Belumosudil is the&nbsp;first and best-in-class ROCK2 inhibitor, specifically designed as an immunomodulator to target both the inflammatory and fibrotic/sclerotic manifestations of cGVHD.1

black

Belumosudil&nbsp;decreases activation of STAT3, triggering the significant&nbsp;downregulation of both Th17 and Tfh cells, leading to the&nbsp;downregulation of pro-inflammatory cytokines (IL-21, IL-17).1,4

↓&nbsp;Inflammation
Belumosudil&nbsp;increases phosphorylation of STAT5, causing the&nbsp;upregulation of Treg cells.3&nbsp;Overall, this has an&nbsp;immunomodulatory effect&nbsp;on STAT3 and STAT5 phosphorylation,&nbsp;reducing inflammation.1,4

200 mg once daily administered orally6

REZUROCK® (belumosudil) is indicated for the treatment of adult and pediatric patients 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy.6

Belumosudil&nbsp;prevents the polymerization of G-actin to F-actin, including the&nbsp;downregulation of MRTF-related profibrotic gene expression.5
↓&nbsp;Fibrosis

Belumosudil&nbsp;downregulates fibrosis, as demonstrated by&nbsp;decreased collagen deposition around the bronchioles&nbsp;and the&nbsp;delayed progression of scleroderma&nbsp;in animal cGVHD models.2

Abbreviations
ROCK2:&nbsp;Rho associated coiled-coil containing protein kinase 2;&nbsp;STAT3:&nbsp;Signal transducer and activator of transcription 3;&nbsp;Th:&nbsp;&nbsp;helper cells;&nbsp;Tfh:&nbsp;T follicular helper cells;&nbsp;IL-21 :&nbsp;Interleukin-21;&nbsp;IL-17:&nbsp;Interleukin-17;&nbsp;Treg:&nbsp;Regulatory&nbsp; ;&nbsp;STAT5: Signal transducer and activator of transcription 5;&nbsp;G-actin:&nbsp;Globular protein;&nbsp;F-actin:&nbsp;Filamentous protein;&nbsp;MRTF:&nbsp;Myocardin-related transcription factor;&nbsp;cGVHD:&nbsp;Chronic graft-versus-host disease.

References

Rezurock Dosage

PAYOR

OUT-OF-TAXONOMY

Rezurock demonstrates strong efficacy with durable ORR across all organs and FFS, along with meaningful improvements in various endpoints and QoL, as supported by clinical trials and RWE across diverse markets.1

Clinical Trial (ROCKstar* 36-month follow-up)1-3

<ul>
 <li>74%: overall response rate (ORR) at 36 months</li>
 <li>Subgroups Best ORR
 <ul>
 <li>75%: Severe cGVHD patients</li>
 <li>72%: Prior ibrutinib cGVHD patients</li>
 <li>69%: Prior ruxolitinib cGVHD patients</li>
 </ul></li>
 <li>Organ-specific complete response:</li>
</ul>

<ul>
 <li>Failure free survival (FFS)&nbsp;</li>
</ul>

<ul>
 <li>86%:&nbsp;Overall survival (OS) at 24months</li>
</ul>

<ul>
 <li>69.9 weeks/16 months: Median duration of response (DoR)</li>
</ul>

<ul>
 <li>68% of the responders experienced clinically meaningful improvement in the Lee Symptom Scale (LSS)</li>
</ul>

*All the results are presented for the 200 mg once daily dosage (N=77)
&nbsp; &nbsp;

<ul>
 <li>44.2% improvement in ORR at 6 months (ref 4): (space) 39% of patients receiving Rezurock (LOT- episodes = 113) achieved a response (space) 27% of those receiving BAT (LOT-episodes = 245) achieved a response</li>
 <li>28% improvement in FFS at 1 year(ref 4): 61.2% of patients treated with Rezurock (LOT-episodes = 113) remained failure-free 47.8% of those on BAT (LOT-episodes = 245) remained failure-free</li>
</ul>

Belumosudil showcased promising efficacy and safety results with no new safety signals identified. This was consistently demonstrated across various country cohorts:

France: In patients receiving at least two prior lines of therapy (N=68).

Germany and Switzerland: In heavily pretreated patients (N=33).6

Canada: In patients with a history of extensive treatment (N=35).

