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American Journal of Clinical Dermatology Apr 2018Current systemic treatments for atopic dermatitis (AD) offer limited efficacy and are often restricted by safety concerns. Biologics may address the unmet need for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Current systemic treatments for atopic dermatitis (AD) offer limited efficacy and are often restricted by safety concerns. Biologics may address the unmet need for improved AD therapeutics.
OBJECTIVE
The aim of this study was to evaluate the efficacy and safety of biologic agents in AD.
METHODS
A systematic review and meta-analysis of studies evaluating AD patients treated with biologics was performed. The primary outcome was the Eczema Area and Severity Index (EASI)-75 response, while secondary outcomes were SCOring Atopic Dermatitis (SCORAD)-75, EASI-50, SCORAD-50, Investigator Global Assessment 0/1 responses, change in responses from baseline, and adverse events.
RESULTS
We included 13 randomized controlled trials (RCTs) and 10 observational studies evaluating nine biologics. High-quality evidence was available for dupilumab, nemolizumab and ustekinumab. Pooling five studies, at weeks 12-16 dupilumab 300 mg every week to every 2 weeks achieved EASI-75 responses of 55%, superior to placebo [relative risk (RR) 3.3, 95% confidence interval (CI) 2.9-3.6]. Nemolizumab had similar EASI-75 responses as placebo, but significantly improved pruritus. In online reports, lebrikizumab demonstrated superior EASI-50 responses versus placebo (RR 1.3, 95% CI 1.04-1.7), while tralokinumab had superior SCORAD-50 responses versus placebo, with borderline significance (RR 1.7, 95% CI 0.97-3.1). In two RCTs each, omalizumab and ustekinumab were comparable with placebo, while antithymic stromal lymphopoietin receptor, infliximab, and rituximab lacked adequate evidence of efficacy. All medications had a comparable safety profile to placebo.
LIMITATIONS
Lack of RCTs and the use of variable outcome measures limited conclusions.
CONCLUSION
Dupilumab is currently the only biologic with robust evidence of efficacy in AD. Nemolizumab, lebrikizumab, and tralokinumab show promise but further data are needed. Longer follow-up and larger studies will establish their safety profile.
Topics: Antibodies, Monoclonal; Biological Products; Dermatitis, Atopic; Dermatologic Agents; Humans; Observational Studies as Topic; Pruritus; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 29098604
DOI: 10.1007/s40257-017-0324-7 -
The Journal of Allergy and Clinical... 2018Solar urticaria (SU) is a rare photodermatosis causing a significant impact on patients' quality of life. Although the condition can be controlled with phototherapy...
BACKGROUND
Solar urticaria (SU) is a rare photodermatosis causing a significant impact on patients' quality of life. Although the condition can be controlled with phototherapy and/or a combination therapy of antihistamines and leukotriene antagonist in most patients, a subset of patients require additional therapy with omalizumab; however, efficacy data are sparse.
OBJECTIVE
The objective of this study was to determine the efficacy and safety of omalizumab for treating SU.
METHODS
A case series of 5 patients with SU refractory to antihistamine and leukotriene antagonist combination who were treated with omalizumab is described. In addition, a systematic review of studies evaluating patients with SU treated with omalizumab was conducted. The primary outcome was partial/complete clinical response. Secondary outcomes were 10-fold decreases in the baseline minimal urticarial dose and adverse events.
RESULTS
Our case series included 5 patients with SU. Monthly omalizumab doses of 150 to 600 mg resulted in clinical improvement in all patients and complete remission in 4. No adverse effects were reported. The systematic review included 22 studies (48 patients). All patients failed to control disease with antihistamines before omalizumab treatment. Patients received omalizumab at monthly doses of 150 to 750 mg over a follow-up period of 4 to 200 weeks. Thirty-eight patients (79%) experienced clinical improvement. Four patients (11%) had mild adverse effects.
CONCLUSIONS
Omalizumab provided clinical benefits in approximately 80% of patients with SU. Patients failing to improve on standard omalizumab doses may benefit from higher monthly dosages.
