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1.
Rheumatol Int ; 44(7): 1337-1343, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38727810

ABSTRACT

In the course of psoriatic arthritis (PsA), depression occurs much more often than in the general population. Depression can be considered a poor prognostic factor. The aim of the study was to assess the relationships between the occurrence of depression and the levels of proinflammatory cytokines in patients with PsA. The study included 86 (47F/39M) patients with PsA. Only patients with high disease activity (DAPSA > 28) were enrolled in the study. The severity of depressive symptoms was assessed using the Beck Depression Inventory II (BDI-II) for all patients. Additionally, sociodemographic data were collected. All patients were also assessed for the levels of interleukins (IL): IL-1, IL-6, IL-17A, IL-23, and tumor necrosis factor alpha (TNF-α) using the enzyme-linked immunosorbent assay (ELISA) test. In the study group, depression (BDI-II ≥ 14) was diagnosed in 45 patients (52%). Patients with coexisting depression reported higher levels of pain and disease activity on the visual analogue scale compared to patients without depression (8.5 vs. 7.7, p < 0.001 and 9.3 vs. 8.4, p < 0.001, respectively). The mean levels of proinflammatory cytokines [pg/ml], IL-1 and IL-6, were also higher in the group of patients with depression (46.4 vs. 4.7, p < 0.001 and 10.5 vs. 4.9, p < 0.001, respectively). The coexistence of depression in the course of Psoriatic Arthritis (PsA) is associated with higher levels of IL-1 and IL-6. Depression has a negative impact on the perception of the underlying disease and is linked to reduced social and occupational activity.


Subject(s)
Arthritis, Psoriatic , Depression , Severity of Illness Index , Humans , Arthritis, Psoriatic/psychology , Male , Female , Depression/epidemiology , Depression/psychology , Depression/blood , Middle Aged , Case-Control Studies , Adult , Interleukins/blood , Aged
2.
Antioxidants (Basel) ; 13(4)2024 Apr 14.
Article in English | MEDLINE | ID: mdl-38671910

ABSTRACT

Aronia (chokeberry, Aronia melanocarpa) is a valuable fruit that combines the health benefits of green tea and red wine and is gaining popularity worldwide. Aronia has a unique chemical composition with strong antioxidant properties, including anthocyanins and chlorogenic acids (CGAs). However, it remains unclear which specific compounds or groups are primarily responsible for the antioxidant properties of chokeberry. Therefore, an analysis of the antioxidant properties of aronia berries based on geographical region and their variability during ripening (from green to frostbitten fruit) was conducted. The fruits were collected from three locations for two years. The aim of our work was to identify the compounds responsible for the antioxidant properties of aronia berry extracts by using chemometric methods. The analyses of anthocyanins and CGAs were performed using HPLC-DAD, and the antioxidant capacity was assessed by FRAP and DPPH methods. The PCA analysis also considered variations in temperature and precipitation. The chemometric analysis revealed a strong correlation between radical-scavenging properties and the content levels of chlorogenic acids. The results obtained in this study show that unripe green chokeberry fruits exhibit the highest antioxidant properties, which can be attributed to the high content of CGAs at this stage.

3.
Int J Mol Sci ; 25(8)2024 Apr 09.
Article in English | MEDLINE | ID: mdl-38673738

ABSTRACT

The high content of bioactive compounds in Aronia melanocarpa fruit offers health benefits. In this study, the anti-atherosclerotic effect of Aronia extracts was assessed. The impact on the level of adhesion molecules and the inflammatory response of human umbilical vein endothelial cells (HUVECs) was shown in relation to the chemical composition and the stage of ripening of the fruits. Samples were collected between May (green, unripe) and October (red, overripe) on two farms in Poland, which differed in climate. The content of chlorogenic acids, anthocyanins, and carbohydrates in the extracts was determined using HPLC-DAD/RI. The surface expression of ICAM-1 and VCAM-1 in HUVECs was determined by flow cytometry. The mRNA levels of VCAM-1, ICAM-1, IL-6, and MCP-1 were assessed using the quantitative real-time PCR method. The farms' geographical location was associated with the quantity of active compounds in berries and their anti-atherosclerotic properties. Confirmed activity for green fruits was linked to their high chlorogenic acid content.


