Omalizumab Improves Quality of Life and Asthma Control in Chinese Patients With Moderate to Severe Asthma: A Randomized Phase III Study

Jing Li,Jian Kang,Changzheng Wang,Jing Yang,Linda Wang,Ioannis Kottakis,Michael Humphries,Nanshan Zhong,China Omalizumab Study Group 대한천식알레르기학회 2016 Allergy, Asthma & Immunology Research Vol.8 No.4

Purpose: Omalizumab is the preferred add-on therapy for patients with moderate-to-severe persistent allergic asthma and has demonstrated efficacy and safety in various ethnicities. This study evaluated the efficacy and safety of omalizumab in Chinese patients with moderate-to-severe allergic asthma. Methods: This randomized, double-blind, parallel-group, placebo-controlled, phase III study assessed lung function, quality of life, asthma control, and safety of omalizumab after 24-week therapy in Chinese patients (18-75 years of age). Results: A total of 616 patients were randomized (1:1) to omalizumab or placebo. The primary endpoint, least squares mean treatment difference (LSM-TD) in morning peak expiratory flow (PEF) (omalizumab vs placebo), at Weeks >20-24 was 8.85 L/min (Full analysis set; P=0.062). Per-protocol analysis set showed significant improvements with LSM-TD of 11.53 L/min in mean mPEF at Weeks >20-24 (P=0.022). The FEV1 % predicted was significantly improved with omalizumab vs placebo from 8 to 24 weeks (after 24-week treatment: LSM-TD=4.12%; P=0.001). At Week 24, a higher proportion of omalizumab-treated patients achieved clinically relevant improvements in standardized AQLQ (58.2% vs 39.3%; LSM=0.51 vs 0.10; P<0.001) and ACQ (49.5% vs 35.5%; LSM=-0.51 vs -0.34; P=0.002) scores vs placebo. Total and nighttime symptom scores reduced significantly with omalizumab vs placebo (LSM-TD=-0.21, P=0.048 and -0.12, P=0.011, respectively). Although the study was not powered to study differences in exacerbation rates (P=0.097), exacerbations in winter months were less frequent in the omalizumab vs placebo group (2 vs 21). Adverse event and severe adverse event rates were comparable between omalizumab and placebo. Conclusions: Omalizumab improves lung function, quality of life, and asthma control in Chinese patients with moderate-to-severe persistent allergic asthma and has a good safety profile.

P040 Treatment effect of omalizumab on recalcitrant chronic idiopathic urticaria

( Yong-yon Won ),( Seung-hee Loh ),( Young-jun Oh ),( Dong-woo Suh ),( Bark-lynn Lew ),( Woo-young Sim ) 대한피부과학회 2016 대한피부과학회 학술발표대회집 Vol.68 No.2

<div style="display:none">fiogf49gjkf0d</div><div style="display:none">fiogf49gjkf0d</div><div style="display:none">fiogf49gjkf0d</div><div style="display:none">fiogf49gjkf0d</div><div style="display:none">fiogf49gjkf0d</div><div style="display:none">fiogf49gjkf0d</div><div style="display:none">fiogf49gjkf0d</div> Background: Chronic idiopathic urticaria (CIU), defined as the occurrence of daily, or almost daily, wheals and itching for at least 6 weeks, with no obvious cause.. Omalizumab is a humanized antibody against IgE drug that has proved to be effective in the treatment of recalcitrant chronic urticaria patients who do not respond to conventional therapy. Objectives: To investigate treatment effect of omalizumab on recalcitrant chronic idiopathic urticaria. Methods: We retrospectively reviewed four patients(3 men, 1 woman; mean age, 35 years) of CIU resistant to high dose antihistiamines, oral cyclosporine, and corticosteroid for several months. All patients showed normal blood laboratory results except elevated IgE level. They have been injected a 300-mg dose of omalizumab for 2 times at a 4 week interval. We used standard seven-day urticarial activity score(UAS7) to assess omalizumab response. Results: Two had a remarkable response to omalizumab (UAS7=0) and the others had no response with stationary UAS7 score (UAS7=18, 19). There was no side effect after injection of omalizumab. Conclusion: Although two patients didn’t show response to omalizumab, our cases suggest that omalizumab may be a potentially interesting treatment for a certain subset of patients with chronic and refractory urticaria. In conclusion, our study showed that omalizumab partially effective in CIU resistant with conventional treatment.

