Refractory Chronic Spontaneous Urticaria Research Articles

Predictors of response to omalizumab and relapse in chronic spontaneous urticaria: a study of 470 patients.

Chronic spontaneous urticaria (CSU) is defined as spontaneous occurrence of wheals and/or angioedema for ≥6weeks. Omalizumab is a monoclonal anti-IgE antibody effective in refractory CSU, but its mechanism of action and markers predictive of response remain not completely defined. To correlate baseline levels of two proposed biomarkers, total IgE (bIgE) and d-dimer (bd-dimer), and clinical parameters to omalizumab response and to relapses after drug withdrawal. In this retrospective Italian multicentre study, clinical data were collected in 470 CSU patients, and bIgE and bd-dimer were measured in 340 and 342 patients, respectively. Disease activity was determined by Urticaria Activity Score 7 (UAS7) at week 1 and 12 after omalizumab starting. Relapses were evaluated during a 2- and 3-month interval after a first and a second course of treatment, respectively. bIgE correlated to a good response to omalizumab since levels were significantly higher in responders than non-responders (P=0.0002). Conversely, bd-dimer did not correlate to response. There was no correlation between both bIgE and d-dimer and either first or second relapse. Disease duration was significantly longer in patients who experienced either first or second relapse (P<0.0001 and P=0.0105, respectively), while baseline UAS7 correlated only to first relapse (P=0.0023). Our study confirms bIgE as a reliable biomarker predicting response to omalizumab in CSU, while it does not support the usefulness of bd-dimer unlike previous findings. CSU duration before omalizumab and baseline UAS7 may be clinical markers of relapse risk.

Omalizumab in Chronic Spontaneous Urticaria Refractory to Conventional Therapy: An Italian Retrospective Clinical Analysis with Suggestions for Long-Term Maintenance Strategies.

IntroductionOmalizumab is indicated for the treatment of patients affected by chronic spontaneous urticaria (CSU) refractory to antihistamines. The aim of this study was to assess the efficacy, safety, and recurrence of symptoms in a real-life experience of omalizumab as an add-on therapy for H1-antihistamine-refractory CSU patients (refractory CSU).MethodsA retrospective review of the clinical records of all refractory CSU treated with omalizumab at our dermatology center from June 2014 to April 2017 was performed. Patients previously treated with second-generation antihistamines at a fourfold increased dose without clinical responses at 4 weeks of treatment were selected. Omalizumab was administered at a single dosage of 300 mg every 4 weeks for 6 months. Disease severity was assessed using the 7-day Urticaria Activity Score (UAS7).ResultsEighteen patients (14 women; mean age 51 years, range 25–74) were enrolled. Mean UAS7 at baseline was 27.3 (range 15–38). Symptoms improved in all patients at 4 weeks (UAS7 = 16.1, range 0–36). Treatment was completed in 17 patients (94.4%), and among these, a complete response (UAS7 = 0) was registered in 10 patients (58.8%). Adverse events included thrombocytopenia in 1 patient (5.6%) at 16 weeks; therapy was suspended after 20 weeks and the complication was resolved, resulting in a freedom from major adverse events of 94.4%. Symptom recurrence occurred in 3 patients (17.6%) at 4, 5, and 7 months from the end of the primary therapy. Retreatment with omalizumab was successful without any adverse effects. Mean follow-up was 9.5 months (range 1–28).ConclusionAdd-on omalizumab therapy for refractory CSU in a real-life setting seems to be effective and safe with a relatively low incidence of symptom recurrence. Further research should investigate personalized omalizumab treatment dosages and administration intervals, and the identification of biomarkers for future treatment algorithms.

Omalizumab in elderly patients with chronic spontaneous urticaria: An Italian real-life experience

BackgroundOmalizumab therapy is effective and safe in patients with chronic spontaneous urticaria (CSU) resistant to nonsedating histamine1 (H1) antihistamines (nsAHs). ObjectiveTo evaluate the efficacy and safety of omalizumab in elderly (aged ≥65 years) patients with nonsedating H1-antihistamine–refractory CSU in a real-life setting. MethodsPatients with nonsedating H1-antihistamine–refractory CSU (n = 322) treated with omalizumab administered every 4 weeks in doses of 300 mg for 24 weeks were divided into 2 groups according to age at omalizumab treatment onset: 15 to 64 years and 65 years or older. Treatment response was assessed using a 7-day urticaria activity score (UAS7). Adverse effects of omalizumab therapy were recorded. ResultsAmong patients, 32 (9.9%) were 65 years or older. At baseline, CSU characteristics were generally similar among the groups, although the presence of angioedema was statistically significantly lower in patients younger than 65 years. Any differences in weekly itch severity score, hive score, and UAS7 between the 2 age groups were not significant at weeks 4, 12, and 24, with the exception of the hive score at 24 weeks and the UAS7 at week 24. No significant between-group differences were seen in the proportion of patients with a UAS7 of 6 or lower and with a UAS7 score of 0 at weeks 4, 12, 24, and 40. The proportion of patients with at least one adverse event reported as suspected to be caused by study drug was 10% in the younger group vs 6.3% in the older group (P = .53). ConclusionOur study found that omalizumab is a well-tolerated and effective therapy for elderly patients with nonsedating H1-antihistamine–refractory CSU.

