NEMOLIZUMAB-ILTO INJ,LYPHL
Clinical Criteria Summary
Document 691
Exclusion Criteria
- Use of live vaccines during therapy
Core Inclusion Criteria
- Documented clinical diagnosis of prurigo nodularis for ≥ 6 months with ≥ 20 prurigo nodularis lesions on the body bilaterally
- Documented patient-reported, moderate-to-very severe itching related to prurigo nodularis within the past 4 weeks
- Prescribed and monitored by a VA / VA Community Care dermatologist or a locally designated expert in consultation with a VA / VA Community Care dermatologist
- Inadequate response or intolerance to one of the following topical therapies (unless medically inadvisable): higher potency (Group 1–3) topical corticosteroid (≥ 2 weeks), pimecrolimus (≥ 12 weeks), or calcipotriene (≥ 8 weeks)
- An oral antihistamine, doxepin, or amitriptyline is medically inadvisable, not tolerated, or not adequate (after ≥ 2 weeks)
- Phototherapy is medically inadvisable, not available, not feasible, not tolerated, or not adequate
- Completed all age-appropriate vaccinations as per current immunization guidelines (preferably ≥ 2 weeks before initiating therapy)
Additional Inclusion Criteria (Select If Applicable)
- For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy.
- For patients who are lactating / providing breastmilk to an infant or planning to do so: Counseling provided on the potential risks vs benefits of treatment.
Phototherapy Parameters & Definitions
- Considered inadequate if NO treatment benefit after 12 treatments or inadequate partial response after 24 treatments.
- Medically inadvisable reasons include (and are not limited to) CONFIRMED (preferably by a written biopsy report) history of skin cancer, melanoma, or strong likelihood of developing them (e.g., Fitzpatrick skin type I or II = pale skin, easily sunburns).
Document 692
Indication & Patient Population
- Treatment of adults with prurigo nodularis (PN)
- Documented clinical diagnosis of PN
- ≥ 20 bilateral PN nodules
Dosing Requirements
- Body Weight < 90 kg: 60 mg (two 30-mg injections) SC then 30 mg every 4 weeks
- Body Weight ≥ 90 kg: 60 mg (two 30-mg injections) SC then 60 mg every 4 weeks
Prior Therapy Criteria
- Inadequate response (after ≥ 2 weeks per therapy) or intolerance to either:
- Two topical therapies (e.g., corticosteroids, calcipotriene, or calcineurin inhibitor) OR
- One topical therapy and an intralesional corticosteroid
- Unless these therapies are medically inadvisable
Safety & Contraindications
- Known hypersensitivity to drug or excipients
- Avoid use of live vaccines during treatment
Treatment Monitoring & Trial Duration
- Onset of Treatment: Week 4 based on PP-NRS–4 and IGA-0/1 responder rates
- Duration of an Adequate Therapeutic Trial: Peak responder rate was not reached by Week 16 based on PP-NRS–4 and IGA-0/1
Document 751
Diagnosis & Provider Requirements
- 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 locally designated expert in the management of atopic dermatitis in consultation with a VA/VA Community Care dermatologist, allergist, or immunologist.
Disease Severity & Treatment History
- 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.
Concomitant Therapy & Monotherapy Considerations
- Used concomitantly with topical corticosteroids and/or topical calcineurin inhibitors initially until disease has sufficiently improved, then topical therapies may be discontinued.
- If topical therapies are medically inadvisable, there is a lack of evidence to support use of nemolizumab monotherapy.
Special Populations & Counseling Requirements
- 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 plan to do so: Counseling provided on the potential risks vs benefits of treatment.
Exclusion Criteria
- Use of live (attenuated) vaccines during treatment with nemolizumab-ilto.
- Concurrent use with therapeutic biologics unless potential risk-benefits favor use.
Dosing & Sequencing Guidelines
- Initial dose: 60 mg then 30 mg every 4 weeks.
- Maintenance dose (after 16 weeks for patients who achieve clear or almost clear skin): 30 mg SC every 8 weeks.
- First-line therapy options include dupilumab, tralokinumab-ldrm, lebrikizumab-lbkz, or nemolizumab-ilto.
- Second-line therapy options include abrocitinib or upadacitinib.
- Methotrexate, azathioprine, and mycophenolate mofetil may be considered with shared decision-making based on lower certainty of risk-benefits, slow onset, feasibility of adhering to follow-ups for laboratory monitoring, comorbidities, and patient values/preferences.
Document 752
Indication & Patient Population
- Adults and pediatric patients ≥ 12 years of age with moderate-to-severe atopic dermatitis
- Disease not adequately controlled with topical prescription therapies
- Used in combination with topical corticosteroids and/or calcineurin inhibitors
- Associated pruritus (PP-NRS ≥ 4; Pruritus VAS score ≥ 50)
Dosage & Administration
- Initial therapy: 60 mg (two 30-mg injections) SC, followed by 30 mg SC every 4 weeks
- Maintenance therapy: For patients who achieve clear or almost clear skin after Week 16, recommended dose is 30 mg SC every 8 weeks
- Discontinue use of topical therapies after disease has sufficiently improved
Pretreatment Requirements & Screening
- Complete all age-appropriate vaccinations per current immunization guidelines prior to initiating treatment
- No recommendations for infection, tuberculosis, or hepatitis B virus screening
Monitoring & Safety Considerations
- Monitor for hypersensitivity reactions
- For patients taking CYP450 substrates (particularly narrow therapeutic index), monitor for effect or drug concentration and modify dosage of the substrate after initiating or discontinuing nemolizumab-ilto
- Higher body weight (>87 kg vs <62 kg) reduces systemic drug exposure, which may impact Investigator Global Assessment of skin lesion response but not pruritus improvement
Contraindications & Warnings
- Contraindicated in patients with known hypersensitivity
- Warning for hypersensitivity reactions
- Avoid use of live vaccines during treatment
Special Populations & Organ Function
- Pregnancy: Insufficient data; may be transferred from mother to fetus. Consider delaying live virus immunizations in exposed infants by a minimum of 3 months post-birth based on drug half-life.
- Lactation: Insufficient data; weigh potential risks vs benefits.
- Geriatric (≥65 years): Insufficient number of patients included in clinical trials to determine differential response.
- Hepatic/Renal Impairment: Mild to moderate impairment shows no clinically significant pharmacokinetic differences. Severe impairment effects are unknown.
VHA Place in Therapy / Utilization Criteria
- Appropriate for patients with moderate-to-severe AD who have an inadequate response to topical prescription therapy (corticosteroids with or without calcineurin inhibitors)
- May be considered for patients experiencing inadequate response or intolerance to anti-IL-4/-13 or anti-IL-13 agents due to novel anti-IL-31 mechanism
- Lacks ocular adverse effects (e.g., conjunctivitis, keratoconjunctivitis) and risk of helminth infections associated with other targeted systemic monoclonal antibodies
- Offers a better safety profile than JAK inhibitors regarding risks of mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis
- Dosing convenience may be favorable due to every 4 or 8 weeks interval compared to every 2 weeks regimens for some alternatives; initial dosing schedule may be simpler than lebrikizumab-lbkz
- Maintenance therapy at 30 mg every 8 weeks represents the lowest cost option among targeted systemic therapies (excluding tralokinumab-ldrm 300 mg every 4 weeks for patients <100 kg); every 4 weeks maintenance has the highest drug cost