Subject(s)
Atherosclerosis , Fruit , Human Umbilical Vein Endothelial Cells , Photinia , Plant Extracts , Photinia/chemistry , Humans , Plant Extracts/pharmacology , Plant Extracts/chemistry , Fruit/chemistry , Atherosclerosis/drug therapy , Vascular Cell Adhesion Molecule-1/genetics , Vascular Cell Adhesion Molecule-1/metabolism , Intercellular Adhesion Molecule-1/metabolism , Intercellular Adhesion Molecule-1/genetics , Anthocyanins/pharmacology , Anthocyanins/chemistry , Chemokine CCL2/genetics , Chemokine CCL2/metabolism , Chlorogenic Acid/pharmacology , Chlorogenic Acid/chemistry , Interleukin-6/metabolism , Interleukin-6/genetics
4.
Palliat Med ; 38(1): 150-155, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37937380

ABSTRACT

BACKGROUND: Studies have shown the risk factors for COVID-19 severity in children, including comorbidities, but information on the infection course in children with life-limiting conditions is sparse. AIM: To describe the effect of COVID-19 on pediatric patients receiving palliative care due to life-limiting conditions. DESIGN: We conducted retrospective cohort study. The WHO Clinical Progression Scale was used to measure COVID-19 severity. SETTING/PARTICIPANTS: Seven of the 24 invited pediatric palliative care centers participated in this study. We analyzed the medical records of children under palliative care with confirmed COVID-19 (January 2020-April 2022). RESULTS: Records of 60 patients with COVID-19 aged 0.24 to 21.6 years (mean (SD); 9.8 (6.6)) were collected. The largest group of patients with COVID-19 was children with congenital malformations and chromosomal abnormalities (42%); the most common manifestation was fever (85%). Bacterial coinfection was confirmed in 17 (28%) children. Fifteen (25%) children required hospitalization, including four admitted to the Intensive Care Unit. Mild COVID-19 was identified in 44 (73%) children, moderate in 11 (18%), severe in 3 (5%), and death in 2 (3%). Six of the 20 eligible children were vaccinated against SARS-CoV-2, followed by 16 mothers and fathers. CONCLUSION: In the study population initial presentation of COVID-19 was predominantly a mild; however, the small sample size precluded definitive conclusions. For children under palliative care, we should identify if they have an advance care plan for COVID-19, such as desires for intensive care support. Further studies are needed to define the short and long-term effects of COVID-19 in children with life-limiting conditions.


Subject(s)
COVID-19 , Humans , Child , SARS-CoV-2 , Palliative Care , Retrospective Studies , Hospitalization
5.
Front Psychol ; 14: 1251357, 2023.
Article in English | MEDLINE | ID: mdl-37842712

ABSTRACT

Presenteeism has often been considered as the correlate of absenteeism and associated to productivity loss. This study sought to re-examine the psychometric properties of the 6-item Stanford Presenteeism Scale (SPS-6), a popular measure which has been translated in a number of languages. The study adopted a cross-sectional design with 268 participants aged 18 - 65 working in a multinational IT company with headquarters based in Poland. The respondents participated willingly in an online questionnaire on a presenteeism health-related productivity measure (SPS-6), job resources (peer support), job demands (work-to-family conflict), engagement and burnout. Their responses were subjected to statistical analyses. Confirmatory Factor Analysis revealed that the SPS-6 is better represented by two singular and independent components, namely completing work and avoiding distractions, rather than an aggregated measure of health-related productivity. In fact, the aggregated measure had convergent and discriminant validity issues. We also assessed, via Structural Equation Modeling (SEM), the explanatory role of the SPS-6 within the wider well-being discourse by subjecting its' factors as outcomes using the JD-R framework. Here, burnout was better at explaining its relationship to avoiding distractions and completing work compared to engagement, while avoiding distractions was more dominant than completing work in explaining indirect pathways. Given the convergent and discriminant validity of its two-dimensional measures, we argue that the SPS-6 is a better assessment of health-related productivity in the light of presenteeism when keeping both components separate rather than adding the scores from both dimensions to provide a global score as has been the practice so far. In addition, the SEM findings suggest that both SPS-6 components may require different theoretical explanations. This study supports a growing chorus of scholars who argue the need to look deeper into the presenteeism phenomenon, not least its measures.

