Ligelizumab More Clinically Beneficial Than Omalizumab in Patients With Urticaria
Ligelizumab More Clinically Beneficial Than Omalizumab in Patients With Urticaria
By Jenny Powers
PARIS -- September 18, 2018 -- More patients with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines demonstrated a complete hives response with ligelizumab than with omalizumab or placebo, according to findings presented here at the 27th Congress of the European Academy of Dermatology and Venereology (EADV).
In 382 patients with moderate to severe CSU, ligelizumab demonstrated a clear dose response in achieving 0 on the Hives Severity Score (HSS7) at week 12 (scale range, 0-5). Forty-three percent and 40% of patients receiving the 2 highest doses of ligelizumab (72 and 240 mg) by week 20 achieved an HSS7 of 0, compared with 23% receiving omalizumab, 8% receiving ligelizumab 24 mg, and 5% receiving placebo, commented Marcus MaurerMD, Allergie-Centrum-Charité, Charité Universitätsmedizin, Berlin, Germany, on September 14.
"Furthermore, more patients receiving ligelizumab at 72 and 240 mg remained symptom free throughout the 20-week treatment period," Dr. Maurer added.
More patients receiving the 2 higher doses of ligelizumab also showed greater improvement in Urticaria Activity Scale (UAS7) scores from baseline compared with the other treatments. The mean changes in UAS7 scores were -15.2, -23.1, and -22.5 for patients on ligelizumab 24, 72, and 240 mg, respectively, compared with -18.2 for omalizumab 300 mg and -13.6 for placebo.
The ligelizumab benefit was more rapid, with high complete response rates of HSS7 of 0 observed as early as week 4.
The study enrolled 382 adult patients with moderate to severe CSU (defined as UAS7 score of ≥16) who were randomly assigned to receive subcutaneous ligelizumab at doses of 24, 72, or 240 mg; omalizumab at the recommended 300 mg; or placebo every 4 weeks for 20 weeks.
Patients then entered a 24-week treatment-free follow-up period. Beginning at week 32, patients with UAS7 scores ≥12 could enter an extension study to receive ligelizumab.
After the end of treatment, the median time to loss of complete response was 10.5 weeks with ligelizumab (240 mg) versus 4 weeks with ligelizumab (72 mg) and omalizumab and 3 weeks with ligelizumab (24 mg).
The study met the primary endpoint of the proportion of patients achieving a complete hives response represented by an HSS7 score of 0 at week 12.
The incidence of adverse events (AEs) was similar across all treatment groups: 83.7%, 75%, 74.1%, 72.9%, and 68.1% of patients receiving ligelizumab 24, 72, or 240 mg; omalizumab; or placebo, respectively. The incidence of serious AEs was <9.5% in all treatment groups.
"No new or unexpected safety signals were identified for ligelizumab, and no cases of anaphylaxis were reported," Dr. Maurer pointed out.
The most frequently reported adverse event was viral upper respiratory tract infection, which occurred in 15.5% to 20% of patients on ligelizumab, 20% of patients on omalizumab, and 38.2% patients on placebo.
Funding for this study was provided by Novartis, Basel, Switzerland.
[Presentation title: Ligelizumab Achieves Rapid Onset of Action, Improved and Sustained Efficacy Compared With Omalizumab in Patients With Chronic Spontaneous Urticaria not Adequately Controlled by H1-Antihistamines. Abstract OP01.03]
posted by dermatica at
October 11, 2018
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