Background
CLIPPER2 was an 8-year, open-label extension of the phase 3b, multicenter, 2-year CLIPPER study of the safety and efficacy of etanercept (ETN) in the treatment of patients (pts) with ...juvenile idiopathic arthritis (JIA) categorized as extended oligoarticular arthritis (eoJIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA).
Objectives
The objective of this analysis was to describe the safety of ETN in this population after 10 years of follow up.
Methods
Pts (n=127) with eoJIA (2-17 years), ERA, or PsA (each 12-17 years) who received ≥1 ETN dose (0.8 mg/kg once weekly max, 50 mg) in CLIPPER were eligible to enter CLIPPER2. The primary outcome measure was the occurrence of malignancy. Long-term safety was assessed as the total incidence of events from CLIPPER baseline (BL) to month (mth) 120, frequency of events per 100 patient-years (EP100PY), and frequency of events in each study year.
Results
A total of 109/127 (86%) pts entered CLIPPER2; 99 (78%) continued in the active treatment period. At mth 120, 84 (66%) pts had completed the study; 27 (21%) while actively taking ETN; 7 (6%) had withdrawn from treatment due to low/inactive disease; 5 (4%) had re-started ETN following an earlier withdrawal from treatment; and 45 (35%) had stopped ETN (but remained under observation); 25 (20%) pts permanently discontinued from the CLIPPER2 study. In CLIPPER/CLIPPER2, 1 case of malignancy (Hodgkin’s disease) was reported (1 pt with eoJIA in Year 3). There was 1 case of uveitis (1 pt with eoJIA in Year 8) and 3 of Crohn’s disease (2 pts with ERA, Year 1/Year 6; 1 pt with eoJIA, Year 5). There were 2 cases of opportunistic infections (both herpes zoster), and no deaths. Overall, there were 559 (81.82 EP100PY) treatment-emergent adverse events (TEAEs) excluding infections and injection-site reactions (ISRs). The overall rate of TE serious infections was low (N=14; 2.05 EP100PY) (Table 1), with the most common TE serious infection being gastroenteritis (N=2; 0.29 EP100PY). The most frequently reported TEAEs (N EP100PY) were headache (28 4.10), arthralgia (24 3.51), pyrexia (21 3.07), diarrhea (14 2.05), and leukopenia (12 1.76). Overall, 39 patients reported serious AEs (excluding infections/ISRs). The number and frequency (N EP100PY) of TEAEs (excluding infections/ISRs) decreased over the 10-year study period from 193 173.81 in Year 1 to 9 27.15 in Year 10. The number and frequency of TE infections and TE serious infections also decreased over the 10-year study period. There was no clear trend of a decrease over time for the incidence of TE serious AEs (Figure 1).
Table 1.
ETN Safety Summary (from CLIPPER BL to mth 120), N (EP100PY) (FAS)*
eoJIA, n=60(EXP=313.667 PY)
ERA, n=38(EXP=206.971 PY)
PsA, n=29(EXP=162.576 PY)
Total, n=12(EXP=683.214 PY)
TEAEs†
269 (85.76)
176 (85.04)
114 (70.12)
559 (81.82)
TE serious AEs†
16 (5.10)
17 (8.21)
7 (4.31)
40 (5.85)
TE ISRs
23 (7.33)
29 (14.01)
12 (7.38)
64 (9.37)
TE infections
418 (133.26)
99 (47.83)
155 (95.34)
672 (98.36)
TE serious infectionsǂ
5 (1.59)
4 (1.93)
5 (3.08)
14 (2.05)
Opportunistic infections§
0
1 (0.48)
1 (0.62)
2 (0.29)
TEAEs causing withdrawal†
7 (2.23)
9 (4.35)
2 (1.23)
18 (2.63)
TE infections causing withdrawal
2 (0.64)
0
1 (0.62)
3 (0.44)
*While on active ETN treatment or within 30 days of last dose
†Excluding infections/ISRs
ǂGastroenteritis, 2 (0.29); acute tonsillitis, anal abscess, bronchopneumonia, gastrointestinal infection, helicobacter gastritis, influenza, peritonitis, pharyngitis, pyelocystitis, sepsis, urinary tract infection, viral infection, all 1 (0.15)
§Both herpes zoster
EXP, exposure to ETN; FAS, full analysis set; n, number of patients; N, number of events
Conclusion
ETN treatment to mth 120 was well tolerated in this patient population and consistent with the known safety profile. Frequency of TEAEs and TE infections decreased over time. Over 10 years, there was 1 reported event of malignancy and the overall rate of TE serious infections was low.
