BMS Attributes Sotyktu Falling Short of Growth Expectations to Access, but Recent Spherix Global Insights’ Data Suggest Safety Concerns Are More of a Barrier to Increased Uptake
There's apprehension surrounding potential side effects and adverse events, notably cardiac incidents, malignancy, thrombosis, and the risk of infection.
Exton, PA, Dec. 07, 2023 (GLOBE NEWSWIRE) -- While access took the forefront of BMS’ response to Sotyktu (deucravacitinib) not meeting growth expectations during the company’s Q3 earnings call, practicing dermatologists in Spherix research highlight safety as the leading, and growing, barrier to adoption when treating plaque psoriasis. According to the fifth wave of Spherix’s Launch Dynamix™: Sotyktu coverage, which fielded November 1st to the 3rd (n=75 dermatologists), one-third of dermatologists, the highest to date, report concerns regarding safety as the primary barrier to increased adoption of the BMS drug. Additionally, while out-of-pocket costs remain a significant barrier, their prominence has diminished, alongside a decrease in reimbursement difficulties as a barrier over the past three waves.Top of Form
The safety concerns for Sotyktu predominantly revolve around comparisons to the broader JAK class, which includes the TYK-2 inhibiting mechanism of action. There's apprehension surrounding potential side effects and adverse events, notably cardiac incidents, malignancy, thrombosis, and the risk of infection. One participating dermatologist highlights, “even though it's not a direct JAK inhibitor, it still is in that same family. So, I do think the black box warnings for the JAK inhibitors are more heavily pronounced, but it is still something that I have to talk to patients about for Sotyktu. So that's really one of the main hesitations for some patients from starting Sotyktu.”
Despite Sotyktu’s clean label in comparison to the black box warnings attached to traditional JAK inhibitors such as Pfizer’s Xeljanz, AbbVie’s Rinvoq, Eli Lilly’s Olumiant and others, there has been a notable increase regarding prescriber reluctance toward the BMS oral. Specifically, the percent agreeing with the statement, “although Sotyktu did not receive a black box warning, I am hesitant to prescribe Sotyktu to my patients ” is on the rise and is at the highest reported since launch. Furthermore, according to dermatologists participating in the Q4 update of Spherix’s market tracker, RealTime Dynamix™, prescribers appear to be retrenching on initial positive sentiments on the differentiation of TYK2s and JAKs, with the rate of those believing that JAKs and TYK2 inhibitors have the same safety profile nearly doubling over the past quarter alone.
While the manufacturer emphasized access challenges during their recent earnings call, they do appear to be attuned to addressing safety perceptions surrounding their product. Contact rates between BMS sales representatives and healthcare professionals have consistently increased, with the majority now reporting interactions with a Sotyktu representative since launch. Additionally, among those recently detailed, the most spontaneously recalled message centered on the brand's safety and tolerability. However, some physicians expressed reservations about the believability of this messaging, casting doubt on the overall effectiveness of the safety communications being conveyed.
An influential factor in reshaping safety perceptions regarding the oral psoriasis treatment involves BMS’ ongoing long-term-extension (LTE) trial, known as POETYK. Data released from this LTE trial at this years’ European Academy of Dermatology and Venereology Congress in Berlin, Germany showcases maintained clinical response rates and consistent safety metrics, with no increase in the rate of adverse events (AEs) or serious AEs over time, and no new safety signals detected. While only one-third of dermatologists were initially aware of Sotyktu’s POETYK LTE trial results during the early November survey, prompting them led to a significant shift: the majority became notably more comfortable with Sotyktu’s safety, due to the compelling LTE data.
When Sotyktu received FDA approval in September 2022, BMS had an opportunity to usher in a new era in dermatology and potentially beyond. However, their struggle to distinguish themselves from their established JAK counterparts might reverberate throughout the entire TYK class, affecting pipeline treatments like Priovant’s ropsacitinib, Takeda’s TAK-279, and Ventyx Bioscience’s VTX985. Indeed, the latest Q4 RealTime Dynamix™ publication reveals a concerning trend: dermatologists expressing belief in TYK2 inhibitors addressing a significant unmet need in the psoriasis market have hit an all-time low.
While Sotyktu successfully introduced an additional oral option into the psoriasis market, dermatologists are advocating for more choices, specifically more oral alternatives. When asked about the top unmet needs in psoriasis treatment, over half of the respondents highlighted the necessity for additional oral therapies. A significant portion specifically emphasized the desire for safer and more effective oral options than those currently available with Sotyktu and Amgen’s Otezla. This could likely bode well for the current oral assets in the pipeline such as: Johnson & Johnson Innovative Medicine’s (Janssen’s) JNJ-2113, Union Therapeutics’ orismilast, and Meiji Seika Pharma ME3183.
Spherix remains committed to ongoing monitoring of the dynamic plaque psoriasis landscape through its RealTime Dynamix™ series, as well as closely observing the launch and trajectory of Sotyktu through their Launch Dynamix™ service.
RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.
Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.
About Spherix Global Insights
Spherix Global Insights is a leading provider of market research, business intelligence and advisory services to the global life sciences industry. The company’s unique service offerings are powered by deep therapeutic knowledge, the Spherix Network specialty physician panel, and commercially relevant analyses to enable strategic decision-making by our valued customers.
A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology, and ophthalmology.
To learn more about Spherix Global Insights, visit spherixglobalinsights.com or connect through LinkedIn and Twitter.
For more details on Spherix’s primary market research reports and interactive dashboard offerings, visit or register here: https://clientportal.spherixglobalinsights.com
NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorse.
Gianna Melendez, Dermatology Franchise Head Spherix Global Insights (484) 879-4284 [email protected]