Weeks Of Treatment Levels Research Articles

Changes of cytokine profile measures during the treatment of rheumatoid arthritis with rituximab biosimilar (Acellbia, BIOCAD) and the original drug (MabThera, F. Hoffmann-La Roche Ltd., Switzerland)

The aimof the investigation was to study the changes of cytokine profile parameters in patients with rheumatoid arthritis (RA) 12 and 24 weeks after initiation of therapy with rituximab (RTM) biosimilar at a total dose of 1200 mg, in comparison with the original drugMaterial and methods.The study included 54 patients with a reliable diagnosis of RA. Depending on the therapy, all patients were divided into two groups: 34 patients received the original RTM (group 1) and 20 patients – biosimilar (group 2) in a total dose of 1200 mg according to the standard scheme. The concentration of 27 cytokines in blood serum was determined by multiplex xMAP technology on the analyzer Bio-Plex Array System (BIO-RAD, USA).Results and discussion.The use of the original drug has been accompanied by reliable and significant reduction (over 30%) by 24 weeks of treatment levels of proinflammatory [interleukin (IL) 1â, IL2, IL6, IL12, IL15, interferon ã (IFN-ã), tumor necrosis factor á (TNF-á)], IL1 receptor antagonist (IL1ra), IL5, IL9, IL10, IL13 cytokines, growth factors (IL7, granulocyte-macrophage colony stimulating factor, fibroblast growth factor) and chemokines (monocyte chemoattractant protein 1 – MCP1). During the treatment with Acellbia a rapid and marked reduction in the concentration of practically the whole range of investigated parameters already 12–24 weeks after the first infusion was achieved. After 24 weeks a decrease in the concentration IL1â, IL1ra, IL2, IL4, IL5, IL6, IL7, IL8, IL9, IL10, IL12, IL13, IL15, IL17, eotaxin, granulocyte colony-stimulating factor, IFN-ã, IFN-ã-induced protein 10, MCP1, macrophage inflammation protein 1â, TNF-á, vascular endothelial growth factor was recorded (p<0.05).Conclusion.Analysis of the effectiveness of two infusions of RTM biosimilar Acellbia («BIOCAD», Russia) 24 weeks after the start of therapy shows its ability to cause a decrease of levels of proinflammatory cytokines, chemokines and growth factors in the blood serum. Changes of the cytokine profile during the therapy with Acellbia are not significantly different from that during the treatment with the original drug.

Time Androgens and Sexual Hormone Binding Globulin (SHBG) Take to Return to Baseline Levels Following Discontinuation of Oral Contraceptives Pills (OCP), in Women With Polycystic Ovary Syndrome (PCOS), A Prospective Study

To determine the time that it takes for androgens and SHBG in women with PCOS to return to their pretreatment levels, following discontinuation of therapy with an OCP containing drospirenone and ethinyl-estradiol. Prospective descriptive clinical trial. Eight (8) subjects with diagnosis of PCOS were assigned to receive a combination OCP containing drospirenone 3 mg and ethinyl-estradiol 30 μg for 12 weeks. After this treatment period, subjects discontinued OCP and were followed up during 8 weeks. All patients had, at least, 12 weeks without hormonal treatment and normal levels of thyroid-stimulating hormone, and prolactin before entering the study protocol. The diagnosis of PCOS was established by the exclusion of other conditions that can cause chronic anovulation with associated hyperandrogenism: 21-OH-deficient-non classic adrenal hyperplasia, ovarian-adrenal tumors, and Cushing’s syndrome. Serum samples were collected prior to and at week 12 of treatment, and also 4 and 8 weeks after discontinuation of OCP. Samples were frozen at -20 °C. We measured total (TT) and free testosterone (FT), dehydroepiandrosterone sulfate (DHEAS), and SHBG levels, by ELISA and RIA. Statistical analysis was performed using KwikStat-4 Statistical Data Analysis Program (TexaSoft, Cedar Hill, TX). A total of 7 PCOS subjects completed the study. Mean age was 26.29 years. Mean body mass index (BMI) at basal conditions and end of treatment period were 24.35 and 24.29 kg/m2, respectively (p = 0.86). Ferriman-Gallwey score decreased during treatment period, but change did not reach significance (mean baseline and post-treatment values were 4.14 and 3.86; p = 0.36). Mean initial and after 12 weeks of treatment levels for TT, FT, DHEAS, and SHBG were 4.14 nmol/L (119 ng/dL) and 1.9 nmol/L (54.86 ng/dL); 0.01 nmol/L (0.28 ng/dL) and 0.004 nmol/L (0.11 ng/dL); 4.4 μmol/L (164 μg/dL) and 2.84 μmol/L (105 μg/dL); 59 nmol/L and 311 nmol/L, respectively. Following discontinuation of OCP androgen levels increased progressively, at 4 and 8 weeks. Levels of TT (3.72 nmol/L = 107.3 ng/dL) and DHEAS (3.81 μmol/L = 140 μg/dL) at week 4 were not significantly different from those measured at baseline. Alternatively, FT (0.008 nmol/L = 0.22 ng/dL) and SHBG (54.4 nmol/L) returned to levels not significantly different from baseline values, only at week 8 post discontinuation of OCP. In this population of PCOS women, discontinuation of an OCP containing drospirenone 3 mg and ethinyl estradiol 30 μg was followed by return of TT and DHEAS to baseline levels in 4 weeks. On the other hand, levels of FT and SHBG returned to basal values only 8 weeks after discontinuation of OCP. These observations are pertinent when measuring androgens and SHBG in subjects suspected of having PCOS, who are currently taking OCP.

Effects of progesterone on the serum levels of FSH and LH in postmenopausal women treated with oestrogen.

ABSTRACT The effect on the serum levels of FSH and LH after the intramuscular administration of 10 or 100 mg progesterone in oil was studied in twenty postmenopausal women. Immunoreactive FSH and LH in the serum were assayed by a radioimmunosorbent technique. The administration of progesterone alone to ten women did not result in any major changes in the serum levels of the gonadotrophins. Ethinyloestradiol in an oral dose of 100 μg daily to the other ten women significantly decreased the high postmenopausal levels of gonadotrophins. After four weeks of treatment levels usually seen in women of fertile age were found. The relative decrease for FSH was greater than for LH. When 10 mg progesterone was administered after four weeks of oestrogen treatment, an increase in the serum levels of LH was found in all the six women studied associated with a sharp conspicuous LH peak in four of them. There was also a small increase in the serum levels of FSH. After the larger dose of progesterone, i. e. 100 mg, only one of five women showed an LH peak combined with a minor FSH increase. In the other four subjects, there was only a minor increase in the serum levels of LH which was not of the same magnitude as that found with the 10 mg dose. The FSH levels were, if anything, decreased. It thus appears that progesterone in low doses was more effective in inducing a release of gonadotrophins in postmenopausal women treated with oestrogen. This suggests that in this experimental situation progesterone does not act as an »antioestrogen[« and that this hormone, particularly in low doses, has a stimulating or facilitating effect on the hypothalamic-pituitary system.