Drug Allergy Research Articles

#425 Felzartamab (anti-CD38) in patients with IgA Nephropathy—interim results from the IGNAZ study

Abstract Background and Aims Most patients with IgA nephropathy (IgAN) will progress to kidney failure within 10-15 years of diagnosis. Sustained proteinuria is the best predictor of adverse long-term kidney outcomes and is a surrogate marker for efficacy. CD38+ plasma cells are likely the main source of pathogenic Gd-IgA1, and the related autoantibodies in IgAN. Felzartamab (felza; HIB202) is a recombinant purified human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to CD38 on plasma cells and is being studied across immune-mediated kidney diseases such as IgAN, Primary Membranous Nephropathy, Lupus Nephritis, and Antibody Mediated Rejection. The primary aims of the IGNAZ study were to assess: 1) efficacy of felza compared to placebo on urine protein:creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR) change from baseline, and 2) the relationship between exposure, safety, and efficacy in each of 3 dose groups vs. placebo. Interim results with 15 months of follow-up from this 24-month trial are presented. Method In Part 1, 48 IgAN subjects were randomized in a 1:1:1:1 ratio across a placebo and 3 active arms in this multicenter, double-blind placebo-controlled, phase IIa trial. The M1, M2, and M3 active arms received 2 doses in 15 days, 5 doses in 2 months, and 9 doses in 5 months, respectively. In Part 2, 6 Japanese subjects received the M3 regimen, open-label, and have been followed for 9 months. Key inclusion criteria included ages 18-80 years, biopsy confirmed diagnosis of IgAN within the past 8 years, proteinuria at screening ≥1.0 g/d, eGFR ≥30 ml/min/1.73 m2 (by CKD-EPI), and background stable and maximally tolerated renin angiotensin system inhibitors. Results 48 randomized subjects were enrolled at 28 sites in the US and in 14 different countries in Europe and in Asia, of which 46 completed the treatment phase. Mean (SD) baseline characteristics (Parts 1 and 2 combined): age 41.6 (12.3) yrs, UPCR 1.67 (1.0) g/g, eGFR 74.6 (30.3) ml/min/1.73 m2. 67% of subjects were male. Intention-to-treat with felza demonstrated rapid, clinically meaningful reductions in UPCR with the maximal treatment effect being observed in the M3 9-dose regimen. In Part 1, percentage change from baseline in UPCR was −14% for placebo and −25% for M3 9-dose arm at month 3, and +9% for placebo and −35% for M3 at month 6 (Fig. A). Reductions in proteinuria observed at month 6 persisted until Month 15, 10 months after the last dose: +6% and −38% mean UPCR change from baseline for placebo and the M3 9-dose arm, respectively (Fig. B). Relatively stable eGFR values were observed for the felza arms compared to loss of eGFR in the placebo arm. Rapid, durable reductions in IgA and Gd-IgA1 levels were seen across the dosing arms, with reductions lasting 10 months after the last dose (Fig. C). IgG recovery occurred faster off-treatment than IgA. Results in the Part 2 subjects were similar to the Part 1 M3 cohort through 9 months. There were no apparent dose-dependent adverse events and no exposure-safety relationship. Treatment-emergent adverse events (TEAEs) were generally of mild or moderate intensity or toxicity grade. The most common TEAE assessed as related by study investigator was infusion related reactions (IRR), most of which occurred on the first infusion. There was one treatment-related serious AE due to an IRR. Five subjects discontinued treatment due to IRRs or drug hypersensitivity; for four of the five subjects, the infusion rate was higher than protocol-specified or had an error in pre-medication. TEAE infections were comparable between placebo and felza arms: Placebo (33.3%), M1 (33.3%), M2 (36.4%), M3 (38.5%), Part 2 (50.0%); all were Grades 1 or 2, and non-serious. Conclusion This proof-of-concept study highlights the potential for disease modification in IgAN with the anti-CD38 mAb felza and supports continued research as a potential treatment for high-risk IgAN patients. Felza treatment resulted in clinically meaningful, prolonged UPCR reductions and eGFR stabilization sustained ≥10 months after dosing was completed. Felza was generally well tolerated with rapid recovery of IgG with durable reductions in IgA and pathogenic Gd-IgA1 levels.

