Chronic Spontaneous Urticaria Cases Research Articles

Real-World Clinical Experience with Oral Cyclosporine in Antihistamine Refractory Cases of Chronic Spontaneous Urticaria

Real-World Clinical Experience with Oral Cyclosporine in Antihistamine Refractory Cases of Chronic Spontaneous Urticaria

Prevalence of omalizumab resistant chronic urticaria and real world effectiveness of dupilumab in omalizumab refractory chronic urticaria patients: a single center experience.

Chronic urticaria (CU) is characterized by wheals, angioedema, or both lasting for ≥ 6 weeks with chronic spontaneous urticaria (CSU) being the most common subtype. Omalizumab-resistant CSU cases represent an unmet clinical need. In this study, we aimed to assess the prevalence and predictors of omalizumab failure in a large cohort of CU patients and assess the effectiveness of dupilumab for omalizumab-recalcitrant CU. Of 338 CU patients, 33 received omalizumab. 69.7% (23 patients) were responders and 30.3% (10 patients) non-responders. Bivariate regression demonstrated that female sex (adjusted OR [aOR] = 1.53; 95%CI = 1.14-2.06), higher baseline UAS7 (aOR = 1.05; 95%CI = 1.01-1.09) and older age (controlling for sex) (aOR = 1.00; 95%CI = 1.00, 1.01) were associated with omalizumab failure. Of 10 omalizumab-refractory patients, three were well controlled with cyclosporine (all children), whereas the seven adults failed on average 5.6 ± 2.6 therapies including cyclosporine. All 7 achieved a complete response with dupilumab with time to response varying between 1 to 6 months. While our results suggest a favourable efficacy of dupilumab omalizumab-resistant cases, future confirmatory studies are required.

Changes in Serum IL-12 Levels following the Administration of H1-Antihistamines in Patients with Chronic Spontaneous Urticaria.

Research regarding the role of the IL-12 cytokine family in modulating immune and inflammatory responses is continuously evolving. In this study, the contribution of the p35 and p40 subunits as monomers (noted as IL-12p35 and IL-12p40) and heterodimers (noted as IL-12p70 or IL-12p35/p40) was analysed in the pathophysiology and progression of chronic spontaneous urticaria (CSU). We conducted a longitudinal, case-control study involving 42 CSU cases and 40 control cases comprising adults without associated conditions. Serial measurements were performed to assess the serum levels of IL-12p70, IL-12p35, and IL-12p40 at the onset of the disease (pre-therapy phase) and 6 weeks after the initiation of the treatment (post-therapy phase). During the pre-therapeutic phase of CSU, elevated serum levels of IL-12 cytokine subtypes were detected compared to the control group. The relationship between IL-12 profiles and the course of CSU highlighted the pro-inflammatory role of IL-12p70 and the anti-inflammatory role of IL-12p35. Significant correlations were observed between IL-12p70 levels and the duration of the disease, as well as between IL-12 and the effectiveness of H1-antihistamines. The molecular background for the pleiotropic activities mediated by IL-12-derived cytokines in patients with CSU lies in the strict regulation of the production, signalling pathways, and cytokine-specific influences on the same pathophysiological events. The results of the present study suggest that the superficial layers of the skin serve as a cellular source of IL-12, a cytokine produced through antigenic stimulation. In patients with CSU, we identified independent, additive, or divergent functions of IL-12p70, IL-12p35, and IL-12p40, all relevant to systemic inflammation. These findings prove that the prototype programming of IL-12 is abnormal in CSU.

