*For medical professionals only
Omalizumab is an anti-IgE humanized monoclonal antibody that is the world's first and only biologic agent approved for CSU with poorly controlled antihistamines, and has accumulated a large amount of evidence-based medical evidence of efficacy and safety in recent years.
Chronic spontaneous urticaria (CSU) is an inflammatory skin disorder characterized by recurrent episodes of wheals, pruritus, and angioedema over 6 weeks. It has been reported that more than half of CSU patients have a course of more than 5 years [1], and the long-term chronic itching and wheal symptoms of CSU have caused a huge burden on patients, seriously damaging their quality of life and mental health.
Recently, a Chinese real-world study published in the World Allergy Organization Journal evaluated the efficacy and safety of omalizumab in all age groups of CSU patients of all ages [2], and the results showed that omalizumab treatment for 12 weeks, the treatment response rate of all age CSU people was as high as 98.7%, effectively improving patients' symptoms and improving quality of life.
This real-world retrospective and observational study collected and analyzed 235 patients with CSU who received omalizumab between October 2018 and August 2021, of whom 54.0% (n=127/235) were women. The average age of patients was 34 years. All patients received omalizumab at least 3 sessions with a mean duration of treatment of 3.4 ± 1.0 months. The urticaria activity score (UAS7) was used to evaluate disease activity and the treatment effect of omalizumab, and the quality of life improvement was assessed by chronic urticaria quality of life questionnaire (CU-Q2oL), dermatological quality of life index (DLQI) and children's dermatological quality of life index (CDLQI).
The overall response rate was as high as 98.7% at 12 weeks,
The vast majority of patients benefit from omalizumab therapy
The results of the study showed that omalizumab had a rapid onset of action in the treatment of CSU. Within the first four weeks of treatment, 96.2% (n=226/235) of patients responded and 76.6% (n=180/235) achieved complete control (CR). At the end of week 12, the proportion of patients responding to treatment increased to 98.7% (n=232/235), and 91.1% (n=214/235) of patients achieved complete control (CR). Consistent with good response to omalizumab, up to 95.3% (n=224/235) of patients achieved UAS7<7 (i.e., "asymptomatic" and "well-controlled") by the end of week 12.
Patients < 12 years of age were all completely controlled by the end of week 8
At the end of 12 weeks, 98.4% (n=186/189) of patients aged > 18 years responded to omalizumab and 89.9% (n=170/189) achieved CR. Twenty-six patients aged < 12 years also showed a good response to omalizumab, with 84.6% (n=22/26) achieving CR by the end of week 4. Patients of all ages < 12 years reached CR at the end of week 8 of treatment and maintained CR continuously throughout treatment.
Figure 1 A. Percentage of patients with no response, partial response, or complete response during omalizumab treatment B. Percentage of patients under 12 years of age who did not respond, partially respond, or fully respond during omalizumab treatment
Clinical symptoms of patients of all age groups,
The quality of life has been continuously improved
According to the results of UAS7 and CU-Q2oL scores, the patient's clinical symptoms and quality of life improved significantly at the end of week 4 and continued to improve during omalizumab treatment. At the end of the fourth week, both UAS7 and CU-Q2oL scores dropped significantly. After 12 weeks of treatment, UAS7, CU-Q2oL, DLQI, and CDLQI scores all decreased significantly. All of the above clinical scores related to efficacy and quality of life remained low during treatment.
At the end of week 12, UAS7, CU-Q2oL, DLQI, and CDLQI scores in all age groups improved significantly from baseline. In patients under 12 years of age, the UAS7 score dropped to 0 at week 8 and remained unchanged throughout treatment.
Fig. 2 Changes in UAS7, CU-Q2oL, DLQI and CDLQI scores from baseline in all patients during treatment
Note: 168 patients aged 18 years were treated with CU-Q2oL and DLQI. CDLQI was used in 44 patients aged < 18 years.
Before starting omalizumab therapy, 73.2% (n=172/235) of patients received double doses of antihistamines (AH). At the end of omalizumab therapy, the proportion of patients using glucocorticosteroids decreased to 0.4%, and no patients received immunosuppressant therapy. At the same time, omalizumab treatment also reduced the use of AH in CSU patients. At the end of treatment, the double-dose AH and the combination of 3 AHs decreased to 5.1% and 0.4%, respectively, and the proportion of patients treated with standard-dose AH increased to 28.1%. It is worth noting that a significant proportion of patients discontinued treatment other than omalizumab at the beginning of treatment, effectively reducing the patient's medication burden.
