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Scientific Reports Feb 2015Currently, limited information is available to clinicians regarding the long-term efficacy of omalizumab treatment for allergic asthma. In this report, we aimed to (i)... (Meta-Analysis)
Meta-Analysis Review
Currently, limited information is available to clinicians regarding the long-term efficacy of omalizumab treatment for allergic asthma. In this report, we aimed to (i) systematically review the evidence regarding the long-term efficacy of omalizumab in patients with persistent uncontrolled allergic asthma, and to (ii) discuss the cost-effectiveness evidence published for omalizumab in this patient population. A comprehensive search for randomized controlled trials (RCTs; ≥52 weeks) was performed, and six studies met our final inclusion criteria (n = 2,749). Omalizumab was associated with significant improvements in quality of life and the Global Evaluation of Treatment Effectiveness. Omalizumab also allowed patients to completely withdraw from inhaled corticosteroid therapy and did not increase the overall incidence of adverse events. However, there was insufficient evidence that omalizumab reduced the incidence of exacerbations, and the cost-effectiveness of omalizumab varied across studies. Our data indicated that omalizumab use for at least 52 weeks in patients with persistent uncontrolled allergic asthma was accompanied by an acceptable safety profile, but it lacked effect on the asthma exacerbations. Use of omalizumab was associated with a higher cost than conventional therapy, but these increases may be cost-effective if the medication is used in patients with severe allergic asthma.
Topics: Age Factors; Anti-Allergic Agents; Asthma; Clinical Trials as Topic; Databases, Factual; Humans; Omalizumab; Severity of Illness Index; Treatment Outcome
PubMed: 25645133
DOI: 10.1038/srep08191 -
The Journal of Allergy and Clinical... Dec 2016
Meta-Analysis Review
Topics: Anti-Allergic Agents; Dermatitis, Atopic; Humans; Omalizumab; Randomized Controlled Trials as Topic
PubMed: 27543070
DOI: 10.1016/j.jaci.2016.05.038 -
The Journal of Allergy and Clinical... Oct 2020Symptomatic dermographism (SD), the most common form of chronic inducible urticaria, presents with transient wheals accompanied by itching in response to scratching.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Symptomatic dermographism (SD), the most common form of chronic inducible urticaria, presents with transient wheals accompanied by itching in response to scratching. Little is known about available treatment options and their efficacy in SD.
OBJECTIVE
To systematically review the efficacy of treatment options for patients with SD.
METHODS
Using predefined search terms, we searched for relevant literature published until September 2019. The systematic review process was consistent with Preferred Reporting Items for Systematic Reviews and Meta-Analysis recommendations.
RESULTS
The 23 studies identified included 15 randomized controlled trials; 22 and 17 assessed treatment responses in patients with SD by provocation/threshold testing and patient/physician clinical assessment, respectively. Thirteen different treatments were investigated in a total of 430 adult patients. The most frequently studied therapy, first-generation H-antihistamines, showed variable efficacy and significant side effects. In contrast, second-generation H-antihistamines (2AH), in all studies, were effective and well tolerated. Monotherapy with an H-antihistamine (AH) was not effective, whereas adding an AH increased the efficacy of treatment with an H-antihistamine (AH). SD improved with omalizumab. All other treatments were only investigated in small, unrepeated, and/or uncontrolled studies. There are no studies on updosing of 2AH.
CONCLUSIONS
The available SD studies are heterogeneous, mostly monocentric, old, small, and unrepeated, pointing to a high need for more and better studies. We suggest that 2AH should be the first-line treatment. In uncontrolled cases, the combination of AH and AH may be tried. Even though there is no evidence of its efficacy over standard dosage, updosing of 2AH may be considered based on the extrapolation of evidence from chronic spontaneous urticaria; omalizumab should be added in recalcitrant patients.
Topics: Adult; Chronic Disease; Chronic Urticaria; Histamine Antagonists; Histamine H1 Antagonists; Humans; Omalizumab; Urticaria
PubMed: 32473421
DOI: 10.1016/j.jaip.2020.05.016 -
Journal of Drugs in Dermatology : JDD Apr 2024Individuals with chronic spontaneous urticaria (CSU) experience significant sleep disturbances and are at risk of anxiety and depression. (Meta-Analysis)
Meta-Analysis
Individuals with chronic spontaneous urticaria (CSU) experience significant sleep disturbances and are at risk of anxiety and depression.