Role of patient-reported outcome measures in the management of chronic urticaria and angioedema

Due to the lack of reliable biomarkers, patient-reported outcome measures (PROMs) have a crucial role in assessing and monitoring the progression of chronic urticaria (CU) and angioedema (AE). PROMs are described as “any report coming directly from subjects without interpretation of the physician or others about how they function overall or feel in relation to a condition and its therapy.” There are four urticaria-specific PROMs, namely, urticaria activity score (UAS), urticaria control test (UCT), CU quality of life (QoL) questionnaire, and urticaria severity score. UAS7 is the most widely used, simple, and validated scoring system to estimate disease activity in chronic spontaneous urticaria cases. UCT on the other hand is a retrospective assessment of the current control of the disease after initiation of the treatment. The current EAACI/GA2LEN/EuroGuiDerm/APAAACI international urticaria guidelines suggest the use of UCT for stepping up or stepping down in the treatment of urticaria. Similarly, the severity and control of AE can be assessed by two PROMs, namely, AE activity score and AE QoL questionnaire.

Prevalence and treatment of Chronic Spontaneous Urticaria in Children

This literature review investigates the prevalence of Chronic Spontaneous Urticaria (CSU) in children, drawing from 15 articles found in PubMed and EMBASE databases, all published in English. Despite CSU being commonly associated with adults, the selected studies consistently demonstrate its presence in pediatric populations. Prevalence rates vary by region, with Western countries reporting figures between 0.1% to 0.3% among children, while some Asian populations exhibit higher rates. These discrepancies may stem from genetic, environmental, and ethnic factors. Additionally, the review emphasizes the substantial impact of CSU on children's lives, disrupting sleep, daily activities, and emotional well-being. Comorbidities, including other allergic diseases, are also prevalent among pediatric CSU cases, necessitating comprehensive clinical assessments and integrated management. The review addresses diagnostic challenges, stressing the importance of accurate differentiation from other urticarial conditions and systemic disorders. It explores evolving insights into CSU's pathophysiology in children, with emerging research implicating autoimmunity and chronic inflammation. In this review reaffirms that CSU affects children, with varying prevalence rates worldwide. It underscores the substantial burden on affected children and the need for accurate diagnosis, multidisciplinary care, and further research to understand CSU's mechanisms and risk factors in children better, ultimately improving their quality of life and outcomes.

Chronic spontaneous urticaria in children: Series of 16 cases

IntroductionChronic urticaria is an inflammatory dermatosis induced by mast cell mediators and is characterized by the occurrence of superficial urticarial plaques and/or angioedema for more than 6weeks. Its prevalence in children is lower than acute urticaria, but its impact on daily life can be major. We report a series of 16 cases of chronic spontaneous urticaria in children. Materials and methodsRetrospective study including 16 children with chronic urticaria evolving for more than 6weeks between January 2018 and April 2022. ResultsSixteen patients were included in the study. The mean age of the patients was 7.4years with extremes ranging from 3 to 10years. A female predominance was observed with a sex ratio M/F of 0.50. The mean time to consultation was 8.54months. A typical clinical picture of migrating and fleeting pruritic erythematous papules and plaques evolving by flare-ups and remissions was found in all patients. Angioedema was associated in 3 children. Physical examination revealed dermographism in 3 cases. The etiological investigation led to the conclusion of idiopathic urticaria in all children. The treatment prescribed in our patients was second-generation anti-H1 antihistamines, in particular desloratadine (2 to 3 times the dose) for at least 6months with a good evolution. DiscussionThe originality of this work lies in the rarity of chronic urticaria in children. This series confirms the predominance of the disease in women and the association with family or personal atopy. Treatment is based on second-generation anti-H1 antihistamines, the dose being doubled or quadrupled in case of ineffectiveness as described in our patients. Its management is often made difficult because of its important impact on the quality of life and a sometimes insufficient response to the first-line treatment.

Results of therapy of chronic urticaria in patients with IgE-dependent and IgE-independent disease profile

