Incidence Of Systemic Reactions Research Articles

Safety of allergen immunotherapy in children.

The current review discusses allergen immunotherapy (AIT) safety in children. AIT is a well tolerated and effective treatment for pediatric allergic conditions. While mostly well tolerated, severe reactions and near fatal reactions may occur with subcutaneous immunotherapy (SCIT) once in every 160 000 visits. Sublingual immunotherapy (SLIT) is associated more with local side effects, but severe systemic reactions, including anaphylaxis, have been rarely reported. Providing informed consent, recognizing risk factors for severe systemic reactions, such as severe or uncontrolled asthma, and mitigating the risk of severe reactions are important components to improving the safety of AIT. Overall, AIT is well tolerated in children, and data suggest that the incidence of systemic reactions in children receiving SCIT is no less than mixed populations of adult and pediatric patients. SLIT carries less risk for systemic reactions, and local oral site-application reactions are usually mild and resolve within 15 days of treatment.

Comparison of rush-subcutaneous and sublingual immunotherapy with house dust mite extract for pediatric allergic rhinitis: A prospective cohort study

BackgroundWe aimed to compare the effectiveness and safety of subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) with standardized house dust mite (HDM) extract for allergic rhinitis. MethodsParticipants with allergic rhinitis selected their treatment between HDM SCIT or HDM SLIT, according to their wishes. We prospectively followed symptoms of allergic rhinitis using the allergic rhinitis symptom medication score (ARSMS), along with adverse reactions, during the dose escalation and maintenance phases for two years. We compared the outcomes between propensity score-matched groups to adjust the confounding factors. ResultsAfter propensity score matching, 88 patients in the HDM SCIT (n = 44) and HDM SLIT groups (n = 44) remained for analysis. The HDM SCIT group showed significantly earlier effectiveness than the HDM SLIT group (median time to decrease in ARSMS [≥2 points]: 5.5 vs. 18.0 months, p < 0.001). The incidence of systemic reactions was not significantly different between the two groups in the dose escalation phase (68.2% vs. 56.8%, p = 0.379). In the maintenance phase, the incidence of systemic reactions was higher in the HDM SCIT group than in the HDM SLIT group (18.2% vs. 0%, p < 0.006). All 44 patients in the HDM SCIT group completed two years of treatment, while nine patients in the HDM SLIT group discontinued treatment. ConclusionsThe HDM SCIT group showed an earlier onset of therapeutic effect and a lower discontinuation rate than the HDM SLIT group, although more severe systemic reactions were observed during the maintenance phase.

Advances in Research on COVID-19 Vaccination for People Living with HIV.

Advances in Research on COVID-19 Vaccination for People Living with HIV.

Safety of house dust mite subcutaneous immunotherapy in preschool children with respiratory allergic diseases

BackgroundAllergen immunotherapy (AIT) is the only causal therapy for IgE-mediated allergy. There is less evidence about the safety and efficacy of AIT especially subcutaneous immunotherapy (SCIT) in children under 5 years old. We aimed to investigate the side effects and associated risk factors of house dust mite (HDM) SCIT in preschool children with respiratory allergic diseases.MethodsThe preschool children who had HDM-related allergic rhinitis with/without asthma were enrolled and undergone standardized HDM SCIT in our department from June 2013 to December 2019. Local reactions (LRs) and systemic reactions (SRs) were recorded and categorized according to World Allergy Organization recommendations. Demographic data and other therapeutic-related parameters were also recorded to investigate potential risk factors for these side effects.ResultsA total of 91 children (60 boys, 65.93%; 31 girls, 34.07%; mean age 4.13 years old) were included in the study. Among the 91 patients, 3109 SCIT injections were recorded, 62/91 (68.13%) experienced 186 immediate LRs, 4 /91(4.40%) experienced 6 delayed LRs, 11/91 (12.09%) children experienced 44 immediate SRs, 21/44 (47.73%) were grade 1 SRs, 21/44 (47.73%) were grade 2, 2/44 (4.55%) were grade 3, no grade 4 or 5 SRs occurred. Furthermore, 1/91 (1.10%) experienced 1 delayed SRs, manifested by urticaria 2 days later after allergen injection. 9/91 (9.89%) experienced 2 or more times SRs. Multivariable logistic regression analysis showed BMI (OR 1.506; 95%CI 1.091 to 2.079; p < 0.05) and sIgE against HDM (OR 1.497; 95%CI 1.082 to 2.071; p < 0.05) were risk factors for LRs. No variable was found to correlate with SRs (all p > 0.05).ConclusionsHDM subcutaneous immunotherapy is considered to be safe in preschool children with respiratory allergic diseases. Higher BMI and HDM sIgE level in children are risk factors for developing LRs. The incidence of SRs and the rate of severe SRs are low in preschool children.

