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1. The South African Pollen Monitoring Network: Insights from 2 years of national aerospora sampling (2019–2021)

Author

Nanike Esterhuizen, Dilys M. Berman, Frank H. Neumann, Linus Ajikah, Lynne J. Quick, Erin Hilmer, Andri VanAardt, Juanette John, Rebecca Garland, Trevor Hill, Jemma Finch, Werner Hoek, Marion Bamford, Riaz Y. Seedat, Ahmed I. Manjra, and Jonny Peter

Subjects
aeroallergens, aerobiology, aerobiomes, pollen, South Africa, Immunologic diseases. Allergy, RC581-607
Abstract

Abstract Background Pollen monitoring has been discontinuously undertaken in South Africa, a country with high biodiversity, a seasonal rainfall gradient, and nine biomes from arid to subtropical. The South African Pollen Monitoring Network was set up in 2019 to conduct the first long‐term national aerospora monitoring across multiple biomes, providing weekly reports to allergy sufferers and healthcare providers. Methods Daily airborne pollen concentrations were measured from August 2019 to August 2021 in seven cities across South Africa. Updated pollen calendars were created for the major pollen types (>3%), the average Annual Pollen Index over 12 months was calculated, and the results were compared to available historical data. Results The main pollen types were from exotic vegetation. The most abundant taxa were Poaceae, Cupressaceae, Moraceae and Buddleja. The pollen season start, peak and end varied widely according to the biome and suite of pollen taxa. The main tree season started in the last week of August, peaked in September and ended in early December. Grass seasons followed rainfall patterns: September–January and January–April for summer and winter rainfall areas, respectively. Major urban centres, for example, Johannesburg and Pretoria in the same biome with similar rainfall, showed substantive differences in pollen taxa and abundance. Some major differences in pollen spectra were detected compared with historical data. However, we are cognisant that we are describing only 2 years of data that may be skewed by short‐term weather patterns. Conclusions Differences in pollen spectra and concentrations were noted across biomes and between geographically close urban centres. Comparison with historical data suggests pollen spectra and seasons may be changing due to anthropogenic climate change and landscaping. These data stress the importance of regional and continuous pollen monitoring for informed care of pollinosis.

Published
2023
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2. A concept for integrated care pathways for atopic dermatitis—A GA2LEN ADCARE initiative

Author

Torsten Zuberbier, Amir Abdul Latiff, Xenofon Aggelidis, Matthias Augustin, Radu‐Gheorghe Balan, Christine Bangert, Lisa Beck, Thomas Bieber, Jonathan A. Bernstein, Marta Bertolin Colilla, Alejandro Berardi, Anna Bedbrook, Carsten Bindslev‐Jensen, Jean Bousquet, Marjolein deBruin‐Weller, Dayanne Bruscky, Betul Buyuktiryaki, Giorgio Walter Canonica, Carla Castro, Natia Chanturidze, Herberto Jose Chong‐Neto, Chia‐Yu Chu, Leena Chularojanamontri, Michael Cork, Roberta F. J. Criado, Laia Curto Barredo, Adnan Custovic, Ulf Darsow, Arben Emurlai, Ana dePablo, Stefano DelGiacco, Giampiero Girolomoni, Tanja Deleva Jovanova, Mette Deleuran, Nikolaos Douladiris, Bruno Duarte, Ruta Dubakiene, Esben Eller, Batya Engel‐Yeger, Luis Felipe Ensina, Nelson Rosario Filho, Carsten Flohr, Daria Fomina, Wojciech Francuzik, Maria Laura Galimberti, Ana M. Giménez‐Arnau, Kiran Godse, Charlotte Gotthard Mortz, Maia Gotua, Michihiro Hide, Wolfram Hoetzenecker, Nicolas Hunzelmann, Alan Irvine, Carolyn Jack, Ioanna Kanavarou, Norito Katoh, Tamar Kinaciyan, Emek Kocatürk, Kanokvalai Kulthanan, Hilde Lapeere, Susanne Lau, Mariana Machado Forti Nastri, Michael Makris, Eli Mansour, Alexander Marsland, Mara Morelo Rocha Felix, Ana Paula Moschione Castro, Eustachio Nettis, J. F. Nicolas, Audrey Nosbaum, Mikaela Odemyr, Niki Papapostolou, Claudio A. S. Parisi, Sushil Paudel, Jonny Peter, Prakash Pokharel, Luis Puig, Tamara Quint, German Dario Ramon, Frederico Regateiro, Giampaolo Ricci, Cristine Rosario, Cansin Sackesen, Peter Schmid‐Grendelmeier, Esther Serra‐Baldrich, Kristina Siemens, Cathrine Smith, Petra Staubach, Katarina Stevanovic, Özlem Su‐Kücük, Gordon Sussman, Simona Tavecchio, Natasa Teovska Mitrevska, Diamant Thaci, Elias Toubi, Claudia Traidl‐Hoffmann, Regina Treudler, Zahava Vadasz, Ingrid vanHofman, Maria Teresa Ventura, Zhao Wang, Thomas Werfel, Andreas Wollenberg, Ariana Yang, Yik Weng Yew, Zuotao Zhao, Ricardo Zwiener, and Margitta Worm

