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

K. A. Papp; K. Reich; A. Blauvelt; A. B. Kimball; M. Gooderham; S. K. Tyring; R. Sinclair; D. Thaci; Q. Li; N. Cichanowitz; S. Green; C. La Rosa

doi:10.1111/jdv.15400

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

K. A. Papp^*, K. Reich, A. Blauvelt, A. B. Kimball, M. Gooderham, S. K. Tyring, R. Sinclair, D. Thaci, Q. Li, N. Cichanowitz, S. Green, C. La Rosa

^*Corresponding author for this work

Institute of Inflammation Medicine

25 Citations (Scopus)

Abstract

Background: Efficacy of tildrakizumab for plaque psoriasis was demonstrated in randomized, placebo-controlled trials. Objective: To consolidate tildrakizumab efficacy results by pooling data. Methods: Data (N = 2081) from tildrakizumab 100 mg, tildrakizumab 200 mg and placebo groups in three trials were pooled. 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: Pooled data confirmed the efficacy of tildrakizumab for moderate-to-severe plaque psoriasis.

Original language	English
Journal	Journal of the European Academy of Dermatology and Venereology
Volume	33
Issue number	6
Pages (from-to)	1098-1106
Number of pages	9
ISSN	0926-9959
DOIs	https://doi.org/10.1111/jdv.15400
Publication status	Published - 06.2019

Funding

K.A. Papp has served as a scientific and medical consultant for AbbVie, Amgen, Anacor, Active Biotech, Allergan, Arcutis, Astellas, Astra-Zeneca, Basilea, Baxalta, Bayer, Biogen-Idec, BMS, Boehringer-Ingelheim, CanFite, Celgene, Cypher, Coherus, Dermira, Eli-Lilly, Forward Pharma, Galderma, Genentech, GSK, Janssen, Kyowa Hako Kirin, Kythera, Leo Pharma, Merck Sharpe and Dohme, Merck-Serono, Novartis, Pfizer, Regeneron, Rigel, Roche, Sanofi-Genzyme, Sun Pharma, Takeda, UCB, Valeant and Xenon; an investigator for AbbVie, Amgen, Anacor, Allergan, Arcutis, Astellas, Basilea, Biogen-Idec, BMS, Boehringer-Ingelheim, Celgene, Coherus, Dermira, Eli-Lilly, Galderma, Genentech, GSK, Janssen, Kyowa Hako Kirin, Leo Pharma, Merck Sharpe and Dohme, Merck-Serono, Novartis, Pfizer, Regeneron, Roche, Takeda, UCB and Valeant; and a speaker for AbbVie, Amgen, Allergan, Astellas, Biogen-Idec, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Galderma, Genentech, GSK, Janssen, Kyowa Hako Kirin, Leo Pharma, Merck Sharpe and Dohme, Merck-Serono, Novartis, Pfizer, Sanofi-Genzyme, Sun Pharma, Takeda, UCB and Valeant. K. Reich has served as consultant and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Amgen, Biogen-Idec, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo, Lilly, Medac, Merck & Co., Inc., Kenilworth, NJ, USA, Novartis, Pfizer, Vertex and Takeda. A. Blauvelt has served as a scientific adviser and clinical study investigator for AbbVie, Aclaris, Allergan, Almirall, Amgen, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly and Company, Genentech/Roche, GlaxoSmithKline, Janssen, Leo, Meiji, Merck & Co., Inc., Kenilworth, NJ, USA, Novartis, Pfizer, Purdue Pharma, Regeneron, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB, Valeant and Vidac and as a paid speaker for Eli Lilly and Company, Janssen, Regeneron and Sanofi Genzyme. A. Kimball has served as consultant and investigator for Merck & Co., Inc., Kenilworth, NJ, USA, AbbVie, Janssen, Novartis, Dermira and UCB and as a consultant to Lilly, and received fellowship funding from Janssen and AbbVie. M. Gooderham has been an investigator, advisor and/or speaker for Amgen, AbbVie, BMS, Boehringer Ingelheim, Celgene, Dermira, Galderma, GSK, Janssen, Kyowa Kirin, Leo Pharma, Lilly, Merck, Merck Serono, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, Takeda, Valeant and UCB. S. Tyring has participated in trials supported by grants from Merck & Co., Inc., Kenilworth, NJ, USA. R. Sinclair has provided professional services to Leo Pharma, Amgen, Novartis, Merck & Co., Inc., Kenilworth, NJ, USA, Celgene, Coherus Biosciences, Janssen, Regeneron, MedImmune, Glaxo Smith Kline, Cutanea, Samson Clinical, Boehringer Ingelheim, Pfizer, MSD, Oncobiologics, Roche, Eli Lilly and Company and Bayer. D. Thaci has served as consultant, advisory board member and/or an investigator for AbbVie, Almiral, Amgen, Biogen-Idec, Boehringer Ingelheim, Celgene, Dignity, Galderma, Glaxo-Smith Kline, Janssen-Cilag, Leo Pharma, Lilly, Maruho, Medac, Medimmune, MSD, Novartis, Regeneron, Sandoz, Sanofi-Aventis, Sun Pharma, Takeda and Pfizer. Q. Li, N. Cichanowitz, S. Green, and C. La Rosa are employees of Merck & Co., Inc., Kenilworth, NJ, USA. This research was supported by Merck & Co., Inc., Kenilworth, NJ, USA. 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., Kenilworth, NJ, USA.

