Perennial is more effective than preseasonal subcutaneous immunotherapy in the treatment of seasonal allergic rhinoconjunctivitis.
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ABSTRACT:
SUBMITTER: Tworek D
PROVIDER: S-EPMC3711679 | biostudies-literature | 2013 Jul-Aug
REPOSITORIES: biostudies-literature
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Perennial is more effective than preseasonal subcutaneous immunotherapy in the treatment of seasonal allergic rhinoconjunctivitis.
Tworek Damian D Bochenska-Marciniak Malgorzata M Kuprys-Lipinska Izabela I Kupczyk Maciej M Kuna Piotr P
American journal of rhinology & allergy 20130429 4
<h4>Background</h4>Two different regimens of subcutaneous immunotherapy (IT), perennial or preseasonal, may be used in the treatment of seasonal allergy. The aim of this study was to compare the efficacy and safety of perennial IT (PIT) and preseasonal IT (PSIT) in patients suffering from seasonal rhinoconjunctivitis.<h4>Methods</h4>The study was planned as a randomized, double-blind, comparative study on the efficacy and safety of PIT and PSIT. The study group comprised 120 patients allergic to ...[more]
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Project description:BackgroundThe capacity of sublingual allergen immunotherapy (SLIT) to provide effective symptom relief in pollen-induced seasonal allergic rhinitis is often questioned, despite evidence of clinical efficacy from meta-analyses and well-powered, double-blind, placebo-controlled randomized clinical trials. In the absence of direct, head-to-head, comparative trials of SLIT and symptomatic medication, only indirect comparisons are possible.MethodsWe performed a meta-analysis of classes of products (second-generation H1-antihistamines, nasal corticosteroids and grass pollen SLIT tablet formulations) and single products (the azelastine-fluticasone combination MP29-02, and the leukotriene receptor antagonist montelukast) for the treatment of seasonal allergic rhinitis in adults, adolescents and/or children. We searched the literature for large (n >100 in the smallest treatment arm) double-blind, placebo-controlled randomized clinical trials. For each drug or drug class, we performed a meta-analysis of the effect on symptom scores. For each selected trial, we calculated the relative clinical impact (according to a previously published method) on the basis of the reported post-treatment or season-long nasal or total symptom scores: 100 × (scorePlacebo - scoreActive)/scorePlacebo.ResultsTwenty-eight publications on symptomatic medication trials and ten on SLIT trials met our selection criteria (total number of patients: n = 21,223). The Hedges' g values from the meta-analyses confirmed the presence of a treatment effect for all drug classes. In an indirect comparison, the weighted mean (range) relative clinical impacts were -29.6% (-23% to -37%) for five-grass pollen SLIT tablets, -19.2% (-6% to -29%) for timothy pollen SLIT tablets, -23.5% (-7% to -54%) for nasal corticosteroids, -17.1% (-15% to -20%) for MP29-02, -15.0% (-3% to -26%) for H1-antihistamines and -6.5% (-3% to -10%) for montelukast.ConclusionsIn an indirect comparison, grass pollen SLIT tablets had a greater mean relative clinical impact than second-generation antihistamines and montelukast and much the same mean relative clinical impact as nasal corticosteroids. This result was obtained despite the presence of methodological factors that mask the clinical efficacy of SLIT for the treatment of seasonal allergic rhinitis.
| S-EPMC4101870 | biostudies-literature
Project description:The European Academy of Allergy and Clinical Immunology (EAACI) is developing Guidelines on Allergen Immunotherapy (AIT) for Allergic Rhinoconjunctivitis (ARC). To inform the development of recommendations, we sought to critically assess the systematic review evidence on the effectiveness, safety and cost-effectiveness of AIT for ARC.We undertook a systematic overview, which involved searching nine international biomedical databases from inception to October 31, 2015. Studies were independently screened by two reviewers against pre-defined eligibility criteria and critically appraised using the Critical Appraisal Skills Programme (CASP) Systematic Review Checklist for systematic reviews. Data were descriptively synthesized.Our searches yielded a total of 5932 potentially eligible studies, from which 17 systematic reviews met our inclusion criteria. Eight of these were judged to be of high, five moderate and three low quality. These reviews suggested that, in carefully selected patients, subcutaneous (SCIT) and sublingual (SLIT) immunotherapy resulted in significant reductions in symptom scores and medication requirements. Serious adverse outcomes were rare for both SCIT and SLIT. Two systematic reviews reported some evidence of potential cost savings associated with use of SCIT and SLIT.We found moderate-to-strong evidence that SCIT and SLIT can, in appropriately selected patients, reduce symptoms and medication requirements in patients with ARC with reassuring safety data. This evidence does however need to be interpreted with caution, particularly given the heterogeneity in the populations, allergens and protocols studied. There is a lack of data on the relative effectiveness, cost-effectiveness and safety of SCIT and SLIT. We are now systematically reviewing all the primary studies, including recent evidence that has not been incorporated into the published systematic reviews.
