A randomized, double-blind, placebo-controlled, dose-finding trial with Lolium perenne peptide immunotherapy

BACKGROUND: A novel subcutaneous allergen immunotherapy formulation (gpASIT+™) containing Lolium perenne peptides (LPP) and having a short up-dosing phase has been developed to treat grass pollen-induced seasonal allergic rhinoconjunctivitis. We investigated peptide immunotherapy containing the hydrolysate from perennial ryegrass allergens for the optimum dose in terms of clinical efficacy, immunogenicity and safety. METHODS: This prospective, double-blind, placebo-controlled, phase IIb, parallel, four-arm, dose-finding study randomized 198 grass pollen-allergic adults to receive placebo or cumulative doses of 70, 170 or 370 μg LPP. All patients received weekly subcutaneous injections, with the active treatment groups reaching assigned doses within 2, 3 and 4 weeks, respectively. Efficacy was assessed by comparing conjunctival provocation test (CPT) reactions at baseline, after 4 weeks and after completion. Grass pollen-specific immunoglobulins were analysed before and after treatment. RESULTS: Conjunctival provocation test (CPT) response thresholds improved from baseline to V7 by at least one concentration step in 51.2% (170 μg; P = .023), 46.3% (370 μg), and 38.6% (70 μg) of patients receiving LPP vs 25.6% of patients receiving placebo (modified per-protocol set). Also, 39% of patients in the 170-μg group became nonreactive to CPT vs 18% in the placebo group. Facilitated allergen-binding assays revealed a highly significant (P < .001) dose-dependent reduction in IgE allergen binding across all treatment groups (70 μg: 17.1%; 170 μg: 18.8%; 370 μg: 26.4%). Specific IgG4 levels increased to 1.6-fold (70 μg), 3.1-fold (170 μg) and 3.9-fold (370 μg) (mPP). CONCLUSION: Three-week immunotherapy with 170 μg LPP reduced CPT reactivity significantly and increased protective specific antibodies

A randomized, double-blind, placebo-controlled, dose-finding trial with Lolium perenne peptide immunotherapy

BackgroundA novel subcutaneous allergen immunotherapy formulation (gpASIT+) containing Lolium perenne peptides (LPP) and having a short up-dosing phase has been developed to treat grass pollen-induced seasonal allergic rhinoconjunctivitis. We investigated peptide immunotherapy containing the hydrolysate from perennial ryegrass allergens for the optimum dose in terms of clinical efficacy, immunogenicity and safety. MethodsThis prospective, double-blind, placebo-controlled, phase IIb, parallel, four-arm, dose-finding study randomized 198 grass pollen-allergic adults to receive placebo or cumulative doses of 70, 170 or 370 g LPP. All patients received weekly subcutaneous injections, with the active treatment groups reaching assigned doses within 2, 3 and 4 weeks, respectively. Efficacy was assessed by comparing conjunctival provocation test (CPT) reactions at baseline, after 4 weeks and after completion. Grass pollen-specific immunoglobulins were analysed before and after treatment. ResultsConjunctival provocation test (CPT) response thresholds improved from baseline to V7 by at least one concentration step in 51.2% (170 g; P = .023), 46.3% (370 g), and 38.6% (70 g) of patients receiving LPP vs 25.6% of patients receiving placebo (modified per-protocol set). Also, 39% of patients in the 170-g group became nonreactive to CPT vs 18% in the placebo group. Facilitated allergen-binding assays revealed a highly significant (P < .001) dose-dependent reduction in IgE allergen binding across all treatment groups (70 g: 17.1%; 170 g: 18.8%; 370 g: 26.4%). Specific IgG(4) levels increased to 1.6-fold (70 g), 3.1-fold (170 g) and 3.9-fold (370 g) (mPP). ConclusionThree-week immunotherapy with 170 g LPP reduced CPT reactivity significantly and increased protective specific antibodies

Survey on Management of Unilateral Axillary Lymphadenopathy after Recent Ipsilateral COVID-19 Vaccination

