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 assessing the potency of MSCs to produce anti-inflammatory cytokines in response to a pro-inflammatory stimulus. The method comprises stimulating the MSCs with one or more proinflammatory cytokines, such as TNF-α, for a duration of time and then identifying and quantifying the production of anti-inflammatory cytokines. MSCs that produce potent levels of anti-inflammatory cytokines in response to TNF-α can be used in treatments for aging-related conditions, including aging frailty and Alzheimer's disease, and can also be used to treat corona virus infections. The method shows that TNF-α induced MSCs robustly secrete several anti-inflammatory cytokines, including IL-1 receptor antagonist (IL-1RA), IL-10, and granulocyte colony stimulating factor (G-CSF).

The present invention provides compounds and methods targeting human interleukin-19, including therapeutic antibodies, pharmaceutical compositions and diagnostic applications useful in the field of immune-mediated diseases including psoriasis, atopic dermatitis, psoriatic arthritis, bronchial asthma and diabetic nephropathy.

The present invention relates to an in vitro method for evaluating the prognosis of an autoimmune or chronic inflammatory disease in an individual, comprising the following steps: a) determining (i) the level of an anti-IL-17 autoantibody and/or (ii) the level of an [IL-17/anti-IL-17 autoantibody] complex in a biological sample of the individual, and b) comparing the level of autoantibody and/or of complex determined in step a) with a reference value, the comparison being indicative of the prognosis of an autoimmune or chronic inflammatory disease in said individual.

Provided are methods for aiding in diagnosis and treatment of non-small cell lung cancer (NSCLC) adenocarcinoma. The methods involve determining elevated circulating Interleukin-18 (IL-18) values to aid in the diagnosis and treatment of NSCLC. Medical interventions based on determining circulating IL-18 levels are provided and include additional scanning, surgical resection of tumors, and administration of adjuvant therapy, such as chemotherapy or immune therapy.

Disclosed herein are immunogenic compositions (e.g., vaccines) for use in the treatment of mycobacteria infections and biomarkers for monitoring of therapeutic responsiveness to the immunogenic compositions in a subject (e.g., a human). In a first aspect, the disclosure features a pharmaceutical composition containing between 1×10{circumflex over ( )}2 CPU and 1×10{circumflex over ( )}10 CPU of a Mycobacterium tuberculosis strain (Mtb) with one or more mutations that ablate or reduce expression of LprG and Rv1410 (ΔLprG Mtb) in a volume of between 0.05 mL and 3 mL.

The present invention provides means and methods for treating Interleukin 18 (IL-18)-associated diseases and disorders. In particular, the present invention discloses antibodies specific for free IL-18 and IL-18 Binding Protein (IL-18BP) for use in such treatments and for the diagnosis of the indications.

Described in certain example embodiments herein are methods of treating or preventing a Borrelia burgdorferi (B. burgdorferi) infection, a symptom thereof, or a disease, disorder or condition resulting therefrom in a subject in need thereof that include reducing or eliminating a B. burgdorferi peptidoglycan-associated protein (PAP), optionally neutrophil attracting protein A (NapA), a function thereof, activity thereof, or any combination thereof in the subject in need thereof. Also described herein are methods of diagnosing and/or prognosing B. burgdorferi infection in a subject that include detecting a B. burgdorferi PAP, optionally NapA.

The present invention relates to the use of components of the IL23 pathway as biomarkers, e.g., IL22, LCN2 and combinations thereof, to stratify or identify populations of patients suffering from IL23-mediated diseases (e.g., Crohn's disease) responsive to treatment with an anti-IL23 antagonist (including, e.g., anti-IL23 antibodies or antigen-binding fragments thereof). Levels of IL23 pathway biomarkers above or below a predetermined threshold can be used, for example, (i) to determine whether a patient with an IL23-mediated disease or disorder such a Crohn's disease is eligible or non-eligible for treatment with a therapeutic agent (e.g., an anti-IL23 antibody), (ii) to determine whether treatment with a certain agent should be commenced, suspended, or modified, (iii) to diagnose whether the IL23-mediated disease is treatable or not treatable with a specific therapeutic agent, or (iv) to predict the outcome of treating the IL23-mediated disease with a specific therapeutic agent.

Provided by the disclosure are compositions and methods for modulating differentiation of regulatory T cells. In some embodiments, methods include selectively decreasing IL-23R activity and/or IL-23R expression without significantly decreasing IL-12RP activity and/or IL-12RP expression.