Nemolizumab is a new medication being currently developed by Chugai Pharmaceutical Company. It will be licensed and developed by Galderma Pharma who picked up the rights to it. With the recent ground breaking FDA approval of Dupixent (dupilumab) for eczema, this will help many patients suffering itchy, inflamed dry skin. As with all new biological medication, the price tag is very high for Dupixent, $37,000. With no competitors for the treatment of eczema, the makers of Dupixent, Regeneron can justify the high price of their medication. Currently in the pipeline, nemolizumab, is an anti-IL-31 receptor antibody being studied to treat eczema. Nemolizumab is being specifically studied to treat pruritis (itching) associated with atopic dermatitis. It would be a subcutaneous injection once per month.
IL-31 is involved in a variety of other pruritic skin diseases and it has a large potential to treat itchy skin. In a recent study involving nemolizumab, patients taking the medication over placebo showed significantly less itching and improved sleep in patients with moderate to severe atopic dermatitis. Patients noticed that the itch was gone very quickly and sometimes within days even before the eczema healed.
Even though nemolizumab is a couple of years away from being FDA approved, it is always good for patients and payers to have options for treating atopic dermatitis. Up until the recent approval of dupilumab, the only treatment available for patients with eczema have been topical medications such as steroids, calcineurin inhibitors (Elidel and Protopic) and Eucrisa. But for patients with more severe forms of eczema that is widespread, these new systemic biologics such as dupilumab and possibly nemolizumab, can be game changers for the treatment of atopic dermatitis.
The pricing of nemolizumab will depend on how Dupixent is doing at the time it is approved. Analysts suggest that Dupixent will generate 5 billion annually. Likely though nemolizumab will be priced lower than dupilumab because it won’t be first in class.
If you currently suffer from eczema, speak to your allergist or dermatologist about which current treatment option is best for you.
UPDATE JUNE 14, 2017
A new study published in the New England Journal of Medicine, showed nemolizumab decreases itching and improves eczema in patients with atopic dermatitis. A phase 2 clinical trial with 264 patients who have eczema were treated with monthly nemolizumab. After 12 weeks, the severity of itching symptoms had decreased from 44%-63%, depending on the mg/kg dosage given. Treatment with all 3 doses (0.1, 0.5 or 2.0 mg/kg body weight) showed improved compared to placebo. Skin signs of eczema improved as well. This study reveals that monthly nemolizumab treatment decreases itching symptoms and skin condition in patients with atopic dermatitis. Experts have commented that “nemolizumab is the first targeted treatment for pruritis directed at Interleukin-31 receptor A.” Not only did itching improve, but also the severity of the eczema was improved by monthly injections.
Nemolizumab for Dogs: Cytopoint is a monclonal antibody that is already being given to dogs for itching. It blocks IL-31 and the injection is given every 4-8 weeks. It is being used to treat atopic dermatitis in dogs currently. It is being administered as 2mg/kg body weight. Side effects have been minimal in dogs compared to placebo. Clinical monitoring has been ongoing since July 2015 and it shows a good safety profile. It has been shown safe for most dogs. It seems that Cytopoint is the same medication as nemolizumab, but its being used currently to treat dog atopic dermatitis as they both neutralize IL-31. For more information on the dog monoclonal anti IL31 monoclonal antibody, click on Cytopoint.
Update 4/25/2018: A study published in Allergy, Asthma Proceedings, titled Interleukin 31 and skin diseases: a systematic review, identified 45 published papers on IL-31 and its role in pathogenesis of chronic skin diseases and associated itching. It highlights the importance of IL-31 in chronic pruritic skin diseases. IL-31 levels were often correlated with itching in patients with different skin diseases. IL-31 therapy may lead to improvement in quality of life, with new treatment options in chronic diseases otherwise recalcitrant to conventional treatment.
Update 10/25/2018: A recent study published in JACI, “Long-term efficacy and safety of anti-IL-31 therapy in patients with atopic dermatitis” had patients taking subcutaneous nemolizumab every 4 or 8 weeks to patients with moderate to severe atopic dermatitis in an initial 12 week phase 2 trial, followed by up to 64 weeks of extension treatment. The main findings were:
- Improvements in pruritus and dermatitis scores observed during the initial 12 weeks was maintained or increased throughout the 64 week extension period.
- Nemolizumab was well tolerated throughout the 64 week extension period, and no new safety concerns were identified.
Update January 22, 2020
A recent study published titled “Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritis” showed its effectiveness. Conclusions were:
- Best effectiveness was observed with the 30-mg dose. All doses of nemolizumab reduced atopic dermatitis severity, as judged by the Eczema Areas and Severity Index and Physician’s Global Assessment.
- One third of patients receiving 30mg of nemolizumab achieved clear/almost clear skin by week 16 versus only 12% in the the placebo group. Nemolizumab rapidly (by week 1) reduced itchy, with a maximum efficacy reached at week 16 (peak reduction, 69% vs 35% with placebo) with an acceptable safety profile.
This study provides confirmation of the importance of IL-31 inhibitors in the management of atopic dermatitis. The study also mentioned that it had an acceptable safety profile. IL-31 has broad actions as a proinflammatory and immunomodulatory cytokine, linking the immune and neural systems to induce itching in patients with eczema.
Update October 16, 2020
Recently published in the New England Journal of Medicine, Nemolizumab was examined in a phase 3 randomized control trial in patients with atopic dermatitis resistant to topical agents and antihistamines. Nemolizumab improved itching after 16 weeks compared to placebo and it was well tolerated. First author said “Nemolizumab plus topical agents may ameliorate both pruritis and signs of eczema and may lessen the severity of atopic dermatitis by disrupting the itch-scratch cycle.”