Omalizumab safe, well-tolerated in Asian patients with urticaria
Omalizumab appears to effectively reduce the signs and symptoms of chronic spontaneous urticaria (CSU) in Japanese and Korean patients who remain symptomatic despite the use of nonsedating second-generation H1 antihistamines (H1AH), according to the results of POLARIS study.
The phase III trial randomized 218 H1AH-refractory CSU patients to treatment with omalizumab 300 mg (n=73; mean age 44.6 years; 54.8 percent female), 150 mg (n=71; mean age 43.6 years; 60.6 percent female) or placebo (n=74; mean age 42.5 years; 64.9 percent female). Treatment was administered three times, given subcutaneously every 4 weeks (days 1, 29 and 57), followed by 12 weeks of follow-up.
The primary outcome measure was change from baseline to week 12 in weekly itch severity score (ISS7). Safety was assessed through the summary of adverse events (AEs).
At week 12, reductions from baseline in ISS7 were significantly higher with omalizumab vs placebo (mean changes, −10.22 for 300 mg and −8.80 for 150 mg vs −6.51; p<0.001 and p=0.006 vs placebo, respectively).
Overall AE incidence did not significantly differ across treatment groups (54.8, 57.7 and 55.4 percent in omalizumab 300 mg, 150 mg and placebo arms, respectively), with nasopharyngitis as the most frequently reported AE.
CSU is a skin disorder characterized by the spontaneous development of hives, angioedema or both, that last for 6 weeks or more. Treatment with H1AH is the current standard of care, and current guidelines recommend dose intensification (up to fourfold) if symptoms persist after 2 weeks. Despite this approach, however, there are still some patients who do not respond or have insufficient response to H1AH. [Allergy 2014; 69: 868–887; Allergy Asthma Immunol Res 2012;4:326–331]
The findings indicate that omalizumab is a well-tolerated treatment option in Japanese and Korean patients who remain symptomatic despite the use of H1AH.
Moreover, the study provides evidence “that ethnic differences do not affect treatment outcomes in patients with CSU who are treated with omalizumab, [a recombinant humanized monoclonal antibody that inhibits IgE-mediated cellular responses]; this is consistent with studies of omalizumab for the treatment of asthma,” researchers said. [Allergol Int 2015;64:364–370; Respirology 2009;14:1156–1165; Allergol Int 2010;59:167–174; Drug Metab Pharmacokinet 2016;31:173–184]