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

cGVHD has a&nbsp;high unmet need beyond 2L, as current treatments&nbsp;inadequately address diverse manifestations&nbsp;such as fibrosis and&nbsp;do not support long-term use, resulting in&nbsp;rapid disease progression.1

Guidelines clearly state that there are&nbsp;no standard therapies for SR patients1,2,4,6, limiting these patients to the following available therapies:

Currently, there is&nbsp;no consensus&nbsp;on the&nbsp;optimal choice of agents for 3L or further lines of therapy&nbsp;as per the major guidelines1
The need to investigate&nbsp;novel therapies&nbsp;to address the&nbsp;fibrotic manifestations&nbsp;of cGVHD in 2L and 3L has been recognized7, 10
cGVHD progression is a key reason to modify or discontinue cGVHD therapy7

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="background-color: rgb(122, 0, 230); border-color: rgb(255, 255, 255);">
 1L</td>
 <td style="background-color: rgb(122, 0, 230); border-color: rgb(255, 255, 255);">
 2L</td>
 <td style="background-color: rgb(122, 0, 230); border-color: rgb(255, 255, 255);">
 3L</td>
 </tr>
 <tr>
 <td style="text-align: center; border-color: rgb(255, 255, 255);">3 to 7 months</td>
 <td style="text-align: center; border-color: rgb(255, 255, 255);">3 to 4 months</td>
 <td style="text-align: center; border-color: rgb(255, 255, 255);">4 to 5 months</td>
 </tr>
 <tr>
 <td style="text-align: center; border-color: rgb(255, 255, 255);">96%7</td>
 <td style="text-align: center; border-color: rgb(255, 255, 255);">71%7</td>
 <td style="text-align: center; border-color: rgb(255, 255, 255);">47%7</td>
 </tr>
 </tbody>
</table>

Abbreviations
1L:&nbsp;First Line;&nbsp;2L:&nbsp;Second Line;&nbsp;3L:&nbsp;Third Line;&nbsp;SR:&nbsp;Steroid-resistant;&nbsp;NCCN :&nbsp;National Comprehensive Cancer Network;&nbsp;ASH:&nbsp;American Society of Hematology;&nbsp;ANZTCT:&nbsp;Australia and New Zealand Transplant &amp; Cellular Therapies;&nbsp;EBMT: European Society for Blood and Marrow Transplantation;&nbsp;ECP:&nbsp;Extracorporeal photopheresis;&nbsp;cGVHD:&nbsp;Chronic graft-versus-host disease.

Unmet Need

cGVHD is the&nbsp;most common complication of alloHSCT, leading to significant multi-organ damage and affecting&nbsp;~54%&nbsp;of patients annually and increasing both premature mortality and healthcare costs.1

Among patients undergoing alloHSCT, approximately 54% develop cGVHD, out of which ~35% experience a moderate form and ~30% a severe form of the disease.1

A substantial proportion of patients with cGVHD present with concomitant inflammatory and fibrotic manifestations.2
<ul>
 <li>Up to 50% of patients with moderate cGVHD and 60% with severe disease may exhibit lung involvement, which can manifest as bronchiolitis obliterans, a fibrotic manifestation that can be especially difficult to treat.3</li>
</ul>

Non-relapse mortality continues to increase over time in patients with cGVHD reaching 22% after 5 years.14

Direct costs increase by 1.5 times in mild cGVHD and 4 times in moderate to severe cGVHD, compared with patients post-alloHSCT without cGVHD.15

Social functioning, physical functioning, general health, and other QoL components are worsened with cGVHD progression.16-17

Abbreviations
alloHSCT:&nbsp;Allogeneic hematopoietic stem cell transplantation;&nbsp;cGVHD:&nbsp;Chronic graft-versus-host disease;&nbsp;QoL:&nbsp;Quality of life.

cGVHD Burden

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

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 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

Patients with chronic spontaneous urticaria (CSU) endure a significant and multifaceted burden that worsens with disease severity1-4.
<ul>
 <li>
 The condition impacts their Quality of Life (QoL) and health-related QoL (HRQoL) due to recurring, debilitating symptoms 1-4.</li>
 <li>
 Additionally, CSU imposes a substantial financial and economic burden, further exacerbated by more severe cases5.</li>
</ul>

