Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial

The Lancet

Volumn 371, Issue 9617, 2008, Pages 987-997

  Smolen, Josef S ^a,b   Beaulieu, Andre ^c   Rubbert Roth, Andrea ^d   Ramos Remus, Cesar ^e   Rovensky, Josef ^f   Alecock, Emma ^g   Woodworth, Thasia ^g   Alten, Rieke ^h  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b Neurological Center Rosenhuegel   (Austria)

^c UNIVERSITÉ LAVAL   (Canada)

^d UNIVERSITY OF COLOGNE   (Germany)

^e Research Unit for Chronic Diseases   (Mexico)

^f NATIONAL INSTITUTE OF RHEUMATIC DISEASES   (Slovakia)

^g ROCHE PRODUCTS LTD   (United Kingdom)

^h Schlosspark Clinic   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ATLIZUMAB; INTERLEUKIN 6 RECEPTOR; METHOTREXATE; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO;

ABDOMINAL PAIN; ADULT; ANAPHYLAXIS; ARTICLE; BLOOD DISEASE; CELLULITIS; CEREBROVASCULAR ACCIDENT; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL FEATURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DERMATITIS; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG MECHANISM; DRUG WITHDRAWAL; DYSPEPSIA; DYSPNEA; EAR DISEASE; EMPYEMA; FATIGUE; FEMALE; FEVER; GASTROENTERITIS; GASTROINTESTINAL SYMPTOM; HEADACHE; HEART DISEASE; HUMAN; HYPERTENSION; IMMUNOPATHOLOGY; INFECTION; INFESTATION; INNER EAR DISEASE; INTERSTITIAL LUNG DISEASE; LABORATORY TEST; LEUKEMOID REACTION; LIVER FUNCTION TEST; LUNG FIBROSIS; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MOUTH ULCER; MUSCULOSKELETAL DISEASE; NEOPLASM; NEUROLOGIC DISEASE; PEPTIC ULCER; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SIDE EFFECT; SORE THROAT; THORAX DISEASE; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION;

EID: 40749114497     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(08)60453-5     Document Type: Article

References (41)

