1.Efficacy, safety, and factors influencing efficacy of omalizumab in the treatment of chronic spontaneous urticaria: a prospective, single-center study
Miaomiao ZHAO ; Peiyao YU ; Haiqian YANG ; Yingyao YU ; Li MA ; Wenjia MOU ; Yuanyuan SHANG
Chinese Journal of Dermatology 2024;57(12):1091-1098
Objective:To evaluate the efficacy of omalizumab in the treatment of chronic spontaneous urticaria (CSU), and to analyze its influencing factors.Methods:CSU patients treated with omalizumab were prospectively enrolled from the Department of Dermatology, General Hospital of Ningxia Medical University from October 2021 to October 2023. These patients received subcutaneous injections of omalizumab at a dose of 300 mg every 4 weeks (150 mg for patients aged under 12 years) for at least 3 consecutive sessions. Data on general information, blood routine test, and serum total IgE levels were collected, and the 7-day Urticaria Activity Score (UAS7), Urticaria Control Test (UCT), Dermatology Life Quality Index (DLQI), Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), and the Beck Anxiety Inventory (BAI) were evaluated by dermatologists at baseline, and after 4, 8, and 12 weeks of treatment. A decrease in UAS7 score of ≥ 11 points was defined as good disease control, while a decrease in UAS7 score of < 11 points was defined as poor control. Univariate binary logistic regression and multivariate logistic regression models were used to identify factors influencing the efficacy.Results:A total of 81 CSU patients were enrolled, including 34 males (42.0%) and 47 females (58.0%) ; their ages ranged from 6 to 66 years (39.2 ± 17.9 years), and the disease duration was 42.3 ± 6.9 months; the serum total IgE levels were 249.5 ± 216.3 IU/ml, with 54 patients (66.7%) showing elevated IgE levels (> 100 IU/ml). Compared with baseline levels, the UAS7, DLQI, and CU-Q2oL scores all significantly decreased at weeks 4, 8, and 12, while the UCT scores significantly increased (all P < 0.05). According to the UAS7 change values, 68 patients (83.9%) were well controlled, and 13 (16.1%) were poorly controlled. Univariate logistic regression analysis showed that higher total IgE levels and higher mean platelet volume (MPV) were associated with better efficacy, while higher body mass index (BMI), higher BAI, and the complication of other allergic diseases were associated with poorer efficacy (all P < 0.05). Multivariate logistic regression analysis indicated that BMI, BAI, and MPV significantly affected efficacy: higher MPV was associated with better efficacy ( OR = 3.36, 95% CI: 1.196 - 9.465, P = 0.020), while higher BMI ( OR = 0.76, 95% CI: 0.599 - 0.957, P = 0.016) and higher BAI ( OR = 0.92, 95% CI: 0.870 - 0.985, P = 0.021) were associated with poorer efficacy. During the whole study, only 4 patients (5%) experienced drowsiness, low fever, redness or discomfort at the injection sites, and no serious adverse events were reported. Conclusion:Omalizumab exhibited significant efficacy and high safety in the 12-week treatment of CSU, and BMI and BAI appeared to be risk factors for efficacy, while MPV seemed to be a protective factor affecting efficacy.
2.Expression of XBP1 and PD-L1 in cutaneous malignant melanoma and their clinical significance
Mou WENJIA ; MA LI ; Yu PEIYAO ; Zhao MIAOMIAO ; Shang YUANYUAN
Chinese Journal of Clinical Oncology 2024;51(21):1098-1102
Objective:To investigate the expression of X-box binding protein 1 (XBP1) and programmed death-ligand 1 (PD-L1) in cutaneous malignant melanoma (CMM) and their clinical significance. Methods:Fifty-three patients with CMM and fifty-six patients with pigmented nevus were selected from those admitted to the General Hospital of Ningxia Medical University between January 2017 and July 2023. The expression levels of XBP1 and PD-L1 in malignant melanoma tissues and pigmented nevus tissues were detected using immunohistochemic-al staining. The relationships between the expression levels of XBP1 and PD-L1 and the clinical characteristics of patients with CMM were then analyzed. Spearman's analysis was applied to assess the correlation between XBP1 and PD-L1 expression levels in CMM. Results:The expression levels of XBP1 and PD-L1 were significantly higher in CMM tissues than those in pigmented nevus tissues (P<0.05). Elevated XBP1 expression levels in patients with CMM were associated with clinical stages Ⅱ-Ⅳ and tumor-infiltrating lymphocytes (TILs) grade 2-3 (P<0.05). Similarly,elevated PD-L1 expression levels in patients with CMM were associated with ulceration of the primary foci,clinical stages Ⅱ-Ⅳ,Clark grades Ⅳ-Ⅴ,and TILs grades 2-3 (P<0.05). Spearman's analysis demonstrated a positive correlation between XBP1 and PD-L1 expression in CMM (P<0.05). Conclusions:XBP1 and PD-L1 can be used as molecular markers for the diagnosis and evaluation of CMM. Ad-ditionally,XBP1 may affect the development of CMM by regulating the expression of PD-L1,thereby altering the tumor microenvironment.
