A multicenter open-label phase I/II study to assess the safety, tolerability, and efficacy of three dose levels of TuNEX in patients with rheumatoid arthritis

Journal of the Chinese Medical Association

Volumn 74, Issue 12, 2011, Pages 544-551

  Chen, Der Yuan ^a,b,c   Lai, Ning Sheng ^d,e   Lu, Ling Ying ^f   Chou, Hsiu Cheng ^a   Chen, Yi Hsing ^a,b   Hsieh, Tsu Yi ^a,c   Chen, Yi Ming ^a,b   Lan, Joung Liang ^a,b,c  

^a TAICHUNG VETERANS GENERAL HOSPITAL   (Taiwan)

^b NATIONAL YANG MING UNIVERSITY   (Taiwan)

^c CHUNG SHAN MEDICAL UNIVERSITY   (Taiwan)

^d Buddhist Dalin Tzuchi Hospital   (Taiwan)

^e TZU CHI UNIVERSITY   (Taiwan)

^f KAOHSIUNG VETERANS GENERAL HOSPITAL   (Taiwan)

Author keywords

Efficacy; Immunology; RA; Rheumatoid arthritis; TNF ; Tumor necrosis factor; TuNEX

Indexed keywords

DISEASE MODIFYING ANTIRHEUMATIC DRUG; RECOMBINANT TUMOR NECROSIS FACTOR ALPHA RECEPTOR; TUMOR NECROSIS FACTOR ALPHA RECEPTOR; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL ASSESSMENT; CONSTIPATION; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ERYTHEMA; FEMALE; HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; IMMUNOGENICITY; INJECTION SITE REACTION; MACULOPAPULAR RASH; MALE; MULTICENTER STUDY; MYOFASCIAL PAIN; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRURITUS; RHEUMATOID ARTHRITIS; TREATMENT DURATION; TREATMENT FAILURE; TREATMENT RESPONSE; URTICARIA;

ADULT; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; FEMALE; HUMANS; IMMUNOGLOBULIN G; MALE; MIDDLE AGED; RECEPTORS, TUMOR NECROSIS FACTOR; RECEPTORS, TUMOR NECROSIS FACTOR, TYPE II; RECOMBINANT FUSION PROTEINS;

EID: 84455208119     PISSN: 17264901     EISSN: 17287731     Source Type: Journal    
DOI: 10.1016/j.jcma.2011.10.009     Document Type: Article

References (28)

