Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

Patient's Assessment of Pain Intensity on a 5-point Likert Scale

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days.

Time frame: 72 hours

Number of Patients With at Least One New Gouty Arthritis Flare After Baseline

Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.

Time frame: 12 weeks

Time to the First New Gouty Arthritis Flare

Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.

Time frame: 12 weeks

Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS

The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.

Time frame: 14 days

Time to Resolution of Gouty Arthritis Flare as Reported by Patient

Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported.

Time frame: 14 days

Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale.

Time frame: 72 hours

Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).

Time frame: 72 hours

Physician's Assessment of Tenderness

The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that "there is pain", 2 = patient states "there is pain and winces" and 3 = patient states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint.

Time frame: 72 hours

Physician's Assessment of Swelling

The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins.

Time frame: 72 hours

Physician's Assessment of Erythema

The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.

Time frame: 72 hours

Physician's Assessment of Range of Motion of the Most Affected Joint

The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized).

Time frame: 72 hours

Proportion of Patients With Rescue Medication Intake

Patients used a diary to record the time of intake of rescue medication and the amount taken.

Time frame: 12 weeks

Time to First Rescue Medication Intake

Patients used a diary to record the time of intake of rescue medication and the amount taken.

Time frame: 14 days

Amount of Rescue Medication Taken (mg)

Patients used a diary to record the time of intake of rescue medication and the amount taken.

Time frame: 14 days

C-reactive Protein Level

A central laboratory was used for analysis of all blood samples collected.

Time frame: 72 hours