A method of determining a pharmacodynamics or pharmacokinetic effect of an inhibitor of IL 1α comprising providing a sample from a subject; administering the inhibitor of IL 1α to the sample; measuring levels of one or more biomarkers in the sample; and determining the pharmacodynamic or the pharmacokinetic effect of the inhibitor of IL 1α based on the levels of the one or more biomarkers.

A method for screening a therapeutic drug used for treating psoriasis includes the steps of: (a) isolating and separating fresh peripheral blood mononuclear cells (PBMC); (b) activating the peripheral blood mononuclear cells with a stimulant to cause the cells to produce IFN-γ and RANTES; (c) administering the plurality of candidate drugs to the activated peripheral blood mononuclear cells; (d) detecting expression levels of IFN-γ and RANTES in the peripheral blood mononuclear cells administered with the plurality of candidate drugs; (e) recognizing and removing a disqualified drug from the plurality of candidate drugs according to a variation degree of the expression level of RANTES; and (f) screening the therapeutic drug from the plurality of the candidate drugs excluding the disqualified drug according to the expression level of IFN-γ.

Methods for treating coronavirus disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, is described. The methods can be used to reduce the severity of outcomes related to COVID-19, such as hospitalization and ventilation. For example, treatment of a subject with a therapeutic agent that neutralizes interleukin 13 (IL-13) can result in reduced risk for mechanical ventilation in the subject. Also described are methods of predicting risk of mechanical ventilation in subjects with COVID-19.

Disclosed are methods for conducting diagnostic tests for the detection of the inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis. Also described are methods for monitoring a patient by administering tests of the present invention. Also described are methods for monitoring patient’s treatment by administering tests of the present invention. Also described are methods for evaluating the effectiveness of a drug or a drug candidate by administering tests of the present invention to samples from patients, animal models, and cell cultures treated with a drug or a drug candidate. Also disclosed are methods for determining the usefulness of analytes, e.g. cytokines, for acting as diagnostic and monitoring markers for inflammatory bowel disease in the various methods of the invention.

Methods of determining one or more ratios of chemokines in gingival crevicular fluid of an individual selected from the group consisting of: MIF:MIP1a, MIF:CXCL1; MIF:CXCL5; M1F:CXCL8; MIF:CXCL2; and MIF:CXCL6 and methods of identifying an individual as having gingivitis comprising determining one or more ratios of the chemokines in gingival crevicular fluid are disclosed. Methods of treating individuals who are identified as having gingivitis by determining one or more ratios of the chemokines in gingival crevicular fluid are disclosed. Also disclosed are methods of monitoring the treatment individuals who have gingivitis.

Systemic Lupus Erythematosus is marked by altered immune regulation linked to waxing and waning clinical disease. Embodiments described herein identify sets of biomarkers/mediators and their use for informing and/or predicting a future SLE disease activity event such as an impending SLE flare or SLE-related organ inflammation. Such an approach can be beneficial in the management of lupus.

Methods of identifying an individual as being a slow gingivitis responder or a high gingivitis responder are disclosed. Some methods are based on IL-1β levels in the individual's GCF at the site of inflammation. Some methods are based on MIF and/or CCL-1 levels in the individual's GCF in healthy tissue distant from the site of inflammation. Some disclosed methods are based on temporal differences in IL-8, IL-6 and/or TNFα levels in the individual's GCF in healthy tissue distant from the site of inflammation during the development of plaque induced inflammation. Methods of treating an individual who has gingivitis and methods of preventing gingivitis are also provided. The treatment and prevention methods comprise determining if individual is a slow gingivitis responder or a high gingivitis responder and applying oral care compositions to the individual's oral cavity.

A method of diagnosis and treatment of primary biliary cholangitis is provided. Additionally, a pharmaceutical composition and a solid dosage form for the treatment of primary biliary cholangitis, containing ursodeoxycholic and obeticholic acids, are provided. The technical contribution resides in obtaining a new all-purpose pharmaceutical composition and solid dosage form for the treatment of PBC, which includes both ursodeoxycholic and obeticholic acids, which is effective in use at all stages of PBC and has a complex mechanism of action. In particular, simultaneous blockage of the transport and synthesis of bile acids is achieved.

This disclosure provides kits and methods for detecting markers in a sample from a subject with unknown status and generating a risk assessment of the presence or absence of cancer, such as colorectal cancer. In embodiments, a kit comprises at least two reagents, each specifically binding to one of at least two polypeptides in a sample from the subject. The polypeptides include IL-8 and ferritin. The kit further includes at least one standard comprising a known amount of at least one of the polypeptides. The kit can also include computer readable media comprising instructions to analyze the detected amounts of the at least two polypeptides using a machine learning algorithm to determine whether a subject has an increased risk of the presence of colorectal cancer.

The invention provides methods, kits and reagents for diagnosing fibromyalgia (FM) in an individual by determining whether the levels of one or more cytokines in the individual are altered, as compared to control levels. The altered level(s) or patterns of expression of the cytokines measured in the affected individual compared to the level from the control is predictive/indicative of FM in the individual.