Since we publicly announced our vitiligo program in 2010, the entire Clinuvel team has aimed to gain a better understand this disease, its possible causes and how SCENESSE® (afamelanotide) may become a vital tool in a dermatologist’s arsenal for vitiligo.
We’ve also worked closely with the broader vitiligo community to better communicate the program’s goals and limitations (if you missed them, you can see the first two videos in a series of interviews between Mr Lee Thomas and our CEO here) as well as reaching out to individuals with vitiligo to better understand how this disease impacts upon lives. For me, one of the most prominent recurring topics in discussions, emails, phone calls and online is the lack of treatment for vitiligo and the frustrations of physicians and patients alike at treatment inconsistency.
Vitiligo is an insidious disease. While it causes no physical harm, the manner in which individuals lose their skin pigmentation can play constantly on their minds. Imagine waking every morning, expecting to see a slightly altered face in the mirror or different hands at your keyboard, feeling as if your identity was constantly under siege. This change in visual identity can lead to serious mental health issues and being ostracised from society or the breakdown of marriages. Compounding this further, stress itself can be a ‘trigger’ for vitiligo – one of many factors which has been linked to the onset of further pigment loss.
Unfortunately, we don’t understand the exact cause of vitiligo. While one can quickly dismiss myths about the disease, both genetic and autoimmune factors are suspected of playing some role. Current understanding suggests that an over active immune system within individuals with vitiligo attacks melanocytes in their skin, causing melanocyte cells to die and subsequent depigmentation. Without an exact cause in vitiligo, however, it is difficult to identify how it may be treated.
The frontline treatments for the disease take a two step approach: firstly aiming to halt the immune system from attacking melanocytes and causing depigmentation to spread, and secondly repigmenting skin via either melanocyte transplant or melanocyte stem cell (‘melanoblast’) stimulation. Some treatments aim to achieve both. Narrowband ultraviolet B (NB-UVB), for example, is known to suppress the immune system locally as well as penetrating to the depth of the hair follicle in skin to activate melanoblast migration. Unfortunately, however, treatments take a long time (NB-UVB, for example, is often administered 2-3 times every week for several years) and are notoriously inconsistent: not every patient will experience repigmentation, nor will it be universal. Even in those cases where repigmentation is seen, treatments often only halt the depigmentation process for a limited period of time before the vitiligo is triggered once more.
Over the past two years I’ve spoken with a large number of patients and families living with vitiligo from all over the world. I’ve also had the opportunity to hear from a number of world-leading vitiligo treatment specialists, both in conference situations and private conversation. In so many instances, due to their own lived experiences, the responses to our approach are the same: most are curious about our program, but approach it with cautious optimism.
This has prompted two responses from Clinuvel, to ensure we can properly evaluate the drug in our pilot study and to keep the vitiligo community abreast of our progress. The first is from our clinical team: following the completion of treatment in the current studies (CUV101 in Europe and CUV102 in the USA), patients will undergo a six month dermatological follow up to determine their levels of repigmentation and any possible disease recurrence. The second comes from a communications perspective: the team has sought to identify and converse with as many members of the vitiligo community as is possible, both 1-1 and through our various online and social media outlets.
Our vitiligo program has some way to come before we are satisfied that the drug is a safe and effective treatment and could present a package of data to satisfy the strict regulatory demand. Despite this, the company will continue to integrate itself as appropriately as it can to helping the vitiligo community and discussing our drug and program.
- Chan MF & Chua TL, (2012). “The effectiveness of therapeutic interventions on quality of life for vitiligo patients: A systematic review”. Int J Nursing Prac, 18:396-405.
- Linthorst Homan MW, et al (2009). “The burden of vitiligo: Patient characteristics associated with quality of life”. JAAD, 61:411-20.
- Ongenae K, et al (2005). “Psychosocial effects of vitiligo”. JEADV 20:1-8.
Two images showing a patient’s elbow before treatment and following exposure to 108 narrowband UVB treatments over 29 months. Images courtesy of Pearl E Grimes MD.