المؤلفون: Sushma Kavikondala, Katrin Haeussler, Xuan Wang, Mary T. Bausch-Jurken, Maria Nassim, Nitendra Kumar Mishra, Mia Malmenäs, Pawana Sharma, Nicolas Van de Velde, Nathan Green, Ekkehard Beck

المصدر: Infectious Diseases and Therapy, Vol 13, Iss 4, Pp 779-811 (2024)

مصطلحات موضوعية: BNT162b2, COVID-19, Effectiveness, mRNA-1273, mRNA vaccine, Older adults, Infectious and parasitic diseases, RC109-216

الوصف: Abstract Introduction The mRNA vaccines mRNA-1273 and BNT162b2 demonstrated high efficacy against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in phase 3 clinical trials, including among older adults. To inform coronavirus disease 2019 (COVID-19) vaccine selection, this systematic literature review (SLR) and meta-analysis assessed the comparative effectiveness of mRNA-1273 versus BNT162b2 in older adults. Methods We systematically searched for relevant studies reporting COVID-19 outcomes with mRNA vaccines in older adults aged ≥ 50 years by first cross-checking relevant published SLRs. Based on the cutoff date from a previous similar SLR, we then searched the WHO COVID-19 Research Database for relevant articles published between April 9, 2022, and June 2, 2023. Outcomes of interest were SARS-CoV-2 infection, symptomatic SARS-CoV-2 infection, severe SARS-CoV-2 infection, COVID-19–related hospitalization, and COVID-19–related death following ≥ 2 vaccine doses. Random effects meta-analysis models were used to pool risk ratios (RRs) across studies. Heterogeneity was evaluated using chi-square testing. Evidence certainty was assessed per GRADE framework. Results Twenty-four non-randomized real-world studies reporting clinical outcomes with mRNA vaccines in individuals aged ≥ 50 years were included in the meta-analysis. Vaccination with mRNA-1273 was associated with significantly lower risk of SARS-CoV-2 infection (RR 0.72 [95% confidence interval (CI) 0.64‒0.80]), symptomatic SARS-CoV-2 infection (RR 0.72 [95% CI 0.62‒0.83]), severe SARS-CoV-2 infection (RR 0.67 [95% CI 0.57‒0.78]), and COVID-19–related hospitalization (RR 0.65 [95% CI 0.53‒0.79]) but not COVID-19–related death (RR 0.80 [95% CI 0.64‒1.00]) compared with BNT162b2. There was considerable heterogeneity between studies for all outcomes (I 2 > 75%) except death (I 2 = 0%). Multiple subgroup and sensitivity analyses excluding specific studies generally demonstrated consistent results. Certainty of evidence across outcomes was rated as low (type 3) or very low (type 4), reflecting the lack of randomized controlled trial data. Conclusion Meta-analysis of 24 observational studies demonstrated significantly lower risk of asymptomatic, symptomatic, and severe infections and hospitalizations with the mRNA-1273 versus BNT162b2 vaccine in older adults aged ≥ 50 years.

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/2193-8229Test; https://doaj.org/toc/2193-6382Test

الوصول الحر: https://doaj.org/article/fa1a755929ba4b9fab28366c3f6e5de5Test

المؤلفون: Joan Mendivil, Mia Malmenäs, Katrin Haeussler, Matthias Hunger, Gagan Jain, Giovanna Devercelli

المصدر: Drugs in R&D, Vol 21, Iss 1, Pp 113-121 (2021)

