<h2>WHAT ROLES DO THE INFLAMMATORY AND FIBROTIC PROCESSES PLAY IN cGVHD?</h2>
Chronic graft-versus-host disease is characterized by a combination of tissue inflammation and fibrosis, which manifest across multiple organ systems.1-4 
 The relationship between these 2 processes in cGVHD is complex and not fully understood.3&nbsp;Fibrosis may be viewed as a natural consequence of inflammation, as an independent process or as interrelated with inflammation in some ways but not completely dependent on it.5

Because of chronic inflammatory changes, cGVHD can present with collagen-producing fibroblasts,2 resulting in fibrotic lesions.2,4
Fibrotic lesions can develop across multiple organs4

SKIN

MOUTH

JOINTS

EYES

GI TRACT

ESOPHAGUS

LIVER

LUNGS

Fibrosis is a major contributor to life-threatening complications and significant morbidity.6

<h3>Patients develop multiorgan manifestations, including skin, mouth, joint/fascia, eye, upper and lower GI tract, esophagus, liver, genitourinary and/or lung manifestations.4,7,8</h3>

Skin manifestations are the most common, occurring in

Approximately half of patients have lung involvement,

which can manifest as bronchiolitis obliterans, a fibrotic manifestation that can be especially difficult to treat.

<div>
 Although the inflammation associated with cGVHD can be addressed, there is limited evidence regarding the impact of current treatments on fibrosis.10-15
</div>

Learn more about patient quality of life

How do inflammation and fibrosis affect patients’ lives?

Learn more about current treatment options

What treatments are currently available for cGVHD?

Reference

Inflammation and Fibrosis Role

CHRONIC-GRAFT-VERSUS-HOST-DISEASE-CGVHD

TRANSPLANT

<h2>WHAT TREATMENTS ARE UNDER CLINICAL DEVELOPMENT?</h2>
There are multiple novel therapies currently being investigated for the treatment of chronic graft-versus-host disease with the hopes of improving patient outcomes.

Selective rho-associated coiled-coil–containing protein kinase (ROCK) 2 inhibitors have been studied as a potential treatment option for cGVHD, given that this molecular pathway&nbsp;mediates both the inflammatory and fibrotic components&nbsp;of the disease.1,2 
 Selective ROCK2 inhibition has been shown to help resolve immune dysregulation by downregulating pro-inflammatory T helper (Th) 17 cells and increasing regulatory T (Treg) cells. Furthermore, selective ROCK2 inhibition has been shown to downregulate key fibrotic processes, such as TGF-β and LPA, leading to a decrease in fibrosis and collagen deposition.1-4 
 Clinical studies are currently ongoing to evaluate the potential benefifits of selective ROCK2 inhibition in cGVHD.

Selective ROCK2 inhibitors

black

The involvement of JAKs in the signaling of pro-inflammatory cytokines involved in cGVHD pathogenesis has been a large area of interest. The potential use of JAK1 selective inhibitors in the treatment of cGVHD is currently being explored.

Selective JAK1 inhibitors5

The important role that IL-2 plays in Treg cell development, expansion, activity and survival has led to interest in its use for the treatment of cGVHD. Clinical studies in patients with cGVHD have shown that low-dose subcutaneous IL-2 has increased Treg cells, with minimal effect on CD4+&nbsp;T cells. Clinical studies are currently ongoing to explore the potential benefits of IL-2 therapy.

IL-26

Combination therapy that is intended to disrupt each phase of the GVHD cascade is another area in which research is underway. This approach to therapy would ideally use synergistic agents with different mechanisms of action and nonoverlapping toxicities

Combination therapy7

As research continues, promising targets in cGVHD are being uncovered, with the possibility of offering patients more comprehensive and optimized treatments in the near future.

Learn more about inflammation and fibrosis

What are the manifestations of cGVHD that need to be addressed?

Abbreviation

References

Treatment under Clinical Development

<h2>cGVHD impacts patients’ psychological health</h2>
Approximately one-third of patients with moderate to severe cGVHD have clinically significant psychological distress, including depression or anxiety.10 
 In a prospective observational study evaluating 53 patients with moderate to severe cGVHD, the rates of clinically significant depression and anxiety symptoms were

Greater cGVHD symptom burden was associated with an increased rate of depression.10 
 In a multicenter, prospective, observational cohort study of 298 patients, when comparing mean SF-36 scores with those of other chronic health conditions, patients with severe cGVHD had MCS comparable with depression.8

cGVHD poses multiple economic challenges for patients
Patients who undergo an allogeneic HCT face financial hardship, which may be further amplified by a diagnosis of cGVHD.
 A multicenter, prospective, observational cohort study evaluated 298 patients wiA study that supplemented data from the multicenter, prospective, observational Chronic GVHD Consortium Response Measures Validation Study found that11

reported having difficulty paying medical bills

24%

did not have enough money at the end of the month

28%

reduced spending on utilities and other expenses

49%

used retirement savings

31%

borrowed money or sold assets&nbsp;&nbsp; &nbsp;

16%

Factors that contributed to this financial burden included multiple treatments, inability to return to work, frequent physician visits and losing/changing insurance.11