The main mechanism for the occurrence of urticaria is the degranulation of mast cells. It has been proven that, regardless of the activation pathway, clinical manifestations will not differ. According to the literature, up to half of cases of chronic spontaneous urticaria are autoimmune in nature, can be combined with autoimmune thyroid disease, SLE, etc., and have a more severe course.In therapy, antihistamines are traditionally used. However, some patients do not respond to the treatment, even with a multiple increase in doses. In the treatment of urticaria resistant to traditional antihistamines, the use of Omalizumab is recommended. The purpose of the study: to determine the profile of patients with chronic urticaria, as well as to evaluate the effectiveness of treatment with Omalizumab in patients with IgE- dependent and IgE-independent chronic urticaria.Eight-one patients with chronic urticaria (60 adults, 21 children) were examined. Patients before the start of therapy had a long history of CU: from 1 to 20 years. Patients before the start of therapy were treated with antihistamines, but no control was obtained. An increase in the level of serum IgE was detected in 51.7% of cases in adults and 42% in children. Concomitant sensitization was determined in 48.3% of adults and 76.2% of children. In children, food, epidermal and pollen sensitization was the most common. Pollen and epidermal sensitization were more common in adults. The level of eosinophilia in the group with IgE-dependent was more pronounced than in other group (p = 0.0097). After 6 months, the group with IgE-dependent showed an improvement in the symptom score (UCT) from 3.1 CI (1.5-4.6) to 12.2 CI (10.8-13.7), (p = 0.0001). In other group, symptoms improved from 0.63 CI (0.36-1.6) to 8.1 CI (5-11.2) after 6 months (no control). After 6 months of genetically engineered biological therapy (GIBT), complete control over the symptoms of CU in group 1 was obtained in 66.7% of patients, partial — in 33.7%. In the second group, in 33.3% of cases, positive treatment results could not be achieved. Thus, genetically engineered biological therapy with Omalizumab increases the control over the course of CU. Treatment outcomes are higher in patients with an IgE-dependent disease profile.

Relapse or worsening of chronic spontaneous urticaria during SARS-CoV-2 infection and vaccination in children: A telemedicine follow-up.

Chronic urticaria (CU), characterized by daily wheals and/or angioedema lasting more than 6 weeks, is a common skin disease. CU is classified as spontaneous or inducible. Because of Coronavirus Disease-19 (COVID-19) pandemic, face-to-face visits were reduced, and many centers started remote consultations to minimize hospital admissions and risk for viral diffusion. Telemedicine became a valuable tool for evaluating and monitoring patients with chronic diseases, such as CU. This study aims to evaluate the effectiveness of telemedicine as a means for the follow-up of patients with chronic spontaneous urticaria (CSU) during the COVID-19 pandemic. In particular, we collected data related to CSU evolution and treatment by remote consultation. Moreover, we specifically investigated the impact of SARS-CoV-2 infection or vaccination on CSU in relapsing or worsening of such a disease. The electronic charts were reviewed for patients diagnosed with CSU, who were referred to the allergy unit of Meyer Children's Hospital, Florence. For each patient, a review of demographic characteristics, diagnostic workup, efficacy, and tolerability of the treatment was performed. Patients with a physical agent triggering CU were excluded from the study. Disease activity was monitored using the Urticaria Activity Score (UAS7). In addition, when the COVID-19 pandemic started, follow-up continued through telemedicine after an initial face-to-face visit when possible. Approximately 1 year after the diagnosis of CSU, patients were recontacted to investigate whether they had experienced a relapse or worsening of urticaria during a possible COVID-19 or immediately after receiving a COVID-19 vaccine. From January 2020 to March 2021, 84 cases of CSU were identified, with 71 (84.5%) of these being evaluated via televisit (remote consultation). During the remote follow-up period, 38/71 (53.5%) patients who were evaluated via televisit recovered completely from CSU, while 24 (33.8%) made therapy adjustments, and 9 (12.7%) had to discontinue follow-up through remote visits and return to face-to-face visits. In February 2022, we recontacted the 71 patients with CSU, and 50 (70.4%) of them answered by phone call interview. Four (19.2%) of the 26 patients who had COVID-19 showed CSU relapse, while 1 (3.8%) had a CSU worsening. Instead, 1 (3.8%) patient of the 26 who were vaccinated had a relapse of CSU, and 1 (3.8%) had a worsening of CSU, both after the first dose. Our data showed that telemedicine can be an effective tool for the follow-up of patients with CSU. Moreover, COVID-19, as well as COVID-19 vaccination, may trigger CSU relapse or worsening, but both are unspecific triggers, and urticaria shows a very short duration in most cases.