Adverse reactions to subcutaneous immunotherapy in patients with allergic rhinitis, a real-world study.

The efficacy of subcutaneous immunotherapy (SCIT) for allergic rhinitis (AR) have been proven but application is still limited by concerns about the safety. The aims of this study were to investigate the incidence of adverse reactions and to ascertain possible risk factors in patients treated with SCIT in central China. This study retrospectively analyzed the application of SCIT from 2016 to 2018, in 236 patients with AR. After each injection, allergen dosage and details about local reactions (LRs)/systemic reactions (SRs) were recorded. Totaling 236 patients received 5844 injections. The rates of LR were 3.0% per injection and 34.7% per patient, while the rates of SR were 0.48% per injection and 10.6% per patient. 86.9 percent LRs were small. Most SRs were grade 1 (16/57.1%), followed by grade 2 (8/28.6%), grade 3 (4/14.3%). No fatal SRs was recorded. Children, high sensitization and absence of premedication were identified as risk factors for LRs. Recurrent LRs increased the risk of SRs. Premedication could reduce the number and severity of LRs, but not SRs. Dual therapy with antihistamine and montelukast did not provide additional benefit when compared with antihistamine alone. The incidence of SRs was low while LRs were common in SCIT. Children may be prone to develop LRs, while pretreatments could reduce the number and severity of LRs. Recurrent LRs was a risk factor for SRs.

Observation and analysis of systemic reactions to house dust mite subcutaneous immunotherapy in 362 patients with allergic rhinitis

Objective: To investigate the frequency and severity of systemic reactions (SRs) to standardized house dust mite subcutaneous immunotherapy (SCIT) in patients with perennial allergic rhinitis (AR), and to analyze the clinical risk factors. Methods: The clinical data of 362 patients including 209 males and 153 females, aged from 5 to 55 years old receiving SCIT at the Department of Otorhinolaryngology, the Third People's Hospital of Changzhou were collected from May 2014 to July 2017. The SRs were classified as early-onset and delayed-onset, and 4 grades (grade Ⅰ to Ⅳ) to assess severity. The records of SRs were retrospectively analyzed, including the numbers/frequencies, symptoms and signs, onset of reaction and treatment. And the relationships between SRs and patient's age, gender, allergen injection dose, accompanied allergic diseases were explored. All the statistical analyses were conducted using SPSS 19.0. Results: There were 57 cases (15.75%) of SRs in 362 patients. All the patients received a total of 12 308 injections and 111 SRs (0.90%) were observed. Among them, 31 (27.93%) were early-onset reactions and 80 (72.07%) were delayed-onset reactions; most of the SRs were grade Ⅰ reactions (n=83, 74.78%), followed by grade Ⅱ (n=25, 22.52%), grade Ⅲ (n=3, 2.70%), and no fatal reactions occurred. The incidence of SRs in patients>14 years old was higher than that in patients ≤14 years old according to the number of cases and injections (35.14% vs 13.54%, 2.34% vs 0.76%, χ(2) value was 11.679, 28.162, respectively, all P<0.05), but no significant differences of SRs were observed in gender (18.66% vs 11.76%, 5.98% vs 5.62%, χ(2) value was 3.166, 0.095, respectively, all P>0.05). Fifteen SRs (13.51%) occurred during the build-up phase and 96 (86.49%) during the maintenance phases. SRs could occur in lots of dose phases, and 95 (85.59%) were distributed at high concentrations more than 40 000 SQ-U. The incidence of SRs in patients with multiple allergic diseases was significantly higher than that in patients with AR alone, with asthma or atopic dermatitis (30.67% vs 11.85%, χ(2)=15.875, P<0.001). Meanwhile, the incidence of SRs in patients with pure AR was also significantly lower than that in patients with other allergic diseases (5.26% vs 20.56%, χ(2)=13.783, P<0.001). Conclusions: The incidence of SRs is less than 1% according to the injection times, the severity of SRs is mostly slight, and the safety and tolerance are good during standardized house dust mite SCIT in perennial AR patients. Delayed-onset SRs are more common. The incidence of SRs is significantly correlated with age, high dose of allergen vaccine injection, and concomitant other allergic diseases (asthma, atopic dermatitis, etc).