1. Christodoulou C., Choy E.H. Joint inflammation and cytokine inhibition in rheumatoid arthritis. Clin Exp Med 2006, 6:13-19.
2. Breedveld F.C., Dijkmans B.A.C. Differential therapy in early and late stages of rheumatoid arthritis. Curr Opin Rheumatol 1996, 8:226-229.
3. Albert D.A., Aksentijevich S., Hurst S., Fries J.F., Wolfe F. Modeling therapeutic strategies in rheumatoid arthritis: use of decision analysis and Markov models. J Rheumatol 2000, 27:644-652.
4. Feldman M., Brennan F.M., Maini R.N. Role of cytokines in rheumatoid arthritis. Annu Rev Immunol 1996, 14:397-440.
5. Brennan F.M., Maini R.N., Feldman M. Role of proinflammatory cytokines in rheumatoid arthritis. Springer Semin Immunopathol 1998, 20:133-147.
6. Neidel J., Schulze M., Lindschau J. Association between degree of bone erosion and synovial fluid levels of tumor necrosis factor α in the knee joints of patients with rheumatoid arthritis. Inflamm Res 1995, 44:217-221.
7. van der Heijde D., Klareskog L., Rodriguez-Valverde V., Codreanu C., Bolosiu H., Melo-Gomes J., et al. Comparison of etanercept and methotrexate, alone and combined, in the treatment of rheumatoid arthritis: two-year clinical and radiographic results from the TEMPO study, a double-blind, randomized trial. Arthritis Rheum 2006, 54:1063-1074.
8. Lan J.L., Chou S.J., Chen D.Y., Chen Y.H., Hsieh T.Y., Young M. A comparative study of etanercept plus methotrexate and methotrexate alone in Taiwanese patients with active rheumatoid arthritis: a 12-week, double-blind, randomized, placebo-controlled study. J Formos Med Assoc 2004, 103:618-623.
9. Su K.Y., Lee H.T., Chou C.T., Tsai S.T., Chen W.S., Tsai C.Y. Improvement of active rheumatoid arthritis after etanercept injection: a single-center experience. J Clin Med Assoc 2009, 72:581-587.
10. Chen D.Y., Chou S.J., Hsieh T.Y., Chen Y.H., Chen H.H., Hsieh C.W., et al. Randomized, double-blind, placebo-controlled, comparative study of human anti-TNF antibody adalimumab in combination with methotrexate and methotrexate alone in Taiwanese patients with active rheumatoid arthritis. J Formos Med Assoc 2009, 108:310-319.
11. Arnett F.C., Edworthy S.M., Bloch D.A., McShane D.J., Fries J.F., Cooper N.S., et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988, 31:315-324.
12. Felson D.T., Anderson J.J., Boers M., Bombardier C., Furst D., Goldsmith C., et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995, 38:727-735.
13. Fries J.F., Spitz P.W., Young D.Y. The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales. J Rheumatol 1982, 9:789-793.
14. Comstock G.W., Edwards L.B., Philip R.N., Winn W.A. A comparison in the United States of America of two tuberculins, PPD-S and RT23. Bull World Health Organ 1964, 31:161-170.
15. Diagnostic standards and classification of tuberculosis in adults and children. Am J Respir Crit Care Med 2000, 161:1376-1395. American Thoracic Society.
16. Brown E.G. Using MedDRA: implications for risk management. Drug Saf 2004, 27:591-602.
17. Sidiropoulos P., Bertsias G., Kritikos H.D., Kouroumali H., Voudouris K., Boumpas D.T. Infliximab treatment for rheumatoid arthritis, with dose titration based on the disease activity score: dose adjustments are common but nor always sufficient to assure sustained benefit. Ann Rheum Dis 2004, 63:144-148.
18. Gordon K., Korman N., Frankel E., Wang H., Jahreis A., Zitnik R., et al. Efficacy of etanercept in an integrated multistudy database of patients with psoriasis. J Am Acad Dermatol 2006, 54:S101-S111.
19. Felson D.T., Anderson J.J., Lange M.L.M. Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent?. Arthritis Rheum 1998, 41:1564-1570.
20. Van Gestel A.M., Prevoo M.L., van Hof M.A., van Rijswijk M.H., van de Putte L.B., van Riel P.L. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis: comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism Criteria. Arthritis Rheum 1996, 39:34-40.
21. Keystone E.C., Schiff M.H., Kremer J.M., Kafka S., Lovy M., DeVries T., et al. Once-weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2004, 50:353-363.
22. Dore R.K., Mathews S., Schechtman J., Surbeck W., Mandel D., Patel A., et al. The immunogenicity, safety, and efficacy of etanercept liquid administered once weekly in patients with rheumatoid arthritis. Clin Exp Rheumatol 2007, 25:40-46.
23. Wolfe F., Michaud K., HAQ- Pincus T. development and validation of a revised version of the Health Assessment Questionnaire (HAQ). Arthritis Rheum 2004, 50:3296-3305.
24. van de Putte L.B.A., Atkins C., Malaise M., Sany J., Russell A.S., van Riel P.L.C.M., et al. Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease-modifying antirheumatic drug treatment has failed. Ann Rheum Dis 2004, 63:508-516.
25. Bathon J.M., Martin R.W., Fleischmann R.M., Tesser J.R., Schiff M.H., Keystone E.C., et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 2000, 343:1586-1593.
26. Ferraro-Peyret C., Coury F., Tebib J.G., Bienvenu J., Fabien N. Infliximab therapy in rheumatoid arthritis and ankylosing spondylitis-induced specific antinuclear and antiphospholipid autoantibodies without autoimmune clinical manifestations: a two-year prospective study. Arthritis Res Ther 2004, 6:R535-R543.
27. Mongey A.B., Hess E.V. Drug insight: autoimmune effects of medications: what's new?. Nat Clin Pract Rheumatol 2008, 4:136-144.
28. Williams E.L., Gadola S., Edwards C.J. Anti-TNF-induced lupus. Rheumatology 2009, 48:716-720.