CU-Q2oL domain scores by disease severity42** ‡

Pruritus occurs spontaneously, with approximately 90% of patients experiencing it, and is the most affected domain of the CU-Q2oL6,9&nbsp;resulting in greater impairments in QoL, daily functioning, and sleep with increased prurituse6,7,10.
 Generalized pruritus, involving the entire body, is reported more frequently by patients with CSU than those with other chronic skin conditions7.

white

Pruritic wheals:
 
 &nbsp;
<ul>
 <li>CSU is usually characterized by the presence of red,&nbsp;superficial, pruritic wheals and flare-type skin reactions12&nbsp;that resolve and recur, migrating across the body12</li>
</ul>

Angioedema(Swelling of deep tissues):
&nbsp;
<ul>
 <li>Angioedema may present alone11&nbsp;or with wheals and is most frequently observed on the hands, face, and feet&nbsp;13.</li>
 <li>Angioedema may be life-threatening if it affects the patient's airway14.</li>
</ul>

Spontaneous and transient development of wheals is a typical symptom of CSU, which is often concomitant with angioedema, and leads to a meaningful burden for patients&nbsp;15,21.

Sudden, unpredictable,&nbsp;and&nbsp;transient&nbsp;outbreaks of wheals15

Visible&nbsp;lesions affecting&nbsp;numerous parts of the body&nbsp;(principally arms, legs, hands/ fingers and chest/abdomen)17

Daily recurrence for at least 6 weeks and often for many years16

Painful&nbsp;lesions associated with&nbsp;strong&nbsp;and&nbsp;persistent itching&nbsp;or&nbsp;burning&nbsp;sensation throughout the day15

Impact on Quality of Life

Chronic spontaneous urticaria (CSU) extends beyond its physical manifestations, profoundly impacting patients' emotional and psychological well-being22,23.
The persistent nature of CSU symptoms, including wheals and Angioedema, leads to significant distress that permeates various aspects of life.
Patients who experience concurrent wheals and angioedema represent approximately&nbsp;40%&nbsp;of CSU patients and often face a longer duration of disease with a higher impact on QoL than patients who experience wheals only20,21.

CU-Q2oL domain scores by disease severity

Sleep disturbances are a key result of CSU symptoms, such as chronic pruritus, and increase with disease severity

More than 50% of patients with CSU report sleep disturbances due to pruritus26,27, which often intensifies in the evenings and consequently affects other aspects of daily life, creating a vicious cycle of sleep problems25,28
Patients with CSU experience&nbsp;mental and emotional impairment, which increases with worsening disease severity and can disturb social interactions and lead to stigmatization&nbsp;29,32.
Compared with the general population, patients with CSU have a higher prevalence of diagnosed psychiatric disorders30,33.

Distribution of psychiatric diagnosis among CSU patients30**

Note:&nbsp;**Data from a cross-sectional study (N=159) in Turkey from January 1 to April 20, 2005, which was collected via SF-36, and the SCID-I

Many patients with CSU feel that their unpredictable / uncontrollable symptoms exclude them from a normal lifestyle and are a source of frustration&nbsp;31,32

90%&nbsp;of patients with CSU report that their&nbsp;symptoms place limitations&nbsp;on their normal physical activity, such as sports, hobbies, work, and sex31

75%&nbsp;of patients with CSU report&nbsp;having to miss out on social occasions&nbsp;because of their skin condition31

56%&nbsp;of patients with CSU report not&nbsp;having control over their symptoms31

48%&nbsp;of patients with CSU are&nbsp;unable to take part in usual social activities31

Financial Burden
The management of CSU imposes a financial burden on healthcare systems due to the increased number of physician visits, hospitalizations, and laboratory monitoring.
The economic burden is higher for patients with CSU than for individuals without CSU, due to increased healthcare visits and medication&nbsp;34,35.
The mean all-cause healthcare cost for patients with CSU was found to be over&nbsp;$9,000 per patient per year35.

Number of all-cause healthcare visits during the prior 6 months34 ¥

Mean annual healthcare costs by category in patients with CSU35&nbsp;‡

Notes: Data from the EU5 NHWS, which is a retrospective, cross-sectional study of patients who reported taking prescription medication for chronic hives identified as the proxy for patients with CSU (N=175,923) in the EU4 and in the UK in 2010, 2011 and 2013; *Difference between the groups was significant, p-value&lt;0.001;&nbsp;**p-value adjusted for violation of homogeneity of variance assumption;^Matched respondents to NHWS who had not experienced chronic urticaria;&nbsp;‡p-values not provided, data is from a retrospective, cross-sectional cohort studv (N=6.350) in the US usina an existina database of commercial health insurance claims in 2012;***Accountina for Prescription medication onlv. as OTC medication (which includes most H1-AH) was not available in the database analyzed
Annual healthcare costs of CSU, including outpatient visits, laboratory monitoring costs, and out-of-pocket expenses, increase with worsening disease severity36,37.

