<a href="${link:{uuid:{c90870f5-b8bd-4138-bee3-88766d4cee04},repository:{dam},path:{/Portal/UK/Prescribing-links/Clexane-pi.pdf}}}" target="_blank">Prescribing Information UK</a>

Clexane is indicated in adults for the extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer based on the RIETECAT trial results.
RIETECAT trial is a multinational observational retrospective cohort study using data from the RIETE registry.1
It is the first and largest&nbsp;study comparing the effectiveness and safety of enoxaparin against dalterparin and tinzaparin in a real-world cohort of cancer patients with VTE.1

<h2>RIETECAT outcomes</h2>
Cancer patients with VTE receiving full dose enoxaparin or tinzaparin/dalteparin had comparable effectiveness and safety outcomes over a 6 month period.
OR: 0.79 (95%CI. 049-1.28) p=0.004

The efficacy outcome was a composite of symptomatic DVT and fatal or non-fatal PE and the safety outcome was a composite of major bleeding events (fatal or non fatal) and non major bleeds of clinical significance.
Due to the non-interventional nature of the study, comparability of patients between groups may be difficult to achieve; however multivariate Cox model was used to minimize the confounding bias.
Patients treated with enoxaparin had a non-significantly lower risk for VTE recurrences, a non-significantly higher risk for major bleeding, and similar risks for non-major bleeding or death over 6 months compared to tinzaparin/dalteparin.

<h2>Footnote</h2>
CAT=cancer-associated thrombosis;&nbsp;VTE=Venous Thromboembolism;&nbsp;CI=confidence interval;&nbsp;OR=Odds Ratio;&nbsp;SC=subcutaneous;&nbsp;IU=international unit;&nbsp;OD=Once daily;&nbsp;PE&nbsp;pulmonary embolism;&nbsp;NMCR=Non-major clinically relevant.

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

Get in touch with the Thrombosis Team

Clexane® (enoxaparin) Prescribing Information UK

THROMBOSIS

CARDIOLOGY

Treatment of CAT Clexane (enoxaparin)


<a href="${link:{uuid:{d4dafd48-4837-4ef7-ab1b-76db53f754ab},repository:{dam},path:{/Portal/UK/Prescribing-links/Dupixent%20(COPD)%20PI%20GB%20September%202024.pdf}}}" target="_blank">Dupixent (dupilumab) Prescribing Information (GB only)</a>

<h2>Type 2 Inflammation may increase the risk of exacerbations and lung function impairment in COPD6,7</h2>
<h3>COPD is characterised by mucus production, airway obstruction, and coughing8</h3>

<h3>Inflammation manifests systemically and locally</h3>

<ul>
 <li>Chronic inflammation causes structural changes, including narrowing of the airways and decreased lung elasticity8</li>
 <li>Studies have identified a relationship between inflammation and mucus hypersecretion in respiratory conditions such as COPD9</li>
</ul>
&nbsp;&nbsp;

<h2>Look for elevated blood eosinophils&nbsp;- A Biomarker of Type 2 Inflammation in COPD8</h2>

<h4>&nbsp;</h4>
<h3>Elevated eosinophils in COPD are a treatable trait and marker of type 2 inflammation11</h3>
The 2024 GOLD Report recognises elevated blood EOS as a clinically used biomarker in identifying COPD with type 2 inflammation8
<h2>Type 2 inflammation in COPD can involve multiple pathways, cytokines, and inflammatory cells12</h2>

<h2>IL-4, IL-13, and IL-5 are type 2 cytokines involved in COPD</h2>

&nbsp;&nbsp;aBased on findings from 5 studies in COPD patients without asthma. Eosinophil levels used to define type 2 inflammation ranged from ≥300 cells/μL to ≥340 cells/μL (blood), ≥2% in induced sputum or 3% in peripheral blood. Percentages of patients with type 2 inflammation ranged from 12.3% to ~40%6,7 bA severe exacerbation was defined as a hospitalisation due to COPD. Exacerbations had to be a minimum of 4 weeks apart to be considered separate exacerbations.10 cIn a cohort of patients with EOS &gt;200 cells/μL.9 dReproduced with permission of the American Thoracic Society. Fritzsching B et al. Am J Respir Crit Care Med. 2015;191(8):902-9139 eAlcian blue PAS staining of mucus in airway epithelial cells.9 fResults from an observational study of 1553 patients with GOLD spirometry grade 2-4 COPD (postbronchodilator FEV1/FVC ratio &lt;0.7, with FEV, &gt;80% predicted)6 gResults from a 1-year observational study of 479 patients with COPD, 173 of whom had blood eosinophil levels ≥200 cells/μL and/or ≥2% of the total white blood cell count.7 
 COPD, chronic obstructive pulmonary disease; EOS, eosinophils; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; GOLD, Global Initiative for Chronic Obstructive Lung Disease; IFN-y, interferon-gamma; ILC2, innate lymphoid type-2 cells; MUC5AC, mucin 5AC; PAS, periodic acid-Schiff; TNF-a, tumor necrosis factor alpha; TSLP, thymic stromal lymphopoietin.

