Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1). Patients met definition of new flare if they had: •Flare in joint, not a previously affected joint (at baseline or during study) •Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Patients did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before flare has resolved completely.

Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.

Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at Baseline and the confidence intervals were determined along with 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose.

Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.

Kaplan-Meier estimates of the time to complete resolution of self-assessed pain intensity in the joint most affected and the confidence interval was determined. Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; 6 and 12 hours; 1, 2, 3, 4, 5, 6, and 7 days post-dose.

Full Analysis Set (FAS): All patients that received study drug.

SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales that can be aggregated into physical and mental component summary scores. Scores are standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. Analysis of covariance (ANCOVA) model was used with treatment group and baseline SF-36 physical function subscore as covariates.

Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with observations at Week 12 were included in the analysis.

The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period.

Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.

Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The analysis of covariance (ANCOVA) analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.

Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.

Canakinumab concentration was analyzed in serum by means of a competitive Enzyme-linked immunosorbent assay (ELISA) assay with a lower limit of quantification (LOQ) at 100 ng/mL.

Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.

Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), from 6 hours to 7 days post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.

Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.

Patient's assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) for the last post-baseline flare, ranging from no pain (0) to unbearable pain (100), was summarized up to 7 days after receiving a re-dose of study drug by time point. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The covariance analysis included treatment group, Baseline VAS score at that flare, and body mass index (BMI) at Baseline as covariates.

The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. For assessments made up to 7 days after re-dosing, pain values were imputed using the Last- Observation-Carried-Forward (LOCF) method.

Kaplan-Meier (KM) estimates of the time to first new flare and confidence intervals were determined. Participants met the definition of a new flare if they had:

• Flare in joint, not a previously affected joint (at baseline or during study)
• Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Participants 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.

The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.

Patients met definition of new flare if they had:

• Flare in joint, not a previously affected joint(at baseline or during study)
• Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Participants 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.

Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.

Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:

• Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.
• If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.

Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.

Kaplan-Meier estimates of the time to first intake of rescue medication, in hours, and the confidence interval were determined for the flare experienced at study entry (Baseline flare) and the last new flare (last post-baseline flare) that occurred up until the end of the first extension period (24 weeks).

For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. Patients who did not take rescue medication had the time-to-first rescue medication intake censored at 7 days post dosing and re-dosing.

Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:

• Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.
• If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.

Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.

For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare.

Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:

• Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.
• If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.

For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare.

The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's own assessments (pain intensity and patient's global assessment of response to treatment).

The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available for this endpoint at the specified time point.

This was primary endpoint of extension study 1. Adverse event is defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. A serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment

Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. The percentage of participants in each category is reported.

The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.

The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that "there is pain", patient states "there is pain and winces", and patient states "there is pain, winces, and withdraws" on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of participants in each category is reported.

The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.

The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of participants in each category is reported.

The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.

This was the primary endpoint of extension study 2. An adverse event was defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.

High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analyses were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.

For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. "N" indicates the number of participants with available data in each analysis.

Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme).

The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.

For each new flare, participants scored the maximum amount of acute gout pain in the most affected joint since the onset of the new flare and the time they were re-dosed on a 5 point Likert scale as None, Mild, Moderate, Severe or Extreme. The percentage of participants with a maximum new flare severity of severe or extreme is reported for the first post-baseline flare that occurred during the 12-week core study and for the last post-baseline flare that occurred up until the end of the first extension period.

The number of participants analyzed (indicated by 'N') for the first new post-baseline flare includes patients who were re-treated for a new flare during the 12-week core study. For the last post-baseline flare the population analyzed includes patients re-treated for at least one new flare during the first 24 weeks.

Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).

Patients met definition of new flare if they had:

• Flare in joint, not a previously affected joint (at baseline or during study)
• Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Patients did not meet criterion of having new gout flare if:

• Increasing/renewed gout pain in an affected joint before flare has resolved completely.

The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.

Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.

Participants met the definition of new flare if they had:

• Flare in joint, not a previously affected joint (at baseline or during study)
• Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Participants did not meet criterion of having new gout flare if:

• Increasing/renewed gout pain in an affected joint before the flare has resolved completely.

Flare rates were estimated from a negative binomial model with body mass index at baseline as a covariate.

The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.

Participants scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe or extreme).

Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.

Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight or poor. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.

The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: very good, good, fair, poor or very poor.

The physician completed the physician's global assessment of response to treatment without viewing any of the patient's assessments.

Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.

The study physician assessed the most affected joint for tenderness on the following 4-point scale:

• no pain;
• participant states that "there is pain;
• participant states "there is pain and winces";
• participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint.

Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.

The study physician assessed the most affected joint for swelling on the following 4-point scale:

• no swelling;
• palpable;
• visible;
• bulging beyond the joint margins.

Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.

The study physician assessed the most affected joint for erythema (redness of the skin) as either present, absent or not assessable.

Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.

High sensitivity C-reactive protein (hsCRP) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.

Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.

Serum Amyloid A Protein (SAA) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.

Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.