6.
Brain Sci ; 13(8)2023 Jul 29.
Article in English | MEDLINE | ID: mdl-37626497

ABSTRACT

OBJECTIVES: To present a personalized approach in three cases of treatment-resistant, locoregionally aggressive forms of cANCA-positive granulomatosis with polyangiitis (GPA) and skull base involvement. METHODS: Three patients with GPA and skull base involvement were described alongside a critical review of the current literature. RESULTS: All presented patients suffered from GPA with an inflammatory tumor at the skull base, alongside cerebellopontine angle involvement, cranial nerve palsies, cerebellar disorders, concomitant hearing loss, and severe otalgia. Symptoms were associated with progressive granulomatous destruction of the temporal bone, laryngopharynx, and central nervous system infiltration. Treatment with cyclophosphamide and high doses of glucocorticoid steroids were ineffective but subsequent therapy with rituximab was successful in the presented cases. The literature review showed that the course of the disease with skull base involvement is associated with poorer clinical and radiological responses to standard pharmacotherapies. CONCLUSION: Granulomatous inflammation localized in the skull base is associated with a more aggressive disease progression and is less likely to respond to pharmacotherapy. Standard induction therapy with cyclophosphamide and glucocorticoid steroids may be ineffective. A better response may be achieved by using rituximab and concomitant local treatment with glucocorticoid steroid injections.

7.
Molecules ; 28(8)2023 Apr 13.
Article in English | MEDLINE | ID: mdl-37110676

ABSTRACT

Turmeric is a traditional Indian spice that has recently become very popular worldwide because it contains a powerful ingredient called curcumin, which has strong anti-inflammatory properties. Hence, dietary supplements containing extracts rich in curcumin have gained great popularity. The main problems related to curcumin-containing dietary supplements are poor water solubility and the fact that they are often faked by using synthetic curcumin instead of the plant extract. In this article, we propose the use of the 13C CPMAS NMR method to control the quality of dietary supplements. The analysis of 13C CPMAS NMR spectra supported by GIPAW computations allowed us to identify a polymorphic form present in dietary supplements (which affected the solubility of curcumin) and to point out a dietary supplement that could be faked by using synthetic curcumin. Further PXRD and HPLC investigations confirmed that the examined supplement contained synthetic curcumin instead of the genuine extract. Our method can be used for routine control, especially because the investigation is performed directly from the capsule/tablet content and does not require any special sample preparation.


Subject(s)
Curcumin , Curcumin/chemistry , Dietary Supplements/analysis , Curcuma/chemistry , Plant Extracts/chemistry
8.
Blood Cells Mol Dis ; 98: 102709, 2023 01.
Article in English | MEDLINE | ID: mdl-36371928

ABSTRACT

OBJECTIVES: To present the rheumatological manifestations of chronic graft versus host disease (cGVHD) and describe how they differ from primary systemic connective tissue diseases. METHODS: Description of 7 patients with cGVHD with symptoms resembling Sjögren's syndrome and scleroderma, with a critical review of the literature. RESULTS: 7 patients treated at the hematology department, who developed cGVHD with present antinuclear antibodies, were referred to the rheumatology department for further evaluation. All patients presented symptoms of dry eye syndrome confirmed with ophthalmic tests. If the diagnosis of GVHD was not an exclusion criterion, Sjögren's syndrome criteria would be met by 4 of our patients - they presented not only with dryness but also with typical antibodies, inflammatory changes in salivary glands on ultrasound examination, and mononuclear cell infiltration in histopathological examination of labial salivary glands. Additionally, three patients presented with scleroderma-like syndromes, but with symptoms easy to differentiate from systemic sclerosis. CONCLUSION: cGVHD may be difficult to distinguish from Sjögren's syndrome, but such distinction is important due to the different standards of treatment in cGVHD and primary connective tissue diseases.


Subject(s)
Graft vs Host Disease , Sjogren's Syndrome , Humans , Sjogren's Syndrome/diagnosis , Sjogren's Syndrome/pathology , Graft vs Host Disease/diagnosis , Graft vs Host Disease/etiology
9.
J Pharm Biomed Anal ; 213: 114682, 2022 May 10.
Article in English | MEDLINE | ID: mdl-35228055