Dupixent (dupilumab) Prescribing Information (GB ONLY)

CHRONIC-OBSTRUCTIVE-PULMONARY-DISEASE-(COPD)

Role of type 2 inflammation 

<h2>The SGRQ measures the qualitative impact of COPD1,2</h2>
Some domains evaluated by the SGRQ include1,2:

Cough

Sputum production

Breathlessness

Wheezing

Exacerbations

Work activities

Daily activities*

Medication use

*Such as walking upstairs or getting dressed.
<h2>E-RS:COPD assesses COPD symptoms3,4,b</h2>
Some domains evaluated by the E-RS:COPD include3,4:

Breathlessness

Cough &amp; Sputum&nbsp;

Chest symptoms

Additional Attributes (tired or weak, sleep disturbance, scared or worried)

<h4>This is not an exhaustive list of items evaluated by the SGRQ and E-RS:COPD.</h4>

a The SGRQ is a 50-item questionnaire designed to measure the qualitative impact of COPD on overall health , daily life, and perceived well-being. Higher scores mean greater disease severity.1,2 b E-RS:COPD is an 11-item patient-reported derivative tool that measures the effect of treatment on respiratory symptom severity in patients with stable COPD . Higher scores mean greater disease severity. 3,4
 
 COPD, chronic obstructive pulmonary disease; E-RS:COPD, Evaluating Respiratory Symptoms in COPD; QoL, quality of life; SGRQ, St George’s Respiratory Questionnaire

RESPIRATORY

Quality of life and symptom measurement in COPD patients

<h2>COPD exacerbation risk has been shown to accelerate after each exacerbation.2,a&nbsp;</h2>
<h3>Exacerbation risk accelerates after each exacerbation2</h3>

*Severe exacerbations were defined as those which resulted in hospitalisation with a primary discharge diagnosis of COPD2
<h3>Despite triple inhaled therapyc, many patients remain symptomatic as defined by persistent symptoms and exacerbations.2</h3>

<h2>COPD exacerbations may lead to an accelerated rate of decline in lung function3,d</h2>

<ul>
 <li>
 Rate of FEV1 decline nearly double3</li>
 <li>
 Lung function decline may occur after only one COPD exacerbation3</li>
</ul>

aBased on data from a large population-based cohort of 73,106 Canadian patients (mean age 75 years) who were hospitalised for the first time because of a severe exacerbation of COPD (1990-2005, followed until death or March 31, 2007). The hazard functions of successive hospitalised COPD exacerbations and all-cause mortality over time were estimated, and HRs adjusted for age, sex, calendar time and comorbidity.&nbsp;2 bAdjusted for age, sex, calendar time, and the modified Chronic Disease Score.2 cOr double inhaled therapy if ICS is contraindicated.4 dFEV1 decline after a single moderate-to-severe exacerbation. Based on a retrospective analysis of data from 586 patients with moderate-to-severe COPD.3&nbsp; 
 aHR, adjusted hazard ratio; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; QoL, quality of life&nbsp;

The impact of exacerbations in COPD

<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>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).

TRANSPLANT

Abbreviations

References

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

Understanding the mechanism of cGvHD: Inflammation and Fibrosis

<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).

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.

cGvHD Quality of Life

<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

<h4><a href="${link:{uuid:{62029ee8-56d6-4bca-932c-770818da2902},repository:{dam},path:{/Portal/UK/Products/Dupixent-Asthma/Dupixent-Asthma-PI-GB-June-2024.pdf}}}">Prescribing Information GB</a></h4>

<h4><a href="${link:{uuid:{8c4aab00-e04d-4f4d-8289-9c2d33dd155b},repository:{dam},path:{/Portal/UK/Products/Dupixent-Asthma/Dupixent-Asthma-PI-IE-XI-June-2024.pdf}}}">Prescribing Information&nbsp;NI/ROI</a></h4>

<h2>What is Severe Asthma?</h2>
&nbsp;
Severe asthma refers to asthma which does not get better with the usual treatment leaving patients with breathing problems most of the time, meaning that a different treatment approach may be necessary to control the symptoms&nbsp;1,2
<ul>
 <li>~200,000 people in the UK have severe asthma*1,2</li>
 <li>39% (61/155) of people that died from asthma were reported to have severe asthma between 2012–2013†3</li>
 <li>In a UK study‡,~93% (748/808) of severe asthma patients had a least one corticosteroid-related morbidity4</li>
</ul>

ASTHMA

Click here to discover the AAC Tool for managing uncontrolled patients.

