Rozrolimupab, a mixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia.

Rozrolimupab, a recombinant mixture of 25 fully human RhD-specific monoclonal antibodies, represents a new class of recombinant human antibody mixtures. In a phase 1 or 2 dose escalation study, RhD(+) patients (61 subjects) with primary immune thrombocytopenia received a single intravenous dose of rozrolimupab ranging from 75 to 300 µg/kg. The primary outcome was the occurrence of adverse events. The principal secondary outcome was the effect on platelet levels 7 days after the treatment. The most common adverse events were headache and pyrexia, mostly mild, and reported in 20% and 13% of the patients, respectively, without dose relationship. Rozrolimupab caused an expected transient reduction of hemoglobin concentration in the majority of the patients. At the dose of 300 µg/kg platelet responses, defined as platelet count ≥ 30 × 10(9)/L and an increase in platelet count by > 20 × 10(9)/L from baseline were observed after 72 hours and persisted for at least 7 days in 8 of 13 patients (62%). Platelet responses were observed within 24 hours in 23% of patients and lasted for a median of 14 days. Rozrolimupab was well tolerated and elicited rapid platelet responses in patients with immune thrombocytopenia and may be a useful alternative to plasma-derived products. This trial is registered at www.clinicaltrials.gov as #NCT00718692.

Role of splenectomy in chronic idiopathic thrombocytopenic purpura.

AIM OF THE STUDY: To evaluate the usefulness of splenectomy and factors which predict long term remission in chronic idiopathic thrombocytopenic purpura (ITP). METHODS: We reviewed the data of 364 patients diagnosed as chronic ITP between January 1983 to December 1996 of whom 71 patients underwent splenectomy. The patients were followed up for an average period of 58 months and the short and long term response to splenectomy were analyzed at the end of one month and 60 months, respectively. RESULTS: At the end of one month after splenectomy, 82% had complete response, 7% partial response and 11% had no response. At the end of 60 months, 42% maintained complete response, 7% partial response, 34% had no response and 17% were lost to follow up. The results were statistically evaluated by using non-parametric test (Chi-square test) to age, sex, platelet count prior to treatment, initial response to steroids, time interval between diagnosis and splenectomy and post-operative platelet count. Of these factors only preoperative response to steroids (p value = 0.018303) and postoperative platelet count (p value = 0.013536) were found to be significant, statistically to predict long term remission. Age, sex, initial platelet count and time interval between diagnosis and splenectomy didn't seem to be statistically significant. CONCLUSION: This study suggests, that patients with an initial complete response to steroids and a post-operative platelet count > 300 x 10(9)/L at the time of discharge were associated with a long term remission. Splenectomy in ITP is a safe procedure with minimal morbidity and mortality and gives a good long term remission in steroid- failure patients with chronic ITP.

Role of splenectomy in chronic idiopathic thrombocytopenic purpura.

AIM OF THE STUDY: To evaluate the usefulness of splenectomy and factors which predict long term remission in chronic idiopathic thrombocytopenic purpura (ITP). METHODS: We reviewed the data of 364 patients diagnosed as chronic ITP between January 1983 to December 1996 of whom 71 patients underwent splenectomy. The patients were followed up for an average period of 58 months and the short and long term response to splenectomy were analyzed at the end of one month and 60 months, respectively. RESULTS: At the end of one month after splenectomy, 82% had complete response, 7% partial response and 11% had no response. At the end of 60 months, 42% maintained complete response, 7% partial response, 34% had no response and 17% were lost to follow up. The results were statistically evaluated by using non-parametric test (Chi-square test) to age, sex, platelet count prior to treatment, initial response to steroids, time interval between diagnosis and splenectomy and post-operative platelet count. Of these factors only preoperative response to steroids (p value = 0.018303) and postoperative platelet count (p value = 0.013536) were found to be significant, statistically to predict long term remission. Age, sex, initial platelet count and time interval between diagnosis and splenectomy didn't seem to be statistically significant. CONCLUSION: This study suggests, that patients with an initial complete response to steroids and a post-operative platelet count > 300 x 10(9)/L at the time of discharge were associated with a long term remission. Splenectomy in ITP is a safe procedure with minimal morbidity and mortality and gives a good long term remission in steroid- failure patients with chronic ITP.