AbstractIntroductionAnkylosing spondylitis (AS) is a condition that is treated with nonsteroidal anti‐inflammatory drugs and biological drugs such as anti tumor necrosis factor alpha (TNF‐α). This study examined the prevalence of COVID‐19 among individuals with AS and compare it between those receiving and not receiving TNF‐α inhibitors.MethodsA cross‐sectional study was conducted at the rheumatology clinic of Imam Khomeini Hospital in Tehran, Iran. The study included patients with AS who sought treatment at the clinic. Demographic information, laboratory and radiographic findings, and disease activity were recorded through interviews and examinations using a questionnaire.ResultsA total of 40 patients were studied over the course of 1 year. Among them, 31 patients were administered anti‐TNF‐α drugs, with 15 patients (48.3%) receiving subcutaneous Altebrel (Etanercept), 3 patients (9.6%) receiving intravenous Infliximab, and 13 patients (41.9%) receiving subcutaneous Cinnora (Adalimumab). Of the total, 7 patients (17.5%) tested positive for COVID‐19, 1 of whom was confirmed through both CT scan and polymerase chain reaction (PCR) testing, while the remaining 6 patients were confirmed only through PCR testing. All patients tested positive for COVID‐19 were male, and 6 of them had received Altebrel. Among the 9 AS patients who did not receive TNF inhibitors, 1 patient contracted SARS‐CoV‐2. The clinical symptoms experienced by these patients were mild, and hospitalization was not required. However, 1 patient who had insulin‐dependent type 1 diabetes and was receiving Infliximab required hospitalization. This patient exhibited more severe COVID‐19 symptoms, including high fever, pulmonary involvement, dyspnea, and decreased oxygen saturation. No cases of COVID‐19 were reported in the Cinnora treatment group. The use of any of the drugs did not demonstrate a significant relationship with the occurrence of COVID‐19 in patients.ConclusionsThe use of the TNF‐α inhibitors in patients with AS, may be associated with reduced hospitalization and death rate in COVID‐19 cases.

2021-03-01·Protein Expression and Purification4区 · 生物学

Optimization of culture conditions for high-level expression of soluble and active tumor necrosis factor-α in E. coli

4区 · 生物学

Article

作者: Mahboudi, Fereidoun ; Bayat, Elham ; Jahandar, Hoda ; Talebkhan, Yeganeh ; Barkhordari, Farzaneh ; Nematollahi, Leila ; Adeli, Ahmad ; Sabzalinezhad, Masoumeh ; Torkashvand, Fatemeh ; Damough, Shadi

Anti-TNF inhibitors exert their therapeutic effect by inhibition of the excessive amounts of TNF-α within the body. Recombinant TNF-α should be produced in a soluble refolded form to investigate the effectiveness and efficiency of anti-TNF-α compounds. In this research, the designed cassette was subcloned in the pET28a expression vector and expressed in E. coli BL21 (DE3). The identity of the protein was confirmed through SDS-PAGE and Western blotting. After optimizing expression conditions, protein purification was performed using native Ni-NTA affinity chromatography. The biological activity of the soluble recombinant TNF-α was investigated using MTT assay. Also, the affinity of an anti-TNF-α agent, Altebrel, was investigated against the expressed protein through ELISA. Optimization of TNF-α expression conditions represented that the highest expression could be achieved at 37 °C using 0.5 mM IPTG 6 h post-induction. The recombinant protein represented an inhibitory effect on the L929 murine fibroblast cell line and was successfully detected by Altebrel in ELISA. Binding kinetics were also studied using Cimzia as an anti-TNF-α molecule and 7.2 E^-13M was calculated as the equilibrium dissociation constant value (K_D). The significant expression level of the recombinant protein in the soluble form, its high purity, and assessment of its biological activity showed that the expressed protein could be used in tests of ELISA and MTT to assess the activity of anti-TNF-α agents.

2019-12-01·Iranian journal of biotechnology4区 · 工程技术

Physicochemical Characterization of Altebrel™, a Proposed Etanercept Biosimilar.

4区 · 工程技术

Article

作者: Mahboudi, Fereidoun ; Seyedjafari, Ehsan ; Sardari, Soroush ; Fazel, Ramin ; Vaziri, Behrouz

BACKGROUNDEtanercept is prescribed for the rapid and effective treatment of chronic immune-mediated inflammatory disorders. Due to the expiration of etanercept patents and worldwide demand for comparable and more affordable substitutes, several biosimilars of etanercept have been approved in different countries and new ones are in the process of approval.OBJECTIVESIn the present study, Altebrel™ as an etanercept proposed biosimilar was investigated in a side by side comparison using various orthogonal analytical methods.MATERIALS AND METHODSThree batches of the Altebrel™ and Enbrel^® samples were used for the study. Several physicochemical properties of samples were compared according to international guidelines, incliding; sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE), Capillary electrophoresis sodium dodecyl sulfate (CE-SDS), size exclusion high performance liquid chromatography (SE-HPLC), hydrophobic interaction chromatography high performance liquid chromatography (HIC-HPLC) and its biological activity was evaluated using surface plasmon resonance affinity analysis and tumor necrosis factor alpha (TNFα) neutralization biological assay. Amino acid analysis was applied to check the primary sequence and far-UV circular dichroism (CD) spectroscopy investigated the secondary structure.RESULTSThe obtained results indicated a high degree of similarity between Altebrel™ and Enbrel^®. Results of SDS-PAGE, CE-SDS, HIC-HPLC and SE-HPLC implied a comparable pattern of size variants for all samples. Based on the data achieved via in vitro bioactivity assays and SPR analysis, the functional property of Altebrel™ was proved comparable to that of the reference product. Moreover, amino acid analysis indicated similar primary structure and circular dichroism study implied a similar secondary structure for Altebrel™ and Enbrel^®.CONCLUSIONOverall, our data provide analytical evidence for structural and in vitro functional similarity between Altebrel™ and Enbrel^®.

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强直性脊柱炎	伊朗	Aryogen Pharmed	-
银屑病关节炎	伊朗	Aryogen Pharmed	-
幼年特发性关节炎	伊朗	Aryogen Pharmed	-
斑块状银屑病	伊朗	Aryogen Pharmed	-
类风湿关节炎	伊朗	Aryogen Pharmed	-