Annual direct healthcare costs by disease severity&nbsp;36*

As treatment many patients remain symptomatic despite, many seek alternative medical therapies which are generally not covered by their country's&nbsp;health insurances, resulting in additional out-of-pocket expenses for patients, estimated at&nbsp;$500-1,000/year37
Note:&nbsp;*Data from a Markov model consisting of health states based on UAS7 and additional states for relapse, spontaneous remission and death. Model cycle length was 4 weeks and the total model time horizon was 20 years in the base case. The model considered early discontinuation of non-responders (response: UAS7 ≤6) and retreatment upon relapse (relapse: UAS7 ≥16) for responders. Clinical and cost inputs were derived from omalizumab trials and published sources, and cost utility was expressed as ICERs. Scenario analyses included no early discontinuation of non-responders and an altered definition of response (UAS7 &lt;16)

The management of CSU imposes a financial burden on healthcare systems due to the increased number of physician visits, hospitalizations, and laboratory monitoring38,39.

Note:&nbsp;*p-value&lt;0.001;&nbsp;**p-value adjusted for violation of homogeneity of variance assumption;&nbsp;¥Data from the EU4 and UK NHWS, which is a retrospective, cross-sectional study of patients (N=175,923) in the EU4 and UK in 2010, 2011 and 2013; Ω CU is used as a proxy for CSU; Matching variables used in matching were year of survey, country, age, and sex. Covariates included cigarette smoking, BMI category, and CCI score;‡p-value not provided in literature; Data from a retrospective medical record abstraction, a cross-sectional patient survey at enrolment and a patient diary completed over an 8-day period (twice daily assessment) after recruitment that included patients from the EU4, the UK, the Netherlands and Canada (N=673) from October 2013 to May 2015

Burdens of CSU

COPD is a progressive lung disease characterized by airflow limitation. Exacerbations, both moderate and severe, can lead to a decline in lung function, particularly FEV-1 (Forced Expiratory Volume in 1 second)&nbsp;1,2.

GOLD Group E patients, according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) classification, are those with a high risk of exacerbations and more symptoms, often experiencing a faster decline in lung function and quality of life&nbsp;3.

FEV-1, or Forced Expiratory Volume in 1 second, is a key measurement in lung function testing. It represents the volume of air a person can forcefully exhale in the first second after a deep breath.
 
 Lung function decline (FEV-1) in COPD patients increases mortality risk, whereas improvement resets the patient’s baseline and lowers exacerbation risk.

BOREAS and NOTUS outcomes are breakthrough for COPD patients, showing statistically significant and clinically meaningful improvements in moderate and severe exacerbation reduction, lung function over 52 weeks4,5.
&nbsp;
These 2 trials have been conducted on approx. 2000 patients and its endpoints were designed according to the GOLD standards4,5.

Dupixent's significantly proven reduction of Moderate and Severe exacerbations6:

In both BOREAS and NOTUS, Dupixent + background therapy has demonstrated statistically significant reductions in moderate and severe exacerbation rate up to 34%, as shown in the NOTUS trial, vs. placebo + background therapy.

<div>
 <div>
 Dupixent's statistically significant FEV-1 improvement6:
 </div>
</div>

<div>
 <div>
 In both BOREAS and NOTUS, Dupixent demonstrated early and significant FEV-1 improvement vs. placebo + background therapy over 52 weeks.
 </div>
</div>

<div>
 <div>
 DUPIXENT + BG therapy has demonstrated a notable improvement in lung function vs. placebo + BG therapy, in particular has shown:
 </div>
</div>

Early onset
 
 (e.g., measurable effect already after 2 weeks in BOREAS)

Sustained effect
 
 over 52 weeks in BOREAS

Significant FEV-1 improvement
 
 at week 52 in both trials

A meta-analysis (52 studies; 62,385 patients) demonstrated significant correlations between mean trough FEV-1 and HRQOL in patients with stable COPD 1,2

