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22nd April 2024
Bimekizumab (brand name Bimzelx) has been granted marketing authorisation by the European Commission (EC) for active moderate-to-severe hidradenitis suppurativa (HS), its manufacturer UCB has announced.
Now indicated for adults with an inadequate response to conventional systemic HS therapy, the humanised monoclonal IgG1 antibody is designed to selectively inhibit the two cytokines interleukin 17A (IL-17A) and interleukin 17F (IL-17F).
This approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in March 2024 and makes bimekizumab the first biologic for moderate-to-severe HS to target IL-17F in addition to IL-17A.
It also marks the fourth marketing authorisation for the drug, adding to the existing indications in moderate-to-severe plaque psoriasis, active psoriatic arthritis and active axial spondyloarthritis.
Professor Christos Zouboulis, director of the departments of dermatology, venereology, allergology and immunology at Städtisches Klinikum Dessau, Brandenburg Medical School, Germany, and president of the European Hidradenitis Suppurativa Foundation, said: ‘The European Commission’s approval of bimekizumab marks a significant milestone for the EU hidradenitis suppurativa community, particularly considering the limited treatment options currently available.
‘As a community, we strive to improve the management of hidradenitis suppurativa. Bimekizumab offers a promising new therapeutic option for moderate to severe disease, supported by Phase 3 evidence that demonstrated clinically meaningful and sustained responses over 48 weeks.’
Indeed, the EC approval was based on results from the BE HEARD I and BE HEARD II studies, which evaluated the efficacy and safety of bimekizumab in the treatment of moderate-to-severe HS.
The multicentre, randomised, double-blind, placebo-controlled phase 3 trials had a combined enrolment of 1,014 adult patients with a diagnosis of moderate to severe HS.
The primary endpoint in both studies was HiSCR50 at Week 16, with HiSCR75 at Week 16 as a key secondary endpoint. These are defined as at least either a 50 or 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
A significantly higher proportion of patients treated with bimekizumab versus placebo achieved a 50% or greater improvement in HS signs and symptoms at Week 16, as measured by HiSCR50.
Bimekizumab treatment also resulted in clinically meaningful improvements in the ranked key secondary endpoint, HiSCR75 versus placebo at Week 16.
Responses were maintained to Week 48, and the safety profile of bimekizumab was consistent with safety data seen in previous trials with no new observed safety signals.
30th October 2023
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.’
2nd August 2023
Two distinct genetic loci that contribute to the risk of an individual developing the chronic skin condition hidradenitis suppurativa (HS) have been identified by researchers at the University of North Carolina (UNC).
In an effort to better understand the genetic factors responsible for HS, researchers undertook a genome-wide association study, which looks for associations between loci and particular chronic diseases. The study, which was published in JAMA Dermatology, sought to identify genetic variants associated with HS and to shed light on the underlying genes involved.
A total of 720 patients with HS were included, and researchers integrated the information they obtained from these individuals with controls from the National Longitudinal Study of Adolescent to Adult Health study. The results were further combined with biological and genetic samples from three other databases.
The study revealed genomic variants pointing to two specific genes: SOX9 and KLF5. The SOX9 gene is thought to be involved in both hair follicle and epidermal development, whereas KLF5 promotes the generation of keratinocytes
The researchers identified mutations at these loci, which were more likely to be found in people with HS than in people without the disease. In addition, variants at these loci were located in enhancer regulatory elements detected in skin tissue. The researchers suggested that these or other nearby genes may be associated with genetic risk of HS and the development of its unique clinical features which include cysts, comedones, and inflammatory tunnels.
Karen Mohkle, from the Department of Genetics at UNC and one of the study authors, said: ‘While more studies are needed to understand how DNA variants near SOX9 and KLF5 contribute to the pathophysiology of HS, both genes are potentially highly relevant and have not previously been linked to the condition.‘
Previous research suggests as many as one person in every 100 has HS, which equates to around 3.5 million people in United States. It has also been shown that black women under the age of 40 have the highest risk of developing HS and are three times more likely to have the condition than white people.
Earlier this year, bimekizumab was found to be an effective treatment for patients with hidradenitis suppurativa, according to the findings of a phase 3 trial.
27th June 2023
A higher dose of adalimumab is likely to be more effective for obese patients with hidradenitis suppurativa, according to the findings of a small trial.
Adalimumab (ADA) is one of only two biologic therapies, together with secukinumab, approved by the EMA for the management of hidradenitis suppurativa (HS). However, adalimumab dosing is not weight-based and in two phase 3 trials, just over half of the patients assigned to adalimumab 40 mg/week (ADA40) achieved a clinical response.
Given that patients with HS are four times more likely to be obese compared to the general population, there might be an advantage of using a higher ADA dose in HS patients who are either overweight or obese.
In the current study, published in the Journal of Drugs in Dermatology, a team of US researchers evaluated the effectiveness of adalimumab 80 mg/week (ADA80) versus 40 mg, in overweight and obese patients with moderate to severe HS. The team included patients with a body mass index greater than 25 and who were refractory to treatment with ADA40. A dose of 80 mg was administered for at least three months and improvements were assessed using the HS-Physician Global Assessment.
A total of eight patients with a mean age of 37 years (six females) and with a median body mass index of 36.6 were included in the study and were followed for a median of 13.2 months on ADA80.
Patients experienced a greater improvement in the HS-Physician Global Assessment with ADA80 compared to ADA40 (p = 0.01). In addition, all five patients who had their lesion counts documented achieved a HS clinical response, and all eight patients reported improvements in pain, drainage, lesions and the frequency of disease flares.
While acknowledging the limitations from a small sample size, the researchers suggested that their data indicates a benefit increasing the dose of adalimumab in overweight and obese patients with HS.
Earlier this year, a phase 3 trial found bimekizumab to be an effective treatment for patients with hidradenitis suppurativa.
13th April 2023
Bimekizumab appears to be an effective treatment for patients with hidradenitis suppurativa, according to the findings of a phase 3 trial.
Hidradenitis suppurativa (HS) is a chronic inflammatory disorder affecting intertriginous areas of skin. and affects around 1% of the population. Clinically, patients experience cutaneous inflamed nodules, abscesses and pus-discharging tunnels that develop in axillary, inguinal, gluteal and perianal body sites.
There is often a diagnostic delay and which leads to more severe disease. Bimekizumab is a humanised, monoclonal antibody that selectively inhibits both IL-17A and IL-17F. A phase 2 trial found use of the drug led to clinically meaningful improvement in patients with HS.
In the recent study, data from two phase 3, randomised, placebo-controlled trials in adult patients with moderate to severe HS. Both trials had a 16-week initial and 32-week maintenance treatment period.
Bimekizumab was used at a dose of 320 mg every two weeks and 320 mg every four weeks. The Hidradenitis Suppurativa Clinical Response (HiSCR50) served as the primary outcome measure. This is defined as a 50% decrease in the total abscess and inflammatory nodule count, with no increase in abscess or draining tunnel count.
There were 1,014 patients in the two trials. In both trials at week 16, more patients using bimekizumab achieved the primary outcome compared to placebo. For example, 45.3% vs28.7%, p = 0.030 (BE HEARD 1) and 53.8% vs 32.2%, p = 0.004 ( BE HEARD II). These improvements were seen for both drug regimens. In addition, over 75% percent of patients using bimekizumab achieved HiSCR50 and over 55% a HiSCR75 at week 48.
The company will submit data for global regulatory approval of the drug in patients with moderate to severe HS later in 2023.
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