GWAS of Chronic Spontaneous Urticaria Reveals Genetic Overlap with Autoimmune Diseases, Not Atopic Diseases

Although chronic spontaneous urticaria (CSU) is a common disease, GWASs of CSU are lacking. We aimed to identify susceptibility SNPs by performing a GWAS in Chinese Han adults with CSU. The discovery cohort included 430 CSU cases and 482 healthy controls. The GWAS findings were validated in 800 CSU cases and 900 healthy controls. Genetic, functional enrichment, and bioinformatic analyses of genome-wide significant SNPs were performed to assess the association between CSU and autoimmunity or atopy. Five genome-wide significant SNPs were identified: rs434124/LILRA3, rs61986182/IGHG1/2, rs73075571/TDGF1, rs9378141/HLA-G, and rs3789612/PTPN22. The first four SNPs were in linkage disequilibrium with autoimmune-related diseases‒associated SNPs and were cis-expression quantitative trait loci in immune cells. The five SNPs-annotated genes were significantly enriched in immune processes. Higher polygenic risk scores and allele frequencies of rs3789612∗T, rs9378141∗C, and rs73075571∗G were significantly associated with autoimmune-related CSU phenotypes, including positive antithyroglobulin IgG, positive anti-FcεRIα IgG, total IgE <40 IU/ml, and positive antithyroid peroxidase IgG but not with atopic or allergic sensitized CSU phenotypes. This GWAS of CSU identifies five risk loci and reveals that CSU shares genetic overlap with autoimmune diseases and that genetic factors predisposing to CSU mainly manifest through associations with autoimmune traits.

Chronic spontaneous urticaria after BNT162b2 mRNA (Pfizer-BioNTech) vaccination against SARS-CoV-2.

Background: The factors that trigger and exacerbate chronic spontaneous urticaria (CSU) are well known, but it is not unclear whether messenger RNA (mRNA) vaccination against severe acute respiratory syndrome coronavirus 2 can trigger new cases of CSU or a relapse of CSU after long-term remission. Objective: To study the clinical cases of patients with new-onset CSU and CSU in remission who relapsed within 3 months after BNT162b2 mRNA vaccination. Methods: All patients with a CSU diagnosis within 12 weeks of BNT162b2 mRNA vaccination were retrospectively identified and included in the new-onset CSU and the relapsed CSU groups. The first control group (CSU control group) retrospectively consisted of patients diagnosed with CSU in complete clinical remission for ≥ 6 months, with no CSU relapse after vaccination. The second control group (healthy control group) consisted of subjects who were fully vaccinated and without CSU, matched 1:2 for age and sex with patients with CSU. Results: Twenty-seven patients were included in the relapsed CSU group, 32 patients in the new-onset CSU group, 179 patients in the CSU control group, and 476 subjects in the healthy control group. The relapsed CSU and new-onset CSU groups had more allergic comorbidities overall (19 [70.4%] and 13 [40.6%], respectively) than the CSU control group and the healthy control group (50 [27.9%] and 110 [23.1%], respectively; p < 0.001). Multiple logistic regression analysis showed that a positive autologous serum skin test result, overall allergic comorbidities, and basopenia were positively associated with the probability of CSU relapse within 3 months after BNT162b2 mRNA vaccination (odds ratio [OR] 5.54 [95% confidence interval {CI}, 2.36-13.02], p < 0.001); OR 6.13 [95% CI, 2.52-14.89], p = 0.001; and OR 2.81 [95% CI, 1.17-6.72, p = 0.020, respectively). Conclusion: It is possible that BNT162b2 mRNA vaccination serves as a provoking and/or relapsing factor of CSU in individuals with allergic diseases and/or predisposed autoimmunity.

