Name:
Spesolimab Treatment for the Prevention of Flares in People with Generalized Pustular Psoriasis (GPP): A Video Summary of the EFFISAYIL® 2 Study
Description:
Spesolimab Treatment for the Prevention of Flares in People with Generalized Pustular Psoriasis (GPP): A Video Summary of the EFFISAYIL® 2 Study
Thumbnail URL:
https://cadmoremediastorage.blob.core.windows.net/ed6c4c45-8de5-402e-93e5-812786aaf4d7/videoscrubberimages/Scrubber_6.jpg
Duration:
T00H07M36S
Embed URL:
https://stream.cadmore.media/player/ed6c4c45-8de5-402e-93e5-812786aaf4d7
Content URL:
https://cadmoreoriginalmedia.blob.core.windows.net/ed6c4c45-8de5-402e-93e5-812786aaf4d7/VJBM-2024-0012 Effisayil v3.mp4?sv=2019-02-02&sr=c&sig=UzfmGlYJ8J83OJMcfKm3nx42B2cqLWjdccjc%2FqnuIY0%3D&st=2025-02-21T23%3A36%3A16Z&se=2025-02-22T01%3A41%3A16Z&sp=r
Upload Date:
2025-02-21T00:00:00.0000000
Transcript:
Language: EN.
Segment:1 Introduction.
[MUSIC PLAYING]
SPEAKER: Spesolimab treatment for the prevention of flares in people with generalized pustular psoriasis, GPP-- a video summary of the EFFISAYIL 2 study.
Segment:2 What is generalised pustular psoriasis (GPP)? .
SPEAKER: Generalized pustular psoriasis, or GPP, is a rare, unpredictable, and lifelong disease. In patients with GPP, the immune system mistakenly attacks healthy skin, causing inflammation and pus-filled blisters. People with GPP may experience disease worsening, known as a flare.
SPEAKER: Some flares can lead to potentially life-threatening complications, often requiring emergency care and hospitalizations. Symptoms of GPP include pain, fever, fatigue, and a general feeling of discomfort. GPP can negatively impact people's lives, including social relationships, mental health, and their ability to perform daily activities, even when they are not having a flare.
SPEAKER: Most people with GPP continue to experience symptoms between flares, including skin redness and scaly patches of skin that are often itchy and painful.
Segment:3 What is spesolimab and how does it work?.
SPEAKER: In people living with GPP, levels of a molecule called interleukin 36 or IL-36 are increased. During a flare, this increase leads to inflammation in the skin, painful pus-filled blisters, and other potentially life-threatening complications. Spesolimab is a medication that targets the IL-36 receptor, stopping inflammation and the formation of pus-filled blisters.
Segment:4 EFFISAYIL® 1 study and spesolimab approval.
SPEAKER: Until recently, there were no approved therapies to prevent flares from happening. In a previous study called EFFISAYIL 1, spesolimab treatments stopped flares in study participants who were having a flare. Within one week, treatment with spesolimab led to skin returning to normal or made the flare less severe. Based on these data, spesolimab was approved for the treatment of GPP flares in the US, Europe, and several countries around the world.
Segment:5 What is the EFFISAYIL® 2 study and who took part?.
SPEAKER: EFFISAYIL 2 was a clinical trial to study how effective and safe spesolimab was at preventing GPP flares. Participants included people with GPP aged between 12 and 75 years from 60 medical centers across 20 countries. 123 participants were randomly divided into four groups to receive a non-active drug, also known as placebo, or one of three doses of spesolimab, and were assessed every four weeks until week 48.
Segment:6 How was the EFFISAYIL® 2 study carried out and what did it investigate?.
SPEAKER: All treatments were given subcutaneously, which means they were injected under the skin. Neither the participants nor the doctors knew which medication, spesolimab or placebo was being administered. Participants could receive an additional dose of spesolimab intravenously, meaning by injection into a vein in the arm if they experienced a GPP flare. At the end of the study, 93 participants entered a long-term study to receive subcutaneous spesolimab for up to five years.
SPEAKER: The main aim of the EFFISAYIL 2 study was to find out if spesolimab could prevent GPP flares from occurring, and which dose was most effective. A GPP flare was defined as a score of two or more on the generalized pustular psoriasis physician global assessment, or GPPGA pustulation scale, and a GPPGA total score of two or more. GPP flares were also defined as worsening of disease based on the doctor's judgment and/or if participants received specific medications for GPP.
SPEAKER: Another aim of the study was to see if spesolimab prevented worsening of a participant's quality of life. This was measured using two different questionnaires, which participants completed every four weeks. The results of the questionnaires were used to calculate a symptom score and a quality of life score, where the lowest score meant no symptoms or effect on quality of life, and higher scores meant worsening of symptoms and quality of life.
SPEAKER: Information was also collected on how many participants reported any health problems.
Segment:7 What were the results of the study?.
SPEAKER: A 300 milligram dose of subcutaneous spesolimab every four weeks, following an initial loading dose of 600 milligrams was the most effective dose and reduced the chance of participants experiencing a flare by 84% compared with placebo. Participants who received the 300 milligram dose of subcutaneous spesolimab every four weeks did not have any flares after week four.
SPEAKER: By the end of the study, fewer participants in the spesolimab groups experienced worsening in quality of life compared with the placebo group. Spesolimab also reduced the risk of a participant's quality of life score, worsening over 48 weeks by up to 74% compared with the placebo group. Overall, 90.3% of participants receiving spesolimab and 86.7% of participants receiving placebo reported health problems.
SPEAKER: These were similar in the three spesolimab groups, and were mostly classified as mild or moderate. It is important to note that the health problems reported are not necessarily due to spesolimab and may instead be symptoms of GPP or caused by other medical problems. Most health problems did not appear to be caused by spesolimab or the dose at which it was given. Infections were a common health problem reported by people who participated in the study.
SPEAKER: They included infections, such as the common cold and COVID-19, which were mostly classified as mild or moderate. Infections were equally common in participants who received spesolimab and those who received placebo. More participants receiving spesolimab experienced swelling, redness, pain, and itch at the injection site. This may be related to the study drug, but can also be a common unwanted effect in studies where participants receive injected treatment.
SPEAKER: Serious health problems are any medical problems that lead to death, require hospitalization, or cause disability. Such effects are not necessarily related to the treatment that participants received during the study. A greater proportion of participants receiving spesolimab experienced serious health problems compared with those receiving placebo. No deaths were reported in the study.
Segment:8 What do the results of the EFFISAYIL® 2 study mean?.
SPEAKER: Controlling systemic symptoms of GPP is a key goal for doctors and patients in managing GPP, a potentially life-threatening disease with a serious impact on patient quality of life. It is important to avoid flares because severe complications can occur during flares. The EFFISAYIL 2 study shows that in people with GPP, long-term treatment with spesolimab reduced the risk of flares and prevented worsening of symptoms and quality of life.
SPEAKER: [MUSIC PLAYING]
