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. 

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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.