Ligelizumab, most effective omalizumab for chronic spontaneous refractory urticaria

Ligelizumab and omalizumab were found to be the most effective treatments for adolescent and adult patients with chronic spontaneous urticaria who failed to respond to H1 antihistamines, according to one study.

“The comparative advantages and disadvantages of all available treatments for chronic spontaneous urticaria refractory to H1 antihistamines have not been established” Surapon Nochaiwong, PharmD, from the Department of Pharmaceutical Care at Chiang Mai University in Chiang Mai, Thailand, and colleagues wrote.

The analysis included the Medline, Embase, PubMed, Cochrane Library, Web of Science, Scopus and Cinahl databases, as well as Google Scholar, ongoing trials and preprint reports. Randomized clinical trials from beginning to April 19, 2021 were included.

Researchers evaluated the treatment effects – including the pros and cons – of various pharmacological therapies used to treat adolescents and adults who had failed to elicit an adequate response to H1 antihistamines.

The final analysis provided data for 2480 participants from 23 trials that included the primary endpoint of changes in urticaria symptoms from baseline and unacceptability of treatment. Eighteen different interventions and dosages were studied, in addition to the placebo cohorts.

The strongest effect was seen with ligelizumab (Novartis) at a dose of 72 mg, which gave a standardized mean difference (SMD) for change in urticaria symptoms of 1.05 (95% CI , 1.37 to 0.73). Ligelizumab 240 mg also produced a positive change in symptoms (DMS = 1.07; 95% CI: 1.39 to 0.75). The researchers described the impact of ligelizumab as a “significant benefit”.

Similar results as assessed by the standardized mean difference for change in urticaria symptoms were reported for omalizumab (Xolair, Genentech) at both the 300 mg dose (SMD = 0.77; 95% CI , 0.91 to 0.63) and at a dose of 600 mg (SMD = 0.59; 95% CI: 1.10 to 0.08). Researchers noted a “moderate benefit” for omalizumab.

The researchers did not observe any significant difference in the unacceptability of treatment for these two drugs.

Regarding the other therapies analyzed, dapsone, hydroxychloroquine, cyclosporine and zafirlukast (Accolate, Annora Pharma) were associated with a “small beneficial effect”. In addition, a small benefit was reported for ligelizumab 24 mg and omalizumab 150 mg.

However, researchers do not recommend these treatments due to uncertain efficacy results or a higher risk of adverse events. Additionally, they said studies of these treatments varied in the magnitude of effect size and the certainty of the evidence.

“The results of this meta-analysis suggest that the biologics ligelizumab, 72 mg or 240 mg, and omalizumab, 300 mg or 600 mg, may be recommended as effective treatments for patients with CCA who have had an inadequate response to H1 antihistamines, ”the researchers wrote. “Comparative trials with high methodological quality and harmonized design and outcome definitions are needed to help inform subsequent international guidelines for the management of [chronic spontaneous urticaria]. “