DELGOCITINIB CREAM,TOP
Clinical Criteria Summary
Document 798
Indication & Patient Population
- Adults with moderate to severe chronic hand eczema (CHE)
- CHE defined as hand eczema persisting for >3 months or returning ≥2 times within the previous 12 months
- Patients who have had an inadequate response to topical corticosteroids, or for whom topical corticosteroids are not advisable
Dosing & Administration
- Apply a thin layer twice daily to affected areas only on the hands and wrists
- Maximum dosage: Do not use more than 30 grams per 2 weeks or 60 grams per month
- Dosage form: Cream 2% (20 mg/g)
Pretreatment Requirements
- Complete any necessary guideline-recommended immunizations, including herpes zoster vaccinations
- Consider viral hepatitis screening prior to initiation
- Consider lipid panel assessment prior to initiation
Monitoring & Safety Warnings
- Monitor for infections
- Monitor for viral hepatitis reactivation
- Monitor for nonmelanoma skin cancer (NMSC)
- Monitor for increases in total cholesterol, low-density lipoprotein, cholesterol, and triglycerides
- Assess for serious infections, immunizations status, and potential risks related to JAK inhibition (mortality, major adverse cardiovascular events, thrombosis, malignancies excluding NMSC)
Contraindications & Precautions
- Not recommended for use in patients with active hepatitis B or hepatitis C
- Insufficient human data for pregnancy; animal studies showed post-implantation loss but no embryofetal toxicity in rabbits, and decreased fetal weight/skeletal variations in rats
- Advise breastfeeding women to avoid direct contact with the nipple and surrounding area immediately after applying to hands/wrists
Therapeutic Positioning & Sequencing
- Positioned after use of moderate-to-high-potency topical corticosteroids, tacrolimus ointment 0.1%, and tapinarof cream 1% (if CHE is the atopic subtype)
Document 813
Exclusion Criteria
- Uncontrolled active infection (may be started/restarted once treatment for the infection is initiated)
- Active hepatitis B or hepatitis C
- Concomitant live or live-attenuated vaccines, or administration of inactivated, live, or live-attenuated vaccines less than 2 weeks before initiation of therapy
Inclusion Criteria
- Prescribed and monitored by a VA/VA Community Care dermatologist or locally-designated expert
- Documented diagnosis of moderate or severe chronic hand eczema (persisted for more than 3 months or returned twice or more in the previous 12 months)
- Offered all age-appropriate vaccinations prior to initiating therapy, including for herpes zoster
- High or super-high potency topical corticosteroid therapy is medically inadvisable, not tolerated, or not adequate (after ≥ 4 weeks)
- Topical tacrolimus ointment 0.1% therapy is medically inadvisable, not tolerated, or not adequate (after ≥ 4 weeks)
Additional Inclusion Criteria
- For atopic subtype chronic hand eczema: Topical tapinarof cream 1% therapy is medically inadvisable, not tolerated, or not adequate (after ≥ 4 weeks)
- Females who are pregnant or planning to become pregnant: Counseling provided on potential risks vs benefits of treatment
- Females who are lactating/providing breastmilk to an infant or planning to do so: Counseling provided on the risks and benefits of treatment