Topics: Anti-Allergic Agents; Humans; Omalizumab; Sunlight; Treatment Outcome; Urticaria
PubMed: 29572192
DOI: 10.1016/j.jaip.2018.02.032 -
Pediatric Allergy and Immunology :... May 2018Chronic spontaneous urticaria (CSU) is not frequent in children. Management guidelines have been developed for adults and randomized controlled trials (RCTs) included... (Review)
Review
BACKGROUND
Chronic spontaneous urticaria (CSU) is not frequent in children. Management guidelines have been developed for adults and randomized controlled trials (RCTs) included teenagers aged 12-18, but data for children under age 12 are limited. We performed a systematic review to assess comorbidities in children <12 years old with CSU and the efficacy and safety of treatments.
METHODS
We searched for original articles of epidemiologic and treatment data in children <12 years old with CSU that were published from 2005 to July 2016 in MEDLINE, EMBASE, CENTRAL, and LILACS. Article selection and data extraction were performed in duplicate.
RESULTS
Our systematic review included 9 reports on epidemiologic data (633 children). Five comorbidities and laboratory anomalies associated with CSU found were atopy (28.1%), positive autologous serum skin test (36.8%), thyroid biologic anomalies (6.4%) and detectable antinuclear antigen (10.4%), seroprevalence for Helicobacter pylori (21.1%), low vitamin D level (69.1%), and psychiatric disorders (70.4%). Only one study allowed for comparison with a control group. Our review included 10 studies (322 children), describing 5 different drug families, mostly H1-antihistamines (n = 297). One randomized controlled study compared single-dose rupatadine with single-dose desloratadine and placebo. Cyclosporine was effective and had no adverse effects in 18 children. Omalizumab, montelukast, and cefuroxime were reported in very small series (5, 1, and 1 patients).
CONCLUSIONS
H1-antihistamines are effective for CSU in children <12 years old, with reassuring safety data at licensed doses. Cyclosporine seems effective, but the level of evidence is low.
Topics: Child; Child, Preschool; Chronic Disease; Comorbidity; Histamine Antagonists; Humans; Immunosuppressive Agents; Prevalence; Urticaria
PubMed: 29392757
DOI: 10.1111/pai.12870 -
Therapeutic Advances in Respiratory... 2024With the rise of targeted treatments for asthma, treatment with omalizumab is a new option. (Meta-Analysis)
Meta-Analysis
BACKGROUND
With the rise of targeted treatments for asthma, treatment with omalizumab is a new option.
OBJECTIVES
To assess the improvement of pulmonary function with additional omalizumab treatment in patients (⩾6 years old) with moderate-to-severe allergic asthma.
DATA SOURCES AND METHODS
Observational studies of randomized controlled trials of add-on omalizumab for the treatment of patients with moderate-to-severe allergic asthma, published from the establishment till August 2022, were retrieved from WAN FANG DATA, PubMed, CNKI, Embase, Cochrane, and Web of Science databases. Data extraction and quality evaluation were performed on the literature that met the inclusion criteria, using RevMan 5.3 to analyze the data.
RESULTS
A total of 11 randomized controlled clinical trials were included, involving a total of 3578 patients with asthma, 1856 patients in the omalizumab group, and 1722 patients in the control group. The improvement in Forced expiratory volume in 1 s as a percentage of predicted normal and Forced expiratory volume in 1 s was more pronounced in the omalizumab-treated group [MD = 3.91, 95% confidence interval (CI): 1.89-5.94, = 0.0002; MD = 0.09, 95% CI: 0.05-0.13, < 0.0001], while the improvement in Morning Peak expiratory flow rate was not statistically different between the two groups (MD = 3.64, 95% CI: -22.17-29.45, = 0.78).
CONCLUSION
Additional omalizumab treatment showed some improvement in lung function in patients with moderate-to-severe asthma.
TRIAL REGISTRATION
PROSPERO ID:CRD42022378498.
Topics: Humans; Anti-Asthmatic Agents; Asthma; Forced Expiratory Volume; Lung; Omalizumab; Treatment Outcome
PubMed: 38235607
DOI: 10.1177/17534666231221771 -
The Journal of Allergy and Clinical... 2014Patients with moderate-to-severe allergic rhinitis who are inadequately controlled despite treatment according to current rhinitis management guidelines have a... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Patients with moderate-to-severe allergic rhinitis who are inadequately controlled despite treatment according to current rhinitis management guidelines have a significant unmet medical need. Such patients have a negative impact on daily functioning and are at risk of developing serious comorbidities, such as asthma and chronic rhinosinusitis.