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="background-color: rgb(153, 204, 0);">
 <ul>
 <li>An MCID improvement in FEV-13&nbsp;corresponded to a larger than MCID improvement in measures of HRQOL (SGRQ)4 and breathlessness (TDI)4 
 &nbsp;</li>
 <li>Analyses of follow-up data at 6 and 12 months suggest that the correlation of trough FEV-1 with HRQOL (SFRQ and TDI) strengthens with time.</li>
 </ul></td>
 </tr>
 </tbody>
</table>
<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="background-color: rgb(0, 153, 102);">
 The correlation between FEV-1 and QoL enhancement, coupled with the significant FEV-1 improvement (+153mL vs. baseline) achieved with Dupixent, further reinforce the robustness of SGRQ improvement results.</td>
 </tr>
 </tbody>
</table>

Dupixent has proven to show consistent results across subpopulations in both BOREAS and NOTUS trials6:

In the BOREAS trial, Dupixent demonstrated consistent clinical benefit in terms of moderate or severe exacerbation reduction and lung function (i.e., FEV-1 change vs. placebo) results across study subgroups.

In the NOTUS trial, Dupixent demonstrated consistent clinical benefit in terms of moderate or severe exacerbation reduction and lung function (i.e., FEV-1 change vs. placebo) results across study subgroups.

Proven Efficacy of Dupixent® in COPD

COPD is associated with persistent respiratory symptoms, exacerbations, and inflammation, which contribute to declines in lung function, reduced QOL, and high mortality.

Persistent symptoms of COPD contribute to&nbsp;patients’ physical debilitation1.
In 2017, COPD was the&nbsp;sixth leading cause of disability-adjusted life years (DALYs)&nbsp;worldwide and accounted for the majority of DALYs associated with chronic respiratory disease2,3

I am continually tired. The simplest tasks take ages to complete and leave me exhausted, breathless, and depressed.
Not being able to breathe and unable to do physical activity. The worst part: Your mind tells you that you can do it.

ASSESS was an observational study which enrolled patients with stable COPD in clinical practice and aimed to investigate the relationship between 24-hour symptoms and other patient-reported outcomes4.
Persistent symptoms of COPD were associated with&nbsp;high levels of anxiety and depression, and poor sleep quality,&nbsp;irrespective of whether symptoms occurred in the early morning, daytime, or night time4.
Patients who experienced symptoms throughout the whole 24-hour day experienced the worst levels of impairment4.
Mean anxiety, depression, and sleep quality scores according to the pattern of COPD symptoms throughout the 24 hour day (n=727)4

Anxiety

Depression

Sleep Disturbance

*0-7 = normal; 8-10 = mild; 11-15 = moderate; 16-21 = severe. Higher scores mean worse sleep quality., 
 CASIS, COPD and Asthma Sleep Impact Scale; HADS, Hospital Anxiety and Depression Scale.
Quality of Life

Persistent debilitating symptoms of COPD have a substantial impact on patients' QoL.
A cross-sectional European observational study illustrated QoL impairment was related to COPD severity:
As disease severity increased,&nbsp;QoL impairment increased, as measured using SGRQ scoress5.
Factors associated with worsening QoL include5:
<ul>
 <li>
 COPD symptoms of breathlessness</li>
 <li>
 Cough and excess sputum</li>
 <li>
 Exacerbations</li>
 <li>
 Lung function decline</li>
 <li>
 Hospitalizations</li>
</ul>

Impairment in QoL related to COPD severity:Data from a cross-sectional European studys5

In many patients,&nbsp;guilt&nbsp;or&nbsp;shame&nbsp;from their perception of COPD as a "self-inflicted" disease can effect their QoL and interaction with HCPs1.
The MIRROR study was conducted in Europe and analysed how perceptions of disease severity and impact on QOL may differ between patients and HCPs. This study found that6:
<ul>
 <li>~90%&nbsp;of patients said they were&nbsp;"not completely frank"&nbsp;when talking to clinicians 
 &nbsp;</li>
 <li>49-53%&nbsp;of primary care doctors and pulmonologists seem to be aware of this but&nbsp;underestimate&nbsp;the extent to which it impacts clinician-patient interactions1</li>
</ul>