| S-EPMC5547534 | biostudies-literature
Project description:Introduction The relevance of allergic rhinitis is unquestionable. This condition affects people's quality of life and its incidence has increased over the last years. Objective Thus, this study aims to analyze the effectiveness of subcutaneous injectable immunotherapy in cases of nasal itching, sneeze, rhinorrhea and nasal congestion in allergic rhinitis patients. Methods In the present study, the same researcher analyzed the records of 281 patients. Furthermore, the researchers identified allergens through puncture cutaneous tests using standardized extracts containing acari, fungi, pet hair, flower pollen, and feathers. Then, the patients underwent treatment with subcutaneous specific immunotherapy, using four vaccine vials for desensitization, associated with environmental hygiene. The authors analyzed conditions of nasal itching, sneeze, rhinorrhea, and nasal congestion throughout the treatment, and assigned them with a score ranging from zero (0), meaning absence of these symptoms to three (3), for severe cases. The symptoms were statistically compared in the beginning, during, and after treatment. Results In this study, authors analyzed the cases distribution according to age and the evolution of symptomatology according to the scores, comparing all phases of treatment. The average score for the entire population studied was 2.08 before treatment and 0.44 at the end. These results represent an overall improvement of ∼79% in symptomatology of allergic rhinitis in the studied population. Conclusion The subcutaneous immunotherapy as treatment of allergic rhinitis led to a reduction in all symptoms studied, improving the quality of life of patients, proving itself as an important therapeutic tool for these pathological conditions.
| S-EPMC4688001 | biostudies-other
Project description:Ragweed (Ambrosia spp.) is an annually flowering plant whose pollen bears high allergenic potential. Ragweed-induced allergic rhinoconjunctivitis has long been seen as a major immunologic condition in Northern America with high exposure and sensitization rates in the general population. The invasive occurrence of ragweed (A. artemisiifolia) poses an increasing challenge to public health in Europe and Asia as well. Possible explanations for its worldwide spread are climate change and urbanization, as well as pollen transport over long distances by globalized traffic and winds. Due to the increasing disease burden worldwide, and to the lack of a current and comprehensive overview, this study aims to review the current and emerging treatment options for ragweed-induced rhinoconjunctivitis. Sound clinical evidence is present for the symptomatic treatment of ragweed-induced allergic rhinoconjunctivitis with oral third-generation H1-antihistamines and leukotriene antagonists. The topical application of glucocorticoids has also been efficient in randomized controlled clinical trials. Combined approaches employing multiple agents are common. The mainstay of causal treatment to date, especially in Northern America, is subcutaneous immunotherapy with the focus on the major allergen, Amb a 1. Beyond this, growing evidence from several geographical regions documents the benefit of sublingual immunotherapy. Future treatment options promise more specific symptomatic treatment and fewer side effects during causal therapy. Novel antihistamines for symptomatic treatment are aimed at the histamine H3-receptor. New adjuvants with toll-like receptor 4 activity or the application of the monoclonal anti-immunoglobulin E antibody, omalizumab, are supposed to enhance conventional immunotherapy. An approach targeting toll-like receptor 9 by synthetic cytosine phosphate-guanosine oligodeoxynucleotides promises a new treatment paradigm that aims to modulate the immune response, but it has yet to be proven in clinical trials.
| S-EPMC4337734 | biostudies-literature
Project description:BackgroundTo date no study has evaluated the efficacy of preseasonal omalizumab therapy with cost effective dose and at appropriate time point compared with standard medication in seasonal allergic rhinitis (SAR) patients.MethodsThis was a prospective randomized controlled open-label single-centre trial. 32 SAR patients were randomized to receive a single injection of omalizumab 300-mg approximately two weeks before start of the pollen period (PP) or medication therapy. All patients completed daily questionnaires; recording symptoms, medication use and quality of life (QoL) throughout the observation period. The primary efficacy parameter was the mean daily Combined Symptom and Medication Score (CSMS).ResultsPreseasonal omalizumab significantly reduced the changes of mean daily CSMS of nose during the PP (p < 0.001), peak pollen period (PPP) and PP after PPP (PPP-PP) (p = 0.002) and Post-PP (p = 0.009) compared to standard medication. The proportion of allergy symptoms-relieving medication-free days during PPP-PP was also significantly higher in preseasonal omalizumab-treated group (76.2(16.7-98.8))% than in medication-treated group (19.0(0-71.4))% (p = 0.030). Omalizumab could achieve the same nasal symptom control during the entire pollen season and better eye symptoms relieving results in PP (p = 0.046) and PPP-PP (p = 0.004) than medication treatment. Significantly greater improvement in QoL was also obtained with omalizumab-pretreatment during the PP (p = 0.037) and PPP-PP (p = 0.004).ConclusionsAdministration of a single injection of 300 mg omalizumab two weeks before start of the pollen season achieves better overall control of symptoms and QoL, with significantly reduced allergy symptoms-relieving medication usage, compared with standard pharmacotherapy in SAR patients.
