Disclosed herein are engineered monovalent binding proteins that bind to one or more antigens, as well as methods of making and using the binding proteins in the prevention, diagnosis, and/or treatment of disease.

Provided herein are methods of adjusting or selecting a gluten peptide therapy based on the human leukocyte antigen (HLA) genotype, in particular HLA-DQ2.5 homozygosity, of a subject having or suspected of having Celiac disease. Also provided herein are methods of identifying (e.g., diagnosing) a subject, such as a subject having or suspected of having Celiac disease and/or assessing the efficacy of treatment of Celiac disease, e.g. by determining responsiveness to a therapeutic gluten peptide composition or cytokine response, and kits relating thereto.

The present invention provides methods for predicting clinical outcome from a sample of a subject having ulcerative colitis (UC), comprising determining a prognostic marker profile and classifying the subject as either a responder or a non-responder. The methods can be used to monitor and to predict the progression of UC, by determining the likelihood for UC to progress either rapidly or slowly in an individual based on the presence or level of at least one marker in a sample. The methods can also be used to predict the regression of UC, by determining the likelihood for UC to regress either rapidly or slowly in an individual.

Disclosed herein is a T-helper cell (“T.sub.H-GM” cell) that is regulated by IL-7/STAT5 and which secrete GM-CSF/IL-3. Also disclosed are methods and compositions for modulating T.sub.H-GM function for the treatment of, e.g., inflammatory disorders. Diagnostic and prognostic methods for specifically identifying T.sub.H-GM-mediated inflammatory disorders (e.g., rheumatoid arthritis), as distinct from and/or in addition to non-T.sub.H-GM-mediated (e.g., TNF-α-mediated) inflammatory disorders, are also provided.

The present system and method are useful for the removal of immune inhibitors such as soluble TNF receptors from the body fluid of cancer patients. In some embodiments, soluble TNF-Receptors 1 and 2 are selectively removed from plasma at 80% or more efficiency. In some embodiments, the system includes an immobilized capture ligand of a single chain TNFα. The system and method are useful for the treatment of different cancer types, stages and severity.

The present invention is directed to therapeutic methods using IL-6 antagonists such as antibodies and fragments thereof having binding specificity for IL-6 to improve survivability or quality of life of a patient in need thereof. In preferred embodiments, the anti-IL-6 antibodies will be humanized and/or will be aglycosylated. Also, in preferred embodiments these patients will comprise those exhibiting (or at risk of developing) an elevated serum C-reactive protein level or a reduced serum albumin level prior to treatment. In another preferred embodiment, the patient's Glasgow Prognostic Score will be increased and survivability will preferably be improved.

Presented herein are systems and methods for developing classifiers useful for predicting response to particular treatments. For example, in some embodiments, the present disclosure provides a method of treating subjects suffering from an autoimmune disorder, the method comprising a step of: administering an anti-TNF therapy to subjects who have been determined to be responsive via a classifier established to distinguish between responsive and non-responsive prior subjects in a cohort who have received the anti-TNF therapy.

The invention relates to a method of predicting therapeutic responses to TNF blockers before anti-TNF therapy comprising analyzing immune parameters to selected stimuli in patients before therapy and its use for anti-TNF therapy. The invention relates also to a method of determining a predictive biomarker of response to anti-TNF therapy and to the use of the predictive biomarker obtained by the method.

The invention relates to the use of IL-22 in prevention and therapy of infections in particular related to viral infections in individuals who are unable to respond to viral exposure with enhanced IL-22 gene expression or protein production.

The present invention relates to novel humanized, chimeric and murine antibodies that have binding specificity for the human CC chemokine ligand 20 (CCL20). The present invention further relates to heavy chains and light chains of said antibodies. The invention also relates to isolated nucleic acids, recombinant vectors and host cells that comprise a sequence which encodes a heavy chain and/or a light chain of said antibodies, and to a method of preparing said antibodies. The anti-CCL20 antibodies of the invention can be used in therapeutic applications to treat, for example, inflammatory and autoimmune disorders and cancer.