Prescribing information

 

   

EXTEND: A PHASE III OPEN-LABEL EXTENSION STUDY EVALUATING THE SAFETY, TOLERABILITY AND EFFICACY OF REVOLADE IN PATIENTS WITH ITP1

Objective

The phase III, open-label EXTEND Study (ClinicalTrials.gov identifier: NCT00351468) was designed to investigate the long-term efficacy and safety of REVOLADE for the treatment of ITP in adult patients who had completed a previous REVOLADE study.

Inclusion criteria

  • Age: 18 years of age or older
  • Diagnosis: chronic ITP (confirmed for a duration of 6 months or more with baseline platelet counts less than 30,000/µL)
  • Previous treatment: patients had had an insufficient response to 1 or more previous ITP treatments. Patients had been treated with REVOLADE in previous trials
  • Splenectomy status: splenectomised or non-splenectomised

Number of patients

  • 302 patients enrolled

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)

Primary endpoint

  • Safety and tolerability parameters, including clinical laboratory tests, ocular tests and frequencies of all adverse events

Secondary endpoints

  • Proportion of patients achieving platelet count thresholds (≥30,000/µL and ≥50,000/µL)
  • Maximum continuous duration of platelet count thresholds
  • Reduction or sparing of concomitant ITP therapies while maintaining a platelet count ≥50,000/µL
  • Proportion of patients achieving stable platelet counts ≥50,000/µL while remaining free of concomitant ITP medication during treatment
  • Proportion of patients needing rescue treatment
  • Incidence and severity of signs and symptoms associated with ITP (measured using the WHO bleeding scale and ITP bleeding score)

*Response: platelet count higher than 50,000/µL at least once in the absence of rescue therapy.

Abbreviations: ITP, immune thrombocytopenia; WHO, World Health Organization.

Reference

  1. Wong RSM, et al. Blood. 2017;130(23):2527–2536. 
HCP19-C002d(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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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
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