Long-Term Efficacy and Safety of Canakinumab in Patients With Tumor Necrosis Factor Receptor-Associated Periodic Syndrome: Results From a Phase III Trial

被引:6
作者
Gattorno, Marco [1 ]
Obici, Laura [2 ]
Penades, Inmaculada Calvo [3 ]
Kallinich, Tilmann [4 ,5 ]
Benseler, Susanne [6 ]
Dekker, Elise [7 ]
Levy, Jeremy [7 ]
De Benedetti, Fabrizio [8 ]
Lachmann, Helen [9 ]
机构
[1] IRCCS Giannina Gaslini Inst, Genoa, Italy
[2] IRCCS Policlin San Matteo Fdn, Pavia, Italy
[3] La Fe Univ & Polytech Hosp, Valencia, Spain
[4] Charite Univ Med Berlin, Berlin, Germany
[5] Deutsch Rheumaforsch Zentrum, Berlin, Germany
[6] Univ Calgary, Alberta Childrens Hosp, Calgary, AB, Canada
[7] Novartis Pharm AG, Basel, Switzerland
[8] Bambino Gesu Pediat Hosp, Rome, Italy
[9] UCL, Sch Med, London, England
关键词
RECURRENT; TRAPS;
D O I
10.1002/art.42695
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective. We aimed at assessing efficacy, safety, and tolerability of canakinumab in patients with tumor necrosis factor receptor-associated periodic syndrome (TRAPS) during a 72-week long-term, open-label extension of the CLUSTER study.Methods. Patients received open-label canakinumab 150 or 300 mg, either every 4 weeks (q4w) or every 8 weeks, with up-titration permitted after on-treatment flares (maximum dose: 300 mg q4w). Efficacy assessments included physician global assessment of disease activity, number of flares, and serum C-reactive protein (CRP) and serum amyloid A protein (SAA) levels. Adverse events were also reported. Results are described for the overall population and according to the cumulative dose of canakinumab adjusted for body weight (<36 mg/kg or >= 36 mg/kg).Results. Of 53 patients entering the final phase (epoch 4) of CLUSTER, 51 completed the treatment. At the end of epoch 4, >94% of patients achieved no or minimal disease activity. Most patients had either no (69.8%) or one flare (24.5%), whereas at baseline, the median number of flares was 9.0 per year. Median CRP levels remained at <10 mg/L. Median SAA concentrations were largely unchanged, with medians of 11.5 mg/L and 14.5 mg/L in the <36 mg/kg and >= 36 mg/kg groups, respectively, at the end of the study. No unexpected safety findings were identified.Conclusion. Control of disease activity, with low flare incidence, was maintained with long-term canakinumab treatment in patients with TRAPS during the 72-week final epoch of the CLUSTER study, with no new safety findings.
引用
收藏
页码:304 / 312
页数:9
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