Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate

A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met:

• 50% improvement in 68 tender joint count;
• 50% improvement in 66 swollen joint count; and
• 50% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]),
• Patient's global assessment of disease activity (measured on a 0-10 Likert scale),
• Physician's global assessment of disease activity (measured on a 0-10 Likert scale),
• Patient's self assessment of disability (Health Assessment Questionnaire - Disability Index [HAQ-DI]),
• Acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever has bigger improvement.

A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met:

• 20% improvement in 68 tender joint count;
• 20% improvement in 66 swollen joint count; and
• 20% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]),
• Patient's global assessment of disease activity (measured on a 0-10 Likert scale),
• Physician's global assessment of disease activity (measured on a 0-10 Likert scale),
• Patient's self assessment of disability (Health Assessment Questionnaire - Disability Index [HAQ-DI]),
• Acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever has bigger improvement.

A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met:

• 70% improvement in 68 tender joint count;
• 70% improvement in 66 swollen joint count; and
• 70% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]),
• Patient's global assessment of disease activity (measured on a 0-10 Likert scale),
• Physician's global assessment of disease activity (measured on a 0-10 Likert scale),
• Patient's self assessment of disability (Health Assessment Questionnaire - Disability Index [HAQ-DI]),
• Acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever has bigger improvement.

The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of tender joints assessed using the 28-jount count and number of swollen joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity (measured on a 0-10 Likert scale). The DAS28 score ranges from 0 to 10, with higher scores indicating more severe disease activity.

AEs are defined as any untoward medical occurrence, that does not necessarily have a causal relationship with this treatment. SAEs are defined as an AE that: is fatal; is life threatening (places the subject at immediate risk of death); requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; other significant medical hazard. The severity of events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.0: mild=grade 1, moderate=grade 2, severe=grade 3, life-threatening=grade 4, death=grade 5.