AB1081 Efficacy and safety of canakinumab vs triamcinolone acetonide in persistent or elderly gouty arthritis patients

Background Gouty arthritis (GA), in the elderly, often remains misdiagnosed or diagnosed late in its clinical course and differs from classical GA as more indolent and recurrent. GA patients (pts) with either long-standing disease (>10 yrs) or advanced age (≥65 yrs) are at higher risk for co-morb...

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Veröffentlicht in:Annals of the rheumatic diseases 2013-06, Vol.71 (Suppl 3), p.700-700
Hauptverfasser: Alten, R., Bloch, M., Bardin, T., So, A., Shpilsky, A., Nebesky, J.M., Kiechle, T., Schlesinger, N.
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Sprache:eng
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Zusammenfassung:Background Gouty arthritis (GA), in the elderly, often remains misdiagnosed or diagnosed late in its clinical course and differs from classical GA as more indolent and recurrent. GA patients (pts) with either long-standing disease (>10 yrs) or advanced age (≥65 yrs) are at higher risk for co-morbidities which may limit treatment options vs the general population. Canakinumab, a fully human anti-IL-1β monoclonal antibody, potentially offers a new therapeutic option. Objectives Evaluate the efficacy and safety of canakinumab vs triamcinolone acetonide (TA) in persistent or elderly GA pts. Methods In two 12-week multi-center, double-blind, double-dummy, active-controlled studies (β-RELIEVED, N=228; β-RELIEVED II, N=226), pts ≥18-≤85 yrs meeting ACR 1977 preliminary criteria for GA and contraindicated, intolerant or refractory to NSAIDs and/or colchicine, with onset of flares ≤5 days were randomized to receive single dose canakinumab 150mg sc or TA 40mg im, and were re-dosed “on demand” on each new flare. Upon completion of core studies, pts enrolled into 12-week extension studies and received canakinumab 150 mg sc or TA 40 mg im “on demand” for new flare. Post-hoc analysis was carried out on GA pts (age ≥65 yrs or GA for >10 yrs) to analyze the efficacy and safety of canakinumab vs TA. Results Of 212 pts (94 in canakinumab group, 118 in TA group) included in the subgroup (β-RELIEVED, N=228; β-RELIEVED II, N=226) 81(35.7%) pts were aged ≥65 yrs and 165 (77.8%) had GA for >10 yrs (69, 73.4% in canakinumab group and 96, 81.4% in TA group). After 24 weeks treatment there was a significant (58%) risk reduction in time to first new flare with canakinumab vs TA (hazard ratio 0.42; 95% CI 0.26 to 0.68; p=0.0002 [one sided]). Mean pain intensity post-dose on VAS at 72h was lower for canakinumab vs TA (LS mean: 26.6 vs 36.3, p=0.0085). The incidence of adverse events (AEs) was 73.4% for canakinumab vs 55.1% for TA. Infections and infestations were reported in 21.3% pts with canakinumab vs 8.5% in TA. Most common infections with canakinumab were urinary tract infections (3.2%), followed by nasopharyngitis, pneumonia, sinusitis, and upper respiratory tract infections (URTI) (2.1% each) vs nasopharyngitis, pneumonia (0.8% each) and URTI (1.7%) in TA group. AEs reported in >5% pts were hypertension, arthralgia, increased gamma-glutamyl transferase and back pain (5.3% each) with canakinumab vs hypertension (6.8%) in TA. Serious AEs were reported in 8.5% and 3.4% pts treated
ISSN:0003-4967
1468-2060
DOI:10.1136/annrheumdis-2012-eular.1080