Safety of omalizumab treatment in patients with chronic spontaneous urticaria and COVID‐19

Abstract

Omalizumab is a recombinant, humanized, monoclonal IgG1 anti-IgE antibody. It is approved for the treatment of chronic spontaneous urticaria (CSU) in H1-antihistamine refractory individuals aged 12 years and older. Omalizumab treatment results in a significant improvement in CSU activity and quality of life, and is well tolerated. 1 The treatment does not seem to be associated with an increased incidence of respiratory tract infections. 2 Rather, it seems to promote restoration of responses to both rhinovirus and influenza viruses. 3 Data on the use of omalizumab during severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) pandemic are limited. However, it has been suggested that continuing treatment with omalizumab is advisable in patients affected with mild-to-moderate Coronavirus disease 2019 ; in severe disease, prolongation of the dosing interval or treatment interruption should be considered. 4 We herein report the data regarding seven CSU patients in whom omalizumab treatment was continued at standard dosage (300 mg every 4 weeks) while suffering from COVID-19. A signed informed consent was obtained from patients to allow extracting data from their clinical records. All the patients (four males; mean age 49.7 ± 17.01; range 28-74 years) had a clinical history of CSU, ranging from 1 to 5 years (mean duration: 2.9 years). Mean baseline urticaria activity score on 7 days (UAS7) score (range 0-42) was 27.1, ranging from 18 to 39. In all the cases, second-generation antihistamine treatment (up to 4-folds the basic dosage) had been inefficacious. The patients, therefore, received omalizumab at standard dosage. All the patients achieved UAS7 score of 0 after an average of 8 weeks (range 1-12 weeks). At the moment of COVID-19 onset, the seven patients were on omalizumab treatment on average for 70.8 weeks (range 26.1-156.4 weeks). COVID-19 symptoms were mild in four (57.1%) patients, while three (42.9%) of them were asymptomatic. No patient discontinued omalizumab treatment. None of the seven patients experienced relapse of CSU during the viral infection.CSU symptoms seem worse in SARS-CoV-2 infected patients, especially in severe COVID-19 5 ; therefore, an effective treatment is needed in these subjects. On the other hand, the use of immunosuppressive drugs for chronic inflammatory skin disease during SARS-CoV-2 pandemic and in patients affected with COVID-19 is debated in literature. The use of biologic drugs such as anti-IL17, anti-IL12/ IL23, and anti-IL23 appears to be safe in psoriasis patients. 6 Moreover, the use of anti-IL4/13 in atopic dermatitis patients is not contraindicated, though a careful assessment is mandatory for each subject and further studies are necessary to characterize the immunologic responses in Few data exist regarding omalizumab therapy in CSU patients with COVID-19. Lommatzsch et al. described a man suffering from asthma and treated with omalizumab, who developed mild COVID-19 that was not influenced by omalizumab treatment. 8 Instead, two of three CSU patients hospitalized f...

COVID-19 Disease Leading to Chronic Spontaneous Urticaria Exacerbation: A Romanian Retrospective Study

“…We may hypothesize that maybe omalizumab has a better effect on inflammation and a protective role for exacerbation in CSU [22,23]. In our patients with CSU treated with omalizumab, the course of COVID-19 disease was not observed to be more severe, as described in recent study of Passante M. et al [24].…”

The effect of allergy and asthma as a comorbidity on the susceptibility and outcomes of COVID-19

“…Omalizumab is approved for the treatment of chronic refractory urticaria. A recent report suggests that Omalizumab did not worsen the disease course of COVID-19 in seven cases with chronic spontaneous urticaria ( 127 ). The risk of discontinuation of Omalizumab on the susceptibility and disease course of COVID-19 was not reported.…”

Impact of Anti-Type 2 Inflammation Biologic Therapy on COVID-19 Clinical Course and Outcome

“…Passante et al (online publication: August 2021) described a mild clinical course of SARS-CoV-2 infection in seven adult CSU patients treated with omalizumab: no one had to stop the biological treatment and three of them were even completely asymptomatic. 20 …”

“…Passante et al (online publication: August 2021) described a mild clinical course of SARS-CoV-2 infection in seven adult CSU patients treated with omalizumab: no one had to stop the biological treatment and three of them were even completely asymptomatic. 20 Shortly after, Muntean et al (online publication: September 2021) analyzed their case series of 218 adult patients affected with CSU: 149 patients had moderate-tosevere CSU, and 25 of them were treated with omalizumab. Among the 72 patients infected with SARS-CoV-2, 10 (13,9%) were on treatment with omalizumab and all developed moderate-severe COVID-19.…”