- Metz M. Barzolvolimab shows profound efficacy and favourable safety over 52 weeks in patients with chronic spontaneous urticaria. D1T01.2D, EADV Congress 2024, 25–28 September, Amsterdam, the Netherlands.
“CSU is a disease that still and urgently needs new treatment options,” Prof. Martin Metz (Charité University Hospital Berlin, Germany) stated1. At 12 weeks, the randomised-controlled phase 2 trial (NCT05368285), evaluating the humanised anti-KIT IgG1 monoclonal antibody barzolvolimab for the treatment of CSU, met its primary endpoint of mean change in UAS7 change from baseline. Currently, Prof. Metz presented the 52-week results after a further 36-week active treatment. For this extension, participants who previously receiving placebo or the 75 mg dose of barzolvolimab were re-randomised at week 16 to the other 2 regimens of either 150 mg every 4 weeks or 300 mg every 8 weeks.
“We are really looking at very severely affected patients,” Prof. Metz commented on the baseline characteristics. The mean age was between 42.2 and 47.2 years, 71–80% of the participants were women, 30.0–31.3% of the participants had a UAS7, and around 20% had previous experience with omalizumab.
The 12-week results showed a significant drop of over 20 points in UAS7 in the 150 mg and 300 mg groups compared with 10.47 points on placebo (P<0.0001 for both comparisons). At week 52, well-controlled disease with a UAS7 of ≤7 was achieved by 67.4–73.7% in the continuous verum groups. Complete disease control was found in 52.3–71.1%. “This is the best data for CSU that we have so far seen,” Prof. Metz highlighted.
“Most events that were seen were Grade 1 and most importantly mechanism-related,” Prof. Metz detailed with special regard to KIT-mediated safety events like hair colour changes (26%), skin hypopigmentation (13%), and neutropenia (17%) after 52 weeks. Treatment-related serious events happened in 1%.“Barzolvolimab has the potential to be an important new treatment option; phase 3 trials will give us more information on that,” he concluded.
Medical writing support provided by Karin Drooff, MPH