Background: In the setting of widespread COVID-19 vaccination and booster administration, there is an increased incidence of axillary lymphadenopathy identified during breast imaging.Purpose: To investigate how breast imaging radiologists manage unilateral axillary lymphadenopathy (UAL) after a recent ipsilateral COVID-19 vaccination.Methods: A 26-question survey was distributed to 12 California breast imaging facilities in June 2022. Results: There were 10 responses to the survey (83% response rate). All respondents considered recent ipsilateral COVID-19 vaccination relevant to the interpretation of UAL. Seven respondents (70%) also&nbsp; considered non-COVID-19 vaccinations relevant. All respondents documented recent COVID-19 vaccinations, but 4 (40%) had no information for other vaccines. Eight respondents (80%) delayed screening after COVID-19 vaccination during initial vaccination efforts, and 3 (30%) still required or suggested delaying screening at the time of the survey. Breast Imaging Reporting and Data System (BI-RADS) categorization for UAL with no abnormal findings in the ipsilateral breast varied by facility and modality. BI-RADS categorization for UAL previously assigned to BI-RADS 0 or associated with suspicious ipsilateral breast findings varied, but practices tended to demonstrate a high level of suspicion unless the UAL showed improvement on follow-up imaging. For unchanged UAL on initial follow-up, 7 (70%) assign BI-RADS 3, and 3 (30%) assign BI-RADS 4.Conclusion: Despite available guidelines, there was no consensus approach to managing UAL after vaccination among academic and community-based breast imaging radiologists in California. Management was more uniform for a subset of patients perceived to be at higher risk for lymph node metastases, with most or all respondents recommending biopsy when there was &nbsp;a suspicious finding in the ipsilateral breast, concurrent ipsilateral breast cancer, or concurrent malignant tumors not in the breast known to metastasize to the axilla

Impact of the COVID-19 Pandemic on Breast Imaging Education

ObjectiveTo determine the impact of the COVID-19 pandemic on breast imaging education.MethodsA 22-item survey addressing four themes during the early pandemic (time on service, structured education, clinical training, future plans) was emailed to Society of Breast Imaging members and members-in-training in July 2020. Responses were compared using McNemar's and Mann-Whitney U tests; a general linear model was used for multivariate analysis.ResultsOf 136 responses (136/2824, 4.8%), 96 U.S. responses from radiologists with trainees, residents, and fellows were included. Clinical exposure declined during the early pandemic, with almost no medical students on service (66/67, 99%) and fewer clinical days for residents (78/89, 88%) and fellows (48/68, 71%). Conferences shifted to remote live format (57/78, 73%), with some canceled (15/78, 19%). Compared to pre-pandemic, resident diagnostic (75/78, 96% vs 26/78, 33%) (P &lt; 0.001) and procedural (73/78, 94% vs 21/78, 27%) (P &lt; 0.001) participation fell, as did fellow diagnostic (60/61, 98% vs 47/61, 77%) (P = 0.001) and procedural (60/61, 98% vs 43/61, 70%) (P &lt; 0.001) participation. Most thought that the pandemic negatively influenced resident and fellow screening (64/77, 83% and 43/60, 72%, respectively), diagnostic (66/77, 86% and 37/60, 62%), and procedural (71/77, 92% and 37/61, 61%) education. However, a majority thought that decreased time on service (36/67, 54%) and patient contact (46/79, 58%) would not change residents' pursuit of a breast imaging fellowship.ConclusionThe pandemic has had a largely negative impact on breast imaging education, with reduction in exposure to all aspects of breast imaging. However, this may not affect career decisions

Breast MRI BI-RADS Assessments and Abnormal Interpretation Rates by Clinical Indication in US Community Practices

RATIONALE AND OBJECTIVES: As breast MRI use grows, benchmark performance parameters are needed for auditing and quality assurance purposes. We describe the variation in breast MRI abnormal interpretation rates (AIRs) by clinical indication among a large sample of U.S. community practices. MATERIALS AND METHODS: We analyzed data from 41 facilities across five Breast Cancer Surveillance Consortium imaging registries. Each registry obtained IRB approval for this HIPAA compliant analysis. We included 11,654 breast MRI exams conducted in 2005–2010 among women aged 18–79 years. We categorized clinical indications as: 1) screening; 2) extent of disease; 3) diagnostic (e.g., breast symptoms); and 4) other (e.g., short-interval follow-up). We characterized assessments as positive (i.e., BI-RADS 0, 4, and 5) or negative (i.e., BI-RADS 1, 2, 6), and provide results with BI-RADS 3 categorized as positive and as negative. We tested for differences in AIRs across clinical indications both unadjusted and adjusted for patient characteristics and registry, and assessed for changes in AIRs by indication over time. RESULTS: When categorizing BI-RADS 3 as positive, AIRs were 21.0% (95% CI: 19.8, 22.3) for screening, 31.7% (95% CI: 29.6, 33.8) for extent of disease, 29.7% (95% CI: 28.3, 31.1) for diagnostic, and 27.4% (95% CI: 25.0, 29.8) for other indications (p<0.0001). When categorizing BI-RADS 3 as negative, AIRs were 10.5% (95% CI: 9.5, 11.4) for screening, 21.8% (95% CI: 19.9, 23.6) for extent of disease, 17.7% (95% CI: 16.5, 18.8) for diagnostic, and 13.3% (95% CI: 11.6, 15.2) for other indications (p<0.0001). The significant differences in AIRs by indication persisted even after adjusting for patient characteristics and registry (p<0.0001). In addition, for most indications, there were no significant changes in AIRs over time. CONCLUSION: Breast MRI AIRs differ significantly by clinical indication. Practices should stratify breast MRI exams by indication for quality assurance and auditing purposes