Data are limited regarding the effectiveness of omalizumab in patients with eosinophilic granulomatosis with polyangiitis (EGPA). Our aim was to evaluate the clinical and functional effectiveness of ...omalizumab in patients with EGPA in long-term follow-up.
This study was a retrospective chart review of patients with EGPA who were treated with omalizumab injections between May 2012 and April 2018. Once treatment with omalizumab was started, data were collected at various time points: baseline, the 16th week, 1st year, and annually until the last evaluation.
Eighteen patients (16F/2M) with a mean age of 48.61 ± 11.94 years were included. Data were available for all patients for the first year, 12 patients for the second year, 10 patients for the third year, 8 patients for the fourth year and 5 patients for the fifth year. All patients were on mean dosage of 15.77 ± 7.6 mg/day oral corticosteroid (OCS) as daily bases for mean 8.61 ± 4 years besides high-dose inhaler corticosteroid/long-acting beta agonist. Antineutrophil cytoplasmic antibodies (ANCA) were positive in 2 patients, and 8 patients were diagnosed as having vasculitis by skin biopsy, one patient had polyneuropathy, and one patient had cardiac involvement.By considering the individual responses of patients and the level of improvement at the last evalulation, 10 (55.6%) patients responded completely, 1 responded partially, and 7 (38.9%) had no improvement. Omalizumab worked as a steroid-sparing agent in all patients and the daily OCS dose was reduced with a mean dosage of 6.28 mg/day at the end of the first year. The mean OCS reduction time for the whole group was 4 months. A reduction in asthma exacerbations/hospitalizations, improvement in forced expiratory volume in 1 second, and no decrease in the eosinophil count during treatment with omalizumab were also observed.
Omalizumab improved asthma control in some patients with EGPA with uncontrolled asthma by reducing asthma exacerbations and oral steroid requirement. However, more data are needed before recommending widespread use of omalizumab in patients with EGPA.
This year, pollen season coincided with the first wave of the coronavirus disease 2019 pandemic. Strict preventive measures have been implemented during April and May and then a normalization phase ...started in our country in June. Our aim is to evaluate the effect of preventive measures during the pandemic process on allergic airway disease symptoms.
A prospective questionnaire-based study was planned and a questionnaire form was sent to the cell-phones of the subjects with pollen allergy followed in our clinic. Number of airborne grass pollens was determined by Burkard volumetric 7-day spore trap.
A total of 222 pollen allergic patients were included in the study. At the beginning of the pandemic, majority of the subjects were spending time mostly indoors. The rate of home-office workers gradually decreased and the rate of office workers and the number of days at work increased from April to June, significantly. Nasal and ocular symptoms of the patients, also increased in June compared to April and May and, approximately one-third of the patients had less symptoms when compared to the same period of the previous year. The rates of using a face mask and taking a shower on return home were high among the subjects during all season.
Our study showed that spending less time outside during the pollen season and wearing a mask outdoors reduces exposure to pollens and causes a reduction in symptoms. Thus, strict application of measures that cannot be applied in daily practice can make a significant contribution to the management of seasonal allergic rhinitis.
There is a continuing debate about whether monoallergen subcutaneous immunotherapy (SCIT) is able to modulate immune and clinical responses toward main causal allergen in polysensitized patients.
To ...investigate short-term immunologic changes and clinical effectiveness of SCIT with Dermatophagoides pteronyssinus in monosensitized and polysensitized patients who have rhinitis with or without asthma.
Nineteen monosensitized and 24 polysensitized patients participated in this prospective, self-placebo-controlled, interventional study. Cluster immunotherapy with D pteronyssinus was administered after 2 months of placebo in both groups. Immunologic parameters, including CD203c expression on basophils after allergen stimulation, total IgE, specific IgE, and specific IgG4, were evaluated at baseline, after placebo, and after immunotherapy. Clinical effectiveness was assessed using monthly symptom-medication scores, visual analog scale, quality-of-life questionnaire, and nasal allergen provocation test.
At baseline, polysensitized patients had higher CD203c expression on basophils than monosensitized patients (P = .007). Activated basophils expressing CD203c, total IgE, and specific IgG4 were significantly increased after immunotherapy compared with baseline and placebo in the polysensitized group (P < .025). After immunotherapy, specific IgE and D pteronyssinus-induced CD203c expression were significantly higher in polysensitized than monosensitized patients (P < .05). The total symptom scores and the Mini Rhinoconjunctivitis Quality of Life Questionnaire scores in polysensitized patients and the visual analog scale scores in both groups were lower after immunotherapy compared with baseline and placebo (P < .025). Titrated nasal allergen provocation test with D pteronyssinus increased after immunotherapy in the monosensitized group (P < .05).
This study indicates that monosensitized and polysensitized patients have distinct humoral response and basophil behavior to SCIT. However, a single-allergen immunotherapy corresponding to the most clinically troublesome allergy in polysensitized patients can lead to early clinical efficacy comparable to that seen in monosensitized patients.
clinicaltrials.gov Identifier: NCT01795846.
