DEUCRAVACITINIB TAB
Clinical Criteria Summary
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Indication & Patient Population
- Treatment of moderate to severe plaque psoriasis (PsO) in adults who are candidates for systemic therapy or phototherapy.
- Not recommended for use in combination with other potent immunosuppressants.
Pretreatment Evaluation & Screening
- Tuberculosis (TB) screening required; initiate TB treatment prior to deucravacitinib if positive. Do not initiate in patients with latent or active TB infection.
- Update immunizations.
- Consider hepatitis B or C screening; not recommended for patients with active hepatitis B or C.
- Consider baseline triglyceride levels.
- Obtain baseline liver enzymes; not recommended for severe hepatic impairment (Child-Pugh C).
- Consider baseline creatine phosphokinase (CPK) (US prescribing information does not recommend routine baseline CPK).
Monitoring During Therapy
- Monitor triglyceride levels per clinical guidelines for hyperlipidemia.
- Monitor liver enzymes in patients with known or suspected liver disease per routine patient management.
- Consider checking CPK periodically or in patients with suspected/diagnosed myopathy; discontinue deucravacitinib if CPK becomes markedly elevated.
Dosing & Administration
- Recommended dose: 6 mg orally once daily with or without food.
- Do not crush, cut, or chew tablets.
- Dosage form: Film-coated tablets, 6 mg in bottles of 30.
Special Populations & Dose Adjustments
- Renal impairment: No dosage adjustments required.
- Hepatic impairment: No adjustments for mild (Child-Pugh A) or moderate (Child-Pugh B). Not recommended for severe (Child-Pugh C) hepatic impairment.
Safety, Contraindications & Precautions
- Contraindication: Hypersensitivity.
- Warnings/Precautions: Infections, herpes viral reactivation, TB, malignancy including lymphomas, rhabdomyolysis and elevated CPK, triglyceride elevations, liver enzyme elevations, update immunizations (avoid live vaccines during treatment), potential JAK inhibitor-related adverse reactions.
- Lacks boxed warnings for serious infections, mortality, major adverse cardiovascular events (MACE), malignancy excluding nonmelanoma skin cancer, and thrombosis (insufficient evidence to determine if TYK2 inhibition increases these risks).
- No increased risk of serious/opportunistic infections, mortality, MACE, thrombosis, liver injury, or GI perforation reported.
- No hematologic adverse events; monitoring for cytopenias is not required.
Place in Therapy & Comparative Considerations
- Not restricted to patients with disease not adequately controlled by other systemic drugs including biologics or when those therapies are inadvisable.
- Superior to apremilast for scalp psoriasis; numerically better for fingernail psoriasis.
- Requires monitoring of triglycerides, liver enzymes, and CPK (unlike apremilast, which requires no lab monitoring except potential age-related renal function checks).
- Offers oral administration convenience similar to other small molecules.
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Exclusion Criteria
- Uncontrolled active infection, including undrained abscess (may start/restart once controlled)
- Untreated latent or active tuberculosis infection
- Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis
- Untreated active hepatitis C
- Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients may be treated)
- Malignancy within the previous 5 years other than successfully treated nonmelanoma skin cancer or successfully treated cervical cancer (unless treating dermatologist and oncologist agree risk-benefits favor use)
- Severe hepatic impairment (Child-Pugh C)
- Concomitant therapy with other potent immunosuppressants
- Concomitant live or live-attenuated vaccines or administration of non-live or live vaccines less than 2 weeks before initiation
Inclusion Criteria
- Diagnosis of moderate to severe plaque psoriasis
- Prescribed and monitored by a VA / VA Community Care dermatologist or locally designated psoriasis expert
- Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay (IGRA)
- Completed liver enzyme tests
- Methotrexate monotherapy is medically inadvisable, not tolerated, or inadequate (NO treatment benefit after 3 months, with at least 2 months at standard target dose of 15–25 mg ONCE WEEKLY PO/SC/IM, or inadequate response after 6 months)
- Phototherapy is medically inadvisable, unavailable, unfeasible, or inadequate (NO treatment benefit after 12 treatments or inadequate response after 24 treatments)
- Three targeted systemic antipsoriatic drugs (≥ 1 drug per class) are medically inadvisable, not tolerated, or not adequate: Inhibitors of TNF, IL-17 (ixekizumab preferred), IL-23 (e.g., risankizumab), IL-12/23 (ustekinumab), or PDE-4 (apremilast)
Additional Inclusion Criteria
- If HBsAg-negative but antibody-to-hepatitis-B-core-antigen (anti-HBc)-positive: Consultation with a GI/liver or infectious diseases expert for advice on antiviral prophylaxis or preemptive monitoring for HBV reactivation
- For patients who can become pregnant: Counseling provided on potential risks vs benefits and use of effective contraception
Supplemental Clinical Considerations & Trial Requirements
- TB Testing: Routine retesting not required for prescription renewals; consider retesting in high-risk patients (e.g., highly endemic areas)
- Methotrexate: Refer to contraindications/risks for serious adverse events; use lower than target doses if limited by toxicity
- Phototherapy Inadvisability: Includes confirmed history of skin cancer/melanoma or strong likelihood of developing them (e.g., Fitzpatrick skin type I or II)
- PDE-4 Inhibitor (Apremilast): NO treatment benefit after 4 months or inadequate response after 6 months; medically inadvisable if too low likelihood of lesion clearance for disease severity, patient averse to injections, or unacceptable risk of weight loss/depression/suicidality
- TNF Inhibitor: NO response after 12 weeks with ONE TNFI; inadequate response after 12-week trials of TWO TNFIs for total 24 weeks; or loss of initial response. Medically inadvisable due to heart failure, demyelinating disease, multiple sclerosis in first-degree relative, lupus, recurrent/serious infections
- IL-17A Inhibitor: NO response after 12 weeks, inadequate/partial response after 24 weeks, or loss of initial response. Medically inadvisable due to inflammatory bowel disease and severe/recurrent Candida infections
- IL-23 Inhibitor: NO response after 16 weeks, inadequate/partial response after 34 weeks, or loss of initial response. Medically inadvisable due to liver cirrhosis in patients with comorbid Crohn’s disease
- IL-12/23 Inhibitor (Ustekinumab): NO response after 16 weeks, inadequate/partial response after 32 weeks, or loss of initial response. Medically inadvisable due to history of noninfectious pneumonia (e.g., interstitial, eosinophilic, cryptogenic organizing)
- Injection Aversity/Barriers: Aversity to injections or barriers to in-clinic administration adjudicated case-by-case as medically inadvisable
- HBV Reactivation Management: For anti-HBc-positive patients, presence of anti-HBs does not guarantee protection; evidence is insufficient to support using anti-HBs titers to decide on antiviral prophylaxis