“Despite treatment options such as antihistamines and omalizumab, an anti-IgE, there are still a lot of patients who need better treatment of CSU to achieve complete control,” explained Prof. Marcus Maurer (Charité University Hospital, Germany) [1]. Prof. Maurer presented results of a phase 2b study (NCT03926611) assessing remibrutinib as a novel, selective, oral BTK inhibitor. The study enrolled 311 adult patients with CSU. All participants suffered from CSU for at least 6 months, which was uncontrolled despite antihistamine treatment, and presented at baseline with an Urticaria Activity Score (UAS7) of ≥16 points. The dose-finding trial evaluated placebo versus 6 different dosages of remibrutinib, ranging from 10 mg once daily to 100 mg twice daily. The primary endpoint was defined as change from baseline UAS7 at week 4. Key secondary endpoints included UAS7 change at week 12, UAS7=0 response over time, as well as safety and tolerability. “The key features and demographics were by and large evenly distributed,” stated Prof. Maurer. The mean duration of CSU was almost 5 years.
At the 4-week assessment, a clear dose-response relationship was seen in all study arms. “More importantly, for all of these different doses used, we saw an effect with a marked reduction in disease activity measured by UAS7 as compared with placebo,” Prof. Maurer stressed. Looking at the changes over 12 weeks, there was an early onset of later maintained disease activity reduction in weeks 1 and 2 with least square mean changes in the different remibrutinib arms between -15.3 and -20.2 compared with -7.9 on placebo. “Half of the patients who were treated with remibrutinib oral treatment achieved a marked reduction in their disease activity at the end, reflecting mild disease or well-controlled disease, so a very encouraging result for this oral BTK inhibitor,” Prof. Maurer elaborated. In terms of safety, the drug was well-tolerated and showed no apparent dose-dependent adverse effects.
- Maurer M. The Bruton’s tyrosine kinase inhibitor remibrutinib (LOU064) in chronic spontaneous urticaria: Top-line results of a phase 2b dose-finding study. D1T01.3C, EADV Congress 2021, 29 Sept–2 Oct.
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Table of Contents: EADV 2021
Featured articles
Letter from the Editor
Long-term disease control in AD could be in reach with anti-OX40 antibody KHK4083
Late-Breaking News
Targeting OX40 in the treatment of atopic dermatitis meets expectations
Superior EASI scores after switch from dupilumab to upadacitinib
CSU: Novel agent targeting Bruton’s tyrosine kinase leads to disease control
Novel JAK3/TEC blocker leads to maintained re-pigmentation in vitiligo
TYK2 inhibitor deucravacitinib shows impressive long-term response in psoriasis
Tapinarof cream for psoriasis leads to high clearance rates and remittive effect
CSU: Ligelizumab likely safe and effective for adolescents
Long-term disease control in AD could be in reach with anti-OX40 antibody KHK4083
Topical JAK1/JAK2 inhibitor effective in vitiligo
Abrocitinib demonstrates fast itch control and skin clearance in atopic dermatitis
AD patients with stable response fare well with a monthly dose of tralokinumab
Opioid receptor agonist difelikefalin disappoints in AD
Atopic Dermatitis: State of the Art
Upadacitinib beats dupilumab in different body regions
Efficacious 2-year AD control with IL-13 inhibitor tralokinumab
Ruxolitinib cream: a safe treatment for elderly AD patients
Novel and upcoming targeted AD treatment
Psoriasis: What's New?
Existing and upcoming small molecules in psoriasis
Treating psoriasis during pregnancies
A patient-related approach to freedom of disease
Ixekizumab superior to secukinumab in real-world psoriasis study
Nail psoriasis: An important target to be treated
Grand debate: Is psoriasis a systemic or skin-only disease?
Spotlight on Alopecia Areata
JAK1/2: A promising novel treatment target in alopecia areata
Alopecia areata: encouraging response rates with JAK3/TEC inhibition
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