<a href="${link:{uuid:{41d82ab0-c017-4e79-be57-e5930764c364},repository:{dam},path:{/Portal/UK/Prescribing-links/Rezurock%20PI%20GB.pdf}}}" target="_blank">Prescribing Information Rezurock belumosudil (tablets)</a>

<h2>Patient impact and treatment goals of cGvHD</h2>
Patients with cGvHD experience a range of physical, functional, psychosocial, and economic 
 deficits.1-3&nbsp;Preventing disease progression and irreversible damage are critical goals in the management of cGvHD.&nbsp;

The inflammation and fibrosis associated with cGvHD can lead to multiple physical ailments impacting numerous organs.4-6

Psychological distress is associated with worsening QoL, physical function and cGvHD symptom burden.7

Only 37.5% of patients with cGvHD are able to return to work.8-9&nbsp;This is associated with decreased QoL, activity level and physical and mental functioning.

Download a summary of the affect that cGvHD has on patients and explore how their quality of life can be impacted. (For full interactivity, download&nbsp;and view in Adobe Acrobat).

TRANSPLANT

Dawn Hart, Katharina Ecsy, Luke Skinner, Arunesh Sil, Richard Hudson and Matthew Bradberry

This poster presents a qualitative study on how cGvHD affects the QoL for patients and their caregivers. It highlights the major challenges faced, especially after multiple failed treatments. The study, based on interviews with patients and caregivers, examines the physical, emotional, social and financial burdens of cGvHD. Key findings include the disease's impact on daily life, the added strain from treatment side effects, and the psychological and financial toll.

Dawn Hart, Katharina Ecsy, Luke Skinner, Arunesh Sil, Richard Hudson and Matthew Bradberry
This poster showcases a quantitative study on how cGvHD affects the QoL for patients and their caregivers. It reveals the severe physical symptoms, heavy treatment burden, and emotional challenges for patients, along with the significant anxiety and financial strain for caregivers. The study highlights the urgent need for better support and management strategies to improve quality of life for both patients and caregivers.

Abbreviations

References

REZUROCK®▼ (belumosudil) Prescribing Information (GB ONLY)

cGvHD Quality of Life

<h2>Early onset and complexity of fibrosis in cGvHD</h2>
Fibrosis in cGvHD may happen earlier than expected.
<ul>
 <li>Inflammation and fibrosis can both occur within the first year post allogenic&nbsp;hematopoietic stem&nbsp;cell transplantation (alloHSCT), but sometimes develop many years after.1-2</li>
 <li>The exact relationship between inflammation and fibrosis is complex and not yet fully understood.3</li>
 <li>Fibrosis may be viewed as a natural consequence of inflammation, but in fact,&nbsp;research suggests it may begin developing prior to&nbsp;any symptoms of cGvHD.4-6</li>
</ul>

<h2>The need for early intervention</h2>
Despite the heterogeneity of cGvHD presentation, the defining features are inflammation and fibrosis1,3&nbsp;which can affect multiple organs.&nbsp;
The condition can affect the skin, liver, lungs, eyes and gastrointestinal system, among others.
Acting as early as possible to target both the fibrotic and inflammatory components of cGvHD could be crucial in appropriate patients.7,9

Gain a deeper understanding of the mechanisms behind cGvHD, including its key drivers - inflammation and fibrosis. (For full interactivity, download&nbsp;and view in Adobe Acrobat).

Understanding the mechanism of cGvHD: Inflammation and Fibrosis

<h3>This is intended for HCPs practising in Great Britain (England, Scotland, Wales) only.</h3>
<a href="${link:{uuid:{41d82ab0-c017-4e79-be57-e5930764c364},repository:{dam},path:{/Portal/UK/Prescribing-links/Rezurock-PI-GB-March-2023.pdf}}}" target="_blank">Prescribing Information (GB only)</a>

<h2>ROCKstar study&nbsp;</h2>
<h3>Responses&nbsp;with REZUROCK were seen after failure of ≥2 prior lines of therapy1</h3>
Study design1:&nbsp;ROCKstar was a pivotal phase 2, open label, non-controlled, randomized, multicenter study that evaluated the efficacy and safety of REZUROCK in patients with cGvHD after receiving 2 to 5 prior lines of systemic therapy.&nbsp;
Treatment consisted of REZUROCK 200 mg and was administered continuously until clinically significant progression of cGvHD or unacceptable toxicity.&nbsp;
Primary end point1:&nbsp;Best ORR at any time, defined as the proportion of subjects who achieved CR or PR according to the 2014 NIH cGVHD Consensus Criteria.

