Results of three analytical approaches on long-term efficacy of etanercept for psoriasis in daily practice - 14/12/12
, Rieke J.B. Driessen, MD, PhD, Wietske Kievit, PhD, Jan B.M. Boezeman, MSc, Peter C.M. van de Kerkhof, MD, PhD, Elke M.G.J. de Jong, MD, PhD
Correspondence to: Paula P. M. van Lümig, MD, Department of Dermatology, Radboud University, Nijmegen Medical Centre, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands.Abstract |
Background |
A problem encountered when analyzing long-term efficacy is that the number of patients in follow-up decreases with time for different reasons. The method used to account for missing observations for the therapy under analysis has a great influence on the inference of efficacy.
Objective |
To describe the long-term efficacy of etanercept for psoriasis in daily practice using 3 analytical approaches.
Methods |
Prospective data from a cohort of patients with psoriasis treated with etanercept for at least 24 weeks were analyzed using 3 analytical approaches: as treated analysis, intention-to-treat analysis (ITT) with last observation carried forward (LOCF) and intention-to-treat analysis with modified nonresponder imputation (modified NRI).
Results |
One hundred thirty-one patients were treated with etanercept during 134 treatment episodes with a mean treatment duration of 2.7 years. The maximum follow-up was 6.0 years. The methodological approach chosen had a great influence. Psoriasis Area and Severity Index (PASI) 75 response rates varied from 60% in the as-treated approach to 34% in LOCF and to 29% in modified NRI at week 264.
Limitations |
All analytical methods applied have limitations. Other outcome measures could be used to overcome the bias introduced by each method of analysis, such as drug survival.
Conclusions |
The methodological approach chosen to analyze long-term efficacy data has a great influence on the inferences that may be drawn regarding the degree of efficacy. Therefore we support the use of different methods to present long-term efficacy data.
Le texte complet de cet article est disponible en PDF.Key words : biologics, daily practice, etanercept, long-term efficacy, method of analysis, psoriasis, registry
Abbreviations used : BMI, LOCF, modified NRI, PASI, RCT, SEM, TNF
Plan
| Funding sources: The Radboud University Nijmegen Medical Centre was supported in part by UMC St Radboud Foundation, which received funding from Pfizer and Abbott for the project. |
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| Disclosure: Dr van Lümig carries out clinical trials for Abbott and Janssen-Cilag, has received speaking and consulting fees from Wyeth and Schering-Plough as well as receiving reimbursement for attending a symposium from Schering-Plough and Pfizer. Dr Driessen has received funding from Merck Serono and carried out clinical trials for Wyeth, Schering-Plough, Centocor, Abbott, Merck Serono and Barrier Therapeutics; in addition, Dr Driessen has received speaking and consulting fees from Wyeth and Schering-Plough as well as reimbursement for attending a symposium from Merck Serono, Wyeth, and Janssen-Cilag. Dr van de Kerkhof serves as a consultant for Schering-Plough, Celgene, Centocor, Allmirall, UCB, Wyeth, Pfizer, Sofinnova, Abbott, Actelion, Galderma, Novartis, Janssen-Cilag and LEO Pharma. In addition, Dr van de Kerkhof receives research grants from Centocor, Wyeth, Schering-Plough, Merck Serono, Abbott, and Philips Lighting. Dr de Jong served as a consultant for Biogen, Merck Serono, Wyeth, and Abbott and has received research grants from or was involved in clinical trials from Schering-Plough, Abbott, Merck Serono, Wyeth, Centocor, and Janssen-Cilag. Authors Kievit and Boezeman have no conflicts of interest to declare. |
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| Reprints not available from the authors. |
Vol 68 - N° 1
P. 57-63 - janvier 2013 Retour au numéro
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