References
1
NCT00962741
/NCT01421069
Acknowledgements
Medical writing support was provided by Iain McDonald, PhD, of Engage Scientific Solutions and was funded by Pfizer.
Disclosure of Interests
Jelena Vojinovic Speakers bureau: Abbvie, Roche, Sandoz, Joke Dehoorne Speakers bureau: Abbvie, Roche, Consultant of: Abbvie, Roche, Violeta Panaviene: None declared, Gordana Susic: None declared, Gerd Horneff Speakers bureau: Chugai, Eli-Lilly, Glaxo Smith and Kline, Janssen, Novartis, Pfizer, Roche and Sobi, Grant/research support from: Novartis, Janssen, Roche, Valda Stanevicha Speakers bureau: Sandoz, Abbvie, Roche, Katarzyna Kobusinska: None declared, Zbigniew Żuber: None declared, Bogna Dobrzyniecka: None declared, Jonathan Akikusa: None declared, Tadej Avcin Speakers bureau: AbbVie, Octapharma, and Takeda, Consultant of: AbbVie, Alexion, Octapharma, and Takeda, Alberto Martini Speakers bureau: Aurinia, Bristol Myers and Squibb, Eli-Lilly, EMD Serono, Janssen, Pfizer, Roche, Consultant of: Aurinia, Bristol Myers and Squibb, Eli-Lilly, EMD Serono, Janssen, Pfizer, Roche, Cecilia Borlenghi Shareholder of: Pfizer, Employee of: Pfizer, Edmund Arthur Employee of: Pfizer, Svitlana Y Tatulych Shareholder of: Pfizer, Employee of: Pfizer, Chuanbo Zang Shareholder of: Pfizer, Employee of: Pfizer, Bonnie Vlahos Shareholder of: Pfizer, Employee of: Pfizer, Nicolino Ruperto Speakers bureau: Ablynx, Amgen, Astrazeneca-Medimmune, Aurinia, Bayer, Bristol Myers and Squibb, Cambridge Healthcare Research (CHR), Celgene, Domain therapeutic, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Idorsia, Janssen, Novartis, Pfizer, Sobi, UCB., Consultant of: Ablynx, Amgen, Astrazeneca-Medimmune, Aurinia, Bayer, Bristol Myers and Squibb, Cambridge Healthcare Research (CHR), Celgene, Domain therapeutic, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Idorsia, Janssen, Novartis, Pfizer, Sobi, UCB.
Background
CLIPPER2 was an 8-year, open-label extension of the phase 3b, 2-year CLIPPER study of the safety and efficacy of etanercept (ETN) in patients (pts) with juvenile idiopathic arthritis ...(JIA), categorized as extended oligoarticular JIA (eoJIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA).
Objectives
Evaluation of the efficacy of ETN and its effect on health outcomes over 10 years of follow-up were secondary objectives and are reported here.
Methods
Pts (n=127) with eoJIA (n=60; 2-17 years of age), ERA (n=38; 12-17), or PsA (n=29; 12-17) who received ≥1 ETN dose (0.8 mg/kg once weekly max, 50 mg) in CLIPPER were eligible to enter CLIPPER2. The study design has been reported previously.
