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Article ; Online: Signal-to-noise ratio to assess magnitude, kinetics and impact on pharmacokinetics of the immune response to an adalimumab biosimilar.

Guerrieri, Davide / Horvat, Matej / Fan, Jamie / Wang, Jessie / Lemke, Lena / Richter, Oliver von / Poetzl, Johann

Bioanalysis

2023 Volume 16, Issue 1, Page(s) 33–48

Abstract: Background: ...

Abstract	Background:
MeSH term(s)	Humans ; Adalimumab/pharmacokinetics ; Biosimilar Pharmaceuticals ; Signal-To-Noise Ratio ; Double-Blind Method ; Antibodies ; Immunity
Chemical Substances	Adalimumab (FYS6T7F842) ; Biosimilar Pharmaceuticals ; Antibodies
Language	English
Publishing date	2023-11-30
Publishing country	England
Document type	Journal Article
ISSN	1757-6199
ISSN (online)	1757-6199
DOI	10.4155/bio-2023-0152
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Article: Prognostic Value of

Ruscica, Massimiliano / Macchi, Chiara / Gandini, Sara / Macis, Debora / Guerrieri-Gonzaga, Aliana / Aristarco, Valentina / Serrano, Davide / Lazzeroni, Matteo / Rizzuto, Alessandra Stefania / Gaeta, Aurora / Corsini, Alberto / Gulisano, Marcella / Johansson, Harriet / Bonanni, Bernardo

Cancers

2024 Volume 16, Issue 7

Abstract: Background and aim: The involvement of cholesterol in cancer development remains a topic of debate, and its association with breast cancer has yet to be consistently demonstrated. Considering that circulating cholesterol levels depend on several ... ...

Abstract	Background and aim: The involvement of cholesterol in cancer development remains a topic of debate, and its association with breast cancer has yet to be consistently demonstrated. Considering that circulating cholesterol levels depend on several concomitant processes, we tested the liability of plasma levels of proprotein convertase subtilisin/kexin type 9 ( Methods: Within a prospective randomized breast cancer prevention trial we measured baseline plasma levels of Results: The plasmatic Conclusions: In premenopausal women at risk of early-stage breast cancer,
Language	English
Publishing date	2024-04-04
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers16071411
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Article ; Online: In vitro characterization of new psychoactive substances at the μ-opioid, CB1, 5HT

Åstrand, Anna / Guerrieri, Davide / Vikingsson, Svante / Kronstrand, Robert / Green, Henrik

Forensic science international

2020 Volume 317, Page(s) 110553

Abstract: New psychoactive substances (NPS) appear on the recreational market on a monthly basis, with unclear toxicology, resulting in an increasing number of fatalities. Identification of drug targets and potencies is crucial for understanding and treating ... ...

Abstract	New psychoactive substances (NPS) appear on the recreational market on a monthly basis, with unclear toxicology, resulting in an increasing number of fatalities. Identification of drug targets and potencies is crucial for understanding and treating intoxications and for scheduling processes. In this study 60 NPS and metabolites belonging to opioids, cannabinoids and serotonergic hallucinogens classes were screened for in vitro activation of the μ-opioid, CB1, 5-HT
MeSH term(s)	Analgesics, Opioid/pharmacology ; Cell Line ; Dose-Response Relationship, Drug ; Fentanyl/analogs & derivatives ; Fentanyl/pharmacology ; Humans ; Psychotropic Drugs/pharmacology ; Receptor, Cannabinoid, CB1/drug effects ; Receptor, Serotonin, 5-HT2A/drug effects ; Receptors, Opioid, mu/drug effects ; Receptors, Serotonin/drug effects
Chemical Substances	Analgesics, Opioid ; Psychotropic Drugs ; Receptor, Cannabinoid, CB1 ; Receptor, Serotonin, 5-HT2A ; Receptors, Opioid, mu ; Receptors, Serotonin ; serotonin 5 receptor ; Fentanyl (UF599785JZ)
Language	English
Publishing date	2020-10-23
Publishing country	Ireland
Document type	Journal Article
ZDB-ID	424042-x
ISSN	1872-6283 ; 0379-0738
ISSN (online)	1872-6283
ISSN	0379-0738
DOI	10.1016/j.forsciint.2020.110553
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Article ; Online: GP2017-HCF, a high concentration formulation, demonstrates similar pharmacokinetics, immunogenicity and safety to GP2017, an approved adalimumab biosimilar.

