Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria

Hide, Michihiro; Park, Hae‐Sim; Igarashi, Atsuyuki; Ye, Young-Min; Kim, Tae‐Bum; Yagami, Akiko; Roh, Joo‐Young; Lee, Jae Hyun; Chinuki, Yuko; Youn, Sang Woong; Lee, Soo Keol; Inomata, Naoko; Choi, Jeong Hee; Fukunaga, Atsushi; Wang, Junyi; Matsushima, Shin; Greenberg, S; Khalil, Sam

doi:10.1016/j.jdermsci.2017.03.009

Cited by 56 publications

(75 citation statements)

References 37 publications

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“…Phases II-IV clinical trials have consistently demonstrated the efficacy and safety of omalizumab in patients with CSU unresponsive to standard or increased doses of AHs. A summary of the data from pivotal phases II-IV trials is given in Table 2 [31][32][33][34][35][36][37][38][39][40]. Numerous real-life studies have confirmed these findings.…”

Section: Omalızumab: From Development To Current Challengesmentioning

confidence: 88%

Targeted Therapy for Chronıc Spontaneous Urtıcarıa: Ratıonale and Recent Progress

Giménez‐Arnau

Salman

2020

Drugs

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Chronic spontaneous urticaria (CSU) is characterized by the presence of wheals, angioedema, or both for at least 6 weeks. It may persist for a long time-up to 50% of the patients have been reported to be symptomatic 5 years after the onset. Some patients can suffer more than one episode of CSU during their lifetime. Considering the recurrences, disabling symptoms, and significant impact on quality of life, proper and effective treatment of CSU is critical. The use of antihistamines (AHs) is still the mainstay of treatment. However, given the low rates of response to AHs (38.6% and 63.2% to standard doses and higher doses, respectively), the complete control of symptoms seems difficult to attain. The use of omalizumab for CSU has been a major breakthrough in the care of patients with CSU. However, the partial response and lack of response to omalizumab in a subgroup of patients, as high as 70% in some studies, make the development of alternative treatments desirable. Ever-increasing knowledge on the pathogenesis is making new target molecules available and enabling drug development for CSU. In addition to drug repurposing as in anti-IL-4/13, IL-5, and IL-17 antibodies, novel targeted therapy options such as ligelizumab and Bruton's tyrosine kinase inhibitors are currently undergoing clinical trials and will be available in the near future. This article reviews the current challenges in the treatment of CSU, the pathogenesis and potential target molecules, and the rationale for novel treatments and their rapidly developing status.

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Section: Omalızumab: From Development To Current Challengesmentioning

confidence: 88%

Targeted Therapy for Chronıc Spontaneous Urtıcarıa: Ratıonale and Recent Progress

Giménez‐Arnau

Salman

2020

Drugs

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“… 17 The efficacy and safety of omalizumab in the treatment of CU has been demonstrated in many studies to date. 1 17 18 19 20 21 22 23 24 Omalizumab received US Food and Drug Administration approval as an add-on therapy for H 1 -antihistamine-refractory urticaria in 2014. In Korea, it was approved as an additional therapy in this patient group by the Ministry of Food and Drug Safety in 2017, based on the results of 1 randomized controlled trial (RCT) conducted in Korea and Japan.…”

Section: Omalizumabmentioning

confidence: 99%

“…In Korea, it was approved as an additional therapy in this patient group by the Ministry of Food and Drug Safety in 2017, based on the results of 1 randomized controlled trial (RCT) conducted in Korea and Japan. 18 …”

Section: Omalizumabmentioning

confidence: 99%

“…We identified 2,031 potentially relevant studies, of which 1,297 were reviewed after excluding duplicates and 985 were excluded following review of information provided in the title and abstract of the publications. After excluding case series with <10 subjects; systematic reviews or meta-analyses; post hoc analysis of existing randomized, placebo-controlled clinical trials; and articles not related to the treatment effects of omalizumab for CSU or those for which pre- and post-treatment response cannot be evaluated, 34 full-text articles were assessed: 8 RCTs 17 18 19 20 21 22 23 24 for Recommendation 1 and 26 observational studies 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 for Recommendation 2 ( Fig. 1 ).…”

Section: Omalizumabmentioning

confidence: 99%

“…Previous studies were primarily conducted in Western populations, with only one RCT conducted in Asian patients (Japanese and Korean). 18 Therefore, additional analysis was conducted to determine whether the dose-dependent treatment effects observed in Western populations remained valid in Asian populations. The Asian population also showed a significant improvement when treated with omalizumab 300 mg compared with 150 mg (mean difference, −3.65; 95% CI, −7.16, −0.14; P = 0.04; I 2 = not applicable; Fig.…”

Section: Omalizumabmentioning

confidence: 99%

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The KAAACI/KDA Evidence-Based Practice Guidelines for Chronic Spontaneous Urticaria in Korean Adults and Children: Part 2. Management of H1-Antihistamine-Refractory Chronic Urticaria