1
Efficacy endpoints included proportions of pts achieving JIA American College of Rheumatology (ACR) 30/50/70/90/100 criteria, Juvenile Arthritis Disease Activity Score (JADAS) inactive disease and clinical remission criteria, and sustained clinical remission (ACR criteria) or JADAS ≤1 for 12 continuous months (mths). Exploratory efficacy endpoints included time to flare following ETN withdrawal (based on ≥30% worsening in ≥3/6 ACR Pedi components, with ≥30% improvement in <2/6 remaining components and ≥2 active joints), and time to re-treatment with ETN.
Observed Cases were used (i.e., there was no imputation for missing data) for pts who were in the Active Treatment Period.
Results
A total of 109/127 (86%) CLIPPER participants entered CLIPPER2 (n=55 eoJIA, n=31 ERA, n=23 PsA), with 99 (78%) pts continuing in the Active Treatment Period. Overall, 84 (66%) pts completed 120 mths of follow-up; 27 (21%) while actively taking ETN. Thirty (24%) pts entered the Withdrawal Period from the Active Treatment Period (i.e., they discontinued ETN, either by meeting the Wallace definition for clinically inactive disease for at least 6 months on ETN, or by having had a good clinical response and being deemed to benefit from withdrawal in the investigator’s judgment). Of the pts in the Active Treatment Period, over 90% achieved JIA ACR 50 response at all study time points. Sustained JADAS and ACR remission was achieved by 42 (33%) pts and 17 (13%) pts, respectively. The mean improvements from baseline in JADAS disease activity at mth 24 of CLIPPER were largely maintained through CLIPPER2 A total of 109/127 (86%) CLIPPER participants entered CLIPPER2 (n=55 eoJIA, n=31 ERA, n=23 PsA), with 99 (78%) pts continuing in the Active Treatment Period. Overall, 84 (66%) pts completed 120 mths of follow-up; 27 (21%) while actively taking ETN. Thirty (24%) pts entered the Withdrawal Period from the Active Treatment Period (i.e., they discontinued ETN, either by meeting the Wallace definition for clinically inactive disease for at least 6 months on ETN, or by having had a good clinical response and being deemed to benefit from withdrawal in the investigator’s judgment). Of the pts in the Active Treatment Period, over 90% achieved JIA ACR 50 response at all study time points. Sustained JADAS and ACR remission was achieved by 42 (33%) pts and 17 (13%) pts, respectively. The mean improvements from baseline in JADAS disease activity at mth 24 of CLIPPER were largely maintained through CLIPPER2.
Conclusion
The low numbers of evaluable pts notwithstanding, efficacy results were consistent with the profile of ETN, and treatment responses were considered clinically meaningful and durable with long-term treatment.
References
1Foeldvari I, et al.
Arthritis Res Ther
2019;21:125.
2Trincianti C, et al.
Arthritis Rheumatol
2021:73;1966-75.
Trial Registration:
NCT00962741
/NCT01421069
Acknowledgements
Medical writing support was provided by Iain McDonald, PhD, of Engage Scientific Solutions and was funded by Pfizer.