von Richter, Oliver / O'Reilly, Terry / Guerrieri, Davide / Fan, Jamie / Fey, Constanze / Schussler, Steven / Furlan, Fabricio / Lemke, Lena

Expert opinion on biological therapy

2022 Volume 23, Issue 8, Page(s) 749–758

Abstract: Background: GP2017 is an adalimumab biosimilar. The objective of this study is to compare the pharmacokinetics (PK) of GP2017 in its approved formulation and GP2017-high concentration formulation (HCF) in a randomized, double-blind, two-arm PK bridging ... ...

Abstract	Background: GP2017 is an adalimumab biosimilar. The objective of this study is to compare the pharmacokinetics (PK) of GP2017 in its approved formulation and GP2017-high concentration formulation (HCF) in a randomized, double-blind, two-arm PK bridging study. Research design and methods: Healthy male subjects received a single 40 mg subcutaneous injection of either GP2017-HCF (n = 162) or GP2017 (n = 168). PK, safety, and immunogenicity were assessed over 72 days post-injection. Results: The 90% confidence intervals [CIs] of geometric mean ratios between GP2017-HCF and GP2017 for C Conclusion: Results show PK comparability between GP2017-HCF and GP2017 and comparable safety and tolerability.
Language	English
Publishing date	2022-08-30
Publishing country	England
Document type	Journal Article
ZDB-ID	2052501-1
ISSN	1744-7682 ; 1471-2598
ISSN (online)	1744-7682
ISSN	1471-2598
DOI	10.1080/14712598.2022.2117546
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Article ; Online: Response to Braillon.

Bonanni, Bernardo / Serrano, Davide / Maisonneuve, Patrick / Lazzeroni, Matteo / Brown, Powel H / Guerrieri-Gonzaga, Aliana / Szabo, Eva

JNCI cancer spectrum

2021 Volume 5, Issue 1

Language	English
Publishing date	2021-01-23
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Comment
ISSN	2515-5091
ISSN (online)	2515-5091
DOI	10.1093/jncics/pkab005
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Article ; Online: Fenretinide in young women at genetic or familial risk of breast cancer: A placebo-controlled biomarker trial.

Aristarco, Valentina / Serrano, Davide / Maisonneuve, Patrick / Guerrieri-Gonzaga, Aliana / Lazzeroni, Matteo / Feroce, Irene / Macis, Debora / Cavadini, Elena / Albertazzi, Elena / Jemos, Costantino / Omodeo Salè, Emanuela / Cortesi, Laura / Massarut, Samuele / Gulisano, Marcella / Daidone, Maria Grazia / Johansson, Harriet / Bonanni, Bernardo

Cancer prevention research (Philadelphia, Pa.)

2024

Abstract: Fenretinide, a retinoid with a low toxicity profile that accumulates in the breast, has been shown to prevent second breast cancer in young women. Fenretinide exhibits apoptotic and anti-invasive properties and it improves insulin sensitivity in ... ...

