Comparison of the efficacy and safety of a proposed biosimilar MSB11456 with tocilizumab reference product in subjects with moderate-to-severe rheumatoid arthritis: results of a randomised double-blind study.

Objective: To evaluate the efficacy, immunogenicity and safety of the proposed biosimilar MSB11456 versus European Union (EU)-approved tocilizumab reference product in patients with rheumatoid arthritis (RA) in a multicentre, randomised, double-blind, multinational, parallel-group study (NCT04512001).

Methods: Adult patients with moderate-to-severe active RA and inadequate clinical response to ≥1 disease-modifying antirheumatic drug (synthetic or biologic) receiving methotrexate were randomised to receive 24 weekly subcutaneous 162 mg injections of either MSB11456 or EU-approved tocilizumab. Equivalence between treatments was considered if the 95% CI (European Medicines Agency)/90% CI (US Food and Drug Administration) for the difference in mean change from baseline to week 24 in Disease Activity Score-28 Joint Count with erythrocyte sedimentation rate (DAS28-ESR) between treatments was entirely within prespecified equivalence intervals (-0.

Blood serum levels of amino-terminal pro-C-type natriuretic peptide in patients with systemic sclerosis.

The aim of this pilot study was to examine the association of serum levels of amino-terminal fragment of pro-C-type natriuretic peptide (NT-proCNP), as a substitute measure of serum C-type natriuretic peptide (CNP), with clinical and laboratory findings in patients with systemic sclerosis (SSc). Serum NT-proCNP, soluble (s)E-and sP-selectin levels were examined using specific enzyme-linked immunosorbent assay in 30 patients with SSc and 30 healthy controls. We found no statistically significant difference in serum levels of NT-proCNP neither between patients with SSc and healthy controls nor between those treated with immunosuppressive agents and untreated patients.

Fucosylation of serum alpha1-acid glycoprotein in rheumatoid arthritis patients treated with infliximab.

To analyze fucosylation of alpha(1)-acid glycoprotein (AGP) and to identify relations between AGP fucosylation and clinical and biochemical indices of disease activity in patients with rheumatoid arthritis (RA) treated with monoclonal antitumor necrosis factor (TNF) antibody infliximab, we examined 22 patients with RA who underwent a 54-week treatment with infliximab according to ATTRACT protocol. Blood samples were collected at baseline and before every infusion of infliximab. AGP fucosylation was measured using lectin-binding enzyme-linked immunosorbent assay utilizing fucose-specific lectin Aleuria aurantia (AAL).

[Anticardiolipin antibodies and cardiac involvement in systemic lupus erythematosus].

Unlabelled: Anticardiolipin antibodies (aCL) are present in 24-61% of patients (pts) with systemic lupus erythematosus (SLE). It is suggested that they may be associated with valvular abnormalities recognized on echocardiography (ECHO). To evaluate the relation of raised aCL and cardiac abnormalities we performed ECHO in 48 pts with SLE.

The effect of methotrexate and azathioprine on the serum levels of IgA-alpha 1-antitrypsin complex in juvenile chronic arthritis.

In the present study we investigated the influence of methotrexate (MTX) and azathioprine (AZA) on the serum levels of the IgA-alpha 1-antitrypsin (IgA-AT) complex in patients with the systemic form of juvenile chronic arthritis (JCA). Fifty-six JCA patients (22 treated with MTX, 18 treated with AZA, and 16 not treated with any immunosuppressive agent) were enrolled in the study. MTX dosage ranged from 0.

Immunoglobulin A--alpha-1-antitrypsin complex in rheumatic diseases.

Immunoglobulin A-alpha-1-antitrypsin complex (IgA-AT) is a nonimmune complex formed by disulphide bonding between an active thiol group available on the cysteine residue of alpha heavy chains of IgA and a cysteine in position 232 of alpha l-antitrypsin in single polypeptide chain. The level of the complex can easy be determined using the ELISA method and findings are expressed in arbitrary units. In the healthy adults' sera the IgA-AT complex level is lower than 0.

The 5-HT3 blockers in the treatment of the primary fibromyalgia syndrome: a 10-day open study with Tropisetron at a low dose.

A 10-day open trial with Tropisetron, the selective serotonin type 3 receptor antagonist, in a dose of 5 mg daily was undertaken in 19 patients with the primary fibromyalgia syndrome (FB). Before and after the therapy, pain was assessed using a visual analogue scale and a pain score. All the patients were asked about the presence and intensity of vegetative and functional symptoms.

Acute phase response in rheumatoid arthritis patients treated with immunosuppressive drugs.

We sought to investigate an influence of immunosuppressive drugs on acute phase response (APR) in rheumatoid arthritis (RA). Ninety-six patients (pts) were treated with methotrexate (MTX), or with cyclophosphamide (CTX) (9-intravenously, 19-orally), or with cyclosporin A (CSA). C-reactive protein (CRP), alpha-1-acid glycoprotein (AGP), and alpha-1 antichymotrypsin (ACT) serum levels were measured by rocket immunoelectrophoresis.

Interleukin 10 inhibits interleukin 6 production and acute phase response in rheumatoid arthritis.

To evaluate the effect of interleukin 10 (IL-10) on acute phase response, we determined serum levels of IL-10, interleukin 6 (IL-6), C-reactive protein (CRP), alpha-1-acid glycoprotein (AGP), alpha-1-anti-chymotrypsin (ACT) in 34 rheumatoid arthritis (RA) patients. IL-10 and IL-6 levels were evaluated using an enzyme-linked immunoassay (ELISA). CRP, AGP and ACT levels were measured using rocket immunoelectrophoresis.

Circulating interleukin 10 and interleukin-6 serum levels in rheumatoid arthritis patients treated with methotrexate or gold salts: preliminary report.

In order to evaluate the relationship between serum concentrations of interleukin-10 (IL-10), IL-6, and acute phase proteins in rheumatoid arthritis (RA) patients treated with methotrexate (MTX) or intramuscular gold (IMG) we determined IL-10, IL-6, C-reactive protein (CRP), alpha-1-acid glycoprotein (AGP) and alpha-1-antichymotrypsin (ACT) in the sera of 35 RA patients. IL-10 and IL-6 levels were evaluated using an enzyme-linked immunoassay (ELISA). AGP and ACT level were measured using rocket immunoelectrophoresis.

Comparison of microheterogeneity of alpha-1-acid-glycoprotein in serum and synovial fluid from rheumatoid arthritis patients.

Microheterogeneity of alpha-1-acid glycoprotein was studied using affinity immunoelectrophoresis with concanavalin A as a ligand in the samples of serum and synovial fluid obtained at the same time from 22 patients with rheumatoid arthritis. Individuals with intercurrent infection or other illnesses were excluded from the study. The results were expressed as reactivity coefficient (RC).

Does IgA-alpha1 antitrypsin complex correlate with IgM, IgG and IgA rheumatoid factor in early rheumatoid arthritis?

This study was undertaken to determine whether the rheumatoid factor (RF) isotypes affect the level of IgA-AT complex in early rheumatoid arthritis. IgA-AT complex and IgM, IgG, and IgA RF were evaluated using a double antibody enzyme-linked immunosorbent assay (ELISA) in sera of 83 (61 women and 22 men) patients. The mean level of the complex was higher in RA patients as compared with the control group (0.