| S-EPMC8727318 | biostudies-literature
Project description:BACKGROUND:A relevant proportion of allergic rhinoconjunctivitis (ARC) patients experience recurrent symptoms after successfully completing allergen immunotherapy (AIT). This prospective, controlled, noninterventional study used internationally standardized instruments to determine the clinical effects of a preseasonal, ultra-short-course booster AIT on clinical outcome parameters. METHODS:This two-arm study included patients aged ?12 years with recurrent grass pollen-induced seasonal AR who had completed a successful course of any grass pollen AIT at least 5 years before enrolment. Overall, 56 patients received one preseasonal short-course booster AIT using tyrosine-absorbed grass pollen allergoids containing the adjuvant monophosphoryl lipid A (MPL® ); 51 control patients received symptomatic medication. The combined symptom and medication score (CSMS) was recorded in the (peak) grass pollen season. Furthermore, concomitant (antiallergic) medication use, the patients' state of health, Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) results and safety/tolerability of the treatment were assessed. RESULTS:The CSMS in the peak grass pollen season was significantly lower in the booster AIT group (?=38.4%, P<.01). Moreover, significantly more patients in this group used no concomitant antiallergic medication throughout the peak grass pollen season. Twice as many patients in the booster AIT group as in the control group reported having a better state of health than in the preceding season. MiniRQLQ results showed significant differences favouring the booster AIT. The booster AIT was generally well tolerated, with only two patients reporting mild, grade 1 systemic adverse events. CONCLUSION:Booster AIT using tyrosine-absorbed allergoids containing the adjuvant MPL® effectively prevents re-occurrence of symptoms in patients with grass pollen-induced ARC.
| S-EPMC5763416 | biostudies-literature
Project description:BackgroundCurrently accepted therapies for ragweed allergy in North America consist of pharmacotherapy and subcutaneous allergen immunotherapy injections to treat symptoms. Allergen immunotherapy not only reduces symptoms and the need for pharmacotherapy but has also been shown to have disease-modifying potential. Recently, ragweed immunotherapy administered via sublingual allergen tablet has been approved in North America for treatment of allergic rhinitis with and without conjunctivitis.MethodsThis was an analysis of pooled data for a prespecified subgroup of Canadian subjects from two multicentre, randomized, double-blind placebo-controlled trials of ragweed sublingual tablet (SLIT-T; 6 and 12 Amb a 1-U of Ambrosia artemisiifolia) in patients aged ≥18y, with ragweed-induced allergic rhinoconjunctivitis (AR/C) with or without asthma. Randomized subjects used once-daily ragweed SLIT-T or placebo for at least 12 weeks before the ragweed season and for up to 52 weeks post-randomization. The primary efficacy endpoint was the total combined score (TCS) based on the sum of AR/C daily symptom score (DSS) and daily medication score (DMS) averaged over the peak season. Treatment effects on TCS, DSS, and DMS in the entire season were also assessed. Adverse events (AEs) were monitored to assess safety.Results337 Canadian subjects were randomized in the two trials. During the peak season, ragweed SLIT-T 6 and 12 Amb a 1-U significantly reduced TCS by 26% (difference, -2.46 score point; p = .0009) and 40% (difference, -3.75 score point; p < .0001), respectively. In the overall population (N = 961), TCS reductions with 6 and 12 Amb a 1-U were 20% and 23%, respectively (both p < .001). Clinically meaningful reductions in entire-season TCS in Canadians were similar to those during peak ragweed season. Dose-dependent reduction of DSS and DMS was also observed for ragweed SLIT-T 6 and 12 Amb a 1-U during the peak season and the entire season. Ragweed SLIT-T was well tolerated in Canadian subjects and the overall population. Adverse events were generally mild to moderate and transient, occurring early in treatment; no systemic allergic reaction/anaphylaxis was noted.ConclusionRagweed SLIT-T is an effective form of immunotherapy that provides symptomatic efficacy of AR/C with a favorable risk profile in Canadian and overall populations.Trial registrationClinicaltrials.gov identifiers NCT00783198 and NCT00770315.