Risk stratification of systemic reactions to subcutaneous immunotherapy: A retrospective study.

Background: Subcutaneous allergen immunotherapy (SCIT) is a very effective treatment modality; however, it can be associated with both local and systemic reactions (SR). Identifying patient factors that predict SR remains paramount. Objective: Our aim was to identify the rate of SRs to SCIT as well as identify patient risk factors associated with the development of SRs. Methods: We conducted an institutional review board approved 10-year retrospective chart review of 459 patients who received SCIT in our clinic. The patients were placed into cohorts according to age, which included pediatric (5-18 years), adult (19-64 years), and senior (>65 years) patients. Results: An SR (N = 177) was identified in 24.8% of the patients (n = 114). The incidence of SR per injection was 0.2% (177 SRs of 74,183 total injections). SRs were identified as class 1 (n = 152), class 2 (n = 21), class 3 (n = 2), and class 4 (n = 2) according to the 2010 World Allergy Organization's SR grading system. There were no observed differences in the number of SRs with respect to age group. Female patients were more likely to have an SR (p = 0.02) overall as well as more than one reaction (p = 0.002). Other risk factors included the following: a patient-reported history of food allergy (p = 0.05), drug allergy (p = 0.005), or positive skin test result to cat and/or dog (p = 0.01). In addition, patients who were receiving SCIT to cat and/or dog (p = 0.004) or to dust mite (p = 0.03) were more likely to have an SR. Conclusion: In our patient population, the majority of SRs to SCIT occurred in female patients, patients with a history of drug or food allergies, and those who were receiving pet or dust-mite SCIT.

Hymenoptera sting reactions in southern Italy forestry workers: our experience compared to reported data

BackgroundHymenoptera sting reactions are among life-threatening causes of allergy. Several epidemiology studies have assessed the risk of these kind of reactions, among the general population, around 3% of adults. This incidence increases among highly at risk populations such as outdoor workers. Hymenoptera stings among forestry workers (FW) are occupational triggers but it has not yet been well defined which is the real incidence of anaphylaxis in these workers, not even in Italy. Two Italian studies reported on the risk of hymenoptera stings (HS) in northern Italy (NI) and central Italy (CI) FW while no data is available on the prevalence in southern Italy (SI) ones.MethodsA population of 341 SI FW (301 males and 40 females, mean age 51 years, range 43–63 years), who worked in Sicily, was investigated submitting a standardized questionnaire dealing with reactions to Hymenoptera stings, such as large local reactions (LLR) and systemic reactions (SR).ResultsHS occurred in 203 FW (59%) and caused reactions in 77 (22%); LLR occurred in 46 (13%) and SR in 31 (9%); SR were life threatening in 9/341 (3%) FW and were treated with epinephrine at the emergency unit as workers did not carry an epinephrine auto-injector. A SR at a subsequent HS followed a LLR in 21/46 FW (46%).ConclusionsFW in SI have a generic risk of HS anaphylaxis as in the general population but a higher risk of SR and LLR respect to forestry populations from different Italian geographical areas.SR among SI FW occurred in 9% of them, while published data report the incidence of SR around 2 and 4%, respectively, in the Centre and North Italy FW. The incidence of LLR in SI FW was also higher (13%) than in CI (2%) and NI (10%) ones. Previous LLR in our SI population represented a high risk factor for developing a SR and therefore a red flag for future anaphylaxis and prescription of an epinephrine auto-injector.

