Ligelizumab associated with low discontinuation rate
Adverse events overall and stratified by severity have been similar across treatment arms, including placebo. The possible exception was a lower rate of moderate events (16.5%) in the placebo arm relative to the 72-mg ligelizumab arm (19.8%), the 120-mg ligelizumab arm (21.6%), and the omalizumab arm (22.3%). Discontinuations because of an adverse event were under 4% in every treatment arm.
Although Dr. Maurer did not present outcomes at 52 weeks, he did note that “only 15% of those who enrolled in these trials have discontinued treatment.” He considered this remarkable in that the study was conducted in the midst of the COVID-19 pandemic, and it appears that at least some of those left the trial did so because of concern for clinic visits.
Despite the similar benefit provided by ligelizumab and omalizumab, Dr. Maurer said that subgroup analyses will be coming. The possibility that some patients benefit more from one than the another cannot yet be ruled out. There are also, as of yet, no data to determine whether at least some patients respond to one after an inadequate response to the other.
Still, given the efficacy and the safety of ligelizumab, Dr. Maurer indicated that the drug is likely to find a role in routine management of CSU if approved.
“We only have two options for chronic spontaneous urticaria. There are antihistamines, which do not usually work, and omalizumab,” he said. “It is very important we develop more treatment options.”
Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, agreed.
“More therapeutic options, especially for disease states that have a small armament – even if equivalent in efficacy to established therapies – is always a win for patients as it almost always increases access to treatment,” Dr. Friedman said in an interview.
“Furthermore, the heterogeneous nature of inflammatory skin diseases is often not captured in even phase 3 studies. Therefore, having additional options could offer relief where previous therapies have failed,” he added.
Dr. Maurer reports financial relationships with more than 10 pharmaceutical companies, including Novartis, which is developing ligelizumab. Dr. Friedman has a financial relationship with more than 20 pharmaceutical companies but has no current financial association with Novartis and was not involved in the PEARL 1 and 2 trials.