Pharmaceutical Market Europe • May 2024 • 10-11

DERMATOLOGY NEWS

Incyte’s JAK inhibitor cream Opzelura shows promise in hidradenitis suppurativa

Image

Incyte has shared positive results for its JAK inhibitor cream, Opzelura (ruxolitinib), in patients with mild-to-moderate hidradenitis suppurativa (HS).

The mid-stage of the selective JAK1/JAK2 inhibitor met its primary endpoint, demonstrating a significantly greater reduction in abscess and inflammatory nodule (AN) count at week 16 in patients treated with Opzelura cream 1.5%, compared to those who applied the vehicle control.

More than 79% of on-treatment patients achieved at least a 50% reduction in AN count, 54.2% achieved a 75% reduction, 20.8% achieved a 90% reduction and 20.8% achieved complete clearance. This is compared to 56.3%, 25%, 12.5% and 12.5%, respectively, in the vehicle control group.

Over 79% of patients receiving Opzelura met the criteria for HS clinical response, which indicates a 50% or greater reduction in AN count without an increase in abscesses or draining fistulas, compared to 50% of patients in the vehicle control group.

Those treated with Opzelura also showed a greater mean reduction in the international HS severity score system at week 16 compared to the vehicle group.

Opzelura already holds approvals to treat non-segmental vitiligo and mild-to-moderate atopic dermatitis.


UCB’s Bimzelx approved by EC to treat hidradenitis suppurativa in adults

Image

UCB’s Bimzelx (bimekizumab) has been approved by the European Commission (EC) to treat active moderate-to-severe hidradenitis suppurativa (HS) in adults who have had an inadequate response to conventional systemic therapy.

Estimated to affect about 1% of the population in most studied countries, HS is an inflammatory skin disease that causes nodules, abscesses and pus-discharging draining tunnels.

Bimzelx is designed to selectively inhibit two key cytokines driving inflammatory processes, and is already approved in the EU to treat plaque psoriasis, psoriatic arthritis and axial spondyloarthritis.

The EC’s latest authorisation follows a recommendation from the European Medicines Agency’s human medicines committee and is supported by data from the phase 3 BE HEARD I and BE HEARD II studies.

Results showed that Bimzelx was associated with statistically significant and clinically meaningful improvements over placebo in the signs and symptoms of adults with moderate-to-severe HS as measured by HiSCR50 at week 16, with responses maintained to week 48.

Treatment with Bimzelx resulted in improvements over placebo in the high threshold endpoint, HiSCR75, at week 16, a key ranked secondary endpoint, with these responses also sustained to week 48.


AbbVie shares positive results for Rinvoq for atopic dermatitis

Image

AbbVie has announced positive topline results from a head-to-head study of its selective JAK inhibitor, Rinvoq (upadacitinib), in adults and adolescents with moderate-to-severe atopic dermatitis.

The phase 3b/4 LEVEL UP trial has been evaluating Rinvoq against Regeneron/Sanofi’s Dupixent (dupilumab) in patients aged 12 years and older who had an inadequate response to, or were not advised, systemic therapy.

An estimated 10% of adults and 24.6% of adolescents are affected by atopic dermatitis, a chronic inflammatory condition characterised by itchy, red, swollen and cracked skin.

AbbVie’s Rinvoq showed superior efficacy to Dupixent in the study’s primary endpoint, with a significantly higher proportion of Rinvoq-treated patients simultaneously achieving near-complete skin clearance and little-to-no itch at week 16.

Results also showed that Rinvoq was superior to Dupixent for all ranked secondary endpoints, including the rapid onset of achieving near-complete skin clearance and little-to-no itch.

Rinvoq already holds approvals to treat certain patients aged 12 years and older with moderate-to-severe atopic dermatitis, as well as adults with rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis and non-radiographic axial spondyloarthritis.


Typharm’s Nystaform advised for skin infections caused by fungi and bacteria

Image

The UK government’s Department of Health and Social Care has advised that Typharm Group’s Nystaform HC Cream should be considered a ‘like-for-like’ alternative following the upcoming discontinuation of Daktacort 2%/1%.

Patients are expected to experience difficulties as the remaining stock of the treatment runs out, with GPs and other healthcare professionals encouraged to issue primary and any replacement prescriptions for suitable like-for-like alternatives.

Nystaform HC Cream, which contains an antifungal (nystatin), an antibacterial (chlorhexidine) and 0.5% hydrocortisone, is indicated to treat skin infections caused by fungi, bacteria, or both, such as ringworm, athlete’s foot and infected nappy rash.

Results from a recent real-world study, undertaken on behalf of Nystaform HC Cream, demonstrated that most of the UK population currently have a skin condition or have previously been affected by one.

The data showed that 70% of respondents said that they have had experience with eczema, 51% have had athlete’s foot, 29% noted dermatitis as a problem, 25% said they had psoriasis and 83% of respondents with children aged under three years said their child gets nappy rash.


UK survey reveals two-thirds of vitiligo patients struggle with mental health

Image

A UK survey commissioned by the Vitiligo Society has revealed that almost two-thirds (63%) of patients diagnosed with the skin condition struggle with their mental health, causing the charity to call for greater awareness among healthcare professionals and the public.

The independent survey of over 700 people with vitiligo, the largest to be conducted in this patient population in the UK, found that eight in ten of those diagnosed with the condition felt that it negatively impacts their appearance and almost half (46%) reported feeling isolated and depressed.

The study also found that only 15% of patients felt informed about vitiligo, with a third feeling dismissed and confused when first speaking to a GP or healthcare professional.  Two-thirds said they wanted better access to GPs and dermatologists and seven in ten wanted more information on how the condition can be treated.

In order to “urgently address” the lack of awareness and understanding surrounding the condition, the Vitiligo Society has launched the #LetsTalkVitiligo campaign, which aims to publicise the results of the survey with national and regional media.


UK scientists discover two genes as potential drug targets for skin cancer

Image

Scientists from the Institute of Cancer Research (ICR) and Imperial College London (ICL) have revealed two genes responsible for sensing the environment and adapting cell shape, offering new potential drug targets to stop skin cancer from metastasising.

Published in Cell Reports and collaboratively funded by the ICR, Cancer Research UK, ICL and the Engineering and Physical Sciences Research Council, the study uncovers how cells become aware of the environment they are in and ‘shapeshift’ to adapt to it.

Researchers developed a new system to study cells in 3D to mimic different areas of the body, using stage-scanning oblique plane microscopy to take images of melanoma cells on a flat and rigid surface or embedded within a 3D soft collagen hydrogel.

After analysing 60,000 cells from the 3D image taken when certain genes were ‘switched off’, the team discovered two genes, TIAM2 and FARP1, that were crucial for melanoma cells to change their shape in response to their environment.

The team believes that both genes could be targeted to prevent melanoma cancer from metastasising and could be strong candidates for drug discovery.