Venom Immunotherapy in High-Risk Patients: The Advantage of the Rush Build-Up Protocol

Background: Venom immunotherapy (VIT) is considered to be the gold standard treatment for patients with hymenoptera venom allergy. This treatment induces systemic reactions (SR) in a significant number of patients. Objective: To evaluate the outcome of VIT in patients with known risk factors for VIT-induced SR and to compare rush VIT (RVIT) and conventional VIT (CVIT). Methods: All of the patients who received VIT and had at least one of the following risk factors were included: current cardiovascular disease, uncontrolled asthma, high basal serum tryptase, current treatment with β-blockers or angiotensin-converting enzyme inhibitors, and age >70 or <5 years. Results: Sixty-four patients were included, and most of them (52; 81.5%) were allergic exclusively to bee venom. Thirty-five (54.7%) patients underwent RVIT and 29 CVIT. The incidence of patients who developed SR during the build-up phase was similar for RVIT and CVIT (25.7 and 27.5%, respectively; p = 1). However, the incidence of SR per injection was significantly higher in CVIT than in RVIT (5.6 and 2.75%, respectively; p = 0.01). Most reactions (79.1%) were mild, limited to the skin. Most of the patients (92.1%) reached the full maintenance dose of 100 μg. This dose was reached by a significantly larger number of patients receiving RVIT compared to CVIT (100 and 82.7%, respectively; p = 0.01). None of the patients experienced exacerbation of their concurrent chronic disease during VIT. Conclusion: VIT can be performed safely and efficiently in patients with risk factors for immunotherapy. In these patients RVIT appears to be safer and more efficient than CVIT.

Rush Venom Immunotherapy in Children

Rush venom immunotherapy (VIT) is highly effective in Hymenoptera venom allergy. Still, specific data regarding its safety and efficiency in children are rather sparse. The objective of this study was to better evaluate the safety and efficiency of rush VIT in this specific age group. Children younger than 16 years with systemic reaction to insect sting involving, at least, one body system other than skin and children aged 16-18 years with any kind of systemic reaction were offered conventional or rush VIT with a build-up phase that lasted 3 days. Eighty-four of 127 children together with their caregivers chose to receive rush VIT. Seventy of them were allergic to bee venom only. There was no difference between the children receiving rush or conventional VIT in the incidence of systemic reactions during the build-up phase (19% and 23.2%, respectively), nor was there any difference in regard to the severity of these reactions. Efficiency was improved with rush VIT, as reflected by a higher number of patients achieving the 100 mcg maintenance dose with the primary protocol (83 of 84 patients, 98.8%, and 39 of 43, 90.7%, for rush and conventional, respectively, P= .04). Rush VIT in children is as safe as and more efficient than conventional VIT.

