Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
Efficacy of Canakinumab on Re-Treatment in Gouty Arthritis Patients with Limited Treatment Options: 24-Week Results From -RELIEVED and -RELIEVED-II Studies.
Alten1, R., So2, A., Kivitz3, A., Bardin4, T., Bloch5, M., Gimona6, A., Widmer6, A.
Charité Teaching HospitalSchlosspark-Klinik, Berlin, Germany
CHUV, Lausanne, Switzerland
Altoona Center for Clinical Research, Duncansville, PA
Hôpital Lariboisière, Paris, France
Holdsworth House Medical Practice, Sydney, Australia
Novartis Pharma AG, Basel, Switzerland
UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ
University of Pennsylvania and VA Medical Center, Philadelphia, PA
Gouty arthritis (GA) is a chronic, recurrent, inflammatory arthritis affecting 14% of the population. A subset of patients experiencing acute flares may have limited anti-inflammatory treatment options due to contraindications, intolerance or unsatisfactory therapeutic response with current therapies. Canakinumab, a fully human anti-IL-1b monoclonal antibody, selectively targets the inflammatory cascade and is a novel therapeutic approach to treat acute GA. Here we report pooled results from two studies on time to first new flare and pain response to treatment of first and last flare.
In two, 12-week multicenter, active-controlled trials (b-RELIEVED and b-RELIEVED-II), GA patients (1885 yrs) meeting preliminary ACR-1977 criteria and unresponsive, intolerant, or contraindicated to NSAIDs and/or colchicine were enrolled to receive one single dose canakinumab 150mg sc or triamcinolone acetonide (TA) 40mg im and were re-dosed "on demand" on each new flare. Patients completing the core studies were enrolled into 12-week extension studies to further investigate "on demand" use of canakinumab 150 mg sc or TA 40 mg im on new flare. Pooled data from 24-weeks treatment were analyzed for time to first new gout flare (Cox proportional Hazard regression model) and pain intensity in most affected joints (0100mm VAS).
454 patients received study drug and 335 patients entered the extension studies. A total of 317 patients (95% of those entering the extension) completed 24-weeks. Over the entire 24-week period 64 patients on canakinumab and 112 patients on TA experienced >=1 new flare and 17 patients on canakinumab and 50 patients on TA experienced >=2 new flares. The probability of a new gout flare was lower with canakinumab (32.4%) vs TA (56.0%) corresponding to a statistically significant risk reduction of 56% (Hazard Ratio: 0.44; 95% CI 0.320.60; p<0.0001) over 24 weeks. The median time to first new flare per patient treated with canakinumab was >168 days (i.e. not reached within the 24 week study duration) vs 131 days with TA. For new flares in the canakinumab patients, pain was less intense than during first flare. With canakinumab, there was a good correlation between pain response during first flare and subsequent flares (r=0.60) vs TA (r=0.28). Treatment of the last new flare was as effective as treatment of the first flare (Figure).
By targeting IL-1b, canakinumab provided effective pain-relief in all flares and reduced the risk of new flares compared to TA. Canakinumab may represent an important advance in the treatment of GA in patients whose disease cannot be appropriately managed with currently available treatments.
To cite this abstract, please use the following information:
Alten, R., So, A., Kivitz, A., Bardin, T., Bloch, M., Gimona, A., et al; Efficacy of Canakinumab on Re-Treatment in Gouty Arthritis Patients with Limited Treatment Options: 24-Week Results From -RELIEVED and -RELIEVED-II Studies. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :1029