OBJECTIVE
To assess the efficacy and safety of omalizumab in poorly controlled allergic rhinitis under a meta-analysis framework.
METHODS
MEDLINE and the Cochrane Central Register of Controlled Trials were searched through September 2013. Studies on the efficacy of omalizumab in allergic rhinitis that assessed clinical outcomes were selected. Descriptive and quantitative information was extracted; mean differences and relative risk estimates were synthesized under a fixed or random effects model. Heterogeneity was assessed by using the Q statistic and the I(2) metric. Subgroup analyses were performed for the presence of specific immunotherapy treatment.
RESULTS
Of the 352 citations retrieved, 11 studies of 2870 patients were finally included. A statistically significant reduction in the daily nasal symptom severity score (standardized mean difference -0.67 [95% CI, -1.3 to -0.31]; P < .0001; I(2), 92%) and a statistically significant reduction in daily nasal rescue medication score (-0.22 [95% CI, -0.39 to -0.05; P = .01; I(2), 58%) were observed. There was not a statistically significant difference in the occurrence of any adverse event (relative risk 1.06 [95% CI, 0.94-1.19; I(2), 55%).
CONCLUSIONS
Omalizumab is statistically significantly associated with symptom relief, decreased rescue medication use, and improvement of quality of life in patients with inadequately controlled allergic rhinosinusitis.
Topics: Adult; Anti-Allergic Agents; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal, Humanized; Child; Desensitization, Immunologic; Female; Humans; Male; Omalizumab; Randomized Controlled Trials as Topic; Rhinitis, Allergic; Treatment Outcome
PubMed: 24811026
DOI: 10.1016/j.jaip.2014.02.001 -
Allergy May 2024Food allergy (FA) is a potentially life-threatening chronic condition that is becoming an increasing public health problem worldwide. This systematic review (SR) was... (Review)
Review
UNLABELLED
Food allergy (FA) is a potentially life-threatening chronic condition that is becoming an increasing public health problem worldwide. This systematic review (SR) was carried out to inform the development of clinical recommendations on the treatment of IgE-mediated FA with biologics and/or IT for the update of the EAACI guidelines. A SR of randomized-controlled trials or quasi-controlled trials was carried out. Studies were identified via comprehensive search strategies in Medline, Embase, and Cochrane Library, up to April 2022.
POPULATION
Human adults, children, and adolescents with IgE-mediated FA.
INTERVENTION
IT and/or biologics.
COMPARATOR
Placebo or standard-of-care (allergen avoidance).
OUTCOME
Efficacy (desensitization, sustained unresponsiveness (SU), remission), quality of life, and safety (systemic and local adverse reactions (AR)). The Cochrane RoB tool was used to assess the risk of bias. It was reported according to PRISMA and registered in PROSPERO CRD4202229828. After screening, 121 studies were included (111 for IT and 10 for biologics). Most studies had a high risk of bias and showed high heterogeneity in design and results. Metanalysis showed a positive effect of biologics and IT in terms of relative risk (RR) for achieving tolerance to the culprit food compared to avoidance or placebo. Omalizumab for any FA showed a RR of 2.17 [95% confidence interval: 1.22, 3.85]. For peanut allergy, oral IT (OIT) had a RR of 11.94 [1.76, 80.84] versus avoidance or placebo, sublingual IT (SLIT) had a RR of 3.00 [1.04, 8.66], and epicutaneous IT (EPIT) of 2.16 [1.56, 3.00]. OIT had a RR of 5.88 [2.27, 15.18] for cow's milk allergy, and of 3.43 [2.24, 5.27] for egg allergy. There was insufficient data on SLIT or EPIT for the treatment of egg and milk allergies. Most ARs reported were mild. For OIT the most common AR involved the gastrointestinal system and for EPIT, AR's most commonly affected the skin. There was limited data on severe or life-threatening ARs. There was limited evidence for long term efficacy and quality of life. In conclusion, biologics and IT, alone or in combination, are effective in achieving desensitization while on active treatment but more evidence is needed on long-term tolerance as current evidence is not of high quality. Adverse events while on therapy are generally mild to moderate but a long-term comprehensive safety profile is missing. There is a critical need to optimize and standardize desensitization protocols and outcome measures to facilitate our understanding of the efficacy and safety as well as to allow for comparison between interventions.
PubMed: 38747333
DOI: 10.1111/all.16129 -
Journal of Asthma and Allergy 2022Data specific to the epidemiology, clinical features, and management of chronic urticaria (CU) in the geriatric population remain limited and not well understood. We aim... (Review)
Review
PURPOSE
Data specific to the epidemiology, clinical features, and management of chronic urticaria (CU) in the geriatric population remain limited and not well understood. We aim to systematically review the prevalence, clinical manifestations, treatment, and clinical course of elderly patients with CU.
PATIENTS AND METHODS
Original articles that included data of elderly (aged >60 years) with CU that were published until February 2021 were searched in PubMed, Scopus, and Embase using predfefined search terms. Related articles were evaluated according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses recommendations.
RESULTS
Among the included 85 studies and 1,112,066 elderly CU patients, most (57.4%) were women. The prevalence of elderly CU in the general population ranged from 0.2-2.8%, and from 0.7-33.3% among all CU patients. Compared to adult CU, elderly CU patients had a higher percentage of wheal alone (73.9%), and lower rate of positive autologous serum skin test and atopy. Gastrointestinal diseases were the most common comorbidity (71.9%), and there was a high rate of malignancies and autoimmune diseases. Second generation H-antihistamines were commonly used, and achievement of complete control was most often reported. Omalizumab was prescribed in 59 refractory patients, and a significant response to treatment was reported in most patients. The treatment of comorbidities also yielded significant improvement in CU.
CONCLUSION
Elderly CU was found to be different from adult CU in both clinical and laboratory aspects. H- antihistamines are effective as first-line therapy with minimal side-effects at licensed doses. Treatment of secondary causes is important since the elderly usually have age-related comorbidities.
PubMed: 36299736
DOI: 10.2147/JAA.S379912 -
Therapeutic Advances in Respiratory... 2019Asthma is a highly prevalent chronic inflammatory airways disease, with a considerable impact on quality of life (QoL). To express the effects of asthma on patients'...
BACKGROUND
Asthma is a highly prevalent chronic inflammatory airways disease, with a considerable impact on quality of life (QoL). To express the effects of asthma on patients' subjective experience, patient-reported outcomes (PROs) represent an important instrument. The asthma QoL questionnaire (AQLQ) is one of the main PROs among these.
MATERIALS AND METHODS
To identify long-term asthma-related QoL outcomes associated with omalizumab therapy in patients with moderate-to-severe asthma, we developed a systematic review according to the PRISMA guidelines. Published real-world effectiveness studies of adults or adolescents (12 years or older) with moderate-to-severe allergic asthma treated with omalizumab for at least 48 weeks were reviewed. Sources used were Medline ( PubMed), the Cochrane Library and Google Scholar up to February 2018. In addition, a cross-referencing search was conducted to complete the revision.
RESULTS
A total of 255 potential papers were identified in the first search through the database. After full-text viewing, eight articles were finally included in the review. We summarized the results according to the study design, patient baseline characteristics and effectiveness outcomes assessed by AQLQ score results: variation from baseline to the end of study. Results confirmed the long-term benefits of omalizumab as an add-on therapy in patients with uncontrolled moderate-to-severe allergic asthma. Since there is a lot of evidence on omalizumab effectiveness, we aimed to focus on how a therapy can change patient's QoL in a long time period. Data showed long-term effects of omalizumab treatment on subjective (PROs) and objective (lung function, corticosteroid use, hospitalizations, asthma exacerbation) effectiveness measures.
CONCLUSION
Studies included in our review were observational trials that, due to their design, present a potential risk of selection bias in the patients included. Beyond this limit, the evaluation of QoL using the AQLQ showed a clear increase over time, following both 48 weeks and 9 years of observation, where QoL improvements still were significant over baseline values.