*Approximately 4% of the 5.4 million people in the UK who have asthma have severe asthma (approximately 200,000–250,000). GINA defines severe asthma as asthma that remains uncontrolled despite optimised treatment with high-dose ICS-LABA or that requires high-dose ICS-LABA to prevent it from becoming uncontrolled1,2,5
†In the National Review of Asthma Deaths (NRAD) (2014) sufficient data was available on 195 people who died of asthma between 2012–2013. From 195 people, 155 had their asthma severity recorded prior to death. No history of asthma was reported as 3% (4/144), mild asthma was reported as 9% (14/155), moderate asthma was reported as 49% (76/155) and severe asthma was reported as 39% (61/155). The NRAD is the first UK-wide investigation into asthma deaths that took place between Feb 2012 to Jan 2013. Experts such as general practitioners (GPs), nurses and pharmacists looked at medical records and other information relating to these deaths from doctors’ surgeries, hospitals, emergency services and coroners’ offices. Severity was defined as follows: The BTS/Scottish Intercollegiate Guidelines Network (SIGN) treatment steps 1 and 2 were used as a surrogate for mild and moderate severity; those who were prescribed four asthma medications and those who had been admitted to hospital in the past year, needed OCS daily or had two or more prescriptions for systemic corticosteroids in the past year were classified as severe.3
‡A cross-sectional observational study to determine the prevalence of systemic corticosteroid-induced morbidity in severe asthma using the Optimum Patient Care Research Database (OPCRD), (7,195 subjects in three age- and gender-matched groups) - severe asthma (GINA treatment step 5 with four or more prescriptions/year of OCS, N=808), 770 subjects with severe asthma from the BTS Difficult Asthma Registry (442 receiving daily OCS to maintain disease control). Severe asthma was defined by the Global Initiative for Asthma (GINA) treatment step 5 with four or more prescriptions/year of OCS. 770 subjects with severe asthma from the BTS Difficult Asthma Registry (442 receiving daily OCS to maintain disease control).4

<h2>Type 2 Inflammation&nbsp;</h2>
No single biomarker fully captures the complexity of Type 2 inflammation in asthma6,7

50 - 70% of adult asthma patients have Type 2 Inflammation, with close to 1 in 2 patients presenting with multiple Type 2 inflamatory biomarkers7,8,9.

Adapted from Robinson 201710 and Gandhi et al. 201611

<h2>Biomarkers</h2>
59% of patients with severe asthma have several elevated biomarkers12

Type 2 biomarkers support the assessment of type 2 inflammation10,11, 13

EOS10,11,14

IgE10,11

FeNO10,13

% of patients presenting with each kind of raised biomarker12.

<h3>&nbsp;</h3>
<h3>Elevated EOS, FeNO, OR IgE is evidence of Type 2 Asthma5</h3>
88% of patients with severe asthma may have type 2 inflammation15&nbsp;
DUPIXENT&nbsp;(dupilumab) is shown to work in patients with severe asthma type 2 biomarkers ((EOS&nbsp;≥ 150 cell/μL and/or FeNO&nbsp;&nbsp;≥ 25 ppb with or without elevated IgE)5,16
Over HALF of type 2 asthma patients have more than one elevated type 2 biomarker12,§
<ul>
 <li>Elevated EOS and FeNO are strong predictors of a good asthma response to DUPIXENT16</li>
 <li>Oral Corticosteriod (OCS) may suppress type 2 biomarkers, which should be accounted for when assessing type 2 asthma status in patients taking OCS 5,17.</li>
</ul>

Click here to learn more about DUPIXENT

§&nbsp;Within the International Severe Asthma Registry (ISAR), data were analysed in adults with severe asthma with available biomarkers (n = 1,175) from 10 countries in North America, Europe, and Asia, with respecified thresholds for biomarker positivity - (serum IgE&nbsp;&nbsp;≥ 75 IU/mL, blood eosinophils&nbsp;&nbsp;≥ 300 cells/mL, and FeNO&nbsp;&nbsp;≥ 25 ppb); and with hierarchical cluster analysis using biomarkers as continuous variables. Distinct clusters were shown with significant overlap of biomarker positivity in severe asthma.12

Watch this video to learn more about Type 2 inflammation in asthma

<h2>Guidelines&nbsp;</h2>

GINA5,18

BTS/ SIGN&nbsp;19

Learn more about Dupixent (dupilumab) for your patients

Prescribing Information GB

Prescribing Information NI / Rol

An Introduction to Severe Asthma

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MAT-XU-2300297 (v3.0) - Date of preparation: October 2023

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