Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

Probability of New Gout Flares at End of Study

The Kaplan-Meier estimates of the proportion of participants with first new gout flare, along with the associated 95% confidence intervals using Greenwood's formula were reported. The first new flare was observed either in the core or extension of the study right prior to the switch. The results were reported as Kaplan-Meier estimates.

Time frame: Up to Day 337

Number of Participant With New Flares

The flare rate was calculated as the number of new flares over the period of observation in years. New flares that occurred before the first study medication dose in the extension 1 study were considered.

Time frame: up to 36 weeks

Change From Baseline in 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. Participants were advised to score their current pain intensity in the most affected joint of the gouty arthritis flare on a 5-point Likert scale of 1 (None) to 5 (extreme pain), where; 1= none, 2= mild pain, 3= moderate pain, 4= severe pain, or 5= extreme pain (none, mild, moderate, severe, extreme). The higher value presented on the scale was the outcome (high intensity of pain). The respondent selects the best response that indicates the respondent's subjective evaluation of the item. The Last-observation-carried-forward (LOCF) method was used to impute post-dose pain intensity Likert measurements up to 14 days.

Time frame: Baseline, upto 14 days post-dose

Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time

Patients scored their current pain intensity in the most affected joint of the current gouty arthritis flare on a 0-100 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.