A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

JIA ACR, is comprised of 6 variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire [CHAQ]), and acute-phase reactants (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]). A JIA ACR30 response is defined as at least 30% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.

JIA ACR, is comprised of 6 variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire [CHAQ]), and acute-phase reactants (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]). A JIA ACR30 response is defined as at least 30% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.

JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire [CHAQ]), and acute-phase reactants (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]). A JIA ACR 50/70/90 response is defined as a greater than or equal to (≥) 50/70/90/100% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.

JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire [CHAQ]), and acute-phase reactants (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]). A JIA ACR 30/50/70/90 response is defined as a greater than or equal to (≥) 30/50/70/90/100% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.

The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling (S), redness (R), and plaque induration/infiltration thickness (T) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Severity is rated for each index (R, S, T) on a 0 to 4 scale (0 for no involvement up to 4 for severe involvement):

0 = none

• = slight
• = moderate
• = severe
• = very severe The various body regions are weighted to reflect their respective proportion of BSA.

The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling (S), redness (R), and plaque induration/infiltration thickness (T) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Severity is rated for each index (R, S, T) on a 0 to 4 scale (0 for no involvement up to 4 for severe involvement):

0 = none

• = slight
• = moderate
• = severe
• = very severe The various body regions are weighted to reflect their respective proportion of BSA.

The LEI was developed specifically for use in psoriatic arthritis (PsA). It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle, (R/L); Achilles tendon insertion, (R/L)). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then added to produce a total score (range 0 to 6) with the higher scores indicating more severe enthesitis.

The LEI was developed specifically for use in psoriatic arthritis (PsA). It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle, (R/L); Achilles tendon insertion, (R/L)). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then added to produce a total score (range 0 to 6) with the higher scores indicating more severe enthesitis.

Disease flare is defined as worsening of ≥30% from baseline in at least 3 of the 6 JIA ACR core set criteria and an improvement of ≥30% in no more than one of the criteria. The JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire [CHAQ]), and acute-phase reactants (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]).

Disease flare is defined as worsening of ≥30% from baseline in at least 3 of the 6 JIA ACR core set criteria and an improvement of ≥30% in no more than one of the criteria. The JIA ACR, is comprised of 6 core set variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire [CHAQ]), and acute-phase reactants (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]).

C-trough were measured at specified time points to assess the minimum concentration of ixekizumab in the blood before the next dose was administered.

C-trough were measured at specified time points to assess the minimum concentration of ixekizumab in the blood before the next dose was administered.

Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.

Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.