ABSTRACT

Energy drinks (EDs) are widely consumed to stimulate psychomotor functions and improve the efficiency of the human body. They typically contain caffeine, taurine, sugars or sweeteners, vitamins and organic acids. EDs were selected for the study in terms of composition diversity, reflecting the variety of products available on the Polish market. The analysis of the composition of energy drinks was performed using 1H NMR spectroscopy, HPLC-DAD, titration and refractometric methods. Diagnostic signals in 1H NMR spectra of the citric acid, caffeine and niacinamide were used for quantitative analysis. The citric acid content in energy drinks ranged from 140 to 780 mg per 100 mL. The niacinamide content in the tested energy drinks varied from 3.4 to 9.7 mg per 100 mL and was usually higher than it was reported on the label. The amount of caffeine (from 19 to 40 mg) was slightly lower than labeled. Quantitative determinations by 1H NMR and HPLC are compatible and can be successfully used interchangeably. In the so-called "sugar-free" drinks, no simple sugars or sucrose were found, thus 1H NMR can easily and quickly recognize ED without the addition of sugar. Our studies showed that 1H NMR spectroscopy is a valuable tool for quality control of energy drinks.


Subject(s)
Energy Drinks , Caffeine/analysis , Chromatography, High Pressure Liquid , Energy Drinks/analysis , Humans , Proton Magnetic Resonance Spectroscopy , Taurine
10.
Diagnostics (Basel) ; 12(3)2022 Mar 21.
Article in English | MEDLINE | ID: mdl-35328313

ABSTRACT

The recently introduced term "two-photon vision" relates to the visual perception resulting from a simultaneous absorption of two photons by photoreceptors. In this study, we determined two-photon retinal sensitivity in age-related macular degeneration (AMD) and compared it that in normal aging. Microperimetry was performed with visible (white) light and infrared (IR) light, which was perceived as green in the two-photon stimulation. In total, 45 subjects were included with one (better) eye studied. Furthermore, best-corrected visual acuity (VA) and ocular straylight were assessed. AMD resulted in decreased median (interquartile range) logMAR VA, i.e., 0.15 (0.05; 0.24), which in normal eyes was −0.02 (−0.06; 0.02). The two groups showed comparable straylight levels. Sensitivity to IR light was significantly lower in the AMD group (p < 0.001): 8.3 (7.4, 9.3) dB than in controls 10.7 (9.7, 11.2) dB. AMD also significantly affected visible light sensitivity (p < 0.001): 14.0 (11.0; 15.5) dB vs. 18.0 (16.3; 18.9) dB. Notably, the two-photon approach yielded a lower data spread. In conclusion, AMD considerably impairs retinal sensitivity measured in the single- and two-photon realm. However, two-photon-vision microperimetry may improve the testing accuracy and offer an additional diagnostic parameter (beyond VA measurements) for retinal function assessment.

11.
J Pharm Biomed Anal ; 212: 114650, 2022 Apr 01.
Article in English | MEDLINE | ID: mdl-35152007

ABSTRACT

Hemp oil is widely used in the food industry, and also in many other industries. It is characterized by a high content of unsaturated fatty acids with the optimal ratio of ω-6 to ω-3 fatty acids (3:1). Such composition means that this oil is often used in the food, pharmaceutical and cosmetic industries. Due to the popularity of hemp oil and its high content of unsaturated fatty acids, methods for the quick oil quality analysis are sought. Six samples of cold-pressed hemp oil were stored under different conditions (2-8 °C and 30 °C) for one month and then their 1H NMR spectra were recorded. The chemometric methods of PCA and OPLS-DA were used to perform the analysis of the spectra. The combination of those methods made it possible to observe the differences in the oil samples after a month of storage. Based on the 1H NMR spectra, it was possible to differentiate the time and conditions of the oil storage.


Subject(s)
Cannabis , Cannabis/chemistry , Chemometrics , Plant Extracts , Plant Oils/chemistry , Proton Magnetic Resonance Spectroscopy , Seeds/chemistry
12.
J Pharm Biomed Anal ; 212: 114658, 2022 Apr 01.
Article in English | MEDLINE | ID: mdl-35168124

ABSTRACT

The fatty acid composition is a parameter that determines the quality and origin of vegetable oils. The standard method used in the analysis of fatty acid composition is gas chromatography (GC). In the last 20 years, however, the 1H NMR method has become more important in the analysis of fatty acids. Thanks to no need of special sample preparation, the high speed of analysis and the possibility to automate the process of analysis, 1H NMR is becoming a popular method of testing vegetable oils. It is possible to test oils both qualitatively and quantitatively, taking into account both the fatty acid profile and the level of minor components. In combination with statistical and chemometric methods, the analysis of 1H NMR spectra allows one to obtain much valuable information about the tested oil, considering its composition, quality, the presence of impurities, or the origin. The paper presents an overview of publications focusing on the application of the 1H NMR method in the profiling of fatty acids in vegetable oils.


