The present invention provides methods to prevent the formation of visible particles in aqueous protein formulations, as well as compositions and pharmaceutical products obtained with said method.

The present invention provides a variety of methods for the identification and/or treatment of subjects that are at risk for developing life-threatening complications of SARS-CoV-2 infection and other infections. Such methods involve determining if a subject has clonal hematopoiesis.

The invention provides anti-oncostatin M receptor-β (OSMR) antigen binding proteins, e.g., antibodies and functional fragments, derivatives, muteins, and variants thereof. OSMR antigen binding proteins interfere with binding of OSM and/or IL-31 to OSMR. In some embodiments, anti-OSMR antigen binding proteins are useful tools in studying diseases and disorders associated with OSMR and are particularly useful in methods of treating diseases and disorders associated with OSMR and binding of OSM and/or IL-31 to OSMR.

The present invention provides methods for selecting treatment methods for rheumatoid arthritis based on an objective selection process (algorithm). The present invention also provides methods for treating rheumatoid arthritis with treatment methods selected based on the algorithm disclosed herein. The methods of the present invention provide a more effective means for treating patients with rheumatoid arthritis.

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 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.

The invention is directed to a method of treating multiloculated hydrocephalus comprising administering to a subject who is suffering from multiloculated hydrocephalus an antibody that binds to an IL-6 receptor.

A method for treating depression or fatigue in a subject comprises administering an agent that blocks binding of IL-6 to IL-6 receptor, for example, an anti-IL-6 antibody or an antigen-binding fragment thereof that may comprise a heavy chain variable region and a light chain variable region of SEQ ID NO:99 and SEQ ID NO:97, respectively or a heavy chain variable region and a light chain variable region of SEQ ID NO:139 and SEQ ID NO:140, respectively. In addition, a method for determining responsiveness of an individual having depression to treatment with IL-6 antibody or antigen-binding fragment thereof, comprises: (a) measuring the amount of soluble IL-6 receptor (sIL-6R) in a biological sample from the subject; (b) providing a threshold value correlating the amount of sIL-6R and responsiveness; (c) comparing the amount of sIL-6R to the threshold value to determine responsiveness; and (d) treating the individual with an agent that blocks binding of IL-6 to IL-6 receptor.

Anti-IL-6 antibodies and antirheumatics are useful to treat and suppress IL-6 related conditions, such as rheumatoid arthritis.

The present invention concerns compositions and methods of use of bispecific antibodies comprising at least one anti-TNF-α antibody or antigen-binding fragment thereof and at least one anti-IL-6 antibody or antigen-binding fragment thereof. Preferably, the bispecific antibody is in the form of a DNL® complex. The anti-TNF-α or anti-IL-6 antibodies may comprise specific CDR sequences disclosed herein. The compositions and methods are of use to treat autoimmune disease, immune system dysfunction or inflammatory disease, as disclosed herein.

The present invention is directed to therapeutic methods using IL-6 antagonists such as an Ab1 antibody or antibody fragment having binding specificity for IL-6 to prevent or treat disease or to improve survivability or quality of life of a patient in need thereof. In preferred embodiments these patients will comprise those exhibiting (or at risk of developing) an elevated serum C-reactive protein level, reduced serum albumin level, elevated D-dimer or other coagulation cascade related protein(s), cachexia, fever, weakness and/or fatigue prior to treatment. The subject therapies also may include the administration of other actives such as chemotherapeutics, anti-coagulants, statins, and others. Additional preferred embodiments of the subject invention relate to therapeutic compositions and methods treating or preventing rheumatoid arthritis, especially subcutaneous and intravenous formulations and dosage regimens using IL-6 antagonists according to the invention, as well as methods for preventing or treating GVHD or leukemia relapse in subjects receiving transplanted cells, tissue or organs, use thereof in the treatment or prevention of mucositis, and use thereof to potentiate the cytotoxic, apoptotic, and anti-metastatic or anti-invasive effects of chemotherapeutics and radiation on cancers, especially cancers that have developed a resistance to radiation or chemotherapy, such as an EGFR inhibitor.