Abstract	Fenretinide, a retinoid with a low toxicity profile that accumulates in the breast, has been shown to prevent second breast cancer in young women. Fenretinide exhibits apoptotic and anti-invasive properties and it improves insulin sensitivity in overweight premenopausal women with insulin resistance. The present study aimed to further characterize its role in cancer prevention by measuring circulating biomarkers related to insulin sensitivity and breast cancer risk. Sixty-two women, aged 20 to 46 years, healthy or who had already undergone breast cancer surgery, with a known BRCA1/2 mutation or a likelihood of mutation ≥ 20% according to the BRCAPRO model, were randomly assigned to receive fenretinide (200 mg/day) or placebo for 5 years (trial registration: EudraCT Number: 2009-010260-41). Fasting blood samples were drawn at baseline, 12 and 36 months, and the following biomarkers were analyzed: retinol, leptin, adiponectin, retinol-binding protein 4, total cholesterol, HDL and LDL cholesterol, triglycerides, glucose, insulin, IGF-I, IGFBP-3, SHBG, testosterone, and VEGF. After 12 months of treatment, we observed a favorable effect of fenretinide on glucose (decrease; P=0.005), insulin (decrease; P=0.03), HOMA index (decrease; P=0.004), HDL cholesterol (increase; P=0.002), even though these effects were less prominent after 36 months. Retinol and retinol-binding protein 4 markedly decreased (P<0.0001) throughout the study. None of the other measured biomarkers changed.
Language	English
Publishing date	2024-03-26
Publishing country	United States
Document type	Journal Article
ZDB-ID	2434717-6
ISSN	1940-6215 ; 1940-6207
ISSN (online)	1940-6215
ISSN	1940-6207
DOI	10.1158/1940-6207.CAPR-23-0422
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Article: Human Papillomavirus Genotype Richness and the Biodiversity of Squamous and Glandular Cervical Dysplasias: A Cross-Sectional Study.

Gozzini, Elisa / Radice, Davide / Bottari, Fabio / Boveri, Sara / Guerrieri, Maria Elena / Preti, Eleonora Petra / Spolti, Noemi / Ghioni, Mariacristina / Ferrari, Federico / Iacobone, Anna Daniela

Pathogens (Basel, Switzerland)

2023 Volume 12, Issue 10

Abstract: The impact of multiple infections on the risk of cervical lesions is a subject of ongoing debate. This study aims to explore whether the richness of HPV genotype infections and the biodiversity of squamous and glandular cervical dysplasias could ... ...

Abstract	The impact of multiple infections on the risk of cervical lesions is a subject of ongoing debate. This study aims to explore whether the richness of HPV genotype infections and the biodiversity of squamous and glandular cervical dysplasias could influence the progression of precancerous lesions. We conducted a cross-sectional analysis involving 469 women who attended the Colposcopy Unit at the European Institute of Oncology in Milan, Italy, from December 2006 to December 2014. HPV type richness was measured as the number of different genotypes per patient. We calculated the associations between richness and age, as well as histologic grade, along with Simpson's biodiversity index for cervical dysplasias. We observed significant inverse relationships between the richness of high-risk (HR) genotypes and both age (
Language	English
Publishing date	2023-10-11
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2695572-6
ISSN	2076-0817
ISSN	2076-0817
DOI	10.3390/pathogens12101234
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Article ; Online: Validation and Cross-Reactivity Data for Fentanyl Analogs With the Immunalysis Fentanyl ELISA.

Guerrieri, Davide / Kjellqvist, Fanny / Kronstrand, Robert / Gréen, Henrik

Journal of analytical toxicology

2018 Volume 43, Issue 1, Page(s) 18–24

Abstract: Every year new fentanyl analog compounds, or fentanyls, appear on the drug scene. Development of immunoassays dedicated for screening individual molecules is challenging due to the short-lived presence of these compounds on the recreational drug market. ... ...

