In adult patients with immune thrombocytopenia (ITP) who failed their first therapy
REVOLADE Provides a
Proven and Trusted Response
REVOLADE gets patients to target…1
And maintains patients at target over the long term1,2
- In this study, 86% of patients achieved a platelet count ≥50 x 109/L at least once2
- EXTEND is the largest and longest clinical trial in chronic ITP
REVOLADE also enables a higher percentage of patients to achieve response when treated before splenectomy.2-3
(see the data below)
In adult patients with ITP who failed their first therapy
Rate of Success With REVOLADE
Is Higher When Used Before Splenectomy3
- Durable response, assessed in patients who completed 26 weeks of treatment with REVOLADE in the RAISE study, was defined as achieving a response in at least 6 of the last 8 weeks of treatment and never receiving rescue therapy3
- Higher rate of response in nonsplenectomised patients was also observed in the long-term EXTEND study2
- In the long-term EXTEND study, response was defined as ≥1 platelet count ≥50 x 109/L. This analysis includes patients who received up to 8 years of continuous treatment with REVOLADE2
REVOLADE reduces bleeding in patients with ITP who failed their first therapy.1-3
(see the data below)
(see the data below)
In adult patients with ITP who failed their first therapy
REVOLADE Reduces Bleeding
And Maintains the Reduction Over Time
Bleeding events were assessed on the WHO bleeding scale (Grades 1-4). Rate decreased from 73% at baseline to 39% at Day 15 with REVOLADE, while it only decreased from 77% at baseline to 68% at Day 15 in the control group.1,3
REVOLADE enables many patients to reduce their use of concomitant medication and rescue therapy.2,3
(see the data below)
(see the data below)
In adult patients with ITP who failed their first therapy
REVOLADE Reduced Patients’ Need for
Additional Medications
Reduction in the use of concomitant medication
Reduction in the need for rescue therapy
This analysis includes patients who received up to 8 years of continuous treatment with REVOLADE.
9 of 10 patients who previously responded to REVOLADE are shown to respond when re-treated with REVOLADE.4
(see the data below)
(see the data below)
In adult patients with ITP previously treated with ≥1 therapy
REVOLADE Provides
Consistent Results for Patients
High rate of response after a repeated course of REVOLADE4
REVOLADE is also proven to improve patients’ quality of life.1,3
(see the data below)
(see the data below)
In adult patients with ITP who failed their first therapy
REVOLADE Protects and Significantly
Improves Patients’ Quality of Life
Patients self-reported improvements at Week 26 in the RAISE study1,3
P values represent significance with REVOLADE vs baseline.
Patients in both arms were permitted local standard of care (SOC), including but not limited to corticosteroids, intravenous immunoglobulin, danazol, azathioprine, mycophenolate, anti-D (ρ) immunoglobulin, ciclosporin, ciclophosphamide, rituximab, and vincristine/vinblastine.1,3
The vitality domain is defined as physical or mental fatigue.1,3
- As shown above, patients receiving REVOLADE reported significant improvement from baseline on 5 of the 8 domains of the Short Form 36 Health Survey, version 2 (SF-36v2) that measure health-related quality of life (HRQoL) (P<0.05)1,3
- Significant changes were also shown in:
- Physical and mental component summary scores (normalised to the 1998 US Census)3
- Functional Assessment of Cancer Therapy—Thrombocytopenia (FACT-Th6) score, a subset of which was used to assess the impact of bleeding and bruising on patients’ quality of life3,5
Improvements in health-related quality of life persisted for up to 5 years in measures of fatigue and bleeding/bruising in the EXTEND study1,5,6
- Approximately 80% of patients self-reported improvements in ≥1 measure of health-related quality of life in EXTEND7
FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy—Fatigue.
