Venom immunotherapy: safety and tolerability of the build-up phase with depot versus aqueous preparations.
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ABSTRACT:
SUBMITTER: Pravettoni V
PROVIDER: S-EPMC9796821 | biostudies-literature | 2022 Oct
REPOSITORIES: biostudies-literature
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Venom immunotherapy: safety and tolerability of the build-up phase with depot versus aqueous preparations.
Pravettoni Valerio V Mauro Marina M Rivolta Federica F Consonni Dario D Cappelletti Camilla C Chiei Gallo Alessandra A Sangalli Andrea A Bilò Maria Beatrice MB
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology 20220729 10
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Project description:Allergy to Polistes dominula (European paper wasp) venom is of particular relevance in Southern Europe, potentially becoming a threat in other regions in the near future, and can be effectively cured by venom immunotherapy (VIT). As allergen content in extracts may vary and have an impact on diagnostic and therapeutic approaches, the aim was to compare five therapeutic preparations for VIT of P. dominula venom allergy available in Spain. Products from five different suppliers were analyzed by SDS-PAGE and LC-MS/MS and compared with a reference venom sample. Three products with P. dominula venom and one product with a venom mixture of American Polistes species showed a comparable band pattern in SDS-PAGE as the reference sample and the bands of the major allergens phospholipase A1 and antigen 5 were assignable. The other product, which consists of a mixture of American Polistes species, exhibited the typical band pattern in one, but not in another sample from a second batch. All annotated P. dominula allergens were detected at comparable levels in LC-MS/MS analysis of products containing P. dominula venom. Due to a lack of genomic information on the American Polistes species, the remaining products were not analyzed by this method. The major Polistes allergens were present in comparable amounts in the majority, but not in all investigated samples of venom preparations for VIT of P. dominula venom allergy.
| S-EPMC9031911 | biostudies-literature
Project description:BackgroundImported fire ant (IFA) venom immunotherapy (VIT) is the only disease-modifying treatment reported to be effective at decreasing the risk of systemic reactions (SRs) to IFA stings.ObjectiveOur aims were to determine the baseline rates of IFA sensitization in subjects, describe IFA VIT prescribing patterns across the military health system (MHS), and retrospectively evaluate the safety and efficacy of IFA VIT.MethodsWe prospectively compared IFA sensitization in participants with and without an SR to flying Hymenoptera venom. Separately, IFA VIT prescription records were extracted from a centralized repository, and rates were described across the MHS. Additionally, we retrospectively reviewed the clinical course of patients being treated with IFA VIT at 11 military treatment facilities.ResultsThe in vitro IFA sensitization rates in our prospective cohort ranged from 19.1% to 24.1%. Sensitization rates did not differ statistically between the subjects with or without an SR to flying Hymenoptera venom. We found that 60.9% of all MHS IFA VIT prescriptions (491 of 806) were from the 11 facilities in this study. We retrospectively identified 137 subjects actively undergoing IFA VIT. Among the subjects actively undergoing IFA VIT, 28 reported an SR to IFA venom and repeat stings by IFAs after reaching VIT maintenance, and 85.7% (24 of 28) of the subjects noted symptoms no worse than a large swelling reaction after a repeat IFA sting. Notably, only 2.9% of the subjects (4 of 137) had an SR due to VIT.ConclusionThis study's results align with those of prior IFA sensitization reports. A substantial proportion of patients undergoing IFA VIT experienced protection against anaphylaxis with reexposure, with relatively few adverse events.
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Project description: Not available
| S-EPMC7078790 | biostudies-literature
Project description:BackgroundAn optimal bowel preparation can result in an improved colonoscopy. This study was to compare the effectiveness and safety of the use of a sports drink (Mizone) plus polyethylene glycol (PEG) solution with a water plus PEG solution in bowel preparations.MethodsThis was a randomised controlled study. All of the included patients were randomly divided into the following two groups: the PEG + Mizone group and the PEG + water group. The palatability of the solution was measured through the use of questionnaires. Additionally, bowel cleanliness was evaluated according to the Ottawa Bowel Preparation Scale (OBPS, 0-14, with higher values indicating worse cleanliness), as well as with the aid of colonoscopy videos.ResultsA total of 270 patients were enrolled. The rate of adequate bowel preparation was 74.8% in the PEG + Mizone group and 68.9% in the PEG + water group, with a risk difference of 5.9% (95% CI: - 4.8-16.6%), which indicated noninferiority (noninferiority margin: - 9.5% < - 4.8%). However, patients rated the palatability (65.9% vs 44.4%, P < 0.001) and willingness to recommend or repeat (88.9% vs 75.6%, P = 0.004) the administration of the PEG + Mizone preparation as being better than those of the PEG + water preparation. The rates of adverse events during the bowel preparations were not significantly different between the two groups, except for bloating (PEG + Mizone vs PEG + water, 4.4% vs 13.3%, P = 0.010).ConclusionThe concomitant use of PEG + Mizone was a well tolerated and effective bowel preparation, compared with the PEG + water treatment.Trial registrationClinicalTrials.gov NCT04247386 . Registered on 30 Jan 2020.
