Rituximab therapy for chonic and refractory immune thrombocytopenic purpura: a long-term follow-up analysis

Abstract

The aim of this study was to evaluate the long-term response to rituximab in patients with chronic and refractory immune thrombocytopenic purpura (ITP). Adults with ITP fail to respond to conventional therapies in almost 30% of cases, developing a refractory disease. Rituximab has been successfully used in these patients. We used rituximab at 375 mg/m 2 , IV, weekly for a total of four doses in 18 adult patients. Complete remission (CR) was considered if the platelet count was >100 × 10 9 /l, partial remission (PR) if platelets were >50 × 10 9 /l, minimal response (MR) if the platelet count was >30 × 10 9 /l and <50 × 10 9 /l, and no response if platelet count remained unchanged. Response was classified as sustained (SR) when it was stable for a minimum of 6 months. Median age was 43.5 years (range, 17 to 70). Median platelet count at baseline was 12.5 × 10 9 /l (range, 3.0 to 26.3). CR was achieved in five patients (28%), PR in five (28%), MR in four (22%), and two patients were classified as therapeutic failures (11%). Two additional patients were lost to follow-up. The median time between rituximab therapy and response was 14 weeks (range, 4 to 32). SR was achieved in 12 patients (67%). There were no severe adverse events during rituximab therapy. During follow-up (median, 26 months; range, 12 to 59), no other immunosuppressive drugs were used. In conclusion, rituximab therapy is effective and safe in adult patients with chronic and refractory ITP. Overall response rate achieved is high, long term, and with no risk of adverse events.

Long‐term follow‐up analysis after rituximab salvage therapy in adult patients with immune thrombocytopenia

“…The results of our analysis confirm the short to mid-term effect of rituximab salvage therapy in adult patients with ITP reported earlier by our group and other authors [4][5][6][7][8][9][10][11][12]. Our data might suggest SD is the preferable therapeutic regimen due to the shorter timing of response, the higher response rate, the lower incidence of relapse, and the similar safety profile.…”

“…To date, there is not yet a gold standard regimen based on evidence, despite different schedules have been proposed, i.e., the standard dose (SD, 375 mg/m 2 weekly for four administrations), the low dose (LD, 100 mg flat dose weekly for four administrations) or 1,000 mg flat dose on day 1 and 15. Several reports addressed the therapeutic activity of rituximab in pediatric and adults patients with chronic refractory or steroid dependent ITP, with nearly 40-70% short term overall (OR) and 20-50% complete response (CR) according to different cohort selection [4][5][6][7][8][9][10][11]. Younger age and shorter period from diagnosis to rituximab have been pointed as possible good prognostic factors for response [7][8].…”

Lower dose rituximab is active in adults patients with idiopathic thrombocytopenic purpura

“…It must be remarked, however, that some other groups did not highlight this prompt response in the majority of patients treated with standard dose. 15,17 The fact that we did not observe any infusion-related reaction appears probably related both to the baseline lower Bcell mass and to the lower dose of rituximab employed. Rituximab pharmacokinetic data showed a concentration time-course profile and a linear decay that was similar, once corrected for the difference in the dose, to that observed in previous studies with standard dose in patients with lymphoma and autoimmune disorders.…”

“…[10][11][12][13][14][15][16][17][18] To date, rituximab has been administered with the same schedule proposed for Bcell lymphomas, i.e. 375 mg/m 2 every seven days for four weeks.…”

Maintenance Therapy with Rituximab in Adult Patients with Immune Thrombocytopenia

“…Garcia-Chaveez et al [22] reported a 67% sustained response in 18 pretreated ITP patients, while Godeau et al [23] reported promising 1-year response in 40% of patients. Aleem et al [24] retrospectively studied 24 patients with refractory ITP, treated with Rituximab and 34% of patient's sustained response after 6 months, 24% responses sustained after 1 year.…”