Objectives Gouty arthritis patients for whom non-steroidal anti-inflammatory drugs and colchicine are inappropriate have limited treatment options. Canakinumab, an anti-interleukin-1β monoclonal antibody, may be an option for such patients. The authors assessed the efficacy/safety of one dose of canakinumab 150 mg (n=230) or triamcinolone acetonide (TA) 40 mg (n=226) at baseline and upon a new flare in frequently flaring patients contraindicated for, intolerant of, or unresponsive to non-steroidal anti-inflammatory drugs and/or colchicine. Core study co-primary endpoints were pain intensity 72 h postdose (0–100 mm visual analogue scale and time to first new flare.
Methods Two 12-week randomised, multicentre, active-controlled, double-blind, parallel-group core studies with double-blind 12-week extensions (response in acute flare and in prevention of episodes of re-flare in gout (β-RELIEVED and β-RELIEVED-II)).
Results 82.6% patients had comorbidities. Mean 72-h visual analogue scale pain score was lower with canakinumab (25.0 mm vs 35.7 mm; difference, −10.7 mm; 95% CI −15.4 to −6.0; p<0.0001), with significantly less physician-assessed tenderness and swelling (ORs=2.16 and 2.74; both p≤0.01) versus TA. Canakinumab significantly delayed time to first new flare, reduced the risk of new flares by 62% versus TA (HR: 0.38; 95% CI 0.26 to 0.57) in the core studies and by 56% (HR: 0.44; 95% CI 0.32 to 0.60; both p≤0.0001) over the entire 24-week period, and decreased median C-reactive protein levels (p≤0.0001 at 72 h and 7 days). Over the 24-week period, adverse events were reported in 66.2% (canakinumab) and 52.8% (TA) and serious adverse events were reported in 8.0% (canakinumab) and 3.5% (TA) of patients. Adverse events reported more frequently with canakinumab included infections, low neutrophil count and low platelet count.
Conclusion Canakinumab provided significant pain and inflammation relief and reduced the risk of new flares in these patients with acute gouty arthritis.
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Funding This study was supported by Novartis Pharma AG, Basel, Switzerland.
Competing interests NS reports having received a grant, travel expenses and payment for advisory board membership from Novartis Pharma, payment for advisory board membership and educational presentations from Takeda and Savient, and payment for advisory board membership from Savient, URL Pharma and Enzyme Rx. REA reports having received consulting fees from Novartis, payment for educational presentations from Novartis, Abbott and BMS, and payment for advisory board membership from Abbott, BMS and Roche. TB reports having received payments for advisory board membership, consultancy and educational presentations from Novartis, for consultancy from Savient, for advisory board membership and development of educational material from Ipsen and Menarini, and for development of educational material from Mayoli Spindler. MB reports having received travel expenses and payments for advisory board membership and educational presentations from Novartis. HRS reports having received grants and payments for consultancy and educational presentations from Takeda, grants and payments for consultancy from Pfizer, and payments for consultancy from Novartis, Regeneron, Savient, and Ardea Biosciences. DR, GK and VM are employees of Novartis and report having equity interests in Novartis. AG reports having equity interests in Novartis. AKS reports having received payment for board membership, consultancy and travel expenses from Novartis, and for educational presentations from Menarini.
Ethics approval Two global multicentre studies were involved (numerous Committees/IRBs reviewed).
Provenance and peer review Not commissioned; externally peer reviewed.