Ligelizumab and Omalizumab Optimal Treatments for Chronic Spontaneous Urticaria

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Investigators believe their study shows the efficacy and safety of the 2 biologic agents, which are known to have anti-inflammatory and immunosuppressant qualities.

Investigators in Thailand determined that the biologic agents ligelizumab and omalizumab could be recommended as effective treatments for patients with H1 antihistamine-refractory chronic spontaneous urticaria.

Patients with chronic spontaneous urticaria, the most common form of chronic urticaria, have experienced significant morbidity and impaired health-related quality of life due to the disease.

The use of H1 antihistamines has been considered for the management of chronic spontaneous urticaria, yet less than half of patients receive adequate treatment.

Despite this, several alternate pharmacologic therapies for the management of H1 anstihistamine-refractory CSU have been studied in the past, most of which had anti-inflammatory, immunosuppressant, immunomodulatory, and biological qualities.

In the present study, investigators led by Mati Chuamanochan, MD Pharmacoepidemiology and Statistics Research Center, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand, summarized available evidence regarding different treatments and evaluated their effectiveness and safety profiles among patients with chronic spontaneous urticaria.

The Study

A systematic review and network meta-analysis (NMA) was performed , which followedthe Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline for reporting of NMAs.

Chuamanochan and investigators searched electronic databases including MEDLINE, Embase, PubMed, Cochrane Library, Web of Science, Scopus, and CINAHL from inception to April 19, 2021. They included randomized clinical trials that featured adolescent or adult (≥12 years) participants who were diagnosed with H1 antihistamine– refractory CSU and used validated measurement tools for treatment assessment with a follow-up of 2 weeks onward.

Th primary outcomes the team established were changes in urticaria symptoms from baseline and unacceptability of treatment, defined as all-cause study dropouts. The secondary outcomes included change in pruritus severity score from baseline, change in hives severity score from baseline,adverse events, and serious adverse events.

From there, 2 of the investigators independently graded the evidence certainty using the confidence in NMA along with the Grading of Recommended Assessment, Development, and Evaluation (GRADE) approach.The evidence certainty was categorized as very low, low, moderate, and high quality.

Finally, Chuamanochan and investigators considered the key components to estimate the effect of the evidence findings, including magnitudes of effect size, evidence certainty, and surface under the cumulative ranking curve (SUCRA) values, to draw evidence-based conclusions, before classifying the treatment effects by incorporating the dimensions of safety profiles as having trivial small, moderate, and large treatment effects.

The Results

A total of 23 trials were evaluated in the study, the sum of which brought about 18 different interventions or dosages and 1 placebo.

The findings suggested that ligelizumab at 72 or 240 mg, and omalizumab at 300 or 600 mg were the most efficacious treatments for H1 antihistamine-refractory CSU.

Based on the safety profiles presented in the study, individuals receiving cyclosporine (OR, 3.45; 95% CI, 1.71-6.97), miltefosine (OR, 3.88; 95% CI, 1.20-12.57), and omalizumab, 150 mg (OR, 1.44; 95% CI, 1.02-2.03), experienced a statistically significantly higher risk of adverse events com- pared with placebo. Ligelizumab, however, had a protective effect.

Encouragingly, the team did not find any significant differences among all treatment comparisons for the serious adverse event outcomes, which prompted them to recommend the lesser treatments for smaller beneficial effects.

However, the probability of unacceptability of treatment and adverse effects should be considered.

“Overall, results of this systematic review and NMA suggest that biologics, namely ligelizumab, 72 or 240 mg (large beneficial effect), and omalizumab, 300 or 600 mg (moderate beneficial effect), are effective pharmacologic treatments with respect to the benefits and harms of H1 antihistamine– refractory CSU,” the team wrote.

The study, “Evaluation of Pharmacologic Treatments for H1 Antihistamine–Refractory Chronic Spontaneous Urticaria A Systematic Review and Network Meta-analysis,” was published online in JAMA Dermatology.