IgE and IgG Anti-Thyroid Autoantibodies in Chinese Patients With Chronic Spontaneous Urticaria and a Literature Review

Immunoglobulin (Ig) E and IgG anti-thyroid autoantibodies (AAbs) play important roles in the immunopathogenesis of chronic spontaneous urticaria (CSU). To date, association of IgE and IgG AAbs with Chinese CSU patients has not been fully investigated. We aimed to explore prevalence rates of IgE and IgG AAbs in Chinese CSU patients and their association with clinical and laboratory parameters. Serum IgE and IgG AAbs against thyroid peroxidase (TPO) and thyroglobulin (TG), total IgE (tIgE) and specific IgEs were measured using enzyme-linked immunosorbent assay, chemiluminescence microparticle immunoassay and immunoblotting. Meta-analyses and literature review were conducted. The meta-analyses indicated that CSU cases were 4.98, 6.90 and 6.68 times more likely to have positive anti-TPO IgE, anti-TPO IgG and anti-TG IgG (all P < 0.001) compared with controls, respectively, and revealed a positive correlation between the prevalence rates of anti-TPO IgE and anti-TPO IgG (r = 0.53, P = 0.025). A total of 1,100 Chinese Han adult CSU patients and 1,100 ethnicity-, age- and sex-matched healthy controls were recruited from 15 centers. Prevalence rates of anti-TPO IgE, anti-TPO IgG, anti-TG IgE or anti-TG IgG in the patients were all significantly higher than those in the controls. Significant correlations were observed between prevalence rates of anti-TPO IgE and anti-TPO IgG (r = 0.297, P < 0.001) as well as between those of anti-TG IgE and anti-TG IgG in the patients (r = 0.137, P < 0.001). Patients with anti-TPO IgE or anti-TPO IgG had significantly lower tIgE levels (P < 0.001). Positive anti-TPO IgE, positive anti-TPO IgG and tIgE < 40 IU/mL were independent predictors of antihistamine-refractory cases. In conclusion, the prevalence rates of IgE and IgG AAbs in Chinese CSU patients are significantly elevated and reciprocally correlated. This study verifies the results of previous case-control studies of CSU patients from other populations and ethnicities.

Resistant Chronic Spontaneous Urticaria - A Case Series Narrative Review of Treatment Options.

Chronic spontaneous urticaria (CSU) can be extremely debilitating to the patient and challenging for the treating clinician. The National Institute of Health and Clinical Excellence (NICE) in the United Kingdom (UK) recommendation of omalizumab for patients who fail to respond to high-dose anti-histamines has improved treatment options and quality of life. However, there is still lack of clear guidelines for treatment of patients resistant to standard and anti-IgE therapies. We discuss the therapeutic strategies employed among nine extremely resistant CSU cases and the heterogeneity between guidelines from different societies. Patients with anti-histamine-resistant urticaria either remained on omalizumab or started on immunosuppressive drugs (dapsone or ciclosporin) when they stopped responding to omalizumab. We used clinical assessment, skin biopsies (when available) and previous published reports to consider dapsone (for predominantly neutrophilic infiltration), or ciclosporin at doses between 2 and 4 mg/kg/day. One patient with ciclosporin-resistant urticaria responded to mycophenolate mofetil. Two patients remain on long-term omalizumab due to its relative safety and efficacy including 1 patient with underlying antibody deficiency where omalizumab was preferred over risks of using immunosuppressive medications. These case studies bring to light the real-world difficulties in managing patients with resistant CSU and the need for generating the evidence base on alternative therapeutic options such as synergistic use of biologics and immunosuppressive drugs.

Effects of Histobulin (Immunoglobulin/Histamine Complex) on Depression and Anxiety in Chronic Urticaria: Psychiatric Manifestations or Psychiatric Comorbidities of Chronic Urticaria?: A Case Report

