Prescribing information

   

 

Tested in adult and paediatric immune thrombocytopenia (ITP) patients across 5 clinical trials

 

A phase III, open-label, extension study evaluating the safety, tolerability and efficacy of REVOLADE in patients with ITP

'Inclusion criteria' for EXTEND study copy - rosette with tick;

Inclusion criteria

 

Age: ≥18 years


Diagnosis: chronic ITP (defined as >6 months duration with baseline platelet counts <30,000/μL)


Previous treatment: patients 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' for EXTEND study copy - 3 human figures, one in yellow;

Number of patients

 

302 patients enrolled

'REVOLADE treatment regimen'  for EXTEND study copy - tablet jar and tablets;

REVOLADE treatment regimen

 
  • REVOLADE starting dose: 50 mg once daily
  • Dose modifications were made on the basis of individual platelet response (dose increases to a maximum of 75 mg/day and decreases 25 mg/day)
 'Primary endpoint' for EXTEND study copy - one flag;

Primary endpoint

 

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

 'Secondary endpoints' for EXTEND study copy - two flags.

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)

A phase III, open-label, extension study evaluating the safety, tolerability and efficacy of REVOLADE in patients with ITP

'Inclusion criteria' for RAISE study copy - rosette with tick;

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' for RAISE study copy - 3 human figures, one in yellow;

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'  for RAISE study copy - tablet jar and tablets;

REVOLADE treatment regimen

 
  • REVOLADE starting dose: 50 mg once daily
  • Dose modifications were made on the basis of individual platelet response (dose increases to a maximum of 75 mg/day and decreases to 25 mg/day)
  • Treatment duration: 6 months
 'Primary endpoint' for RAISE study copy - one flag; e) 'Secondary endpoints' for RAISE study copy - two flags.

Primary endpoint

 

The odds of response to REVOLADE (defined as platelet count of 50,000–400,000/μL) vs. 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

A phase III, open-label, extension study evaluating the safety, tolerability and efficacy of REVOLADE in patients with ITP

'Inclusion criteria' for REPEAT study copy - rosette with tick;

Inclusion criteria

 

Age: ≥18 years


Diagnosis: chronic ITP (defined as >6 months duration with baseline platelet counts between 20,000/μL and 50,000/μL)


Previous treatment: patients had received 1 or more previous ITP treatments

'Number of patients' for REPEAT study copy - 3 human figures, one in yellow;

Number of patients

 

66 patients enrolled

'REVOLADE treatment regimen'  for REPEAT study copy - tablet jar and tablets;

REVOLADE treatment regimen

 
  • REVOLADE 50 mg once daily over 3 cycles
  • Patients with platelet counts <50,000/μL for 2 successive weeks could receive 75 mg on or after Day 22 during the on-therapy treatment periods
  • A treatment cycle consisted of an on-therapy period of up to 6 weeks followed by an off-therapy period of up to 4 weeks. Patients who did not respond in Cycle 1 were not eligible to continue with further cycles of treatment
'Primary endpoint' for REPEAT study copy - one flag;

Primary endpoint

 

Consistency of response, defined as the proportion of patients with a response (platelet count 50,000/μL and at least twice the baseline) in Cycle 1 who also responded to REVOLADE in Cycle 2 or 3

 'Secondary endpoints' for REPEAT study copy - two flags.

Secondary endpoints

 
  • The proportion of patients who achieved a platelet count 50,000/μL and at least double the baseline value in at least 80% of assessments during Weeks 2–6 of study treatment in each cycle
  • The proportion of patients requiring rescue treatment over 3 cycles
  • The incidence and severity of bleeding assessed with the WHO bleeding scale
  • Safety and tolerability

A phase III, open-label, extension study evaluating the safety, tolerability and efficacy of REVOLADE in patients with ITP

 'Inclusion criteria' for PETIT study copy - rosette with tick

Inclusion criteria

 

Age: 1–17 years


Diagnosis: persistent and chronic ITP (defined as >6 months duration and platelets counts <30,000/μL)


Previous treatment: patients had received at least one previous ITP treatment

 'Number of patients' for PETIT study copy - 3 human figures, one in yellow;

Number of patients

 

67 patients randomised (2:1)

  • REVOLADE: n=45
  • Placebo: n=22
 'REVOLADE treatment regimen'  for PETIT study copy - tablet jar and tablets;

