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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 -
American Journal of Otolaryngology 2022The management of chronic rhinosinusitis with nasal polyps (CRSwNP) is challenging due to disease recurrence and adverse effects. Both surgical and medical treatment... (Review)
Review
The management of chronic rhinosinusitis with nasal polyps (CRSwNP) is challenging due to disease recurrence and adverse effects. Both surgical and medical treatment modalities impact the quality of patients' lives. Monoclonal antibody treatment has recently been used successfully in CRS with limited reported adverse events. We aimed to review the literature to shed more light on the safety and adverse events associated with the biological therapy of CRSwNP. A comprehensive systematic review was conducted on the safety of different biological treatments when used for managing CRSwNP. We have included 13 studies in the present systematic review, including 12 randomized controlled trials (RCTs) and one cross-sectional study. The total sample size for the included studies was 2282 patients. Six studies investigated the safety and adverse events of dupilumab; three investigated omalizumab, three investigated mepolizumab, and only one investigated reslizumab. Some studies have reported that adverse events were common with these types of drugs. However they were not specific and self-limited. Headaches, injection site reactions, and pharyngitis were the most common adverse events found among the reported adverse events. The Dupilumab trial reported pharyngitis in 225 patients (22.4 %) followed by erythema in 9.4 %, headache in 8.1 %, epistaxis in 5.1 %, and asthma in 1.7 % of patients. Trials which used omalizumab reported headaches, nasal pharyngitis, injection-site reactions to be the most common adverse events with estimated prevalence rates of 8.1 %, 5.9 %, and 5.2 %, respectively. Mepolizumab and reslizumab studies reported that 40 % of patients were complicated by nasal polyps/congestion/pharyngitis/infections, 14 had a headache (15.5 %), two developed asthma (2.2 %), and only one patient (1.1 %) had epistaxis as an adverse event. Although the literature's current investigations indicate the safety of the biologic treatment modalities, further studies are needed as some uncertainty among the trials have been reported.
Topics: Humans; Nasal Polyps; Rhinitis; Omalizumab; Epistaxis; Sinusitis; Chronic Disease; Biological Therapy; Asthma; Antibodies, Monoclonal; Biological Products; Headache; Pharyngitis; Quality of Life
PubMed: 36057193
DOI: 10.1016/j.amjoto.2022.103615 -
Dermatologic Therapy Dec 2022This meta-analysis aimed to assess the efficacy of omalizumab in the treatment of refractory-to-antihistamines chronic induced urticaria (CIndU) in comparison with that... (Meta-Analysis)
Meta-Analysis Review
This meta-analysis aimed to assess the efficacy of omalizumab in the treatment of refractory-to-antihistamines chronic induced urticaria (CIndU) in comparison with that of refractory-to-antihistamines chronic spontaneous urticaria (CSU). We retrieved interventional studies and observational studies on omalizumab efficacy to CIndU patients and efficacy comparison between CSU and CIndU both refractory to H1-antihistamines in electronic databases (accessed till May 2022). The odd ratio (OR) and 95% confidence interval (CI) was calculated with a random-effect model in this meta-analysis. The majority of patients with different CIndU subtypes gained complete or partial response and good safety after omalizumab treatment. A total of five studies with 355 CSU patients and 103 CIndU patients were included for the meta-analysis. There was no significant difference in the efficacy of omalizumab in the treatment of CSU and CIndU (OR -0.83, 95% CI [0.84, 2.21], P > 0.05). Based on the validity of omalizumab in the treatment of various CIndU subtypes and non-differential efficacy between CSU and CIndU, it is reasonable to list omalizumab as a third-line treatment of refractory CIndU.
Topics: Humans; Omalizumab; Anti-Allergic Agents; Urticaria; Chronic Disease; Chronic Urticaria; Histamine Antagonists; Treatment Outcome
PubMed: 36222320
DOI: 10.1111/dth.15928 -
Rhinology Dec 2021Allergic rhinitis (AR), an IgE mediated inflammatory disease, significantly impacts quality of life of a considerable proportion of the general population. Omalizumab, a... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Allergic rhinitis (AR), an IgE mediated inflammatory disease, significantly impacts quality of life of a considerable proportion of the general population. Omalizumab, a humanized monoclonal antibody against IgE, has been evaluated for both seasonal and perennial AR. We aimed to assess the efficacy and safety of omalizumab in randomized controlled trials (RCTs) in inadequately controlled AR.
METHODS
We conducted a systematic literature search of RCTs evaluating the safety and efficacy of omalizumab in AR. We synthesized evidence for clinical improvement of AR symptoms, quality of life, reduction of the use of rescue medication, and adverse events.
