ABROCITINIB TAB
Clinical Criteria Summary
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Exclusion Criteria
- Uncontrolled active infection (may start/restart once treatment for infection is initiated)
- Untreated latent or active tuberculosis
- Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting prophylaxis)
- Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients may be treated)
- Congenital or acquired immunodeficiency
- Malignancy in the previous 5 years other than successfully treated nonmelanoma skin cancer or cervical cancer (unless dermatologist and oncologist agree risk-benefits favor use)
- Thrombosis or major adverse cardiovascular events where potential harms outweigh anticipated benefits
- Platelets < 150,000/mm3, lymphocytes < 500 cells/mm3 confirmed by repeat testing, neutrophils < 1000 cells/mm3, or hemoglobin < 8 g/dL (may start/restart once values normalize)
- Severe renal impairment (eGFR 15–29 mL/min) or end-stage renal disease (eGFR < 15 mL/min)
- Severe hepatic impairment (Child-Pugh class C)
- Concomitant therapy with other JAK inhibitors, biologic DMARDs, other immunosuppressive biologics, or potent immunosuppressants (except during treatment transition; co-use with antirheumatic doses of conventional immunomodulators like methotrexate or leflunomide is acceptable)
- Concomitant therapy with moderate to strong inhibitors of both CYP2C19 and CYP2C9 (e.g., fluconazole)
- Concomitant therapy with strong inducers of CYP2C19 or CYP2C9 (e.g., rifampin)
- Antiplatelet use in the first 3 months except low-dose aspirin (≤ 81 mg/day)
- Pregnancy
- Breastfeeding
Inclusion Criteria
- Diagnosis of chronic atopic dermatitis
- Prescribed and monitored by a VA/VA Community Care dermatologist, immunologist, or allergist, OR a locally designated expert in consultation with a VA/VA Community Care dermatologist
- Assessment of moderate to severe atopic dermatitis within the last 2 weeks (gestalt assessment of “moderate” or “severe” OR EASI ≥ 16)
- Dupilumab, tralokinumab-ldrm, lebrikizumab-lbkz, OR nemolizumab-ilto therapy is medically inadvisable, not tolerated, not adequate, or lost response
Laboratory & Screening Requirements
- Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay (IGRA)
- Completed hepatitis B screening (HBsAg, total antibody to hepatitis B core antigen [anti-HBc], and antibody to hepatitis B surface antigen [anti-HBs])
- Current or past completion of hepatitis C screening (may initiate while waiting for results)
- Routine retesting not required for prescription renewals; retesting in high-risk patients should be considered
Vaccination & Infection Management
- Offered all age-appropriate vaccinations prior to initiating therapy
- Administration of live or live-attenuated vaccines within 2 weeks before initiation is excluded
- When possible, update vaccinations before initiation; recombinant zoster vaccine should be completed or initiated by end of first year (preferably when dosage is low, disease stable, or immune response robust)
Prior Therapy Requirements
- If biologic agents are contraindicated, therapies required prior to those biologics must still be tried before abrocitinib
Special Populations & Counseling
- For females who can become pregnant and patients with partners who can become pregnant: Counseling on potential risks vs benefits and use of effective contraception
- For females who are breastfeeding/providing breastmilk: Counseling on potential risks vs benefits
- If HBsAg-negative but anti-HBc-positive and consult deemed indicated: GI/liver or infectious diseases expert consulted for advice on antiviral prophylaxis or preemptive monitoring for HBV reactivation
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Indication & Patient Population
- Treatment of adults with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
Pretreatment Requirements & Screening
- Tuberculosis screening required.
- Viral hepatitis screening required.
- Complete blood count (CBC) required.
- Baseline lipid panel may be considered (not a US Prescribing Information recommendation).
- Guideline-recommended immunizations, including herpes zoster vaccination, should be completed prior to initiating therapy.
Contraindications & Limitations of Use
- Not recommended for use in combination with other JAKIs, biologic immunomodulators, or other immunosuppressants.
- Contraindicated with antiplatelet therapy except for low-dose aspirin (≤ 81 mg daily) during the first 3 months of treatment.
- Not recommended in patients with platelet count < 150,000/mm3, absolute lymphocyte count < 500/mm3, absolute neutrophil count < 1,000/mm3, or hemoglobin < 8 g/dL.
- Not recommended in severe renal impairment (estimated glomerular filtration rate [eGFR] 15–29 mL/min) and end-stage renal disease (eGFR < 15 mL/min).
- Not recommended in severe (Child-Pugh C) hepatic impairment.
- Not recommended in patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV).
Dosing & Administration
- Recommended starting dose: 100 mg orally once daily with or without food.
- If there is an inadequate response after 12 weeks, the dose can be increased to 200 mg once daily.
- Discontinue therapy if there is an inadequate response to 200 mg once daily.
- Dose reduction required for patients with renal impairment per US Prescribing Information.
- Dose reduction required for known or suspected CYP2C19 poor metabolizers.
- Dose reduction required when taking strong inhibitors of CYP2C19.
Monitoring During Treatment
- CBC at 4 weeks after starting therapy and 4 weeks after dose increases to monitor for hematocytopenias, especially thrombocytopenia and lymphopenia.
- Lipid panel approximately 4 weeks after starting therapy, then per clinical guidelines for hyperlipidemia.
- HBV DNA, ALT, AST per guideline recommendations to monitor for HBV reactivation.
- Annual TB screening should be considered for patients in highly endemic areas.
- Monitor patients with inactive HBV for expression of HBV DNA; consult a liver specialist if detected.
Safety Considerations & Warnings
- Boxed warnings include serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis.
- Current or past smokers are at additional increased risk of malignancies and MACE.
- Avoid live vaccines immediately prior to, during, and immediately after therapy.
- Discontinuation or dosage adjustment recommended for hematologic abnormalities per US Prescribing Information.