Subjects
atopic dermatitis, eczema, guidance, ICP, integrated care pathways, multidisciplinary, Immunologic diseases. Allergy, RC581-607
Abstract

Abstract Introduction The integrated care pathways for atopic dermatitis (AD‐ICPs) aim to bridge the gap between existing AD treatment evidence‐based guidelines and expert opinion based on daily practice by offering a structured multidisciplinary plan for patient management of AD. ICPs have the potential to enhance guideline recommendations by combining interventions and aspects from different guidelines, integrating quality assurance, and describing co‐ordination of care. Most importantly, patients can enter the ICPs at any level depending on AD severity, resources available in their country, and economic factors such as differences in insurance reimbursement systems. Methods The GA2LEN ADCARE network and partners as well as all stakeholders, abbreviated as the AD‐ICPs working group, were involved in the discussion and preparation of the AD ICPs during a series of subgroup workshops and meetings in years 2020 and 2021, after which the document was circulated within all GAL2EN ADCARE centres. Results The AD‐ICPs outline the diagnostic procedures, possible co‐morbidities, different available treatment options including differential approaches for the pediatric population, and the role of the pharmacists and other stakeholders, as well as remaining unmet needs in the management of AD. Conclusion The AD‐ICPs provide a multidisciplinary plan for improved diagnosis, treatment, and patient feedback in AD management, as well as addressing critical unmet needs, including improved access to care, training specialists, implementation of educational programs, assessment on the impact of climate change, and fostering a personalised treatment approach. By focusing on these key areas, the initiative aims to pave the way for a brighter future in the management of AD.

Published
2023
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3. Long‐term safety and effectiveness of berotralstat for hereditary angioedema: The open‐label APeX‐S study

Author

Henriette Farkas, Marcin Stobiecki, Jonny Peter, Tamar Kinaciyan, Marcus Maurer, Emel Aygören‐Pürsün, Sorena Kiani‐Alikhan, Adrian Wu, Avner Reshef, Anette Bygum, Olivier Fain, David Hagin, Aarnoud Huissoon, Miloš Jeseňák, Karen Lindsay, Vesna Grivcheva Panovska, Urs C. Steiner, Celia Zubrinich, Jessica M. Best, Melanie Cornpropst, Daniel Dix, Sylvia M. Dobo, Heather A. Iocca, Bhavisha Desai, Sharon C. Murray, Eniko Nagy, and William P. Sheridan

Subjects
berotralstat, hereditary angioedema, long‐term, prophylaxis, safety, Immunologic diseases. Allergy, RC581-607
Abstract