Clinical burden of co-existing conditions in COPD
The inflammatory processes associated with COPD may affect the functioning of extrapulmonary systems, and as a result, COPD patients present with co-existing diseases across a range of organ systems7. This can greatly increase the burden of COPD.
In a retrospective analysis of 14,603 Dutch patients with COPD, 88% had ≥1 co-existing disease7

*The consideration of asthma as a separate co-existing disease from COPD is controversial.
CRS, chronic rhinosinusitis; AF, atrial fibrilation; CHD, coronary heart disease; GERD, gastroesophageal reflux disease; PVD, peripheral vascular disease; TIA, transient ischemic attack.
COPD with co-existing conditions is associated with negative health impact, worse treatment management:

<ul>
 <li>Patients with COPD and co-existing diseases, such&nbsp;as heart failure, osteoporosis/osteopenia, and asthma have an increased risk of frequent exacerbations7</li>
 <li>COPD and co-existing Asthma also result in increased hospital admissions, whereas COPD and cardiovascular disease has a higher rate of hospitalization and death8,9</li>
</ul>

Health Impact

<ul>
 <li>30% of patients with COPD and Asthma have ≥2 records of OCS dispensing over their lifetime vs. 12%&nbsp;of patients with COPD alone10</li>
 <li>Short&nbsp;and long-term OCS use has been linked to multiple&nbsp;adverse-events11</li>
</ul>

Worse treatment management

Exacerbations
Patients with COPD can experience "flare-ups", which can be defined as general worsening of symptoms as well as more serious exacerbations.
An exacerbation of COPD is defined as an event characterized by&nbsp;increased dyspnea and/or cough and sputum that worsens in &lt;14 days which may be accompanied&nbsp;by tachypnea and/or tachycardia and is often associated with increased local and systemic inflammation caused by infection, pollution, or other insult to the airways12.
Exacerbations can be mild, moderate and severe. Severe exacerbations usually require hospitalisation13.
Exacerbations of COPD significantly impact on the health status of a patient, increase the rate of lung function decline, and worsen the prognosis of patients.
Quality of life
In a study of 70 COPD patients, SGRQ total and component scores — a tool used to measure quality of life-were significantly higher in the frequent exacerbator group compared with those who less frequently experienced exacerbations23.

Relationship between SGRQ score and exacerbation frequency14
<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td>Exacerbation frequency</td>
 <td>n</td>
 <td>SGRQ total score</td>
 <td>SGRQ 
 component: Symptoms</td>
 <td>SGRQ 
 component: Activities</td>
 <td>SGRQ 
 component: Impact</td>
 </tr>
 <tr>
 <td>0-2</td>
 <td>32</td>
 <td>48.9 ± 15.6</td>
 <td>53.2 ± 17.2</td>
 <td>67.7 ± 17.2</td>
 <td>36.3 ± 18.2</td>
 </tr>
 <tr>
 <td>3-8</td>
 <td>38</td>
 <td>64.1 $ 14.6</td>
 <td>77.0 $ 15.8</td>
 <td>80.9 $ 16.0</td>
 <td>50.4 ‡ 17.6</td>
 </tr>
 <tr>
 <td>Mean difference</td>
 <td>&nbsp;</td>
 <td>-15.1</td>
 <td>-21.9</td>
 <td>-12.2</td>
 <td>-14.1</td>
 </tr>
 <tr>
 <td>95% CI</td>
 <td>&nbsp;</td>
 <td>-22.3 to -7.8</td>
 <td>-29.7 to -14.0</td>
 <td>-21.2 to -5.3</td>
 <td>-22.9 to -5.6</td>
 </tr>
 <tr>
 <td>P value</td>
 <td>&nbsp;</td>
 <td>0.0005</td>
 <td>0.0005</td>
 <td>0.001</td>
 <td>0.002</td>
 </tr>
 </tbody>
</table>

Mortality
In a study of 73,106 COPD patients,&nbsp;the risk of death increased with each successive severe exacerbation experienced.
The rate of death after the second severe exacerbation was&nbsp;1.9x&nbsp;higher than after the first, while after the 10th it was&nbsp;5x&nbsp;higher than after the first15.
HR for death increases with every successive severe exacerbation15

Lung function
The UPLIFT study of 5,992 COPD patients observed that a higher frequency of severe hospitalized COPD exacerbations was associated with a&nbsp;marked decline in lung functions16.
Mean change in lung function parameters by increasing frequency of hospitalized exacerbations in the 4-year UPLIFT study16

Exacerbations were defined as an increase in or the onset of more than one respiratory symptom (cough, sputum, sputum purulence, wheezing, or dyspnea) lasting 3 days or more and requiring treatment with an antibiotic or systemic corticosteroids.
BD, bronchodilator; FVC, forced vital capacity; SE, standard error.

