Informative dropout modeling of longitudinal ordered categorical data and model validation: Application to exposure-response modeling of physician's global assessment score for ustekinumab in patients with psoriasis

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 38, Issue 2, 2011, Pages 237-260

  Hu, Chuanpu ^a   Szapary, Philippe O ^a   Yeilding, Newman ^a   Zhou, Honghui ^a  

^a CENTOCOR INC   (United States)

Author keywords

Informative censoring; Monoclonal antibody; Nonlinear mixed effect modeling; NONMEM; Visual predictive check

Indexed keywords

PLACEBO; USTEKINUMAB;

ARTICLE; CONCENTRATION RESPONSE; CONTROLLED STUDY; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG MECHANISM; DRUG TOLERANCE; HAZARD ASSESSMENT; HUMAN; LONG TERM EXPOSURE; MATHEMATICAL COMPUTING; MATHEMATICAL MODEL; OUTCOME ASSESSMENT; PHYSICIAN GLOBAL ASSESSMENT SCORE; PLACEBO EFFECT; PREDICTIVE VALUE; PRIORITY JOURNAL; PSORIASIS; SCORING SYSTEM; TREATMENT RESPONSE; VALIDATION PROCESS;

ANTIBODIES, MONOCLONAL; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; HUMANS; LONGITUDINAL STUDIES; MODELS, STATISTICAL; PATIENT DROPOUTS; PHYSICIANS; PSORIASIS;

EID: 79956001386     PISSN: 1567567X     EISSN: 15738744     Source Type: Journal    
DOI: 10.1007/s10928-011-9191-7     Document Type: Article

References (27)

1. Koo J (1996) Population-based epidemiologic study of psoriasis with emphasis on quality of life assessment. Dermatol Clin 14:485-496
2. Krueger GG, Duvic M (1994) Epidemiology of psoriasis: clinical issues. J Invest Dermatol 102:14S-18S
3. Schon MP, Boehncke WH (2005) Psoriasis. N Engl J Med 352:1899-1912 (Pubitemid 40627816)
4. Chan JR, Blumenschein W, Murphy E, Diveu C, Wiekowski M, Abbondanzo S, Lucian L, Geissler R, Brodie S, Kimball AB, Gorman DM, Smith K, de Waal Malefyt R, Kastelein RA, McClanahan TK, Bowman EP (2006) IL-23 stimulates epidermal hyperplasia via TNF and IL-20R2-dependent mechanisms with implications for psoriasis pathogenesis. J Exp Med 203:2577-2587 (Pubitemid 44833335)
5. Langrish CL, Chen Y, Blumenschein WM, Mattson J, Basham B, Sedgwick JD, McClanahan T, Kastelein RA, Cua DJ (2005) IL-23 drives a pathogenic T cell population that induces autoimmune inflammation. J Exp Med 201:233-240 (Pubitemid 40189432)
6. Yawalkar N, Karlen S, Hunger R, Brand CU, Braathen LR (1998) Expression of interleukin-12 is increased in psoriatic skin. J Invest Dermatol 111:1053-1057 (Pubitemid 29115174)
7. Rozenblit M, Lebwohl M (2009) New biologics for psoriasis and psoriatic arthritis. Dermatol Ther 22:56-60
8. Zhu Y, Hu C, Lu M, Liao S, Marini JC, Yohrling J, Yeilding N, Davis HM, Zhou H (2009) Population pharmacokinetic modeling of ustekinumab, a human monoclonal antibody targeting IL-12/23p40, in patients with moderate to severe plaque psoriasis. J Clin Pharmacol 49:162-175
9. Hu C, Zhou H (2008) An improved approach for confirmatory phase III population pharmacokinetic analysis. J Clin Pharmacol 48:812-822 (Pubitemid 351871963)
10. Zhou H, Hu C, Zhu Y, Lu M, Liao S, Yeilding N, Davis HM (2010) Population-based exposure-efficacy modeling of ustekinumab in patients with moderate to severe plaque psoriasis. J Clin Pharmacol 50:257-267
11. Ashcroft DM, Wan Po AL, Williams HC, Griffiths CE (1999) Clinical measures of disease severity and outcome in psoriasis: a critical appraisal of their quality. Br J Dermatol 141:185-191 (Pubitemid 29397982)
12. Hutmacher MM, Krishnaswami S, Kowalski KG (2008) Exposure-response modeling using latent variables for the efficacy of a JAK3 inhibitor administered to rheumatoid arthritis patients. J Pharmacokinet Pharmacodyn 35:139-157
13. Lacroix BD, Lovern MR, Stockis A, Sargentini-Maier ML, Karlsson MO, Friberg LE (2009) A pharmacodynamic Markov mixed-effects model for determining the effect of exposure to certolizumab pegol on the ACR20 score in patients with rheumatoid arthritis. Clin Pharmacol Ther 86:387-395
14. Hu C, Xu Z, Rahman MU, Davis HM, Zhou H (2010) A latent variable approach for modeling categorical endpoints among patients with rheumatoid arthritis treated with golimumab plus methotrexate. J Pharmacokinet Pharmacodyn 37:309-321
15. Holford N, Nutt JG (2008) Disease progression, drug action and Parkinson's disease: why time cannot be ignored. Eur J Clin Pharmacol 64:207-216
16. Hazra A, Krzyzanski W, Jusko WJ (2006) Mathematical assessment of properties of precursor-dependent indirect pharmacodynamic response models. J Pharmacokinet Pharmacodyn 33:683-717 (Pubitemid 44819258)
17. Sharma A, Ebling WF, Jusko WJ (1998) Precursor-dependent indirect pharmacodynamic response model for tolerance and rebound phenomena. J Pharm Sci 87:1577-1584 (Pubitemid 28559645)
18. Hu C, Sale ME (2003) A joint model for nonlinear longitudinal data with informative dropout. J Pharmacokinet Pharmacodyn 30:83-103 (Pubitemid 36571070)
19. Klein J, Moeschberger M (1997) Survival analysis. Springer, New York
20. Sheiner LB (1994) A new approach to the analysis of analgesic drug trials, illustrated with bromfenac data. Clin Pharmacol Ther 56:309-322
21. Guidance for Industry (1999) Population pharmacokinetics. Food and Drug Administration, Washington, DC
22. Leonardi CL, Kimball AB, Papp KA, Yeilding N, Guzzo C, Wang Y, Li S, Dooley LT, Gordon KB (2008) Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet 371:1665-1674 (Pubitemid 351671883)
23. Papp KA, Langley RG, Lebwohl M, Krueger GG, Szapary P, Yeilding N, Guzzo C, Hsu MC, Wang Y, Li S, Dooley LT, Reich K (2008) Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet 371:1675-1684 (Pubitemid 351671884)
24. Boeckmann AJ, Sheiner LB, Beal SL (2008) NONMEM Users Guide Part VIII. Regents of the University of California, San Francisco
25. Byon W, Fletcher CV, Brundage RC (2008) Impact of censoring data below an arbitrary quantification limit on structural model misspecification. J Pharmacokinet Pharmacodyn 35:101-116 (Pubitemid 351420764)
26. Zhang L, Beal SL, Sheiner LB (2003) Simultaneous vs. sequential analysis for population PK/PD data I: best-case performance. J Pharmacokinet Pharmacodyn 30:387-404 (Pubitemid 38221931)
27. Post TM, Freijer JI, DeJongh J, Danhof M (2005) Disease system analysis: basic disease progression models in degenerative disease. Pharm Res 22:1038-1049 (Pubitemid 41127061)