Disclosure of Interests
Jelena Vojinovic Speakers bureau: Abbvie, Roche, Sandoz, Joke Dehoorne Speakers bureau: Abbvie, Roche, Consultant of: Abbvie, Roche, Violeta Panaviene: None declared, Gordana Susic: None declared, Gerd Horneff Speakers bureau: Chugai, Eli-Lilly, Glaxo Smith and Kline, Janssen, Novartis, Pfizer, Roche and Sobi, Grant/research support from: Novartis, Janssen, Roche, Valda Stanevicha Speakers bureau: Sandoz, Abbvie, Roche, Katarzyna Kobusinska: None declared, Zbigniew Żuber: None declared, Bogna Dobrzyniecka: None declared, Jonathan Akikusa: None declared, Tadej Avcin Speakers bureau: AbbVie, Octapharma and Takeda, Consultant of: AbbVie, Octapharma and Takeda, Alberto Martini Speakers bureau: Aurinia, Bristol Myers and Squibb, Eli-Lilly, EMD Serono, Janssen, Pfizer, Roche, Consultant of: Aurinia, Bristol Myers and Squibb, Eli-Lilly, EMD Serono, Janssen, Pfizer, Roche, Cecilia Borlenghi Shareholder of: Pfizer, Employee of: Pfizer, Edmund Arthur Employee of: Pfizer, Svitlana Y Tatulych Shareholder of: Pfizer, Employee of: Pfizer, Chuanbo Zang Shareholder of: Pfizer, Employee of: Pfizer, Vasileios TSEKOURAS Shareholder of: Pfizer, Employee of: Pfizer, Bonnie Vlahos Shareholder of: Pfizer, Employee of: Pfizer, Nicolino Ruperto Speakers bureau: Ablynx, Amgen, Astrazeneca-Medimmune, Aurinia, Bayer, Bristol Myers and Squibb, Cambridge Healthcare Research (CHR), Celgene, Domain therapeutic, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Idorsia, Janssen, Novartis, Pfizer, Sobi, UCB., Consultant of: Ablynx, Amgen, Astrazeneca-Medimmune, Aurinia, Bayer, Bristol Myers and Squibb, Cambridge Healthcare Research (CHR), Celgene, Domain therapeutic, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Idorsia, Janssen, Novartis, Pfizer, Sobi, UCB.
Background:
In the RE-EMBARK trial (
NCT02509026
), etanercept (ETN)-treated patients with non-radiographic axial spondyloarthritis (nr-axSpA) who achieved inactive disease (defined as Ankylosing ...Spondylitis Disease Activity Score with C-reactive protein ASDAS CRP <1.3) in Period 1 (P1)
1
discontinued ETN for ≤40 weeks.
Objectives:
To assess the proportion of patients with inactive disease after P1 who experienced disease flare (ASDAS with erythrocyte sedimentation rate ASDAS ESR ≥2.1) within 40 weeks of ETN withdrawal and to estimate time to flare following ETN withdrawal.
Methods:
RE-EMBARK was a multicenter, open-label, Phase IV trial of ETN in patients with active nr-axSpA (meeting Assessment in SpondyloArthritis international Society criteria and with ASDAS CRP ≥2.1) and an inadequate response to ≥2 nonsteroidal anti-inflammatory drugs (NSAIDs) while taking a stable dose of 1 NSAID for ≥2 weeks before the first ETN dose. All patients received ETN (50 mg/week) plus NSAID for the first 24 weeks (P1). At week 24, patients with inactive disease discontinued ETN for ≤40 weeks (Period 2 P2). Those who experienced flare during P2 were re-treated with ETN for 12 weeks in Period 3 (P3). Kaplan-Meier (KM) analysis and Cox proportional hazard models were used to 1) estimate the probability of experiencing flare within a given time period, and 2) compare data between RE-EMBARK and the EMBARK trial (
NCT01258738
) of patients with nr-axSpA who met RE-EMBARK P2 entry criteria (achieved inactive disease after 24 weeks of ETN treatment) and continued treatment for a further ≤40 weeks.
Results:
Of the 209 patients in P1 (mean age, 33 years; women, 46%; white, 89%), 119 (57%) entered P2. The proportion of patients experiencing ≥1 flare increased from 22% (25/112) at P2 week 4 to 67% (77/115) at P2 week 40. Overall, 75% (86/115) of patients in P2 experienced flare and 50% experienced flare within 16 weeks (95% CI: 13-24 weeks, KM analysis). Conversely, data from the comparator EMBARK trial suggested that <25% of patients receiving continuous ETN treatment over 40 weeks experienced flare. Cox proportional hazard model analysis showed an 85% relative risk reduction of experiencing flare during P2 in patients with inactive disease who continued ETN treatment vs those who discontinued. By P3 end 62% (54/87) of patients re-treated with ETN re-achieved inactive disease; 50% of patients who re-achieved inactive disease in P3 did so within 5 weeks (95% CI: 4-8 weeks, KM analysis). The observed trend of clinical improvement (P1), worsening (P2), and improvement (P3) was reflected in other clinical measures (Figure) plus measures of joint damage (Spondyloarthritis Research Consortium of Canada Sacroiliac Joint magnetic resonance imaging score) and quality of life (EQ-5D visual analog scale score); mean (standard deviation) score changes from each study period baseline–end were –6.1 (11.7) P1, +1.5 (4.4) P2, –2.0 (8.8) P3 and +27.7 (26.7) P1, –26.4 (30.5) P2, +32.1 (26.3) P3, respectively. There were no unexpected safety signals.
