scholarly journals The Use of Omalizumab in Chronic Urticaria: Available Data and Future Aspects of Anti-IgE Treatment

2021 ◽  
Author(s):  
Young-Min Ye

Chronic urticaria (CU) defined as repeatedly occurred itchy wheals and/or angioedema for at least 6 weeks. Due to the unpredictability, recurrent and disabling symptoms, and a considerably impaired quality of life, effective and tolerable treatment for CU patients is crucial. Almost a half of patients with CU are refractory to H1-antihistamines, even though the dose of antihistamines is increased up to 4-fold. Recently treatment modulating IgE levels and activities provides an efficient therapeutic approach. Omalizumab, the only approved anti-IgE treatment for chronic spontaneous urticaria (CSU) patients until now, with a strong evidence of the efficacy and safety, opened a new horizon in the care of the patients whose urticaria is not controlled with antihistamines. Recent international guidelines recommend omalizumab as the first choice of treatment for antihistamine-refractory CSU. However, as it is not curative neither disease-modifying agent, there is a subpopulation of CSU patients responding partly or never to omalizumab. The other things to be solved in the treatment of CU is that clinical evidence is still limited on chronic inducible urticaria (CIndU) and special populations. Thus, a new anti-IgE treatment, ligelizumab is actively evaluated in the efficacy compared with both placebo and omalizumab. Further understandings on the pathogenesis of CU can lead to the development of new mechanism-based therapeutics for CU patients.

2020 ◽  
pp. 66-74
Author(s):  
Elena Petkova ◽  
Maria Staevska

Chronic urticaria (CU) is one of the most commonly diagnosed skin conditions. CU is characterised by the presence of recurrent wheals and/or angioedema and intense pruritus persisting for at least 6 weeks. Subtypes of CU include chronic spontaneous urticaria and chronic inducible urticaria. Following diagnosis, adequate trigger identification and appropriate treatment can significantly reduce disease activity and improve the patient’s quality of life and disease outcomes. Current guidelines recommend a stepwise approach in the management of CU, including non-sedating oral antihistamines, administered in up to four times the conventional dose, the monoclonal antibody omalizumab (anti-IgE), and eventually cyclosporine as an add-on therapy for patients with antihistamine-refractory CU. Potential disease-related biomarkers are needed to predict the therapeutic response that would lead to establishment of personalised regimens and treatment plans. This paper reviews the current perspectives and guidelines for classification, diagnosis, and management of CU.


2015 ◽  
Vol 12 (3) ◽  
pp. 16-21
Author(s):  
I V Danilycheva ◽  
O G Elisyutina ◽  
N I Ilina ◽  
E A Latysheva ◽  
T V Latysheva ◽  
...  

Background. To study the efficacy and safety of omalizumab in patients with chronic urticaria, refractory to antihistamines in clinical practice. Methods. In this retrospective clinical analysis, we assessed effectiveness, time to relief of symptoms, dose change after omalizumab administration, and safety in 17 CU patients, 16 with chronic spontaneous urticaria (CSU), 1 with different forms of chronic inducible urticaria (CindU) and 4 with both. Results. Treatment with omalizumab showed excellent effect in 70,6%, significant - in 17,7%, no effect - in 11,7% of CU patients. Eight patients marked effect for 24 hours, 2 - within 2-3 days, 2 - during 2 weeks, 1 - 4 weeks, and 2 patients - for 8 weeks. Eleven patients were receiving omalizumab 300 mg once per 4 weeks, one patient - 150 mg, 4 patients 2 injections of 300 mg, followed by 150 mg of 2, one patient had started treatment with a dose of 150 mg, continued treatment with omalizumab 300 mg. Omalizumab was safe. There was no influence of baseline total IgE levels and the results of test with autosera on the efficacy of omalizumab treatment. Conclusion. Our observation of patients with chronic spontaneous urticaria, with the concomitant or separate physical (induced) hives can resume high efficacy and safety of omalizumab treatment which can be recommended for CU patients, torpid to the first and secondline therapy.


2021 ◽  
Vol 24 (3) ◽  
pp. 211-226
Author(s):  
Elena Yu. Borzova ◽  
Christina Yu. Popova ◽  
Marcin Kurowski ◽  
Maia T. Rukhadze ◽  
Razvigor Darlenski ◽  
...  