The Role of the Allergist in the Management of Chemotherapy-Induced Hypersensitivity Reactions

Chemotherapy-Induced Hypersensitivity Reactions are one of the main problems for oncology physicians and chemotherapy patients. The hypersensitivity reaction can either cause the cessation of the first-line treatment and it may impair the final result and impede or decrease the chances for successful treatment. Chemotherapy drugs are foreign substances that are capable to inducing the various hypersensitivity reactions from mild cutaneous symptoms to severe respiratory distress and cardiovascular collapse. The original Gell and Coomb’s classification categorizes hypersensitivity reactions into four types according to the type of immune response and the effector mechanism responsible for cell and tissue injury. The most common reactions are caused by platinum compounds, taxanes, epipodophyllotoxins, and asparaginase. The use of biologicals is increasing now, and these drugs are frequent causes of hypersensitivity reactions too. Skin testing is a method of diagnosing drug hypersensitivity, but it has not been developed enough in the field of medical oncology where a variety of the antineoplastic agents may be caused hypersensitivity reactions. Drug desensitization is the benefitial therapy in patients with chemotherapyinduced hypersensitivity reactions to chemotherapeutic drugs. This is useful for chemotherapy patients with malignancies and hematological diseases when no comparable alternative is available.

Systematic evaluation and meta-analysis of the prognosis of down-staging human papillomavirus (HPV) positive oropharyngeal squamous cell carcinoma using cetuximab combined with radiotherapy instead of cisplatin combined with radiotherapy.

To evaluate the efficacy and safety of cetuximab instead of cisplatin in combination with downstaging radiotherapy for papillomavirus (HPV) positive oropharyngeal squamous cell carcinoma (HPV+ OPSCC). Meta-analysis and systematic evaluation. The PubMed, Embase, Web of Science, and Cochrane library databases were searched up to June 8, 2023, as well as Clinicaltrials.gov Clinical Trials Registry, China Knowledge Network, Wanfang Data Knowledge Service Platform, and Wiprojournal.com. Randomized controlled trials reporting results of standard regimens of cetuximab + radiotherapy vs cisplatin + radiotherapy in treating HPV+ OPSCC were included. The primary outcomes of interest were overall survival (OS), progression-free survival (PFS), local regional failure rate (LRF), distant metastasis rate (DM), and adverse events (AE). Two reviewers independently extracted data and assessed the risk of bias of the included studies. The HR and its 95% CI were used as the effect analysis statistic for survival analysis, while the OR and its 95% CI were used as the effect analysis statistic for dichotomous variables. These statistics were extracted by the reviewers and aggregated using a fixed-effects model to synthesise the data. A total of 874 relevant papers were obtained from the initial search, and five papers that met the inclusion criteria were included; a total of 1,617 patients with HPV+ OPSCC were enrolled in these studies. Meta-analysis showed that OS and PFS were significantly shorter in the cetuximab + radiotherapy group of patients with HPV+ OPSCC compared with those in the conventional cisplatin + radiotherapy group (HR = 2.10, 95% CI [1.39-3.15], P = 0.0004; HR = 1.79, 95% CI [1.40-2.29], P < 0.0001); LRF and DM were significantly increased (HR = 2.22, 95% CI [1.58-3.11], P < 0.0001; HR = 1.66, 95% CI [1.07-2.58], P = 0.02), but there was no significant difference in overall grade 3 to 4, acute and late AE overall (OR = 0.86, 95% CI [0.65-1.13], P = 0.28). Cisplatin + radiotherapy remains the standard treatment for HPV+ OPSCC. According to the 7th edition AJCC/UICC criteria, low-risk HPV+ OPSCC patients with a smoking history of ≤ 10 packs/year and non-pharyngeal tumors not involved in lymphatic metastasis had similar survival outcomes with cetuximab/cisplatin + radiotherapy. However, further clinical trials are necessary to determine whether cetuximab + radiotherapy can replace cisplatin + radiotherapy for degraded treatment in individuals who meet the aforementioned characteristics, particularly those with platinum drug allergies. CRD42023445619.