Treatment response to omalizumab in patients with refractory chronic spontaneous urticaria.

Previous clinical trials have demonstrated the efficacy and safety of the anti-IgE monoclonal antibody omalizumab in chronic spontaneous urticaria (CSU) not responding to antihistamine treatment. The primary aim of our study was to describe the response patterns of patients with refractory CSU treated with omalizumab in a real-world clinical setting. A retrospective analysis of medical records of 20 patients with refractory CSU was performed. Demographic, clinical, and laboratory features were retrieved and analyzed in correlation with treatment data. Mean age of our patient population was 54.5 years, while the majority were females (15/20 cases, 75%). Mean disease duration prior to omalizumab administration was 21.8 months. All patients had a history of chronic urticaria, refractory to high antihistamine and corticosteroid treatment, and responded favorably to omalizumab after administration of 1-5 doses of omalizumab; complete response was observed in 17/20 patients (85%) and well-controlled disease in the remaining 3/20 patients (15%). In a subset of cases (6/20, 30%), best response to omalizumab was achieved after interval administration of a 9-day course of methylprednisolone (total dose of 188 mg). Late response to omalizumab (after three-month treatment) was significantly correlated (P = 0.026) with shorter disease duration before initiation of omalizumab. In the present series, omalizumab, either alone or in combination with a short-term course of corticosteroids, was highly effective in resolution of refractory CSU. Furthermore, disease duration prior to omalizumab had a significant effect on timing of response.

Role of omalizumab in refractory chronic spontaneous urticaria: A single referral center experience

Background: Multiple evidence have shown that omalizumab, a subcutaneous (SC) anti-IgE monoclonal antibody, is highly effective for the treatment of chronic spontaneous urticaria (CSU). Objective: The objective is to evaluate the safety and efficacy of omalizumab administered 300 mg SC 1st month followed by 150 mg every month for another 5 months in cases of refractory CSU in a routine clinical setting. Materials and Methods: This was open-label, prospective, pilot study to know the efficacy and safety profile of omalizumab administered 300 mg SC first 1st month followed by 150 mg every month for another five 5 months in refractory CSU. The study was conducted at tertiary center in routine clinical setting. The primary efficacy evaluation was a change in Urticaria Activity Score-7 (UAS-7) and Urticaria Control Test (UCT) from baseline. Results: A total of 13 patients (7 females and 6 males) were enrolled in the study with the mean age of 35 years, having CSU from the mean duration of 3.15 years. Mean UAS-7 of patients decreased from 31.62 at baseline to 6.85 after the first dose of omalizumab treatment. This further reduced to 2.31 after 6 months (P = 0.001). Mean UCT increased from 4.46 at baseline to 13.92 after 1 month and further increased to 14.85 after 6 months (P = 0.001). A total of 11 patients (84.6%) achieved complete remission. Conclusion: Injection omalizumab is safe and highly effective therapy for refractory CSU in the routine clinical setting. It can be made cost effective without compromising the efficacy in resource-poor country of Indian subcontinent if barring first dose other can be halved of recommended dose. However, small number of patients, uncontrolled study and lack of long-term follow-up data are the limitations of the study.