Cholinergic urticaria (CholU) is a chronic inducible urticaria, characterised by itchy pinpoint wheals up to 3 mm in diameter, surrounded by a prominent flare, that occur following an exposure to characteristic triggers such as active or passive heating, physical exercise, emotions, hot or spicy foods. Key pathophysiologic mechanisms include immediate hypersensitivity to autologous sweat antigens, functional sweating disorders, impaired acethylcholine metabolism, abnormal skin vascular permeability and disturbed skin innervation. Clinical manifestations of CholU may vary from typical itchy pinpoint urticarial lesions, angioedema to anaphylaxis. Atypical CholU forms include cholinergic pruritus, cholinergic dermographism, cold cholinergic urticaria and persistent cholinergic erythema. The diagnosis of cholinergic urticaria relies on patients history, сlinical manifestations and challenge tests. Treatment options include nonsedating H1 antihistamines in standard or increased doses. The evidence is accumulating for the use of biological treatment with omalizumab in cholinergic urticaria. The prospect of personalized treatment of cholinergic urticaria include autologous sweat desensitization. The main research efforts in ColdU are directed at optimizing diagnostic approaches and developing innovative therapeutic options.


2019 ◽  
Vol 56 (2) ◽  
pp. 202-208
Author(s):  
Schlioma ZATERKA ◽  
Sandra Beatriz MARION ◽  
Fabiana ROVEDA ◽  
Marcos Antônio PERROTTI ◽  
Decio CHINZON

ABSTRACT BACKGROUND: Gastroesophageal reflux disease (GERD) is one of the most prevalent gastrointestinal diseases. GERD generates significant impairment in patients’ quality of life and it is associated to relevant medical resources utilization. A better understanding of GERD pathophysiology in the past five decades has favored the evolution of therapeutic strategies from non-drug interventions and antacids to more efficacious and safer alternatives. OBJECTIVE: To summarize data about the historical evolution of GERD management in Brazil, focusing on medical therapy and addressing evidence on efficacy and safety of drug classes currently recommended. METHODS: A narrative review was conducted by systematizing information about discoveries on GERD pathophysiology. We also addressed efficacy and safety of medications currently used to reduce symptoms and improve endoscopic healing of esophageal lesions. A structured search on Pubmed was performed to identify systematic reviews and meta-analysis investigating GERD outcomes positively impacted by proton pump inhibitors (PPIs), the first choice of pharmacotherapy for the disease. RESULTS: The chronological development of therapeutic measures for GERD in Brazil evolved from lifestyle interventions with relative poor effect on symptoms related to esophageal acid exposure, particularly heartburn, to effective and safe pharmacological interventions such as histamine H2-receptor antagonists and PPIs. In the present days, some drug classes play a minor role in disease management, namely prokinetics and antacids, due to their reduced efficacy and relevant safety concerns (particularly with prokinetics). The main challenge for prescribers and researchers seems to be finding long-acting acid suppressants strategies able to ameliorate patients’ symptoms and quality of life, thereafter, reducing medical resource consumption. The dual delayed-release PPI dexlansoprazole seems to respond for some of the limitations other PPIs have. CONCLUSION: Recognizing the historical evolution of GERD management can help care providers to better understand therapeutic options for their patients, as well as focus on unmet needs that deserve further attention. PPIs are still the first choice therapy, with good evidence in favor of their efficacy, despite some safety concerns. However, as with any medical intervention, it is recommended to prescribe PPIs for patients with clear indication, using adequate dosing and monitoring for adverse events.


Author(s):  
Kam L. Hon ◽  
Alexander K.C. Leung ◽  
Wing G.G. Ng ◽  
Steven K. Loo