Background: Psychiatric comorbidities of chronic urticaria (CU) have been reported and examined recently. The prevalence of mental disorders and emotional distress is high in patients with CU. This is a case report in which Histobulin was found to be effective for psychiatric manifestations in chronic spontaneous urticaria (CSU). Case Presentation: Three cases of CSU accompanying psychiatric manifestations (PMs) were treated with Histobulin. One patient with CSU with severe depression showed clinical changes in depressive symptoms in parallel to changes in allergic symptoms during treatment. Histobulin clearly improved not only CSU but also the accompanying PMs in one patient and slightly improved them in another patient. The PMs were not improved by an antihistamine (H1 blocker) in any case. Histobulin is effective not only for allergic manifestations (AMs) but also for PMs of CSU. Conclusions: PMs as well as AMs of CSU were improved by Histobulin therapy. PMs were suspected to be a part of the clinical manifestations in CSU, possibly through histamine-mediated mechanisms. These conditions were suggested to be ‘allergic psychiatric manifestations (APMs)’ or ‘histamine-mediated psychiatric manifestations (HPMs)’. Further study of PMs based on histamine-mediated mechanisms, including allergies, may be necessary. Accordingly, it should be clarified whether the PMs of CSU are a part of the clinical manifestations of CSU or are psychiatric comorbidities of CSU.

Perfluoroalkyl substances are linked to incident chronic spontaneous urticaria: A nested case-control study

Previous studies suggested immunotoxicity of perfluoroalkyl substances (PFASs), but contradictory findings were reported for the associations of PFASs with allergies. The current study aimed to investigate the association of serum PFASs with incident chronic spontaneous urticaria (CSU) in adults. A nested case-control study within a longitudinal cohort of 7051 government employees in China was conducted. Participants with urticaria at the baseline were excluded. During the first follow-up, 70 incident CSU cases were included, and 70 matched healthy controls were randomly selected. In serum samples collected at the baseline, eight PFASs were determined using the UHPLC-MS/MS approach. The median serum concentrations of perfluorobutanoic acid (PFBA) and perfluoroheptanoic acid (PFHpA) were significantly higher in participants with incident CSU. The area under the receiver operating characteristic curve was 0.714 (95% CI: 0.60–0.83) based on the joint prediction by PFBA and PFHpA. The Bayesian kernel machine regression showed a nonlinear positive overall effect of the mixture of PFASs, and identified significant single effects of PFBA and PFHpA. Serum interleukin-4 was significantly higher in the case group at baseline, and was positively associated with PFHpA (r = 0.24). Causal mediation analysis indicated interleukin-4 as a partial mediator (14.8%) in the association of PFHpA with CSU. In conclusion, serum PFASs are associated with an increased risk of incident CSU, and PFBA and PFHpA might be the effective compounds.

Pengaruh Suplementasi Oral Vitamin D terhadap Penurunan Keparahan Gejala pada Urtikaria Spontan Kronis: Sebuah Tinjauan Naratif

Background: Chronic Spontaneous Urticaria (CSU) is a common allergic skin disease. The etiopathogenesis remains unclear. Recommended therapy is only aimed to reduce and control the symptoms. Vitamin D is a potential immunomodulator that can be used as an alternative therapy of urticaria.&#x0D; Objective: This literature study aims to explores various original research literature about the effect of vitamin D in CSU and the mechanism behind that.&#x0D; Methods: Narrative review of the literature that searched through three databases with determined keywords, then selected based on inclusion and exclusion criteria.&#x0D; Results: There are six literatures with 621 CSU cases. &#x0D; Conclusion: Vitamin D supplementation can reduce the severity of the symptom in CSU patient

A novel histopathological scoring system to distinguish urticarial vasculitis from chronic spontaneous urticaria.