Disease onset, course, and severity
COPD can start early in life and take a long time to manifest clinically. As identifying early COPD can be difficult, patients are typically diagnosed with COPD aged &gt; 40 years&nbsp;12,13.
Morbidity due to COPD increases with age: 
 As lung function declines with age, patients experience more exacerbations, which increases the risk of future exacerbations and the rate of lung function decline12.

Clinical Burden of COPD

Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung condition characterized by breathing difficulties, with significant impacts on patients' quality of life.
Global Impact

Global Death Toll:
<ul>
 <li>Globally, COPD is the&nbsp;third leading cause of death,&nbsp;following ischemic heart disease and stroke1</li>
 <li>In 2019 alone, it caused&nbsp;3.23 Million deaths worldwide,&nbsp;representing&nbsp;6% of total global deaths1,2.</li>
</ul>

Widespread Prevalence:
<ul>
 <li>Approximately&nbsp;299.4 Million cases&nbsp;were reported globally in 2017, showing a&nbsp;24%&nbsp;increase since 20073.</li>
 <li>The&nbsp;prevalence of COPD is projected to increase, with an estimated&nbsp;5.4 Million deaths by 20604. &nbsp;</li>
</ul>

DALYs:
<ul>
 <li>COPD accounts for the majority of Disability-Adjusted Life Years (DALYs) among chronic respiratory diseases5, causing 2.6% of global DALYs in 20156.</li>
</ul>

<h3>COPD Burden in Kingdom of Saudi Arabia</h3>
COPD presents a significant health challenge with&nbsp;rising prevalence rates and economic impact:
<ul>
 <li>
 COPD prevalence&nbsp;increased by&nbsp;49%&nbsp;from 1990 to 2019, with&nbsp;2,053 cases&nbsp;per 100,000 people reported in 20197.</li>
 <li>
 Mortality Impact:&nbsp;COPD accounts for about&nbsp;1.65%&nbsp;of all-cause deaths8.</li>
 <li>
 Macroeconomic Impact:&nbsp;According to the World Bank, the estimated economic loss attributed to COPD in 2017 was approximately&nbsp;$12.497 Billion, reflecting the long-term economic consequences of unmanaged COPD in the region9.</li>
</ul>

<h3>Costs of Treatment and Care in Kingdom of Saudi Arabia:</h3>

Direct Costs:
Healthcare Expenditures:&nbsp;COPD is one of the non-communicable diseases (NCDs) contributing to Saudi Arabia's healthcare expenditures, which amount to&nbsp;SAR 66 Billion&nbsp;annually10.
Hospitalization and Treatment:&nbsp;The direct costs associated with COPD primarily include expenses related to hospitalization and treatment of exacerbations. These costs are significant drivers of healthcare spending11-12.

Indirect Costs
Productivity Losses:&nbsp;The indirect costs of COPD include reduced workforce participation and loss in national productivity due to premature mortality, disability, and workplace losses. These losses are valued at&nbsp;SAR 25.6 Billion annually10.

Productivity claims associated with COPD were responsible for 10% of the overall COPD cost burden for working patients13:

Productivity Losses:
<ul>
 <li>Frequent exacerbators experience the highest productivity loss: 456.5</li>
 <li>Infrequent exacerbators have a significant loss as well: 361.8</li>
 <li>Non-exacerbators show the lowest productivity loss: 255.4</li>
</ul>
→ Exacerbations directly correlate with increasing productivity losses.

Lost Work Time (sick leave):
<ul>
 <li>Frequent exacerbators also show the highest amount of lost work time: 60.0</li>
 <li>Non-exacerbators experience less time away from work: 49.8</li>
 <li>Infrequent exacerbators fall in between: 60.0</li>
</ul>
→ Exacerbations are key drivers of absenteeism in COPD patients.

Decreased Productivity (Presenteeism)
<ul>
 <li>Frequent exacerbators suffer a higher loss in productivity while at work: 29.3</li>
 <li>Non-exacerbators: 11.4</li>
</ul>
→ Exacerbations are key drivers of absenteeism in COPD patients.

