Analysis of clinical factors as possible predictors of response to omalizumab and relapse after treatment discontinuation in chronic spontaneous urticaria

Abstract

Omalizumab is a monoclonal anti‐IgE antibody which is effective in chronic spontaneous urticaria (CSU), although clinical response appears to be variable in the real‐life setting. The aim of this study was to evaluate whether the response of CSU to omalizumab and disease relapse are associated with individual and/or clinical characteristics of patients. We retrospectively evaluated the clinical records of 124 patients treated with omalizumab for moderate to severe CSU refractory to antihistamines. Disease activity was assessed using the urticaria activity score over the last 7 days (UAS7). After 24 weeks of treatment, 91% of patients showed complete remission (UAS7 = 0) or good control (UAS7 < 7) of CSU. Omalizumab was re‐administered in 45 patients because of recurrence of moderate to severe symptoms at week 8 after treatment discontinuation or later, and clinical results achieved with retreatment were similar to those observed in the first course. Among the parameters included in our analysis (age and sex of patients, documented history of atopy or autoimmune thyroid disease, CSU duration and baseline severity, concurrent angioedema, and association with chronic inducible urticaria), none was associated with response to omalizumab in our study population. Similarly, these parameters did not significantly differ between patients who experienced CSU relapse and those without relapse. Predictors of response to omalizumab treatment in CSU patients are still unclear, and further studies are needed to evaluate the presence of baseline factors that can influence treatment outcome.

Atopy and Response to Omalizumab Treatment in Chronic Spontaneous Urticaria

“…Our results are in line with the results of Foti C et al [7], a two-center study that also reported that atopy had no influence in omalizumab response in CSU patients. In contrast, Cakmak ME reported that atopic CSU patients are better responders to omalizumab [5].…”

“…We compared our results with previous studies that have also explored the possible influence of atopy on omalizumab response in CSU [5‒7]. It is known that some techniques of skin prick testing may be more likely to trigger dermographism.…”

“…Cakmak ME reported that CSU patients with atopy (n = 77 in a total of 220; 35%) are good responders to omalizumab, since in this study, response rate in atopic patients (n = 73, in a total of 77; 95%) was significantly higher than in non-atopic patients (n = 116, in a total of 143; 81%) (p = 0.0045) [5]. On the other hand, Mehta H et al stated that the presence of atopy in patients with CSU (n = 13 in a total of 56; 23%) was associated with a lack of response to omalizumab and Foti C et al that the presence of atopy (n = 14 in a total of 124; 11%) did not influence the pattern of response to OMZ [6,7].…”

Sex, Allergic Diseases and Omalizumab

“…With respect to sex and recurrence, there is no correlation with age, body mass index, peripheral eosinophil counts, total IgE levels, D-dimer levels, plasma prothrombine levels or C-reactive protein, and no sex differences in tolerability or safety are observed [ 113 ]. In contrast, other authors found no significant differences in sex, age and thyroid autoimmunity between responders and non-responders in CSU patients treated with omalizumab [ 114 ]. The pathogenic role played by female hormones in CU and allergic asthma, both of which exhibit a good response to omalizumab and high prevalence in females, highlights the possible action of omalizumab directly on sex hormones, or indirectly on the downstream mechanisms they mediate.…”

Stepping Down Treatment in Chronic Spontaneous Urticaria: What We Know and What We Don’t Know

“…In some studies, but not others, higher rates of relapse were linked to long pre-treatment disease duration, being female, fast response to treatment, or high baseline disease activity [36][37][38]. While these markers may predict relapse on a group level, they are not useful for the prediction of relapse or for guiding stepping-down decisions for individual patients.…”