After discontinuation of omalizumab therapy,
82.8% of patients did not relapse for a long time
87 patients completed follow-up 3~9 months after the end of treatment. Among them, 82.8% (n=72/87) did not relapse, and none of the patients aged < 12 years (17.2%, n=15/87) did not relapse during follow-up. There were no differences in demographic characteristics, duration of disease, baseline clinical scores, and laboratory findings between relapsed and non-relapsed patients.
Table 1 Clinical features and laboratory test results of relapsed and non-relapsed patients
At the end of week 12, 84.7% (n=199/235) of patients had discontinued omalizumab therapy, with a maximum duration of 28 weeks. During treatment, only 2.6% (n=6/235) of patients reported adverse events (AEs). The most common AEs were injection site reactions with no serious adverse events.
Summary:
In April this year, the innovative biologics omalizumab was approved by the National Medical Products Administration for the treatment of "adults and adolescents (12 years and older) with chronic spontaneous urticaria who remain symptomatic after treatment with H1 antihistamines", providing a new treatment option for CSU patients. In addition, several studies have demonstrated the multiple benefits of omalizumab in the treatment of chronic spontaneous urticaria. Patients treated with omalizumab for chronic spontaneous urticaria saw symptomatic relief as quickly as the same day [3,4], with real-world response rates of over 90 percent [5], significantly improving quality of life scores by nearly 80 percent [6].
In this latest real-world study, it was found that children of all ages, including age < 12 years, achieved rapid remission and improved quality of life after omalizumab. In general, omalizumab performed well in terms of therapeutic effect, response rate and safety in CSU patients of all ages in China. Omalizumab is also an effective and well-tolerated treatment option particularly in patients with CSU < 12 years of age.
Expert profiles
Professor Yao Xu
- Chief physician, doctoral supervisor. Director of the Department of Allergy and Rheumatology and Immunology, Institute of Dermatology, Chinese Academy of Medical Sciences
- Academic Appointments:
- Member of the Standing Committee of the Allergist Branch of the Chinese Medical Doctor Association
- Member of Allergology Branch of Chinese Medical Association
- Vice Chairman of the Allergy Subspecialty Committee of the Dermatologist Branch of the Chinese Medical Doctor Association
- Vice Chairman of the Allergology Branch of Jiangsu Medical Association, etc
Expert profiles
Professor Yunsheng Liang
- Director of the Department of Dermatology, Dermatology Hospital, Southern Medical University, doctoral supervisor, postdoctoral cooperation supervisor
- Member of the Immunology Group of the Dermatology and Venereology Branch of the Chinese Medical Association
- Member of the Dermatology Group of the Allergology Branch of the Chinese Medical Association
-
Member of the Allergy (Allergy) Subspecialty Committee and Youth Committee of the Dermatologist Branch of the Chinese Medical Doctor Association
- National member of the Allergology Professional Committee of the Chinese Association of Integrative Medicine
- 2014 "China Outstanding Young and Middle-aged Dermatologist Award"
- 2015 "Hunan Province Excellent Doctoral Dissertation Award"
- 2016 Chinese Medical Association Dermatology and Venereology Branch "Annual Academic Award"
- 2017 China Allergology First Top Ten "Outstanding Youth Award"
- The first Guangdong Province "Outstanding Medical Young Talents" in 2018
- 2019 "Lingnan Famous Doctor"
- The first prize of the "Most Influential Research Award" in Chinese dermatovenereology in 2020
-
He has presided over 4 projects of the National Natural Science Foundation of China, participated in 5 key projects such as the 973 Program, and published more than 10 SCI papers in JACI, Arthritis Rheumat, Allergy and other journals.
-
Proficient in the clinical diagnosis and treatment of various common, difficult and critical skin diseases, good at the clinical diagnosis and treatment of allergic, autoimmune and critical skin diseases, as the author of a number of national diagnosis and treatment guidelines or consensus
Bibliography:
[1] Li J, Mao D, Liu S et al. Epidemiology of urticaria in China: a population-based study. Chin Med J (Engl) 2022; 135: 1369-1375.
[2] Wang et al. Efficacy and safety of omalizumab against chronic spontaneous urticaria: Real-world study from China. World Allergy Organization Journal （2022） 15:100719.
[3] Marcus Maurer, et al. J Allergy Clin Immunol. 2011 Jul;128(1):202-209.e5.
[4] Metz M, et al. Journal of Dermatological Science. 2014,73:57–62.
[5] Tharp MD, et al. JAMA Dermatol. 2019 Jan 1;155(1):29-38.
[6] Maurer M, et al. N Engl J Med 2013;368:924−35.
This article is only for providing scientific information to healthcare professionals and does not represent the position of the platform.