Topics: Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Humans; Omalizumab; Quality of Life; Severity of Illness Index; Surveys and Questionnaires; Time Factors
PubMed: 31035904
DOI: 10.1177/1753466619841350 -
Expert Review of Clinical Immunology May 2019Omalizumab is a recombinant monoclonal anti-IgE antibody approved in the US as add-on treatment in moderate-to-severe allergic asthma (in severe allergic asthma [SAA] in...
Omalizumab is a recombinant monoclonal anti-IgE antibody approved in the US as add-on treatment in moderate-to-severe allergic asthma (in severe allergic asthma [SAA] in Europe). A 2016 review of 24 real-world effectiveness studies in SAA published between 2008-2015 concluded that omalizumab was associated with significant improvements in objective and subjective outcomes with benefits extending beyond 2 years. Several new real-world studies have been published since, bringing the total to 42 studies. Areas covered: This systematic review of 42 studies published since 2008 updates and extends the 2016 review on the real-word evidence on omalizumab in SAA. It offers greater granularity as to time windows within which outcomes are reported and includes studies extending well beyond 4 years post omalizumab initiation. Expert commentary: This review firmly establishes the short-term effectiveness of omalizumab in adolescent and adult patients with SAA at 1 year, and provides strong evidence of long-term effectiveness up to 4 years and emergent evidence of effectiveness beyond 4 years. In the aggregate, these 42 studies underscore the long-term effectiveness of omalizumab in terms of: reducing exacerbations and symptoms, achieving asthma control, improving lung function, enhancing quality of life, decreasing emergency department visits and hospitalizations, and promoting concomitant medication-sparing.
Topics: Adolescent; Adult; Asthma; Clinical Trials as Topic; Humans; Omalizumab; Quality of Life; Severity of Illness Index; Time Factors
PubMed: 30763137
DOI: 10.1080/1744666X.2019.1574571 -
Medicine May 2019A wide range of pharmacological and nonpharmacological interventions for chronic urticaria (CU) have been evaluated in systematic reviews (SRs). We conducted an umbrella... (Comparative Study)
Comparative Study
A wide range of pharmacological and nonpharmacological interventions for chronic urticaria (CU) have been evaluated in systematic reviews (SRs). We conducted an umbrella review of SRs of the effectiveness and safety of pharmacological and nonpharmacological interventions for CU, which allow the findings of separate reviews to be compared and contrasted and thereby provide decision makers in healthcare with the evidence they need.We included SRs evaluating pharmacological and nonpharmacological interventions for CU. Comprehensive searches were conducted in 7 bibliographic databases, relevant journals up to July 2018. Two reviewers independently assessed the studies' relevance and quality. The assessment of multiple systematic reviews tool and grading of recommendations assessment, development and evaluation method was used to assess the methodological quality of the SRs and classify the quality of the outcomes.In total, 41 SRs were included. Thirty-seven reviews performed quantitative research syntheses, and 4 reviews performed qualitative research syntheses. The majority of SRs evaluated interventions based on combination therapies, antihistamines, traditional Chinese medicines, autohemotherapy, omalizumab, acupuncture, cyclosporine, and leukotriene receptor antagonist. Positive intervention outcomes were reported in the majority (75.32%) of the reviews. However, the methodological quality and evidence quality of the reviews were generally poor.There is some evidence to support a variety of interventions for CU. However, there was much heterogeneity in evidence quality among SRs. Many of the SRs had methodological weaknesses that make them vulnerable to bias. Moreover, there remained little information on the relative effectiveness of one intervention compared with another. Therefore, further SRs that adherence to strict scientific methods are necessary, and primary studies make comparisons between the different treatment options directly.
Topics: Acupuncture Therapy; Anti-Allergic Agents; Chronic Disease; Cyclosporine; Decision Making; Female; Histamine Antagonists; Humans; Immunosuppressive Agents; Leukotriene Antagonists; Male; Medicine, Chinese Traditional; Omalizumab; Quality Improvement; Treatment Outcome; Urticaria
PubMed: 31096521
DOI: 10.1097/MD.0000000000015711