Angiotensin‐converting enzyme inhibitors do not impair the safety of Hymenoptera venom immunotherapy build‐up phase

There is an ongoing debate on whether angiotensin-converting enzyme inhibitors (ACEI) should be substituted prior to initiation of venom immunotherapy (VIT) for safety reasons. We aimed to assess the influence of ACEI medication on the incidence of systemic reactions (SR) during the build-up phase of VIT in a large and homogeneous cohort of patients. The frequency of SR during 775 consecutive cycles of VIT initiation was analyzed in relation to cardiovascular medication, age, sex, venom, reactivity in diagnostic tests, severity of preceding sting-induced anaphylaxis, comorbidities, latency before the initiation of VIT, and treatment protocols. ACEI were routinely maintained throughout VIT, beta-blockers replaced if appropriate. During VIT-initiation, 190 (24.5%) patients were on some kind of cardiovascular treatment, 90 (11.6%) on ACEI, 23 (3.0%) on beta-blockers. VIT-related SR rates were 11.7% (any documented reactions including subjective symptoms) and 3.0% (reactions fulfilling objective diagnostic criteria of anaphylaxis). Medication with ACEI (P=0.097) or beta-blockers (P=1.0) was not significantly related to the incidence of SR. A reduced rate of SR in patients taking cardiovascular drugs was not statistically significant in the final multivariate regression model. A prolonged latency before the initiation of VIT (P=0.018, odds ratio = 1.010), and use of 5-day compared to 3-day rush protocols (P=0.008, odds ratio = 3.522) increased the frequency of SR. Study data do not provide evidence of an ACEI-mediated increase of VIT-related SR, supporting the continued use of these valuable and hard-to-replace substances throughout VIT.

A Prospective Multicenter Study of Systemic Reactions in Standardized Specific Immunotherapy for Allergic Rhinitis in China

Standardized allergen-specific immunotherapy (SIT) has been used in China for years. However, there is no extensive study of the safety of standardized SIT in Chinese patients until now. The aim of the current study is to perform a prospective and multicenter study to evaluate the systemic reactions (SRs) of standardized SIT in Chinese patients. The study was performed in 13 allergy centers in China, using the same vaccine and practice procedure. The length of observation period was 2 years. SRs were recorded and analyzed. There were 666 patients included (261 children and 405 adults). All patients finished the initial phase and 47 patients withdrew during the maintenance phase. There were 0.47% (94/19,963) SRs in all injections (0.72% in children and 0.31% in adults); 8.26% (55/666) patients experienced SRs (12.26% children and 5.68% adults). The occurrence of SRs was significantly higher in children than that in adults (p < 0.01). A higher ratio of SRs was found among patients accompanied with asthma. There were 74.47% SRs of grade I, 15.96% SRs of grade II, 7.45% SRs of grade III, and 2.13% SRs of grade IV. There were 90.43% of SRs associated with the discomfort of lower respiratory tract. This multicenter study showed that properly conducted standardized SIT was a safe treatment for allergic rhinitis in China. The incidence of SRs was higher in children than that in adults.

Immunotherapy of Allergic Rhinitis: New Therapeutic Opportunities with Virus-like Particles Filled with Cpg Motifs

The incidence of allergic rhinitis (AR) has increased constantly over the last decades. The disease can significantly lower quality of life and subsequently might progress to allergic asthma. Allergen-specific immunotherapy is mostly used to cope with the cause of the disease. However, incidence of systemic reactions or limited compliance hampers the widespread use of this therapeutic approach. Therefore, new candidates are examined to improve immunotherapy of allergies. Recently, a new technology was developed with the aim to positively influence the immune system of allergic patients. Virus-like particles (VLPs) represent a potent vaccine platform that has been proven to be immunogenic and clinically effective. To enhance immune cell activation, addition of Toll-like receptor ligands and/or depot-forming adjuvants seems to be helpful. In this context, CpG motifs represent intensive investigated and potent stimulators of T cells. This article focuses on the function of VLPs and CpG motifs and their clinical experience for treatment of AR. A literature review was performed. Several published studies showed a beneficial impact of the treatment on allergic symptoms. They tested VLPs filled with or without CpG motifs in combination with or without allergen. Results encourage further investigations of VLPs and CpG motifs as adjuncts to or even alternative candidates for immunotherapy of allergic disorders.