REVOLADE treatment regiment

 
  • REVOLADE starting dose:
    • Patients aged 12–17 years: 37.5 mg/day
    • Patients aged 6–11 years: 50 mg/day for patients ≥27 kg (25 mg/day for east Asian patients) or 25 mg/day for patients <27 kg (12.5 mg/day for east Asian patients)
    • Patients aged 1–5 years: 1.5 mg/kg/day (0.8 mg/kg once per day for east Asian patients)
  • Dose modifications where made on the basis of platelet response up to a maximum dosage of 75 mg/day or 2 mg/kg
 'Primary endpoint' for PETIT study copy - one flag;

Primary endpoint

 

The proportion of patients achieving a platelet count 50,000/μL at least once from Weeks 1–6 (Days 8–43) of the randomised phase of the study in the absence of rescue therapy

'Secondary endpoints' for PETIT study copy - two flags.

Secondary endpoints

 
  • Safety and tolerability
  • The proportion of patients achieving platelet counts of 50,000/μL in at least 60% of assessments from Weeks 2–6 (Days 15–43)
  • The proportion of patients achieving platelet counts of 50,000/μL at least once during 24 weeks of treatment
  • Reduction or discontinuation of concomitant ITP treatment for and need for rescue medication
  • Reduction in bleeding symptoms, in accordance with the WHO bleeding scale
  • Effects of treatment on quality of life
  • Pharmacokinetics

A phase III, open-label, extension study evaluating the safety, tolerability and efficacy of REVOLADE in patients with ITP

 'Inclusion criteria' for PETIT2 study copy - rosette with tick;

Inclusion criteria

 

Age: 1–17 years


Diagnosis: chronic ITP (defined as >12 months duration and platelets counts <30,000/μL)


Previous treatment: patients had received at least one previous ITP treatment

 'Number of patients' for PETIT2 study copy - 3 human figures, one in yellow;

Number of patients

 

92 patients randomised (2:1)

  • REVOLADE: n=63
  • Placebo: n=29
'REVOLADE treatment regimen'  for PETIT2 study copy - tablet jar and tablets;

REVOLADE treatment regiment

 
  • REVOLADE starting dose:
    • Patients aged 6–17 years: 25 mg/day to 50mg/day based on bodyweight and ethnic origin
    • Patients aged 1–5 years: 1.2 mg/kg/day (0.8 mg/kg once per day for east Asian patients)
  • Dose modifications where made on the basis of platelet response up to a maximum dosage of 75 mg/day
'Primary endpoint' for PETIT2 study copy - one flag;

Primary endpoint

 

The primary outcome was the proportion of patients achieving a platelet count 50,000/μL for 6 weeks from Weeks 5–12 of the double-blind period in the absence of rescue therapy

'Secondary endpoints' for PETIT2 study copy - two flags.

Secondary endpoints

 
  • Both double-blind and open-label period
    • Safety
    • Need for rescue treatment
    • Incidence of WHO-classified bleeding
    • Maximum continuous platelet response 50,000/μL
  • Double-blind period
    • Weighted mean platelet change up to Week 12
    • The proportion of patients achieving platelet counts 50,000/μL any time during the first 6 weeks and 12 weeks in the absence of rescue therapy
    • Odds ratio of patient achieving platelet count 50,000/μL at least once from Weeks 1–12 in the absence of rescue therapy
  • Open-label period
    • The proportion of patients achieving platelet counts 50,000/μL any time from 4 weeks and 24 weeks in the absence of rescue therapy
    • Reduction or discontinuation of concomitant ITP medication

Choose REVOLADE with confidence for a tested ITP treatment

 

FCT, film-coated tablet; ITP, immune thrombocytopenia; PfOS, powder for oral suspension; WHO, World Health Organization.

References:

  1. Wong R, et al. Blood. 2017;130:2527–2536.
  2. Cheng G, et al. Lancet. 2011;377:393–402.
  3. Bussel J, et al. Br J Haematol. 2013;160:538–546.
  4. Bussel J, et al. Lancet. 2015:315–325.
  5. Grainger J, et al. Lancet. 2015;386:1649–1658.
Rate this content: 
No votes yet
UK | June 2021 | 125345
×

Ask Speakers

×

Medical Information Request

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]