Evidence-Based Answers

Evidence Central™ is an integrated web and mobile solution that helps clinicians quickly answer etiology, diagnosis, treatment, and prognosis questions using the latest evidence-based research.

Browse

Evidence Central for Mobile Devices

Evidence Central iOS iPhone iPad Android

Evidence Central from Unbound Medicine, available for iOS® and Android™, is optimized for each platform and features superior navigation, so answers are easy to find at the bedside or anywhere they’re needed. Learn More

Word of the Day

Omalizumab at highest dose modestly effective for chronic idiopathic urticaria

Clinical Question:
Is omalizumab an effective treatment for chronic idiopathic urticaria?

Bottom Line:
Omalizumab (Xolair) is a very expensive and modestly effective treatment for chronic idiopathic urticaria. (LOE = 1b)

Reference:
Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med 2013;368(10):924-935.  [PMID:23432142]

Study Design:
Randomized controlled trial (double-blinded)

Funding:
Industry

Setting:
Outpatient (any)

Synopsis:
Chronic idiopathic urticaria is treated with antihistamines, but some patients do not respond. The researchers in this industry-sponsored trial included patients between the ages of 12 and 75 years who had at least 6 months of chronic idiopathic urticaria and moderately severe symptoms during a 2-week run-in period. Patients with a known cause of urticaria or previous treatment with steroids, immunomodulators,or H2 blockers were excluded. The patients were randomized to receive 1 of 3 doses of subcutaneous omalizumab (75 mg, 150 mg, or 300 mg) or matching placebo. They received a dose once every 4 weeks for 12 weeks, followed by a 16-week untreated follow-up period. Patients recorded symptoms daily, and the primary outcome was the change in weekly itch-severity scores on a 21-point scale. Groups were balanced at the start of the study, with a mean age of 43 years, approximately 75% were female, and 88% were white. And the outcomes? The itch-severity score dropped 3 points in the 150-mg dose group and 4.7 points in the 300-mg group, while the 75-mg group did not show significant improvement. A skin-specific quality-of-life index improved slightly for the 150-mg and 300-mg groups compared with placebo. Patients in the 300-mg group took 4 fewer 25-mg diphenhydramine tablets than those in the placebo group. Adverse events were more common in the 300-mg dose group (5 versus 1 or 2 in the other groups; statistical significance not reported). Xolair costs between $500 and $2000 a month, depending on the dose. Since only the higher doses were effective in this study, 3 years of treatment (a typical duration for this condition) would cost $36,000 to $72,000. Those 4 extra diphenhydramine tablets per week are probably a bit cheaper.

RSS FEED

Site Licenses

Site license

Site Licenses are available for schools, universities, hospitals, government agencies, and companies. For more information, contact us.