Abstract Background Berotralstat (BCX7353) is an oral, once‐daily inhibitor of plasma kallikrein recently approved for prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE). The objective of this report is to summarize results from an interim analysis of an ongoing long‐term safety study of berotralstat in patients with HAE. Methods APeX‐S is an ongoing, phase 2, open‐label study conducted in 22 countries (ClinicalTrials.gov, NCT03472040). Eligible patients with a clinical diagnosis of HAE due to C1 inhibitor deficiency (HAE‐C1‐INH) were centrally allocated to receive berotralstat 150 or 110 mg once daily. The primary objective was to determine long‐term safety and the secondary objective was to evaluate effectiveness. Results Enrolled patients (N = 227) received berotralstat 150 mg (n = 127) or 110 mg (n = 100) once daily. The median (range) duration of exposure was 342 (11–540) and 307 (14–429) days for the 150‐mg and 110‐mg groups, respectively. Treatment‐emergent adverse events (TEAEs) occurred in 91% (n = 206) of patients. The most common TEAEs across treatment groups were upper respiratory tract infection (n = 91, 40%), abdominal pain (n = 57, 25%), headache (n = 40, 18%), and diarrhea (n = 31, 14%) and were mostly mild to moderate. Fifty percent (n = 113) of patients had at least one drug‐related adverse event (AE; 150 mg, n = 57 [45%]; 110 mg, n = 56 [56%]), and discontinuations due to AEs occurred in 19 (8%) patients (150 mg, n = 13 [10%]; 110 mg, n = 6 [6%]). Three (1.3%) patients experienced a drug‐related serious TEAE. Among patients who received berotralstat through 48 weeks (150 mg, n = 73; 110 mg, n = 30), median HAE attack rates were low in month 1 (150 mg, 1.0 attacks/month; 110 mg, 0.5 attacks/month) and remained low through 12 months (0 attacks/month in both dose groups). Mean HAE attack rates followed a similar trend, and no evidence for patient tolerance to berotralstat emerged. In both dose groups, angioedema quality of life scores showed clinically meaningful changes from baseline. Conclusions In this analysis, both berotralstat doses, 150 and 110 mg once daily, were generally well tolerated. Effectiveness results support the durability and robustness of berotralstat as prophylactic therapy in patients with HAE. Trial registration The study is registered with ClinicalTrials.gov (NCT03472040).

Published
2021
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4. Adrenaline autoinjector is underprescribed in typical cold urticaria patients

Author

Mojca Bizjak, Mitja Košnik, Dejan Dinevski, Simon Francis Thomsen, Daria Fomina, Elena Borzova, Kanokvalai Kulthanan, Raisa Meshkova, Fernando Monteiro Aarestrup, Dalia Melina Ahsan, Mona Al‐Ahmad, Sabine Altrichter, Andrea Bauer, Maxi Brockstädt, Célia Costa, Semra Demir, Roberta Fachini Criado, Luis Felipe Ensina, Asli Gelincik, Ana Maria Giménez‐Arnau, Margarida Gonçalo, Maia Gotua, Jesper Grønlund Holm, Naoko Inomata, Alicja Kasperska‐Zajac, Maryam Khoshkhui, Aliya Klyucharova, Emek Kocatürk, Rongbiao Lu, Michael Makris, Natalya Maltseva, Maria Pasali, Marisa Paulino, David Pesqué, Jonny Peter, German Dario Ramón, Carla Ritchie, Solange Oliveira Rodrigues Valle, Michael Rudenko, Agnieszka Sikora, Nicola Wagner, Paraskevi Xepapadaki, Xiaoyang Xue, Zuotao Zhao, Dorothea Terhorst‐Molawi, and Marcus Maurer