Cyclosporine 저항성 만성 자발성 두드러기환자에서 Omalizumab 치료에 대한 단일기관 후향적 연구

김학준 ( Hak-jun Kim ),김우일 ( Woo-il Kim ),신기혁 ( Kihyuk Shin ),손진화 ( Jin-hwa Son ),이원구 ( Won-ku Lee ),김훈수 ( Hoon-soo Kim ),김병수 ( Byungsoo Kim ),김문범 ( Moon-bum Kim ),고현창 ( Hyun-chang Ko ) 대한피부과학회 2021 대한피부과학회지 Vol.59 No.3

Background: Cyclosporine is a recommended third-line treatment for chronic spontaneous urticaria (CSU) that is resistant to H1-antihistamines according to the EAACI/GA²LEN/EDF/WAO guidelines for management of urticaria. However, some patients with refractory urticaria do not respond to cyclosporine or antihistamines. Omalizumab, a humanized anti-immunoglobulin E antibody, has been shown to be effective and safe for antihistamine-resistant CSU. However, there are few reports on the efficacy of omalizumab in patients with CSU who are resistant to cyclosporine. Objective: To evaluate the efficacy of omalizumab in patients with cyclosporine-resistant CSU. Methods: Recalcitrant CSU patients who had symptoms (seven-day urticaria activity score, UAS7≥7) despite being administered cyclosporine (3∼5 mg/kg/day) and H1-antihistamine at up to a four-fold increased dose for 4 weeks were included in this study. Omalizumab was administered at 150 mg or 300 mg by subcutaneous injection every 4 weeks. Efficacy was assessed using UAS7 12 weeks after the initial administration of omalizumab. Results: A total of 28 patients (18 women, 10 men) with an average age of 43.8 years were included in the study. The mean duration of CSU was 40.0 (2∼288) months, and the mean UAS7 at baseline was 14.2 (9∼35) months. Overall, 22 patients (78.6%) showed a complete (UAS7=0) or partial response (0<UAS7≤6) at 12 weeks. Patients who were administered 300 mg of omalizumab had a more complete response (9/15, 60%) than those who were treated with 150 mg (3/13, 23.1%). Conclusion: Omalizumab is an effective therapy for CSU patients who do not respond to cyclosporine. (Korean J Dermatol 2021;59(3):175∼180)

Therapeutic Effect of Omalizumab in Severe Asthma: A Real-World Study in Korea

Lee, Ji-Ho,Lee, Hyun Young,Jung, Chang-Gyu,Ban, Ga-Young,Shin, Yoo Seob,Ye, Young-Min,Nahm, Dong-Ho,Park, Hae-Sim The Korean Academy of Asthma, Allergy and Clinical 2018 Allergy, Asthma & Immunology Research Vol.10 No.2

<P><B>Purpose</B></P><P>Omalizumab, an anti-immunoglobulin E (IgE) monoclonal antibody, has proved to be effective for the treatment of severe asthma. However, there is no direct evidence of effectiveness of omalizumab in Korean patients with severe asthma. We sought to evaluate the real-world effectiveness of omalizumab in Korean adult patients suffering from severe asthma and to identify predictors of favorable response.</P><P><B>Methods</B></P><P>A retrospective analysis of electrical medical records was performed on severe allergic asthmatic patients with omalizumab treatment group (OT group) for more than 6 months between March 2008 and February 2016. Propensity score matching was applied to define the standardized treatment control group (STC group) treated without omalizumab. Asthma-related outcomes were compared between the 2 groups, and analyzed before and after omalizumab use in the OT group. Responders to treatment were defined as patients showing >50% reduction in asthma exacerbations and/or systemic steroid requirement during the outcome period.</P><P><B>Results</B></P><P>One hundred twenty-four patients with severe asthma (62 in the OT group; 62 in the STC group) were enrolled in the study. Proportion of patients having the reduction of asthma exacerbation (53.2% vs 35.5%, <I>P</I>=0.015) and the rate of responders (67.7% vs 41.9%, <I>P</I>=0.007) were significantly higher in the OT group than in the STC group. Significant reductions were noted in asthma exacerbation (<I>P</I>=0.006), hospitalization (<I>P</I>=0.009), hospitalization days (<I>P</I>=0.006), systemic corticosteroid requirements (<I>P</I>=0.027), and sputum eosinophil count (<I>P</I>=0.031) in OT group compared with STC group. There were no significant differences in changes of forced expiratory volume in the 1 second (FEV1) levels between the 2 groups. No predictors of responders were found for omalizumab treatment.</P><P><B>Conclusions</B></P><P>Omalizumab can reduce exacerbations/hospitalization/systemic steroid burst in Korean adult patients with severe asthma.</P>

FCP 1 : A case of chronic urticaria treated with omalizumab

( Young Chae Lee ),( Tae Young Han ),( June Hyunkyung Lee ),( Sook Ja Son ) 대한피부과학회 2014 대한피부과학회 학술발표대회집 Vol.66 No.1

