ITP诊治进展课件.pptVIP

RAISE (TRA102537; NC: this was a Phase III, randomised, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Revolade in adult patients with chronic ITP Adults with chronic ITP who had a platelet count 30?x?109/L and who had received at least one prior ITP therapy were eligible for RAISE. These patients were randomized 2:1 (Revolade: placebo) and stratified by splenectomy status, baseline ITP therapy and baseline platelet count ≤15?x?109/L. The treatment was conducted with standard of care (SoC), which included a variety of different ITP medications, provided the dose and schedule were stable for at least one month prior to randomisation and were expected to be stable until the end of the treatment period. Safety assessments, bleeding and platelet counts were monitored at weekly visits during the first 6 weeks of the study, and at least every 4 weeks thereafter. Post-therapy visits were scheduled for 1, 2, and 4 weeks following discontinuation or completion of the study and months 3 and 6. Patients initiated treatment with Revolade 50 mg (or matching placebo) once daily, and after Day 22, the dose was individualised based upon each patient’s platelet response, to a maximum of 75 mg once daily or decreased to 25 mg once daily or less frequently. If platelet counts exceeded 200?x?109/L, study medication was decreased to the next lowest dose If platelet counts exceeded 400?x?109/L, study medication was interrupted until platelet counts fell below 150?x?109/L. Once platelet counts fell below 150?x?109/L, treatment was restarted at the next lowest dose After 6 weeks of treatment, patients with a platelet count 100 x 109/L could reduce their concomitant ITP medication. Any change in Revolade or concomitant ITP medication dose resulted in weekly visits during the subsequent 4 weeks. Reference Cheng G, et al. Lancet 2011; 377: 393–402. Erratum in Lancet 2011; 377: 382 * * 西班牙研究者Tomás José González-López发现 1.260例ITP患者接受elt