Deucravacitinib

SOTYKTU

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What it isAllosteric TYK2 inhibitor acting at the regulatory domain; plaque psoriasis.

Why this oneIts TYK2 selectivity avoids broad JAK inhibition and the class boxed warning carried by JAK inhibitors.

What limits itInfections, herpes reactivation, and liver-enzyme elevations require attention; long-term safety is still accruing.

FDA label

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FDA dosing	Population	Start	Target	Max
Plaque psoriasis (moderate-to-severe, candidates for systemic therapy or phototherapy)	Adults	6 mg QD	6 mg QD	6 mg QD
Psoriatic arthritis (active)	Adults	6 mg QD	6 mg QD	6 mg QD

Renal No adjustment needed (mild, moderate, severe, or ESRD on dialysis)

Hepatic Mild-moderate (Child-Pugh A/B): no adjustment. Severe (Child-Pugh C): not recommended

Instructions

With or without food; do not crush, cut, or chew tablets
Evaluate for active and latent TB before initiation; do not give with active TB; treat latent TB first
Complete all immunizations per current guidelines before starting; avoid live vaccines during treatment

Cautions

Hypersensitivity reactions incl. angioedema — discontinue if clinically significant
Infections (serious, incl. pneumonia, COVID-19; herpes virus reactivation): avoid with active/serious infection; interrupt until resolved
Tuberculosis: evaluate before treatment
Malignancies incl. lymphomas observed — weigh benefit/risk with prior malignancy
Rhabdomyolysis/elevated CPK — discontinue if markedly elevated CPK or myopathy
Laboratory abnormalities: periodic triglycerides; liver enzymes with known/suspected liver disease
Avoid live vaccines
Potential class risks of JAK inhibition (mortality, MACE, thrombosis, malignancy observed with a JAK inhibitor vs TNF blockers in RA; hypoglycemia in diabetics) — TYK2 relationship unknown

Adverse reactions

>=1%: upper respiratory infections, increased blood CPK, herpes simplex, mouth ulcers, folliculitis, acne

Pregnancy Insufficient human data; no embryo-fetal effects in rats/rabbits at exposures at least 72x MRHD

Lactation No human data; present in rat milk (likely present in human milk) — weigh benefits of breastfeeding against maternal need and infant risk

NO BOXED WARNINGS

Principal riskLong-term safety still accruing