Chronic urticaria is defined as the presence of spontaneously occurring wheals with pruritus lasting at least 6 weeks, sometimes accompanied with angioedema. It may be idiopathic or autoimmune as defined by the presence of the IgG anti-IgE receptor, α subunit antibodies, or IgG anti-IgE antibodies. Recent treatment guideline recommends the use of non-sedating antihistamines up to fourfold dosage as the first line of treatment, followed by leukotriene antagonist, and lastly systemic immunosuppressants or omalizumab. Omalizumab is a recombinant humanized monoclonal antibody that blocks the high-affinity Fc receptor of IgE. A 14-year-old male presented with chronic urticaria. Along the guideline, he was treated by high-dose anti-histamines, corticosteroids and cyclosporine and no improvement was shown. So we decided to use omalizumab. The patient experienced a remarkable response to omalizumab. But during the observation period, the response disappeared and showed flare-ups. He had been injected omalizumab for 4 times. Along the injection schedule, the symptoms were repeated wax and wane. In conclusion, omalizumab is an excellent treatment choice for those who with severe, chronic refractory urticaria usually recommended treatments with prednisone. However, it does not seem to be a cure for the disease, but a symptomatic treatment. Herein, we report the case of the effects of omalizumab in the treatment of chronic urticaria.

Use of omalizumab in combination with oral immunotherapy in a 6-year-old boy with atopic dermatitis and an egg white allergy

( Jee Hee Son ),( Yong Se Cho ),( Yun Sun Byun ),( Bo Young Chung ),( Hye One Kim ),( Hee Jin Cho ),( Chun Wook Park ) 대한피부과학회 2016 대한피부과학회 학술발표대회집 Vol.68 No.1

In atopic dermatitis (AD), food allergy sometimes occurs in same patients, about 10-20%. Most common allergic foods in children are egg, peanut and milk. Children often outgrow allergies to milk and egg. There are reports of success in several clinical trials of oral food allergen immunotherapy (OIT) for milk, egg and peanut. However, patients with high specific IgE levels to certain food are refractory to OIT. Combined with OIT, omalizumab has been used in peanut and milk allergy to reduce allergic reactions. Here we report a use of omalizumab in combination with OIT in 6 year-old boy with AD and an egg white allergy. He has AD since 2 years old and at first visit, the CAP-RAST test showed high level in egg white, milk and peanut (Class 5, 2 and 2). In food challenge test, only egg white allergy was diagnosed. He had no reaction when he ate milk or peanut. 4 years later, he underwent an egg OIT, but failed after given 0.2mg of powdered egg white. We decided to use omalizumab. After 4 consecutive monthly omalizumab (150mg) injections, specific IgE antibodies to milk and egg were slightly reduced but persistent elevated (Class 3 and 1). He underwent an egg OIT and failed again after given 0.4mg of powdered egg white. 3rd egg OIT will be planned after 4 more consecutive monthly omalizumab injections. Our case suggests omalizumab can also be considered as a combination therapy with egg OIT, not only milk and peanut OIT.

Omalizumab on Chronic Spontaneous Urticaria and Chronic Inducible Urticaria: A Real-World Study of Efficacy and Predictors of Treatment Outcome

Jeong Soo Hyun,Lim Dong Jun,Chang Sung Eun,Kim Kwang Ho,Kim Kwang Joong,Park Eun Joo 대한의학회 2022 Journal of Korean medical science Vol.37 No.27

Background: Omalizumab is a very important drug for the treatment of chronic urticaria. Although omalizumab’s therapeutic efficacy has been demonstrated, data on real-world experiences in Korea, especially regarding chronic inducible urticaria (CIndU), are limited. This study attempted to compare the efficacy of omalizumab in Korean chronic spontaneous urticaria (CSU) and CIndU patients. Methods: Fifty-two CSU and 29 CIndU patients were included and Urticaria Activity Score 7 (UAS7) at baseline, week 4, and week 12 was assessed retrospectively. Results: Omalizumab 150 mg significantly decreased UAS7 in both patients with CSU and CIndU with only one dose (P < 0.001). The significant decrease in the UAS7 scores of both groups of patients continued from weeks 4 to 12. Although there was no significant difference in treatment efficacy between the two groups, the symptoms of patients with CSU tended to improve faster; furthermore, the number of antihistamines administered daily reduced more significantly in this patient group (P = 0.047). Additionally, the decrease in the UAS7 score between baseline and week 12 and the response rate were higher in patients with CSU. Conclusion: Omalizumab may be slightly more effective against CSU than against CIndU. Regarding the CIndU subtypes, dermatographic urticaria was associated with the greatest reduction in the UAS7 score, and patients with this condition showed the highest response rate, indicating the best effect of omalizumab. The duration of chronic urticaria was greater in non-responders than in responders (P = 0.025). Conversely, baseline immunoglobulin E levels were significantly higher in responders (P = 0.039).