| S-EPMC9419325 | biostudies-literature
Project description:BackgroundBUP-XR (RBP-6000 or SUBLOCADE) is the first Food and Drug Administration-approved subcutaneously administered monthly extended-release buprenorphine medication for the treatment of moderate or severe opioid use disorder. The primary objective of this phase III study was to assess the long-term safety, tolerability, and efficacy of BUP-XR.MethodsThis open-label multicenter study in adults with moderate or severe opioid use disorder enrolled 257 participants from a previously conducted placebo-controlled, double-blind phase III study (rollover group) and 412 de novo participants not previously treated with BUP-XR. Participants received an initial injection of BUP-XR 300 mg and subsequent monthly 300 mg or 100 mg flexible doses. By study end, participants received up to 12 injections.ResultsOverall, 66.8% of participants reported more than 1 treatment-emergent adverse event (TEAE). Injection-site TEAEs (13.2% of participants) were mostly mild or moderate in severity. There were no clinically meaningful changes in safety assessments. An integrated analysis of the double-blind and open-label study participants showed that the incidence of TEAEs, including injection-site TEAEs, was lower in the second 6 months of treatment versus the first 6 months. After 12 months of treatment, 61.5% of the rollover participants and 75.8% of the de novo participants were abstinent. Retention rates after 12 months were 50.6% for the participants who initiated BUP-XR in the double-blind study and 50.5% for de novo participants.ConclusionsThis study demonstrates that the clinical benefits and acceptable safety profile of BUP-XR demonstrated in the 6-month double-blind study are sustained over a 12-month open-label study, with lower incidence of TEAEs in the second 6 months of treatment.
| S-EPMC7188268 | biostudies-literature
Project description:Introduction. The poor long-term adherence is known to affect the efficacy of allergen immunotherapy (AIT). In the case of injection AIT (SCIT), one of the main determinants is the inconvenience for patients to undergo prolonged build-up phases. Thus, simplifying the time schedule of the induction protocol could be effective in increasing the adherence to SCIT. Methods:We backtracked the SCIT renewal orders, thanks to the cooperation of the manufacturing company, and we compared the long-term adherence of 152 patients, who were prescribed with an abbreviated build-up schedule (4 injections, allergoid) with that of 302 patients treated with the same product, but with the traditional build-up protocol (7 injections). Results:According to the patient-named refills, those patients on the abbreviated build-up were significantly more compliant at the 2nd and 3rd year of treatment compared to the other group (p=0.0001). The drop-out rate after one year was also significantly lower between the two groups (p=0.0001). The drop-out rate after one year was also significantly lower between the two groups (p=0.0001). The drop-out rate after one year was also significantly lower between the two groups (. Conclusions:Abbreviating the build-up phase by reducing the number of injections significantly improves patients' adherence to SCIT.
| S-EPMC7049433 | biostudies-literature
Project description:BackgroundPleural effusions may be aspirated manually or via vacuum during thoracentesis. This study compares the safety, pain level, and time involved in these techniques.MethodsWe randomized 100 patients receiving ultrasound-guided unilateral thoracentesis in an academic medical center from December 2015 through September 2017 to either vacuum or manual drainage. Without using pleural manometry, the effusion was drained completely or until the development of refractory symptoms. Measurements included self-reported pain before and during the procedure (from 0 to 10), time for completion of drainage, and volume removed. Primary outcomes were rates of all-cause complications and of early termination of the procedure with secondary outcomes of change in pain score, drainage time, volume removed, and inverse rate of removal.ResultsPatient characteristics in the manual (n=49) and vacuum (n=51) groups were similar. Rate of all-cause complications was higher in the vacuum group (5 vs. 0; P=0.03): pneumothorax (n=3), surgically treated hemothorax with subsequent death (n=1) and reexpansion pulmonary edema causing respiratory failure (n=1), as was rate of early termination (8 vs. 1; P=0.018). The vacuum group exhibited greater pain during drainage (P<0.05), shorter drainage time (P<0.01), no association with volume removed (P>0.05), and lower inverse rate of removal (P≤0.01).ConclusionDespite requiring less time, vacuum aspiration during thoracentesis was associated with higher rates of complication and of early termination of the procedure and greater pain. Although larger studies are needed, this pilot study suggests that manual aspiration provides greater safety and patient comfort.