Background: Up to 1% of the general population in the USA and Europe suffer from chronic urticaria (CU) at some point in their lifetime. CU has an adverse effect on the quality of life. Objectives: This study aims to provide an update on the epidemiology, pathogenesis, clinical manifestations, diagnosis, aggravating factors, complications, treatment and prognosis of CU. Methods: The search strategy included meta-analyses, randomized controlled trials, clinical trials, reviews and pertinent references. Patents were searched using the key term "chronic urticaria" at the following links: www.google.com/patents, www.uspto.gov, and www.freepatentsonline.com. Results: CU is a clinical diagnosis, based on the episodic appearance of characteristic urticarial lesions that wax and wane rapidly, with or without angioedema, on most days of the week, for a period of six weeks or longer. Triggers such as medications, physical stimuli, and stress can be identified in 10 to 20% of cases. C-reactive protein/erythrocyte sedimentation rate, and complete blood cell count with differential are the screening tests that may be used to rule out an underlying disorder. The mainstay of therapy is reassurance, patient education, avoidance of known triggers, and pharmacotherapy. Secondgeneration H1 antihistamines are the drugs of choice for initial therapy because of their safety and efficacy profile. If satisfactory improvement does not occur after 2 to 4 weeks or earlier if the symptoms are intolerable, the dose of second-generation H1 antihistamines can be increased up to fourfold the manufacturer’s recommended dose (all be it off license). If satisfactory improvement does not occur after 2 to 4 weeks or earlier if the symptoms are intolerable after the fourfold increase in the dosage of second-generation H1 antihistamines, omalizumab should be added. If satisfactory improvement does not occur after 6 months or earlier if the symptoms are intolerable after omalizumab has been added, treatment with cyclosporine and second-generation H1 antihistamines is recommended. Short-term use of systemic corticosteroids may be considered for acute exacerbation of CU and in refractory cases. Recent patents for the management of chronic urticaria are also discussed. Complications of CU may include skin excoriations, adverse effect on quality of life, anxiety, depression, and considerable humanistic and economic impacts. On average, the duration of CU is around two to five years. Disease severity has an association with disease duration. Conclusion: CU is idiopathic in the majority of cases. On average, the duration of CU is around two to five years. Treatment is primarily symptomatic with second generation antihistamines being the first line. Omalizumab has been a remarkable advancement in the management of CU and improves the quality of life beyond symptom control.


F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 177 ◽  
Author(s):  
Yasmin Moolani ◽  
Charles Lynde ◽  
Gordon Sussman

There have been recent advances in the classification and management of chronic urticaria. The new term chronic spontaneous urticaria (CSU) has replaced chronic idiopathic urticaria and chronic autoimmune urticaria. In addition, chronic inducible urticaria (CINDU) has replaced physical urticaria and includes other forms of inducible urticaria, such as cholinergic and aquagenic urticaria. Furthermore, novel research has resulted in a new understanding with guidelines being revised in the past year by both the American Academy of Allergy, Asthma, and Immunology (AAAAI) and the European Academy of Allergy and Clinical Immunology (EAACI)/Global Allergy and Asthma European Network (GA2LEN)/European Dermatology Forum (EDF)/World Allergy Organization (WAO). There are some differences in the recommendations, which will be discussed, but the core updates are common to both groups. The basic treatment for chronic urticaria involves second-generation non-sedating non-impairing H1 antihistamines as first-line treatment. This is followed by up to a 4-fold increase in the licensed dose of these H1 antihistamines. The major therapeutic advance in recent years has been in third-line treatment with omalizumab, a humanized monoclonal anti-immunoglobulin E (anti-IgE) antibody that prevents binding of IgE to the high-affinity IgE receptor. Several multicenter randomized controlled trials have shown safety and efficacy of omalizumab for CSU. There are also some small studies showing efficacy of omalizumab in CINDU. While there were previously many treatment options which were lacking in strong evidence, we are moving into an era where the treatment algorithm for chronic urticaria is simplified and contains more evidence-based, effective, and less toxic treatment options.


2021 ◽  
Author(s):  
Patrizia Pepe ◽  
Victor Desmond Mandel

Chronic urticaria, a common mast cell driven disease, has been considered so far an underestimated and difficult to treat disease, very often resulting in high physical, psychological and socio-economic burden. More than 60% of these patients are unresponsive to second generation H1 antihistamines, the first-line symptomatic treatment for urticaria. However, anti-IgE drugs (omalizumab and ligelizumab) showed improved activity in urticaria-treated patients with inadequate symptom control. Omalizumab has been widely proven to be very effective and well-tolerated in patients with antihistamine-refractory chronic spontaneous urticaria and inducible urticaria and is currently licensed for these indication as third-line treatment. Ligelizumab, a next-generation monoclonal anti-IgE antibody with higher affinity to IgE compared to omalizumab and a similar safety profile, has recently demonstrated to be even more effective than omalizumab. This review is focused on the role of anti-IgE antibodies in chronic urticaria.


2020 ◽  
Author(s):  
Iolanda Alen Coutinho ◽  
Frederico Soares Regateiro ◽  
Rosa Anita Fernandes ◽  
Joana Sofia Pita ◽  
Raquel Gomes ◽  
...  