Conclusion:
For patients with nr-axSpA who achieved inactive disease with ETN and then discontinued treatment, a quarter maintained treatment-free inactive disease for 40 weeks and 50% maintained an ASDAS ESR score of <2.1 for ≥16 weeks. Re-starting ETN allowed 62% of patients who flared to re-achieve inactive disease within 12 weeks.
References:
1Van den Bosch F, et al.
Ann Rheum Dis
2019;78:896-7
Acknowledgments:
Medical writing support was provided by Lorna Forse, PhD, of Engage Scientific Solutions and was funded by Pfizer.
Disclosure of Interests:
Filip van den Bosch Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, James Cheng-Chung Wei Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer Inc, Sanofi-Aventis, UCB Pharma, Peter Nash Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Francisco J. Blanco Grant/research support from: Sanofi-Aventis, Lilly, Bristol MS, Amgen, Pfizer, Abbvie, TRB Chemedica International, Glaxo SmithKline, Archigen Biotech Limited, Novartis, Nichi-iko pharmaceutical Co, Genentech, Jannsen Research & Development, UCB Biopharma, Centrexion Theurapeutics, Celgene, Roche, Regeneron Pharmaceuticals Inc, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, Ltd, Gilead Sciences Inc, Consultant of: Lilly, Bristol MS, Pfizer, Daniela Graham Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Chuanbo Zang Shareholder of: Pfizer, Employee of: Pfizer, Edmund Arthur Shareholder of: Pfizer, Employee of: Pfizer, Cecilia Borlenghi Shareholder of: Pfizer, Employee of: Pfizer, Bonnie Vlahos Shareholder of: Pfizer, Employee of: Pfizer, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB
ObjectivesTo evaluate work capacity and quality of life in patients with early Psoriatic Arthritis (PsA).MethodsMulti-center study in which patients with recent onset of PsA (disease duration <3 ...years) who met the CASPAR criteria established by the Early Spondyloarthritis Committee (CONEART) were enrolled. Work loss and lost workdays within six months prior to the baseline visit attributable to their baseline condition were evaluated, as well as quality of life, measured by PsAQol. Statistical analysis: descriptive statistics, Spearman's correlation, multiple linear regression model.Results108 patients with a PsA diagnosis were enrolled. 53% (57/108) were male, of a mean age of 48.4 (SD 12.5). The mean PsA disease duration was 17.6 (SD 9.8) months. 4/60 patients (6.6%) were positive for HLA-B27. BASDAI 4.81±2.66; BASFI 3.75±2.70; PsAQoL 7.24±6.44; HAQ-A 0.72±0.61, physician global activity assessment (by Visual Numeric Scale, VNS) 3.76±2.33, and pain assessment (VNS) 5.22±2.98. The average days lost due to the condition within the past 6 months was 8.6 (SD 32.1), it was significantly associated with the presence of enthesitis, number of swollen joints, worse BASDAI, BASFI, lower level of education, and higher pain and physician global activity assessment (p<0.0001). Five patients lost their job due to PsA. 12% of the patients had a disability certificate and the possession of one, according to the logistic regression model, was associated with a longer PsA disease duration (OR 1.09, p=0.02). A poorer quality of life was significantly correlated to the physician assessment of disease activity (p<0.001) and pain (p<0.01) using a linear regression model.ConclusionsIn this cohort of patients with early PsA, the deterioration of work capacity expressed in lost workdays was associated with disease activity parameters and functional disability. The physician global activity assessment and pain were the main factors associated with the impact on patient's quality of life. Having a disability certificate was associated with longer disease duration. Although this is an early cohort of PsA patients, a worsening in quality of life and work disability was observed.Disclosure of InterestF. Colombres: None