The efficacy and safety of omalizumab in refractory chronic spontaneous urticaria: real-life experience in Turkey

This study used real-world data to evaluate the effectiveness and reliability of omalizumab in treating recalcitrant chronic spontaneous urticaria in Turkish patients. Study data were collected retrospectively from eight tertiary-care hospitals in Turkey. This study included 132 patients with chronic spontaneous urticaria that were resistant to H1 antihistamine treatment in a dose up to four times the licensed dose and were treated with 300 mg/month of omalizumab for 6 months. The mean weekly urticarial activity score (UAS7) after omalizumab treatment improved significantly compared to the pre-treatment score (p < 0.001). Treatment response was detected primarily in the 1st and 2nd months after treatment. No significant association was observed between omalizumab's treatment effectiveness and disease-related parameters or laboratory data. The mean dermatology life quality index was 23.12 ± 6.15 before treatment and decreased to 3.55 ± 3.60 6 months after treatment (p < 0.001). No side effects were reported in 89.4% (118) of the patients. This study showed that UAS7 decreased significantly and quality of life improved in omalizumab-treated patients. Moreover, treatment effectiveness was mainly observed in the first 2 months after treatment. However, no association was observed between omalizumab treatment effectiveness and disease-related parameters or laboratory data.

Efficacy of Omalizumab Treatment with Concomitant Antihistamines as Needed for Moderate, Refractory Chronic Spontaneous Urticaria.

Efficacy of Omalizumab Treatment with Concomitant Antihistamines as Needed for Moderate, Refractory Chronic Spontaneous Urticaria.

Omalizumab for Management of Refractory Urticaria: Experience of a Tertiary Care Centre in Eastern India.

Aim:To study the effects of omalizumab in chronic spontaneous urticaria in Indian patients.Setting and Design:The study was conducted in a tertiary care centre and it was retrospective and descriptive in nature.Material and Methods:We analysed the data of patients who were administered omalizumab between June 2014 and June 2015 for the management of refractory chronic spontaneous urticaria at our centre. Omalizumab was used in those patients who did not respond to updosing of antihistaminics and cyclosporine. Omalizumab was used in dose of 300 mg per month for 3 doses.Results:Twenty-four patients were administered omalizumab during the study period. Average age of the patients was 36.54 years, female:male ratio was 1.4:1, mean duration of disease was 20.66 months, and autologous serum skin test was positive in 33% of studied individuals. Ninety six percent of cases showed response to treatment in our study. Remission was seen in 25% of patients, 50% showed satisfactory response, and 20.83% showed partial response. Average UAS7 scoring before starting omalizumab in preceding week was 24.4. Average UAS7, 2 weeks after starting omalizumab was 4 in responsive patients.Conclusion:Omalizumab is safe and effective treatment for the management of chronic spontaneous urticaria. It can be used in Indian setting after failure to other third-line therapies such as addition of montelukast and cyclosporine due to high cost of treatment.

Efficacy and safety of omalizumab for the treatment of refractory chronic spontaneous urticaria in Japanese patients: Subgroup analysis of the phase 3 POLARIS study

BackgroundOmalizumab, a humanized anti-IgE monoclonal antibody, proved efficacious and well tolerated in patients with chronic spontaneous urticaria (CSU) refractory to H1 antihistamines (H1AH) in the POLARIS study (NCT02329223), a randomized, double-blind, placebo-controlled trial in East Asian patients. However, data in Japanese patients, who have specific baseline characteristics (e.g., low angioedema incidence, different background medications) that may impact clinical outcomes, are lacking. This pre-specified analysis presents additional patient-level data over time, pharmacokinetic and pharmacodynamics data for omalizumab and IgE, and efficacy and safety data for omalizumab in Japanese patients. MethodsJapanese patients (N = 105) were randomized 1:1:1 to omalizumab 300 mg, 150 mg, or placebo by subcutaneous injection every 4 weeks. Efficacy and safety were assessed primarily based on changes from baseline to Week 12 in weekly itch-severity scores (ISS7) and weekly urticaria activity scores (UAS7), and incidence of adverse events (AEs), respectively. Patient-level UAS7 data over time were also reviewed. ResultsAt Week 12, least squares mean (LSM) changes from baseline in ISS7 were greater with omalizumab vs. placebo (−9.54 and −7.29 for omalizumab 300 mg and 150 mg, respectively, vs. placebo [−5.17]). Corresponding LSM changes from baseline in UAS7 were −21.61 and −15.59 (vs. placebo [−10.88]). Most responders in the omalizumab 300 mg group displayed improvement of disease activity within 2–4 weeks and had well-controlled symptoms during the treatment period. Overall AE incidence was similar across treatment arms. ConclusionsThis subgroup analysis demonstrated that omalizumab is a well-tolerated, beneficial option for treatment of CSU in H1AH-refractory Japanese patients.

Hydroxychloroquine in the treatment of anti-histamine refractory chronic spontaneous urticaria, randomized single-blinded placebo-controlled trial and an open label comparison study.

