Golimumab Pharmacokinetics After Repeated Subcutaneous and Intravenous Administrations in Patients with Rheumatoid Arthritis and the Effect of Concomitant Methotrexate: An Open-Label, Randomized Study

Clinical Therapeutics

Volumn 34, Issue 1, 2012, Pages 77-90

  Zhuang, Yanli ^a   Xu, Zhenhua ^a   Frederick, Bart ^a   De Vries, Dick E ^b   Ford, Joyce A ^a   Keen, Monica ^a   Doyle, Mittie K ^a,c   Petty, Kevin J ^a   Davis, Hugh M ^a   Zhou, Honghui ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^b Janssen Biologics   (Netherlands)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

C reactive protein; Golimumab; Human anti tumor necrosis factor monoclonal antibody; Methotrexate; Pharmacokinetics; Rheumatoid arthritis

Indexed keywords

C REACTIVE PROTEIN; CORTICOSTEROID; GOLIMUMAB; METHOTREXATE; RHEUMATOID FACTOR;

ABDOMINAL DISCOMFORT; ACOUSTIC NEURINOMA; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; ASTHMA; BLOOD SAMPLING; BURSITIS; CAUCASIAN; CLINICAL ARTICLE; CONTROLLED STUDY; CORTICOSTEROID THERAPY; DIARRHEA; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE REGIMEN; DRUG FATALITY; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; EDEMA; ELECTROCHEMICAL ANALYSIS; ERYTHROCYTE SEDIMENTATION RATE; FATIGUE; FEMALE; FOLLOW UP; HAY FEVER; HERPES ZOSTER; HUMAN; HYPOTENSION; IMMUNOASSAY; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; INJECTION SITE IRRITATION; MALE; MAXIMUM PLASMA CONCENTRATION; NONCARDIAC CHEST PAIN; OPEN STUDY; OUTCOME ASSESSMENT; PARESTHESIA; PATIENT MONITORING; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SINUSITIS; STEADY STATE; SYSTOLIC HYPERTENSION; TIME TO MAXIMUM PLASMA CONCENTRATION; UPPER RESPIRATORY TRACT INFECTION; VOMITING;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOLOGICAL MARKERS; C-REACTIVE PROTEIN; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; INJECTIONS, SUBCUTANEOUS; MALE; METHOTREXATE; MIDDLE AGED; MODELS, BIOLOGICAL; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA; UNITED STATES; YOUNG ADULT;

EID: 84862964714     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2011.11.015     Document Type: Article

References (36)