Subjects
Epinephrine, Urticaria, adrenaline autoinjector, Cold-induced anaphylaxis, Immunology, cold urticaria, Cold Temperature, COLD-CE, cold-induced anaphylaxis, Cold urticaria, Immunology and Allergy, Humans, Adrenaline autoinjector, Anaphylaxis
Published
2022

5. Long‐term safety and effectiveness of berotralstat for hereditary angioedema: The open‐label APeX‐S study

Author

David Hagin, Emel Aygören-Pürsün, Aarnoud Huissoon, Olivier Fain, Marcus Maurer, Sorena Kiani-Alikhan, William P. Sheridan, Urs C. Steiner, Marcin Stobiecki, Adrian Wu, Melanie Cornpropst, Bhavisha Desai, Avner Reshef, Sylvia Dobo, Celia Zubrinich, Anette Bygum, Henriette Farkas, Jonny Peter, Eniko Nagy, Heather Iocca, Jessica M. Best, Daniel Dix, Vesna Grivcheva Panovska, Tamar Kinaciyan, S. Murray, Miloš Jeseňák, Karen Lindsay, University of Zurich, Sheridan, William P, Semmelweis University [Budapest], Uniwersytet Jagielloński w Krakowie = Jagiellonian University (UJ), University of Cape Town, University of Vienna [Vienna], Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Goethe-University Frankfurt am Main, Royal Free Hospital [London, UK], The University of Hong Kong (HKU), Barzilai Medical Center, University of Southern Denmark (SDU), Service de médecine interne [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Tel Aviv University [Tel Aviv], University Hospitals Birmingham [Birmingham, Royaume-Uni], Comenius University in Bratislava, University of Auckland [Auckland], Ss. Cyril and Methodius University in Skopje, University hospital of Zurich [Zurich], Melbourne School of Health Sciences [Melbourne], Faculty of Medicine, Dentistry and Health Sciences [Melbourne], University of Melbourne-University of Melbourne, and BioCryst Pharmaceuticals

Subjects
safety, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Abdominal pain, Immunology, 610 Medicine & health, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Internal medicine, medicine, Immunology and Allergy, Adverse effect, long-term, 2403 Immunology, Angioedema, business.industry, Research, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, RC581-607, medicine.disease, Interim analysis, berotralstat, hereditary angioedema, 3. Good health, Diarrhea, Upper respiratory tract infection, 030228 respiratory system, 2740 Pulmonary and Respiratory Medicine, Hereditary angioedema, 10033 Clinic for Immunology, 2723 Immunology and Allergy, long‐term, prophylaxis, Immunologic diseases. Allergy, medicine.symptom, business
Abstract

Background: Berotralstat (BCX7353) is an oral, once-daily inhibitor of plasma kallikrein recently approved for prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE). The objective of this report is to summarize results from an interim analysis of an ongoing long-term safety study of berotralstat in patients with HAE. Methods: APeX-S is an ongoing, phase 2, open-label study conducted in 22 countries (ClinicalTrials.gov, NCT03472040). Eligible patients with a clinical diagnosis of HAE due to C1 inhibitor deficiency (HAE-C1-INH) were centrally allocated to receive berotralstat 150 or 110 mg once daily. The primary objective was to determine long-term safety and the secondary objective was to evaluate effectiveness. Results: Enrolled patients (N = 227) received berotralstat 150 mg (n = 127) or 110 mg (n = 100) once daily. The median (range) duration of exposure was 342 (11–540) and 307 (14–429) days for the 150-mg and 110-mg groups, respectively. Treatment-emergent adverse events (TEAEs) occurred in 91% (n = 206) of patients. The most common TEAEs across treatment groups were upper respiratory tract infection (n = 91, 40%), abdominal pain (n = 57, 25%), headache (n = 40, 18%), and diarrhea (n = 31, 14%) and were mostly mild to moderate. Fifty percent (n = 113) of patients had at least one drug-related adverse event (AE; 150 mg, n = 57 [45%]; 110 mg, n = 56 [56%]), and discontinuations due to AEs occurred in 19 (8%) patients (150 mg, n = 13 [10%]; 110 mg, n = 6 [6%]). Three (1.3%) patients experienced a drug-related serious TEAE. Among patients who received berotralstat through 48 weeks (150 mg, n = 73; 110 mg, n = 30), median HAE attack rates were low in month 1 (150 mg, 1.0 attacks/month; 110 mg, 0.5 attacks/month) and remained low through 12 months (0 attacks/month in both dose groups). Mean HAE attack rates followed a similar trend, and no evidence for patient tolerance to berotralstat emerged. In both dose groups, angioedema quality of life scores showed clinically meaningful changes from baseline. Conclusions: In this analysis, both berotralstat doses, 150 and 110 mg once daily, were generally well tolerated. Effectiveness results support the durability and robustness of berotralstat as prophylactic therapy in patients with HAE. Trial registration: The study is registered with ClinicalTrials.gov (NCT03472040).

