Fezakinumab is a human monoclonal antibody that can prevent inflammatory responses by targeting Interleukin-22. A German-American research group, including scientists from the Helmholtz Zentrum München, has now tested this active substance in a clinical study on the treatment of moderate-to-severe forms of atopic dermatitis. The findings have now been published in the ‘Journal of the American Academy of Dermatology’.
Atopic dermatitis (AD), which is also known as atopic eczema or neurodermatitis, is nowadays regarded as a portal of entry for allergens that can give rise to long-term allergies. This is because skin barrier impairment often predates the development of sensitization and the manifestation of an allergic response. There is no cure for AD, but it can be well managed. It is a chronic disease that needs to be treated, even during symptom-free periods. This latest study has now tested a further option for patients who fail to respond to the usual treatment methods.
For this purpose, the scientists, who also include IEM-Director Professor Claudia Traidl-Hoffmann and IEM scientist Professor Avidan Neumann, conducted a randomly assigned, double-blind clinical trial with a total of 60 volunteers with moderate to severe atopic dermatitis. Forty of them were given the antibody fezakinumab intravenously five times every two weeks. The 20 remaining test subjects received a placebo injection. Neither the doctors nor the patients knew which treatment was being administered in each individual case. After a ten-week treatment phase, the patients were monitored for a further 20 weeks.
The authors reported that fezakinumab reduced the entire area of skin affected by eczema. In addition, the so-called SCORAD (SCORing Atopic Dermatitis) index, which evaluates six typical morphological changes in atopic dermatitis, improved. Significant improvement was noted in the case of severe atopic dermatitis, in particular. Moreover, the authors reported only minor side effects during the 20-week observation period. The most common adverse events were upper respiratory tract infections.
“Our study demonstrates for the first time the efficacy and relative safety of treatment with an IL-22 blockade,” explains Claudia Traidl-Hoffmann. The authors assume that other diseases that are caused by an excess of IL-22 could also be treated in this way. “This approach appears to be a possible therapeutic option, especially for patients with severe atopic eczema and patients who show no significant clinical effects of an IL-4 and IL-13 blockade, for example with the antibody dupilumab,” she says, assessing the trial. In the near future, the authors hope to substantiate their findings in Phase 2b and Phase 3 trials with a larger number of test subjects.
Guttman-Yassky, E. et al.: Efficacy and safety of fezakinumab (an anti-IL-22 monoclonal antibody) in adults with moderate to severe atopic dermatitis inadequately controlled by conventional treatments – A randomized, double-blind, phase 2a trial. In: Journal of the American Academy of Dermatology, 2018, DOI: 10.1016/j.jaad.2018.01.016
Helmholtz Zentrum München