TRALOKINUMAB-LDRM INJ,SOLN

Clinical Criteria Summary

Concurrent use of live (attenuated) vaccines or treatment with live (attenuated) vaccines within the previous 4 weeks
Concurrent use with targeted immunomodulators unless potential risk-benefits favor use
Untreated parasitic (helminth) infection

Diagnosis of chronic atopic dermatitis made or confirmed by a VA / VA Community Care dermatologist
Prescribed by a VA / VA Community Care dermatologist, allergist, immunologist, or other designated expert in the management of atopic dermatitis in consultation with a VA / VA Community Care dermatologist, allergist, or immunologist
Offered all age-appropriate vaccinations prior to initiating therapy
Assessment of moderate to severe atopic dermatitis in the last 2 weeks as determined by either a gestalt assessment of “moderate” or “severe” OR Eczema Area and Severity Index (EASI) ≥ 16
Refractory to ≥ 2 drug classes of topical therapies for atopic dermatitis (e.g., corticosteroids, calcineurin inhibitors, PDE4 inhibitors, JAK inhibitors) for ≥ 4 weeks total unless the therapy is medically inadvisable or not tolerated

For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy
For females who are breastfeeding/providing breastmilk to an infant: Counseling provided on potential risks vs benefits of treatment

If patient weighs < 100 kg, consider tralokinumab prior to dupilumab
First-line therapy options include dupilumab, tralokinumab-ldrm, lebrikizumab-lbkz, or nemolizumab-ilto
Second-line therapy options include abrocitinib or upadacitinib
Consider offering methotrexate, azathioprine, or mycophenolate mofetil in the context of shared decision-making (prior trials not required), with use conditional on risk-benefit certainty, onset speed, follow-up feasibility, comorbidities, and patient preferences

When possible, vaccinations should be updated before initiating therapy
Unless contraindicated, recombinant zoster (SHINGRIX) vaccine should be completed or at least initiated by the end of the first year of treatment, preferably when dosage is low, disease is stable, or at other times when a robust immune response to vaccination can be expected

• Treatment of moderate to severe atopic dermatitis (AD) in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
• Can be used with or without topical corticosteroids (TCSs).

• Update vaccinations prior to initiation.
• Treat pre-existing helminth infections before initiating therapy.
• No pretreatment screening recommended for tuberculosis, hepatitis B, hepatitis C, or HIV.

• Initial dose: 600 mg (four 150-mg injections) subcutaneously (SC).
• Maintenance dose: 300 mg (two 150-mg injections) SC every 2 weeks (Q2W).
• Dose reduction option: For patients weighing less than 100 kg who achieve clear or almost clear skin after 16 weeks of treatment, a maintenance dose of 300 mg SC every 4 weeks (Q4W) may be considered.
• Formulation: 150 mg/mL in single-dose prefilled syringes (PFS).

• Appropriate for patients with severe AD who have an inadequate response or intolerance to prescription topical therapies, phototherapy (only if available, feasible, and not medically inadvisable), and/or conventional synthetic immunomodulators.
• May be considered for patients with severe AD who have an inadequate response or contraindication to cyclosporine A.
• Dosing frequency reduction from Q2W to Q4W should only be considered after weighing the potential risk of loss of response and acknowledging a lack of data on recapturing response upon returning to Q2W dosing.

• Contraindicated in patients with hypersensitivity to tralokinumab-ldrm.
• Monitor for conjunctivitis and keratitis.
• Avoid use of live vaccines due to risk of infection.
• Insufficient data to determine age-related differences in efficacy or safety for geriatric populations.