," Dr. Zaja concluded. "The long period of relapse-free survival registered in some patients suggests a possible curative effect of rituximab," he added. "Rituximab can be offered as an option before splenectomy, particularly in those patients with a higher risk of complications or who are not candidates for surgery."

Funding for this study was provided by Hoffmann-La Roche Ltd.

[Presentation title: A Prospective Randomized Study Comparing Rituximab and Dexamethasone vs Dexamethasone Alone in ITP: Results of Final Analysis and Long Term Follow up. Abstract 1]

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