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Project description:ObjectivesLittle is known about the Hymenoptera venom allergy impact on work ability and the effect of venom immunotherapy (VIT) on work. The objective of this study was to evaluate the prevalence and predictors of work disability in patients treated with VIT and the effects of VIT on occupational functioning.Methods181 patients, aged 18-71 years, treated with VIT while working, were investigated by questionnaire. Participants were classified into employed and self-employed and, based on work exposure to Hymenoptera, into three risk categories: high risk, occasionally high risk and low risk. Work disability was defined as having to have changed jobs/tasks and/or suffered economic loss because of Hymenoptera venom allergy. Predictors of work disability were assessed in logistic regression models.Results31 (17%) patients reported work disability. Being self-employed and having the severe reaction at work were associated with work disability (p<0.01). Having a high-risk job for exposure to Hymenoptera was a significant predictor of work disability (OR 2.66, 95% CI 1.04 to 6.75). 24% of patients referred a positive effect of VIT on work. Determinants of the positive effect of VIT on work were having a high-risk job for exposure to hymenoptera (OR 3.60, 95% CI 1.52 to 8.51) and having already concluded VIT (OR 2.82, 95% CI 1.30 to 6.14).ConclusionsHymenoptera venom allergy could determine work disability. Patients with Hymenoptera venom allergy having a high-risk job for exposure to Hymenoptera seem to have higher risk of work disability and refer more frequently a positive effect of VIT on work.
| S-EPMC4127938 | biostudies-literature
Project description:Towards a better understanding of molecular processes underlying the acquisition of immune-tolerance during VIT (venom immunotherapy), we analysed genome-wide gene expression profiles of patients with severe hymenoptera venom allergy (HVA), who were analyzed prior to VIT and 12 months after the beginning of a VIT. The study also includes individuals withhout signs of HVA (as revealed by skin tests); beekepers and HVA patients sampled between 1st and 2nd month of VIT.
2017-01-21 | GSE92866 | GEO
Project description:PurposeVitamin D (VitD) is an immunomodulatory molecule capable of alleviating allergic symptoms. However, the effectiveness of allergen-specific immunotherapy (AIT) is not commonly evidenced in the early build-up phase. The aim of the study was to determine the potential of VitD supplementation in this treatment phase.MethodsThirty-four house dust mite (HDM)-allergic adult patients treated with subcutaneous AIT were randomized to receive VitD2 60,000 IU/week or placebo for 10 weeks and followed up for 10 weeks. The primary endpoints were the symptom-medication score (SMS) and the treatment response rate. The secondary endpoints were eosinophil count and levels of plasma IL-10, Der p 2-specific IgG4, and dysfunctional regulatory T (CRTH2+ Treg) cells.ResultsOf 34 patients, 15 in each group completed the study. Patients with VitD deficiency receiving a VitD supplement showed significantly lower mean change SMS than the placebo group in weeks 10 (mean difference -54.54%, P = 0.007) and 20 (mean difference -42.69%, P = 0.04). The percentage of treatment responders reached 78% and 50% in the VitD and placebo groups, respectively, and the effect remained in week 20 (89% and 60%). No significant difference was observed for the tested immunological read-outs, with the exception of the frequency of CRTH2+ Treg cells, which was remarkably reduced in the VitD-treated patients. Moreover, improvement in SMS was correlated to the number of CRTH2+ Treg cells. Our in vitro experiment indicated that VitD downregulated activation markers, whereas it improved the function of CRTH2+ Treg cells.ConclusionsVitD supplementation in the build-up phase of AIT could relieve symptoms and decrease Treg cell dysfunction, especially in patients with VitD deficiency.
| S-EPMC10186127 | biostudies-literature