Abstract Background: Chronic urticaria (CU) is defined as recurrent urticaria lasting for more than 6 weeks. Objectives: We aimed to characterize the phenotypesof patients with CU refractory to standard dose anti-H1 antihistamine treatment and search for clinical predictors of poor disease control.Methods: Retrospective collection of data regarding clinical characteristics, manifestations, comorbidities, treatment,and disease control of all adult CU patients presenting to the Allergy and Immunology Department during one year. Descriptive and inferential analysis was performed to search for factors associated with disease control.Results: Sixty-one adult patients were included, 74% females, average age 44.5 years (18 to 84 years old). Most patients (78.7%) had initiated CU less than 1 year before enrolment. Chronic spontaneous urticaria (CSU) accounted for 55.7% of the patients and chronic inducible urticaria (ClndU)for44.3%. Angioedema was present in 55.7% of the patients. Evidence for autoimmunity (positive anti-thyroid peroxidase antibodies, anti-nuclear antibodies or autologous serum test) was found in38.8% (n=19)of 49 tested patients.High C-reactive protein was presenti in 20.7% of 29 patients evaluated; half of these also had positive antinuclear antibodies.Forty-six patients (75.4%) had at least one significant exacerbation, requiring medical appointment, emergency room, hospitalization or job absenteeism. The number of exacerbations correlated with the presence of angioedema (p=0.022), with a recent diagnosis (<1 year), and with higher UAS7 severity (p=0.006). Clnd Uassociated with poor symptom control(p=0.022) buthad less exacerbations requiring medical observation or hospitalization (p=0.015).Conclusions: About one thirdof patients with CU presented autoimmunity. UAS7 severity and Angioedema are associated with disease exacebations. UAS7 and UCT presented unequal accuracy, with UAS7 better associating with the occurrence of exacerbations and treatment dosis. Accurate diagnostic tests, namely autoimmune parameters and inflammatory markers, should be recommended in some individual cases.


2021 ◽  
Author(s):  
Evmorfia Ladoyanni

Chronic urticaria can be subclassified into chronic spontaneous urticaria and chronic inducible urticaria. Up to 30% of cases are associated with functional immunoglobulin G antibodies to the high affinity immunoglobulin E receptor FcεRIα or to immunoglobulin A. Pathogenic activation of mast cells and basophils gives rise to release of pro-inflammatory mediators that lead to development of hives. CSU is a debilitating disease with a relapsing course. It affects 0.5–1% of the population at any given time. The duration of CSU is generally 1–5 years but can be longer in cases associated with angioedema and autoreactivity. CSU has detrimental effects on life quality with sleep-deprivation and psychiatric disorders being the most frequent. In a great number of patients an underlying cause or eliciting factor cannot be identified. Among the patients in which an aetiology is suspected, infections, medication, food and psychological factors are most commonly associated. A potential autoimmune cause has been reported in up to 50% of patients. Chronic inducible urticaria is characterised by its ability to be triggered consistently and reproducibly in response to a specific stimulus (pressure, temperature, vibration, water, heat, light). Antihistamines form the mainstay of therapy. In recalcitrant chronic urticaria, a variety of other drugs have been tried.


1992 ◽  
Vol 3 (3) ◽  
pp. 204-207 ◽  
Author(s):  
A T Nayagam ◽  
M D Smith ◽  
G L Ridgway ◽  
E Allason-Jones ◽  
A J Robinson ◽  
...  

The efficacy and safety of ofloxacin, 200 mg twice daily for 7 days, was compared with metronidazole, 400 mg twice daily for 7 days, for the treatment of bacterial vaginosis (BV). Diagnosis of BV was confirmed by at least 3 of the following 4 criteria: the presence of an abnormal vaginal discharge on examination, clue cells on microscopy of vaginal specimens, vaginal pH>5.0 and a positive amine test. Vaginal specimens were examined for Mobiluncus spp, analysed for the succinate/lactate (S/L) ratio and cultured for Trichomonas vaginalis, Gardnerella vaginalis, Bacteroides spp. and Mycoplasma hominis. Patients were reviewed on completion of treatment (visit 2) and 14 days later (visit 3). The diagnosis of BV was accepted in 119 of 149 patients recruited, 60 of whom received treatment with ofloxacin and 59 received metronidazole. Sixty-two patients, 31 in each treatment group, completed the study. Diagnostic cure at visit 2 was significantly better in the metronidazole group with cure rates of 56% (metronidazole) vs 23% (ofloxacin) ( P=0.001); this was associated with higher eradication rates for G. vaginalis (100% vs 56%) and Bacteroides spp. (97% vs 49%). There were no significant differences between the two groups in clinical cure at either visit 2 or 3 or in diagnostic cure at visit 3. Both treatments were well tolerated. We conclude that metronidazole is likely to remain the first choice of treatment for BV but ofloxacin offers a safe and effective alternative.


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