Background. The management of anti-histamine refractory chronic spontaneous urticaria (CSU) has poorly defined therapeutic options. Some patients with CSU respond poorly to a fourfold increase in dosage of H1-anti-histamines treatment. Aim. The objective of this study was to determine the effect of an adjunct treatment of hydroxychloroquine (HCQ) on remission rate and reduction of urticarial symptoms. Methods. Sixty subjects with anti-histamine refractory CSU were randomly assigned to 400 mg of HCQ daily or placebo for 12 weeks in a single blind placebo controlled trial. In a second follow up trial, non-remission subjects were offered open-label HCQ in the placebo group or a leukotriene receptor antagonist (LTRA) in the HCQ group for 12 weeks. All subjects took 4 H1-anti-histamines tablets throughout the study. The endpoints measured were the urticarial symptom score (USS) and dermatology life quality index (DLQI). Results. Forty-eight patients (24 HCQ, 24 placebos) completed the randomized trial medication. Five of 24 on HCQ treatment but none on placebo had a remission at 12 weeks (P = 0.01). There was a low proportion of therapeutic failures occurred with 12-week HCQ treatment (n = 5) compared with placebo (n = 14, P = 0.001). After 12 weeks, USS and DLQI significantly improved in HCQ group over the placebo group. Forty non-remission subjects completed an open-label HCQ (n = 22) or LTRA (n = 18) comparison study. The remission rates on HCQ and LTRA were 22.72% and 5.55% at 12 weeks. However, no significant difference between the two groups in the therapeutic responses was observed. The mean USS on HCQ significantly decreased compared to the LTRA group, but there was no significant difference in DLQI. The adverse events reported were minimal and there were no subjects who discontinued the trial. Conclusions. This study suggests that HCQ is clinically effective as an adjunct treatment for CSU.

Efficacy of omalizumab treatment for patients with chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) in Taiwan

Accumulating evidence has shown that omalizumab is an effective and safe treatment for chronic spontaneous urticaria (CSU), but there is little information regarding the use of omalizumab to treat CSU in Taiwan. Reports on clinical experiences with using omalizumab for CSU for more than 6 months are also lacking. A retrospective review of medical records of consecutive CSU patients receiving omalizumab treatment in the Urticaria Special Clinic of one tertiary referral center in Taiwan was conducted. We analyzed clinical features of the patients, treatment efficacy and safety, and also long-term outcomes after omalizumab treatment. An Urticaria Activity Score over 7 days (UAS7) was recorded at each visit. A total of 17 CSU patients were identified (11 females and 6 males, age range: 21–83 years) with a baseline mean UAS7 of 29.8 ± 8.9 despite antihistamine treatment. All patients were treated with at least 3 doses of monthly subcutaneous injections of omalizumab. Fifteen patients achieved a UAS7 of 6 or less after 3 doses of monthly omalizumab injections. Seven of those 15 patients received an additional 1 to 3 doses and all ended up with a UAS7 of less than 2 at the 24-week follow-up. A sustained response to maintenance treatment after 24 weeks was observed in 5 patients with individual tailoring of treatment duration and dosing interval. Omalizumab is an effective and safe treatment for antihistamine refractory CSU. Maintenance therapy with individual tailoring of the treatment duration and interval is possible.

Alternative treatments for chronic spontaneous urticaria beyond the guideline algorithm.

The international EAACI/GALEN/EDF/WAO guideline suggests a stepwise approach for the therapeutic management of chronic spontaneous urticaria (CSU), outlined in an algorithm. The aim of this article is to summarize and review the evidence available on alternative treatment options for CSU outside of this algorithm. Although CSU is a common disease, there are a limited number of high-quality studies, and only antihistamines and omalizumab are licensed for its treatment. Most studies regarding alternative therapies for CSU show methodological limitations and a high risk of bias. For many therapies, only case reports and uncontrolled studies exist. Recent publications on alternative treatments for chronic urticaria/CSU include reports on the use of adalimumab, rituximab, vitamin D, probiotics, histaglobulin, injection of autologous whole blood or serum, and phototherapy. Numerous treatments beyond the guideline algorithm have been evaluated in patients with refractory CSU. The global level of evidence to support their efficacy in CSU is low or very low. Further research is needed to assess the efficacy and safety of alternative therapies of CSU to manage adequately those patients who do not respond to the treatments included in the algorithm.

Long-term management of chronic spontaneous urticaria with omalizumab.