Spain: In patients receiving at least two prior lines of therapy (N=63).9

Abbreviations
ORR:&nbsp;Overall response rate;&nbsp;FFS:&nbsp;Failure-free survival;&nbsp;QoL:&nbsp;&nbsp;Quality of life;&nbsp;RWE:&nbsp;Real-world evidence;&nbsp;GI :&nbsp;Gastrointestinal;&nbsp;n:&nbsp;Sample size;&nbsp;DoR:&nbsp;Duration of response;&nbsp;LOT: Line of therapy;&nbsp;BAT:&nbsp;Best available therapies;&nbsp;cGVHD:&nbsp;Chronic graft-versus-host disease.

Rezurock Efficacy

Long term data on Rezurock demonstrates efficacy without compromising safety, establishing it as a well-tolerated 3L therapy for patients with cGVHD1

Clinical Trial (ROCKstar 36-month follow-up)1

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="text-align: center; background-color: rgb(229, 199, 255);">Category</td>
 <td style="text-align: center; background-color: rgb(229, 199, 255);">Patients, n (%) 
 (n=152*)</td>
 </tr>
 <tr>
 <td>Any AE</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">151 (99)</td>
 </tr>
 <tr>
 <td>Grade ≥3 AEs</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">94 (62)</td>
 </tr>
 <tr>
 <td>Drug-related AEs</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">109 (72)</td>
 </tr>
 <tr>
 <td>Drug related SAEs, n(%)</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">12 (8)</td>
 </tr>
 <tr>
 <td>On study death</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">28 (18)</td>
 </tr>
 <tr>
 <td>AE leading to deaths</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">10 (7)</td>
 </tr>
 </tbody>
</table>

*152 patients include 77 patients on belumosudil 200 mg QD treatment and 75 patients on belumosudil 200 mg BID treatment

RWE2

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td colspan="1" rowspan="2" style="text-align: center; background-color: rgb(229, 199, 255);">Category</td>
 <td style="text-align: center; background-color: rgb(229, 199, 255);">belumosudil 
 LOT-episodes (n=113)</td>
 <td style="text-align: center; background-color: rgb(253, 243, 217);">BAT LOT-episodes 
 (n=245)</td>
 </tr>
 <tr>
 <td style="text-align: center; background-color: rgb(229, 199, 255);">Patients, n (ratea)</td>
 <td style="text-align: center; background-color: rgb(253, 243, 217);">Patients, n (ratea)</td>
 </tr>
 <tr>
 <td style="background-color: rgb(242, 242, 242);">Any AE</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">52&nbsp;(41.2)</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">175 (51.3)</td>
 </tr>
 <tr>
 <td style="background-color: rgb(242, 242, 242);">Moderate, n (rate2)</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">17 (13.5)</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">67 (19.7)</td>
 </tr>
 <tr>
 <td style="background-color: rgb(242, 242, 242);">Severe, n (rate2)</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">30 (23.8)</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">80 (23.5)</td>
 </tr>
 <tr>
 <td style="background-color: rgb(242, 242, 242);">AE attributed to background cGVHD medication, n (rate2)</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">12 (9.5)</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">47 (13.8)</td>
 </tr>
 <tr>
 <td style="background-color: rgb(242, 242, 242);">AE led to death, n (rate2)</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">5 (16)</td>
 <td style="text-align: center; background-color: rgb(242, 242, 242);">11 (16)</td>
 </tr>
 </tbody>
</table>

a: Rate is the incidence rate per 100 episode-years (rate = count / ( total exposure time in years / 100))

Abbreviations
3L:&nbsp;Third line;&nbsp;AE:&nbsp;Adverse event;&nbsp;QoL:&nbsp;&nbsp;Quality of life;&nbsp;RWE:&nbsp;Real-world evidence;&nbsp;n:&nbsp;Sample size;&nbsp;LOT: Line of therapy;&nbsp;BAT:&nbsp;Best available therapies;&nbsp;cGVHD:&nbsp;Chronic graft-versus-host disease.

