Background/Purpose: Patients with gouty arthritis (GA) experience frequent flares with pain and inflammation. The limited available treatment options and typical comorbidities warrant effective alternative treatments¹. A liquid formulation of canakinumab (CAN), presented as pre-filled syringe (CAN-PFS) has been developed to improve upon the lyophilized form (CAN-LYO). Efficacy and safety profile of CAN-PFS vs triamcinolone acetonide (TA) over 12 weeks in GA patients was reported earlier. Here we present the cumulative, safety, and efficacy results over 48 weeks.

Methods: Patients with GA who completed the 12-week core study¹ were enrolled in this 36-week, open-label extension (E1) study. All patients entering E1 received CAN-PFS 150 mg s.c. on demand upon new GA flare irrespective of the assigned treatment during randomization (CAN-PFS, CAN-LYO or TA 40 mg). The primary objective was to confirm the long-term safety of CAN-PFS vs TA. Secondary objectives included evaluation of CAN-PFS vs TA and CAN-LYO vs CAN-PFS for the time to first new flare over 48 weeks. Long-term safety outcomes and safety upon retreatment were assessed as the exposure-adjusted incidence rate of adverse events (AEs) and serious AEs (SAEs).

Results: Of the 397 patients randomized in the core study, 232 (58.4%) entered E1, of whom, 198 (50%) completed E1. Baseline characteristics were comparable between the treatment groups. The exposure-adjusted incidence of AEs was lower for both CAN-PFS [254.9/100 patient-years (pyr)] and CAN-LYO (224.8/100 pyr) groups vs TA (362.7/100 pyr) group over the 48 weeks. The exposure-adjusted incidence of SAEs was 14.7/100, 16.1/100, and 15.5/100 pyr in patients randomized to CAN-PFS, CAN-LYO, and TA groups, respectively. Infections and infestations were the most frequently reported SAEs in the CAN-PFS (3.4/100 pyr), CAN-LYO (3.2/100 pyr), and TA (0/100 pyr) groups. Over the 48 weeks, one death (cardiac failure), not suspected to be related to study drug, was reported in a patient randomized to CAN-PFS who was not re-treated during this period. CAN-PFS significantly delayed time to first new flare vs TA, with a relative risk reduction of 55% (hazards ratio [HR], 0.45; 95% confidence interval [CI], 0.32 to 0.64; p<0.0001) over 48 weeks. The mean number of new GA flares per patient was lower for both CAN-LYO (0.50) and CAN-PFS (0.76) groups than the TA group (0.96). Patients in the CAN-PFS group showed a 56% reduction in the number of new flares than the TA group (flare rate ratio, 0.44; 95% CI, 0.32 to 0.61; p<0.0001).

Conclusion:

These results provide evidence for the long-term safety and efficacy of CAN-PFS in patients with frequent GA flares, compared with TA. The safety profiles were consistent with those observed in the core study, and the efficacy of CAN-PFS was maintained upon retreatment.

Reference:

1. Sunkureddi P, et al. Arthritis & Rheum. 2013;65(10):1177.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/canakinumab-liquid-formulation-in-acute-gouty-arthritis-patients-long-term-safety-and-efficacy-results-from-a-36-week-extension-study/