COPD treatment not only affects productivity of patients, but also of the caregivers: 
A Spanish study analyzed the burden borne by informal caregivers (n=220,892) of patients with COPD14.

% of informal caregivers (of COPD patients) with health-, 
 professional-,and leisure/social-related problems

% of informal caregivers of COPD patients having problems 
 vs. caregivers of patients with other chronic diseases

Caregivers face severe challenges: 
<ol>
 <li>83% of caregivers report leisure/social-related problems, followed by 38% experiencing professional-related problems and 35% facing health issues. 
 &nbsp;</li>
 <li>COPD caregivers, more than those of other chronic diseases like stroke or myocardial infarction, face greater deterioration of health and a marked decrease in leisure time. 
 &nbsp;</li>
 <li>The comparison with caregivers of other chronic diseases further emphasizes the unique burden COPD imposes, showing higher rates of decreased leisure time and overall strain on caregivers.</li>
</ol>

Economic Burden of COPD in KSA

Mechanism of Action
Dupixent has emerged as a groundbreaking therapeutic option for various type 2 inflammatory diseases. As a fully human monoclonal antibody, Dupixent uniquely inhibits the signaling of both interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, key drivers of type 2 inflammation 1,2.

Figure 1: DUPIXENT is the only dual inhibitor of IL-4 and IL-13 signaling3
This mechanism of action has demonstrated&nbsp;significant clinical benefits across multiple indications, including Atopic Dermatitis, Asthma, Chronic Rhinosinusitis with Nasal Polyposis, Eosinophilic Esophagitis, Prurigo Nodularis and most recently, Chronic Obstructive Pulmonary Disease2&nbsp;with regulatory approvals in&nbsp;&gt;60 countries and over 1,000,000 patients treated globally1.
Dupixent has rapidly become an essential therapy in the management of type 2 inflammatory diseases and has&nbsp;demonstrated sustained improvement in symptoms&nbsp;across various indications, with&nbsp;long-term safety data&nbsp;available for&nbsp;up to 5 years&nbsp;in some conditions&nbsp;1,2.
This unique mechanism of action has demonstrated significant clinical benefits across multiple type 2 inflammatory diseases as seen in the 3 examples below:
Atopic Dermatitis (AD):

1.Mechanism of Action: 
 Targeting of&nbsp;IL-4&nbsp;and&nbsp;IL-13&nbsp;signaling, key drivers of type 2 inflammation in AD4

2.Long-term Efficacy: 39% 
 Achieved IGA score of 0-1 (clear/ almost clear) with a reduction of ≥2 points on a 0-4 IGA scale at 16 weeks in adults® 42.7% 
 Had an IGA score of 0/1 (clear/almost clear) by week 52 in adolescents (12-17 years)5

Sustained improvement in skin clearance up to 52 weeks in adults®

3. Real-World Evidence: 5-year clinical trial data&nbsp;and experience in&nbsp;&nbsp;&gt; 1,000,000 
 patients worldwide across all indications have proven Dupixent's efficacy*

Approved for use in patients as young as 6 months old5

1.Mechanism of Action: 
 Targeting of&nbsp;IL-4&nbsp;and&nbsp;IL-13&nbsp;signaling, reducing Type 2 Inflammation in airways4,6

2.Long-term Efficacy: 
 Up to 3 years of data show&nbsp;sustained&nbsp;improvment in lung function and reduction in severe exacerbations4,7 13-22% 
 Improvement in lung function (FEV-1) at 96 weeks&nbsp;4

3. Real-World Evidence: 
 &nbsp;&gt; 2,200 patients&nbsp; 
 Enrolled in the Phase 3 open-label extension trial making it the largest biologic medicine trial in Asthma4,8

Chronic Obstructive Pulmonary Disease (COPD):

1.Mechanism of Action: 
 Targeting of&nbsp;IL-4&nbsp;and&nbsp;IL-13&nbsp; 
 pathways to reduce Type 2&nbsp; Inflammation in COPD7

2.Long-term Efficacy: 30% and 34% 
 Annualized rate of moderate or severe COPD exacerbations over 52 weeks in BOREAS and NOTUS trial7

Improvements in lung function (FEV-1) observed as early as week 2 and sustained at 52 weeks7

Enhanced health-related quality of life7

3. Real-World Evidence: 1st&nbsp; 
 new treatment approach for COPD in more than a decade7

Approved for ~220,000 adults in the European Union7

In Conclusion
Dupixent (dupilumab) has proven to be a transformative treatment option for multiple type 2 inflammatory diseases by targeting IL-4 and IL-13 pathways.
Its efficacy across diverse indications demonstrates significant improvement in patient outcomes, reducing exacerbation rates, enhancing lung function, and improving skin clarity and quality of life.
Long-term data highlight its consistent safety profile across various age groups, further supported by real-world evidence.
Dupixent remains a promising therapy for sustained disease control and relief from the burdens of type 2 inflammation.