Long-Term Outcomes Associated With β-Lactam Allergies

β-lactam (BL) allergies are the most common drug allergy worldwide, but most are reported in error. BL allergies are also well-established risk factors for adverse drug events and antibiotic-resistant infections during inpatient health care encounters, but the understanding of the long-term outcomes of patients with BL allergies remains limited. To evaluate the long-term clinical outcomes of patients with BL allergies. This longitudinal retrospective cohort study was conducted at a single regional health care system in western Pennsylvania. Electronic health records were analyzed for patients who had an index encounter with a diagnosis of sepsis, pneumonia, or urinary tract infection between 2007 and 2008. Patients were followed-up until death or the end of 2018. Data analysis was performed from January 2022 to January 2024. The presence of any BL class antibiotic in the allergy section of a patient's electronic health record, evaluated at the earliest occurring observed health care encounter. The primary outcome was all-cause mortality, derived from the Social Security Death Index. Secondary outcomes were defined using laboratory and microbiology results and included infection with methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile, or vancomycin-resistant Enterococcus (VRE) and severity and occurrence of acute kidney injury (AKI). Generalized estimating equations with a patient-level panel variable and time exposure offset were used to evaluate the odds of occurrence of each outcome between allergy groups. A total of 20 092 patients (mean [SD] age, 62.9 [19.7] years; 12 231 female [60.9%]), of whom 4211 (21.0%) had BL documented allergy and 15 881 (79.0%) did not, met the inclusion criteria. A total of 3513 patients (17.5%) were Black, 15 358 (76.4%) were White, and 1221 (6.0%) were another race. Using generalized estimating equations, documented BL allergies were not significantly associated with the odds of mortality (odds ratio [OR], 1.02; 95% CI, 0.96-1.09). BL allergies were associated with increased odds of MRSA infection (OR, 1.44; 95% CI, 1.36-1.53), VRE infection (OR, 1.18; 95% CI, 1.05-1.32), and the pooled rate of the 3 evaluated antibiotic-resistant infections (OR, 1.33; 95% CI, 1.30-1.36) but were not associated with C difficile infection (OR, 1.04; 95% CI, 0.94-1.16), stage 2 and 3 AKI (OR, 1.02; 95% CI, 0.96-1.10), or stage 3 AKI (OR, 1.06; 95% CI, 0.98-1.14). Documented BL allergies were not associated with the long-term odds of mortality but were associated with antibiotic-resistant infections. Health systems should emphasize accurate allergy documentation and reduce unnecessary BL avoidance.

Vaccine hesitancy in patients presenting to a specialized allergy center: clinical relevant sensitizations, impact on mental health and vaccination rates.

The COVID vaccination program with new types of vaccinations and early reports of allergic reactions to vaccines led to vaccination hesitancy in patients with allergies. In this study, we aimed to characterize patients who present at an allergy center with specific questions regarding risk assessment to COVID vaccines in comparison to regular allergy center patients. A total of 50 patient charts of patients with risk assessment for COVID vaccination (COV group) and 50 regular allergy center patients (ALL group) were assessed for documented allergies, comorbidities, total IgE, and tryptase levels and hospital anxiety and depression score (HADS). Skin prick testing (SPT) with additives of COVID vaccines [polyethylene glycol (PEG), polysorbate] were performed if indicated based on medical history. Patients who presented for examination prior to a possible COVID vaccination were mostly female (86%) and had more frequently reported allergic reactions to drugs in the past, but only in a minor group (28%) were the reactions qualified as anaphylaxis. The group COV patients scored significantly higher in the HADS for anxiety and depression than the regular group ALL patients. The same trend was observed when data were corrected for gender. It is worth noting that patients without any prior contact to COVID vaccines scored comparable regarding anxiety to patients with prior reaction to COVID vaccinations, but significantly higher in the depression score. In 19 patients (38%) who met the indications for SPT for the suspicious contents PEG and Polysorbate 80, the tests did not show a positive result. Furthermore, 84% of patients underwent the prick test, but only 15% of patients who received consultation alone agreed to vaccination at our center. No vaccination-related event was documented in these patients. In conclusion, vaccination hesitancy was frequently elicited by negative experiences with drugs and putative drug allergies. Female patients predominate in this patient group, and the anxiety and depression scores were significantly elevated. Allergological workup, including SPT, led to a high rate of subsequent vaccinations, whereas a discussion with the patients about risks and individualized advice for vaccination without testing only rarely resulted in documented vaccinations.