Subject(s)
Fatty Acids , Plant Oils , Chromatography, Gas , Fatty Acids/chemistry , Magnetic Resonance Spectroscopy , Plant Oils/chemistry , Proton Magnetic Resonance Spectroscopy
13.
J Clin Med ; 11(3)2022 Jan 30.
Article in English | MEDLINE | ID: mdl-35160217

ABSTRACT

OBJECTIVE: To investigate the associations of IL-18 serum levels with serum lipids, cardiovascular risk, and disease activity in patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) with axial (axPsA) and peripheral (perPsA) joint involvement. METHODS: 155 adult patients (PsA 61/AS 94) were enrolled in the study. Standard disease activity indices, BASDAI, and ASDAS, were calculated for AS and PsA and DAPSA for PsA. Sera from peripheral blood samples were obtained after night fasting. Serum concentrations of cytokines (IL-18, IL-17) were measured by ELISA, while lipid profile with total cholesterol (TC), triglycerides (TG), low-density cholesterol-(LDL), high-density cholesterol (HDL), and C-reactive protein (CRP) concentrations were determined using routine procedures. The atherogenic index was calculated using the standard formula AI = TC/HDL. RESULTS: Patients with PsA and peripheral joint involvement (perPsA) had significantly higher IL-18 serum levels than axial PsA and AS patients (medians 160 vs. 116 vs. 80 pg/mL). In patients with PsA and in the subgroup with PsA+ ischemic heart disease (IHD), IL-18 positively correlated with atherogenic index (AI) (rho = 0.46 and rho = 0.67, respectively) and TG serum concentrations (rho = 0.4 and rho = 0.675), while negatively with HDL levels (rho = -0.37 and rho = -0.608). In PsA + IHD subgroup IL-18 serum levels correlated positively also with disease activity (DAPSA) (rho = 0.613). Importantly, in patients with perPsA, characterized by the highest IL-18 serum levels, cardiovascular risk, and frequency of both hypertriglyceridemia and IHD, positive correlations between IL-18 and IL-17 (rho = 0.47, p = 0.002), TG (rho = 0.45 p = 0.01) levels and AI (rho = 0.63 p = 0.021) were found. Whereas linear regression models revealed that IL-17, TG concentrations and the tender joint count had an impact on IL-18 Conclusions: We confirmed that patients with perPsA are characterized by a more pronounced proinflammatory and proatherogenic cardiovascular risk profile than patients with axPsA and AS. Importantly our study indicates that in PsA, but not in AS, elevated serum concentration of IL-18 is associated with higher disease activity and proatherogenic lipid profile, leading to a higher cardiovascular risk. Thus, our results point out IL-18 as a critical contributor in these pathological processes and possible therapeutic targets.

14.
Rheumatology (Oxford) ; 61(4): 1385-1395, 2022 04 11.
Article in English | MEDLINE | ID: mdl-34142111

ABSTRACT

OBJECTIVE: To compare the safety and efficacy of switching from reference adalimumab to adalimumab biosimilar CT-P17 with continuing reference adalimumab/CT-P17 in active RA. METHODS: This double-blind, phase III study randomized (1:1) subjects with active RA to receive 40 mg (100 mg/ml) CT-P17 or European Union-sourced reference adalimumab subcutaneously every 2 weeks (Q2W) until week (W) 24 [treatment period (TP) 1]. Thereafter, subjects receiving reference adalimumab were randomized (1:1) to continue reference adalimumab or switch to CT-P17 from W26 (both Q2W until W48; TP2). Subjects receiving CT-P17 in TP1 continued CT-P17. W0-W24 results were previously reported; we present W26-W52 findings. End points were efficacy (including joint damage progression), pharmacokinetics, safety and immunogenicity. RESULTS: Of 607 subjects who initiated TP2 treatment, 303 continued CT-P17, 153 continued reference adalimumab and 151 switched to CT-P17. Efficacy improvements up to W24 were maintained during TP2; efficacy was comparable among groups. At W52, 20% improvement in ACR response rates were 80.5% (continued CT-P17), 77.8% (continued reference adalimumab) and 82.2% (switched to CT-P17). Joint damage progression was minimal. Mean trough serum adalimumab concentrations were similar among groups. CT-P17 and reference adalimumab safety profiles were numerically similar and switching did not affect immunogenicity. At W52, 28.4% (continued CT-P17), 27.0% (continued reference adalimumab) and 28.3% (switched to CT-P17) of subjects were anti-drug antibody-positive. CONCLUSION: Efficacy, pharmacokinetics, safety and immunogenicity of CT-P17 and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to CT-P17. TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT03789292.


