Daily Archives: May 18, 2021

NEW YORK (CBSNewYork) Millions of children and adults in the U.S. have to cope with the constant itching of eczema. And all that scratching can lead to bleeding and infections.

A new technology can finally measure just how much someone is scratching and help to better treat patients, CBS2s Dr. Max Gomez reported.

Jan-Kai Chang said his daughter Cynthias eczema is so bad that sometimes the five-year-old scratches until she bleeds.

We tried to ask her to stop scratching when she feels itchy. But you can imagine that its too hard, Chang said.

The itching can be unbearable for the 10 million kids and 16 million adults with atopic dermatitis (eczema). But its a challenge to actually measure how much someone is scratching.

Researchers at Northwestern University have developed a first-of-its-kind wearable sensor that can quantify itching by measuring scratching.

Its sort of an old saying. If you cant measure it, you cant manage it,' said Northwesterns Dr. Steve Xu.

The soft, flexible, wireless device measures vibrations from the hand and can capture all forms of scratching finger, wrist and elbow motion related.

An algorithm picks out just scratching and doesnt flag similar movements, like waving. A study validating its accuracy was recently published in Science Advances.

Dr. Xu said having an objective measure of scratching can lead to better care for itchy conditions.

If things look like theyre getting worse, that might require a treatment change, a treatment adaptation, Xu said. And also can reinforce that something is working right, that this child is scratching less, sleeping better.

Cynthia took part in the sensor testing and her dad said they learned a lot.

When its windy, we have to apply a lot of topical lotion, moisturizer before she went to bed, Chang said. And that can significantly reduce the scratching time.

While the sensor was tested in patients with eczema, it can be used with any condition that causes children and adults to itch.

Researchers expect the sensor to be widely available as soon as the end of this year.

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Researchers Develop Wireless Sensor That Measures Scratching To Improve Eczema And Other Anti-Itch Treatments - CBS New York

Systemic alitretinoin is safe and effective for patients with moderate to severe chronic hand eczema (CHE) that is refractory to standard therapy with potent topical corticosteroids, according to study findings published in Dermatologic Therapy.

The DECISA project (Dermatology Clinics in Italy: Survey on Alitretinoin), a retrospective cohort study conducted in 15 Italian dermatology clinics, sought to collect clinical data for patients with CHE unresponsive to potent or super-potent topical corticosteroids. All participants were treated with oral alitretinoin 30 mg daily for 6 consecutive months.

Investigators assessed patients disease severity at baseline and after 3 and 6 months of treatment with use of the 5-point Physician Global Assessment (PGA) and the modified Total Lesion Symptom Score (mTLSS).

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A total of 438 patients (mean age, 49.7113.20 years; 248 men, 56.6%) were enrolled from 2010 to 2018. Within the cohort, irritant contact dermatitis (ICD) was diagnosed in 189 cases (43.2%), allergic contact dermatitis (ACD) in 97 (22.2%), and atopic dermatitis in 79 (18.0%). Eczema was considered mixed type (ICD/ACD) in the other 73 patients (16.7%).

At baseline, 364 patients (83.1%) had a severe PGA score (4), and 74 (16.9%) had a moderate score (3). The mean mTLSS score was 12.86 (2.76). After 3 months, 420 patients were re-evaluated, and the decrease in mTLSS score was significant compared with baseline (6.293.27, P <.0000001). The PGA score was clear (0) in 33 cases (7.5%), almost clear (1) in 123 (28.1%), mild (2) in 101 (23.1%), moderate (3) in 130 (29.7%), and severe (4) in 33 (7.5%), confirming the improvement (P <.0000001 vs baseline). There were 26 nonresponders (5.9%).

After the first follow-up, 350 patients continued alitretinoin treatment, and 341 (97.4%) were re-evaluated after 6 months, at which time the PGA score was clear in 85 cases (24.9%), almost clear in 117 (34.3%), mild in 56 (16.4%), moderate in 59 (17.3%), and severe in 24 (7.0%). The mTLSS score was not assessed in 23 cases, and in the remaining 318 cases, the average score was 4.32 (3.29). The improvement of both scores was evident compared with scores at baseline and the 3-month visit (P <.0000001 in all comparisons), according to the study authors.

After 6 months of alitretinoin treatment, 125 patients had relapses and another course of treatment was prescribed for 58 of them.

Side effects during treatment were reported by 17.6% of patients (n=77), and 7.1% (n=31) discontinued treatment owing to these effects. After the study authors applied the worst case scenario criteria for the 9 patients lost at follow-up and assessed them as though they had experienced adverse effects that had forced them to discontinue treatment, the percentages were 19.6% and 9.1%, respectively.

In a majority of cases, the type of side effect was not reported in the database; headache was the most common side effect among those that were reported, occurring in 12 patients, followed by dyslipidemia in 4 patients.

These statistical trends and significant associations deserve, in our opinion, further investigation in larger and different populations, and, if confirmed, could give an important contribution to the definition of the risk profile of patients who undergo treatment with alitretinoin for CHE, the researchers commented.

