Methods and compositions for determining the efficacy of a treatment for ankylosing spondylitis using biomarkers

A method for determining the efficacy of a human anti-TNFα antibody, or an antigen-binding portion thereof, for treating a subject having ankylosing spondylitis (AS), said method comprising

• determining a level of a collagen degradation biomarker and a synovitis biomarker in a sample(s) obtained from the subject following administration of the human anti-TNFα antibody, or antigen-binding portion thereof;
• and
• comparing the level of the collagen degradation biomarker and the synovitis biomarker in the sample(s) to a baseline level of the collagen degradation biomarker and the synovitis biomarker, wherein a lower level of the collagen degradation biomarker and the synovitis biomarker in the sample(s) relative to the baseline level of the collagen degradation biomarker and the synovitis biomarker indicates that the human anti-TNFα antibody, or an antigen-binding portion thereof, is efficacious for the treatment of AS in the subject.

A method for determining the efficacy of a human anti-TNFα antibody, or an antigen-binding portion thereof, for the treatment of ankylosing spondylitis (AS) in a subject having AS, said method comprising

• determining level of type II collagen C-telopeptide (CTX-II) in a sample from the subject following treatment with the human anti-TNFα antibody, or an antigen-binding portion thereof, and
• comparing the level of CTX-II in the sample with a baseline level of CTX-II from the subject having AS, wherein a decrease in the level of the CTX-II in the sample of at least 9% relative to the baseline level of CTX-II indicates that the human anti-TNFα antibody, or an antigen-binding portion thereof, is effective for the treatment of AS in the subject.

A method of determining the efficacy of a human anti-TNFα antibody, or antigen-binding portion thereof, for the treatment of ankylosing spondylitis (AS) in a subject having AS, said method comprising

• determining a level of type II collagen C-telopeptide (CTX-II) in a sample obtained from the subject following administration of the anti-human TNFα antibody, or antigen-binding portion thereof, and
• comparing the level of CTX-II in the sample with a known standard level of CTX-II associated with AS, wherein a decrease in the level of CTX-II in the sample of at least 9% relative to the known standard level of CTX-II indicates that the human anti-TNFα antibody, or antigen-binding portion thereof, is effective for the treatment of AS in the subject.

A method for determining the efficacy of a human anti-TNFα antibody, or an antigen-binding portion thereof, for treating ankylosing spondylitis (AS) in a subject having AS, said method comprising

• determining levels of type II collagen C-telopeptide (CTX-II) and matrix metalloprotease 3 (MMP3) in a sample(s) obtained from the subject having AS following administration of the human anti-TNFα antibody, or an antigen-binding portion thereof, and
• comparing the levels of CTX-II and MMP3 in the sample(s) with known standard levels of CTX-II and MMP3 associated with AS,
• wherein lower CTX-II and MMP3 levels in the sample(s) from the subject relative to the known standard levels of CTX-II and MMP3 indicates that the human anti-TNFα antibody, or an antigen-binding portion thereof, is effective at decreasing structural damage associated with AS in the patient.

A method for determining the efficacy of a TNFα antibody, or an antigen-binding portion thereof, for treating a subject having ankylosing spondylitis (AS), said method comprising

• determining a level of a collagen degradation biomarker and a synovitis biomarker in a sample(s) obtained from the subject following administration of the TNFα antibody, or an antigen-binding portion thereof;
• and
• comparing the level of the collagen degradation biomarker and the synovitis biomarker in the sample(s) obtained from the subject with a known standard level of the collagen degradation biomarker and the synovitis biomarker associated with AS, wherein a lower level of the collagen degradation biomarker and the synovitis biomarker in the sample(s) from the subject relative to the known standard level of the collagen degradation biomarker and the synovitis biomarker indicates that the TNFα antibody, or an antigen-binding portion thereof, is efficacious for the treatment of AS in the subject.

A method for determining the efficacy of a TNFα antibody, or an antigen-binding portion thereof, for treating a subject having ankylosing spondylitis (AS), said method comprising

• determining a level of a collagen degradation biomarker and a synovitis biomarker in a sample(s) obtained from the subject following administration of the TNFα antibody, or antigen-binding portion thereof;
• and
• comparing the level of the collagen degradation biomarker and the synovitis biomarker in the sample(s) to a baseline level of the collagen degradation biomarker and the synovitis biomarker, wherein a lower level of the collagen degradation biomarker and the synovitis biomarker in the sample(s) relative to the baseline level of the collagen degradation biomarker and the synovitis biomarker indicates that the TNFα antibody, or an antigen-binding portion thereof, is efficacious for the treatment of AS in the subject.

A method for determining the efficacy of a TNFα antibody, or an antigen-binding portion thereof, for the treatment of ankylosing spondylitis (AS) in a subject having AS, said method comprising

• determining level of type II collagen C-telopeptide (CTX-II) in a sample from the subject following treatment with the TNFα antibody, or an antigen-binding portion thereof, and
• comparing the level of CTX-II in the sample with a baseline level of CTX-II from the subject having AS, wherein a decrease in the level of the CTX-II in the sample of at least 9% relative to the baseline level of CTX-II indicates that the TNFα antibody, or an antigen-binding portion thereof, is effective for the treatment of AS in the subject.

A method of determining the efficacy of a TNFα antibody, or antigen-binding portion thereof, for the treatment of ankylosing spondylitis (AS) in a subject having AS, said method comprising

• determining a level of type II collagen C-telopeptide (CTX-II) in a sample obtained from the subject following administration of the TNFα antibody, or antigen-binding portion thereof, and
• comparing the level of CTX-II in the sample with a known standard level of CTX-II associated with AS, wherein a decrease in the level of CTX-II in the sample of at least 9% relative to the known standard level of CTX-II indicates that the TNFα antibody, or antigen-binding portion thereof, is effective for the treatment of AS in the subject.

A method for determining the efficacy of a TNFα antibody, or an antigen-binding portion thereof, for treating ankylosing spondylitis (AS) in a subject having AS, said method comprising

• determining levels of type II collagen C-telopeptide (CTX-II) and matrix metalloprotease 3 (MMP3) in a sample(s) obtained from the subject having AS following administration of the TNFα antibody, or an antigen-binding portion thereof, and
• comparing the levels of CTX-II and MMP3 in the sample(s) with known standard levels of CTX-II and MMP3 associated with AS,
• wherein lower CTX-II and MMP3 levels in the sample(s) from the subject relative to the known standard levels of CTX-II and MMP3 indicates that the TNFα antibody, or an antigen-binding portion thereof, is effective at decreasing structural damage associated with AS in the patient.

A method for determining the efficacy of a TNFα antibody, or an antigen-binding portion thereof, for treating ankylosing spondylitis (AS) in a subject having AS, said method comprising

• determining levels of type II collagen C-telopeptide (CTX-II) and matrix metalloprotease 3 (MMP3) in a sample(s) obtained from the subject having AS following administration of the human anti-TNFα antibody, or an antigen-binding portion thereof, and
• comparing the levels of CTX-II and MMP3 in the sample(s) with baseline levels of CTX-II and MMP3 associated with AS,
• wherein lower CTX-II and MMP3 levels in the sample(s) from the subject relative to the baseline levels of CTX-II and MMP3 indicates that the anti-TNFα antibody, or an antigen-binding portion thereof, is effective at decreasing structural damage associated with AS in the patient.