Clinical trials have shown the efficacy of omalizumabs efficacy in refractory chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), but real-life management strategies are lacking. To assess the long-term efficacy and safety of omalizumab, and to identify predictive factors and optimum dosage regimens. This was a prospective study of 13 patients (11 women, 2 men) with severe CSU [weekly urticaria activity score (UAS7) >28] resistant to anti-H1 antihistamines. Patients were started on omalizumab 150mg subcutaneously every 4weeks. Dose and interval between administrations were adjusted according to clinical response (189 administrations; treatment duration range 2-38months). Mean UAS7 was 36.3±5.4. Of the 13 patients, all had experienced angio-oedema, while in addition, 7 had delayed pressure urticaria (DPU) and 1 had solar urticaria (SU). After omalizumab treatment, 4 (30.8%) of the 13 patients had complete response (CR), and the remaining 8 (61.5%) had partial response. CR was achieved with a dose of 150mg every 4 (n=2 patients) or 5 (n=2)weeks. One of these patients remained disease-free after stopping treatment. Partial responses were achieved with 150mg every 4weeks (n=4) and with 300mg (n=4) at intervals of 5weeks (n=1), 4weeks (n=2) or 3weeks (n=1). Only one patient (7.7%) did not show significant improvement, despite a dose of 300mg every 4weeks. There were no significant differences in epidemiological, clinical and laboratory data between the different response groups. Only two adverse events were observed: one was mild headache and the other was severe angio-oedema and aggravation of urticaria within 6h of omalizumab administration. Omalizumab dose and interval between administrations could be individualized for long-term management of CSU.

Effectiveness of Autologous Whole-Blood Injections in Patients with Refractory Chronic Spontaneous Urticaria

Background: Nonsedating antihistamines are the treatment of choice for chronic spontaneous urticaria (CSU), while omalizumab and immunosuppressants have also been approved as an add-on treatment. Autologous whole-blood injection (AWBI) has been used in previous studies with ambiguous results. The aim of our study was to evaluate changes in the Urticaria Activity Score (UAS7), Dermatology Life Quality Index (DLQI), and Chronic Urticaria Quality of Life (CU-Q₂oL) score, and also the association of serologic markers with disease severity measures after AWBI. Methods: In this observational study, AWBIs were performed (8 courses on a weekly basis) in adults with refractory CSU, who refused an add-on treatment with either omalizumab or immunosuppressants. UAS7, DLQI, and CU-Q₂oL questionnaires and serum concentrations of total IgE, C-reactive protein (CRP), and D-dimer were evaluated before and after the intervention. Results: Nineteen patients (12 females; mean age 54 ± 20.8 years) completed the protocol. Following AWBI, significant improvements in the UAS7 (34.26 ± 8.04 vs. 12.52 ± 10.83, p < 0.001), DLQI (11.63 ± 5.51 vs. 3.47 ± 2.85, p < 0.001), and CU-Q₂oL score (32.97 ± 18.71 vs. 10.94 ± 7.71, p < 0.001) were recorded. A negative correlation between the baseline D-dimer levels and UAS7 and DLQI variations (p = 0.002 and p = 0.001, respectively) was noted. D-dimer levels ≥292 ng/mL have been associated with poor responsiveness (sensitivity 75%; specificity 83.3%). No correlation with either total immunoglobulin E or CRP levels was observed. Conclusion: AWBI appears to be a safe, alternative, add-on therapeutic option in refractory CSU, particularly in patients with low plasma levels of D-dimer.

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

BackgroundMany patients with chronic spontaneous/idiopathic urticaria (CSU/CIU) do not respond adequately to treatment with non-sedating H1 antihistamines (H1AH). There are limited studies on use of omalizumab as add-on therapy for treatment of CSU in an Asian population. ObjectiveThe POLARIS study (NCT02329223), representing the first randomized, double-blind, placebo-controlled phase III trial of omalizumab for CSU in an Eastern Asian population, evaluated efficacy and safety of omalizumab as add-on therapy for treatment of CSU. MethodsThis 26-week multicenter (41 Japanese/Korean sites) study enrolled patients (12–75 years) who were symptomatic despite H1AH treatment. Eligible participants (N=218) were randomized 1:1:1 to receive three subcutaneous injections of omalizumab 300mg, 150mg, or placebo every 4 weeks, followed by 12 weeks of follow-up. Primary outcome was change from baseline to Week 12 (Wk12) in weekly itch severity score (ISS7). Safety was assessed through the summary of adverse events (AEs). ResultsBaseline demographics and disease characteristics were generally well balanced across treatment groups. At Wk12, statistically significant decreases from baseline were observed in ISS7 with omalizumab vs placebo (mean changes −10.22, −8.80, and −6.51 for omalizumab 300mg, 150mg and placebo; p<0.001 and p=0.006 vs placebo, respectively). Overall AE incidence was similar across treatment groups (54.8%, 57.7%, and 55.4% in omalizumab 300mg, 150mg, and placebo groups, respectively); nasopharyngitis was the most frequently reported AE in all treatment arms. ConclusionThe POLARIS study demonstrates that omalizumab is an efficacious and well-tolerated add-on therapy in Japanese and Korean H1AH-refractory patients with CSU.

