With patient safety in mind, SCARLETRED®Vision can be used as a digital aid to measure and document treatment safety and efficacy of newly developed JAK inhibitors either on site and/or home based clinical trials.
As the classification and treatment options of skin diseases are becoming more complex, the advancement in therapeutic procedures contributed to improved prognosis and diagnosis, especially in the field of dermatology.
Inhibitors of signaling proteins linked to cytokine receptors have been introduced to treat patients with chronic inflammatory conditions, like psoriatic arthritis (tofacitinib) and rheumatoid arthritis (baricitinib/tofacitinib), however they are also used to treat atopic dermatitis, ulcerative colitis, juvenile idiopathic arthritis and ankylosing spondylitis. The inhibitors target Janus kinases (JAKs), which are involved in the modulation of inflammatory processes. Since JAK inhibitors (JAKi) can be administered both orally or topically, they are receiving growing attention from dermatologists and other health professionals to treat more dermatological diseases next to the already mentioned ones, such as alopecia areata, dermatomyositis, graft-versus-host disease, hidradenitis suppurativa, vitiligo, lupus erythematous or lichen planus.
Due to recent events, JAKis are now under stricter monitoring as released by both the FDA and EMA. The results of a large randomized safety clinical trial concluded risks, exposed to patients taking tofacitinib or baricitinib for rheumatoid arthritis, of heart disease, major cardiovascular problems and increased risk of developing cancer. Until the confirmation of the risks, the regulatory bodies are requiring revisions to the Boxed Warning, which is the most prominent warning by the FDA.
How can Scarletred®Vision be used to ensure patient safety?
Implementing a digital system from the start of clinical trials ensures the continuous availability of high-quality and standardized data. Based on machine learning and artificial intelligence, Scarltered®Vision provides a solution to document, measure and analyze skin changes in numerous dermatological conditions.
With the newly received EC declaration of conformity approved, Scarletred®Vision as a physiological measuring system and a CE Class 1m medical device, the offered measurement tools are clinically validated and certified, and thus it can also be easier integrated in later stages of clinical research. The main objective of the SCARLETRED team is to understand the study specific requirements and to adapt and implement the offered services accordingly. The software can be completely customized as a flexible Software as a Service (SaaS) based on the needs and requirements of clinical trials. Electronic patient reported outcomes (ePROs) can be customized and configured to appear after image documentation on the mobile app, and the answers and resulting score are documented centrally on the platform together with the participant´s image, allowing for real-time tracking of symptoms.
Keeping patient safety in mind, Scarletred®Vision can easily be integrated into patient safety studies and used as a digital aid to measure and document treatment safety and efficacy of newly developed JAK inhibitors whether the study takes place on site or remotely. Also, the early implementation of the software enables the generation of organized, quantifiable and smart data, while reducing the occurring costs and improving the quality of the results of clinical trials. Scarletred®Vision, can not only be used in clinical trials, but also it is a powerful tools when used in post marketing studies and safety monitoring of pharmaceuticals, through providing standardized data which complies to the ICH-GCP, GDPR- and HIPAA regulations and is a certified ISO-13485 Quality Management System.
Now, with the even stricter safety regulations regarding the use of JAKi, the JAK Inhibitors Drug Development Summit is specifically focuses on this aspect and hosts conversations around JAKi safety, drug delivery methods as well as explores JAK selectivity with the focus on treating chronic dermatologic, autoimmune, oncological and many more inflammatory indications. Read more about the 3rd JAK Inhibitors Drug Development Summit this year here.