Efficacy of tildrakizumab for moderate-to-severe plaque psoriasis: pooled analysis of three randomized controlled trials at weeks 12 and 28.


Journal

Journal of the European Academy of Dermatology and Venereology : JEADV
ISSN: 1468-3083
Titre abrégé: J Eur Acad Dermatol Venereol
Pays: England
ID NLM: 9216037

Informations de publication

Date de publication:
Jun 2019
Historique:
received: 02 07 2018
accepted: 14 11 2018
pubmed: 7 3 2019
medline: 3 1 2020
entrez: 7 3 2019
Statut: ppublish

Résumé

Efficacy of tildrakizumab for plaque psoriasis was demonstrated in randomized, placebo-controlled trials. To consolidate tildrakizumab efficacy results by pooling data. Data (N = 2081) from tildrakizumab 100 mg, tildrakizumab 200 mg and placebo groups in three trials were pooled. Proportions of Psoriasis Area and Severity Index (PASI) 75 responders at week 12 were better with tildrakizumab 100 mg (62.3%) and tildrakizumab 200 mg (64.8%) vs. placebo (5.6%; P < 0.0001) and for PASI 90, PASI 100 and Physician's Global Assessment (PGA) 'clear' or 'minimal' vs. placebo (P < 0.0001). Responses increased from weeks 12 to 28. Week 12 PASI and PGA responses to tildrakizumab vs. placebo were numerically greater in patients with lower vs. higher bodyweight and were better with tildrakizumab 200 mg than tildrakizumab 100 mg for patients with higher bodyweight. Week 12 PASI 75 responses vs. placebo with tildrakizumab 100 mg were similar between patients with (55.0%) or without (56.7%) prior biologics. PASI 90, PASI 100 and PGA responses were generally higher in patients without prior biologics. Week 8 PASI 50 response predicted PASI 90 response. Pooled data confirmed the efficacy of tildrakizumab for moderate-to-severe plaque psoriasis.

Sections du résumé

BACKGROUND BACKGROUND
Efficacy of tildrakizumab for plaque psoriasis was demonstrated in randomized, placebo-controlled trials.
OBJECTIVE OBJECTIVE
To consolidate tildrakizumab efficacy results by pooling data.
METHODS METHODS
Data (N = 2081) from tildrakizumab 100 mg, tildrakizumab 200 mg and placebo groups in three trials were pooled.
RESULTS RESULTS
Proportions of Psoriasis Area and Severity Index (PASI) 75 responders at week 12 were better with tildrakizumab 100 mg (62.3%) and tildrakizumab 200 mg (64.8%) vs. placebo (5.6%; P < 0.0001) and for PASI 90, PASI 100 and Physician's Global Assessment (PGA) 'clear' or 'minimal' vs. placebo (P < 0.0001). Responses increased from weeks 12 to 28. Week 12 PASI and PGA responses to tildrakizumab vs. placebo were numerically greater in patients with lower vs. higher bodyweight and were better with tildrakizumab 200 mg than tildrakizumab 100 mg for patients with higher bodyweight. Week 12 PASI 75 responses vs. placebo with tildrakizumab 100 mg were similar between patients with (55.0%) or without (56.7%) prior biologics. PASI 90, PASI 100 and PGA responses were generally higher in patients without prior biologics. Week 8 PASI 50 response predicted PASI 90 response.
CONCLUSION CONCLUSIONS
Pooled data confirmed the efficacy of tildrakizumab for moderate-to-severe plaque psoriasis.

Identifiants

pubmed: 30838709
doi: 10.1111/jdv.15400
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Dermatologic Agents 0
Placebos 0
tildrakizumab DEW6X41BEK

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1098-1106

Subventions

Organisme : Merck & Co., Inc.

Informations de copyright

© 2019 European Academy of Dermatology and Venereology.

Auteurs

K A Papp (KA)

K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.

K Reich (K)

Dermatologikum Berlin, Berlin, Germany.
ScIderm Research Institute, Hamburg, Germany.

A Blauvelt (A)

Oregon Medical Research Center, Portland, OR, USA.

A B Kimball (AB)

Harvard Medical School, Boston, MA, USA.

M Gooderham (M)

SKiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada.
Queens University, Kingston, ON, Canada.

S K Tyring (SK)

Department of Dermatology, University of Texas, Houston, TX, USA.

R Sinclair (R)

University of Melbourne, Melbourne, VIC, Australia.

D Thaci (D)

University of Lübeck, Lübeck, Germany.

Q Li (Q)

Merck & Co., Inc., Kenilworth, NJ, USA.

N Cichanowitz (N)

Merck & Co., Inc., Kenilworth, NJ, USA.

S Green (S)

Merck & Co., Inc., Kenilworth, NJ, USA.

C La Rosa (C)

Merck & Co., Inc., Kenilworth, NJ, USA.

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Classifications MeSH