Immunologic Effect and Tolerability of Intra-Seasonal Subcutaneous Immunotherapy With an 8-Day Up-Dosing Schedule to 10,000 Standardized Quality-Units: A Double-Blind, Randomized, Placebo-Controlled Trial

BackgroundInternational guidelines recommend that allergen-specific immunotherapy for pollen-induced rhinoconjunctivitis is initiated preseasonally. However, because subjects often present to physicians with allergy symptoms during the pollen season, “within-season” initiation of specific immunotherapy is of special interest. ObjectiveWe evaluated the immunomodulatory effects and tolerability of subcutaneous immunotherapy (SCIT) with Standardized Quality (SQ) 6-grass mix and rye allergen extract, using an 8-day intra-seasonal up-dosing schedule to 10,000 SQ-units (SQ-U). MethodsIn a 9-week, multicenter, randomized, double-blind, placebo-controlled trial, adults (mean age, 34.6 years; 99.3% whites) with grass pollen–induced rhinoconjunctivitis (mean disease duration, 15.1 years) were randomized 3:1 to receive SCIT or placebo. Treatment was initiated during the 2008 pollen season, with an 8-day up-dosing from 100 to 10,000 SQ-U (6 daily injections) followed by 2 maintenance injections of 10,000 SQ-U at intervals of 2 and 4 weeks, respectively. The primary end point examined immunologic effects, assessing the difference in IgE-blocking factor (serum components competing with IgE for allergen binding) between SCIT and placebo at week 9. Secondary/explorative end points included the difference in IgE-blocking factor, specific IgG4, and specific IgE at various times. Tolerability (adverse events, local and systemic allergic reactions) of the up-dosing schedule was also evaluated. ResultsOf the 148 treated subjects 144 (SCIT n = 109; placebo n = 35) were analyzed for the primary parameter. Immunologic response (significantly higher increase in IgE-blocking factor and IgG4 levels) occurred with SCIT versus placebo at week 9 (IgE-blocking factor, P = 0.0017; IgG4,P = 0.0215). Significant differences were observed as early as week 3. AEs were reported in 60.7% of SCIT- and 30.6% of placebo-treated subjects, with no treatment-related serious AEs. Local allergic reactions occurred in 46.4% of SCIT and 8.3% of placebo subjects (χ2 test, P < 0.0001). No significant difference was observed between groups in the incidence of systemic reactions (7.1% SCIT vs 5.6% placebo; χ2 test, P = 0.7413). ConclusionsThis trial provides the first description of short (8-day) intra-seasonal up-dosing with SCIT, which induced immunologic effects after only 3 weeks, and was generally well tolerated, although it induced a marked increase in the rate of local reactions compared with placebo. ClinicalTrials.gov identifier NCT00807547; ALK trial ID SHX0562.

Cytokine Dermatitis and Febrile Seizure From Imiquimod

Cytokine dermatitis is a well-known and common clinical adverse effect of imiquimod 5% cream (Aldara, 3M). Data from initial Phase III clinical trials reveal a minority of study drug patients experience systemic adverse effects, including fever, arthralgia, headache, myalgia, and lymphadenopathy. These adverse effects are caused, presumably, from increased absorption of study drug over the area of dermatitis, leading to systemic cytokine release. Furthermore, the incidence of systemic reactions was rarely statistically increased above control patients. We describe herein a case of severe cytokine dermatitis in a 2-year-old female patient treated with daily imiquimod for molluscum contagiosum who subsequently developed febrile seizure. We believe this to be the first reported case of seizure associated with imiquimod 5% cream (Aldara, 3M) in a pediatric setting.

