In an all-new Sotyktu commercial, Bristol Myers-Squibb delivered the central message, “Live Unfiltered“. The commercial featured real-life scenarios of individuals affected by moderate-to-severe plaque psoriasis, engaging in everyday activities without the burden of their symptoms. The portrayal opened up the possibility of a life unhindered by the visible signs of psoriasis.
Sotyktu (deucravacitinib) is a one-of-its-kind oral medication approved by the US Food and Drug Administration (FDA) indicated to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Related: Sotyktu (deucravacitinib) Gets FDA Approval for Moderate-to-Severe Plaque Psoriasis
Sotyktu’s effectiveness stems from its selective inhibition of tyrosine kinase 2 (TYK2), a key enzyme involved in the pathogenesis of many immune-mediated inflammatory diseases.
“When psoriasis gets really bad, it’s really hard to get up again,” shared popstar Cindy Lauper in an interview with the American Academy of Dermatology Association. It is a sentiment that heavily resonates within the psoriasis community.
More About Psoriasis
About 7.55 million US adults and 100 million people worldwide are estimated to be living with psoriasis.
According to the National Psoriasis Foundation, “Psoriasis is a chronic disease where skin cells build up quickly, typically causing red or discolored, scaly and itchy patches on the skin. It is not contagious and can vary in severity.” In addition to patchy red skin typically found on the scalp, elbows and knees, a person can suffer cracked bleeding skin, poor mental health and low quality of sleep from the pain associated with the disease.
Psoriasis vulgaris, or plaque psoriasis, is the most common form, affecting around 80 to 90 percent of psoriasis patients. It is characterized by raised round or oval plaques lined with dry-looking silvery-white scales.
The cause of psoriasis has yet to be fully understood, but scientists estimate its origins in genetic and environmental factors and immune dysregulation (where the body is unable to control its immune response).
The visibility of psoriasis, which is a life-long condition, can cause people to withdraw from social situations to avoid exposure and potential judgment. Historical perspectives have documented how psoriasis patients might encounter curiosity, hostility and disgust due to “unclean skin” misconceptions that persist despite the knowledge that psoriasis is not contagious. Studies have also shown that a patient’s experience with stigmatization can affect the severity of the disease, response to some treatments and overall quality of life.
While the disease primarily manifests on the skin, it also has systemic implications, including psoriatic arthritis — affecting one in three people with psoriasis — and other comorbidities such as cardiovascular diseases and diabetes. Understanding the complex immunopathogenesis of psoriasis has been crucial in developing targeted therapies that significantly improve disease outcomes.
What Is Sotyktu?
Sotyktu, a once-daily oral pill, is a highly selective allosteric (causing structural or functional change to the target) inhibitor of TYK2, which disrupts the signaling pathways essential for the activation of the immune response involved in psoriasis.
As the first and only approved TYK2 inhibitor, a member of the Janus kinase (JAX) family, Sotyktu offers a novel mechanism of action different from traditional biologics and other small-molecule therapies. TYK2 is a key enzyme in the signaling pathways of several pro-inflammatory cytokines implicated in psoriasis, such as interleukin-23 (IL-23), interleukin-12 (IL-12) and type 1 interferons.
The approval of Sotyktu was based on robust data from the pivotal POETYK PSO-1 and POETYK PSO-2 Phase III clinical trials. The rate of skin clearance was determined by the PASI (Psoriasis Area and Severity Index) score, which determines the percentage of improvement from baseline, and the static Physician’s Global Assessment (sPGA) score, which scores the thickness of psoriasis lesions from 0 (absent) to 5 (severe).
The POETYK PSO-1 and POETYK PSO-2 studies demonstrated that Sotyktu, administered at 6 mg as a once-daily oral treatment, significantly improved skin clearance at 16 weeks compared to placebo and Amgen’s Otezla (apremilast), administered twice daily at 30 mg. These responses continued through week 24, with 82 percent and 80 percent of patients on Sotyktu from week 24 in the POETYK PSO-1 and POETYK PSO-2 studies respectively maintaining a PASI 75 score at week 52.
In the subsequent four-year long-term extension trial of the POETYK PSO clinical program (POETYK PSO-LTE), 71.7 percent of patients achieved a PASI 75 score and 47.5 percent of patients achieved a PASI 90 score, with a consistent safety profile.
In all three studies, a significantly higher percentage of patients on Sotyktu — compared to placebo and Otezla — demonstrated an sPGA score of 0 or 1.
The most common adverse reactions included upper respiratory infections, increased blood creatine phosphokinase, herpes simplex, mouth ulcers, folliculitis and acne.
“Many patients and their healthcare providers are looking for an efficacious, convenient oral treatment option that provides sustained relief from this chronic disease, allowing patients to prioritize other aspects of their daily lives. These findings further reinforce that we are able to offer a potential oral standard of care to meet patients’ needs,” noted April Armstrong, MD, MPH, clinical investigator in the POETYK PSO clinical trial program and professor and chief of dermatology at the University of California, Los Angeles, in a recent press release on the safety and efficacy of Sotyktu.
Current Advances in Psoriasis Treatment
The strategy of using TV ads has been particularly effective in reaching a wide audience, increasing both patient awareness and engagement. With its compelling clinical data and innovative Sotyktu commercial, the “Live Unfiltered” campaign is set to make a significant impact on the psoriasis treatment landscape.
However, psoriasis treatment is a competitive area. Companies like Amgen, Pfizer and Novartis have long been players in this space, each promoting their own unique treatments.
Amgen’s Otezla — which demonstrated significant skin clearance in patients with moderate-to-severe plaque psoriasis between the ages of six and 17 — and Novartis’ Cosentyx (secukinumab) — the first fully human biologic which was also approved to treat hidradenitis suppurativa (acne inversa) patients — are among the top contenders that have also been promoted through impactful TV commercials in the US.
These competitors have established a strong presence in the market through both direct-to-consumer (DTC) advertising and robust clinical data that support the efficacy of their treatments.
Recently, Novartis Pharmaceuticals Canada Inc. announced a significant partnership with Clarius Mobile Health to enhance the early detection of psoriatic arthritis in Canada. This collaboration aims to address the lengthy delays in diagnosing psoriatic arthritis, a common complication of psoriasis affecting approximately a third of Canadians.
If successful, rheumatologists will be able to identify diagnostic markers of psoriatic arthritis by using handheld ultrasound devices. These devices connect wirelessly to smart devices using an AI-powered application that optimizes imaging in real-time, enabling earlier identification and potentially reducing the time to diagnosis.
Sotyktu differentiates itself by being the first oral treatment approved for psoriasis in nearly a decade. It is also the first to offer a once-daily dosing regimen. This positions Sotyktu not just as a new option but as a potentially preferable choice for patients seeking less frequent dosing without compromising efficacy.
“Live Unfiltered” invites the audience to envision a life beyond the constraints of psoriasis. As the voiceover in the Sotyktu commercial concludes, “You don’t have to hide your skin.”
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