Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 6 mg) |
Drug Class | Tyrosine kinase 2 (TYK2) inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
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Summary
- Sotyktu (deucravacitinib) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Deucravacitinib significantly increased the achievement of PASI 75 compared to placebo (RR 5.7; 95% CI 4.32-7.53; P<0.001) and improved ss-PGA 0/1 (RR 3.86; 95% CI 3.02-4.94; P<0.001) and DLQI 0/1 (RR 3.89; 95% CI 2.89-5.22; P<0.001).
- Compared to apremilast, deucravacitinib (at various dosages) showed superior efficacy in PASI 75, sPGA 0/1, PASI 90, PASI 100, and DLQI 0/1 at week 16.
- Tofacitinib (15 mg BID) had a higher probability of achieving PASI 75 compared to deucravacitinib (12 mg QD), with similar trends observed in PGA response rates.
- The incidence of serious adverse events (SAEs) was similar between deucravacitinib and placebo groups, and deucravacitinib was generally well-tolerated with a low and balanced incidence of adverse events (AEs), SAEs, and AE-related treatment discontinuations across groups.
- Deucravacitinib did not lead to a higher incidence of AEs than apremilast (30 mg BID), and among JAK inhibitors, deucravacitinib (6 mg BID and 12 mg QD) was non-inferior in safety compared to placebo, with tofacitinib (2 mg BID) ranked highest for safety.
- The reviewed studies primarily focus on adult patients with moderate-to-severe psoriasis, predominantly male (70.2%), with a mean age of 45.4 years, and a significant proportion had a history of scalp psoriasis; deucravacitinib significantly decreased disease severity and improved quality of life in this population without a concerning increase in the incidence of serious adverse events.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Sotyktu (deucravacitinib) prescribing information. | 2022 | Bristol-Myers Squibb Company Princeton, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Deucravacitinib for moderate-to-severe psoriasis: a systematic review and meta-analysis of randomized controlled trials. | 2024 | Journal of Drugs in Dermatology |
Oral small-molecule tyrosine kinase 2 and phosphodiesterase 4 inhibitors in plaque psoriasis: a network meta-analysis. | 2023 | Frontiers in Immunology |
The efficacy and safety of tyrosine kinase 2 inhibitor deucravacitinib in the treatment of plaque psoriasis: a systematic review and meta-analysis of randomized controlled trials. | 2023 | Frontiers in Medicine |
The efficacy and safety of tofacitinib, peficitinib, solcitinib, baricitinib, abrocitinib and deucravacitinib in plaque psoriasis - a network meta-analysis. | 2022 | Journal of the European Academy of Dermatology and Venereology |