Response to State Epinephrine IM (epi IM) Dose vs. BMI and WAO Systemic Reaction Grading in the Incidence of Systemic Reactions (SRs) to Prick (P) and Intradermal (ID) Skin Tests

To determine incidence of SRs to P and ID tests, response to stat epi IM, dosage of epi IM vs. BMI, and World Allergy Organization (WAO) Grading of SRs. From 07/2010 to 06/2011 SRs were recorded for combination of pollen, animal emanation, mold and Hymenoptera to P and ID testing in 1,332 subjects. Stat epi IM (1:1000 v/v), 0.2 mg was administered by medical staff for signs/symptoms (SS) of SRs, including, not limited to, itchy eyes, nose, pharynx, palms; rhinorrhea, nasal congestion, sneezing; generalized erythema, pruritus, or urticaria. Total epi IM dose and SS utilizing the WAO Grade system were recorded. BMIs were obtained from WHO criteria. 2%, 31 subjects, had SRs; 77% (24) female, 23% (7) male; 16% (5) pediatric, 84% (26) adult. 84% (26) Grade I, 16% (5) Grade II; no Grade III, IV, V occurred. During P 42% (13) experienced SS. During ID or at completion of P and ID 58% (18) experienced SS. All received stat epi IM. 28 SRs, mean BMI 28.5 (overweight range 25.0-29.9) received epi IM 0.2 mg; one BMI 20.4 (normal 18.5-24.9) received two epi IM (total 0.3 mg). No underweight (<18.5) or obese (>30.0) subjects had SS. There was no relationship of epi IM dose to BMI. 2% (31) of 1,332 tested subjects had SRs to P and/or ID tests; 30 received one stat epi IM dose (0.2 mg); 1 received two doses (total 0.3 mg). All but one were WAO Grade I reactions. Stat epi IM may prevent serious SRs.

183 Incidence of Systemic Reactions (SRS) to Prick (P) and Intradermal (ID) Tests, Response to Immediate (“STAT”) Epinephrine IM (EPI IM) Dose versus BMI, Number of Delayed SRS, and WAO Systemic Reaction Grade

BackgroundTo determine the incidence of SRs to P and ID tests, the response to stat epi IM, number of delayed SRs, the dose of epi IM versus BMI and the World Allergy Organization (WAO) Grade (1-5) of the SRs.MethodsSRs were compiled from 07/2010 to 06/2011 to P and ID tests for any combination of approximately 20 allergens (pollens, animal emanations, molds and Hymenoptera) in 1,332 subjects. Nurses administered stat epi IM (1:1000 v/v), 0.2 mg IM, into the arm or thigh for any signs or symptoms (SS) of a SR, including, but not limited to, itchy eyes, nose, pharynx, or palms; rhinorrhea, nasal congestion, sneezing; and generalized erythema, skin pruritus, or urticaria. SS (WAO Grade), total epi IM dose, and delayed SRs were recorded. Repeat doses of epi IM were given if SS persisted or worsened.Results31 (2%) had SRs: 24 (77%) female, 7 (23%) male; 5 (16%) pediatric, 26 (84%) adult. Of the 31 SRs, 26 (84%) had Grade 1, 5 (16%) Grade 2 and Grades 3 to 5. 13 (42%) experienced SS during P and 18 (58%) during ID or at the completion of P and ID. All received stat epi IM with any SS. 2 BMIs were not available. 28 SRs, with a mean BMI of 28.5 (overweight range 25.0–29.9) received one epi IM, 0.2 mg, and one BMI 20.4 (normal range 18.5–24.9) received 2 epi IM (total 0.3 mg). There were no underweight (less than 18.5) or obese (30.0 or greater) subjects.Conclusions31 (2%) had SRs to P and/or ID tests; 30 received one epi IM dose (0.2 mg) and one, 2 doses (0.3 mg total). There were no delayed SRs or relationship of epi IM dose to BMI and all but one were WAO Grade 1 reactions. Stat use of EPI IM may prevent more serious SRs and delayed reactions.