declared, H. Berman: None declared, A. Spindler: None declared, W. Spindler: None declared, J. Maldonado Cocco Grant/research support from: Pfizer Argentina, M. Orozco: None declared, E. Schneeberger Grant/research support from: Pfizer Argentina, A. Ortiz: None declared, S. Paira Grant/research support from: Pfizer Argentina, M. Zalazar: None declared, O. Rillo Grant/research support from: Pfizer Argentina, D. Baenas: None declared, A. Alvarellos Grant/research support from: Pfizer Argentina, T. Alvarellos: None declared, M. Garcia Grant/research support from: Pfizer Argentina, A. Salas: None declared, V. Duarte: None declared, F. Romanini Grant/research support from: Pfizer Argentina, L. Ferreyra Garrott: None declared, E. Soriano Grant/research support from: Pfizer Argentina, L. Galindo: None declared, G. Castelli: None declared, C. Borlenghi: None declared, A. Berman Grant/research support from: Pfizer Argentina
In rheumatoid arthritis (RA), little is known about clinical responses to treatment as predictors of patient-reported outcome (PRO) changes. In this post hoc analysis, we examined the relationship ...between clinical outcomes at week 12 and PRO changes at week 24 in patients with RA.
In an open-label study, Latin American patients with moderate-to-severe RA and an inadequate response to methotrexate (MTX) were randomized to receive etanercept 50 mg/week plus MTX (ETN+MTX; n=281) or an additional conventional disease-modifying anti-rheumatic drug (DMARD) plus MTX (DMARD+MTX; n=142) for 24 weeks. The PROs included Health Assessment Questionnaire Disability Index (HAQ-DI), 36-item Short Form (SF-36), Physician and Patient Global Assessment scores (PGA, PtGA), Physician and Patient Satisfaction, and an activity impairment assessment. PRO changes at week 24 were calculated by week-12 improvements using the American College of Rheumatology criteria (ACR <20, ≥20 to <50, ≥50 to <70, and ≥70) and the 28-joint Disease Activity Scores (DAS28 ≥3.2, ≥2.6 to <3.2, and <2.6). Observed-cases data were analyzed using an ANCOVA model with linear contrast, adjusted for baseline PRO and ACR/DAS28 values.
For both ETN+MTX- and DMARD+MTX-treated patients, there was a significant linear trend between week-12 changes in ACR and DAS28 responses and week-24 changes in HAQ-DI (P<0.001 for all), with numerical improvements generally favoring ETN+MTX. Similar relationships were observed for SF-36, PGA, PtGA, Physician Satisfaction, Patient Satisfaction, and activity impairment.
In patients with RA, clinical response after 12 weeks of treatment with ETN+MTX or DMARD+MTX could be a predictor of week-24 response for several PROs.
ClinicalTrials.gov, NCT00848354.
Evaluación del estado nutricional en pacientes internados en un servicio de medicina interna.
Estudio longitudinal, prospectivo y observacional sobre una población de 412 pacientes, utilizando la ...valoración global subjetiva. En cuanto a la estadística, se utilizaron los métodos de la χ
2 para análisis univariado y regresión logística.
Se incluyó a 412 pacientes, de los que el 47,58% presentó desnutrición, el 39% desnutrición moderada (grupo B) y el 8,58% desnutrición grave (grupo C). La desnutrición se relacionó con edad mayor de 65 años, el sexo varón y el diagnóstico de enfermedades oncológicas e infecciosas, así como con una mayor estancia hospitalaria
La incidencia de desnutrición en el servicio de medicina interna es elevada y se aprecia un alto desinterés sobre el estado nutricional de los pacientes internados. Los resultados hallados son comparables a los de otros estudios latinoamericanos.
To evaluate nutritional status in patients admitted to an Internal Medicine Service.
We performed a longitudinal, prospective, observational study in 412 patients, using Subjective Global Assessment. The chi-square test for univariate analysis and logistic regression were used.