Published
2021

6. GenoType® MTBDRsl assay for resistance to second-line anti-tuberculosis drugs

Author

Keertan Dheda, Rob Warren, Karen R Steingart, Marty Richardson, Grant Theron, and Jonny Peter

Subjects
0301 basic medicine, medicine.medical_specialty, Pathology, Tuberculosis, biology, business.industry, Cross-sectional study, 030106 microbiology, Drug resistance, medicine.disease, biology.organism_classification, Confidence interval, 03 medical and health sciences, Anti tuberculosis, Second line, Mycobacterium tuberculosis complex, Internal medicine, Genotype, Medicine, Pharmacology (medical), business
Abstract

Background Genotype® MTBDRsl (MTBDRsl) is a rapid DNA-based test for detecting specific mutations associated with resistance to fluoroquinolones and second-line injectable drugs (SLIDs) in Mycobacterium tuberculosis complex. MTBDRsl version 2.0 (released in 2015) identifies the mutations detected by version 1.0, as well as additional mutations. The test may be performed on a culture isolate or a patient specimen, which eliminates delays associated with culture. Version 1.0 requires a smear-positive specimen, while version 2.0 may use a smear-positive or -negative specimen. We performed this updated review as part of a World Health Organization process to develop updated guidelines for using MTBDRsl. Objectives To assess and compare the diagnostic accuracy of MTBDRsl for: 1. fluoroquinolone resistance, 2. SLID resistance, and 3. extensively drug-resistant tuberculosis, indirectly on a M. tuberculosis isolate grown from culture or directly on a patient specimen. Participants were people with rifampicin-resistant or multidrug-resistant tuberculosis. The role of MTBDRsl would be as the initial test, replacing culture-based drug susceptibility testing (DST), for detecting second-line drug resistance. Search methods We searched the following databases without language restrictions up to 21 September 2015: the Cochrane Infectious Diseases Group Specialized Register; MEDLINE; Embase OVID; Science Citation Index Expanded, Conference Proceedings Citation Index-Science, and BIOSIS Previews (all three from Web of Science); LILACS; and SCOPUS; registers for ongoing trials; and ProQuest Dissertations & Theses A&I. We reviewed references from included studies and contacted specialists in the field. Selection criteria We included cross-sectional and case-control studies that determined MTBDRsl accuracy against a defined reference standard (culture-based DST, genetic sequencing, or both). Data collection and analysis Two review authors independently extracted data and assessed quality using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. We synthesized data for versions 1.0 and 2.0 separately. We estimated MTBDRsl sensitivity and specificity for fluoroquinolone resistance, SLID resistance, and extensively drug-resistant tuberculosis when the test was performed indirectly or directly (smear-positive specimen for version 1.0, smear-positive or -negative specimen for version 2.0). We explored the influence on accuracy estimates of individual drugs within a drug class and of different reference standards. We performed most analyses using a bivariate random-effects model with culture-based DST as reference standard. Main results We included 27 studies. Twenty-six studies evaluated version 1.0, and one study version 2.0. Of 26 studies stating specimen country origin, 15 studies (58%) evaluated patients from low- or middle-income countries. Overall, we considered the studies to be of high methodological quality. However, only three studies (11%) had low risk of bias for the reference standard; these