مصطلحات موضوعية: Therapeutics. Pharmacology, RM1-950

الوصف: Abstract Background Hereditary angioedema (HAE) with C1-esterase inhibitor (C1-INH) deficiency is a rare disease associated with painful, potentially fatal swelling episodes affecting subcutaneous or submucosal tissues. HAE attacks recur with unpredictable severity and frequency throughout patients’ lives; long-term prophylaxis is essential for some patients. In the absence of head-to-head studies, indirect treatment comparison (ITC) of long-term prophylactic agents is a valid approach to evaluate comparative efficacy. Methods We conducted an ITC using data from the placebo-controlled HELP study (assessing patients receiving lanadelumab 300 mg every 2 or 4 weeks) and the 12-week, parallel arm, crossover CHANGE study (assessing intravenous C1-INH). Outcomes of interest were attack rate ratio (ARR) and time to attack after day 0 (TTA0) and after day 70 (TTA70). Two ITC methodologies were used: a Bayesian approach using study results to update non-informative prior distributions to posterior distributions on relative treatment effects, and a frequentist approach using patient-level data from HELP and CHANGE to generate Poisson regressions (for ARR) and Cox models (for TTA0 and TT70). Results Both Bayesian and frequentist analyses suggested that lanadelumab reduced HAE attack rate by 46–73% versus intravenous C1-INH. Relative to intravenous C1-INH, risk of first attack after day 0 was comparable between intravenous C1-INH and both lanadelumab doses; risk of first attack after day 70 was reduced by 81–83% with lanadelumab 300 mg every 2 weeks, compared with C1-INH. Conclusions Findings from these two ITC methodologies support the favorable efficacy of lanadelumab in reducing the HAE attack rate and extending attack-free intervals in patients with HAE.

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/1174-5886Test; https://doaj.org/toc/1179-6901Test

الوصول الحر: https://doaj.org/article/a5a91c96dc2d4abf9f7858c9f06f3c2aTest

المؤلفون: Jennifer Eriksson, Mayur Amonkar, Gemma Al-Jassar, Jeremy Lambert, Mia Malmenäs, Monica Chase, Lucy Sun, Linda Kollmar, Michelle Vichnin

المصدر: Journal of Clinical Medicine, Vol 8, Iss 4, p 558 (2019)

مصطلحات موضوعية: colorectal cancer, survey, mismatch repair/microsatellite instability testing, Medicine

الوصف: The study objective was to assess US physicians’ Mismatch Repair/Microsatellite Instability (MMR/MSI) testing practices for metastatic colorectal cancer (mCRC) patients. A non-interventional, cross-sectional online survey was conducted among 151 physicians (91 oncologists, 15 surgeons and 45 pathologists) treating mCRC patients in the US. Eligible physicians were US-based with at least 5 years of experience treating CRC patients, had at least one mCRC patient in their routine care in the past 6 months, and had ordered at least one MMR/MSI test for CRC in the past 6 months. Descriptive and logistic regression analyses were performed. Awareness of specific MMR/MSI testing guidelines was high (n = 127, 84.1%). Of those, 93.7% (119/127) physicians had awareness of specific published guidelines with majority 67.2% (80/119) being aware of National Comprehensive Cancer Network (NCCN) guidelines. Universal testing for all CRC patients was performed by 68.9% (104/151) physicians, while 29.8% (45/151) selectively order the test for some CRC patients. Key barriers for testing included insufficient tissue sample (48.3%, 73/151), patient declined to have the test done (35.8%, 54/151) and insurance cost concerns for patients (31.1%, 47/151), while 27.2% (41/151) reported no barriers. The survey demonstrated high awareness and compliance with MMR/MSI testing guidelines although universal testing rates seem to be suboptimal.

وصف الملف: electronic resource

العلاقة: https://www.mdpi.com/2077-0383/8/4/558Test; https://doaj.org/toc/2077-0383Test

الوصول الحر: https://doaj.org/article/ba01c7e1b0154b08bec2345f387a5b01Test

المؤلفون: Afisi S. Ismaila, Katrin Haeussler, Mia Malmenäs, Raj Sharma, Chris Compton, Claus F. Vogelmeier, MeiLan K. Han, David M. G. Halpin

المصدر: Advances in Therapy. 40:2556-2561

مصطلحات موضوعية: Pharmacology (medical), General Medicine

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::a28c59a042515d71ddc239404256aa4bTest
https://doi.org/10.1007/s12325-023-02495-0Test

المؤلفون: Afisi S. Ismaila, Katrin Haeussler, Alexandrosz Czira, Ji-Hee Youn, Mia Malmenäs, Nancy A. Risebrough, Jatin Agarwal, Maria Nassim, Raj Sharma, Chris Compton, Claus F. Vogelmeier, MeiLan K. Han, David M. G. Halpin

المصدر: Advances in Therapy. 39:3957-3978

مصطلحات موضوعية: Adult, Quinuclidines, Network Meta-Analysis, Muscarinic Antagonists, General Medicine, Chlorobenzenes, Bronchodilator Agents, Androstadienes, Drug Combinations, Pulmonary Disease, Chronic Obstructive, Adrenal Cortex Hormones, Administration, Inhalation, Budesonide, Formoterol Fumarate Drug Combination, Fluticasone, Humans, Pharmacology (medical), Benzyl Alcohols

