Ligelizumab Immunogenicity and Impact on Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety in Patients With Chronic Spontaneous Urticaria.

What was studied

This study looked at ligelizumab, a drug for chronic spontaneous urticaria. The drug is an antibody that acts on IgE. People got 72 or 120 mg as a shot under the skin. They got a shot once every 4 weeks. Some people first got placebo and then moved to 120 mg. The data came from the PEARL-1 and PEARL-2 phase 3 trials. The team checked if the body made its own antibodies against the drug.

What they found

In each group, some people made antibodies against the drug. In most of them, these antibodies could block the drug. For many, the antibody response did not go away. The antibodies showed up from week 12. Their levels then leveled off near week 20. The typical start was at 143 to 147 days. People with these antibodies had lower drug levels in the blood. A blood test of the drug's effect on total IgE was also lower in them. But hive scores changed in much the same way in both groups. Rates of allergy-type reactions and shot-site reactions did not differ in a way that mattered.

What it means for patients

The authors say the antibodies cut how much drug was in the body. They also cut how well the drug reached its target. Still, the authors found no real change in how well the drug worked. They also found no real change in safety. The authors say this is the first report of its kind for ligelizumab.

Why it is not certain yet

The data were pooled from the PEARL-1 and PEARL-2 trials. People were not put by chance into groups with or without antibodies. The abstract does not give the number of people in each group. The abstract does not say how long people were followed.

Source

Ligelizumab Immunogenicity and Impact on Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety in Patients With Chronic Spontaneous Urticaria.

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