Electronic prescription systems in Greece: a large-scale survey of healthcare professionals’ perceptions

BackgroundThe national e-prescription system in Greece is one of the most important achievements in the e-health sector. Healthcare professionals’ feedback is essential to ensure the introduced system tends to their needs and reduces their everyday workload. The number of surveys collecting the users’ views is limited, while the existing studies include only a small number of participants.MethodsIn this study, healthcare professionals’ perceptions on e-prescription are explored. For this, a questionnaire was distributed online, containing closed- and open-ended questions aiming to address strengths and identify drawbacks in e-prescription. Answers were collected from primary health care physicians, specialized medical doctors and pharmacists.ResultsIn total, 430 answers were collected (129 from primary health care physicians, 164 responses from specialized medical doctors and 137 pharmacists). Analysis of the collected answers reveals that the views of the three groups of healthcare professionals mostly converge. The positive impact e-prescribing systems have on the overall prescribing procedure in preventing errors and providing automation is commented. Among gaps identified and proposed improvements, health care professionals note the need for access to information on adverse drug reactions, side effects, drug-to-drug interactions and allergies. Flexible interaction with Therapeutic Prescription Protocols is desired to ameliorate monitoring and decision-making, while drug dosing features, and simplified procedures for copying, repeating, canceling a prescription, are perceived as useful to incorporate.ConclusionsCollecting healthcare professionals’ feedback is important, as their views can be transcribed to system requirements, to further promote e-prescribing and improve the provided health care services by facilitating decision making through safer and more efficient e-prescription. Introduction of the identified improvements can simplify the everyday workflow of healthcare professionals. To the best of our knowledge, a survey with more than 400 answered questionnaires on the use of e-prescription systems by healthcare professionals has never been conducted in Greece before.

English

Background: Interest in finding efficient ways to remove penicillin allergy alerts has grown as a result of awareness of the considerable excess of false-negative diagnoses in patients with penicillin allergy labels (90%-95%), the poorer course with non–ß-lactam antibiotics, the increase in bacterial resistance, and the fact that these problems can affect up to 20% of the population in some countries. The strategies proposed have generated many publications in countries where the number of allergists to conduct such studies is low. In many cases where delabeling is performed, the risk of ß-lactam allergy is low, and a single penicillin challenge is sufficient to delabel the alert. However, other less “ultrarapid” strategies can be used to administer a ß-lactam during an admission for infection and thus postpone delabeling until traditional drug allergy consultations. However, the definitive withdrawal of ß-lactam alerts is threatened by nonremoval of alerts in electronic health records and by the reactivation or nonsynchronization of alerts between electronic systems at different levels of care. Allergy departments need to reflect on how to implement practices that enable rapid and efficient delabeling of drug allergy alerts, especially in patients with major comorbidities.

Bibliometric characterization of Revista Alergia Mexico

To characterize the scientific production of the Revista Alergia Mexico. A descriptive study was carried out that took into consideration the bibliometric information of the Revista Alergia México hosted in PubMed (MEDLINE) and Scopus. The total number of articles published during 1991 to 2021 according to Pubmed was 1,115 (annual mean: 37.2 ± 12.3). Scopus registered 1,541 articles during 1972 to 2021 (annual mean: 30.8 ± 14.9); in both sources, original articles (49 and 78%, respectively) and review articles (21 and 12%, respectively) were the most published document modalities; the most relevant topics included asthma (32%), allergic rhinitis (16%) and drug allergy (9%). Public institutions in Mexico were the institutions with the highest number of published articles. The country with the highest number of published papers was Mexico (54%), followed by Colombia (5%) and Spain (4%). The 2020 citation index according to Scopus was 0.9; an H-index of 15; and an impact factor of 0.150. During the period 2016 - 2020, the annual rejection rate ranged from 7% to 30%. Promoting the internationalization of the journal, publishing articles in the English language and achieving the impact factor are among some of the main needs of the Revista Alergia Mexico.

