Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Canakinumab (ACZ885) Relieves Pain and Controls Inflammation Rapidly in Patients with Difficult-To-Treat Gouty Arthritis: Comparison with Triamcinolone Acetonide.
So6, A., De Meulemeester4, M., Pikhlak2, A., Yucel1, A. E., Arulmani3, U., Richard3, D., Murphy3, V.
Baskent University, Ankara, Turkey
Moscow State University of Medicine and Dentistry, Moscow, Russian Federation
Novartis Pharma AG, Basel, Switzerland
Private Practice, Gozée, Belgium
UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ
University of Lausanne, Lausanne, Switzerland
Monosodium urate (MSU) crystals stimulate the production of interleukin (IL)-1b, a potent inflammatory cytokine. Targeted IL-1b blockade with canakinumab, a fully human monoclonal anti-IL-1b antibody, is a novel treatment for gouty arthritis. Its effects on pain and inflammation in acute gouty arthritis flares were compared with triamcinolone acetonide (TA). TA has been shown to be effective in the treatment of acute gouty arthritis flares1.
This was an 8-week, dose-ranging, multicenter, blinded, active-controlled trial. Patients >=18 to <=80 years with an acute gouty arthritis flare, refractory to or contraindicated to NSAIDs and/or colchicine were randomized to 1 subcutaneous dose of canakinumab (10, 25, 50, 90, or 150 mg; n=143) or 1 intramuscular dose of TA (40 mg; n=57). Primary outcome was pain intensity at 72 hours post dose on VAS scale (0100 mm). Secondary outcomes included C-reactive protein (CRP), serum amyloid A (SAA), and physician's assessment of tenderness, swelling and erythema of target joint at 72 hours, 7 days, 4- and 8-weeks post dose.
191/200 patients completed the study. Canakinumab showed a statistically significant dose response at 72 hours. The 150 mg dose group reached superior pain relief compared to TA group starting from 24 hours as previously reported2. At 72 hours post dose, 78% of canakinumab 150 mg treated patients achieved >=75% and 96% achieved >=50% reduction in pain from baseline. In contrast, 45% and 61% of patients treated with TA achieved >=75% and >=50% pain reduction, respectively. Median CRP/SAA levels were normalized by Day 7 for all canakinumab doses above 10 mg and remained below the Upper Limit of Normal [(ULN): CRP 3.0 mg/L; SAA 6.7 mg/L)] for rest of the study. In TA group, median CRP levels remained above the ULN throughout the study while median SAA levels decreased below ULN only 28 days after first dose. At 72 hours post dose, canakinumab 150 mg group was 3.2 (95% CI, 1.277.89) times more likely to have less joint tenderness and 2.7 (95% CI, 1.096.5) times more likely to have less joint swelling than TA group (p<0.05). At 72 hours post dose, erythema disappeared in 74.1% of patients receiving canakinumab 150 mg and 69.6% of patients receiving TA. At 7 days post dose, erythema was absent in 96.3% of canakinumab 150 mg treated patients vs. 83.9% of patients receiving TA. The overall incidence of AEs was similar for canakinumab (41%) and triamcinolone acetonide (42%). Serious AEs (canakinumab treatment groups n=4, TA n=1) were not considered treatment related by investigators. No discontinuations occurred due to AEs.
Canakinumab 150 mg provided superior pain relief compared to TA for acute flares in difficult-to-treat gouty arthritis patients. Canakinumab provided rapid normalization of markers of inflammation accompanied by reduction of clinical signs and symptoms of inflammation.
To cite this abstract, please use the following information:
So, A., De Meulemeester, M., Pikhlak, A., Yucel, A. E., Arulmani, U., Richard, D., et al; Canakinumab (ACZ885) Relieves Pain and Controls Inflammation Rapidly in Patients with Difficult-To-Treat Gouty Arthritis: Comparison with Triamcinolone Acetonide. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :145