Almirall, LLC, a global biopharmaceutical company focused on skin health, is excited to announce the release of its privately funded PROSES study at this year’s Fall Clinical Dermatology Conference® in Las Vegas, Nevada, October 20-23, 2022. Over the course of the 12-week study, patients with moderate to severe non-nodular acne vulgaris showed a significant improvement in certain health-related quality of life measures during treatment with sarecycline.
“This important real-world study demonstrated not only the impact that acne has on a patient’s mental health, but also that successful treatment can improve both a patient’s acne and related quality of life outcomes,” says Emmy Graber, MD, co-principal investigator of PROSES.
The study evaluated patient-reported outcomes (PROs), using two separate questionnaires (ASIS and EPQ*), investigator global assessment (IGA), and safety of sarecycline use among patients with moderate to severe non-nodular acne vulgaris.
Baseline results from PROs clearly reflect an impact of substantial burden on certain aspects of a patient’s quality of life across four distinct domains within the ASIS tool. When asked about the impact of acne on measures specific to social or emotional attributes over the past seven days, patient’s baseline response was recorded as all/most/some of the time in the following categories: 78.77% felt sad, 71.15% felt embarrassed, 76.68% felt self-conscious, and 35.57% chose not to be around others.1
“With the PROSES initiative, we are able to witness the emotional and physical suffering of individual acne patients and – for the first time – how treatment is able to make a difference for these patients,” says Hilary Baldwin, MD, co-principal investigator of PROSES. “We’re very excited to present PROSES results and look forward to publishing our findings in a peer-reviewed journal by the end of this year.”
Overall, the change from baseline measures across all domains of the ASIS questionnaire reflected a significant improvement. Additionally, PROSES study results showed an overwhelming majority of physicians (88.1%) were satisfied/very satisfied with patient sarecycline treatment.1
Over the 12-week study period, EPQ responses displayed a significant increase in patients reporting no/least acne burden.2
“Almirall US is proud to have spearheaded this innovative real-world evidence study and we are looking forward to seeing the outcomes realized in how the dermatology community recognizes the importance of evaluating the patient beyond their skin,” says Pablo Alvarez, PhD, President & General Manager, Almirall, LLC.
General understanding of acne impact on patients and burden of the disease beyond the skin is still evolving. Assessing the impact of sarecycline treatment on patient-reported outcomes in real-world community practice settings highlights the improvement of certain health-related quality of life measures.
This study reinforces Almirall’s vision for improving patient lives. “I know from personal experience the profound impact acne can have on a young adult’s life. This is also compounded by social media and lack of understanding of these societal pressures. To this end, I am confident that the PROSES study will make a significant contribution to a deeper understanding of the true burden of acne and the potential impact novel therapies such as sarecycline can bring to patients,” says Volker Koscielny, MD, Almirall’s Chief Medical Officer.