Prescribing information

   

Improving the symptoms that matter to patients

 

Immune thrombocytopenia (ITP) patients treated with REVOLADE were able to achieve significant improvements in fatigue at Week 26, with an almost three-fold increase compared with those receiving placebo [difference 3.1 (4.2 vs. 1.1 respectively), p=0.007, n=135]1*

Bar graph showing that ITP patients treated with REVOLADE were able to achieve significant improvements in fatigue at Week 26, with an almost three-fold increase compared with those receiving placebo. Includes icon of man kneeling on ground to represent treatment with placebo and of icon of man standing on a mound holding a flag to represent the end point with REVOLADE.

 

In the EXTEND study, at least half (50%–64%) of REVOLADE patients were able to achieve clinically meaningful improvements in health-related quality of life (HRQoL)2

REVOLADE patients have also been shown to achieve positive mean changes in all HRQoL measures during treatment, with significant improvements seen in:2

  • Physical health
  • Motivation and energy
  • Fatigue severity
  • Concerns regarding bleeding and bruising

 

Adjusted mean change in HRQoL score over time compared with baseline (positive change indicates improvement)2

Histogram to show the adjusted mean change in health-related quality of life score over time compared with baseline.

 

Choose REVOLADE with confidence for a TRUSTED treatment without compromising quality of life

 

FACT-Th6, Functional Assessment of Cancer Therapy – Thrombocytopenia 6 Item Version; FACIT-fatigue, Functional Assessment of Chronic Illness Therapy - fatigue scale; HRQoL, health-related quality of life; ITP, immune thrombocytopenia; MEI-SF, Motivation and Energy Inventory-Short Form; SF-36v2 MCS, 36-Item Short Form Survey version 2 Mental Component Score; SF-36v2 PCS, 36-Item Short Form Survey version 2 Mental Component Score.

*The phase III, double-blind, placebo-controlled RAISE study evaluated the response of ITP patients (defined as >6 months duration with baseline platelet counts <30,000/μL) to REVOLADE over 6 months of treatment.1

The phase III, open-label EXTEND study 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 patient were enrolled and 135 (45%) completed the study, 60% were treated for at least 2 years and 35% at least 3 years.2

References:

  1. Cheng G, et al. Lancet. 2011;377:393–402.
  2. Khelif A, et al. Am J Hematol. 2019;94:200–208.
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UK | June 2021 | 125340
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