Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis

被引:59
|
作者
Gordon, K. B. [1 ]
Lebwohl, M. [2 ]
Papp, K. A. [3 ]
Bachelez, H. [4 ]
Wu, J. J. [5 ]
Langley, R. G. [6 ]
Blauvelt, A. [7 ]
Kaplan, B. [8 ]
Shah, M. [8 ]
Zhao, Y. [8 ]
Sinvhal, R. [8 ]
Reich, K. [9 ]
机构
[1] Med Coll Wisconsin, Dept Dermatol, Milwaukee, WI 53226 USA
[2] Icahn Sch Med Mt Sinai, Dept Dermatol, New York, NY 10029 USA
[3] K Papp Clin Res & Prob Med Res, Waterloo, ON, Canada
[4] Univ Paris, Hop St Louis, AP HP, Paris, France
[5] Dermatol Res & Educ Fdn, Irvine, CA USA
[6] Dalhousie Univ, Dept Med, Div Dermatol, Halifax, NS, Canada
[7] Oregon Med Res Ctr, Portland, OR USA
[8] AbbVie Inc, N Chicago, IL USA
[9] Univ Med Ctr Hamburg Eppendorf, Ctr Translat Res Inflammatory Skin Dis, Inst Hlth Serv Res Dermatol & Nursing, Hamburg, Germany
关键词
POPULATION; RATES; USTEKINUMAB; EVENTS; COHORT; RISK;
D O I
10.1111/bjd.20818
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Background Risankizumab has demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis in randomized clinical trials. Objectives To evaluate safety data from risankizumab psoriasis phase I-III clinical trials. Methods Short-term safety (through week 16) was analysed using integrated data from five phase II and III clinical trials. Long-term safety was evaluated using integrated data from 17 phase I-III completed and ongoing trials. Results Short-term safety analyses included 1306 patients receiving risankizumab 150 mg and 300 patients receiving placebo [402 center dot 2 and 92 center dot 0 patient-years (PY) of exposure, respectively]. Long-term analyses included 3072 risankizumab-treated patients (exposure: 7927 PY). The median (excluding four outliers) treatment duration was 2 center dot 9 years (range 2 days to 5 center dot 9 years). Exposure-adjusted adverse event rates did not increase with long-term treatment (318 vs. 171 events per 100 PY for short- and long-term analyses). With long-term risankizumab treatment, rates of serious adverse events were 7 center dot 8 per 100 PY, serious infections 1 center dot 2 per 100 PY, nonmelanoma skin cancer (NMSC) 0 center dot 7 per 100 PY, malignant tumours excluding NMSC 0 center dot 5 per 100 PY, and adjudicated major adverse cardiovascular events 0 center dot 3 per 100 PY, with no important identified risks. Limitations include that the study inclusion and exclusion criteria varied and that three studies enrolled <= 50 patients. Conclusions Risankizumab demonstrated a favourable safety profile over short- and long-term treatment in patients with moderate-to-severe psoriasis.
引用
收藏
页码:466 / 475
页数:10
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