Abstract	Every year new fentanyl analog compounds, or fentanyls, appear on the drug scene. Development of immunoassays dedicated for screening individual molecules is challenging due to the short-lived presence of these compounds on the recreational drug market. Therefore, we investigated the detecting capabilities of the immunalysis fentanyl direct enzyme-linked immunosorbent assay (ELISA) kit against fentanyl in whole blood, and determined the cross-reactivity of nine fentanyl analogs (2-fluorofentanyl, acetylfentanyl, acrylfentanyl, carfentanil, cyclopropylfentanyl, tetrahydrofuranylfentanyl, furanylfentanyl, ocfentanil, valerylfentanyl) to confirm its validity for the general screening of fentanyls. Immunalysis ELISA assay was used to test whole blood samples fortified with fentanyl on a TECAN Freedom EVOlyzer platform, according to manufacturer specifications. The kit successfully was validated for fentanyl screening with a cutoff set at 0.5 ng/mL, and all tested analogs, with the exclusion of carfentanil, were detected. The lowest cross-reactivity with the kit was obtained with furanylfentanyl (20% ± 1, 95% confidence intervals (CI)) and 4-fluoroisobutyrfentanyl (25% ± 1, 95% CI), while the highest was recorded using acetylfentanyl (99% ± 11, 95% CI) and acrylfentanyl (94% ± 10, 95% CI). Post-mortem samples containing fentanyl, acrylfentanyl, cyclopropylfentanyl, THF-fentanyl and 4-fluoroisobutyrfentanyl were screened, and sensitivity and specificity of each analog were calculated. Positive screening results were generated by all post-mortem cases containing fentanyl (n = 14), acrylfentanyl (n = 11), cyclopropylfentanyl (n = 14), tetrahydrofuranylfentanyl (n = 13) and 4-fluoroisobutyrfentanyl (n = 10). Concentration of post-mortem fentanyl samples ranged from 0.5 ng/mL (cutoff) to 230 ng/mL, while the range for analogs was 3.4-36 ng/mL (cyclopentylfentanyl), 0.76-370 ng/mL (4-fluoroisobutyrfentanyl), 0.02-12 ng/mL (acrylfentanyl) and 2-26 ng/mL (tetrahydrofuranylfentanyl). The immunalysis fentanyl direct ELISA kit was successfully validated and showed significant cross-reactivity for all tested fentanyls, except carfentanil, making it a suitable technique for fentanyl and fentanyl analogs screening.
MeSH term(s)	Analgesics, Opioid/blood ; Analgesics, Opioid/immunology ; Antibodies/immunology ; Antibody Specificity ; Calibration ; Cause of Death ; Cross Reactions ; Enzyme-Linked Immunosorbent Assay/methods ; Enzyme-Linked Immunosorbent Assay/standards ; Fentanyl/analogs & derivatives ; Fentanyl/blood ; Fentanyl/immunology ; Forensic Toxicology/methods ; Forensic Toxicology/standards ; Humans ; Opioid-Related Disorders/blood ; Opioid-Related Disorders/diagnosis ; Opioid-Related Disorders/mortality ; Predictive Value of Tests ; Reference Standards ; Reproducibility of Results ; Substance Abuse Detection/methods ; Substance Abuse Detection/standards
Chemical Substances	Analgesics, Opioid ; Antibodies ; Fentanyl (UF599785JZ)
Language	English
Publishing date	2018-09-14
Publishing country	England
Document type	Journal Article ; Validation Studies
ZDB-ID	752391-9
ISSN	1945-2403 ; 0146-4760
ISSN (online)	1945-2403
ISSN	0146-4760
DOI	10.1093/jat/bky060
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Article: Sparing Is Caring: Hormonal Retreatment in Women with Recurrent Endometrial Cancer after Fertility Preservation Management-A Single Centre Retrospective Study.

Pino, Ida / Di Giminiani, Maria / Radice, Davide / Vidal Urbinati, Ailyn Mariela / Iacobone, Anna Daniela / Guerrieri, Maria Elena / Preti, Eleonora Petra / Martella, Silvia / Franchi, Dorella

Healthcare (Basel, Switzerland)

2023 Volume 11, Issue 7

Abstract: Fertility-sparing treatment (FTS) of endometrial cancer (EC) has a high rate of remission but also a high rate of relapse (10-88%). Many women still wish to conceive at the time of relapse, but results regarding retreatment are still lacking. This study ... ...