Subject(s)
Antirheumatic Agents , Arthritis, Rheumatoid , Biosimilar Pharmaceuticals , Adalimumab/adverse effects , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/diagnostic imaging , Arthritis, Rheumatoid/drug therapy , Biosimilar Pharmaceuticals/adverse effects , Double-Blind Method , Humans , Tomography, X-Ray Computed , Treatment Outcome
15.
Invest Ophthalmol Vis Sci ; 62(15): 23, 2021 12 01.
Article in English | MEDLINE | ID: mdl-34935882

ABSTRACT

Purpose: Two-photon vision relies on the perception of pulsed infrared light due to two-photon absorption in visual pigments. This study aimed to measure human pupil reaction caused by a two-photon 1040-nm stimulus and compare it with pupil responses elicited by 520-nm stimuli of similar color. Methods: Pupillary light reflex (PLR) was induced on 14 dark-adapted healthy subjects. Three types of fovea-centered stimuli of 3.5° diameter were tested: spirals formed by fast scanning 1040-nm (infrared [IR] laser) or 520-nm (visible [VIS] laser) laser beams and uniformly filled circle created by 520-nm LED (VIS light-emitting diode [LED]). The power of visible stimuli was determined with a dedicated procedure to obtain the same perceived brightness equivalent as for 800 µW used for two-photon stimulation. Results: The minimum pupil diameter for IR laser was 88% ± 10% of baseline, significantly larger than for both VIS stimuli: 74% ± 10% (laser) and 69% ± 9% (LED). Mean constriction velocity and time to maximum constriction had significantly smaller values for IR than for both VIS stimuli. Latency times were similar for IR and VIS lasers and slightly smaller for VIS LED. Conclusions: The two-photon stimulus caused a considerably weaker pupil reaction than one-photon stimuli of the same shape, brightness, and similar color. The smaller pupil response may be due to weaker two-photon stimulation of rods relative to cones as previously observed for two-photon vision. Contrary to normal vision, in a two-photon process the stray light is not perceived, which might reduce the number of stimulated photoreceptors and further weaken the PLR.


Subject(s)
Light , Pupil/radiation effects , Reflex, Pupillary/physiology , Adult , Dark Adaptation , Female , Humans , Infrared Rays , Male , Photons , Reaction Time , Young Adult
17.
Ther Adv Musculoskelet Dis ; 13: 1759720X211051471, 2021.
Article in English | MEDLINE | ID: mdl-34707696

ABSTRACT

BACKGROUND: This study aimed to evaluate the efficacy and safety of secukinumab 150 mg compared with placebo in the management of spinal pain and disease activity in patients with axial spondyloarthritis (axSpA) at Week 8 and up to Week 24. METHODS: Patients (n = 380) with active axSpA were randomized (3:1) to secukinumab 150 mg (Group A) or placebo (Group B). At Week 8, patients from Group A with an average spinal pain score <4 were defined as responders and were re-assigned to secukinumab 150 mg (Arm A1); whereas non-responders were re-randomized to secukinumab 150/300 mg (Arm A2/A3). Patients from Group B were re-randomized (1:1) to secukinumab 150/300 mg (Arm B1/B2). RESULTS: At Week 8, the odds of achieving an average spinal pain score of <4 were significantly higher for patients on secukinumab 150 mg than for patients on placebo (odds ratio (OR): 1.89; 95% confidence interval (CI): 1.08-3.33; p = 0.0264). Further reductions in spinal pain were observed across treatment groups up to Week 24. Pronounced improvements were also observed in other disease activity measurements, such as Bath Ankylosing Spondylitis Disease Activity Index and Ankylosing Spondylitis Disease Activity Score. Responders from Group A showed the highest improvements for all measured parameters of spinal pain compared with the other arms. No new or unexpected safety signals were observed. CONCLUSION: Secukinumab provided rapid and significant improvement in spinal pain at Week 8 which was sustained or increased further up to Week 24 in patients with axSpA. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03136861. Registered May 2, 2017.