studies used World Health Organization (WHO)-recommended critical concentrations for all drugs in the culture-based DST reference standard. MTBDRsl version 1.0 Fluoroquinolone resistance: indirect testing, MTBDRsl pooled sensitivity and specificity (95% confidence interval (CI)) were 85.6% (79.2% to 90.4%) and 98.5% (95.7% to 99.5%), (19 studies, 2223 participants); direct testing (smear-positive specimen), pooled sensitivity and specificity were 86.2% (74.6% to 93.0%) and 98.6% (96.9% to 99.4%), (nine studies, 1771 participants, moderate quality evidence). SLID resistance: indirect testing, MTBDRsl pooled sensitivity and specificity were 76.5% (63.3% to 86.0%) and 99.1% (97.3% to 99.7%), (16 studies, 1921 participants); direct testing (smear-positive specimen), pooled sensitivity and specificity were 87.0% (38.1% to 98.6%) and 99.5% (93.6% to 100.0%), (eight studies, 1639 participants, low quality evidence). Extensively drug-resistant tuberculosis: indirect testing, MTBDRsl pooled sensitivity and specificity were 70.9% (42.9% to 88.8%) and 98.8% (96.1% to 99.6%), (eight studies, 880 participants); direct testing (smear-positive specimen), pooled sensitivity and specificity were 69.4% (38.8% to 89.0%) and 99.4% (95.0% to 99.3%), (six studies, 1420 participants, low quality evidence). Similar to the original Cochrane review, we found no evidence of a significant difference in MTBDRsl version 1.0 accuracy between indirect and direct testing for fluoroquinolone resistance, SLID resistance, and extensively drug-resistant tuberculosis. MTBDRsl version 2.0 Fluoroquinolone resistance: direct testing, MTBDRsl sensitivity and specificity were 97% (83% to 100%) and 98% (93% to 100%), smear-positive specimen; 80% (28% to 99%) and 100% (40% to 100%), smear-negative specimen. SLID resistance: direct testing, MTBDRsl sensitivity and specificity were 89% (72% to 98%) and 90% (84% to 95%), smear-positive specimen; 80% (28% to 99%) and 100% (40% to 100%), smear-negative specimen. Extensively drug-resistant tuberculosis: direct testing, MTBDRsl sensitivity and specificity were 79% (49% to 95%) and 97% (93% to 99%), smear-positive specimen; 50% (1% to 99%) and 100% (59% to 100%), smear-negative specimen. We had insufficient data to estimate summary sensitivity and specificity of version 2.0 (smear-positive and -negative specimens) or to compare accuracy of the two versions. A limitation was that most included studies did not consistently use the World Health Organization (WHO)-recommended concentrations for drugs in the culture-based DST reference standard. Authors' conclusions In people with rifampicin-resistant or multidrug-resistant tuberculosis, MTBDRsl performed on a culture isolate or smear-positive specimen may be useful in detecting second-line drug resistance. MTBDRsl (smear-positive specimen) correctly classified around six in seven people as having fluoroquinolone or SLID resistance, although the sensitivity estimates for SLID resistance varied. The test rarely gave a positive result for people without drug resistance. However, when second-line drug resistance is not detected (MTBDRsl result is negative), conventional DST can still be used to evaluate patients for resistance to the fluoroquinolones or SLIDs. We recommend that future work evaluate MTBDRsl version 2.0, in particular on smear-negative specimens and in different settings to account for different resistance-causing mutations that may vary by strain. Researchers should also consider incorporating WHO-recommended critical concentrations into their culture-based reference standards.

Published
2016

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