Abstract | BACKGROUND: OBJECTIVES: To assess efficacy, safety and usability of secukinumab administration via PFS in subjects with moderate-to-severe plaque psoriasis. MATERIALS AND METHODS: Subjects in this phase 3 trial were randomized 1 : 1 : 1 to secukinumab 300 or 150 mg or matching placebo. Results to week 12 are presented here. Each treatment was delivered using a PFS once weekly to week 4, and again at week 8. Co-primary endpoints were secukinumab superiority over placebo for week 12 PASI 75 (≥ 75% reduction in Psoriasis Area and Severity Index) and IGA mod 2011 (2011 modified Investigator's Global Assessment) 0/1 response rates. Secondary endpoints included PFS usability, determined by observer rating of successful, hazard-free self-injection and subject rating of acceptability by the Self-Injection Assessment Questionnaire (SIAQ). RESULTS: Co-primary endpoints were met, with demonstration of superiority for each secukinumab dose vs. placebo at week 12 (PASI 75: 75·9%, 69·5% and 0% for secukinumab 300 mg, 150 mg and placebo; IGA mod 2011 0/1: 69·0%, 52·5% and 0%, respectively; P < 0·0001 for all comparisons vs. placebo). PFS usability was high: 100% of subjects successfully self-administered treatment at week 1, and subjects reported high SIAQ-assessed acceptability of the PFS throughout the trial. No new/unexpected safety signals were observed. CONCLUSIONS:
Secukinumab administration by PFS was effective, with an acceptable safety profile and high usability. The PFS provides a reliable, convenient form of secukinumab administration in subjects with moderate-to-severe plaque psoriasis.
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Authors | A Blauvelt, J C Prinz, A B Gottlieb, K Kingo, H Sofen, M Ruer-Mulard, V Singh, R Pathan, C Papavassilis, S Cooper, FEATURE Study Group |
Journal | The British journal of dermatology
(Br J Dermatol)
Vol. 172
Issue 2
Pg. 484-93
(Feb 2015)
ISSN: 1365-2133 [Electronic] England |
PMID | 25132411
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2014 British Association of Dermatologists. |
Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Dermatologic Agents
- secukinumab
|
Topics |
- Adolescent
- Adult
- Aged
- Antibodies, Monoclonal
(administration & dosage, adverse effects)
- Antibodies, Monoclonal, Humanized
- Dermatologic Agents
(administration & dosage, adverse effects)
- Double-Blind Method
- Drug Administration Schedule
- Female
- Humans
- Injections
- Male
- Middle Aged
- Patient Satisfaction
- Psoriasis
(drug therapy)
- Self Administration
- Syringes
- Treatment Outcome
- Young Adult
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