1. Gabriel S.E. The epidemiology of rheumatoid arthritis. Rheum Dis Clin North Am 2001, 27:269-281.
2. Di Giovine F.S., Nuki G., Duff G.W. Tumour necrosis factor in synovial exudates. Ann Rheum Dis 1988, 47:768-772.
3. Feldmann M., Brennan F.M., Maini R.N. Role of cytokines in rheumatoid arthritis. Annu Rev Immunol 1996, 14:397-440.
4. Gravallese E.M., Goldring S.R. Cellular mechanisms and the role of cytokines in bone erosions in rheumatoid arthritis. Arthritis Rheum 2000, 43:2143-2151.
5. Shealy D., Cai A., Staquet K., et al. Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor alpha. MAbs 2010, 2:428-439.
6. Breedveld F.C., Weisman M.H., Kavanaugh A.F., et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum 2006, 54:26-37.
7. Klareskog L., van der Heijde D., de Jager J.P., et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet 2004, 363:675-681.
8. Lipsky P.E., van der Heijde D.M., St Clair E.W., et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med 2000, 343:1594-1602.
9. St Clair E.W., van der Heijde D.M., Smolen J.S., et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum 2004, 50:3432-3443.
10. Zhou H., Jang H., Fleischmann R.M., et al. Pharmacokinetics and safety of golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with rheumatoid arthritis. J Clin Pharmacol 2007, 47:383-396.
11. Xu Z., Wang Q., Zhuang Y., et al. Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects. J Clin Pharmacol 2010, 50:276-284.
12. Maini R.N., Breedveld F.C., Kalden J.R., et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum 1998, 41:1552-1563.
13. Velagapudi R.B., Noertersheuser P.A., Awni W.M. Effect of methotrexate (MTX) coadministration on the pharmacokinetics (PK) of adalimumab (HUMIRA, Abbott) following a single intravenous (IV) injection. Arthritis Rheum 2003, 48:S141.
14. Simponi [package insert] 2011, Centocor Ortho Biotech, Inc, Horsham, Pa.
15. Xu Z., Vu T., Lee H., et al. Population pharmacokinetics of golimumab, an anti-tumor necrosis factor-alpha human monoclonal antibody, in patients with psoriatic arthritis. J Clin Pharmacol 2009, 49:1056-1070.
16. Xu Z., Lee H., Vu T., et al. Population pharmacokinetics of golimumab, a human anti-tumor necrosis factor-a monoclonal antibody, in patients with rheumatoid arthritis. J Clin Pharmacol 2008, 48:1112.
17. Badolato R., Oppenheim J.J. Role of cytokines, acute-phase proteins, and chemokines in the progression of rheumatoid arthritis. Semin Arthritis Rheum 1996, 26:526-538.
18. Otterness I.G. The value of C-reactive protein measurement in rheumatoid arthritis. Semin Arthritis Rheum 1994, 24:91-104.
19. Humira [package insert] 2011, Abbott Laboratories, Abbott Park, Ill.
20. Arnett F.C., Edworthy S.M., Bloch D.A., et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988, 31:315-324.
21. Emery P., Fleischmann R.M., Moreland L.W., 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.
22. Keystone E.C., Genovese M.C., Klareskog L., et al. Golimumab, a human antibody to tumour necrosis factor a given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis 2009, 68:789-796.
23. Kremer J., Ritchlin C., Mendelsohn A., et al. Golimumab, a new human anti-tumor necrosis factor alpha antibody, administered intravenously in patients with active rheumatoid arthritis: Forty-eight-week efficacy and safety results of a phase III randomized, double-blind, placebo-controlled study. Arthritis Rheum 2010, 62:917-928.
24. Smolen J.S., Kay J., Doyle M.K., et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet 2009, 374:210-221.
25. Regulations and guidelines US Food and Drug Administration (FDA), Accessed December 1, 2011. http://www.fda.gov/RegulatoryInformation/Guidances.
26. Guidelines on good clinical practice International Conference on Harmonisation (ICH), Accessed December 1, 2011. http://www.ich.org.
27. Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. Br Med J 1996, 313:1448.
28. Thway T., Macaraeg C., Calamba D., et al. Applications of a planar electrochemiluminescence platform to support regulated studies of macromolecules: benefits and limitations in assay range. J Pharm Biomed Anal 2010, 51:626-632.
29. Gibaldi M., Perrier D. Pharmacokinetics 1982, Marcel Dekker, New York. 2nd ed.
30. Ling J., Lyn S., Xu Z., et al. Lack of racial differences in the pharmacokinetics of subcutaneous golimumab in healthy Japanese and Caucasian male subjects. J Clin Pharmacol 2010, 50:792-802.
31. Seitz K., Zhou H. Pharmacokinetic drug-drug interaction potentials for therapeutic monoclonal antibodies: reality check. J Clin Pharmacol 2007, 47:1104-1118.
32. Huang S.M., Zhao H., Lee J.I., et al. Therapeutic protein-drug interactions and implications for drug development. Clin Pharmacol Ther 2010, 87:497-503.
33. Mallya R.K., de Beer F.C., Berry H., Hamilton E.D., Mace B.E., Pepys M.B. Correlation of clinical parameters of disease activity in rheumatoid arthritis with serum concentration of C-reactive protein and erythrocyte sedimentation rate. J Rheumatol 1982, 9:224-228.
34. Buch M.H., Seto Y., Bingham S.J., et al. C-reactive protein as a predictor of infliximab treatment outcome in patients with rheumatoid arthritis: defining subtypes of nonresponse and subsequent response to etanercept. Arthritis Rheum 2005, 52:42-48.
35. Emery P., Gabay C., Kraan M., Gomez-Reino J. Evidence-based review of biologic markers as indicators of disease progression and remission in rheumatoid arthritis. Rheumatol Int 2007, 27:793-806.
36. Wolbink G.J., Voskuyl A.E., Lems W.F., et al. Relationship between serum trough infliximab levels, pretreatment C reactive protein levels, and clinical response to infliximab treatment in patients with rheumatoid arthritis. Ann Rheum Dis 2005, 64:704-707.