The biologic treatment secukinumab (brand name Cosentyx) has been recommended in final draft guidance by the National Institute for Health and Care Excellence (NICE) for hidradenitis suppurativa (HS), its manufacturer Novartis has announced.
The first biologic treatment to be recommended for the condition since adalimumab in 2016, secukinumab is suitable for adults in England and Wales with active moderate to severe HS, where there has been an inadequate response to conventional systemic therapy and where adalimumab is not suitable, did not work or has stopped working.
Commenting on the development, Dr John Ingram, clinical reader and consultant dermatologist at Cardiff University, said: ‘HS is an undertreated disease that causes substantial physical and emotional distress to those who live with it. Until now, there has only been one approved biologic treatment for HS, and many patients can lose response.
‘[The] NICE decision provides physicians with a second treatment option that has shown significant clinical benefits in the domains that matter most to patients, including swift improvement in quality of life and skin pain.’
The NICE recommendation is based on the results of the SUNSHINE and SUNRISE multicentre, randomised, double-blind, placebo-controlled, parallel group trials, which formed the largest phase 3 programme in HS to date.
Across the two trials, 1,084 participants were randomly assigned (1:1:1) to receive subcutaneous secukinumab 300 mg every two weeks or every four weeks, or subcutaneous placebo.
The treatment response rates in patients randomised to secukinumab continued to improve beyond the primary endpoint analysis at Week 16 to more than 55% of patients achieving a Hidradenitis Suppurativa Clinical Response at Week 52.
Approximately 50% of patients randomised to secukinumab had a reduction in HS-related pain at Week 52. Safety findings were consistent with the generally well-tolerated safety profile of secukinumab in its approved dermatological and rheumatological licensed indications and are further supported by data from eight years of real-world use.
The authors concluded that ‘when given every two weeks, secukinumab was clinically effective at rapidly improving signs and symptoms of hidradenitis suppurativa with a favourable safety profile and with sustained response up to 52 weeks of treatment’.
Through an agreement between Novartis and NHS England, eligible people living with HS to obtain immediate access to secukinumab through the interim Innovative Medicines Fund, which provides funding to accelerate NICE-recommended non-cancer medicines into the NHS.
In addition, the New Treatment Fund in Wales will enable early access to secukinumab for eligible patients in Wales.
Secukinumab, an interleukin-17A inhibitor, was approved in the EU and UK in 2015 for treating moderate to severe plaque psoriasis in adults. The license was extended to include children and young people aged six to 17 in the EU in 2020 and UK in 2021.
Marie-Andrée Gamache, country president, Novartis Innovative Medicines UK and Ireland, said: ‘[The] NICE recommendation is an example of how we are reimagining medicine to improve the lives of people with hard-to-treat inflammatory conditions and has been made possible through effective collaboration with NICE and NHS England.
‘Since its first approval in the UK in 2015, secukinumab has been used to treat over one million patients worldwide and could now provide another option for eligible patients in England and Wales who continue to struggle with the painful and debilitating symptoms of HS.’