| S-EPMC4363352 | biostudies-literature
Project description:BackgroundPatients are often dissatisfied with the symptom control obtained from available pharmacological treatments for seasonal allergic rhinoconjunctivitis (ARC). Therefore, patients seek for alternative, nonpharmacological options to treat their symptoms. Here, we assessed the efficacy of ectoine nasal spray and ectoine eye drops in comparison to placebo to prevent nasal and ocular symptoms following exposure to pollen in patients with ARC.MethodsIn this double-blind, randomized, placebo-controlled, cross-over study, 46 patients with ARC applied ectoine eye drops and nasal spray in immediate succession or placebo eye drops and nasal spray for 13 days before ARC symptoms were induced in an environmental exposure chamber. Primary endpoint was the baseline-adjusted area under the curve (AUC) posttreatment total nasal symptom score (TNSS) and the total ocular symptom score (TOSS) using analysis of covariance. Secondary endpoints were, amongst others, total nonnasal symptoms score (TNNSS) and nasal patency (measured using acoustic rhinometry).ResultsTreatment with both ectoine and placebo reduced TNSS, TOSS, and TNNSS upon allergen exposure. The analysis of parameters at baseline and after allergen exposure demonstrated that ectoine induced a clinically relevant improvement in ARC symptoms compared to placebo: the least square mean difference for baseline-adjusted AUC was -1.87 for TNSS, -1.45 for TOSS and -2.20 for TNNSS. The mean change from baseline AUC of TNNSS for ectoine was also significantly greater than for placebo (-5.49 vs. -3.46; p = 0.011). Ectoine significantly improved the singular symptoms "sneezing," "watery eyes" and "itchy eyes" (p ≤ 0.021) as well as "itchy ear/palate" (p = 0.036) in comparison to placebo. Mean cross sectional areas of the nasal cavity were reduced to a lesser extent after treatment with ectoine (-0.020 ± 0.022) than with placebo (-0.047 ± 0.029). The current study also demonstrated a very good safety profile of ectoine treatment. Few AEs with comparable numbers in both treatment groups were reported during the study, which were mild in severity and resolved without medical treatment.ConclusionThe study suggests that ectoine is effective in reducing nasal and ocular symptoms associated with ARC. Being a natural, bacteria derived stress protection molecule functioning by a physical mode of action, it therefore represents an alternative nonpharmacological treatment option.
| S-EPMC8099269 | biostudies-literature
Project description:BackgroundGrass allergen immunotherapy (AIT) reduces symptom severity in seasonal allergic rhinoconjunctivitis (ARC) but its impact on general health-related utility has not been characterised for the purposes of economic evaluation. The aim of this study was to model the preferred measure of utility, EQ-5D index, from symptom severity and estimate incremental quality adjusted life years (QALYs) associated with SQ-standardised grass immunotherapy tablet (GRAZAX®, 75,000 SQ-T/2,800 BAU, ALK, Denmark).MethodsData were analysed from five consecutive pollen seasons in a randomised placebo controlled trial of GRAZAX®. Binomial and Gaussian mixed effects modelling related weekly EQ-5D index score to daily symptom and medication scores (DSS & DMS respectively). In turn, daily EQ-5D index was estimated from ARC symptoms and medication use.ResultsDSS and DMS were the principal predictors of 'perfect' health (EQ-5D = 1.000; binomial) and 'imperfect' health (EQ-5D < 1.000; Gaussian). Each unit increase in DSS and DMS reduced the odds of 'perfect' health (EQ-5D = 1.000) by 27% and 16% respectively, and reduced 'imperfect' health by 0.17 and 0.13, respectively. Gender remained the only other significant main fixed effect (Male odds ratio [OR] = 1.82). Incremental estimated EQ-5D index utility for GRAZAX® was observed from day -30 to day +70 of the pooled pollen season; mean daily utility for GRAZAX® = 0.938 units (95%CI 0.932-0.943) vs. 0.914 (0.907-0.921) for placebo, an incremental difference of 0.0238 (p < 0.001). This translates into an incremental 0.0324 Quality Adjusted Life Years over the five year study period.ConclusionsARC symptoms and medication use are the main predictors of EQ-5D index. The incremental QALYs observed for GRAZAX® may not fully describe the health benefits of this treatment, suggesting that economic modelling may be conservative.
| S-EPMC4094440 | biostudies-literature
Project description:Nutraceuticals represent interesting therapeutic options in clinical practice. In this regard, a new compound has been designed: Lertal®. It contains quercetin, perilla extract, and vitamin D3. These agents exert anti-allergic and anti-inflammatory activities. This article reports and discusses the results of four clinical studies conducted in adult and paediatric patients suffering from AR. Outcomes provided evidence that Lertal® may significantly prevent clinical worsening when prescribed as add-on to continuous antihistaminic treatment and also prevent clinical exacerbations, such as the need of rescue medication, when used alone as preventive strategy in AR patients.
| S-EPMC7569599 | biostudies-literature