Facilitated subcutaneous immunoglobulin treatment patterns in pediatric patients with primary immunodeficiency diseases.

Aim: This retrospective study investigated real-world hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) treatment patterns in pediatric patients with primary immunodeficiency diseases (PIDs) in Poland. Methods: Clinical and demographic information, fSCIG treatment parameters and clinical outcomes were extracted from medical records of 28 participants (aged ≤18 years) with PIDs who received fSCIG. Results: 18 participants (64.3%) started fSCIG with a ramp-up (median duration: 35.5 days). 27 patients (96.4%) were administered fSCIG every 4 weeks and one patient every 3 weeks. 25 patients (89.3%) used one infusion site. No serious bacterial infections occurred. Conclusion: Data support the feasibility of administering fSCIG to children and adolescents with PIDs every 3-4 weeks using a single infusion site and indicate flexibility in modifying fSCIG infusion parameters. Clinical Trial Registration: NCT04636502 (ClinicalTrials.gov).

Antibodies, also known as immunoglobulins, are proteins that are made by the immune system to help fight infections. In primary immunodeficiency diseases (PIDs), part of the immune system may be missing or not working properly. This study looked at the use of an antibody treatment called hyaluronidase-facilitated subcutaneous immunoglobulin (or fSCIG) in Polish children aged 18 years or younger with PIDs. Information on patients, their disease, how fSCIG was being used and how patients responded to treatment was taken from medical records. Out of 28 patients, 18/28 (64.3%) had their fSCIG dose slowly increased, which took an average of 35.5 days. Overall, 27/28 patients were treated with fSCIG every 4 weeks (96.4%), and 25/28 patients used one place to inject fSCIG (89.3%). No serious infections caused by bacteria happened during the study. The study results suggest that children with PIDs could be treated every 3 to 4 weeks with fSCIG, and that flexibility in how fSCIG is injected may offer options suited to individual patients.

Subcutaneous immunoglobulin 20% (Ig20Gly) treatment regimens in pediatric patients with primary immunodeficiencies - real-world data from the IG TATRY study.

BACKGROUND: Subcutaneous administration of immunoglobulins is associated with fewer systemic adverse events and easier infusion compared to intravenous administration. Ig20Gly is a 20% immunoglobulin formulation effective and safe in patients with primary immune deficiency diseases (PIDDs). Real-world data are scarce, therefore our study aimed to examine the real-life treatment regimen and clinical outcomes of Ig20Gly in Polish children with PIDDs. RESEARCHDESIGN: We retrospectively analyzed the medical documentation of 75 pediatric patients aged 0-17 years (mean 9.9) who received Ig20Gly (Cuvitru®; Baxalta US, Inc.; part of Takeda, MA, U.S.A.). RESULTS: The median exposure to treatment of the study population was 22.3 months. At the end of the study, 59 (78.7%) were still on Ig20Gly. The median monthly dose was 0.40 g/kg. The median treatment interval was 7.7 days. Most patients (96%) used one infusion site. The median infusion rate increased with patient age. The median IgG level in the study population, 8.0 g/L, was stable. There was one case of serious bacterial infection. CONCLUSION: This is the largest, long-term real-world study to date on the treatment patterns of Ig20Gly in pediatric patients with PIDDs. The results of this study support the feasibility and tolerability of Ig20Gly usage in PIDD patients across the pediatric age spectrum. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (NCT04636502).

Modelling the growth, development and yield of Triticum durum Desf under the changes of climatic conditions in north-eastern Europe.

How agricultural ecosystems adapt to climate change is one of the most important issues facing agronomists at the turn of the century. Understanding agricultural ecosystem responses requires assessing the relative shift in climatic constraints on crop production at regional scales such as the temperate zone. In this work we propose an approach to modeling the growth, development and yield of Triticum durum Desf. under the climatic conditions of north-eastern Poland. The model implements 13 non-measurable parameters, including climate conditions, agronomic factors, physiological processes, biophysical parameters, yield components and biological yield (latent variables), which are described by 33 measurable predictors as well as grain and straw yield (manifest variables). The agronomic factors latent variable was correlated with nitrogen fertilization and sowing density, and biological yield was correlated with grain yield and straw yield. An analysis of the model parameters revealed that a one unit increase in agronomic factors increased biological yield by 0.575. In turn, biological yield was most effectively determined by climate conditions (score of 60-62) and biophysical parameters (score of 60-67) in the 2nd node detectable stage and at the end of heading. The modeled configuration of latent and manifest variables was responsible for less than 70% of potential biological yield, which indicates that the growth and development of durum wheat in north-eastern Europe can be further optimized to achieve high and stable yields. The proposed model accounts for local climate conditions and physiological processes in plants, and it can be implemented to optimize agronomic practices in the cultivation of durum wheat and, consequently, to expand the area under T. durum to regions with a temperate climate.

