Aided by "Clean" FDA Label, US Dermatologists Report BMS' Sotyktu Has Potential to Delay Biologic Treatment in Plaque Psoriasis, According to Spherix Global Insights

Amgen's Otezla likely to face the most immediate impacts of increased Sotyktu adoption

EXTON, Pa., Dec. 8, 2022 /PRNewswire/ -- On September 9, 2022, BMS announced the FDA approval of Sotyktu for moderate-to-severe plaque psoriasis (PsO), making it the first selective TKY2 inhibitor available in the US to treat the disease. In October 2022, Spherix began tracking the launch of Sotyktu as part of their Launch Dynamix™ series in which approximately 75 US dermatologists provide monthly perspectives on their use and perceptions of Sotyktu in PsO.

While Sotyktu's mechanism of action (MOA) is part of the broader JAK family of proteins involved in the inflammation and autoimmune signaling pathways, it differs from other FDA-approved JAKs due to its specific targeting of the TYK2 signal. The narrowing of activity provides a more attractive safety and side effect profile than what is associated with other members of the JAK class, which carry warnings for increased risk of serious heart-related events, cancer, blood clots, and death. As such, to the surprise of many community-level dermatologists, BMS' brand was approved without the dreaded black box warning that accompanies the other US inflammatory JAK approvals (Pfizer's Xeljanz, Eli Lilly's Olumiant, AbbVie's Rinvoq, Pfizer's Cibinqo, Incyte's Opzelura, etc).

Spherix's launch coverage of Sotyktu reveals that at just two months post-launch, the brand is off to a positive start, with dermatologists excited about the newest addition to their PsO armamentarium. Over one-third of dermatologists report already prescribing the drug to their PsO patients, and current and future initiations are highly positive. The "clean" label is certainly aiding in favorable brand perceptions. As one dermatologist noted, "[Sotyktu] is going to be an effective agent and perhaps, since it does not have a black box warning as the other JAK inhibitors, I'm looking a little more favorably."

All current Sotyktu users report satisfaction with the agent and the majority are extremely satisfied, which is attributed mostly to the agent's efficacy, safety, and oral administration. Indeed, the leading reasons for Sotyktu initiation include the desire to trial the product, patient severity, and the oral administration, though one-tenth specifically call out the brand's safety as a primary driver of use.

Rationale behind Sotyktu trial may be to the detriment of the only other oral advanced systemic agent in PsO, Amgen's Otezla. When put head-to-head against Otezla, dermatologists perceive Sotyktu as outperforming on overall efficacy and the MOA. Interestingly, the two oral products are perceived similarly on overall tolerability, though at this point post-launch, Otezla maintains a clear competitive edge on safety and access.

When it comes to the potential erosion of Otezla, one-third of recent Sotyktu patients would have been placed on Otezla had the TYK2 not been available. Additionally, a subset of dermatologists note they will switch a substantial percentage of current Otezla patients to the newest entrant, with one community dermatologist specifically stating:

"The most compelling thing is that I'm convinced by some of the studies that it's going to work better, at least equally as well as Otezla and probably better. I [also] think it could be a bit easier on the GI tract than Otezla. So given those two advantages, I might as well use it where I previously used Otezla. I also will probably switch some patients from Otezla."

Dermatologists are still trying to figure out exactly where Sotyktu will fit in the PsO treatment algorithm.

When specifically queried on likely positioning, dermatologists are largely divided between prescribing Sotyktu instead of Otezla but immediately before a biologic and prescribing Sotyktu after Otezla but prior to biologics. In either scenario, use of biologics will be delayed, if they are even needed at all.  Indeed, in the Q4 update of Spherix's companion service RealTime Dynamix™: Plaque Psoriasis, 40% of dermatologists agreed that the availability of Sotyktu and pending development/entry of other TYK2 inhibitors would likely delay the onset of biologics. Furthermore, dermatologists perceive Sotyktu and AbbVie's Humira, one of the most commonly prescribed first-line agents for psoriasis, to have similar overall efficacy.

Despite the favorable label and positive experiences among early adopters, BMS may still have their work cut out for them. There remains a subset of dermatologists that are hesitant of the safety profile, associating Sotyktu with the broader JAK class. Furthermore, nearly half of sampled dermatologists have yet to be visited by a BMS/Sotyktu sales representative, and awareness and education of the new MOA and messaging on the safety profile will be key for increased adoption. Overall, dermatologists' opinions on the general Sotyktu launch execution are largely neutral; as one respondent disclosed, "I would say that I haven't seen anything that would set [BMS] apart."

About Launch Dynamix™

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 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.

Spherix Global Insights Contacts:

Gianna Melendez, Dermatology Franchise Head
[email protected]

Scott Upham, Corporate Communications
[email protected]

SOURCE Spherix Global Insights