Abstract: Methods for treating fibrodysplasia ossificans progressiva (FOP) in human subjects are provided. Such methods involve administering to a subject having FOP a therapeutically effective amount of an Activin A antagonist, such as an antibody against Activin A.

Abstract: The present invention provides methods for treating autosomal dominant hypercholesterolemia (ADH). According to certain embodiments, the ADH is caused by or associated with a gain-of-function mutation (GOFm) in a gene encoding PCSK9. The present invention therefore includes methods comprising selecting a patient who carries a GOFm in one or both alleles of the PCSK9 gene, and administering to the patient a pharmaceutical composition comprising a PCSK9 inhibitor. In certain embodiments, the PCSK9 inhibitor is an anti-PCSK9 antibody such as the exemplary antibody referred to herein as mAb316P.

Abstract: The present invention provides methods for treating autosomal dominant hypercholesterolemia (ADH). According to certain embodiments, the ADH is caused by or associated with a gain-of-function mutation (GOFm) in a gene encoding PCSK9. The present invention therefore includes methods comprising selecting a patient who carries a GOFm in one or both alleles of the PCSK9 gene, and administering to the patient a pharmaceutical composition comprising a PCSK9 inhibitor. In certain embodiments, the PCSK9 inhibitor is an anti-PCSK9 antibody such as the exemplary antibody referred to herein as mAb316P.

Abstract: Methods of treating, inhibiting, or ameliorating an autoinflammatory disorder, disease, or condition in a subject in need thereof, comprising administering to a subject in need a therapeutic amount of an interleukin 1 (IL-1) antagonist, wherein the autoinflammatory disorder, disease, or condition is treated, inhibited, or ameliorated. The IL-1 antagonist is a molecule capable of binding and inhibiting IL-1. The therapeutic methods are useful for treating a human adult or child suffering from Neonatal Onset Multisystem Inflammatory Disorder (NOMID/CINCA), Muckle-Wells Syndrome (MWS), Familial Cold Autoinflammatory Syndrome (FCAS), familial mediterranean fever (FMF), tumor necrosis factor receptor-associated periodic fever syndrome (TRAPS), or systemic onset juvenile idiopathic arthritis (Still's Disease).

Abstract: Methods of treating, inhibiting, or ameliorating gout, including chronic active (refractory) gout, pseudogout, or drug-induced gout, in a human subject, are provided. The methods comprise administering to a subject in need thereof a therapeutic amount of an interleukin 1 (IL-1) antagonist, such as IL-1 trap rilonacept.

Abstract: Methods of treating, inhibiting, or ameliorating gout, including chronic acute (refractory) gout, pseudogout, or drug-induced gout, in a human subject in need thereof, comprising administering to a subject in need a therapeutic amount of an interleukin 1 (IL-1) antagonist, wherein the incidence of a gout flare is reduced or inhibited.

Abstract: Methods of treating, inhibiting, or ameliorating an autoinflammatory disorder, disease, or condition in a subject in need thereof, comprising administering to a subject in need a therapeutic amount of an interleukin 1 (IL-1) antagonist, wherein the autoinflammatory disorder, disease, or condition is treated, inhibited, or ameliorated. The IL-1 antagonist is a molecule capable of binding and inhibiting IL-1. The therapeutic methods are useful for treating a human adult or child suffering from Neonatal Onset Multisystem Inflammatory Disorder (NOMID/CINCA), Muckle-Wells Syndrome (MWS), Familial Cold Autoinflammatory Syndrome (FCAS), familial mediterranean fever (FMF), tumor necrosis factor receptor-associated periodic fever syndrome (TRAPS), or systemic onset juvenile idiopathic arthritis (Still's Disease).

Abstract: Methods of treating, inhibiting, or ameliorating Familial Mediterranean Fever (FMF) by administering to a subject in need thereof a therapeutically effective amount of an interleukin 1 (IL-1) antagonist, are provided. The IL-1 antagonist can be an antibody or derivative thereof, which is capable of blocking or inhibiting the biological action of IL-1, thereby treating, inhibiting or ameliorating FMF. Also provided are methods of treating, inhibiting, or ameliorating FMF by administering a therapeutically effective amount of an IL-1 antagonist in combination with additional therapeutic agents, including IL-1-specific fusion proteins, TNF inhibitors, NSAIDs, steroids, and the like.

Abstract: Methods of treating, inhibiting, or ameliorating gout, including chronic acute (refractory) gout, pseudogout, or drug-induced gout, in a human subject in need thereof, comprising administering to a subject in need a therapeutic amount of an interleukin 1 (IL-1) antagonist, wherein the incidence of a gout flare is reduced or inhibited.

Abstract: Methods of treating, inhibiting, or ameliorating gout, including chronic acute (refractory) gout, pseudogout, or drug-induced gout, in a human subject in need thereof, comprising administering to a subject in need a therapeutic amount of an interleukin 1 (IL-1) antagonist, wherein the incidence of a gout flare is reduced or inhibited.