Patient-Reported Outcome Measures in Food and Drug Allergy

A patient-reported outcome is directly reported by the patient without interpretation of the patient's response by anyone else. It refers to the patient's health (symptoms and feelings), quality of life, or functional status associated with health care or treatment. Patient-reported outcome measures (PROMs) are defined as the tools or instruments that are used to measure patient-reported outcomes. Health-related quality of life has been the most studied psychosocial PROM in food allergy, using validated questionnaires. In drug allergy, PROMs are useful in capturing patients' experiences of potential allergic reactions, including subjective symptoms such as headache, dizziness, or fatigue. Patient-reported outcome measures can also help differentiate true allergies from side effects or other nonallergic reactions and inform decisions about drug challenges and de-labeling strategies. Ensuring the chosen tool is validated for the specific allergy context is crucial for accurate data collection. Integrating patient-reported experiences alongside traditional methods can lead to more accurate assessments and personalized care.

Alpha-gal syndrome: when treatment of hypovolemic shock can lead to anaphylaxis.

Delayed anaphylaxis after ingestion of red meat because of galactose-alpha-1,3-galactose (alpha-gal) syndrome has increased in recent years. The mechanism involves an immunoglobulin E reaction to alpha-gal, a molecule found in mammalian meat, dairy products, medications and excipients containing mammalian-derived components, and tick salivary glycans. Sensitization occurs due to the bite of a lone star tick and the transmission of alpha-gal molecules into person's bloodstream. We describe a case of alpha-gal syndrome with severe food, drug, and perioperative allergy in which anaphylaxis with hypovolemic shock occurred immediately after an emergency surgical procedure, when a gelatin-containing drug was injected. This case study confirms that the clinical manifestations of alpha-gal syndrome could be different depending on the route of administration, with immediate reactions if an alpha-gal-containing drug is injected and delayed type allergic manifestations occurring several hours after oral intake. The purpose of this report is to highlight the importance of risk communication in case of exposure to medical products and surgical procedures of patients with alpha-gal syndrome and to encourage drug manufacturers to indicate clearly the origin of excipients in product literature.

Drug Allergy Mimics

Drug Allergy Mimics

How to Define and Manage Low-Risk Drug Allergy Labels

How to Define and Manage Low-Risk Drug Allergy Labels

How to Define and Manage Low-Risk Drug Allergy Labels

Risk stratification in drug allergy implies that specific risk categories (eg, low, moderate, and high) classify historical drug hypersensitivity reactions. These risk categories can be based on reaction phenotypic characteristics, the timing of the reaction and evaluation, the required reaction management, and individual characteristics. Although a multitude of frameworks have been described in the literature, particularly for penicillin allergy labels, there has yet to be a global consensus, and approaches continue to vary between allergy centers. Immune-mediated drug allergies can sometimes be confirmed using skin testing, but a negative drug challenge is required to demonstrate tolerance and remove the allergy from the electronic health record ("delabel" the allergy). Even for quintessential IgE-mediated drug allergy, penicillin allergy, recent data reveal that a direct oral challenge, without prior skin testing, is an appropriate diagnostic strategy in those who are considered low-risk. Drug allergy pathogenesis and clinical manifestations may vary depending on the culprit drug, and as such, the optimal approach should be based on risk stratification that considers individual patient and reaction characteristics, the likely hypersensitivity reaction phenotype, the drug class, and the patient's clinical needs. This article will describe low-risk drug allergy labels, focusing on β-lactam and sulfonamide antibiotics, nonsteroidal anti-inflammatory drugs, iodinated contrast media, and common chemotherapeutics. This review will also address practical management approaches using currently available risk stratification and clinical decision tools.

