Prescribing information

 

   

RAISE: A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING ITP PATIENTS’ RESPONSE TO REVOLADE VERSUS PLACEBO1

Objective

The phase III, double-blind, placebo-controlled RAISE study (ClinicalTrials.gov, number NCT00370331) aimed to investigate the response to REVOLADE versus placebo in ITP patients during a 6-month period.

Inclusion criteria

  • Age: ≥18 years
  • Diagnosis: chronic ITP (defined as >6 months' duration with baseline platelet counts <30,000/µL)
  • Previous treatment: patients had responded to 1 or more previous ITP treatments
  • Splenectomy status: splenectomised or non-splenectomised

Number of patients

  • 197 patients randomised (2:1)
    • REVOLADE + local standard of care: n=135
    • Placebo + local standard of care: n=62

REVOLADE treatment regimen

  • REVOLADE starting dose: 50 mg once daily
  • Dose modifications were made on the basis of individual platelet response (increases to a maximum of 75 mg/day and dose decreases to 25 mg/day)
  • Treatment duration: 6 months

Primary endpoint

  • The odds of response to REVOLADE (defined as platelet count of 50,000–400,000/µL) versus placebo over 6 months of treatment

Secondary endpoints

  • Median platelet count
  • Proportion of patients responding at ≥75% of assessments
  • Mean cumulative weeks of response
  • Mean maximum weeks of continuous response
  • Bleeding symptoms
  • Reduction of baseline treatment for ITP
  • Use of rescue medicine

 

Abbreviation: ITP, immune thrombocytopenia.

Reference

  1. Cheng G, et al. Lancet. 2011;377:393–402.
HCP19-C002f(1) June 2020.

For more information, refer to the REVOLADE® (eltrombopag olamine) Summary of Product Characteristics: https://www.medicines.org.uk/emc/product/7819/smpc

Legal Category: POM.

Aluminium blisters (PA/Alu/PVC/Alu) in a carton containing 14 or 28 film-coated tablets and multipacks containing 84 (3 packs of 28) film-coated tablets. Marketing Authorisation (MA) number, quantities and NHS price: EU/1/10/612/002 – 25 mg x 28 tablet pack £770, EU/1/10/612/005 – 50 mg x 28 tablet pack £1540, EU/1/10/612/008 – 75 mg x 28 tablet pack £2310

 

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