الوصف: Randomized controlled trials (RCTs) comparing triple therapies (inhaled corticosteroid [ICS], long-acting βThis NMA was conducted on the basis of a systematic literature review (SLR), which identified RCTs in adults aged at least 40 years with COPD. The RCTs compared different ICS/LABA/LAMA combinations or an ICS/LABA/LAMA combination with any dual therapy (ICS/LABA or LAMA/LABA). Outcomes of interest included forced expiratory volume in 1 s (FEVThe NMA was informed by five trials reporting FEVThe findings of this NMA suggest favorable efficacy with single-inhaler triple therapy comprising FF/UMEC/VI. Further analysis is required as additional evidence becomes available.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::180a1885fc8a3e1ac1f7f5e7ce63d963Test
https://doi.org/10.1007/s12325-022-02231-0Test

المؤلفون: Afisi S. Ismaila, Katrin Haeussler, Alexandrosz Czira, Vanita Tongbram, Mia Malmenäs, Jatin Agarwal, Maria Nassim, Marija Živković-Gojović, Yunrong Shen, Xinzhe Dong, Maria Duarte, Chris Compton, Claus F. Vogelmeier, David M. G. Halpin

المصدر: Advances in Therapy. 39:5011-5012

مصطلحات موضوعية: Pharmacology (medical), General Medicine

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::b3676300842b29072cd0a7de8a247a09Test
https://doi.org/10.1007/s12325-022-02288-xTest

المؤلفون: Afisi S. Ismaila, Katrin Haeussler, Alexandrosz Czira, Vanita Tongbram, Mia Malmenäs, Jatin Agarwal, Maria Nassim, Marija Živković-Gojović, Yunrong Shen, Xinzhe Dong, Maria Duarte, Chris Compton, Claus F. Vogelmeier, David M. G. Halpin

المصدر: Advances in therapy. 39(11)

مصطلحات موضوعية: Adult, Quinuclidines, Network Meta-Analysis, General Medicine, Muscarinic Antagonists, Chlorobenzenes, Glycopyrrolate, Bronchodilator Agents, Drug Combinations, Pulmonary Disease, Chronic Obstructive, Dyspnea, Treatment Outcome, Forced Expiratory Volume, Administration, Inhalation, Humans, Pharmacology (medical), Tiotropium Bromide, Adrenergic beta-2 Receptor Agonists, Salmeterol Xinafoate, Benzyl Alcohols

الوصف: Few randomised controlled trials (RCTs) have directly compared long-acting muscarinic antagonist/long-acting βA systematic literature review (October 2015-November 2020) was performed to identify RCTs ≥ 8 weeks long in adult patients with COPD that compared LAMA/LABA combinations against any long-acting bronchodilator-containing dual therapy or monotherapy. Data extracted on changes from baseline in trough forced expiratory volume in 1 s (FEVThe NMA included 69 full-length publications (including 10 GSK clinical study reports) reporting 49 studies. At 24 weeks, UMEC/VI provided statistically significant greater improvements in FEVUMEC/VI provided generally better outcomes compared with LAMA or LABA monotherapies, and consistent improvements in lung function (measured by change from baseline in trough FEVBronchodilators are medicines that open the airways, allowing patients with chronic obstructive pulmonary disease (COPD) to breathe more easily. There are two different types of bronchodilators, namely long-acting muscarinic antagonists (LAMAs) and long-acting β

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0ac9983a0408e6b91a448ca96b9b9a9aTest
https://pubmed.ncbi.nlm.nih.gov/36056291Test

المؤلفون: Jérémy Lambert, Gemma Al-Jassar, Lucy Sun, Mayur Amonkar, Linda Kollmar, Mia Malmenäs, Jennifer Eriksson, Michelle Vichnin, Monica Chase

المصدر: Current Medical Research and Opinion. 36:1355-1361

مصطلحات موضوعية: Adult, Oncology, congenital, hereditary, and neonatal diseases and abnormalities, medicine.medical_specialty, Colorectal cancer, 030204 cardiovascular system & hematology, DNA Mismatch Repair, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, 030212 general & internal medicine, Neoplasm Metastasis, neoplasms, Aged, business.industry, Microsatellite instability, General Medicine, Middle Aged, medicine.disease, digestive system diseases, Cross-Sectional Studies, Microsatellite Instability, DNA mismatch repair, Colorectal Neoplasms, business

الوصف: Objective: We assessed knowledge and awareness of MMR/MSI testing among advanced/metastatic CRC patients in the US who had previously taken the test.Methods: A non-interventional, cross-sectional o...