Test Panel of Hidden Allergens for “Idiopathic Anaphylaxis” Reveals Wheat Allergy Dependent on Augmentation Factors as Common Final Diagnosis

Idiopathic anaphylaxis (IA) is an unresolved concern. Hidden allergens may be relevant in IA and in nonsteroidal anti-inflammatory drug hypersensitivity (NSAID-HS). To identify hidden elicitors for IA and NSAID-HS by a skin prick test (SPT) (13 allergens) and allergen-specific IgE (sIgE) panel (12 allergens) and to determine the value of each tested allergen. We retrospectively included all patients from 2018 to 2021 referred with a suspicion of IA or NSAID-HS by history in whom SPT and/or sIgE to allergens of the IA panel were performed. Patient characteristics from patients' records included comorbidities, history and symptoms of anaphylaxis, serum baseline tryptase level, total IgE level, SPT, sIgE, challenge results, and final diagnoses. A total of 134 patients (77 female, mean age 39.7 ± 14.6 years) were included. Median serum baseline tryptase and total IgE levels were 4.23 μg/L and 133.5 kU/L, respectively. Allergologic workup with the IA panel resulted in positive SPT and sIgE in 61 (47%) and 66 (60%) patients, respectively. In those, confirmation or exclusion of allergy, mostly by challenge, led to a definitive diagnosis in 61 of 134 patients (46%). Skin prick test was most frequently positive to gluten (22.4%) and sIgE to ω5-gliadin (21.6%), which correlated with the history (r= 0.310, P < .001; and r= 0.407, P < .001, respectively). In 28 of 134 patients (21%) with initially suspected IA or NSAID-HS, challenges confirmed occult food allergy in which wheat allergy dependent on augmentation factors was the most frequent cause of anaphylaxis (19%). Wheat allergy dependent on augmentation factors should be considered in all patients with anaphylaxis of unknown cause or after NSAID intake.

Comparison of Allergic Diseases in terms of Anxiety, Depression and Quality of Life

Studies have shown the frequency of anxiety and depression and decreased quality of life (QoL) in patients with allergic diseases. The aim of this study was to evaluate anxiety and depression symptoms and QoL in patients with asthma, allergic rhinitis (AR), urticaria/angioedema (U/A) and drug allergy without any psychiatric diagnosis and to compare these four diseases in these respects. In this cross-sectional study demographic and clinical characteristics were collected from patients’records. Hospital Anxiety and Depression Scale (HADS) and Short Form 36 (SF-36) were used to assess anxiety and depression symptoms and QoL. A total of 159 patients were included in the study and grouped as asthma (n=43, 27.1%), AR (n=45, 28.3%), U/A (n=44, 27.7%) and drug allergy (n=27, 17%). There was a significant difference in HADS anxiety score and SF-36 physical functioning subscore (p&amp;lt;0.001 and p=0.001, respectively). HADS anxiety score was higher in the U/A group and SF-36 physical functioning was lower in asthma group. Among asthmatics, SF-36 subscores of physical role functioning, emotional role functioning, social role functioning were lower in the patients at step 4 and 5 (n=22, 51.2%) than in those at step 2 and 3 (n=21, 48.8%) (p=0.001, p=0.031 and p=0.005, recpectively). In the U/A group, there was a positive moderate correlation between the urticaria activity score 7 and the HADS anxiety score (r:0.579, p&amp;lt;0.001). Our study showed that U/A patients had more anxiety symptoms comparing to other allergic diseases. Disease activity and severity had a significant relationship with anxiety level in U/A patients and with QoL in asthmatics.

Mast cell versus basophil activation test in allergy: Current status.