Of the 412 patients included,47.58% had malnutrition, which was moderate in 39% (group B) and severe in 8.58% (group C). Malnutrition was related to age older than 65 years, male sex, oncologic and infectious diseases, and longer length of hospital stay.
The incidence of malnutrition in our Internal Medicine Service is high,and little interest is shown in the nutritional status of admitted patients. The results of the present study are similar to those of other studies performed in Latin America.
Invasive fungal infections (IFIs), mainly due to pulmonary aspergillosis, are considered a serious complication in acute leukaemia, with an unfavourable impact on patient. In this well‐conducted ...retrospective study, Reynolds et al. suggest that the use of posaconazole prophylaxis in association with venetoclax plus hypomethylating agents or chemotherapy leads to a reduction of IFI incidence. Therapeutic drug monitoring of posaconazole levels is suggested, even if no correlation with IFI risk has been demonstrated.
Commentary on: Reynolds et al. Invasive fungal infection following venetoclax and posaconazole co‐administration. Br J Haematol 2023;203:593‐598.
With the development of micro-LIBS imaging, the ever-increasing size of datasets (sometimes >1 million spectra) makes the processing of spectral data difficult and time consuming. Advanced ...statistical methods have become necessary to process these data, but most of them still require strong expertise and are not adapted to fast data treatment or a high throughput analysis. To address these issues, we evaluate, in the present work, the use of an artificial neural network (ANN) for LIBS imaging spectral data processing for the identification of different mineral phases in archaeological lime mortar. Common in ancient architecture, this building material is a complex mixture of lime with one or more aggregates, some components of which are of the same chemical nature (
e.g.
calcium carbonates). In this study, we trained an artificial neural network (ANN) for automatic detection of different phases in these complex samples. The training of such a predictive model was made possible by building a LIBS dataset of more than 1300 reference spectra, obtained from various selected materials that may be present in mortars. The ANN parameters (pre-treatment of data, number of neurons and of iterations) were optimized to ensure the best recognition of mortar components, while avoiding overtraining. The results demonstrate a fast and accurate identification of each component. The use of an ANN appears to be a strong means to provide an efficient, fast and automated LIBS characterization of archaeological mortar, a concept that could later be generalized to other samples and other scientific fields and methods.
With the development of micro-LIBS imaging, the ever-increasing size of datasets (sometimes >1 million spectra) makes the processing of spectral data difficult and time consuming.
To introduce the topic of “Roman aqueducts of Lyon and elsewhere: New points of reference” is to follow in the footsteps of several generations of researchers from the 16th century onwards, as well ...as to present the framework of contemporary archaeological research. Over the past three decades, a vast amount of data has been collected, which had to be shared and organised. The “Aqueducts of Lyon” group, which all the researchers, regardless of their institutional affiliations, were invited to join, has been at work since 2015 to produce this volume. Mostly unpublished material from Lyon and other Roman canals is brought together under four categories –routes, construction works, dating, water distribution in the city– combined, like other Imperial sources, with a process of collation intended to provide new points of reference for the exploration of one of the mostextensive water distribution networks of its time.
Introduire le dossier « Les aqueducs romains de Lyon et d’ailleurs : nouveaux repères», c’est se placer à la suite de plusieurs générations de chercheurs depuis le XVIe s. et présenter le cadre de la recherche archéologique contemporaine. Celle-ci a généré en trois décennies un grand nombre de données qu’il a fallu partager et organiser. Le groupe « Aqueducs lyonnais », où tous les chercheurs, quelle que soit leur institution de rattachement, étaient invités à échanger, s’est attelé à la tâche à partir de 2015 pour aboutir à ce volume. Ce dernier propose de faire un état des lieux en quatre thèmes – tracés, construction, datation, arrivée à Lyon – et y ajoute, à l’aune d’autres adductions de l’Empire, un travail de synthèse à même de poser de nouveaux repères pour l’exploration d’un réseau d’adduction d’eau parmi les plus étendus de son temps.
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