Abstract: Exemplary embodiments provide wearable automatic injection devices for subcutaneously injecting a therapeutic agent into a patient's body at controlled rates, for example, in a single bolus. Exemplary embodiments provide methods for assembling wearable automatic injection devices for subcutaneously injecting a therapeutic agent into a patient's body at controlled rates. Exemplary embodiments provide methods for using wearable automatic injection devices for subcutaneously injecting a therapeutic agent into a patient's body at controlled rates.

Abstract: A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Abstract: The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

Abstract: The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

Abstract: The invention describes methods of treating erosive polyarthritis comprising administering a TNF? antibody, or antigen-binding portion thereof. The invention also describes a method for testing the efficacy of a TNF? antibody, or antigen-binding portion thereof, for the treatment of erosive polyarthritis.

Abstract: The invention provides a method for determining the efficacy of a TNF? inhibitor, such as a TNF? antibody, or an antigen-binding portion thereof, for treating ankylosing spondylitis (AS), using a collagen degradation biomarker and/or a synovitis biomarker.

Abstract: The invention provides an aqueous formulation comprising water and a protein, and methods of making the same. The aqueous formulation of the invention may be a high protein formulation and/or may have low levels of conductity resulting from the low levels of ionic excipients. Also included in the invention are formulations comprising water and proteins having low osmolality.

Abstract: The invention describes methods of treating erosive polyarthritis comprising administering a TNF? antibody, or antigen-binding portion thereof. The invention also describes a method for testing the efficacy of a TNF? antibody, or antigen-binding portion thereof, for the treatment of erosive polyarthritis.

Abstract: Methods of treating disorders in which TNF? activity is detrimental via biweekly, subcutaneous administration of human antibodies, preferably recombinant human antibodies, that specifically bind to human tumor necrosis factor ? (hTNF?) are disclosed. The antibody may be administered with or without methotrexate. These antibodies have high affinity for hTNF? (e.g., Kd=10?8 M or less), a slow off rate for hTNF? dissociation (e.g., Koff=10?3 sec?1 or less) and neutralize hTNF? activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. Kits containing a pharmaceutical composition and instructions for dosing, and preloaded syringes containing pharmaceutical compositions are also encompassed by the invention.

Abstract: The invention describes methods of treating erosive polyarthritis comprising administering a TNF? antibody, or antigen-binding portion thereof. The invention also describes a method for testing the efficacy of a TNF? antibody, or antigen-binding portion thereof, for the treatment of erosive polyarthritis.

Abstract: Multiple-variable dose methods for treating TNF?-related disorders, including Crohn's disease and psoriasis, comprising administering TNF? inhibitors, including TNF? antibodies, are described. Multiple-variable dose methods include administration of a TNF-inhibitor in an induction or loading phase followed by administration of the agent in a maintenance or treatment phase, wherein the TNF-inhibitor is administered in a higher dosage during the induction phase.

Abstract: Methods of treating disorders in which TNF? activity is detrimental via biweekly, subcutaneous administration of human antibodies, preferably recombinant human antibodies, that specifically bind to human tumor necrosis factor ? (hTNF?) are disclosed. The antibody may be administered with or without methotrexate. These antibodies have high affinity for hTNF? (e.g., Kd=10?8 M or less), a slow off rate for hTNF? dissociation (e.g., Koff=10?3 sec?1 or less) and neutralize hTNF? activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. Kits containing a pharmaceutical composition and instructions for dosing, and preloaded syringes containing pharmaceutical compositions are also encompassed by the invention.

Abstract: An injection device comprises a syringe extendible against a spring bias from a retracted position in a housing to a projecting injecting position. A spring biased plunger has collapsible elbows which, when the plunger is released, initially engage the end of the syringe to drive it to the projecting position, whereupon arresting of the syringe movement causes the elbows to collapse inside the syringe to allow the plunger to engage and drive the bung.

Abstract: The invention provides methods and compositions for the treatment of juvenile idiopathic arthritis (JIA) where a TNF? inhibitor, such as a human TNF? antibody, or antigen-binding portion thereof, is used to treat JIA. In particular, the invention is directed to methods and compositions relating to a fixed dosing regimen for treating JIA with a TNF? inhibitor.

Abstract: Methods of treating disorders in which TNF? activity is detrimental via biweekly, subcutaneous administration of human antibodies, preferably recombinant human antibodies, that specifically bind to human tumor necrosis factor ? (hTNF?) are disclosed. The antibody may be administered with or without methotrexate. These antibodies have high affinity for hTNF? (e.g., Kd=10?8 M or less), a slow off rate for hTNF? dissociation (e.g., Koff=10?3 sec?1 or less) and neutralize hTNF? activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. Kits containing a pharmaceutical composition and instructions for dosing, and preloaded syringes containing pharmaceutical compositions are also encompassed by the invention.

Abstract: The invention describes methods of treating erosive polyarthritis comprising administering a TNF? antibody, or antigen-binding portion thereof. The invention also describes a method for testing the efficacy of a TNF? antibody, or antigen-binding portion thereof, for the treatment of erosive polyarthritis.

Abstract: Methods of treating disorders in which TNF? activity is detrimental via biweekly, subcutaneous administration of human antibodies, preferably recombinant human antibodies, that specifically bind to human tumor necrosis factor ? (hTNF?) are disclosed. The antibody may be administered with or without methotrexate. These antibodies have high affinity for hTNF? (e.g., Kd=10?8 M or less), a slow off rate for hTNF? dissociation (e.g., Koff=10?3 sec?1 or less) and neutralize hTNF? activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. Kits containing a pharmaceutical composition and instructions for dosing, and preloaded syringes containing pharmaceutical compositions are also encompassed by the invention.

Abstract: Compositions and methods comprising proteins that bind specifically to adalimumab are disclosed herein. Adalimumab is a monoclonal antibody specific for the cytokine TNF-? and was developed to treat TNF-? mediated inflammatory diseases. In one aspect of the instant invention, the binding proteins are antibodies directed toward adalimumab. These antibodies, including binding fragments thereof, can be used in a clinical setting as well as for research and development. For example, these anti-adalimumab antibodies can be employed to neutralize adalimumab.

Abstract: Multiple-variable dose methods for treating TNF?-related disorders, including Crohn's disease and psoriasis, comprising administering TNF? inhibitors, including TNF? antibodies, are described. Multiple-variable dose methods include administration of a TNF-inhibitor in an induction or loading phase followed by administration of the agent in a maintenance or treatment phase, wherein the TNF-inhibitor is administered in a higher dosage during the induction phase.

Abstract: Multiple-variable dose methods for treating TNF?-related disorders, including Crohn's disease and psoriasis, comprising administering TNF? inhibitors, including TNF? antibodies, are described. Multiple-variable dose methods include administration of a TNF-inhibitor in an induction or loading phase followed by administration of the agent in a maintenance or treatment phase, wherein the TNF-inhibitor is administered in a higher dosage during the induction phase.