Back pain in physically inactive students compared to physical education students with a high and average level of physical activity studying in Poland.

BACKGROUND: The aim of the study was (1) to characterise back pain in physically inactive students as well as in trained (with a high level of physical activity) and untrained (with an average level of physical activity) physical education (PE) students and (2) to find out whether there exist differences regarding the declared incidence of back pain (within the last 12 months) between physically inactive students and PE students as well as between trained (with a high level of physical activity) and untrained (with an average level of physical activity) PE students. METHODS: The study included 1321 1st-, 2nd- and 3rd-year students (full-time bachelor degree course) of Physical Education, Physiotherapy, Pedagogy as well as Tourism and Recreation from 4 universities in Poland. A questionnaire prepared by the authors was applied as a research tool. The 10-point Visual Analogue Scale (VAS) was used to assess pain intensity. Prior to the study, the reliability of the questionnaire was assessed by conducting it on the group of 20 participants twice with a shorter interval. No significant differences between the results obtained in the two surveys were revealed (p < 0.05). RESULTS: In the group of 1311 study participants, 927 (70.7%) respondents declared having experienced back pain within the last 12 months. Physically inactive students declared back pain frequency similar to the frequency declared by their counterparts studying physical education (p > 0.05). Back pain was more common in the group of trained students than among untrained individuals (p < 0.05). Back pain was mainly located in the lumbar spine. CONCLUSIONS: A frequent occurrence of back pain (70.7%) was noted in the examined groups of students. The percentage of students declaring back pain increased in the course of studies (p < 0.05) and, according to the students' declarations, it was located mainly in the lumbar spine. No significant differences regarding the incidence of back pain were found between physically inactive students and physical education students (p > 0.05). The trained students declared back pain more often than their untrained counterparts (p < 0.05).

[Nutritional status of patients in hospitals in Poland. I. Screening of adult patients]. / Stan odzywienia pacjentów w szpitalach w Polsce. I. Ocena przesiewowa pacjentów doroslych.

The aim of the study was a screening assessment of the nutritional status of patients admitted to hospitals and discharged from hospitals. The study was carried out in 4 university hospitals, 4 woivodeship hospitals and 4 district hospitals. In randomly selected 3310 patients (every 10th patient admitted to hospital) anthropometric parameters were assessed: body height, body mass, body mass index (BMI), waist-hip ratio (WHR), arm circumference, blood morphological and biochemical parameters were determined (erythrocyte, white blood cell and lymphocyte count in blood, albumin and haemoglobin concentration in serum). The mean values of the assessed parameters in the whole studied population of patients admitted to various types of hospitals were not different from the normative values for adults, however, a gradual decrease of the values of certain parameters in the over 70 years age group was observed. Although, the mean values of the studied parameters of the nutritional status were within the accepted normal range, 10.43% of the studied patients had BMI below 20 kg/m2, and 20.7% of the patients the serum albumin level was below 3.5 g/dl on admission, which could suggest protein-energy malnutrition. In a yet higher proportion of patients (21%) lymphocyte count was below 1500/mm3. During hospital stay tendency became even more pronounced. On discharge from hospital the proportion of patients with BMI below 20 kg/m2 rose to 11.21%, and with serum albumin level below 3.5 g/dl rose to 28.6%. Only the proportion of patients with low lymphocyte count remained unchanged during hospital stay and was 21.1% on discharge. In the studied population 42.29% of the patients reported receiving of additional food beyond hospital diet.

[Nutritional status of patients in hospitals in Poland. More thorough assessment of nutritional status of adult patients]. / Stan odzywienia pacjentów w szpitalach w Polsce. II. Poglebiona ocena stanu odzywienia pacjentów doroslych.

The purpose of the study was a more thorough assessment of the nutrition state of patients admitted to hospitals in Poland. The study was carried out in four hospitals at teaching centre level, in four hospitals at province level, and in four county hospitals. The patients for the study were selected randomly from 3310 adult patients (every 10th patient admitted to these hospitals). For the study 210 patients (122 women and 88 men) were qualified. Their mean age was 54 +/- 16 years (range 15-82 years). The patients were subjected to various biochemical tests including determination of antioxidant vitamins (vitamins A, E and C), vitamin B12, folic acid, ferritin, and homocysteine and blood lipids. Vitamin deficiency accepted as vitamin malnutrition was found in the case of vitamin C in 51.8% of the patients, folic acid in 32%, vitamin E in 10%, vitamin B12 in 6.8%, vitamin A in 1.4%. Vitamin deficiency was equally frequent in patients with malnutrition, overweight or with obesity. Lipid profile disturbances were found in 51% and high homocysteine level in 63% of the studied patients.