NEMLUVIO: A New Treatment Option for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis
NEMLUVIO (nemolizumab-ilto) is a newly approved specialty medication indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults and adolescents aged 12 years and over and for moderate-to-severe nodular prurigo in adults. Systemic treatment is necessary for these indications. NEMLUVIO works by targeting interleukin 31 (IL-31), a cytokine involved in the inflammation and itch associated with these conditions. By blocking IL-31, NEMLUVIO helps to relieve symptoms.
The medication is delivered via a pre-filled pen containing two compartments: one with the powder (active ingredient) and one with the solvent. The solution for injection must be reconstituted before use, following the instructions in the package leaflet. The pen is for single use and delivers 30 mg of nemolizumab subcutaneously. Patients can self-inject, with physician agreement and prior training.
Dosage and Administration
Atopic Dermatitis (AD)
For AD, the recommended dosage is:
- An initial dose of 60 mg (two injections of NEMLUVIO), followed by 30 mg (one injection) every 4 weeks.
- After 16 weeks, if a clinical response is observed, a maintenance dose of 30 mg (one injection) every 8 weeks.
NEMLUVIO can be used with or without topical corticosteroids or topical calcineurin inhibitors (TCIs), with TCIs reserved for sensitive areas like the face, neck, and skin folds.
Prurigo Nodularis
Dosage for prurigo nodularis depends on the patient’s weight:
- Patients weighing less than 90 kg: an initial dose of 60 mg (two injections of NEMLUVIO), followed by 30 mg (one injection) every 4 weeks.
- Patients weighing 90 kg or more: an initial dose of 60 mg (two injections), followed by 60 mg (two injections) every 4 weeks.
Clinical Trial Results
Efficacy in Atopic Dermatitis
Clinical trials, including ARCADIA 1, ARCADIA 2, and ARCADIA CYCLO, have demonstrated the effectiveness of nemolizumab in treating AD. These phase III, randomized, double-blind, and multicenter trials showed that nemolizumab, in combination with topical corticosteroids, was superior to placebo in achieving IGA 0 or 1 responses (improvement of ≥ 2 points), EASI-75, and a reduction in PP-NRS ≥ 4 after 16 weeks of treatment. Improvements in sleep quality (SD-NRS) were as well observed.
Efficacy in Prurigo Nodularis
Two phase III trials (OLYMPIA 1 and OLYMPIA 2) demonstrated the effectiveness of nemolizumab in treating prurigo nodularis. Nemolizumab was superior to placebo, showing significant reductions in pruritus (PP-NRS ≥ 4), overall assessment of nodules (IGA response of 0 or 1 with improvement ≥ 2 points), and improvements in sleep quality (SD-NRS ≥ 4) at weeks 16 and 4.
Ongoing extension studies (OLYMPIA LTE) suggest maintenance of clinical responses up to week 100 with intermittent dosing. A 32-week durability study (SPR.203890) indicated a lower risk of relapse with nemolizumab compared to placebo.
Pharmacoeconomic Analysis and Reimbursement
The Transparency Commission (CT) has issued opinions regarding NEMLUVIO’s coverage. For AD, reimbursement is restricted to second-line treatment – after failure, intolerance, or contraindication to cyclosporin. For prurigo nodularis, NEMLUVIO has been granted an important medical service rendered (SMR) and a moderate added medical service rendered (ASMR III), indicating a partially unmet medical need.
Important Safety Information
NEMLUVIO requires additional monitoring to identify potential safety concerns. Healthcare professionals should report any suspected adverse reactions. Reporting information can be found here. Prior to initiating treatment, vaccination status should be reviewed and updated as needed. Signs of asthma exacerbation should be monitored during treatment.
Practical Considerations
NEMLUVIO is supplied as a single-use pre-filled pen with separate compartments for the powder and solvent. The solution must be reconstituted before injection. The pen should be stored in the refrigerator (2°C to 8°C) and removed 30-45 minutes before reconstitution. Once reconstituted, the solution should be used within 4 hours.
The injection should be administered subcutaneously in the upper front thigh or abdomen, rotating injection sites. The injection process involves gently pressing the pen until a click is heard and holding for 15 seconds.
Administrative Details
- List I medication
- Prescription required, reserved for specialists in allergology, dermatology, internal medicine, or pediatrics.
- Reimbursable at 65% with an exceptional medication prescription.
- Public price: 2,007.43 euros