RESULTS
The systematic search returned 289 articles, of which 12 RCTs were eligible for data extraction and meta-analysis. Omalizumab reduced the Daily Nasal Symptom Severity Score (DNSSS) by a summary standardized mean difference of -0.41 points with large heterogeneity; omalizumab significantly reduced the DNSSS both in the 3 cedar pollen-induced AR trials by -0.97 points and to a lower extent in the remaining five non-cedar trials by -0.19 points. Omalizumab also improved the Daily Ocular Symptom Severity Score (DOSSS) by a summary standardized mean difference of -0.30 points with large heterogeneity; the Rhino-conjunctivitis Quality of Life Questionnaire by a summary standardized mean difference of -0.45 points with no heterogeneity and the mean daily consumption of rescue antihistamines by a summary standardized mean difference of -0.21 with large heterogeneity. No statistically significant difference in the occurrence of adverse events was observed between omalizumab and placebo.
CONCLUSION
Our findings further support the efficacy and safety of omalizumab in the management of patients with allergic rhinitis inadequately controlled with a conventional treatment.
Topics: Antibodies, Monoclonal, Humanized; Humans; Nose; Omalizumab; Rhinitis, Allergic; Treatment Outcome
PubMed: 34714895
DOI: 10.4193/Rhin21.159 -
Journal of Cutaneous Medicine and... 2022Bullous pemphigoid (BP) is an autoimmune blistering skin disease. Current treatment strategies are limited by their efficacy and/or side effect profile and the need for...
Bullous pemphigoid (BP) is an autoimmune blistering skin disease. Current treatment strategies are limited by their efficacy and/or side effect profile and the need for safer and effective alternatives is undeniable. We aimed to conduct a systematic review focusing on the efficacy and safety of omalizumab in BP patients. Embase, PubMed, Cochrane, and clinicaltrials.gov were searched for English and French articles published from inception to July 1, 2021, using search terms "omalizumab" OR "Xolair" OR "IGE025" OR "olizumab" AND "bullous pemphigoid." Screening and data extraction was performed by two raters independently. The primary outcome was complete response (CR), and secondary outcomes were partial response (PR), flare-ups, adverse events/vital status. In total, 22 articles were included, with a total of 56 patients. All patients had a refractory BP with mean disease duration of 13.5 ± 20.2 months (Standard Deviation (SD)) and failed 3.1 ± 1.6 therapies and many remained corticosteroids dependent. Overall, 87.5% of patients responded to treatment (55.4% CR and 32.1% PR), 7.1% discontinued the protocol and only 5.4% were non responders. A third of patients were able to discontinue all other therapies and most others were able to discontinue or taper systemic corticosteroids to <10 mg daily. Flare-ups occurred in 57.7% of patients upon discontinuation of omalizumab and/or steroid tapering, most patients recaptured response thereafter. Omalizumab was well tolerated by most patients. Omalizumab appears to be a promising treatment for BP with a good response rate and safety profile. However, several limitations were identified in current literature, and highlight the need for randomized controlled trials of omalizumab in BP.
Topics: Autoimmune Diseases; Humans; Omalizumab; Pemphigoid, Bullous
PubMed: 35379011
DOI: 10.1177/12034754221089267 -
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 -
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 -
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 -
Giornale Italiano Di Dermatologia E... Aug 2019Omalizumab, has been used for almost two decades, mainly in allergic asthma and chronic spontaneous urticaria for which it is highly beneficial. Smaller studies have...
INTRODUCTION
Omalizumab, has been used for almost two decades, mainly in allergic asthma and chronic spontaneous urticaria for which it is highly beneficial. Smaller studies have evaluated the effects of omalizumab in atopic dermatitis (AD). Current treatments options, such as cyclosporine and azathioprine have limited effect on AD and numerous side effects. The recently introduced biologic dupilumab (anti-IL4) shows promising results, however with conjunctivitis as a prevalent side effect. We evaluate the current evidence for the use of omalizumab in AD.
EVIDENCE ACQUISITION
Systematic literature searches were performed in PubMed, Web of Science, Embase and Clinicaltrials.gov to identify any study (case reports, case series, and controlled trials) evaluating the effect of treatment with omalizumab in AD.
EVIDENCE SYNTHESIS
Thirty-four studies (12 single case studies, 15 case series, 5 prospective studies and 2 small pilot randomized placebo-controlled trials [RCTs]), including a total of 214 patients with median of 3, ranging from 1-35 patients were identified. A total of 169 patients (79.0%) experienced a beneficial effect from treatment, ranging from little to complete response, whereas 45 patients (21.0%) reported no or negative effect from omalizumab treatment.
CONCLUSIONS
Omalizumab is a safe and well-tolerated treatment with some clinical benefit in AD patients. However, the lack of larger RCTs and possible publication bias limit the recommendation of omalizumab for use in clinical practice for AD. Newer and more effective treatments exist and should be prioritized.
Topics: Anti-Allergic Agents; Dermatitis, Atopic; Humans; Omalizumab; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 30717578
DOI: 10.23736/S0392-0488.19.06302-8