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9d5dc8ec1b0f9890994ee24fc9fd86c3Test
https://doi.org/10.1080/03007995.2020.1776235Test

المؤلفون: Giovanna Devercelli, Mia Malmenäs, Joan Mendivil, Gagan Jain, Matthias Hunger, Katrin Haeussler

المصدر: Drugs in R&D
Drugs in R&D, Vol 21, Iss 1, Pp 113-121 (2021)

مصطلحات موضوعية: medicine.medical_specialty, Injections, Subcutaneous, Bayesian probability, Attack rate, Lanadelumab, Antibodies, Monoclonal, Humanized, 030226 pharmacology & pharmacy, Drug Administration Schedule, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Frequentist inference, Internal medicine, medicine, Humans, Poisson Distribution, Original Research Article, Randomized Controlled Trials as Topic, 030203 arthritis & rheumatology, Pharmacology, Cross-Over Studies, Proportional hazards model, business.industry, lcsh:RM1-950, Angioedemas, Hereditary, Bayes Theorem, medicine.disease, lcsh:Therapeutics. Pharmacology, Treatment Outcome, Clinical Trials, Phase III as Topic, Hereditary angioedema, Administration, Intravenous, Kallikreins, business, Complement C1 Inhibitor Protein, Monte Carlo Method, Rare disease

الوصف: Background Hereditary angioedema (HAE) with C1-esterase inhibitor (C1-INH) deficiency is a rare disease associated with painful, potentially fatal swelling episodes affecting subcutaneous or submucosal tissues. HAE attacks recur with unpredictable severity and frequency throughout patients’ lives; long-term prophylaxis is essential for some patients. In the absence of head-to-head studies, indirect treatment comparison (ITC) of long-term prophylactic agents is a valid approach to evaluate comparative efficacy. Methods We conducted an ITC using data from the placebo-controlled HELP study (assessing patients receiving lanadelumab 300 mg every 2 or 4 weeks) and the 12-week, parallel arm, crossover CHANGE study (assessing intravenous C1-INH). Outcomes of interest were attack rate ratio (ARR) and time to attack after day 0 (TTA0) and after day 70 (TTA70). Two ITC methodologies were used: a Bayesian approach using study results to update non-informative prior distributions to posterior distributions on relative treatment effects, and a frequentist approach using patient-level data from HELP and CHANGE to generate Poisson regressions (for ARR) and Cox models (for TTA0 and TT70). Results Both Bayesian and frequentist analyses suggested that lanadelumab reduced HAE attack rate by 46–73% versus intravenous C1-INH. Relative to intravenous C1-INH, risk of first attack after day 0 was comparable between intravenous C1-INH and both lanadelumab doses; risk of first attack after day 70 was reduced by 81–83% with lanadelumab 300 mg every 2 weeks, compared with C1-INH. Conclusions Findings from these two ITC methodologies support the favorable efficacy of lanadelumab in reducing the HAE attack rate and extending attack-free intervals in patients with HAE. Supplementary Information The online version contains supplementary material available at 10.1007/s40268-021-00337-4.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4cbb9dd6eea0a700e2f7005f2ebdb4bcTest
https://pubmed.ncbi.nlm.nih.gov/33646565Test

المؤلفون: Maureen Watt, Mia Malmenas, Katrin Haeussler

المصدر: Journal of Comparative Effectiveness Research, Vol 13, Iss 5 (2024)

مصطلحات موضوعية: berotralstat, comparative effectiveness, hereditary angioedema, indirect treatment comparison, lanadelumab, prophylaxis, Public aspects of medicine, RA1-1270

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/2042-6313Test

الوصول الحر: https://doaj.org/article/0f84a52f5f454695a2268ec5ca4094d6Test