Clinically meaningful&nbsp;and&nbsp;statistically significant&nbsp;best ORR&nbsp;of 74%&nbsp;(n=66, 95% CI, 62-84)2&nbsp;at 1 year was maintained after 3 years of treatment with REZUROCK (n=77, 95% CI, 63-83)3.

Responses across&nbsp;all evaluated organs, including those with fibrotic manifestations1,4.

Median time to response to the initiation of new systemic cGVHD therapy was 100.3 weeks (54.14-NA)2.

Over 3 years, 65% (n/N=50/76) reduced their CS dose and 27% (n/N=21/73) discontinued CS therapy3

ORR, overall response rate; CR, complete response;&nbsp;CS, corticosteroids;&nbsp;PR, partial response; FFS, failure free survival; OS, overall survival.

<a href="/uk/transplant">SEE MORE FROM SCIENCE</a>

<h3>REZUROCK</h3>
Get the latest updates&nbsp;about&nbsp;REZUROCK​. 
 This is intended for&nbsp;HCPs&nbsp;practising&nbsp;in&nbsp;Great Britain (England,&nbsp;Scotland, Wales) only​.

<h3>Safety Profile</h3>
Download safety profile summary.&nbsp; 
 This is intended for HCPs practising Great Britain (England, Scotland, Wales) only​.

Get in touch with the Transplant Team

Study Summary

<table border="0" cellpadding="1" cellspacing="1" style="width: 500px;">
 <tbody>
 <tr>
 <td style="background-color: rgb(212, 22, 117);">
 <h3>In the 3-year follow-up to the 2021 ROCKstar study, no new safety signals were observed.1</h3></td>
 </tr>
 </tbody>
</table>

<h2>In the ROCKstar and KD025-208 studies 
 REZUROCK was generally well tolerated in patients with cGVHD2</h2>
<h3>Safety was evaluated across 2 clinical studies (n=186)3,4</h3>
Consider the safety profile of REZUROCK in patients with cGVHD who often receive immunosuppressive therapy.&nbsp;
Please refer to the full Summary of Product Characteristics before prescribing.

The most common adverse reactions leading to discontinuation were nausea (2.4%) and headache (2.4%). Adverse reactions leading to dose interruption occurred in 9.6% of patients and were mainly investigations (3.6%), including ALT increased, GGT increased and blood creatine phosphokinase increased (1.2% each), and infections (2.4%)2

The most common adverse reactions (≥5%) were asthenia (21.0%), nausea (12.4%), liver function test abnormalities of elevation of AST (7.5%), elevation of ALT (7.0%) and elevation of GGT (4.8%), headache (8.6%), diarrhoea (7.0%) and musculoskeletal pain (5.9%)2

Serious adverse reactions were pneumonia (1.1%), cellulitis, infectious colitis, staphylococcal bacteraemia, diarrhoea, nausea, vomiting, microangiopathic haemolytic anaemia, multiple organ dysfunction syndrome and cGVHD (0.5% each)2

There were&nbsp;no reports of CMV&nbsp;infection in both the ROCKstar and the foundational, dose-finding KD025-208 studies, and only&nbsp;1 report of CMV reactivation&nbsp;in total3,4

In the ROCKstar and KD025-208 clinical studies of REZUROCK,&nbsp;grade ≥3 cytopenias&nbsp;were reported in&nbsp;&lt;4%&nbsp;and&nbsp;4%&nbsp;of patients, respectively3,4

<h3>REZUROCK</h3>
Get the latest updates&nbsp;about&nbsp;REZUROCK​. 
 This is intended for&nbsp;HCPs&nbsp;practising&nbsp;in&nbsp;Great Britain (England,&nbsp;Scotland, Wales) only​

<h3>ROCKstar Study</h3>
Download ROCKstar study summary. 
 This is intended for HCPs&nbsp;practising&nbsp;in&nbsp;Great Britain (England, Scotland,&nbsp;Wales) only​

Safety Profile

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The ADCT gives a measure of how controlled your patient’s eczema is. Use these 6 concise questions to evaluate all dimensions of atopic dermatitis control.

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Transplant

Latest Articles

cGvHD Quality of Life

Understanding the mechanism of cGvHD: Inflammation and Fibrosis

Study Summary

Safety Profile