Novartis’ Cosentyx (secukinumab) has been recommended by the European Medicines Agency’s human medicines committee to treat adults with active moderate-to-severe hidradenitis suppurativa (HS).

If approved, Cosentyx will be the first new treatment option for the inflammatory skin disease in nearly a decade.

An estimated one in 100 people globally are affected by HS, which causes boil-like abscesses that can burst, creating open wounds and irreversible scarring.

There is currently only one approved biologic treatment for HS, with around half of patients potentially losing response to this.

Currently approved to treat a range of inflammatory conditions such as psoriatic arthritis and severe plaque psoriasis, Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in inflammation.

The positive opinion from the Committee for Medicinal Products for Human Use is based on results from two identical phase 3 trials, with a combined enrolment of more than 1,000 patients in 40 countries.

Results showed that Cosentyx continued to improve response rates beyond the primary endpoint analysis at week 16 to more than 55% of patients achieving an HS clinical response measure at week 52.

Additionally, approximately 50% of Cosentyx-treated patients had a meaningful reduction in HS-related pain at week 52.

Almirall has announced the publication in the British Medical Journal of its POSITIVE study protocol, which represents the first clinical study in dermatology assessing patients’ well-being as a primary endpoint.

The ongoing study is aiming to capture patients’ overall well-being in a real-world setting when being treated with tildrakizumab, a recombinant human monoclonal antibody indicated for moderate-to-severe plaque psoriasis.

Psoriasis affects an estimated 60 million people worldwide, with almost 77% of patients reporting that the condition negatively affects their normal daily activities and well-being.

It is hoped that the results could potentially be added to the available psoriasis evaluation methods and provide dermatologists with new tools to improve their own and their patients’ well-being.

Almirall’s POSITIVE study uses the five-item World Health Organization (WHO) Well-being Index, a widely used questionnaire that assesses health-related psychological well-being in a variety of chronic diseases, but that had never been used in dermatology.

Following the holistic approach, the study will use secondary endpoints, such as evaluating the impact on the family environment and on physician well-being.

Around 780 adults with moderate-to-severe psoriasis are enrolled in the study, which will follow patients for 24 months in their treatment with tildrakizumab.