19.
Arthritis Res Ther ; 23(1): 51, 2021 02 05.
Article in English | MEDLINE | ID: mdl-33546755

ABSTRACT

BACKGROUND: To demonstrate equivalent efficacy of the proposed high-concentration (100 mg/ml), citrate-free adalimumab biosimilar CT-P17 to European Union-approved adalimumab (EU-adalimumab) in subjects with active rheumatoid arthritis (RA). METHODS: This randomized, double-blind phase III study ( ClinicalTrials.gov , NCT03789292) randomized (1:1) subjects with active RA at 52 centers to receive CT-P17 or EU-adalimumab 40 mg subcutaneously every 2 weeks until week 52. Results to week 24 are reported here. The primary endpoint was 20% improvement by American College of Rheumatology criteria (ACR20) response rate at week 24. Equivalence was concluded if the corresponding confidence intervals (CIs) for the estimate of treatment difference were within predefined equivalence margins: - 15 to 15% (95% CI; European Medicines Agency assumption); - 12 to 15% (90% CI; Food and Drug Administration assumption). Additional efficacy, pharmacokinetic, usability, safety, and immunogenicity endpoints were evaluated. RESULTS: 648 subjects were randomized (324 CT-P17; 324 EU-adalimumab). The ACR20 response rate at week 24 was 82.7% (n = 268/324) in both groups (intention-to-treat population). The 95% CI (- 5.94 to 5.94) and 90% CI (- 4.98 to 4.98) were within predefined equivalence margins for both assumptions and equivalent efficacy was concluded. Additional endpoints and overall safety were comparable between groups. Mean trough serum concentrations of CT-P17 were slightly higher than those of EU-adalimumab. Immunogenicity was slightly lower numerically for the CT-P17 group than for the EU-adalimumab group. CONCLUSIONS: CT-P17 and EU-adalimumab have equivalent efficacy and comparable safety and immunogenicity in subjects with active RA. Overall safety of CT-P17 is consistent with the known safety profile of reference adalimumab. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03789292 . Registered 28 December 2018-retrospectively registered.


Subject(s)
Antirheumatic Agents , Arthritis, Rheumatoid , Biosimilar Pharmaceuticals , Adalimumab/therapeutic use , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/drug therapy , Biosimilar Pharmaceuticals/adverse effects , Double-Blind Method , Humans , Tomography, X-Ray Computed , Treatment Outcome
20.
Clin Anat ; 34(2): 244-262, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33090551

ABSTRACT

Iatrogenic nerve injury during surgery is a major source of concern for both patients and surgeons. This study aimed to identify the nerves most commonly injured during surgery, along with the commonly associated operative procedures. A literature search was conducted using the PubMed database to identify nerves commonly injured during surgery, along with the surgical procedure associated with the injury. The following 11 nerves, ranked in order with their associated surgical procedures, were found to be the most commonly injured: (a) intercostobrachial nerve in axillary lymph node dissections and transaxillary breast augmentations, (b) vestibulocochlear nerve in cerebellopontine tumor resections and vestibular schwannoma removals, c) facial nerve in surgeries of the inner ear and cheek region, (d) long thoracic nerve in axillary lymph node dissections, (e) spinal accessory nerve in surgeries of the posterior triangle of the neck and cervical lymph node biopsies, (f) recurrent laryngeal nerve in thyroid surgeries, (g) genitofemoral nerve in inguinal hernia and varicocele surgeries, (h) sciatic nerve in acetabular fracture repairs and osteotomies, (i) median nerve in carpal tunnel release surgeries, (j) common fibular nerve in varicose vein and short saphenous vein surgeries, and (k) ulnar nerve in supracondylar fracture surgeries. Although the root cause of iatrogenic nerve injury differs for each nerve, there are four unifying factors that could potentially decrease this risk for all peripheral nerves. These four influencing factors include knowledge of potential anatomical variations, visual identification of at-risk nerves during the procedure, intraoperative nerve monitoring, and expertise of the surgeon.


Subject(s)
Iatrogenic Disease , Peripheral Nerve Injuries/etiology , Surgical Procedures, Operative/adverse effects , Humans
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