Anti-tnf antibodies, compositions, and methods for the treatment of active ankylosing spondylitis

A method for treating a tumor necrosis factor alpha (TNF-α) related condition, wherein the TNF-α related condition is active psoriatic arthritis, the method comprising:

• administering to a subject having active psoriatic arthritis a composition comprising a safe and effective amount of at least one isolated mammalian anti-TNF-α antibody comprising:
• a. a heavy chain (HC) complementary determining region (CDR) 1 comprising an amino acid sequence of SEQ ID NO:
• 1;
• b. a HC CDR2 comprising an amino acid sequence of SEQ ID NO:
• 2;
• wherein position 1 of SEQ ID NO:
• 2 is phenylalanine, position 2 of SEQ ID NO:
• 2 is methionine, position 3 of SEQ ID NO:
• 2 is serine, position 4 of SEQ ID NO:
• 2 is tyrosine, position 10 of SEQ ID NO:
• 2 is lysine, position 11 of SEQ ID NO:
• 2 is tyrosine, and position 17 of SEQ ID NO:
• 2 is glycine;
• c. a HC CDR3 comprising an amino acid sequence of SEQ ID NO:
• 3;
• wherein position 4 of SEQ ID NO:
• 3 is isoleucine, position 5 of SEQ ID NO:
• 3 is alanine, and position 9 of SEQ ID NO:
• 3 is asparagine;
• d. a light chain (LC) CDR1 comprising an amino acid sequence of SEQ ID NO:
• 4;
• wherein position 7 of SEQ ID NO:
• 4 is tyrosine;
• e. a LC CDR2 comprising an amino acid sequence of SEQ ID NO:
• 5;
• and
• f. a LC CDR3 comprising an amino acid sequence of SEQ ID NO:
• 6,
• and at least one pharmaceutically acceptable carrier or diluent, wherein said composition is administered via intravenous (IV) infusion, and wherein at week 14 of treatment patients treated with the anti-TNF-α antibody achieve a mean change from baseline in one or more criteria selected from the group consisting of:
• Health Assessment Questionnaire Disability Index score (HAQ-DI)=−0.60±0.53 SD, enthesitis=−1.87±1.75 SD, dactylitis=−7.8±8.57 SD, Short-Form Health Survey Physical Summary score (SF-36 PCS)=8.65±7.60 SD, and Short-Form Health Survey Mental Component Summary score (SF-36 MCS)=5.33±9.95 SD.

A method for treating a TNF-α related condition, wherein the TNF-α related condition is active psoriatic arthritis, the method comprising:

• administering to a subject having active psoriatic arthritis a composition comprising a safe and effective amount of at least one isolated mammalian anti-TNF-α antibody comprising:
• a. a heavy chain (HC) complementary determining region (CDR) 1 comprising an amino acid sequence of SEQ ID NO:
• 1;
• b. a HC CDR2 comprising an amino acid sequence of SEQ ID NO:
• 2;
• wherein position 1 of SEQ ID NO:
• 2 is phenylalanine, position 2 of SEQ ID NO:
• 2 is methionine, position 3 of SEQ ID NO:
• 2 is serine, position 4 of SEQ ID NO:
• 2 is tyrosine, position 10 of SEQ ID NO:
• 2 is lysine, position 11 of SEQ ID NO:
• 2 is tyrosine, and position 17 of SEQ ID NO:
• 2 is glycine;
• c. a HC CDR3 comprising an amino acid sequence of SEQ ID NO:
• 3;
• wherein position 4 of SEQ ID NO:
• 3 is isoleucine, position 5 of SEQ ID NO:
• 3 is alanine, and position 9 of SEQ ID NO:
• 3 is asparagine;
• d. a light chain (LC) CDR1 comprising an amino acid sequence of SEQ ID NO:
• 4;
• wherein position 7 of SEQ ID NO:
• 4 is tyrosine;
• e. a LC CDR2 comprising an amino acid sequence of SEQ ID NO:
• 5;
• and
• f. a LC CDR3 comprising an amino acid sequence of SEQ ID NO:
• 6,
• and at least one pharmaceutically acceptable carrier or diluent, wherein said composition is administered via IV infusion, and wherein at week 24 of treatment patients treated with the anti-TNF-α antibody achieve a mean change from baseline in total modified van der Heijde-Sharp score (vdH-S)=−0.36±0.144 SE.

A method for treating a TNF-α related condition, wherein the TNF-α related condition is active psoriatic arthritis, the method comprising:

• administering to a subject having active psoriatic arthritis a composition comprising a safe and effective amount of at least one isolated mammalian anti-TNF-α antibody comprising:
• a. a heavy chain (HC) complementary determining region (CDR) 1 comprising an amino acid sequence of SEQ ID NO:
• 1;
• b. a HC CDR2 comprising an amino acid sequence of SEQ ID NO:
• 2;
• wherein position 1 of SEQ ID NO:
• 2 is phenylalanine, position 2 of SEQ ID NO:
• 2 is methionine, position 3 of SEQ ID NO:
• 2 is serine, position 4 of SEQ ID NO:
• 2 is tyrosine, position 10 of SEQ ID NO:
• 2 is lysine, position 11 of SEQ ID NO:
• 2 is tyrosine, and position 17 of SEQ ID NO:
• 2 is glycine;
• c. a HC CDR3 comprising an amino acid sequence of SEQ ID NO:
• 3;
• wherein position 4 of SEQ ID NO:
• 3 is isoleucine, position 5 of SEQ ID NO:
• 3 is alanine, and position 9 of SEQ ID NO:
• 3 is asparagine;
• d. a light chain (LC) CDR1 comprising an amino acid sequence of SEQ ID NO:
• 4;
• wherein position 7 of SEQ ID NO:
• 4 is tyrosine;
• e. a LC CDR2 comprising an amino acid sequence of SEQ ID NO:
• 5;
• and
• f. a LC CDR3 comprising an amino acid sequence of SEQ ID NO:
• 6,
• wherein said anti-TNF-α antibody is administered via intravenous (IV) infusion, and wherein ≥65% of patients receiving the treatment achieve ACR20 at week 14 of treatment.