Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial

被引:50
作者
Lacour, J. -P. [1 ]
Paul, C. [2 ]
Jazayeri, S. [3 ]
Papanastasiou, P. [4 ]
Xu, C. [5 ]
Nyirady, J. [6 ]
Fox, T. [4 ]
Papavassilis, C. [4 ]
机构
[1] Univ Hosp Nice, Dept Dermatol, Nice, France
[2] Paul Sabatier Univ, Dept Dermatol, Toulouse, France
[3] Alliance Dermatol & MOHS Ctr, Phoenix, AZ USA
[4] Novartis Pharma AG, Basel, Switzerland
[5] Stanford Univ, Stanford, CA 94305 USA
[6] Novartis Pharmaceut, E Hanover, NJ USA
关键词
MONOCLONAL-ANTIBODY; CLINICAL-TRIALS; EFFICACY; MODERATE; ADHERENCE; OUTCOMES; SAFETY; ADALIMUMAB; USABILITY; THERAPY;
D O I
10.1111/jdv.14073
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
BackgroundUser satisfaction is an important factor associated with treatment adherence in chronic diseases including moderate-to-severe psoriasis. ObjectiveTo evaluate the efficacy, safety and patient acceptability of 300 and 150 mg secukinumab - a fully human anti-interleukin-17A monoclonal antibody that has demonstrated efficacy in the treatment of patients with moderate-to-severe plaque psoriasis - self-administered by autoinjection. MethodsPatients with moderate-to-severe plaque psoriasis were randomized to secukinumab 300 mg, secukinumab 150 mg or placebo self-administered by autoinjection at baseline, Weeks 1, 2 and 3 and then every 4 weeks from Week 4 to Week 48. Efficacy responses [75/90/100% improvement in Psoriasis Area and Severity Index (PASI 75/90/100) and clear/almost clear skin by Investigator's Global Assessment 2011 modified version (IGA mod 2011 0/1)] were measured at Week 52. Patient-reported usability of the autoinjector was evaluated by the self-injection assessment questionnaire to Week 48. ResultsAt Week 52 with secukinumab 300 mg, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 81.4/64.1/38.8% and 69.6% of patients, respectively, by multiple imputation. At Week 52 with secukinumab 150 mg, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 75.2/57.4/33.1% and 60.2% of patients, respectively, by multiple imputation. Patient-assessed acceptability of the autoinjector remained high to Week 48. The proportion of patients experiencing adverse events was greater with secukinumab 300 mg (88.6%) than with secukinumab 150 mg (78.7%). ConclusionSelf-administration of secukinumab using an autoinjector was associated with robust and sustained efficacy, a good safety profile and high acceptability.
引用
收藏
页码:847 / 856
页数:10
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