Effects of Omalizumab Treatment in Patients With Refractory Chronic Urticaria

남영희,김주희,진현정,황의경,신유섭,예영민,박해심 대한천식알레르기학회 2012 Allergy, Asthma & Immunology Research Vol.4 No.6

Purpose Chronic urticaria (CU) is a common and debilitating disease, and the need for effective treatment has increased. Omalizumab may be an alternative regimen in patients with CU who do not respond to conventional treatments. The aim of this study is to investigate the efficacy and to observe the clinical results of omlizumab in patients with refractory CU. Methods We conducted a retrospective analysis of 26 patients with refractory CU who were treated with omalizumab. Omalizumab was administered every 2 or 4 weeks, depending on body weight and the total serum IgE level, for 24 weeks. Results Fourteen patients (53.8%) achieved remission after the treatment; they had a significantly higher prevalence of personal (P=0.033) and family history of allergic diseases (P=0.002) than those who did not achieve remission. During omalizumab treatment, the urticaria activity score declined significantly (12.11±1.97 to 2.7±4.23; P=0.001) and the CU-quality of life score improved significantly (34.65±13.58 to 60.88±11.11; P=0.004). There were significant decreases in the use of systemic steroids (42.3%-11.5%; P=0.027) and immunomodulators (65.4%-19.2%; P=0.002). The dose of antihistamines required to control CU also decreased significantly (215.66±70.06 to 60.85±70.53 mg/week of loratadine equivalents; P<0.001). No serious adverse event was noted. Conclusions These findings suggest that omalizumab can be an effective and safe treatment in patients with refractory CU. Keywords: Chronic urticaria, refractory, omalizumab.

Real-life Efficacy of Omalizumab After 9 Years of Follow-up

Francesco Menzella,Carla Galeone,Debora Formisano,Claudia Castagnetti,Patrizia Ruggiero,Anna Simonazzi,Luigi Zucchi 대한천식알레르기학회 2017 Allergy, Asthma & Immunology Research Vol.9 No.4

Omalizumab is frequently used as add-on treatment to inhaled corticosteroids (ICS) and long-acting β2-agonists in patients with suboptimal control of severe asthma. Patients with severe asthma will typically require chronic treatment, although due to the limited amount of data available there are still some concerns about the safety and efficacy of long-term therapy with omalizumab. Herein, in an extension of a previous 4-year study, we report disease-related outcomes of 8 patients with severe persistent allergic asthma who have been followed for a total of 9 years in a real-life setting. Both quality of life (QoL) (evaluated using the Juniper Asthma-Related QoL Questionnaire [AQLQ]) and forced expiratory volume in 1 second (FEV1) showed sustained improvement at 9 years. The median values of AQLQ and FEV1 at 4 years were 5.5 and 82.0% compared to 5.9 and 85.5%, respectively, at 9 years, which were all significantly increased from baseline. After 9 years, the mean annual number of severe exacerbations was 0.63 compared to 5 at baseline. There also appeared to be a trend toward use of a lower dose of ICS at longer follow-up times. After 9 years, there were no safety concerns for continued use of omalizumab, and no asthma-related hospitalizations or emergency department visits were documented over the last 5 years. The present analysis is the longest reported clinical follow-up of omalizumab. Long-term maintenance treatment with omalizumab for up to 9 years is associated with continued benefits in reducing symptoms, exacerbations, and medication burden without any safety concerns.

Omalizumab 투여로 호전된 반복적 아나필락시스를 보인 전신 비만세포증 1예

문홍란,장희준,이춘근,김영찬,유신혜,이동순,강혜련 대한내과학회 2018 대한내과학회지 Vol.93 No.1

Mastocytosis is a disorder characterized by abnormal mast cell proliferation and accumulation in one or more tissues. It presents in two major variants: cutaneous mastocytosis and systemic mastocytosis. Because the symptoms are related to mast cells, histamine receptor antagonists and leukotriene receptor antagonists are recommended as therapeutic options. Here, we report a 54-year-old male patient with a history of urticaria pigmentosa who presented with recurrent anaphylaxis. His serum tryptase level was 31.7 ng/mL and mast cell infiltration was observed in his bone marrow. He had frequent attacks of anaphylaxis despite treatment with ketotifen, levocetirizine, and montelukast. Symptoms related to systemic mastocytosis were controlled and the patient exhibited no recurrence of anaphylaxis following the introduction of monthly omalizumab injection. Omalizumab can be considered as a treatment option in patients with systemic mastocytosis unresponsive to conventional oral medications. 저자들은 빈번한 아나필락시스를 보이는 환자에서 비활동성 비만세포증을 확진하였으며, omalizumab으로 효과적으로 치료하였기에 문헌고찰과 함께 보고하는 바이다.