Fibroblast growth factor-23 in patients with systemic sclerosis: A case–control study

AbstractBackgroundFibroblast growth factor-23 (FGF-23) is actively involved in phosphate homeostasis and skeletogenesis.Aim of the workTo assess the serum level of FGF-23 in systemic sclerosis (SSc) patients (both diffuse dSSc and limited lSSc subtypes) in order to find if it has a role in the pathogenesis of the disease and study its relation to the clinical manifestations.Patients and methodsThe study included 30 dSSc patients, 30 lSSc and 28 age and sex matched controls. In patients, clinical examination and laboratory investigations were performed and Medsger severity scale assessed. Serum FGF-23 was measured using ELISA.ResultsThe age of dSSc patients was 36.94±9.89years and the lSSc 38.36±10.04years. The serum FGF-23 level was 23.44±14.86pg/ml in dSSc patients, 20.01±13.92pg/ml in lSSc patients and 23.09±11.45pg/ml in the control (p=0.58). No significant difference in the FGF-23 level was found according to the presence of lung fibrosis (p=0.6). There was no significant difference in FGF levels among patients according to the severity (p=0.39). In SSc patients there was a significant correlation between FGF and serum phosphorus especially in dSSc patients (r=0.6, p=0.003). Serum urea significantly correlated with FGF-23 in those with dSSc (r=0.46, p=0.037). There was no significant difference in the FGF-23 levels (p=0.18) between those with a normal and impaired glomerular filtration rate.ConclusionThe mean serum level of FGF-23 in this study showed no significant difference between systemic sclerosis patients and their subtypes with the normal subjects. It seems to have no role in the clinical manifestations of the disease

Determination of serum visfatin levels in patients with Behcet’s disease: a case–control study

Abstract Aim of the work: Behc¸et’s disease (BD) is an inflammatory, systemic and chronic disorder with unknown etiology affecting multiple systems. Visfatin is a new adipokine with insulinmimetic properties and pro-inflammatory function. The serum visfatin levels were evaluated in BD patients to investigate its role in the pathogenesis and clinical manifestations of the disease. Patients and methods: Forty BD patients were recruited from the Behc¸et’s disease clinic at Shiraz University of Medical Sciences in southern Iran and 40 healthy control subjects of matching age, sex and body mass index (BMI) were also included. Serum visfatin level was measured using ELISA. Results: The 40 BD patients included 16 males and 24 females. Seventeen had active clinical manifestations; 16 with oral ulcer, 5 with genital ulcer, 6 with arthritis and 2 with uveitis. The mean age of the BD patients was 34.95 ± 9.6 years and mean BMI was 23.98 ± 4.44. There were no significant differences between cases (5.05 ± 3.05 ng/ml) and controls (4.72 ± 2.84 ng/ml) in the visfatin level (p = 0.61). The difference in the visfatin level between patients with active and inactive manifestations did not reach statistical significance (6.13 ± 3.20 and 4.25 ± 2.73, respectively; p = 0.07). There was no significant difference according to the gender of the patients or the presence of clinical manifestations

Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial

Background/objective: Osteoporosis is a global health concern with an increasing prevalence worldwide. Denosumab is an antiresoptive agent that has been demonstrated to be effective and safe in osteoporotic patients. This study aimed to compare the efficacy and safety of the biosimilar denosumab candidate (Arylia) to the originator product (Prolia®) in postmenopausal osteoporotic patients. Methods: In this randomized, double-blind, active-controlled, noninferiority trial, postmenopausal osteoporotic patients received 60 mg of subcutaneous Arylia or Prolia® at months 0, 6, and 12 and were followed up for 18 months. The primary endpoint was the noninferiority of the biosimilar product to the reference product in the percentage change of bone mineral density (BMD) in 18 months at the lumbar spine (L1-L4), total hip, and femoral neck. The secondary endpoints were safety assessment, the incidence of new vertebral fractures, and the trend of bone turnover markers (BTMs). Results: A total of 190 patients were randomized to receive either biosimilar (n = 95) or reference (n = 95) denosumab. In the per-protocol (PP) analysis, the lower limits of the 95 two-sided confidence intervals of the difference between Arylia and Prolia® in increasing BMD were greater than the predetermined noninferiority margin of � 1.78 at the lumbar spine, total hip, and femoral neck sites (mean differences 95% CIs of 0.39 � 1.34 to 2.11, 0.04 � 1.61 to 1.69, and 0.41 � 1.58 to 2.40, respectively). The two products were also comparable in terms of safety, new vertebral fractures, and trend of BTMs. Conclusion: The efficacy of the biosimilar denosumab was shown to be noninferior to that of the reference denosumab, with a comparable safety profile at 18 months. Trial registration: ClinicalTrials.gov, NCT03293108; Registration date: 2017�09-19. © 2022, The Author(s)