10 years of heritage

REVOLADE has:

Been licensed for ITP treatment for over a decade^1,2

Accumulated 270,623 patient-years of experience across all indications¹²*^†

Demonstrated maintained platelet counts over 7 years of treatment^1,2,7‡

A heritage of providing patients with ITP with a rapid and sustained response with an established safety and tolerability profile^6,7,9–11

EC, European Commission; HCP, healthcare professional; ITP, immune thrombocytopenia; I-WISh, ITP World Impact Survey; QoL, quality of life.

*Therapeutic indications: REVOLADE is indicated for the treatment of patients aged 1 year and above with primary ITP lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).^1,2

^†The cumulative post-marketing exposure is estimated to be 270,623 patient-years since the international birth date in October of 2004.¹²

^‡REVOLADE was administered to 302 patients. Median platelet counts at 1, 2, 3, 4, 5, 6 and 7 years of treatment were 85,000/μL (n=218), 85,000/μL (n=180), 105,000/μL (n=107), 64,000/μL (n=75), 75,000/μL (n=34), 119,000/μL (n=18) and 76,000/μL, respectively.^1,2

^§The RAISE study was a phase III, double-blind, placebo-controlled study (N=197) which evaluated the response of ITP patients (defined as a platelet count of 50,000–400,000/μL) to REVOLADE over 6 months of treatment.⁶

**The REPEAT study was a phase II, open-label, single-arm study (N=66) which evaluated the safety and consistency of response in ITP patients (defined as >6 months duration with baseline platelet counts between 20,000/μL and 50,000/μL) treated with repeated intermittent dosing of REVOLADE across 3 cycles (defined as consisting 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 the trial.⁹

^††The PETIT study was a three-part randomised, multicentre, placebo-controlled study (N=67) which assessed efficacy and safety of REVOLADE in children aged 1–17 years with chronic ITP (defined as >6 months duration and platelet 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.¹⁰

^‡‡The PETIT2 study was a two-part randomised, multicentre, placebo-controlled study (N=92) which assessed efficacy and safety of REVOLADE in children aged 1–17 years with chronic ITP (defined as >12 months duration and platelet counts <30,000/μL). Starting doses for REVOLADE were based on results from the open-label, dose-finding phase of the PETIT study.¹¹

^§§The EXTEND study was a phase III, open-label study (N=302) which evaluated long-term safety and efficacy of REVOLADE in adults with ITP (defined as >6 months duration with baseline platelet counts <30,000/μL) who have completed a previous REVOLADE study. The study reviewed more than 8 years of continuous treatment; 302 patients were enrolled and 135 (45%) completed the study, 60% were treated for at least 2 years and 35% at least 3 years.⁷

References:

1. REVOLADE FCT Summary of Product Characteristics.
2. REVOLADE PfOS Summary of Product Characteristics.
3. Novartis. Patient resources. ITP Pocket Log. 2021. Available at: https://w​ww.novartis.co.uk/itp-p​atient-resources#pocket-log-app.
4. Novartis. Patient resources. 2021. Available at: https://w​ww.novartis.co.uk/itp-​patient-resources.
5. Data on file I-WISh Global Survey Report 2018.
6. Cheng G, et al. Lancet. 2011;377:393–402.
7. Wong R, et al. Blood. 2017;130:2527–2536.
8. Khelif A, et al. Am J Hematol. 2019;94:200–208.
9. Bussel J, et al. Br J Haematol. 2013;160:538–546.
10. Bussel J, et al. Lancet. 2015;2:315–325.
11. Grainger J, et al. Lancet. 2015;386:1649–1658.
12. Data on file REVDOFPATIENTYEARS.
13. Bussel J, et al. N Engl J Med. 2007;357:2237–2247.
14. REVOLADE EPAR Authorisation for Paediatric Patients 2016. Available at: https://w​ww.ema.europa.eu/en/medicines/human/paediatric​-investigationplans/emea-000170-pip01-07-m04.
15. REVOLADE EPAR Variation Assessment Report 2015. Available at: https://w​ww.ema.europa.eu/en/documents/variation​-report/revolade-h-c-1110-ii-0020-epar-assessment-report-variation_en.pdf.
16. REVOLADE EPAR Assessment Report 2019. Available at: https://w​ww.ema.europa.eu/en/documents/variation​-report/revolade-h-c-1110-ii-0050-eparassessment-report-variation_en.pdf.
17. NHS Specialist Pharmacy Service. Eltrombopag dm+d. Available at: https://w​ww.sps.nhs.uk/medicines/elt​rombopag/.