Omalizumab reduces clinical symptoms and signs of chronic idiopathic urticaria after H1-antihistamine therapy


Many patients with chronic idiopathic urticaria ( also called chronic spontaneous urticaria ) do not have a response to therapy with H1-antihistamines, even at high doses.
In phase 2 trials, Omalizumab ( Xolair ), an anti-IgE monoclonal antibody that targets IgE and affects mast-cell and basophil function, has shown efficacy in such patients.

In this phase 3, multicenter, randomized, double-blind study, researchers have evaluated the efficacy and safety of Omalizumab in patients with moderate-to-severe chronic idiopathic urticaria who remained symptomatic despite H1-antihistamine therapy.

323 patients were randomly assigned to receive three subcutaneous injections, spaced 4 weeks apart, of Omalizumab at doses of 75 mg, 150 mg, or 300 mg or placebo, followed by a 16-week observation period.

The primary efficacy outcome was the change from baseline in a weekly itch-severity score ( ranging from 0 to 21, with higher scores indicating more severe itching ).

The baseline weekly itch-severity score was approximately 14 in all four study groups.

At week 12, the mean change from baseline in the weekly itch-severity score was -5.1±5.6 in the placebo group, -5.9±6.5 in the 75-mg group ( P=0.46 ), -8.1±6.4 in the 150-mg group ( P=0.001 ), and -9.8±6.0 in the 300-mg group ( P less than 0.001 ).

Most prespecified secondary outcomes at week 12 showed similar dose-dependent effects.

The frequency of adverse events was similar across groups. The frequency of serious adverse events was low, although the rate was higher in the 300-mg group ( 6% ) than in the placebo group ( 3% ) or in either the 75-mg or 150-mg group ( 1% for each ).

In conclusion, Omalizumab diminished clinical symptoms and signs of chronic idiopathic urticaria in patients who had remained symptomatic despite the use of approved doses of H1-antihistamines. ( Xagena )

Maurer M et al, N Engl J Med 2013; 368:924-935

XagenaMedicine_2013



Indietro

Altri articoli

Ocrelizumab ( Ocrevus ) is an infusible humanized monoclonal antibody that selectively depletes CD20+ B cells. Infusion-related reactions ( IRRs...


Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions...


Vimizim ( Elosulfase alfa ) is the first enzyme replacement therapy ( ERT ) designed to target the underlying cause...


Novartis has announced that the European Commission ( EC ) has approved the use of Xolair ( Omalizumab ) as...


Grastek is an allergen extract for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis. The efficacy of...


Siltuximab ( Sylvant ) is an anti-interleukin-6 ( IL-6 ) chimeric monoclonal antibody that binds to human IL-6.1 IL-6 is...


A clinical study of cardiac patients who suffered an allergic reaction to the widely-prescribed drug Clopidogrel ( Plavix ), found...


According to NICE ( National Institute for Health and Clinical Excellence ) Ofatumumab ( Arzerra ) is not recommended for...


Corticosteroids are the mainstay of treatment for immune-mediated diseases, including non-infectious uveitis and ocular inflammation, because they are inexpensive, potent...