Ferrucci S, Persichini P, Gola M, et al. DECISA Project (DErmatology Clinics in Italy: Survey on Alitretinoin): a real-life retrospective cohort multicenter study on 438 subjects with chronic hand eczema. Dermatol Ther. Published online February 22, 2021. doi:10.1111/dth.14911

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Alitretinoin a Treatment Option for Chronic Hand Eczema - Dermatology Advisor

BALLERUP, Denmark--(BUSINESS WIRE)--NOT FOR DISTRIBUTION IN THE UK OR IRELAND

LEO Pharma A/S, a global leader in medical dermatology, today announced it has enrolled the first adult patient in the first of two pivotal Phase 3 clinical trials with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, for the potential treatment of adult patients with moderate-to-severe chronic hand eczema (CHE).

Delgocitinib inhibits activation of the JAK-STAT pathway, which plays a key role in the immune system in driving the pathophysiology of chronic inflammatory skin diseases.1,2 The cream formulation of delgocitinib is an investigational therapy under clinical development and has not been approved by any regulatory authority.

The primary objective for the randomized, double-blind, vehicle-controlled, multi-center Phase 3 clinical trials (DELTA 1 and DELTA 2) is to evaluate the efficacy of twice-daily applications of delgocitinib cream 20 mg/g compared with vehicle in the treatment of adults with moderate-to-severe CHE.3,4

The primary endpoint of the trials is the Investigators Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16.3,4 Treatment success is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline.3,4

Key secondary endpoints at Week 16 include reduction of itch and pain scores of 4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline to Week 16,3,4 as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at Week 16.3,4 The number of treatment-emergent adverse events per patient from baseline to Week 16 defines the key safety endpoint of the trials.3,4

"Managing moderate-to-severe CHE is challenging because of limited available treatment options for chronic use, said Dr. Sibylle Schliemann, Consultant, Department of Dermatology, University Hospital Jena, Germany and lead investigator for DELTA 2. These trials will evaluate whether delgocitinib cream can potentially offer a new treatment option for adult patients with moderate-to-severe CHE who suffer from a considerable burden of disease.

CHE is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year.5,6 HE is the most common skin disorder of the hands7 that affects an estimated 1 5% of the general population8 with a one-year prevalence rate of approximately 10%.9 It is an inflammatory, non-infectious skin disorder of the hands and wrists5,10 and can cause itching, blisters, swelling and pain so severe that it can impair the ability to work.5,7,11 In a substantial number of patients, HE can develop into a chronic condition.7

We have been encouraged by the positive results from the Phase 2b CHE clinical trial with delgocitinib cream and look forward to learning whether it has the potential to offer benefits to adult patients through a larger Phase 3 clinical development program, said Dr. Jrg Mller, Executive Vice President, Global Research & Development, LEO Pharma. We are committed to developing innovative therapies that may help improve the lives of patients who need more treatment options for skin diseases.

#ENDS#

About Delgocitinib

In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.

In 2020, LEO Pharma completed a multi-center, randomized Phase 2b dose-finding clinical trial with twice-daily topical delgocitinib cream for the treatment of adults with mild-to-severe CHE. The company presented top-line results of the trial at the European Academy of Dermatology and Venereology (EADV) Virtual 202012 and presented the results of HECSI measurements during the trial at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021.13

About LEO Pharma

LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company generated net sales of DKK 10,133 million. For more information please visit http://www.LEO-Pharma.com.

References

1 Damsky W, and King BA. JAAD; 2017;76(4):736-744.

2 Virtanen AT, et al. BioDrugs. 2019;33:1532.

3 ClinicalTrials.Gov: https://clinicaltrials.gov/ct2/show/NCT04871711?term=delgocitinib&draw=1&rank=8 (Accessed May 2021).

4 ClinicalTrials.Gov: https://clinicaltrials.gov/ct2/show/NCT04872101?term=delgocitinib&draw=1&rank=7 (Accessed May 2021).

5 Lynde C, et al. J Cutan Med Surg. 2010;14:26784.

6 Diepgen TL, et al. J Dtsch Dermatol Ges. 2015 Jan;13(1):e122. doi: 10.1111/ddg.12510_1.

7 Bissonnette R, et al. JEADV. 2010;24;120.

8 Christoffers WA, et al. Cochrane Database Syst Rev. 2019;4:CD004055.

9 Thyssen, et al. Contact Dermatitis. 2010;62:75-87.

10 Menn T, et al. Contact Dermatitis. 2011;65:312.

11 Politiek K, et al. Contact Dermatitis. 2016;75:6776.

12 Worm M, et al. The topical pan-JAK inhibitor delgocitinib cream demonstrates dose response in a 16-week phase 2b trial in chronic hand eczema. Presented during the Late Breaking News session of the European Academy of Dermatology and Venereology (EADV) Virtual 2020 on 29 October 2020.

13 Soerensen P, et al. A phase 2b trial evaluating the efficacy of delgocitinib cream for the treatment of chronic hand eczema (CHE) using and validating the Hand Eczema Severity Index (HECSI). E-poster presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 23-25 April 2021.

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LEO Pharma initiates the first Phase 3 clinical trial with delgocitinib cream in adult patients with moderate-to-severe chronic hand eczema (CHE) -...

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