Choi

Lee

Song

et al. 2020

Allergy Asthma Immunol Res

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Quite a few patients with chronic spontaneous urticaria (CSU) are refractory to H 1 -antihistamines, even though the dose of H 1 -antihistamines is increased up to 4-fold. CSU that is not controlled with H 1 -antihistamines results in increased disease burden. Several immunomodulators have been used to manage these patients. The guidelines reported herein are connected to Part 1 of the KAAACI/KDA Evidence-Based Practice Guidelines for Chronic Spontaneous Urticaria in Korean Adults and Children, and aimed to provide evidence-based recommendations for the management of H 1 -antihistamine-refractory CSU. Part 2 focuses on the more commonly used additional treatment options for refractory CSU, including omalizumab, cyclosporine, leukotriene receptor antagonist, dapsone, methotrexate, and phototherapy. The evidence to support their efficacy, dosing, safety, and selection of these agents is systematically reviewed. To date, for patients with refractory CSU, the methodologically sound data to evaluate the use of omalizumab has been growing; however, the evidence of other immunomodulators and phototherapy is still insufficient. Therefore, an individualized stepwise approach with a goal of achieving complete symptom control and minimizing side effects can be recommended. Larger controlled studies are needed to elevate the level of evidence to select a rational therapeutic agent for patients with refractory CSU.

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Evaluation of Pharmacologic Treatments for H₁ Antihistamine–Refractory Chronic Spontaneous Urticaria

et al. 2021

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IMPORTANCEThe comparative benefits and harms of all available treatments for H 1 antihistamine-refractory chronic spontaneous urticaria (CSU) have not been established. OBJECTIVE To evaluate different treatment effects of pharmacologic treatments among patients with H 1 antihistamine-refractory CSU.DATA SOURCES Searches were conducted of MEDLINE, Embase, PubMed, Cochrane Library, Web of Science, Scopus, and CINAHL from inception to April 19, 2021, with no language restrictions. Gray literature from Google Scholar, ongoing trial registers, and preprint reports was added to the searches of electronic databases.STUDY SELECTION Randomized clinical trials using validated measurement tools that investigated the benefits and harms of pharmacologic treatments among adolescent or adult patients with CSU who had an inadequate response to H 1 antihistamines were screened for inclusion independently by 2 investigators. DATA EXTRACTION AND SYNTHESISTwo investigators independently extracted study data according to the predefined list of interests. A random-effects model was used to calculate the network estimates reported as standardized mean differences and odds ratios with corresponding 95% CIs. MAIN OUTCOMES AND MEASURESThe primary outcomes that reflect the patient's perspective included changes in urticaria symptoms from baseline and unacceptability of treatment (all-cause dropouts).RESULTS Twenty-three randomized clinical trials with 2480 participants that compared 18 different interventions or dosages and placebo were included. The standardized mean differences for change in urticaria symptoms were −1.05 (95% CI, −1.37 to −0.73) for ligelizumab, 72 mg; −1.07 (95% CI, −1.39 to −0.75) for ligelizumab, 240 mg; −0.77 (95% CI, −0.91 to −0.63) for omalizumab, 300 mg; and −0.59 (95% CI, −1.10 to −0.08) for omalizumab, 600 mg. No significant differences in treatment unacceptability were observed. With respect to benefits and harms, the network estimates illustrated that the most efficacious treatments were achieved with ligelizumab, 72 or 240 mg (large beneficial effect) and omalizumab, 300 or 600 mg (moderate beneficial effect). CONCLUSIONS AND RELEVANCEThe findings in this meta-analysis suggest that the biologic agents ligelizumab, 72 or 240 mg, and omalizumab, 300 or 600 mg, can be recommended as effective treatments for patients with CSU who have had an inadequate response to H 1 antihistamines. Head-to-head trials with high methodologic quality and harmonized design and outcome definitions are needed to help inform subsequent international guidelines for the management of CSU.

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Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria

Abstract: The POLARIS study demonstrates that omalizumab is an efficacious and well-tolerated add-on therapy in Japanese and Korean H1AH-refractory patients with CSU.

Cited by 56 publications

References 37 publications

Targeted Therapy for Chronıc Spontaneous Urtıcarıa: Ratıonale and Recent Progress

Targeted Therapy for Chronıc Spontaneous Urtıcarıa: Ratıonale and Recent Progress

The KAAACI/KDA Evidence-Based Practice Guidelines for Chronic Spontaneous Urticaria in Korean Adults and Children: Part 2. Management of H1-Antihistamine-Refractory Chronic Urticaria

Evaluation of Pharmacologic Treatments for H₁ Antihistamine–Refractory Chronic Spontaneous Urticaria

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Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria

Abstract: The POLARIS study demonstrates that omalizumab is an efficacious and well-tolerated add-on therapy in Japanese and Korean H1AH-refractory patients with CSU.

Cited by 56 publications

References 37 publications

Targeted Therapy for Chronıc Spontaneous Urtıcarıa: Ratıonale and Recent Progress

Targeted Therapy for Chronıc Spontaneous Urtıcarıa: Ratıonale and Recent Progress

The KAAACI/KDA Evidence-Based Practice Guidelines for Chronic Spontaneous Urticaria in Korean Adults and Children: Part 2. Management of H1-Antihistamine-Refractory Chronic Urticaria

Evaluation of Pharmacologic Treatments for H1 Antihistamine–Refractory Chronic Spontaneous Urticaria

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Evaluation of Pharmacologic Treatments for H₁ Antihistamine–Refractory Chronic Spontaneous Urticaria