Rezurock Safety

Rezurock is a cost-effective treatment when compared to the available treatments against 3L cGVHD,with a coverage resulting in a neutral/limited incremental budget impact.1

Cost-effectiveness Analysis1,3

<ul>
 <li>At a WTP of&nbsp;£30,000&nbsp;per QALY gained, Belumosudil demonstrated a&nbsp;significant clinical benefit&nbsp;versus BATs with an incremental gain of:&nbsp;0.854&nbsp;QALYs</li>
 <li>Belumosudil is cost-effective vs. BAT in patients aged&nbsp;12&nbsp;years and older&nbsp;with cGVHD who received&nbsp;at least two prior lines of systemic therapy.</li>
</ul>

Budget-impact Analysis2

<ul>
 <li>Costs savings associated with the&nbsp;management of AEs&nbsp;(e.g., neutropenia and thrombocytopenia) in 2026 are projected to be&nbsp;≈$108.4M</li>
 <li>Costs savings associated with&nbsp;healthcare resources utilization&nbsp;(e.g., emergency room visits, ICU stays) in 2026 are projected to be&nbsp;≈$65.1M</li>
</ul>

Belumosudil allows for the offset of healthcare system costs compared with BAT, resulting in a $128.8M cost savings from a national US payer perspective

3L:&nbsp;Third line;&nbsp;WTP:&nbsp;Willingness-to-pay;&nbsp;AE:&nbsp;Adverse event;&nbsp;RWE:&nbsp;Real-world evidence;&nbsp;ICU:&nbsp;Intensive Care Unit;&nbsp;LOT: Line of therapy;&nbsp;BAT:&nbsp;Best available therapies;&nbsp;cGVHD:&nbsp;Chronic graft-versus-host disease;&nbsp;US:&nbsp;United States.

Rezurock Economic Value

ACID-SPHINGOMYLENASE-DEFICIENCY-NIEMANN-PICK

RARE-DISEASE

How is ASMD inherited?

This video explains how the condition is passed from parents to children.

<h2>Are you interested in knowing more about this topic?</h2>

POMPE

Their Stories shaped them like Pearls

Their stories can help you diagnose Pompe Disease faster, watch the video below and help shape the world's understanding of Pompe.

Professor Tawfeq Ben Omran video on ASMD

Awareness on ASMD disease
Professor Tawfeq Ben Omran explains the signs and most common symptoms of the disease. In addition to that, he takes us through the different specialties that can encounter ASMD patients. He also highlights the necessity of increasing awareness in order to eliminate the long diagnostic odyssey.

Professor Moeen Al Sayed video on ASMD

Awareness on ASMD disease.
Professor Moeen Al Sayed gives a detailed overview of the complications faced by the patients suffering from ASMD disease from its most severe form to its most prevalent form.

Professor Fatma Al-Jasmi video on ASMD

Awareness on ASMD disease
In this video, Professor Fatma Al – Jasmi explains the causes of the disease and the different types falling under its spectrum. She explains the difference between each ASMD form and the main characteristics and symptoms related to each type.

To read the full content, activate your Sanofi Campus account. Please confirm your email address in the email you received.

If you didn't receive our first email at {email} to confirm your account you can request a new one below. If you don't see it, you may need to check your spam folder.

This information will only be used to validate your account and will not be distributed.

title

Before starting exploring, we can suggest you specific and relevant content

Title

This website is for healthcare professionals only

Welcome to BP Sanofi Campus

Create new password

To offer you a personalised experience, you must

Your profile is incomplete

The ADCT gives a measure of how controlled the eczema is. Answer these 6 simple questions with your patient to find the ADCT score. It will indicate proper course of action.

Atopic dermatitis, a type of eczema, may be affecting your Patient's life in more ways than you know.

Take the Atopic Dermatitis Control Test (ADCT)

Enjoy more exclusive content{newline}by <a>registering today</a>

Already have an account? <a>Sign in here</a>

Best practices on optimising patient care

Get a customised view of the topics that you're interested in, along with the ability to save content to watch or read at a later date.

Unlimited access to premier content, white papers, case studies, research papers, webinars, training, and up-to-date scientific medical resources.

Personalised content based on your areas of interest

Connect and stay up-to-date with peers in your area of speciality and topics of interest through free events and leadership forums.

Please sign in to continue and read the full article

Please sign up to continue reading the full article.

We respect your privacy and will not share your information with any 3rd parties.

Topical guides written specifically for patients

Unlimited access to the latest patient guide guides and resources. Share content with your patients with easy-to-use online tools.

Please complete your profile to read the content.

Your profile is not validated yet. Please verify your inbox.

Restricted Access

We can't find the page you're looking for

You are going to a website that is not operated by Sanofi. Sanofi has no control over the content or availability of linked sites or resources, and accepts no liability or responsibility for them or for any loss or damage that may arise from your use of them. Please ensure that you read the legal and privacy policy sections of any third-party site to which you link.

You are about to leave Sanofi Campus website.

