How long can I take Sotyktu for?
Sotyktu is an oral tablet given daily that has been shown to work for at least 2 years in plaque psoriasis studies. It is meant to be taken on a daily basis, but how long you take this medicine will depend on your individual response to treatment. Continue your treatment as long as recommended by your healthcare provider.
Long-term Efficacy Studies of Sotyktu
Following the 52-week POETYK PSO trials, patients could enroll in the longer-term POETYK PSO-LTE trial and receive open-label Sotyktu 6 mg once daily.
- The POETYK PSO long-term extension (LTE) trial showed that effectiveness lasted throughout two years of treatment in adult patients with moderate to severe plaque psoriasis.
- At week 112 of the LTE study, patients showed 82% for Psoriasis Area and Severity Index (PASI) 75, 55% for PASI 90 and 67% for static Physician's Global Assessment (sPGA) 0/1.
- A PASI 75 or PASI 90 score indicates a 75% reduction or 90% reduction, respectively, in disease severity and a significant improvement in psoriasis (extent of skin coverage of the psoriasis, discoloration, thickness, and scaling). PASI is a score used by doctors to determine the effectiveness of psoriasis treatments.
- Also, at week 112 (over 2 years), the static Physician's Global Assessment (sPGA) 0/1 was determined to be 67%, meaning the average of all skin lesions were clear (0) or almost clear (1).
How fast does it work?
Sotyktu has been shown to be effective in 16 weeks when compared to a placebo agent. Of the 262 Sotyktu patients in the long-term analysis, 171 had achieved 75% improvement in skin symptoms (PASI 75) at Week 16 of the POETYK PSO-1 trial, and among these patients, efficacy was maintained for up to 112 weeks (over 2 years) including response rates for:
- PASI 75 (Week 16, 100%; Week 52, 90.1%; Week 112, 91.0%)
- PASI 90 (Week 16, 62.6%; Week 52, 64.9%; Week 112, 63.0%)
- sPGA 0/1 (Week 16, 84.2%; Week 52, 73.7%; Week 112, 73.5%)
What does Sotyktu treat and how do you take it?
Sotyktu is used in adults 18 years and older to treat moderate-to-severe plaque psoriasis that is a candidate for systemic therapy or phototherapy. The recommended dosage is 6 mg taken orally once daily, with or without food. Be sure not to cut, crush, or chew the tablets because it can affect how this medication is absorbed and works.
This medicine is safe to take if you have kidney problems or mild-to-moderate liver problems. If you have severe liver disease, you may not be able to use this medicine.
Tell your doctor and pharmacist about all of the medications you take, including prescription, over-the-counter (OTC), vitamins or herbal or dietary supplements. You may not be able to use certain other immunosuppressant medicines or live vaccines with Sotyktu.
Sotykto (deucravacitinib) is manufactured by Bristol Myers Squibb’s and was first approved in September 2022.
Always take Sotyktu, pronounced "soh-tik-too", exactly as prescribed by your healthcare provider.
Related questions
- Sotyktu vs Otezla: How do they compare?
- How long does it take for Sotyktu to work?
- How is Sotyktu given / administered?
Are side effects common with Sotyktu?
The most common side effects seen in at least 1% of patients in clinical studies were:
- upper respiratory infections, like the common cold, sore throat, and sinus infection (19.2%)
- increased blood creatine phosphokinase (2.7%), which may indicate muscle damage. Report any unexplained muscle pain, tenderness or weakness to your doctor right away.
- cold sores (2%)
- canker sores (1.9%)
- inflamed hair pores (1.7%)
- acne (1.4%)
Warnings and precautions include allergic reactions (some may be serious), increased risk of infections, increased risk of developing malignancies including lymphomas; increased risk of developing rhabdomyolysis (severe muscle damage), and changes in laboratory values.
Learn more: Side Effects and Warnings with Sotyktu (in more detail)
How does Sotyktu work?
Sotyktu works by blocking an immune system enzyme (protein) called TYK2 that can lead to the inflammation (swelling, redness) seen in plaque psoriasis. Blocking TYK2 may improve psoriasis symptoms and lead to clearer skin. Symptoms of psoriasis include pain, itching, stinging, burning, and skin tightness.
- Sotyktu (deucravacitinib) is classified as a selective, allosteric tyrosine kinase 2 (TYK2) inhibitor. It was the first agent approved in this class.
- TYK2 is a kinase that activates the cytokines IL-23, IL-12 and Type I IFN in the body. These cytokines are naturally occurring proteins found in the immune system that activate the inflammation from plaque psoriasis.
Does Sotyktu work for scalp psoriasis?
Yes, studies have shown that Sotyktu is effective for psoriasis that occurs on the scalp when compared to Otezla (apremilast), another oral psoriasis treatment and a placebo (an inactive treatment).
- The effect of treatment on scalp psoriasis is measured using the scalp severity PGA (ss-PGA) score of 0 (clear) or 1 (almost clear).
- In a clinical study, 70% of people taking Sotyktu had a clear or almost clear scalp at 16 weeks compared to 39% of people taking Otezla and 17% taking a placebo.
- In another study, 60% of people taking Sotyktu had a clear or almost clear scalp at 16 weeks compared to 37% of people taking Otezla and 17% taking a placebo.
This is not all the information you need to know about Sotyktu (deucravacitinib) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss any questions you have with your doctor or other health care provider.
References
- New Two-Year Deucravacitinib Data Reinforce Durable Efficacy and Consistent Safety Profile in Treatment of Moderate to Severe Plaque Psoriasis. Drugs.com. Accessed Jan. 17, 2023 at https://www.drugs.com/clinical_trials/new-two-year-deucravacitinib-data-reinforce-durable-efficacy-consistent-safety-profile-moderate-20139.html
- Bristol Myers Squibb Announces New Sotyktu (deucravacitinib) Long-Term Data Showing Clinical Efficacy Maintained for Up to Two Years with Continuous Treatment in Moderate-to-Severe Plaque Psoriasis. Sept. 10, 2022. Drugs.com. Accessed Jan 17, 2023 at https://www.drugs.com/clinical_trials/bristol-myers-squibb-announces-new-sotyktu-deucravacitinib-long-term-data-showing-clinical-efficacy-20396.html
- Sotyktu (deucravacitinib) prescribing information. Sept. 2022. Bristol-Myers Squibb. Princeton, New Jersey. Accessed Jan 17, 2023 at https://packageinserts.bms.com/pi/pi_sotyktu.pdf
- Sotyktu.com. Study results. Bristol-Myers Squibb. Accessed Jan 17, 2023 at https://www.sotyktu.com/about-sotyktu/study-results
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