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Academic Focus: Center for Infection and Inflammation Research (ZIEL)

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Papp, K. A., Reich, K., Blauvelt, A., Kimball, A. B., Gooderham, M., Tyring, S. K., Sinclair, R., Thaci, D., Li, Q., Cichanowitz, N., Green, S., & La Rosa, C. (2019). Efficacy of tildrakizumab for moderate-to-severe plaque psoriasis: pooled analysis of three randomized controlled trials at weeks 12 and 28. Journal of the European Academy of Dermatology and Venereology, 33(6), 1098-1106. https://doi.org/10.1111/jdv.15400

@article{a3fdae97fed04d68b25defc7724580f8,

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

abstract = "Background: Efficacy of tildrakizumab for plaque psoriasis was demonstrated in randomized, placebo-controlled trials. Objective: To consolidate tildrakizumab efficacy results by pooling data. Methods: Data (N = 2081) from tildrakizumab 100 mg, tildrakizumab 200 mg and placebo groups in three trials were pooled. 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) {\textquoteleft}clear{\textquoteright} or {\textquoteleft}minimal{\textquoteright} 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: Pooled data confirmed the efficacy of tildrakizumab for moderate-to-severe plaque psoriasis.",

author = "Papp, \{K. A.\} and K. Reich and A. Blauvelt and Kimball, \{A. B.\} and M. Gooderham and Tyring, \{S. K.\} and R. Sinclair and D. Thaci and Q. Li and N. Cichanowitz and S. Green and \{La Rosa\}, C.",

year = "2019",

month = jun,

doi = "10.1111/jdv.15400",

language = "English",

volume = "33",

pages = "1098--1106",

journal = "Journal of the European Academy of Dermatology and Venereology",

issn = "0926-9959",

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number = "6",

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Papp, KA, Reich, K, Blauvelt, A, Kimball, AB, Gooderham, M, Tyring, SK, Sinclair, R, Thaci, D, Li, Q, Cichanowitz, N, Green, S & La Rosa, C 2019, 'Efficacy of tildrakizumab for moderate-to-severe plaque psoriasis: pooled analysis of three randomized controlled trials at weeks 12 and 28', Journal of the European Academy of Dermatology and Venereology, vol. 33, no. 6, pp. 1098-1106. https://doi.org/10.1111/jdv.15400

Efficacy of tildrakizumab for moderate-to-severe plaque psoriasis: pooled analysis of three randomized controlled trials at weeks 12 and 28. / Papp, K. A.; Reich, K.; Blauvelt, A. et al.
In: Journal of the European Academy of Dermatology and Venereology, Vol. 33, No. 6, 06.2019, p. 1098-1106.

Research output: Journal Articles › Journal articles › Research › peer-review

TY - JOUR

T1 - Efficacy of tildrakizumab for moderate-to-severe plaque psoriasis: pooled analysis of three randomized controlled trials at weeks 12 and 28

AU - Papp, K. A.

AU - Reich, K.

AU - Blauvelt, A.

AU - Kimball, A. B.

AU - Gooderham, M.

AU - Tyring, S. K.

AU - Sinclair, R.

AU - Thaci, D.

AU - Li, Q.

AU - Cichanowitz, N.

AU - Green, S.

AU - La Rosa, C.

PY - 2019/6

Y1 - 2019/6

N2 - Background: Efficacy of tildrakizumab for plaque psoriasis was demonstrated in randomized, placebo-controlled trials. Objective: To consolidate tildrakizumab efficacy results by pooling data. Methods: Data (N = 2081) from tildrakizumab 100 mg, tildrakizumab 200 mg and placebo groups in three trials were pooled. 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: Pooled data confirmed the efficacy of tildrakizumab for moderate-to-severe plaque psoriasis.

AB - Background: Efficacy of tildrakizumab for plaque psoriasis was demonstrated in randomized, placebo-controlled trials. Objective: To consolidate tildrakizumab efficacy results by pooling data. Methods: Data (N = 2081) from tildrakizumab 100 mg, tildrakizumab 200 mg and placebo groups in three trials were pooled. 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: Pooled data confirmed the efficacy of tildrakizumab for moderate-to-severe plaque psoriasis.

UR - https://www.scopus.com/pages/publications/85062511651

U2 - 10.1111/jdv.15400

DO - 10.1111/jdv.15400

M3 - Journal articles

C2 - 30838709

AN - SCOPUS:85062511651

SN - 0926-9959

VL - 33

SP - 1098

EP - 1106

JO - Journal of the European Academy of Dermatology and Venereology

JF - Journal of the European Academy of Dermatology and Venereology

IS - 6

ER -

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

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