LEBRIKIZUMAB-LBKZ INJ,SOLN

Clinical Criteria Summary

Use of live (attenuated) vaccines immediately prior to or during treatment
Concurrent use with therapeutic biologics 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, or immunologist, or other locally 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 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 pregnant or plan to become pregnant: Counseling provided on potential risks vs benefits of treatment
For females who are lactating/providing breastmilk to an infant or planning to do so: Counseling provided on the potential risks vs benefits of treatment

Consider tralokinumab-ldrm prior to lebrikizumab-lbkz if patient weighs <100 kg
First-line therapy options include dupilumab, tralokinumab-ldrm, lebrikizumab-lbkz, or nemolizumab-ilto; second-line includes abrocitinib or upadacitinib
Consider offering methotrexate, azathioprine, or mycophenolate mofetil in the context of shared decision-making (prior trials not required), conditional on risk-benefit certainty, onset speed, follow-up feasibility, comorbidities, and patient values/preferences
Unless contraindicated, recombinant zoster vaccine should be completed or at least initiated by the end of the first year of treatment

Treatment of adults with moderate-to-severe atopic dermatitis (AD) 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 (TCS).

Induction: 500 mg subcutaneous (SC) at Weeks 0 and 2, then 250 mg SC every 2 weeks until Week 16 or later when adequate clinical response is achieved.
Maintenance: 250 mg SC every 4 weeks.

Monitor for adverse reactions including conjunctivitis and keratitis, injection site reactions, and herpes zoster.
No laboratory test monitoring recommendations.
Contraindicated in patients with hypersensitivity.
Warnings include hypersensitivity, conjunctivitis and keratitis, parasitic (helminth) infections, and avoidance of live vaccines during treatment.

May be used for patients with moderate-to-severe AD who are refractory to ≥ 2 classes of topical therapies for ≥ 4 weeks total unless medically inadvisable or not tolerated.
May be considered as an alternative to dupilumab and tralokinumab-ldrm based on a favorable efficacy-safety-cost profile.
Biologics are recommended when there is refractoriness, intolerance, or inability to use mid- to high-potency topical therapies.