From regulatory limitations to new opportunities: Real‐life experience on the effectiveness of short courses of omalizumab in the treatment of chronic idiopatic urticaria

Abstract

Economic sustainability of long-term continuous treatment of antihistamine refractory chronic urticaria with omalizumab may be an issue. We assessed the efficacy of relatively short courses (5-6 months) of omalizumab in patients with chronic idiopathic urticaria (CIU). We retrospectively studied 40 patients (observed between June 2015 and January 2019) affected by moderate-to-severe CIU refractory to anti-H1 antihistamines (up to fourfold doses). Omalizumab was administered every 4 weeks for 24 weeks, then for 20 weeks in case of a relapse of moderate-to-severe degree, then again for 24 weeks in case of a second relapse. Monthly clinical evaluations were performed. Mean disease severity significantly dropped after 1 month and further decreased thereafter, with 30 complete remissions after the first course of treatment. In 2-4 months, 18 patients had a relapse of moderate-to-severe degree.The profile of response to the second course of omalizumab was similar to the first.A third course was necessary for seven patients. No adverse effects were recorded.Courses of 5-6 months of omalizumab may induce rapid significant improvement of urticaria and many prolonged complete remissions. In case of relapse, further courses show a similar profile of response and may induce additional long-term complete remissions. K E Y W O R D Schronic idiopathic urticaria, omalizumab, real life

Omalizumab for treatment of refractory severe atopic dermatitis. A pediatric perspective

“…Omalizumab is a humanized anti‐IgE antibody indicated for the treatment of severe allergic asthma and spontaneous chronic urticaria in patients older than 6 and 12 years, respectively 8 …”

“…Omalizumab is a humanized anti-IgE antibody indicated for the treatment of severe allergic asthma and spontaneous chronic urticaria in patients older than 6 and 12 years, respectively. 8 Efficacy and safety of Omalizumab in treatment of IgE-mediated conditions like allergic asthma and rhinitis has been demonstrated, 9 some F I G U R E 3 A-D, Significant improvement of lower limbs before, A and B, and after, C, therapy with persistence of lichenification but complete disappearance of exudation F I G U R E 2 A-D, Atopic eczema of the upper trunk before, A and C, and after, B and D, 3 months of therapy with Omalizumab. Reduction of active lesions and scratching signs with the prevalence of postinflammatory hyperpigmentation can be noted studies define this therapy as an effective and useful concomitant therapy in pediatric refractory severe AD, 10,11 especially improving the quality of life, reducing the severity of skin lesions and the need for systemic therapies (steroids, immunosuppressors) with their potential side-effects.…”

Biologics for atopic diseases: Indication, side effect management, and new developments

“…The approval documents a fixed dose of 300 mg s.c., which corresponds to two 150-mg syringes, to be administered every 4 weeks. Recent real-life results show, however, that under certain circumstances, if there is no treatment response, it may be appropriate to either shorten the interval or increase the dose [ 24 , 25 ]. In particular, overweight patients may benefit from an upward dose adjustment.…”

Pityriasis rosea during omalizumab treatment for chronic spontaneous urticaria

“…Furthermore, cytopathic effects specific for herpesviruses and virions resembling herpesviruses Even if economic sustainability of omalizumab long-term treatment may be an issue, this drug had shown high and rapid efficacy and a very good safety profile in phase-III studies as well as in real-life experience. 10 We describe two cases of PR arising shortly after the beginning of therapy with omalizumab for CSU. Figure 1A,B).…”

“…Even if economic sustainability of omalizumab long‐term treatment may be an issue, this drug had shown high and rapid efficacy and a very good safety profile in phase‐III studies as well as in real‐life experience 10 …”