Sanofi has announced positive results from a phase 2b trial of amlitelimab in adults with moderate-to-severe cases of atopic dermatitis, one of the most common inflammatory skin diseases.

Typically referred to as eczema, atopic dermatitis affects an estimated 16.5 million adults in the US, with nearly 40% affected by moderate-to-severe cases.

Sanofi’s amlitelimab is an investigational anti-OX40-ligand monoclonal antibody that is designed to rebalance the immune system by blocking inappropriate activation and proliferation of pro-inflammatory effector T cells and promoting expansion of anti-inflammatory regulatory T cells.

The company said the candidate “has the potential to be a first-in-class treatment for a range of immune-mediated diseases and inflammatory disorders”, including moderate-to-severe atopic dermatitis and asthma.

The dose-ranging STREAM-AD study has been evaluating amlitelimab in adult patients whose disease was inadequately controlled with topical therapies or where such therapies were not advisable.

The study met its primary endpoint with amlitelimab-treated patients demonstrating statistically significant improvements from baseline at 16 weeks on the EASI test, which is used to measure the extent and severity of the condition, compared to placebo.

Improvements were also seen in key secondary outcome measures, the company said, and continued benefits were observed through week 24.

Bristol Myers Squibb’s (BMS) Sotyktu (deucravacitinib) has been recommended for use on the NHS in England as a treatment option for certain adults with moderate-to-severe plaque psoriasis.

The new guidance from the National Institute for Health and Care Excellence (NICE) specifically applies to patients with a Psoriasis Area and Severity Index score of ten or more and a Dermatology Life Quality Index score of more than ten.

Eligible patients will have also not responded to or been able to receive other systemic treatments, including ciclosporin, methotrexate and phototherapy.

Up to 90% of patients with psoriasis have plaque psoriasis, characterised by distinct round or oval plaques typically covered by silvery-white scales.

Despite the availability of effective systemic therapies, BMS reports that many patients with moderate-to-severe psoriasis remain under-treated, untreated or dissatisfied with current treatment options.

The decision from NICE follows the Medicines and Healthcare products Regulatory Agency’s approval of Sotyktu in May for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

This was supported by positive results from two phase 3 trials, in which once-daily Sotyktu was associated with superior improvements in skin clearance, symptom burden and quality of life measures compared to both placebo and twice-daily Otezla (apremilast).

Almirall has published the results of a survey revealing that 85% of respondents are unaware of the existence of actinic keratosis (AK), the most common precancerous skin condition.

AK is one of the most common diagnoses made by dermatologists, with an estimated prevalence of 13.3% in the European population.

Although AK lesions are not harmful in themselves, it is estimated that 40% to 80% of squamous cell carcinomas – the second most common skin cancer after melanoma – develop from them.

Almirall’s survey, which included 2,500 participants aged over 35 years, aimed to understand the level of knowledge about AK and skin health habits within the general populations of the UK, US, Spain, Germany and Italy.

Despite its high prevalence, the survey found that the majority of respondents (57.73%) do not get their skin checked by a professional, and almost a third do not check their skin at least once a year to find signs of suspicious marks and lesions.

The results were presented in conjunction with the launch of the company’s second annual AK Global Day campaign on 24 May, which aimed to raise awareness of the condition and emphasise the importance of regular skin checks.

The European Commission (EC) has approved UCB’s Bimzelx (bimekizumab) as a treatment option for certain adults with psoriatic arthritis.

The authorisation, which follows a recommendation from the European Medicines Agency’s human medicines committee earlier this year, specifically applies to patients with active disease who have had an inadequate response or have been intolerant to one or more disease-modifying anti-rheumatic drugs.

The EC’s decision was supported by results from two phase 3 trials in which Bimzelx showed improvements over placebo in joint and skin symptoms across biologic naïve and TNF inhibitor-inadequate responder populations.

The approval is one of two new marketing authorisations granted to the inflammatory disease drug in the EU. The second applies to certain adults with active axial spondyloarthritis – a type of arthritis that mainly affects the joints of the spine.

Together, the authorisations make Bimzelx the first and only IL-17A and IL-17F inhibitor approved in the EU for these two indications.

The approvals also represent the first marketing authorisations for Bimzelx in psoriatic arthritis and axial spondyloarthritis worldwide, according to UCB, as well as the second and third indications for Bimzelx in the EU, following its approval for the treatment of moderate-to-severe plaque psoriasis in 2021.

Amgen has announced positive new research evaluating the use of its inflammatory disease medication Otezla (apremilast) in psoriatic arthritis.

Otezla regulates inflammation by inhibiting an enzyme known as phosphodiesterase 4. This enzyme controls much of the inflammatory action within cells, which can affect the level of inflammation associated with psoriatic disease.

The new data for the drug, which was presented at the 2023 European Congress of Rheumatology, includes results from the phase 4 MOSAIC study, which evaluated its effect on joint inflammation and structural progression of psoriatic arthritis using MRI.

Results showed that patients treated with Otezla had improvements in both clinical and MRI measures of inflammation up to week 48.

An exploratory analysis of cardiometabolic risk factors, which are commonly elevated in patients with psoriatic disease, is also included within the new research.

The post hoc exploratory analysis of data from five pooled phase 3 trials showed Otezla treatment was associated with improvement in cardiometabolic parameters across psoriatic disease activity groups.

Amgen bought Otezla from Celgene Corporation in 2019 for $13.4bn to strengthen its inflammation portfolio. The drug is already indicated to treat certain patients with plaque psoriasis, active psoriatic arthritis and those with oral ulcers associated with Behçet’s Disease.