The clinical and immunological efficacy of preseasonal allergoid immunotherapy has been previously investigated, however, studies comparing the effectiveness of the two protocols are limited in the ...literature.
The aim of this study is to compare the clinical and immunological efficacy of pre-seasonal and perennial allergoid immunotherapy.
This is a prospective cross sectional two-arm study. During the season; symptom and medication scores were filled. Before and at the end of the season; RQLQ was applied, Phl p sIgE, sIgG4 and IL-10 levels were measured.
In preseasonal group patients had better symptom control for most of the weeks, particularly during the peak pollen period (April: w-2 & w-4, p = 0.04; May: w-2, p = 0.02; June: w-1, w-2, p = 0.02; w-3, w-5, p = 0.03; July: w-2, p = 0.01; w-3, p = 0.02; w-4, p = 0.04). In the perennial group, sIgG4 1st time point: preseasonal 0.02 mgA/L vs perennial 0.13 mgA/L (p < 0.0001); 2nd time point: preseasonal 0.52 mgA/L vs perennial 0.33 mgA/L; 3rd time point: preseasonal 0.04 mgA/L vs perennial 0.12 mgA/L (p < 0.0001) and IL-10 (1st time point: preseasonal 1.45 pg/ml vs perennial 2.03 pg/ml; 2nd time point: preseasonal 2.29 pg/ml vs perennial 2.19 pg/ml; 3rd time point: preseasonal 2.32 pg/ml vs perennial 2.16 pg/ml) levels were higher and more stable.
Preseasonal immunotherapy provided better control of symptoms throughout the pollen season. However, the blocking antibody response was stronger and more permanent in the perennial immunotherapy group.
Background. Asymptomatic airway hyperreactivity in allergic rhinitis is a risk factor for later development of asthma. Although non-specific bronchial hyperresponsiveness (BHR) has been measured by ...several stimuli, the most appropriate measurement technique still remains unclear. Objective. To investigate whether an exercise challenge can be used to predict BHR in seasonal allergic rhinitis patients with or without asthma and to compare this bronchial reactivity with a methacholine challenge technique. Methods. Forty-six consecutive patients with seasonal allergic rhinitis only (n = 31) and with both seasonal allergic rhinitis and asthma (n = 15) were included in the study during the pollination period. Subjects underwent first methacholine (mch) and then exercise challenge testing (ECT). There was a 1-week interval between the tests. ECT was performed on a bicycle ergometer. Positive result was defined as a 15% decrease in forced expiratory volume in 1 second (FEV1) post-exercise. A patient's bronchial reactivity to methacholine was considered as hyperresponsive if PC20 was less than 8 mg/mL. Results. Mch PC20 values were significantly lower in patients with both rhinitis and asthma (p < 0.062). Among the 46 patients, mch PC20 values were significantly different between patients who had positive and negative exercise challenge tests (p = 0.007). All patients with rhinitis alone had a negative ECT and 10 had a positive mch challenge. Change in FEV1 values after ECT was significantly higher in patients with both rhinitis and asthma compared to those with rhinitis alone (p = 0.009). There was a significant relation between positivity of mch and exercise challenges (p = 0.025). ECT positivity was found to be a significant confounding factor in the diagnosis of asthma (p = 0.001). Specificity and sensitivity values were 100% and 24% for ECT and 68% and 100% for mch, respectively. Conclusion. Exercise challenge presents poor diagnostic value for detecting bronchial responsiveness in individuals with allergic rhinitis alone during the pollen season.
Data showing effectiveness of mepolizumab in patients with eosinophilic granulomatosis with polyangiitis (EGPA) are limited.
This is a single-center retrospective chart review of patients with EGPA ...treated with mepolizumab. Clinical, laboratory, functional parameters and asthma, rhinitis control, and quality of life scores (Asthma Control Test ACT, Asthma Quality of Life Questionnaire AQLQ, Rhinoconjunctivitis Quality of Life Questionnaire RQLQ, and SinoNasal Outcome Test SNOT-22) were evaluated at the baseline, 6th month, and 12th month. Complete response was defined as the absence of asthma and/or ear, nasal symptoms and exacerbations with a prednisone of ≤7.5 mg/day, partial response if it was achieved with a prednisone of >7.5 mg/day.
Overall, 25 patients (18 F/7 M) with a median age of 47 years (23-76) were enrolled. Mepolizumab 100 mg/month was administered (dose increased to 300 mg/month in 3 patients). Mepolizumab significantly decreased daily dose of oral corticosteroid (OCS) from 11.04 mg to 3.65 mg together with a significant improvement in ACT, AQLQ, RQLQ, and SNOT-22 scores and a significant reduction in asthma exacerbations and blood eosinophil count at the 6th and 12th month (all p values <0.05). The mean forced expiratory volume in 1 s increased (at baseline: 1.88 L to 2.46 L at the 12th month p = 0.037). Seventy-six percent of patients responded completely at the 6th month and 81.25% at the 12th month. The complete responders at the 6th and 12th month were older than partial responders and nonresponders (p = 0.030 and p = 0.057, respectively). Patients with complete response at the 6th month were on lower doses of OCS than partial responders and nonresponders (p = 0.029).