- The prespecified domain analyses were observational in nature; as such, there were no prespecified statistical procedures controlling for type 1 errors.1
The improvements in health-related quality of life seen with REVOLADE are statistically associated not only with increases in platelet count but with decreases in bleeding.3
(see the data below)
(see the data below)
Improving health-related quality of life helps relieve the physical and emotional burden ITP can have on patients
- The majority of patients self-reported several negative impacts of ITP on their lives1
Data shown are based on responses of patients (N=1,491, unless otherwise stated) involved in a patient and physician survey on ITP conducted in 13 countries.1
The ITP Life Quality Index is a 10-item patient-reported outcomes measure that assesses impact of ITP on patients in order to aid communication between patients and physicians, helping to inform treatment decisions. Results shown reflect the 5 items of the ITP Life Quality Index with the highest percentage of patients in the international survey stating that ITP had an impact on the item “sometimes,” “more than half the time,” or “all the time.”1,8
Results reflect the 5 most impactful, patient-perceived, ITP-related factors affecting emotional well-being, based on responses to the international ITP survey. Data include the percentage of patients who gave a response of 5 to 7 on a 7-point scale (1=Not at all; 7=A great deal).1
-
Patients in other studies have also reported a negative impact of ITP on their lives9,10
- Fatigue leads to impairment in both physical and mental health
- Productivity and attendance at work are adversely affected, as is career advancement
- Sleep disturbance, anxiety, and depression are common
- Embarrassment due to bruising may lead patients to limit social interactions and be hesitant to meet new people9
REVOLADE provides rapid response in paediatric patients (≥1 year of age) with ITP who failed their first therapy.11-13 (see the data below)
In paediatric patients (≥1 year of age) with ITP who failed their first therapy
REVOLADE Provides
Rapid Response as Early as Week 11
Significant improvements in platelet counts were observed in a 7-week double-blind study11,12
Response was defined as a platelet count ≥50 x 109/L at least once between Week 1 and Week 6 in the randomised, double-blind period of the study.11,12
- At Week 1, response rates were 24.4% for REVOLADE and 13.6% for placebo1
Response was defined as a platelet count ≥50 x 109/L for ≥6 weeks of the 8 weeks between Week 5 and Week 12 in the randomised, double-blind period of the study.11,13
- Responses shown above were maintained for ≥6 weeks11
- At Week 1, response rates were 15.9% for REVOLADE and <1% for placebo1
REVOLADE enables many patients to reduce their use of concomitant medication and rescue therapy.14
(see the data below)
(see the data below)
In paediatric patients (≥1 year of age) with ITP who failed their first therapy
REVOLADE Reduced Patients’ Need
For Additional Medications
Reduction in the use of concomitant medication14
- In the open-label phase of both PETIT and PETIT 2, many patients were able to reduce or discontinue concomitant ITP medications14
Reduction in the need for rescue therapy14
- Less need for rescue therapy for patients taking REVOLADE (vs those who received placebo) was observed in the randomised, double-blind phase of both PETIT and PETIT 214
References:
1. Data on file. 2. Wong RSM, Saleh MN, Khelif A, et al. Safety and efficacy of long-term treatment of chronic/persistent ITP with eltrombopag: final results of the EXTEND study. Blood. 2017;130(3):2527-2536. 3. Cheng G, Saleh MN, Marcher C, et al. Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study. Lancet. 2011;377(9763):393-402. 4. Bussel JB, Saleh MN, Vasey SY, Mayer B, Arning M, Stone NL. Repeated short-term use of eltrombopag in patients with chronic immune thrombocytopenia (ITP). Br J Haematol. 2013;160(4):538-546. 5. Khelif A, Saleh MN, Salama A, et al. Patient-reported health-related quality of life improves over time in patients with chronic immune thrombocytopenia receiving long-term treatment with eltrombopag. Blood. 2016;128(22):3750. 6. Khelif A, Saleh MN, Salama A, et al. Patient-reported health-related quality of life improves over time in patients with chronic immune thrombocytopenia receiving long-term treatment with eltrombopag. Presented at: 58th American Society of Hematology Annual Meeting and Exposition; December 3-6, 2016; San Diego, CA. Poster 3750. 7. Khelif A, Mansoor N, Salama S, et al. Changes in health-related quality of life with long-term eltrombopag treatment in adults with persistent/chronic immune thrombocytopenia: Findings from the EXTEND study. Am J Hematol. 2019;94:200–208. 8. Grant L, Bonner N, Harper A, et al. Qualitative research to support the content validity of the Immune Thrombocytopenia (ITP) Life Quality Index (ILQI). Br J Haematol. 2018;181(suppl 1):196. 9. Trotter P, Hill QA. Immune thrombocytopenia: improving quality of life and patient outcomes. Patient Relat Outcome Meas. 2018;9:369-384. 10. Efficace F, Mandelli F, Fazi P, et al. Health-related quality of life and burden of fatigue in patients with primary immune thrombocytopenia by phase of disease. Am J Hematol. 2016;91(10):995-1001. 11. REVOLADE Summary of Product Characteristics. February 2019. 12. Bussel JB, de Miguel PG, Despotovic JD, et al. Eltrombopag for the treatment of children with persistent and chronic immune thrombocytopenia (PETIT): a randomised, multicentre, placebo-controlled study. Lancet Haematol. 2015;2(8):e315-e325. 13. Grainger JD, Locatelli F, Chotsampancharoen T, et al. Eltrombopag for children with chronic immune thrombocytopenia (PETIT2): a randomised, multicentre, placebo-controlled trial. Lancet. 2015;386(10004):1649-1658. 14. REVOLADE Core Data Sheet. Version 2.4. 17 June 2019.