Topics: Humans; Omalizumab; Chronic Urticaria; Anti-Allergic Agents; Chronic Disease; Urticaria; Treatment Outcome
PubMed: 38564395
DOI: 10.36849/JDD.7919 -
BMJ Open Sep 2021To assess the efficacy and safety of omalizumab for chronic rhinosinusitis with nasal polyps (CRSwNP) and to identify evidence gaps that will guide future research on... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To assess the efficacy and safety of omalizumab for chronic rhinosinusitis with nasal polyps (CRSwNP) and to identify evidence gaps that will guide future research on omalizumab for CRSwNP.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
A comprehensive search was performed in PubMed, Embase, Web of Science and the Cochrane Library on 13 October 2020.
ELIGIBILITY CRITERIA
Randomised controlled trials (RCTs) comparing omalizumab with placebo, given for at least 16 weeks in adult patients with CRSwNP.
DATA EXTRACTION AND SYNTHESIS
Two independent authors screened search results, extracted data and assessed studies using the Cochrane risk of bias tool. Data were pooled using the inverse-variance method and expressed as mean differences (MDs) with 95% CIs. Heterogeneity was assessed by the χ test and the I statistic.
RESULTS
A total of four RCTs involving 303 participants were identified. When comparing omalizumab to placebo, there was a significant difference in Nasal Polyps Score (MD=-1.20; 95% CI -1.48 to -0.92), Nasal Congestion Score (MD=-0.67; 95% CI -0.86 to -0.48), Sino-Nasal Outcome Test-22 (MD=-15.62; 95% CI -19.79 to -11.45), Total Nasal Symptom Score (MD=-1.84; 95% CI -2.43 to -1.25) and reduced need for surgery (risk ratio (RR)=5.61; 95% CI 1.99 to 15.81). Furthermore, there was no difference in the risk of serious adverse events ((RR=1.40; 95% CI 0.29 to 6.80), adverse events (RR=0.83; 95% CI 0.60 to 1.15) and rescue systemic corticosteroid (RR=0.52; 95% CI 0.17 to 1.61).
CONCLUSIONS
This was the first meta-analysis that identified omalizumab significantly improved endoscopic, clinical and patient-reported outcomes in adults with moderate to severe CRSwNP and it was safe and well tolerated.
PROSPERO REGISTRATION NUMBER
CRD42020207639.
Topics: Adult; Chronic Disease; Humans; Nasal Polyps; Omalizumab; Quality of Life; Randomized Controlled Trials as Topic; Sinusitis
PubMed: 34479933
DOI: 10.1136/bmjopen-2020-047344 -
Omalizumab in patients with chronic spontaneous urticaria: a systematic review and GRADE assessment.The British Journal of Dermatology Aug 2015Chronic spontaneous urticaria (CSU) is characterized by the occurrence of hives, angio-oedema or both for a period of at least 6 weeks. Many patients remain symptomatic... (Review)
Review
Chronic spontaneous urticaria (CSU) is characterized by the occurrence of hives, angio-oedema or both for a period of at least 6 weeks. Many patients remain symptomatic despite treatment with H1 antihistamines, even at higher doses. This systematic review assessed the quality of the evidence for the effects of omalizumab as treatment in patients with CSU. We searched PubMed, the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials up to 7 August 2014. Three review authors independently carried out study selection, risk of bias assessment and data extraction. Two review authors analysed the data. Five randomized controlled trials (RCTs), which included 1116 participants, were evaluated. All the RCTs were judged as having a low risk of bias. There was a statistically significant improvement in measures of disease activity and quality of life following treatment with omalizumab when compared with placebo [mean difference (MD) -11·58, 95% confidence interval (CI) -13·39 to -9·77 and MD -13·12, 95% CI -16·30 to -9·95, respectively]. Complete response and partial response were more frequent after treatment with omalizumab [risk ratio (RR) 6·44, 95% CI 3·95-10·49 and RR 4·08, 95% CI 2·98-5·60, respectively]. There was no difference in the proportion of participants reporting adverse events between the omalizumab and placebo treatment groups (RR 1·05, 95% CI 0·96-1·16). There was high-quality evidence to support the effectiveness and safety of omalizumab 300 mg per month for the treatment of CSU for up to 6 months.