Abstract	Fertility-sparing treatment (FTS) of endometrial cancer (EC) has a high rate of remission but also a high rate of relapse (10-88%). Many women still wish to conceive at the time of relapse, but results regarding retreatment are still lacking. This study aims to evaluate the safety, oncological and pregnancy outcomes of repeated FST in women with recurrent EC. This is a retrospective single-center study that recruited patients who had uterine recurrence after achieving a complete response (CR) with FST for FIGO stage IA, well-differentiated (G1), endometrioid EC. All eligible women underwent a second FST. Among 26 patients with recurrence, 6 decided to receive a hysterectomy and 20 received fertility-sparing retreatment. In total, 17 out of 20 women (85%) achieved a CR in a median time of 6 months. A total of 2/20 women showed a stable disease and continued the treatment for a further 6 months and finally achieved a CR. In total, 1/20 women showed disease progression and underwent demolitive surgery. After relapse and a CR, 14 patients attempted to become pregnant, among whom 7 became pregnant (pregnancy rate 50%-life birth rate 29%). Secondary FST is a safe and effective option for women who desire to preserve fertility after the recurrence of early-stage EC.
Language	English
Publishing date	2023-04-06
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2721009-1
ISSN	2227-9032
ISSN	2227-9032
DOI	10.3390/healthcare11071058
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Article: Which Risk Factors and Colposcopic Patterns Are Predictive for High-Grade VAIN? A Retrospective Analysis.

Iacobone, Anna Daniela / Radice, Davide / Guerrieri, Maria Elena / Spolti, Noemi / Grossi, Barbara / Bottari, Fabio / Boveri, Sara / Martella, Silvia / Vidal Urbinati, Ailyn Mariela / Pino, Ida / Franchi, Dorella / Preti, Eleonora Petra

Diagnostics (Basel, Switzerland)

2023 Volume 13, Issue 2

Abstract: Colposcopic patterns of Vaginal Intraepithelial Neoplasia (VAIN) are not definitively related to histological grade. The aim of the present study was to investigate any correlation between clinical and colposcopic features and the development of high- ... ...

Abstract	Colposcopic patterns of Vaginal Intraepithelial Neoplasia (VAIN) are not definitively related to histological grade. The aim of the present study was to investigate any correlation between clinical and colposcopic features and the development of high-grade VAIN. Two hundred and fifty-five women diagnosed with VAIN (52 VAIN1, 55 VAIN2 and 148 VAIN3) at the European Institute of Oncology, Milan, Italy, from January 2000 to June 2022, were selected for a retrospective analysis. Multivariate logistic regression was performed to estimate the association of risk factors and colposcopic patterns with VAIN grade. Smoking was associated with the development of VAIN (34.1%, p = 0.01). Most women diagnosed with VAIN3 (45.3%, p = 0.02) had a previous history of hysterectomy for CIN2+. At multivariate analysis, colposcopic grade G2 (OR = 20.4, 95%CI: 6.67−61.4, p < 0.001), papillary lesion (OR = 4.33, 95%CI: 1.79−10.5, p = 0.001) and vascularity (OR = 14.4, 95%CI: 1.86−112, p = 0.01) were significantly associated with a greater risk of VAIN3. The risk of high-grade VAIN should not be underestimated in women with a history of smoking and previous hysterectomy for CIN2+, especially when colposcopic findings reveal vaginal lesions characterized by grade 2, papillary and vascular patterns. Accurate diagnosis is crucial for an optimal personalized management, based on risk factors, colposcopic patterns and histologic grade of VAIN.
Language	English
Publishing date	2023-01-04
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662336-5
ISSN	2075-4418
ISSN	2075-4418
DOI	10.3390/diagnostics13020176
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