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Dupilumab - The ong...
 

Dupilumab - The ongoing studies on its efficacy and side effects  


Mei
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 Mei
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Dupilumab has been approved for use in March 2017 in the US for adults with moderate to severe eczema. It is the only biologic for eczema, by prescription and via injection. It works by suppressing inflammation biomarkers via blocking the shared receptor unit for interleukin-4 and interleukin-13.

It is not available for children below 12 years old and there is a clinical trial for children 6 to 11 years old for which the paper has not yet been published. The results indicate safety and efficacy.

There are many papers published on Dupilumab as doctors prescribe it to their patients, and then monitor its efficacy and side effects. Below is an ongoing compilation of such studies from second half of 2019:

Dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: results from a phase IIa open-label trial and subsequent phase III open-label extension

By US, UK, France and Germany doctors - published Oct 2019 - conclusion:

In adolescents with moderate-to-severe eczema, data collected over 52 weeks demonstrated safety and efficacy of dupilumab and supported the use of dupilumab in combination with topical corticosteroids.

Dupilumab is very effective in a large cohort of difficult-to-treat adult atopic dermatitis patients: First clinical and biomarker results from the BioDay registry.

By Netherlands doctors - published Oct 2019 - conclusion:

Treatment with dupilumab significantly improved disease severity and decreased severity related serum biomarkers in patients with very difficult-to-treat AD in a daily practice setting.

Dupilumab-induced ocular surface disease (DIOSD) in patients with atopic dermatitis: clinical presentation, risk factors for development and outcomes of treatment with tacrolimus ointment.

By Israel doctors - published Sep 2019 - conclusion:

DIOSD (dupilumab-induced ocular surface disease) is common in patients with AD receiving dupilumab. While most cases are mild, some patients can develop blepharoconjunctivitis which responds well to tacrolimus ointment. The more severe the eczema, the higher chance of DIOSD.

Effectiveness of Dupilumab for the Treatment of Generalized Prurigo Nodularis Clinical Phenotype of Adult Atopic Dermatitis.

By Italy doctors - published Sep 2019 - conclusion:

Generalized prurigo nodularis (a type of adult eczema) improved when treated with Dupilumab,  especially in cases where history of atopy is recorded and conventional treatments are ineffective.

Efficacy and safety of dupilumab in Japanese adults with moderate-to-severe atopic dermatitis: a subanalysis of three clinical trials.

By Japan doctors - published Sep 2019 - conclusion:

Dupilumab significantly improved signs and symptoms of eczema, including itch and quality of life. There was increased incidence of injection site reactions and conjunctivitis but considered acceptable safety profile in the study.

Efficacy of Dupilumab in Different Racial Subgroups of Adults With Moderate-to-Severe Atopic Dermatitis in Three Randomized, Placebo-Controlled Phase 3 Trials

By US doctors - published Aug 2019 - conclusion:

Dupilumab significantly improved eczema in White and Asian subgroups. Dupilumab was generally well tolerated, with an acceptable safety profile in White, Asian and Black/African American subgroups. 

Effect of dupilumab on hand eczema in patients with atopic dermatitis: An observational study.

By Netherlands doctors - published Aug 2019 - conclusion:

Dupilumab is used in atopic dermatitis but not for isolated hand eczema. From 47 patients, there were favorable response of hand eczema to dupilumab in patients with AD. 

Dupilumab shows long-term safety and efficacy in moderate-to-severe atopic dermatitis patients enrolled in a phase 3 open-label extension study.

By US doctors - published Jul 2019 - conclusion:

Dupilumab is safe and effective as continuous long-term treatment for patients with moderate-to-severe AD (monitored patients who were enrolled in the trial).

Real-world experience of dupilumab treatment for atopic dermatitis in adults: a retrospective analysis of patients' records.

By US doctors - published Jul 2019 - conclusion:

Dupilumab improved eczema in over 90% of the 70+ patients, and generally well tolerated. The most common side effects included dry eyes, conjunctivitis, and keratitis. The most common reason for discontinuation of treatment was lack of substantial clinical improvement or progression of disease severity, followed by ophthalmologic side effects.

IL-4Rα Blockade by Dupilumab Decreases Staphylococcus aureus Colonization and Increases Microbial Diversity in Atopic Dermatitis.

By US doctors - published Jul 2019 - conclusion:

In a double-blind, placebo-controlled study of 54 patients with moderate to severe AD, skin microbial diversity increased and the abundance of Staphylococcus aureus decreased. It was concluded that clinical improvement of AD that is mediated by interleukin-4 receptor α inhibition and the subsequent suppression of type 2 inflammation is correlated with increased microbial diversity and reduced abundance of S. aureus.

Ocular Surface Diseases Induced by Dupilumab in Severe Atopic Dermatitis.

By French doctors - published Jul 2019 - conclusion: 

64% of 10 patients had abnormal ocular surface with posterior blepharitis, evaporative dry eyes, conjunctivitis, keratitis, and limbal neovascularization. This was therefore suggested for patients to visit ophthalmologist for evaluation before starting dupilumab to establish baseline and monitor side effects. 

Conjunctivitis in atopic dermatitis patients with and without dupilumab therapy – international eczema council survey and opinion

By doctors from 19 countries - published May 2019 - conclusion:

Given that conjunctivitis is a side effect, the recommendation is that eczema patients on dupilumab should (i) routinely be asked about ocular complaints or symptoms, (ii) obtain information about the potential for conjunctivitis before starting dupilumab therapy and (iii) if indicated, be treated with dupilumab despite previous or current conjunctivitis. In cases of new‐onset conjunctivitis, there was consensus that dupilumab treatment should be continued when possible, with appropriate referral to an ophthalmologist.

Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data.

By Netherlands doctors - published May 2019 - conclusion:

Dupilumab treatment improved eczema, and regarded as safe; side effects were eye symptoms and orofacial (non-ocular) herpes simplex virus reactivation.

Infections in Dupilumab Clinical Trials in Atopic Dermatitis: A Comprehensive Pooled Analysis

By USA, Germany, Netherlands, Denmark and Spain doctors - published May 2019 - conclusion:

Dupilumab is associated with reduced risk of serious/severe infections and non-herpetic skin infections and does not increase overall infection rates versus placebo in patients with moderate-to-severe AD.

The background for this is that many oral medications for eczema are immuno-suppressants, but in suppressing the skin inflammation, it makes the skin more susceptible to skin infections. There was some incidents of herpes simplex virus infection noted by the doctors.

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