Immunotherapy for allergic rhinitis: clinical benefits and its working mechanisms

SummaryPollen immunotherapy exerts greater efficacy in the pollen season when the pollen count is not high than when it is high. Every pollen season, around half or more patients who have received pollen immunotherapy for &gt;5 years are judged as good responders; those who have received immunotherapy for &lt;5 years generally do less well. Therefore, the clinical response seems to depend on natural pollen counts and the duration of immunotherapy. In this study, peripheral blood mononuclear cells (PBMCs) were sampled before and during the pollen season to examine IL‐4, IL‐5, and IFN‐γ levels. It was revealed that pollen immunotherapy could decrease IL‐4 and ‐5 expression by pollen antigen‐stimulated PBMCs. When patients under immunotherapy were divided into good and poor response groups, clinical effectiveness was related to the depressed level of IL‐5 synthesis, but not to that of IL‐4 synthesis. Our study suggests that a decrease of IL‐5 expression during the pollen season is a key working mechanism of immunotherapy related to clinical effectiveness. In our patients, the incidence of systemic reactions was 5.8%/patient and &lt;0.1%/injection. A higher incidence of systemic reactions was observed in patients with the presence or a past history of asthma, the presence but not a past history of atopic dermatitis, and higher levels of total IgE (&gt;1000 U/mL). The incidence of systemic reactions in patients with 1 risk factor such as asthma, atopic dermatitis, and high IgE was 16.9%/patient and 0.1%/injection, whereas that in those without risk factors was 1.6%/patient and &lt;0.1/injection.

Specific Immunotherapy with Standardized Latex Extract versus Placebo in Latex-Allergic Patients

Background: Allergy to natural rubber latex proteins continues to be an important medical problem among health care professionals, but also in multioperated children. Clinical manifestations range from urticaria to angioedema, rhinoconjunctivitis, bronchial asthma and anaphylactic shock. Methods: The aim of this study was to investigate the efficacy and safety of a 12-month latex-specific immunotherapy in sensitized patients, most often health care workers. Twenty-three patients with latex rhinoconjunctivitis (20 of whom also had asthma) were included in this randomized, double-blind, placebo-controlled trial (11 in the active group, 12 in the placebo group). Treatment efficacy was assessed by means of symptom and medication scores. Conjunctival provocation tests and quantitative skin prick tests were also performed. Results: The clinical index (derived by combining changes from baseline of six efficacy variables during the treatment period) did not differ significantly between treatment groups. Change from baseline of rhinitis, conjunctivitis, skin symptoms, asthma symptoms, medication score and cutaneous reactivity were not significantly different between the two groups. A nonsignificant difference in conjunctival reactivity was observed in favor of the active group (p = 0.09). Systemic reactions were much higher in the specific immunotherapy than in the placebo group. Conclusions: The present study failed to show a significant improvement of symptoms and medication scores, probably because of the low level of symptoms at baseline and the low maintenance dose of therapy, even if allergen-specific conjunctival reactivity decreased in the active group. Moreover, the incidence of systemic reactions was very high in the active group.

Systemic Reactions to Allergen Immunotherapy: A Review of the Literature

Since its introduction the safety of specific immunotherapy (SIT) was assessed by many well-designed studies. SIT is accepted as an effective treatment of allergic diseases despite the occurrence of side-effects, among which systemic reactions (SRs) are the most dangerous. The reported frequency of SRs after SIT varies among the studies and several factors influence it.Asthma is a particular risk factor for systemic side-effects. Furthermore, SRs occur more often in patients with high allergen sensitivity as determined by skin testing or RAST. Making dosage errors is also considered to be a high risk. It is reported that reactions are more common during rush and clustered induction treatment, whereas a significantly lower incidence of SRs occurred with the use of standardized modified allergen vaccines than with aqueous extracts.On the basis of valuable guidelines, precautions to minimize the risk of SRs from SIT were recommended. Injections should be given or supervised by doctors well-trained in this form of treatment in a clinic where there is the immediate availability of a resuscitative equipment. Consideration should be given to evaluate the patient's conditions and to monitor subjects for a minimum of 30 minutes after the injections. Therefore, if appropriately done, the risk of SIT is negligible.