In the past two decades, we witnessed the evolution of the basophil activation test (BAT) from mainly research applications to a potential complementary diagnostic tool to document IgE-dependent allergies. However, BAT presents some technical weaknesses. Around 10%-15% of tested patients are non-responders, BAT can be negative immediately post-reaction and the use of fresh basophils, ideally analysed within 4 h of collection, restricts the number of tests that can be performed per sample. The need for fresh basophils is especially limiting when conducting batch analyses and interlaboratory comparisons to harmonize BAT methodology. These limitations significantly hinder the wider application of BAT and urge the development of alternative testing, such as the mast cell activation test (MAT). The essential difference between BAT and MAT is the heterogeneity of the starting material used to perform the assays. Mast cells are tissue-resident, so cannot be easily accessed. Current alternative sources for functional studies are generating primary human mast cells, differentiated from donor progenitor cells, or using immortalized mast cell lines. Hence, the methodological approaches for MAT are not only vastly different from BAT, but also different among MAT protocols. This review summarizes the advantages and disadvantages of BAT and MAT assays, dedicating special attention to elucidating the key differences between the cellular sources used and provides an overview of studies hitherto performed comparing BAT and MAT in the diagnosis of IgE-mediated food and drug allergies.

Multimorbidity of Allergic Diseases Is Associated With Functional Gastrointestinal Disorders in a Young Japanese Population.

Although certain allergic diseases have been reported to be associated with the prevalence of functional dyspepsia (FD) and irritable bowel syndrome (IBS), it is unclear whether the presence of multiple allergic diseases further increases the prevalence of FD and IBS. The aim of this study is to determine this issue in young people. A cohort of 8923 Japanese university students was enrolled and diagnoses of FD and IBS were confirmed using Rome III criteria. Allergic disorders diagnosed at medical institutions were obtained by means of a self-administered questionnaire. The prevalence of FD, IBS, and their overlap was found to be 1.9%, 6.5%, and 1.1%, respectively. Pollen allergy was independently positively correlated with FD, IBS, and overlap of FD and IBS. Allergic rhinitis was positively linked to IBS. Drug allergy was positively associated with FD. The presence of multiple allergic diseases was positively correlated with FD and IBS (FD: adjusted OR for 2 allergic diseases: 1.95 [95% CI, 1.24-2.98], P for trend = 0.003; and IBS: adjusted OR for 1 allergic disease: 1.40 [95% CI, 1.15-1.69], 2 allergic diseases 1.47 [95% CI, 1.12-1.91], and 3 or more allergic diseases: 2.22 [95% CI, 1.45-3.28], P for trend = 0.001). Additionally, the concomitant existence of multiple allergic diseases was also demonstrated to have a trend that correlated with the overlap of FD and IBS (P for trend = 0.018). Allergic disease multimorbidity is positively correlated with the prevalence of FD and IBS in a young population.

Amikacin induced Stevens Johnson syndrome and toxic epidermal necrolysis overlap: a rare case report

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are the most severe adverse drug reactions. They are characterized by necrosis and epidermal release in vesicobulosa skin, mucous orifice, and eyes, with more severe general symptoms. SJS/TEN-overlap syndrome is the term used to characterize situations where 10–30% of the body skin area is detached. TEN or SJS is one of the deadliest dermatological catastrophes. Despite being a rare condition, it frequently has a high death rate. Different types of purpuric macules or rounded patches with mucosal lesions are characteristic features of these type 3 hypersensitivity reactions. We are presenting a case of 50-year-old female patient brought to hospital on account of multiple black to red coloured raised lesions over body in the last 8 days. Patient was asymptomatic in the last 8 days after that patient noted red coloured lesions first over face followed by lower back, upper limb, lower limb followed by itching and Jiburning sensation all over the body. The patient had symptoms such as redness of eyes in the last 3-4 days, burning sensation and ulcers in mouth in the last 3-4 days. These symptoms developed day after she received amikacin. She was diagnosed with SJS-TEN overlap. This case highlights the precipitant of antibiotics for SJS. She was recovered completely after stopping the causative drug and treatment with Immunoglobulin with other symptomatic measures. The causative drug was found to be Amikacin and medicine taken for comorbid conditions like epilepsy, hypothyroidism and hypertension. Rarely, amikacin has been linked to a range of drug hypersensitivity reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome, and overlap between the two conditions.

