Omalizumab in chronic spontaneous and inducible urticaria: a 9 year retrospective study in Portugal

Abstract

Describe the safety and long-term use of omalizumab in chronic urticaria (CU), both spontaneous (CSU) and inducible (CIndU). Retrospective chart-review (2006-15) of CU patients treated with omalizumab for ≥ 6 months. Statistical analyses: descriptive statistics, Mann-Whitney, generalized linear models. 23 patients with CSU (3 men), 3 with CIndU (2 men). Generalized linear models showed UAS reduction per omalizumab administration of 16% in CIndU and CSU and UAS7, of 15% in CIndU, and 20% in CSU. DLQI score at baseline had a median of 19 (CIndU and CSU) and after omalizumab a median of 0 (in both). Seven CSU patients stopped omalizumab and remain asymptomatic. No side-effects were observed. Omalizumab is safe and efficacious in CU. Stopping omalizumab can be tried, as some patients achieve remission.

Long‐term follow‐up effect of omalizumab in chronic spontaneous urticaria and its association with serum C‐reactive protein levels

“…For the patients in our study cohort who achieved remission free of omalizumab, average treatment duration was 21 months. Another important finding in our cohort, also shown by Metz et al 19 and Marcelino et al20 is that there is no decrease in the effect of omalizumab when reinitiating after it has been discontinued.…”

“…Overall, approximately 41% to 48% of patients in clinical trials 2,5,7 and 12% to 23% in “real‐world clinical setting” 13,19,23‐26 do not have a complete or significant response to omalizumab therapy. However, there are also some studies of omalizumab in the literature without any non‐responder patients 20 . Relatively high percentage of non‐responders in our cohort may be due to high number of patients and, being more resistant to various therapy options which are usually referred to our tertiary research center.…”

“…However, there are also some studies of omalizumab in the literature without any nonresponder patients. 20 Relatively high percentage of non-responders in our cohort may be due to high number of patients and, being more resistant to various therapy options which are usually referred to our tertiary research center.…”

“…In agreement with other studies, [16][17][18] Thirty-seven percent of patients in our study group were nonresponders, which was similar to previous data reported by Har et al 21 and Savic et al 22 but higher than some other studies. 18,20 Overall, approximately 41% to 48% of patients in clinical trials 2,5,7 and 12% to 23% in "real-world clinical setting" 13,19,[23][24][25][26] do not have a complete or significant response to omalizumab therapy. However, there are also some studies of omalizumab in the literature without any nonresponder patients.…”

The impact of omalizumab on quality of life and its predictors in patients with chronic spontaneous urticaria: Real‐life data

“…Furthermore, most of the previous studies are limited by the small number of patients and lack of detailed analysis of subscales. A total 89 of patients with CSU were enrolled in seven studies (n = 2-28) and a significant improvement in DLQI scores was obtained following omalizumab treatment (Kai, Flohr, & Grattan, 2014;Kaplan, Joseph, Maykut, Geba, & Zeldin, 2008;Lefévre, Deleuran, & Vestergaard, 2013;Marcelino et al, 2018;Savic et al, 2015;Subramaniyan & Chopra, 2016;Vestergaard & Deleuran, 2010). Accordingly with our results, the decrease in DLQI scores was most significant during the first month of treatment and then stabilized as long as the treatment is continued (Kai et al, 2014;Lefévre et al, 2013;Vestergaard & Deleuran, 2010 Consistently with our findings, two previous studies including 14 and 18 patients have reported a significant decrease in CU-Q2oL-total scores which was maintained up to 6 months (Büyüköztürk et al, 2012;Larrea-Baca & Gurpegui-Resano, 2017).…”