1. Smolen J., Aletaha D., Koeller M., Weisman M., and Emery P. New therapies for treatment of rheumatoid arthritis. Lancet 370 (2007) 1861-1874
2. Firestein G. Evolving concepts of rheumatoid arthritis. Nature 423 (2003) 356-361
3. Emery P., Fleischmann R., Filipowicz-Sosnowska A., et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum 54 (2006) 1390-1400
4. Jiang Y., Genant H., Watt I., et al. A multicenter, double-blind, dose-ranging, randomized, placebo-controlled study of recombinant human interleukin-1 receptor antagonist in patients with rheumatoid arthritis: radiologic progression and correlation of Genant and Larsen scores. Arthritis Rheum 43 (2000) 1001-1009
5. Kremer J., Genant H., Moreland L., et al. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med 144 (2006) 865-876
6. Lipsky P., van der Heijde D., St Clair E., 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 343 (2000) 1594-1602
7. Emery P., and Salmon M. Early rheumatoid arthritis: time to aim for remission?. Ann Rheum Dis 54 (1995) 944-947
8. Mierau M., Schoels M., Gonda G., Fuchs J., Aletaha D., and Smolen J. Assessing remission in clinical practice. Rheumatology (Oxford) 46 (2007) 975-979
9. Firestein G., Alvaro-Gracia J., and Maki R. Quantitative analysis of cytokine gene expression in rheumatoid arthritis. J Immunol 144 (1990) 3347-3353
10. Steiner G., Tohidast-Akrad M., Witzmann G., et al. Cytokine production by synovial T cells in rheumatoid arthritis. Rheumatology (Oxford) 38 (1999) 202-213
11. Naka T., Nishimoto N., and Kishimoto T. The paradigm of IL-6: from basic science to medicine. Arthritis Res 4 suppl 3 (2002) S233-S242
12. Aletaha D., Nell V., Stamm T., et al. Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score. Arthritis Res Ther 7 (2005) R796-R806
13. van Leeuwen M., van der Heijde D., van Rijswijk M., et al. Interrelationship of outcome measures and process variables in early rheumatoid arthritis. A comparison of radiologic damage, physical disability, joint counts, and acute phase reactants. J Rheumatol 21 (1994) 425-429
14. Nishimoto N., Yoshizaki K., Miyasaka N., et al. Treatment of rheumatoid arthritis with humanized anti-interleukin-6 receptor antibody: a multicenter, double-blind, placebo-controlled trial. Arthritis Rheum 50 (2004) 1761-1769
15. Maini R., Taylor P., Szechinski J., et al. Double-blind randomized controlled clinical trial of the interleukin-6 receptor antagonist, tocilizumab, in European patients with rheumatoid arthritis who had an incomplete response to methotrexate. Arthritis Rheum 54 (2006) 2817-2829
16. Arnett F., Edworthy S., Bloch D., et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 31 (1988) 315-324
17. Felson D., Anderson J., Boers M., et al. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 38 (1995) 727-735
18. Prevoo M., van 't Hof M., Kuper H., van Leeuwen M., van de Putte L., and van Riel P. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 38 (1995) 44-48
19. van Gestel A., Prevoo M., van 't Hof M., van Rijswijk M., van de Putte L., and van Riel P. 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 39 (1996) 34-40
20. Fransen J., Creemers M., and van Riel P. Remission in rheumatoid arthritis: agreement of the disease activity score (DAS28) with the ARA preliminary remission criteria. Rheumatology (Oxford) 43 (2004) 1252-1255
21. Bruce B., and Fries J. The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol 30 (2003) 167-178
22. Ware Jr. J., and Sherbourne C. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30 (1992) 473-483
23. Cella D., Lai J., Chang C., Peterman A., and Slavin M. Fatigue in cancer patients compared with fatigue in the general United States population. Cancer 94 (2002) 528-538
24. Cella D., Yount S., Sorensen M., Chartash E., Sengupta N., and Grober J. Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis. J Rheumatol 32 (2005) 811-819
25. Wells G., Tugwell P., Kraag G., Baker P., Groh J., and Redelmeier D. Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. J Rheumatol 20 (1993) 557-560
26. Wolfe F., and Michaud K. Anemia and renal function in patients with rheumatoid arthritis. J Rheumatol 33 (2006) 1516-1522
27. Keystone E., Kavanaugh A., Sharp J., 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: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum 50 (2004) 1400-1411
28. Maini R., St Clair E., Breedveld F., et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet 354 (1999) 1932-1939
29. Nishimoto N., Hashimoto J., Miyasaka N., et al. Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x-ray reader-blinded randomized controlled trial of tocilizumab. Ann Rheum Dis 66 (2007) 1162-1167
30. Nagabhushanam V., Solache A., Ting L., Escaron C., Zhang J., and Ernst J. Innate inhibition of adaptive immunity: Mycobacterium tuberculosis-induced IL-6 inhibits macrophage responses to IFN-gamma. J Immunol 171 (2003) 4750-4757
31. Sattar N., McCarey D., Capell H., and McInnes I. Explaining how "high-grade" systemic inflammation accelerates vascular risk in rheumatoid arthritis. Circulation 108 (2003) 2957-2963
32. Dursunoglu D., Evrengul H., Polat B., et al. Lp(a) lipoprotein and lipids in patients with rheumatoid arthritis: serum levels and relationship to inflammation. Rheumatol Int 25 (2005) 241-245
33. Sattar N., Crompton P., Cherry L., Kane D., Lowe G., and McInnes I. Effects of tumor necrosis factor blockade on cardiovascular risk factors in psoriatic arthritis: a double-blind, placebo-controlled study. Arthritis Rheum 56 (2007) 831-839
34. Vis M., Nurmohamed M., Wolbink G., et al. Short term effects of infliximab on the lipid profile in patients with rheumatoid arthritis. J Rheumatol 32 (2005) 252-255
35. Dahlqvist S., Engstrand S., Berglin E., and Johnson O. Conversion towards an atherogenic lipid profile in rheumatoid arthritis patients during long-term infliximab therapy. Scand J Rheumatol 35 (2006) 107-111
36. Allanore Y., Kahan A., Sellam J., Ekindjian O., and Borderie D. Effects of repeated infliximab therapy on serum lipid profile in patients with refractory rheumatoid arthritis. Clin Chim Acta 365 (2006) 143-148
37. Choi H., Hernan M., Seeger J., Robins J., and Wolfe F. Methotrexate and mortality in patients with rheumatoid arthritis: a prospective study. Lancet 359 (2002) 1173-1177
38. Jacobsson L., Turesson C., Hanson R., et al. Joint swelling as a predictor of death from cardiovascular disease in a population study of Pima Indians. Arthritis Rheum 44 (2001) 1170-1176
39. Turesson C., and Matteson E. Cardiovascular risk factors, fitness and physical activity in rheumatic diseases. Curr Opin Rheumatol 19 (2007) 190-196
40. Wolfe F., Freundlich B., and Straus W. Increase in cardiovascular and cerebrovascular disease prevalence in rheumatoid arthritis. J Rheumatol 30 (2003) 36-40
41. Wolfe F., and Michaud K. Heart failure in rheumatoid arthritis: rates, predictors, and the effect of anti-tumor necrosis factor therapy. Am J Med 116 (2004) 305-311