<table align="center" border="0" cellpadding="1" cellspacing="1" style="width: 1500px;">
 <tbody>
 <tr>
 <td style="text-align: center; background-color: rgb(136, 146, 153); border-color: rgb(136, 146, 153);">Sixty-six percent of patients with cGVHD face a financial challenge&nbsp;after transplant, regardless of insured status.11&nbsp;Twenty-five percent of patients will lose 20 years of&nbsp;earnings because of permanent disability.12&nbsp;Overall, patients with cGVHD are significantly&nbsp;less likely to return to the workforce, even 2 to 3 years after transplant,&nbsp;compared with those without cGVHD.13</td>
 </tr>
 </tbody>
</table>

Even in patients receiving treatment, cGVHD has a considerable impact on QOL, as well as psychological and financial well-being.

Learn more about treatment options

Could optimizing treatment help improve patient outcomes?

Psychological & Economical impact

ACID-SPHINGOMYLENASE-DEFICIENCY-NIEMANN-PICK

RARE-DISEASE

What is ASMD?

This video explains the different types of the disease, its causes and its symptoms.

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

<h2>The clinical objective in PN is to relieve intense itch and heal nodular lesions, which may improve patients’ QoL2-4</h2>

<h2>A multimodal treatment approach is recommended for PN by a US consensus panel2,</h2>
Treatment is selected based on a patient’s clinical presentation, comorbidities, and response to prior treatments and should address both neural and immunologic components of disease, which often requires use of multiple therapeutic agents2,5
<ol>
 <li>Mainly topical therapies</li>
 <li>Widespread skin-directed or systemic therapies</li>
 <li>Experimental therapies</li>
</ol>

There remains an unmet need in the management of PN1

There is significant unmet need in the management of PN¹

PRURIGO-NODULARIS

DERMATOLOGY

<h2>PN is characterized by the following:</h2>
<ul>
 <li>Chronic pruritus1,2
 <ul>
 <li>Pruritus lasting ≥6 weeks is required for a diagnosis2</li>
 <li>Most patients (&gt;80%) have pruritus for &gt;6 months and over half of patients experience pruritus for &gt;2 years3</li>
 <li>PN is regarded as having the highest itch intensity among the many diverse&nbsp;types of chronic pruritus4-6</li>
 <li>The most burdensome symptom as rated by patients with PN is itch3,a&nbsp;</li>
 </ul></li>
</ul>
<ul>
 <li>Presence of multiple, firm, pruriginous lesions1,2,b
 <ul>
 <li>Visibility of skin lesions and bleeding of skin lesions are the second and third most burdensome symptoms as rated by patients3,b 
 &nbsp;</li>
 </ul></li>
 <li>History and/or evidence of repeated scratching, picking, or rubbing (eg, excoriations and scars)2</li>
</ul>

<h2>PN negatively affects many aspects of patients’ quality of life, including7,8:</h2>
<ul>
 <li>
 <h3>Sleep9,c</h3>
 <ul>
 <li>
 Pruritus is often worse in the evening or at night</li>
 <li>Over 60% of patients with PN report that itching disturbs their sleep “to a great extent” 
 &nbsp;</li>
 </ul></li>
 <li>
 <h3>Mental health7,10,11</h3>
 <ul>
 <li>Patients with PN are more likely to have depression or anxiety compared with healthy individuals 
 &nbsp;</li>
 </ul></li>
 <li>
 <h3>Activities of daily living12,d</h3>
 <ul>
 <li>Over 50% of patients report that their everyday life is affected by PN 
 &nbsp;</li>
 </ul></li>
 <li>
 <h3>Social interactions12,d</h3>
 <ul>
 <li>38% of patients report that itch affects their interactions with others</li>
 </ul></li>
</ul>

<h2>PN may be associated with the following comorbidities2,8:</h2>
<ul>
 <li>Chronic conditions eg, Chronic kidney disease</li>
 <li>Dermatological conditions eg, Atopic dermatitis</li>
 <li>Infections eg, HIV</li>
 <li>Psychiatric conditions eg, Depression</li>
</ul>

<h2>PN can arise as a distinct disease in the absence of any of the comorbidities above</h2>
The debilitating signs and symptoms of PN result in significantly reduced quality of life, including negatively impacting sleep, mental health, activities of daily living, and social interactions. In addition, PN may also be associated with a range of comorbidities8

Prurigo Nodularis is a distinct, Chronic, Neural and Immune- Mediated skin disease characterized by intense itch and Nodular Lesions¹

PN Expert Interview Series with Dr. Shawn Kwatra

PN Expert interview with Dr. Shawn Kwatra about his perspective on aspects of PN

MUCOPOLYSACCHARIDOSIS-MPS

MPSI – Rheumatology Case Study

By simulating a real-life Scenario this case study developed to increase the awareness of MPS I, by highlighting familiar symptoms that suggest the possibility of an unfamiliar underlying metabolic disease for Rheumatologist specialty.

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

MPSI – ENT Case Study

By simulating a real-life Scenario this case study developed to increase the awareness of MPS I, by highlighting familiar symptoms that suggest the possibility of an unfamiliar underlying metabolic disease for ENT specialty.

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