BackgroundUrticarial vasculitis (UV) is defined by long‐lasting urticarial lesions combined with the histopathologic findings of leukocytoclastic vasculitis. As one of the major unmet needs in UV, diagnostic criteria are rather vague and not standardized. Moreover, there seems to be considerable overlap with chronic spontaneous urticaria (CSU), particularly for the normocomplementemic variant of UV. Therefore, this study aimed to develop a diagnostic scoring system that improves the histopathologic discrimination between UV and CSU.MethodsLesional skin sections of patients with clinical and histopathologic diagnosis of UV (n = 46) and CSU (n = 51) were analyzed (blinded to the diagnosis) for the following pre‐defined criteria: presence of leukocytoclasia, erythrocyte extravasation, fibrin deposits, endothelial cell swelling, ectatic vessels, blurred vessel borders, dermal edema, intravascular neutrophil, and eosinophil numbers and numbers of dermal neutrophils, macrophages and mast cells.ResultsThe greatest differences between UV and CSU samples were observed for leukocytoclasia (present in 76% of UV vs. 3.9% of CSU samples; p < 0.0001), erythrocyte extravasation (present in 41.3% of UV vs. 2.0% of CSU samples; p < 0.0001), and fibrin deposits (present in 27.9% of UV vessels vs. 9.7% of CSU vessels; p < 0.0001). Based on these findings, we developed a diagnostic score, the urticarial vasculitis score (UVS), which correctly assigned 37 of 46 cases of UV and 49 of 51 cases of CSU to the previously established diagnosis.ConclusionOur results suggest that the UVS, a combined quantitative assessment of the three criteria leukocytoclasia, fibrin deposits and extravasated erythrocytes, distinguishes UV from CSU in skin histopathology. The UVS, if validated in larger patient samples, may help to improve the diagnostic approach to UV.

One hundred five cases of chronic spontaneous urticaria treated with omalizumab

オマリズマブ（ゾレア®）は，2017年に慢性特発性蕁麻疹の治療薬として，追加適応された．さらに2018年に発表された国際ガイドラインと整合性をとりながら，日本皮膚科学会の蕁麻疹ガイドラインには，オマリズマブ使用手順が詳細に記載されている．しかし，本邦ではオマリズマブの慢性特発性蕁麻疹に対する効果をまとめた報告がない． 2017年6月～2021年3月まで，東京医科大学病院で慢性特発性蕁麻疹に対して，オマリズマブ 300 mg/month を投与した105例を検討した．男性23例，女性82例，平均年齢は45.4±16.0歳．罹病期間は，46.9±99.4ヵ月であった．治療開始後3カ月間 Uriticaria Control Test 16点の63例で，オマリズマブ治療を中止した．その結果，平均投与終了回数は6.4±4.1回であった．再発例は9例であった．9例中7例は，オマリズマブ投与6回以内で中止していた． 再発例の多くは，オマリズマブ再投与で改善し，再度中止できた症例は5例であった． オマリズマブは，ステロイド・シクロスポリンに比べて副作用が少ない．2018年に使用可能施設基準が改定され，“アレルギー専門医または皮膚科専門医が，当該施設で，あるいは近隣医療機関と連携して，喘息，アナフィラキシー等の有害事象に対応できる体制のもとで使用すること”となり，皮膚科のクリニックでも使用可能となっている．本剤は，重症な慢性特発性蕁麻疹治療に有効な治療薬であり，さらに多数の皮膚科医によって投与されることが期待される．

Real-Life Experience of Efficacy and Safety of Bilastine in the Refractory Cases of Chronic Spontaneous Urticaria and its Effect on the Quality of Life of Patients.

Introduction:Second-generation H1-antihistamines (SGAHs) are the mainstay of treatment of chronic spontaneous urticaria (CSU). Bilastine, newer non-sedating SGAHs, was recently introduced in India after the approval of the Drugs Controller General of India. There is a paucity of evidence about the long-term efficacy and safety of Bilastine in Indian patients. We undertook this study to find the long-term efficacy and tolerability of Bilastine in patients with CSU in India.Materials and Methods:This retrospective chart analysis was conducted by analyzing electronic medical records from May 1, 2019, to March 20, 2020, to identify patients of CSU who were prescribed Bilastine. Adult patients, with CSU >6 months were included, who had an unsatisfactory response as per Urticaria Activity Score 7 (UAS7) to previous antihistamine therapies, and who continued treatment for at least 6 months were included. Treatment effectiveness was determined by retrospectively reviewing their UAS7 scores from their medical records and evaluating their scores at weeks 4, 8, 12, 16, 20, and 24. Also, DLQI was assessed and compared at baseline and week 24.Result:Forty-nine patients were found to fulfill the criteria and included in the study. At the end of 24 weeks, 51% of patients (n = 25) achieved complete treatment response (UAS = 0), whereas 49% of patients (n = 24) were labeled as well-controlled urticaria (UAS<6). At 24 weeks, the mean UAS7 score (1.35 ± 1.61) was statistically significant compared to the baseline score (20.2 ± 5.73). The mean score of DLQI was also reduced to 1.63 ± 1.18 at 24 weeks from 8.39 ± 2.49 at baseline (P-value <0.001).Conclusion:The study showed that in patients who had an inadequate response with commonly used antihistamines at a double dose or combined use, switching over to Bilastine resulted not only in relieving the symptoms of CSU but also improved the quality of life of the patients with CSU.

