Anti-tnf antibodies, compositions, methods and use for the treatment or prevention of type 1 diabetes

At least one isolated mammalian anti-TNF antibody having a heavy chain (HC) comprising SEQ ID NO:36 and a light chain (LC) comprising SEQ ID NO:37 for use in the treatment or prevention of Type I Diabetes.

(canceled)

(canceled)

(canceled)

A method for treating pre-Type 1 Diabetes (pre-T1D) in a human subject, wherein the subject is 6 to 21 years of age and has ≥2 auto-antibodies for T1D, and wherein said pre-T1D is prior to onset of symptoms and requirement for exogenous insulin, the method comprising administering to the subject an anti-TNF antibody having a heavy chain (HC) comprising an amino acid sequence of SEQ ID NO:36 and a light chain (LC) comprising an amino acid sequence of SEQ ID NO:37, wherein said anti-TNF antibody is administered with a medical device suitable for self-administration, and wherein the device is a prefilled syringe with an ULTRASAFE PASSIVE® (needle guard) if the subject weighs ≥45 kg and VARIOJECT™ (injector) if the subject weighs <45 kg.

A composition comprising at least one isolated mammalian anti-TNF antibody having a heavy chain (HC) comprising SEQ ID NO:36 and a light chain (LC) comprising SEQ ID NO:37, and at least one pharmaceutically acceptable carrier or diluent for use in the treatment or prevention of Type I Diabetes.

(canceled)

(canceled)

(canceled)

A method for treating pre-Type 1 Diabetes (pre-T1D) in a human subject, wherein the subject is 6 to 21 years of age and has ≥2 auto-antibodies for T1D, and wherein said pre-T1D is prior to onset of symptoms and requirement for exogenous insulin, the method comprising administering to the subject a composition comprising an anti-TNF antibody having a heavy chain (HC) comprising an amino acid sequence of SEQ ID NO:36 and a light chain (LC) comprising an amino acid sequence of SEQ ID NO:37, wherein said composition is administered with a medical device suitable for self-administration, and wherein the device is a prefilled syringe with an ULTRASAFE PASSIVE® (needle guard) if the subject weighs ≥45 kg and VARIOJECT™ (injector) if the subject weighs <45 kg.

A method for treating pre-Type I Diabetes (pre-T1D) in a human subject, wherein the subject is 6 to 21 years of age and has ≥2 auto-antibodies for T1D, and wherein said pre-T1D is prior to onset of symptoms and requirement for exogenous insulin, the method comprising using a medical device to administer a composition comprising at least one isolated mammalian anti-TNF antibody having a heavy chain (HC) comprising SEQ ID NO:36 and a light chain (LC) comprising SEQ ID NO:37, wherein said device is suitable for subcutaneously (SC) administering said composition comprising at least one anti-TNF antibody.

A pharmaceutical composition for the treatment or prevention of Type I Diabetes, comprising an isolated mammalian anti-TNF antibody or fragment thereof having a heavy chain (HC) comprising SEQ ID NO:36 and a light chain (LC) comprising SEQ ID NO:37, or fragment thereof and at least one pharmaceutically acceptable carrier or diluent.

A method for treating pre-Type 1 Diabetes (pre-T1D) in a human subject, wherein the subject is about 6 to 21 years of age and has about ≥2 auto-antibodies for T1D, wherein said pre-T1D is prior to onset of symptoms and requirement for exogenous insulin, the method comprising administering to the subject an anti-TNF antibody having a heavy chain (HC) comprising an amino acid sequence of SEQ ID NO:36 and a light chain (LC) comprising an amino acid sequence of SEQ ID NO:37, or antigen binding fragment thereof.

A composition for treatment or prevention of Type I Diabetes comprising at least one isolated mammalian anti-TNF antibody having a heavy chain (HC) comprising SEQ ID NO:36 and a light chain (LC) comprising SEQ ID NO:37 or fragment thereof.