Journal article
Safety of tildrakizumab for moderate-to-severe plaque psoriasis: pooled analysis of three randomized controlled trials
A Blauvelt, K Reich, KA Papp, AB Kimball, M Gooderham, SK Tyring, R Sinclair, D Thaçi, Q Li, N Cichanowitz, S Green, C La Rosa
British Journal of Dermatology | WILEY | Published : 2018
DOI: 10.1111/bjd.16724
Abstract
Background: Short-term interleukin-23p19 inhibition by tildrakizumab improves plaque psoriasis and appears to be well tolerated. Objectives: Safety and tolerability were assessed for up to 64 weeks of tildrakizumab therapy using pooled data from three randomized controlled trials for moderate-to-severe psoriasis. Methods: Data pools for the placebo-controlled (up to 16 weeks) and full trial periods (up to 64 weeks) were analysed (n = 2081). Results: In the placebo-controlled period, frequencies of treatment-emergent adverse events (TEAEs; range 47·9–54·0%), serious TEAEs (range 1·4–2·3%), discontinuations due to AEs (range 0·6–1·9%), major adverse cardiovascular events (MACEs; range 0·0–0·1%..
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Funding Acknowledgements
This research was supported by Merck & Co., Inc., Kenilworth, NJ, U.S.A. Medical writing and editorial assistance were provided by Erin P. Scott, PhD, of Scott Medical Communications, LLC. This assistance was funded by Merck & Co., Inc.