Prescribing information

   

For a trusted response in paediatric immune thrombocytopenia (ITP) patients

 

Managing ITP in children

Children diagnosed with ITP show a high rate of spontaneous remission* which may occur at any time. Due to this, a 'watch and wait' strategy is often taken with disease management.1,2 However, there are cases where paediatric ITP patients may benefit from treatment, including:

  • If they are at higher risk of serious haemorrhage2
  • If they are diagnosed at an older age1,2†
  • If their health-related quality of life (HRQoL) is compromised and activities are reduced2

For children with chronic or persistent ITP, the International Consensus Report (ICR) encourages the use of thrombopoietin receptor agonists (TPO-RAs). TPO-RAs, such as REVOLADE, are recommended for paediatric patients where alleviating disease will improve HRQoL and/or reduce the risk of bleeding2

 

REVOLADE could help improve your paediatric patients’ lives through responses that are:3,4

Platelet counts 50,000/μL as early as Week3‡

REVOLADE is nearly twice as effective as placebo at achieving a platelet response (n=28/45 vs. n=7/22, respectively).

The majority of paediatric REVOLADE patients (62%, n=28/45) are able to achieve platelet counts 50,000/μL at least once during Weeks 1–63

Percentage of patients achieving platelet counts 50,000/μL at least once during Weeks 1–63

Bar graph to show the percentage of patients achieving platelet counts 50,000/μL at least once during Weeks 1–6 for REVOLADE versus placebo.

Platelet counts 50,000/μL maintained for 6 weeks

Regardless of age group, REVOLADE patients are able to achieve and maintain higher plateler counts. 40% (n=25/63) of paediatric REVOLADE patients maintain platelet counts 50,000/μL for 6 weeks without rescue therapy, compared to 3% (n=1/29) receiving placebo4

 

Percentage of patients maintaining platelet counts 50,000/μL for 6 weeks without rescue therapy4

Bar graph to show the percentage of patients maintaining platelet counts 50,000/μL for 6 weeks without rescue therapy REVOLADE versus placebo.

REVOLADE could also offer your ITP patients:3,4

 

'Reduced bleeding symptoms' of downward arrows and a blood droplet;

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Reduced bleeding symptoms

Patients receiving REVOLADE (27%, n=12/45) had less clinically significant bleeding vs. patients receiving placebo (59%, n=13/22; OR 0.21, 95% CI 0.06–0.72; p=0·013) as well as reduced incidence of bleeding**

'Reduction or discontinuation of concomitant medication' of downward arrows and some tablets.

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Reduction or discontinuation of concomitant medication

50% (n=14/28)†† of REVOLADE patients were able to reduce or discontinue concomitant ITP medication, with 10 patients permanently discontinuing all baseline concomitant drugs

 

For more information about the clinical trials, visit the study design page

Read more

 

Choose REVOLADE when your paediatric patients and carers want a treatment they can trust

 

CI, confidence interval; ITP, immune thrombocytopenia; ITT, intent to treat; OR, odds ratio; TPO-RA, thrombopoietin receptor agonist.

*The probability of complete remission of chronic ITP was 50% and 76% at 2 and 5 years after diagnosis, respectively.1

Age at diagnosis had a statistically significant influence of remission rate, the frequency of 50% remission in patients aged <1 year at presentation was 3.8 times that of patients aged >1 year (p=0.02).1

The three-part-randomised, multicentre, placebo-controlled PETIT study assessed efficacy and safety of REVOLADE in children aged 1–17 years with persistent and chronic ITP (defined as >6 months duration and platelets counts <30,000/μL). Because the study was the first to evaluate REVOLADE use in children, an initial open-label, dose-finding phase was conducted. The double-blind phase and open-label phase of the study recruited additional patients who had not participated in the dose-finding phase.3

§The two-part-randomised, multicentre, placebo-controlled PETIT2 study assessed efficacy and safety of REVOLADE in children aged 1–17 years with chronic ITP (defined as >12 months duration and platelets counts <30,000/μL). Starting doses for REVOLADE were based on results from the open-label, dose-finding phase of the PETIT study.4

**The primary endpoint (proportion of patients achieving a platelet count of 50,000/μL or more at least once from Weeks 1–6 of the randomised phase of the study in the absence of rescue therapy) was compared between treatment groups using a logistic regression model in the randomised phase for the ITT population.

††Cumulative number of patients receiving REVOLADE who discontinued [(n=3/13)+(n=7/15)] or reduced [(n=3/13)+(n=1/15)] concomitant ITP medication from all phases of the PETIT and PETIT2 trials.3,4

References:

  1. Kim C, et al. Yonsei Med J. 2016;57:127–131.
  2. Provan D, et al. Blood Adv. 2019;3:3780–3817.
  3. Bussel J, et al. Lancet Haematol. 2015:315–325.
  4. Wong R, et al. Blood. 2017;130:2527–2536.
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UK | June 2021 | 125342
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