3.Efficacy, safety, and factors influencing efficacy of omalizumab in the treatment of chronic spontaneous urticaria: a prospective, single-center study
Miaomiao ZHAO ; Peiyao YU ; Haiqian YANG ; Yingyao YU ; Li MA ; Wenjia MOU ; Yuanyuan SHANG
Chinese Journal of Dermatology 2024;57(12):1091-1098
Objective:To evaluate the efficacy of omalizumab in the treatment of chronic spontaneous urticaria (CSU), and to analyze its influencing factors.Methods:CSU patients treated with omalizumab were prospectively enrolled from the Department of Dermatology, General Hospital of Ningxia Medical University from October 2021 to October 2023. These patients received subcutaneous injections of omalizumab at a dose of 300 mg every 4 weeks (150 mg for patients aged under 12 years) for at least 3 consecutive sessions. Data on general information, blood routine test, and serum total IgE levels were collected, and the 7-day Urticaria Activity Score (UAS7), Urticaria Control Test (UCT), Dermatology Life Quality Index (DLQI), Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), and the Beck Anxiety Inventory (BAI) were evaluated by dermatologists at baseline, and after 4, 8, and 12 weeks of treatment. A decrease in UAS7 score of ≥ 11 points was defined as good disease control, while a decrease in UAS7 score of < 11 points was defined as poor control. Univariate binary logistic regression and multivariate logistic regression models were used to identify factors influencing the efficacy.Results:A total of 81 CSU patients were enrolled, including 34 males (42.0%) and 47 females (58.0%) ; their ages ranged from 6 to 66 years (39.2 ± 17.9 years), and the disease duration was 42.3 ± 6.9 months; the serum total IgE levels were 249.5 ± 216.3 IU/ml, with 54 patients (66.7%) showing elevated IgE levels (> 100 IU/ml). Compared with baseline levels, the UAS7, DLQI, and CU-Q2oL scores all significantly decreased at weeks 4, 8, and 12, while the UCT scores significantly increased (all P < 0.05). According to the UAS7 change values, 68 patients (83.9%) were well controlled, and 13 (16.1%) were poorly controlled. Univariate logistic regression analysis showed that higher total IgE levels and higher mean platelet volume (MPV) were associated with better efficacy, while higher body mass index (BMI), higher BAI, and the complication of other allergic diseases were associated with poorer efficacy (all P < 0.05). Multivariate logistic regression analysis indicated that BMI, BAI, and MPV significantly affected efficacy: higher MPV was associated with better efficacy ( OR = 3.36, 95% CI: 1.196 - 9.465, P = 0.020), while higher BMI ( OR = 0.76, 95% CI: 0.599 - 0.957, P = 0.016) and higher BAI ( OR = 0.92, 95% CI: 0.870 - 0.985, P = 0.021) were associated with poorer efficacy. During the whole study, only 4 patients (5%) experienced drowsiness, low fever, redness or discomfort at the injection sites, and no serious adverse events were reported. Conclusion:Omalizumab exhibited significant efficacy and high safety in the 12-week treatment of CSU, and BMI and BAI appeared to be risk factors for efficacy, while MPV seemed to be a protective factor affecting efficacy.
4.Expression of XBP1 and PD-L1 in cutaneous malignant melanoma and their clinical significance
Mou WENJIA ; MA LI ; Yu PEIYAO ; Zhao MIAOMIAO ; Shang YUANYUAN
Chinese Journal of Clinical Oncology 2024;51(21):1098-1102
Objective:To investigate the expression of X-box binding protein 1 (XBP1) and programmed death-ligand 1 (PD-L1) in cutaneous malignant melanoma (CMM) and their clinical significance. Methods:Fifty-three patients with CMM and fifty-six patients with pigmented nevus were selected from those admitted to the General Hospital of Ningxia Medical University between January 2017 and July 2023. The expression levels of XBP1 and PD-L1 in malignant melanoma tissues and pigmented nevus tissues were detected using immunohistochemic-al staining. The relationships between the expression levels of XBP1 and PD-L1 and the clinical characteristics of patients with CMM were then analyzed. Spearman's analysis was applied to assess the correlation between XBP1 and PD-L1 expression levels in CMM. Results:The expression levels of XBP1 and PD-L1 were significantly higher in CMM tissues than those in pigmented nevus tissues (P<0.05). Elevated XBP1 expression levels in patients with CMM were associated with clinical stages Ⅱ-Ⅳ and tumor-infiltrating lymphocytes (TILs) grade 2-3 (P<0.05). Similarly,elevated PD-L1 expression levels in patients with CMM were associated with ulceration of the primary foci,clinical stages Ⅱ-Ⅳ,Clark grades Ⅳ-Ⅴ,and TILs grades 2-3 (P<0.05). Spearman's analysis demonstrated a positive correlation between XBP1 and PD-L1 expression in CMM (P<0.05). Conclusions:XBP1 and PD-L1 can be used as molecular markers for the diagnosis and evaluation of CMM. Ad-ditionally,XBP1 may affect the development of CMM by regulating the expression of PD-L1,thereby altering the tumor microenvironment.

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