Abstract: Methods of treating, inhibiting, or ameliorating gout, including chronic acute (refractory) gout, pseudogout, or drug-induced gout, in a human subject in need thereof, comprising administering to a subject in need a therapeutic amount of an interleukin 1 (IL-1) antagonist, wherein the incidence of a gout flare is reduced or inhibited.

Abstract: Methods of treating, inhibiting, or ameliorating gout, including chronic acute (refractory) gout, pseudogout, or drug-induced gout, in a human subject in need thereof, comprising administering to a subject in need a therapeutic amount of an interleukin 1 (IL-1) antagonist, wherein the incidence of a gout flare is reduced or inhibited.

Abstract: Methods of treating, inhibiting, or ameliorating an autoinflammatory disorder, disease, or condition in a subject in need thereof, comprising administering to a subject in need a therapeutic amount of an interleukin 1 (IL-1) antagonist, wherein the autoinflammatory disorder, disease, or condition is treated, inhibited, or ameliorated. The IL-1 antagonist is an IL-1 trap, preferably comprising a sequence selected from the group consisting of SEQ ID NO: 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, or a substantially identical having at least 95% identity to the sequence shown in SEQ ID NO: 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and capable of binding and inhibiting IL-1. The therapeutic methods are useful for treating a human adult or child suffering from Neonatal Onset Multisystem Inflammatory Disorder (NOMID/CINCA), Muckle-Wells Syndrome (MWS), Familial Cold Autoinflammatory Syndrome (FCAS), familial mediterranean fever (FMF), or systemic onset juvenile rheumatoid arthritis (Still's Disease).

Abstract: Methods of treating, inhibiting, or ameliorating gout, including chronic acute (refractory) gout, pseudogout, or drug-induced gout, in a human subject in need thereof, comprising administering to a subject in need a therapeutic amount of an interleukin 1 (IL-1) antagonist, wherein the incidence of a gout flare is reduced or inhibited.

Abstract: Methods of treating, inhibiting, or ameliorating gout, including chronic acute (refractory) gout or pseudogout in a human subject in need thereof, comprising administering to a subject in need a therapeutic amount of an interleukin 1 (IL-1) antagonist, wherein gout or pseudogout are inhibited or ameliorated. Preferably, the IL-1 antagonist is the protein of SEQ ID NO:10 (rilonacept).

Abstract: Methods of treating, inhibiting, or ameliorating an autoinflammatory disorder, disease, or condition in a subject in need thereof, comprising administering to a subject in need a therapeutic amount of an interleukin 1 (IL-1) antagonist, wherein the autoinflammatory disorder, disease, or condition is treated, inhibited, or ameliorated. The IL-1 antagonist is a molecule capable of binding and inhibiting IL-1. The therapeutic methods are useful for treating a human adult or child suffering from Neonatal Onset Multisystem Inflammatory Disorder (NOMID/CINCA), Muckle-Wells Syndrome (MWS), Familial Cold Autoinflammatory Syndrome (FCAS), familial mediterranean fever (FMF), tumor necrosis factor receptor-associated periodic fever syndrome (TRAPS), or systemic onset juvenile idiopathic arthritis (Still's Disease).

Abstract: Methods of treating, inhibiting, or ameliorating arthritis, including rheumatoid arthritis, osteoarthritis, psoriatic arthritis, ankylosing spondylitis, or juvenile rheumatoid arthritis, in a human subject in need thereof, comprising administering to a subject in need a therapeutic amount of an interleukin 1 (IL-1) antagonist, wherein arthritis inhibited, or ameliorated. The IL-1 antagonist is an IL-1-specific fusion protein comprising an IL-1 binding portion of the extracellular domain of human II-1RAcP, an IL-1 binding portion of the extracellular domain of human IL-1RI, and a multimerizing component antagonist, preferably comprising a sequence selected from the group consisting of SEQ ID NO:4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, or a substantially identical sequence.

Abstract: Methods of identifying human subjects for treatment of obesity or an obesity-related condition with ciliary neurotrophic factor (CNTF) or a CNTF-related molecule, such as Axokine®, based on the presence of human leukocyte antigen (HLA) DR?1 allele 1501 or the absence of HLA DR?1 allele 0701.

Abstract: Methods of reducing C-reactive protein (CRP) in a subject, comprising administering to the subject a therapeutic amount of an interleukin 1 (IL-1) antagonist, wherein CRP is reduced. The IL-1 antagonist is preferably an IL-1-binding fusion protein (IL-1 trap), preferably comprising SEQ ID NO:2.

Abstract: Methods of identifying human subjects for treatment of obesity or an obesity-related condition with ciliary neurotrophic factor (CNTF) or a CNTF-related molecule, such as Axokine®, based on the presence of human leukocyte antigen (HLA) DR?1 allele 1501 or the absence of HLA DR?1 allele 0701.