Rheumatoid Arthritis Disease Progression Modeling

Therapeutic Innovation and Regulatory Science

Volumn 47, Issue 6, 2013, Pages 641-650

  Reeve, Russell ^a   Pang, Lei ^a,b   Ferguson, Bradley ^c   O'Kelly, Michael ^a   Berry, Seth ^a   Xiao, Wei ^c  

^a IQVIA   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

^c NORTH CAROLINA STATE UNIVERSITY   (United States)

Author keywords

ACR20; DMARD; nonlinear model; rheumatoid arthritis; time progression model; TNF inhibitor

Indexed keywords

ABATACEPT; ADALIMUMAB; ANTIRHEUMATIC AGENT; CERTOLIZUMAB PEGOL; ETANERCEPT; GOLIMUMAB; INFLIXIMAB; METHOTREXATE; MONOCLONAL ANTIBODY; SALAZOSULFAPYRIDINE; TOCILIZUMAB;

ARTICLE; DISEASE COURSE; DISEASE MODEL; HUMAN; META ANALYSIS; METHODOLOGY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; RHEUMATOID VASCULITIS; TIME PROGRESSION MODEL;

EID: 84886799370     PISSN: 21684790     EISSN: 21649200     Source Type: Journal    
DOI: 10.1177/2168479013499571     Document Type: Article

References (33)

1. Amgen. 10-Q. Filed August 8, 2012; Thousand Oaks, California.
2. Abbott. 10-K. Filed February 21, 2012; Abbott Park, Illinois.
3. Johnson and Johnson. 10-K. Filed February 22, 2012; New Brunswick, New Jersey.
4. Reeve R,Turner IR.Pharmacodynamic models: parameterizing the Hill equation, Michaelis-Menten, and the logistic curve, and relationships among these models.J Biopharm Stat. In press;:.
5. Demin I,Hamrén B,Luttringer O,Pillai G,Jung T.Longitudinal model-based meta-analysis in rheumatoid arthritis: an application toward model-based drug development.Clin Pharmacol Ther. 2012;92:352-359.
6. Siegal J,Zhen B-G.Use of the American College of Rheumatology N (ACR-N) index of improvement in rheumatoid arthritis: argument in favor.Arthritis Rheum. 2005;52:1637-1641.
7. Harth M,Pope J.The measure of our measures.Rheumatology. 2004;43:1465-1467.
8. WelsingPMJLandeweBMvan RielPLCM. The relation between disease activity and radiological progression in patients with rheumatoid arthritis: a longitudinal analysis. In: WelsingPMJ, ed. Interrelations Between Process and Outcome Measures Over the Course of Rheumatoid Arthritis. 2005. http://repository.ubn.ru.nl/bitstream/2066/49209/1/49209.pdf.
9. Welsing PMJ,Landewe RBM,van Riel PLCM, et al.The relationship between disease activity and radiologic progression in patients with rheumatoid arthritis: a longitudinal analysis.Arthritis Rheum. 2004;50:2082-2093.
10. Gabrielson J,Weiner D.Pharmacokinetic/Pharmacodynamic Data Analysis: Concepts and Applications. Stockholm, Sweden: Swedish Pharmaceutical Press; 2000:.
11. Lacroix BD,Lovern MR,Stockis A,Sargentini-Maier ML,Karlsson MO,Friberg LE.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. 2009;86:387-395.
12. Anderson JJ,Bolognese JA,Felson DT.Comparison of rheumatoid arthritis clinical trial outcome measures: a simulation study.Arthritis Rheum. 2003;48:3031-3038.
13. Hu C,Xu Z,Zhang Y,Rahman MU,Davis HM,Zhou H.Population approach for exposure-response modeling of golimumab in patients with rheumatoid arthritis.J Clin Pharmacol. 2011;51:639-648.
14. Lee H,Kimko HC,Rogge M,Wang D,Nestorov I,Peck C.Population pharmacokinetic and pharmacodynamic modeling of etanercept using logistic regression analysis.Clin Pharmacol Ther. 2003;73:348-365.
15. Thomas N.An example of simulation-based calculations of the probability of technical success. Presented at: the Joint Statistical Meetings; July 30 to August 2, 2012; San Diego, California;.
16. Lindstrom MJ,Bates DM.Nonlinear mixed effects models for repeated measures data.Biometrics. 1990;46:673-687.
17. Keystone EC,Kavanaugh AF,Sharp JT, et al.Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy.Arthritis Rheum. 2004;50:1400-1411.
18. Weinblatt ME,Keystone EC,Furst DE, et al.Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial.Arthritis Rheum. 2003;48:35-45.
19. Genovese MC,McKay JD,Nasonov EL, et al.Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the Tocilizumab in Combination With Traditional Disease-Modifying Antirheumatic Drug Therapy Study.Arthritis Rheum. 2008;58:2968-2980.
20. Kremer JM,Blanco R,Brzosko M, et al.Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year.Arthritis Rheum. 2011;63:609-621.
21. Jones G,Sebba A,Gu J, et al.Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study.Ann Rheum Dis. 2010;69:88-96.
22. Keystone E,van der Heijde DM,Mason D, et al.Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study.Arthritis Rheum. 2008;58:3319-3329.
23. Smolen J,Landewé RB,Mease P, et al.Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial.Ann Rheum Dis. 2009;68:797-804.
24. Emery P,Fleischmann RM,Moreland LW, et al.Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis.Arthritis Rheum. 2009;60:2272-2283.
25. Keystone EC,Genovese MC,Klareskog L, et al.Golimumab, a human antibody to tumour necrosis factor α given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD study.Ann Rheum Dis. 2009;68:789-796.
26. Maini R,St Clair EW,Breedveld F, et al.Infliximab (chimeric anti-tumour necrosis factor α monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group.Lancet. 1999;354:1932-1939.
27. Schiff M,Keiserman M,Codding C, et al.Clinical response and tolerability to abatacept in patients with rheumatoid arthritis previously treated with infliximab or abatacept: open-label extension of the ATTEST Study.Ann Rheum Dis. 2008;70:2003-2007.
28. St Clair EW,van der Heijde DM,Smolen JS, et al.Active-controlled study of patients receiving infliximab for the treatment of rheumatoid arthritis of early onset study group combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial.Arthritis Rheum. 2004;50:3432-3443.
29. Kremer JM,Dougados M,Emery P, et al.Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept.Arthritis Rheum. 2005;50:2263-2271.
30. Genovese MC,Becker JC,Schiff M, et al.Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition.N Engl J Med. 2005;353:1114-1123.
31. Bathon JB,Martin R,Fleischmann R, et al.A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis.N Engl J Med. 2005;343:1586-1593.
32. Klareskog L,van der Heijde D,de Jager JP, et al.Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomized controlled trial.Lancet. 2004;363:675-681.
33. Billingsley PProbability and Measure. 2nd ed. New York: John Wiley & Sons; 1986.New York: John Wiley & Sons; 1986:.