Omalizumab for treating chronic spontaneous urticaria: an expert review on efficacy and safety

ABSTRACTIntroduction: Chronic spontaneous urticaria (CSU) is characterized by the recurrence of itchy hives and/or angioedema for greater than six weeks, with no known external trigger. Omalizumab, a humanized, recombinant, monoclonal anti-IgE antibody, is the only approved add-on therapy for H1-antihistamine refractory CSU patients.Areas covered: The objective of this article is to discuss the mechanism of action, pharmacokinetics and pharmacodynamics of omalizumab for the treatment of CSU. The review also summarizes efficacy and safety data from proof-of-concept, phase II (X-CUISITE, MYSTIQUE), and pivotal phase III omalizumab studies (ASTERIA I, ASTERIA II, and GLACIAL).Expert opinion: Omalizumab is a clinically effective and safe biological therapy for treating H1-antihistamine refractory CSU patients. It significantly reduces CSU symptoms (hives, itch and angioedema), and improves patient health-related quality of life. While omalizumab is already integral to the treatment of antihistamine refractory CSU, widespread use will depend on legal and economic factors, as well as improvements in the early and accurate diagnosis of CSU patients who would benefit from treatment.

Treatment of Refractory Chronic Spontaneous Urticaria with Adalimumab.

Treatment of Refractory Chronic Spontaneous Urticaria with Adalimumab.

A randomized trial of quilizumab in adults with refractory chronic spontaneous urticaria

A randomized trial of quilizumab in adults with refractory chronic spontaneous urticaria

Economic burden of refractory chronic spontaneous urticaria on Kuwait's health system.

BackgroundChronic spontaneous urticaria (CSU) is a common problem worldwide. We evaluated the direct medical costs of treating patients with refractory CSU and the budget effect of omalizumab use in these patients in Kuwait.MethodsThe prevalence of CSU was estimated using the Delphi method. Medical records of patients with refractory CSU in Kuwait were reviewed. Costs were calculated from a health system perspective. One-way sensitivity analyses were conducted on the price and utilization of each cost component.ResultsBefore omalizumab use, the total direct costs of treating 1,293 patients with refractory CSU were estimated to be USD 3,650,733 per year. This estimation was principally generated by outpatient visits. After omalizumab use, the cost was sensitive to price variation and estimated to be USD 15,828,612 per year. All other direct costs were reduced.ConclusionThe economic burden of refractory CSU in Kuwait is high. Omalizumab use is costly, but its administration reduces all other direct costs.

Treatment of Chronic Spontaneous Urticaria with a Single Dose of Omalizumab: A Study of Four Cases.

Background:Chronic spontaneous urticaria (CSU) has a detrimental effect on patients’ emotional and physical quality of life. Omalizumab, an anti-immunoglobulin E humanized monoclonal antibody, has been shown to be very effective in the treatment of refractory chronic urticaria patients but may not be an economically viable option for all CSU patients. However, we present a case series where a single dose of omalizumab gave sustained relief of symptoms in patients with CSU, which may be an economical option.Aims:The aim of this study is to assess the efficacy of a single dose of omalizumab in the treatment of CSU. Materials and Methods: Four patients of CSU whose disease was not controlled with four times the licensed dose of tablet fexofenadine 180 mg were exhibited one subcutaneous injection of omalizumab and were followed up at 4 weekly intervals for 24 weeks for Weekly Urticaria Activity Score 7 (UAS7) and Dermatology Life Quality Index (DLQI).Results:A sharp decline in UAS7 and DLQI was documented in 7–10 days. The decline was maintained up to 16 weeks in one case and 20 weeks in the other three cases. Both the scores at the end of the follow-up period of 24 weeks were better than the pre-omalizumab scores.Conclusion:The results of this case series indicate the efficacy of a single-dose omalizumab in treating moderate to severe refractory CSU. Further studies are required to identify the minimum frequency of administering omalizumab to effectively control CSU. This would greatly reduce the cost of this novel therapy.