You are now leaving this site to visit a partner website.

Thank you for visiting COPD Sanofi Campus.

This website is for healthcare professionals only.

Welcome to COPD Sanofi Campus.

Welcome to COPD Sanofi Campus

Welcome to CSU Sanofi Campus

Please refresh the page to access the content

Sorry, something went wrong

We're usually a treasure chest of knowledge, but we couldn't find what you're looking for.

We were unable to find what you're searching for

You are about to leave Campus.sanofi/uk.

Images from <a>iStockphoto.com</a>, Fotolia.de, <c>gettyimages.de</c>, <d>pexels.com</d> and <e>photocase.de</e> were used for our websites.

Thank you for registering. Before we get started, we need to confirm your email address to ensure that we have the correct information.

Please follow these steps to complete your registration:

Would you like to receive future text messages about Beyfortus updates?

Sanofi is here to help support your patients, their families, and caregivers. For more information regarding Beyfortus®, call <a.callPhoneNumberBeyfortus>1-855-BEYFORTUS (1-855-239-3678)</a.callPhoneNumberBeyfortus> or sign up below to receive the latest updates via email or text. All fields are required.

Would you like to learn more about Beyfortus® (nirsevimab-alip) 50 mg and 100 mg injection? Leave us your contact details, and a Sanofi representative will be in touch. All fields are required.

Would you also like to receive future messages and updates about Beyfortus?

Do you want to participate in the Beyfortus Reservation Program?

What information are you interested in learning more about? (Optional)

Are you enrolled in CENRIFKI REMS?

Request a visit from your local ALPROLIX representative to learn more. Call <a.callPhoneNumberAltuviiio>1-800-745-4447</a.callPhoneNumberAltuviiio>, Option 5, or complete the form below. The information you provide will be maintained in accordance with our <a.usPrivacyPolicy>Privacy Policy</a.usPrivacyPolicy>. All fields are required.

Request a visit from your local ALTUVIIIO representative to learn more. Call <a.callPhoneNumberAltuviiio>1-800-745-4447</a.callPhoneNumberAltuviiio>, Option 5, or complete the form below. The information you provide will be maintained in accordance with our <a.usPrivacyPolicy>Privacy Policy</a.usPrivacyPolicy>. All fields are required.

Request a visit from your local QFITLIA representative to learn more. Call <a.callPhoneNumberAltuviiio>1-800-745-4447</a.callPhoneNumberAltuviiio>, Option 5, or complete the form below. The information you provide will be maintained in accordance with our <a.usPrivacyPolicy>Privacy Policy</a.usPrivacyPolicy>. All fields are required.

Sign up to schedule an office visit with your ALPROLIX® Representative or receive updates about ALPROLIX. Please complete the form below. The information you provide will be maintained in accordance with our <a.usPrivacyPolicy>Privacy Policy</a.usPrivacyPolicy>. All fields are required.

Sign up to schedule an office visit with your local Sanofi representative and/or to receive updates about Qfitlia. Please complete the form below. The information you provide will be maintained in accordance with our <a.usPrivacyPolicy>Privacy Policy</a.usPrivacyPolicy>. All fields are required (unless otherwise specified).

All fields are required. (unless otherwise specified)

This site is intended for healthcare professionals only and contains information on Sanofi medicines, educational resources and more. Please click the appropriate button below. By entering this site, you are confirming that you are a healthcare professional. This site contains promotional information. Please note that some of the content on the website is only relevant for HCPs.

Welcome to Sanofi Campus

Welcome to ITP Sanofi Campus

This content is only available to registered users. Please sign in or register to view this content.

Please Sign In

Email verification

You're seeing a preview of the portal. Clear your cookies (by closing your browser window for example) to go back to public mode.

We've updated our privacy notice to better protect your data and enhance your experience. Please take a moment to review the changes by <privacyNewTab>clicking here</privacyNewTab>. Your privacy matters for us. Please click on continue to confirm you have read the new privacy notice.

Privacy Notice Update

Communication consent

My consents

Password

Confirm password

{resultsCount, plural, one {result} other {results}}

Please log in to access to the results

You need to sign-in to your account in order to access medical content.

Please Log In

To access the results, please register in under 1 minute

You are now leaving the Sanofi content section of our site and entering the external medical bibliographic search content section.

You are entering to the External Scientific Content Site

You are now leaving the external medical bibliographic search section of our site and entering the Sanofi content section.

Latest Articles