A qualitative study exploring how undergraduate pharmacy students undertake a drug allergy history

Abstract Introduction If antimicrobial resistance (AMR) is not controlled, a post-antibiotic era could result in common infections and minor injuries becoming fatal. One way to combat AMR is the ‘de-labelling’ or removal of incorrect antibiotic allergy labels. At least 92% of labels corresponding to penicillin allergy are incorrect when tested.[1] This means that patients may not be receiving the correct antibiotic treatment and take longer to recover. Therefore, taking an accurate allergy history is important. Pharmacists routinely take drug allergy histories. From 2026, pharmacy students in England will graduate as prescribers, highlighting the importance of drug allergy knowledge and skills. Aim To explore how undergraduate pharmacy students undertake a drug allergy history. Methods A qualitative study utilising a constructivist approach involving a low-fidelity simulation followed by a one-to-one face-to-face semi-structured interview was conducted. Final year undergraduate Master of Pharmacy students of an English school of pharmacy were recruited via email and word-of-mouth to take part in this study. Following informed consent, participants simulated taking a drug allergy history with a student researcher. The simulation was audio-recorded and then played back to the participant as a cue for a subsequent audio-recorded semi-structured interview that explored their thought-process when taking a drug allergy history. All audio-recordings were transcribed verbatim. Transcripts were analysed using reflexive thematic analysis.[2] Results Nine participants took part in the study. The simulation and interview lasted seven minutes on average. Four themes were generated through the analysis. Theme 1: taking drug allergy history is learnt mainly through practice-based learning. Theme 2: nature, type and severity of allergic reactions information were deemed important for making clinical judgements. Theme 3: skills for taking drug allergy history are underdeveloped despite having knowledge. Theme 4: real patient contact exposure is needed to translate learning into practice. Most participants remembered learning about taking drug allergy history through practice-based learning sessions such as workshops, objective structured clinical examinations (OSCEs) and hospital placements. Participants seemed to follow a set of ‘rules’ when undertaking the simulation. For example, they stopped asking questions about allergies and decide not to dispense penicillin when they were informed that the patient was allergic to penicillin. Most participants recognised the risk of serious harm to patients if they made a mistake about patient allergies, and the need to have more real-world experiences to help translate their learning into practice. Conclusion Pharmacy students appeared to have the theoretical knowledge about drug allergies, but they were not yet able to make an appropriate clinical judgement in real-world situations. An increase in real-world clinical experience such as patient consultations in work-based placements can provide pharmacy students with valuable opportunities. By knowing how to undertake an accurate allergy history, fewer people will be inaccurately labelled as allergic, promoting antimicrobial stewardship. To our knowledge, this is the first study investigating how United Kingdom undergraduate pharmacy students undertake a drug allergy history. Our participants studied in one pharmacy school and undergraduate pharmacy students studying in other pharmacy schools may have different experiences around drug allergy history taking.

ALDRESS: A Retrospective Pilot Study to Develop a Pharmacological Causality Algorithm for Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

Background: The drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome represents a severe form of drug hypersensitivity reaction characterized by significant morbidity, mortality, and long-term sequelae, coupled with limited therapeutic avenues. Accurate identification of the causative drug(s) is paramount for acute management, exploration of safe therapeutic alternatives, and prevention of future occurrences. However, the absence of a standardized diagnostic test and a specific causality algorithm tailored to DRESS poses a significant challenge in its clinical management. Methods: We conducted a retrospective case-control study involving 37 DRESS patients to validate a novel causality algorithm, the ALDRESS, designed explicitly for this syndrome, comparing it against the current standard algorithm, SEFV. Results: The ALDRESS algorithm showcased superior performance, exhibiting an 85.7% sensitivity and 93% specificity with comparable negative predictive values (80.6% vs. 97%). Notably, the ALDRESS algorithm yielded a substantially higher positive predictive value (75%) compared to SEFV (51.40%), achieving an overall accuracy rate of 92%. Conclusions: Our findings underscore the efficacy of the ALDRESS algorithm in accurately attributing causality to drugs implicated in DRESS syndrome. However, further validation studies involving larger, diverse cohorts are warranted to consolidate its clinical utility and broaden its applicability. This study lays the groundwork for a refined causality assessment tool, promising advancements in the diagnosis and management of DRESS syndrome.