Topics: Anti-Allergic Agents; Chronic Disease; Humans; Omalizumab; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome; Urticaria
PubMed: 25891046
DOI: 10.1111/bjd.13845 -
American Journal of Clinical Dermatology Apr 2019Bullous pemphigoid (BP) is the most common autoimmune blistering skin disease worldwide. Systemic corticosteroids are considered the mainstay of therapy; however, they... (Comparative Study)
Comparative Study
BACKGROUND
Bullous pemphigoid (BP) is the most common autoimmune blistering skin disease worldwide. Systemic corticosteroids are considered the mainstay of therapy; however, they may cause significant adverse effects and treatment failures, so additional therapeutic modalities with better safety profiles are required. Rituximab and omalizumab are novel biologic agents administered in recent years for the treatment of BP, yet data regarding their use in the disease are limited.
OBJECTIVE
Our objective was to systematically review the current literature regarding the use of rituximab and omalizumab for the treatment of BP to evaluate their safety and efficacy.
METHODS
A systematic review of all publications evaluating patients with BP treated with rituximab or omalizumab was performed. The primary outcome was clinical response; secondary outcomes were adverse events and recurrence rate.
RESULTS
The systematic review included 35 publications (84 patients: 62 receiving rituximab and 22 receiving omalizumab). In total, 61 of 63 patients had not experienced disease control with systemic corticosteroids before receiving the biologic treatment. Complete response rates were 85% and 84% for rituximab and omalizumab, respectively. The recurrence rate was considerably lower with rituximab (29%) than with omalizumab (80%). Mean time to recurrence was 10.2 and 3.4 months, and adverse effects occurred in 24% and 20% of the patients, respectively.
CONCLUSIONS
Available data, although potentially limited because of publication bias, suggest that rituximab and omalizumab have similar safety profiles and provide clinical benefit for patients with BP. The reviewed data indicated that rituximab resulted in lower recurrence rates and a longer time until recurrence than omalizumab.
Topics: Dermatologic Agents; Humans; Immunologic Factors; Omalizumab; Pemphigoid, Bullous; Recurrence; Rituximab; Treatment Outcome
PubMed: 30421306
DOI: 10.1007/s40257-018-0401-6 -
Allergologia Et Immunopathologia 2019Chronic spontaneous urticaria (CSU) affects approximately 1% of the population, affecting both children and adults. Omalizumab (Oma) is a therapeutic option for patients... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Chronic spontaneous urticaria (CSU) affects approximately 1% of the population, affecting both children and adults. Omalizumab (Oma) is a therapeutic option for patients with refractory forms of CSU.
OBJECTIVES
To determine the effectiveness and safety of Oma in the treatment of CSU.
METHODS
Systematic review (Cochrane Collaboration methodology) of randomized clinical trials comparing Oma to placebo in refractory CSU treatment. The search is based on MEDLINE; EMBASE, Central Cochrane Library, and LILACS. The outcomes evaluated were: control of the illness, adverse events, and quality of life.
RESULTS
Of the 848 identified studies 13 were selected for further review and six were included in the meta-analysis. For all outcomes, high-quality evidence has confirmed that Oma is effective in the treatment of CSU. The dosage of 300mg/month achieved better results; namely a significant reduction in pruritus, papules, and urticaria activity, as well as an increase in the number of patients with a controlled condition, improvement in the quality of life and no differences in adverse events compared to the placebo.
CONCLUSIONS
High-quality evidence demonstrates that Oma is effective and safe in the treatment of CSU refractory to therapy with H1 antihistamines.
