Methods for imputing missing efficacy data in clinical trials of biologic psoriasis therapies: Implications for interpretations of trial results

TY - JOUR

T1 - Methods for imputing missing efficacy data in clinical trials of biologic psoriasis therapies

T2 - Implications for interpretations of trial results

AU - Langley, Richard G.B.

AU - Reich, Kristian

AU - Papavassilis, Charis

AU - PharmD, Todd Fox

AU - Gong, Yankun

AU - Güttner, Achim

N1 - Funding Information: the most precise estimates for responder rates. Compared with MI, strict NRI underestimated PASI 90 response rates by as much as 6% in the first year of the FIXTURE and ERASURE studies; LOCF and mNRI yielded similar response rates. Given the divergences in response rates estimated with different imputation methods, comparison of long-term efficacy data for different biologics in psoriasis should be undertaken with caution. Awareness of differences among imputation methods is necessary for well-informed interpretation of trial data. DISCLOSURES Dr Langley reported serving as a principal investigator, advisory board member, or speaker for AbbVie, Amgen, Celgene, Janssen, LEO Pharma, Merck, Novartis, and Pfizer. Dr Reich reported receiving honoraria as consultant and/or advisory board member and/or acted as paid speaker and/or participated in clinical trials sponsored by AbbVie, Amgen, Biogen Idec, Celgene, Centocor, Covagen, Eli Lilly, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, MSD, Novartis, Ocean Pharma, Pfizer, Regeneron, Takeda, UCB, Vertex, and Xenoport. Dr Papavassilis, Dr Fox, Dr Gong, and Dr Güttner are employed by Novartis. This study was supported by Novartis Pharma AG (Basel, Switzerland?. ACKNOWLEDGMENTS Novartis personnel participated in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication. The authors thank Mouna Akacha, PhD, of Novartis Pharma AG for contributions to the statistical analysis and Stephen Molloy, PhD, of Novartis Pharma AG for medical communications leadership. Eleanore Gross, PhD, and Andrew Horgan, PhD, of BioScience Communications (New York, NY? provided writing and editorial assistance, supported by Novartis. All authors agreed to submit the current version of the manuscript for publication. Data from this manuscript were presented at the 7th International Congress of Psoriasis: From Gene to Clinic; London, United Kingdom; 11–13 December 2014. REFERENCES Publisher Copyright: © 2017 Journal of Drugs in Dermatology.

PY - 2017/8

Y1 - 2017/8

UR - http://www.scopus.com/inward/record.url?scp=85029426853&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85029426853&partnerID=8YFLogxK

M3 - Article

C2 - 28809988

AN - SCOPUS:85029426853

SN - 1545-9616

VL - 16

SP - 734

EP - 742

JO - Journal of Drugs in Dermatology

JF - Journal of Drugs in Dermatology

IS - 8

ER -