Adding Rituximab to Prednisolone May Improve Long-Term Response in Immune Thrombocytopenia

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The efficacy of rituximab plus prednisolone had not been evaluated prior to the current study.
The efficacy of rituximab plus prednisolone had not been evaluated prior to the current study.

Low-dose rituximab plus prednisolone leads to higher long-term response and lower relapse rates among newly diagnosed adult patients with immune thrombocytopenia (ITP) in the frontline setting compared with prednisolone alone, according to a poster presentation at the 23rdAnnual Congress of the European Hematology Association in Stockholm, Sweden.1

Previous studies have shown that the addition of rituximab to dexamethasone led to improved long-term remission rates compared with the steroid alone in primary ITP, but the efficacy of rituximab and prednisolone — the most frequently used first-line steroid — has not been evaluated. 

For this study, researchers randomly assigned 52 patients with newly diagnosed ITP and symptomatic bleeding manifestations to receive low-dose rituximab 100 mg weekly plus prednisolone 1 mg/kg over 4 weeks or prednisolone alone. Prednisolone was tapered over the course of 4 additional weeks. 

Initial response evaluations after 1 month showed that the overall response rate (ORR) was not significantly different (= .368) between the study arms. In the rituximab-prednisolone arm the ORR was 80.7%, including a complete response (CR) rate of 69.2%, and in the prednisolone arm the ORR was 69.2%, with a CR rate of 50%. 

At 6-month follow-up, the ORR and CR were 76.9% and 65.4% in the rituximab-prednisolone arm, respectively, compared with 38.4% and 26.9% in the prednisolone arm, respectively (P= .013). 

After 1 year of follow-up, the CR was 52.6% in the rituximab-prednisolone arm and was 15.4% in the prednisolone arm among evaluable patients (P= .008). 

Analyses evaluating the rates of relapse revealed that 27.8% of patients treated with prednisolone alone relapsed versus 0% in the rituximab-prednisolone arm after 3 months (P= .01), 44.4% versus 4.8% relapsed after 6 months (P= .003), and 77.8% versus 28.6% relapsed after 1 year (= .002). 

All reported adverse events were grade 1 or 2, and occurred in 42.3% and 38.5% of patients in the rituximab-prednisolone arm and prednisolone alone arm, respectively. 

The authors concluded that “the combination of low-dose rituximab plus prednisolone as frontline therapy for adult patients with newly diagnosed primary ITP is well tolerated and induces a higher long-term response and lower incidence of relapse than prednisolone alone.”

Reference

  1. Datta S, Kalantri S, Saha S, et al. Low-dose rituximab plus prednisolone yields higher sustained response rates than prednisolone monotherapy as frontline therapy in adult patients with primary immune thrombocytopenia. Poster presented at: 2018 European Hematology Association 23rdAnnual Congress; June 2018; Stockhom, Sweden.

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