Association between Clinico-epidemiological Features in Chronic Urticaria with Autologous Serum Skin Test: A Cross-sectional Observational Study

Introduction: Urticaria is a frequent and heterogeneous skin disease characterised by the development of wheals (hives), angioedema, or both. Chronic urticaria is characterised by the occurrence of wheals lasting less than 24 hours, with or without angioedema occurring daily or almost daily lasting more than six weeks. The two subtypes of chronic urticaria are Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CIU). Autologous Serum Skin Test (ASST) is the simplest and the best in-vivo clinical test for the detection of basophil histamine- releasing activity. ASST has a sensitivity of approximately 70% and a specificity of 80%. Aim: To study the association between clinico-epidemiological features of CSU with positive and negative ASST. Materials and Methods: The cross-sectional study was conducted on 80 clinically diagnosed cases of CSU attending the Department of Dermatology Venereology Leprology Outpatient Department at Mahatma Gandhi Memorial Hospital (Kakatiya Medical College), Warangal, Telangana, India; during the period of January 2016 to September 2017. The detailed history was taken; complete physical and cutaneous examination and laboratory investigations like Complete Blood Picture (CBP), Absolute Eosinophil Count (AEC), Erythrocytic Sedimentation Rate (ESR), Thyroid Function Test (TFT) were carried out. ASST was done and read after 30 minutes. Chi- square test was applied and the results analysed using Statistical Package for the Social Sciences (SPSS) version 10.0. Results: Out of total 80 patients included in the study, ASST was positive in 36 (45%) and negative in 44 (55%). ASST positive patients showed longer duration of the disease with increased frequency of attacks and longer duration of wheals. However, both ASST positive and negative groups did not show statistically significant difference in the age of occurrence, gender, angioedema, dermographism. Conclusion: Autoimmune urticaria has no distinctive clinical features. ASST positive, autoimmune urticaria patients have more severe disease with greater impact on quality of life. Thus, they may need more aggressive treatment.

How to Treat Patients with Chronic Spontaneous Urticaria with Omalizumab: Questions and Answers

Omalizumab is an effective treatment for patients with chronic spontaneous urticaria (CSU). In routine clinical practice, physicians often face complex cases of CSU and need to decide whether patients are suitable for omalizumab treatment and how to manage this therapy. Here, we provide evidence and experience-based answers to the most common and important questions on omalizumab treatment of CSU. At 4 large urticaria centers, questions on the use of omalizumab in the treatment of patients with CSU were collected and then ranked by frequency and importance and grouped into top 5 domains using an interactive consensus approach. We suggest that omalizumab can be used to treat patients with CSU with any of the 3 CSU phenotypes (wheals only, angioedema only, wheals and angioedema), with comorbid chronic inducible urticaria, with cancer, who receive other biologics or cyclosporine, or who are pregnant or want to become pregnant, or are breast-feeding. Omalizumab treatment should be started with 300 mg every 4 weeks, monitored with validated patient-reported outcome measures, and maintained, in responders, until remission of CSU. Finally, partial responders or non responders can benefit from omalizumab updosing or adding or switching to cyclosporine. We believe our suggestions on the use of omalizumab in CSU will help to inform clinical decision making. Follow-up efforts should increase, systematically review, and profile the data available andprovide evidence-based recommendations on how to best use omalizumab in CSU.