Topics: Anti-Allergic Agents; Chronic Urticaria; Drug Therapy, Combination; Histamine H1 Antagonists; Humans; Immunoglobulin E; Immunotherapy; Omalizumab; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 31607407
DOI: 10.1016/j.aller.2019.05.003 -
Pediatric Allergy and Immunology :... Sep 2015There are less data on omalizumab treatment in pediatric asthma than in adult population. Thus, to establish the efficacy and safety of subcutaneous omalizumab as an... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
There are less data on omalizumab treatment in pediatric asthma than in adult population. Thus, to establish the efficacy and safety of subcutaneous omalizumab as an add-on therapy, a systematic review of placebo-controlled studies was performed.
METHODS
Primary outcome was the frequency of asthma exacerbations. Secondary outcomes included spirometric measures, rescue medication use, asthma symptoms, health-related quality of life, and adverse events.
RESULTS
Three randomized controlled trials (1381 participants) fulfilled the selection criteria. During the stable phase, omalizumab decreased the number of patients with at least one significant asthma exacerbation (26.7% vs. 40.6%, NNTB = 7, 95% CI, 5, 11). The predefined post hoc subgroup analysis showed that duration of treatment did not influence this result. During the steroid reduction phase, omalizumab reduced the number of patients with at least one exacerbation (RR = 0.48, 95% CI, 0.38, 0.61; NNTB = 6, 95% CI, 4, 8) and also the mean number of asthma exacerbations per patient (MD = -0.44, 95% CI, -0.72, -0.17) when compared to placebo. The frequency of serious adverse events was similar between omalizumab (5.2%) and placebo (5.6%), and there were no evidence of increased risk of hypersensitivity reactions, nor malignant neoplasms.
CONCLUSIONS
Data indicate that the efficacy of an add-on omalizumab in patients with moderate-to-severe allergic asthma uncontrolled with recommended inhaled steroid treatment is accompanied by an acceptable safety profile.
Topics: Adolescent; Age Factors; Anti-Asthmatic Agents; Asthma; Chi-Square Distribution; Child; Disease Progression; Drug Therapy, Combination; Female; Humans; Lung; Male; Odds Ratio; Omalizumab; Quality of Life; Risk Factors; Spirometry; Treatment Outcome
PubMed: 25963882
DOI: 10.1111/pai.12405 -
The Journal of Allergy and Clinical... Jun 2020Delayed pressure urticaria (DPU) is characterized by recurrent erythematous and often painful swelling after the skin is exposed to sustained pressure. Treatment is...
BACKGROUND
Delayed pressure urticaria (DPU) is characterized by recurrent erythematous and often painful swelling after the skin is exposed to sustained pressure. Treatment is challenging. Antihistamines, the first-line and only approved treatment, are often not effective.
OBJECTIVE
To systematically review the treatment options for DPU.
METHOD
A literature search of electronic databases for all relevant articles published till April 29, 2019, was conducted using the search terms "delayed pressure urticaria" and "pressure urticaria." This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses recommendations.
RESULTS
Twenty-one studies (8 randomized controlled trials [RCTs], 10 retrospective cohort studies, and 3 open-label prospective studies) were included. Second-generation H antihistamines (sgAHs) were effective in 3 RCTs. The combination of an sgAH and montelukast (2 RCTs) or an sgAH and theophylline (1 non-RCT) was more effective than the sgAH alone. The disease improved with omalizumab (4 non-RCTs), sulphones (3 non-RCTs), oral prednisolone (1 RCT and 2 non-RCTs), intravenous immunoglobulin (1 non-RCT), and gluten-free diet (1 non-RCT). There are no studies on updosing of antihistamines over standard dosage in DPU.
CONCLUSIONS
Overall, the quality of studies on DPU is low. Because of the lack of other evidence, antihistamines remain the first-line therapy. Updosing of sgAHs could be considered in patients with uncontrolled symptoms on the basis of the extrapolation of evidence from chronic spontaneous urticaria, even though there is no evidence of its efficacy over standard dosage. Addition of montelukast may be considered. Omalizumab or sulphones may be used in treatment-resistant patients. High-quality DPU studies should be conducted.
Topics: Anti-Allergic Agents; Chronic Disease; Chronic Urticaria; Histamine Antagonists; Humans; Omalizumab; Urticaria
PubMed: 32179196
DOI: 10.1016/j.jaip.2020.03.004