EXTEND: A PHASE III OPEN-LABEL EXTENSION STUDY EVALUATING THE SAFETY, TOLERABILITY AND EFFICACY OF REVOLADE IN PATIENTS WITH ITP1
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.
- 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)
- Safety and tolerability parameters, including clinical laboratory tests, ocular tests and frequencies of all adverse events
- 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.
- Wong RSM, et al. Blood. 2017;130(23):2527–2536.