Oral difelikefalin effective in reducing atopic dermatitis- associated pruritus: Study

Written By :  Medha Baranwal
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2022-03-17 03:30 GMT   |   Update On 2022-03-17 05:46 GMT
Advertisement

USA: In a recent study, the researchers observed a rapid, significant anti-pruritic effect of difelikefalin (DFK) in an atopic dermatitis (AD) mouse model and in subjects having mild-to-moderate AD. The results of the study support DFK's role as an anti-pruritic agent for itch-predominant AD patients. 

The findings were presented at the AAAAI annual meeting 2022 and subsequently published in the Journal of Allergy and Clinical Immunology.

Many AD patients exhibit itch that is disproportionate to rash. In AD, only limited therapies specifically target itch. Difelikefalin is a selective kappa-opioid receptor agonist that is being developed for chronic pruritic conditions. 

In the phase 2, randomized, double-blind study, Brian Kim, Washington University School of Medicine, and colleagues enrolled adults with AD and moderate-to-severe pruritus. They received oral placebo (PBO) or DFK (0.25, 0.5, or 1.0 mg) BID for 12 weeks. Also, mice with topical MC903-induced AD were treated with DFK (0.5 mg/kg) intraperitoneally and itch was assessed early (30 minutes).

Change from baseline in mean Itch Numerical Rating Scale (I-NRS) and >_4-point improvement in I-NRS at week 12 were the primary and key secondary endpoints. 

The research led to the following findings:

  • In mice, DFK promoted rapid, significant itch reduction independently of skin inflammation.
  • Among 401 subjects randomized, ;64% had mild-to-moderate AD.
  • In the overall population, treatment difference in mean I-NRS change between the combined DFK group (all doses) and PBO was 20.43 at week 12.
  • In subjects with mild- to-moderate AD, a significant difference in mean I-NRS was observed at week 12 (20.75) in the DFK group versus PBO (P50.036); a significantly greater proportion of subjects achieved >_4-point improvement in I-NRS with DFK. Itch reduction was observed early (week 1).
  • Adverse events with DFK were most commonly abdominal pain, nausea, dry mouth, head- ache, dizziness, and hypertension.

"We observed a rapid, significant anti-pruritic effect of DFK in an AD mouse model and in patietns with mild-to-moderate AD," wrote the authors. "The findings supports DFK's role as an anti-pruritic agent for patients with itch-predominant AD."

Reference:

The study titled, "Oral Difelikefalin Reduces Atopic Dermatitis–Associated Pruritus," was published in the Journal of Allergy and Clinical Immunology.

DOI: https://doi.org/10.1016/j.jaci.2021.12.075

KEYWORDS: atopic dermatitis, difelikefalin, pruritis, Journal of Allergy and Clinical Immunology, anti-pruritic, AAAAI annual meeting 2022, skin inflammation, skin disease, itching, rash 

Tags:    
Article Source : Journal of Allergy and Clinical Immunology

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News