Bristol Myers Squibb received approval from the U.S. Food and Drug Administration (FDA) for Sotyktu™ (deucravacitinib) tablets on Sept. 9, 2022. Indicated to treat adults who have moderate-to-severe plaque psoriasis treatable by systemic therapy or phototherapy, it is the first drug in a new therapy class, allosteric tyrosine kinase 2 (TYK2) inhibitors. Dosing is once a day. Plans are to introduce Sotyktu later this month, but pricing is not yet available. It will be available through open distribution. Look here for prescribing information.
At a Glance
- Brand (Generic) Name: Sotyktu (deucravacitinib)
- Manufacturer: Bristol Myers Squibb
- Date Approved: Sept. 9, 2022
- Indication: treatment of adults who have moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy.
- Dosage Forms Available: 6mg oral tablets
- Launch Date: September 2022
- Estimated Annual Cost: Pricing information is not yet available.
- Psoriasis is an autoimmune disease that causes skin cells to grow much faster than normal. As a result, cells build up on the skin’s surface as large, raised spots (plaques). In addition to itchy, painful, reddened skin, patients who have psoriasis also may experience internal organ damage due to inflammation.
- According to the National Psoriasis Foundation NPF), an estimated 8 million Americans have some degree of psoriasis, with about 25% of cases in the moderate-to-severe range. Usually showing symptoms when patients are between 15 years and 25 years of age, it is slightly more common among Caucasians than among other ethnic groups and it affects about equal numbers of men and women.
- Although Sotyktu blocks one of the Janus-associated kinases (JAK) to lessen inflammation, it affects a different pathway than other FDA-approved JAK inhibitors do. It does not require a boxed warning for severe side effects or regular laboratory tests, and it can be used as first-line therapy.
- Two clinical trials tested the effectiveness and safety of Sotyktu against Otezla® (apremilast) tablets, which is taken twice daily, and placebo tablets. After 16 weeks of treatment, over 52% of patients taking Sotyktu showed 75% or greater improvement in Psoriasis Area and Severity Index (PASI 75), versus 35% or 40% of those using Otezla and fewer than 15% of participants taking a placebo.
- In the trials, static Physician’s Global Assessment (sPGA) score of clear or almost clear skin was sustained over 112 weeks for 66.5% of patients taking Sotyktu.
- Nearly 20% of patients taking Sotyktu developed various types of infections during the studies, but only 2.4% stopped treatment due to adverse effects. Other side effects included a rise in blood levels of creatine phosphokinase, which could result from muscle damage.
- Oral JAK inhibitors, such as Rinvoq® (upadacitinib) and Xeljanz®/Xeljanz® XL (tofacitinib), are FDA-approved to treat other inflammatory conditions, but not for psoriasis.
- Several injectable drugs that treat moderate-to-severe plaque psoriasis inhibit interleukins (IL) or tumor necrosis factor (TNF).