Proven Efficacy of Dupixent® against Type 2 Inflammation

Dupixent has emerged as a significant therapeutic option for the treatment of various type 2 inflammatory diseases. As a fully human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, Dupixent offers a targeted approach to managing conditions such as Atopic Dermatitis, Asthma, Chronic Rhinosinusitis with Nasal Polyposis, and Eosinophilic Esophagitis and COPD1.
Mechanism of Action and Safety Implications
Dupixent's unique action as an immunomodulator, rather than a broad immunosuppressant, supports its positive safety profile. By targeting IL-4 and IL-13 pathways specifically, Dupixent provides immune response control without significantly compromising immune defenses, which may lower the risk of serious infections often seen with other immunosuppressive treatments.
Inhibition of IL-4 and IL-13 signaling has a substantial impact on Type 2 inflammation diseases as it helps reduce the inflammation by2:
<ol>
 <li>Helping reduce Itch: May break itch-scratch cycle and reduce nerve sensitization</li>
 <li>Helping achieve nodule clearance: Reduce skin fibrosis</li>
</ol>

Figure 1: DUPIXENT is the only dual inhibitor of IL-4 and IL-13 signaling2
Long-Term Safety Data
Dupixent's safety has been confirmed through studies extending&nbsp;up to five years, covering over&nbsp;800,000 patients&nbsp;globally.

The LIBERTY AD OLE trial, a long-term extension study, highlighted the&nbsp;tolerability of Dupixent&nbsp;in patients with moderate to severe atopic dermatitis&nbsp;over a five-year period. 
 This trial, involving 2,677 patients, found that&nbsp;the safety profile remained consistent with earlier controlled trials1.

Common Adverse Events
Common adverse effects seen across trials include injection site reactions, conjunctivitis (more common in those with atopic dermatitis), nasopharyngitis, headache, and back pain.
In recent COPD trials, adverse effects with a frequency of ≥5% included COVID-19 infection and diarrhea compared to placebo3,4.

Safety by Indication

2%&nbsp;of TEA leading to permanent Dupixent discontinuation vs 8% for placebo5

3%&nbsp;of TEA leading to permanent Dupixent discontinuation vs 6% for placebo6

4%&nbsp;of TEA leading to permanent Dupixent discontinuation vs 11% for placebo7

Most TAEAs mild or moderate8

Similar incidences of TEAEs in patients treated with DUPIXENT vs placebo arm (64% and 57% respectively)9

Regulatory Perspective and Approvals
Regulators like the U.S. FDA and the European Medicines Agency (EMA) have reviewed comprehensive safety data, concluding that Dupixent's benefits outweigh associated risks, which has led to approval in over 60 countries. The consistent safety profile across various inflammatory conditions has supported regulatory endorsements1.
Special Considerations

Pediatric Use: 
 Dupixent has shown a favorable safety profile in younger patients, receiving approval for certain conditions in patients as young as 6 months old1.

Minimal Immunosuppression: 
 Unlike many biologic therapies, Dupixent does not broadly suppress the immune system, contributing to its positive long-term safety profile1.

Monitoring Needs: 
 Dupixent does not require initial or ongoing laboratory testing, highlighting its low risk of serious systemic effects. 
 &nbsp;

Clinical trial and post-market data affirm Dupixent's consistent and favorable safety profile across multiple type 2 inflammatory diseases. 
 Its targeted action and generally mild side effects underscore its strong benefit-risk profile. 
 Dupixent's safety has been maintained across different age groups and in extended use, with no significant safety issues arising in long-term studies. 
 Current evidence supports its use as a safe and effective option for patients with type 2 inflammatory diseases.

Conclusion

Proven Safety of Dupixent® against Type 2 Inflammation

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