Low-dose mepolizumab was effective in EGPA patients by improving sinonasal and asthma outcomes, while reducing the need for OCS.
Background
There is controversy whether taking β‐blockers or ACE inhibitors (ACEI) is a risk factor for more severe systemic insect sting reactions (SSR) and whether it increases the number or ...severity of adverse events (AE) during venom immunotherapy (VIT).
Methods
In this open, prospective, observational, multicenter trial, we recruited patients with a history of a SSR and indication for VIT. The primary objective of this study was to evaluate whether patients taking β‐blockers or ACEI show more systemic AE during VIT compared to patients without such treatment.
Results
In total, 1,425 patients were enrolled and VIT was performed in 1,342 patients. Of all patients included, 388 (27.2%) took antihypertensive (AHT) drugs (10.4% took β‐blockers, 11.9% ACEI, 5.0% β‐blockers and ACEI). Only 5.6% of patients under AHT treatment experienced systemic AE during VIT as compared with 7.4% of patients without these drugs (OR: 0.74, 95% CI: 0.43–1.22, p = 0.25). The severity of the initial sting reaction was not affected by the intake of β‐blockers or ACEI (OR: 1.14, 95% CI: 0.89–1.46, p = 0.29). In total, 210 (17.7%) patients were re‐stung during VIT and 191 (91.0%) tolerated the sting without systemic symptoms. Of the 19 patients with VIT treatment failure, 4 took β‐blockers, none an ACEI.
Conclusions
This trial provides robust evidence that taking β‐blockers or ACEI does neither increase the frequency of systemic AE during VIT nor aggravate SSR. Moreover, results suggest that these drugs do not impair effectiveness of VIT. (Funded by Medical University of Graz, Austria; Clinicaltrials.gov number, NCT04269629).
Patients under antihypertensive treatment with β‐blockers and angiotensin‐converting enzyme inhibitor (ACEI) do not have a higher risk for severe insect sting reactions. The intake of β‐blockers and ACEI does not increase the frequency of systemic adverse events during venom immunotherapy (VIT). Results suggest that β‐blockers and ACEI do not impair VIT effectiveness.
Abbreviations: ACEI, angiotensin‐converting enzyme inhibitor; VIT, venom immunotherapy.
Mepolizumab has been approved as a treatment option for severe eosinophilic asthma (SEA) patients in our country. We aimed to evaluate the clinical and functional efficacy of mepolizumab in this ...group of patients in real life as well as the response rates to mepolizumab and the possible factors affecting the response.
The study was a retrospective chart review of patients with SEA treated with mepolizumab. The data were collected at baseline, and at the 6th and 12th month.
A total of 62 patients (41F/21M) with a mean age of 44.41 ± 13.24 years were included in the study. They had poor symptom control with a mean asthma control test (ACT) score of 16.61 ± 5.59, frequent exacerbations with a mean of 3.4 ± 3.7 in the previous 12 months, and 80.6% required daily oral corticosteroid (OCS) with a median dosage of 8 mg/day as methylprednisolone. The ACT score increased to 22.47 ± 3.18 and 22.03 ± 4.31, respectively, and blood eosinophil count decreased from 1,146/μL to 89/μL and 85/μL at the 6th and 12th month, respectively. The mean FEV1 at baseline was 2.102 L there was an increase of 0.373 L at 6th month and 0.596 L at 12th month. The percentage of regular users of OCS decreased to 66.0% at 6th month with a median dosage of 4 mg and 52.6% at 12th month with a median dosage of 2 mg. Mepolizumab reduced the rate of exacerbations compared with the previous year from a mean of 3.40 to 0.15 at 6th month and 0.36 at 12th month. There was a significant improvement in Asthma Quality of Life Questionnaire (AQLQ), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and Sino-nasal Outcome Test (SNOT-22) scores at both of time points. The rate of responders and super-responders at 6th month was 60% and 28%, respectively, and consequently, the overall response rate was 88%. At the 12th month, the super-responder rate increased to 44.7% as well as the overall response to 89.4%. The only difference between the nonresponders, responders, and super-responders at the 6th and 12th month was whether regular daily OCS was used pre-mepolizumab. All nonresponders at both 6th and 12th month were using OCS regularly, whereas most of super-responder used the OCS only during exacerbations.
Mepolizumab effectively reduced asthma exacerbations, steroid requirement, blood eosinophil counts and improved asthma control, pulmonary function, sinonasal symptoms and quality of life. Our data suggest that mepolizumab would be effective in selected patients in real-life settings.