Long-term outcomes of patients with recent-onset rheumatoid arthritis after 10 years of tight controlled treatment: A randomized trial

Annals of Internal Medicine

Volumn 164, Issue 8, 2016, Pages 523-531

  Markusse, Iris M ^a   Akdemir, Gülşah ^b   Dirven, Linda ^b   Goekoop Ruiterman, Yvonne P M ^c   Van Groenendael, Johannes H L M ^d   Han, K Huub ^e   Molenaar, T H Esmeralda ^f   Cessie, Saskia Le ^b   Lems, Willem F ^g   Van Der Lubbe, Peter A H M ^h   Kerstens, Pit J S M ⁱ   Peeters, André J ^j   Ronday, H Karel ^c   De Sonnaville, Peter B J ^k   Speyer, Irene ^l   Stijnen, Theo ^b   Ten Wolde, Saskia ⁱ   Huizinga, Tom W J ^b   Allaart, Cornelia F ^b  

^a Tergooi Location Hilversum   (Netherlands)

^b LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^c HAGA HOSPITAL   (Netherlands)

^d Bravis Hospital   (Netherlands)

^e Maasstad Hospital   (Netherlands)

^f GROENE HART HOSPITAL   (Netherlands)

^g VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^h Vlietland Hospital   (Netherlands)

ⁱ Westfriesgasthuis ^*  (Netherlands)

^j REINIER DE GRAAF HOSPITAL   (Netherlands)

^k Admiraal De Ruyter Hospital   (Netherlands)

^l MEDICAL CENTER HAAGLANDEN   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AZATHIOPRINE; CYCLOSPORIN A; GOLD; HYDROXYCHLOROQUINE; INFLIXIMAB; LEFLUNOMIDE; LIVER ENZYME; METHOTREXATE; METHYLPREDNISOLONE ACETATE; PREDNISONE; SALAZOSULFAPYRIDINE; ANTIRHEUMATIC AGENT; MONOCLONAL ANTIBODY;

ADULT; AGED; ARTICLE; CARDIOVASCULAR DISEASE; COMBINATION DRUG THERAPY; CONTROLLED STUDY; DISEASE ACTIVITY; DISEASE ACTIVITY SCORE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG DOSE SEQUENCE; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; FOOT RADIOGRAPHY; FUNCTIONAL ASSESSMENT; GASTROENTERITIS; GASTROINTESTINAL DISEASE; HAND RADIOGRAPHY; HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; HYPERTENSION; INFECTIOUS COMPLICATION; INITIAL COMBINATION THERAPY; JOINT DESTRUCTION; LOWER RESPIRATORY TRACT INFECTION; LUNG DISEASE; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; MIDDLE AGED; MONOTHERAPY; MORTALITY; MUCOSAL DISEASE; MULTICENTER STUDY; NAUSEA AND VOMITING; NETHERLANDS; NEUROLOGIC DISEASE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REMISSION; RHEUMATOID ARTHRITIS; SEQUENTIAL MONOTHERAPY; SHARP VAN DER HEIJDE SCORE; SIDE EFFECT; SINGLE BLIND PROCEDURE; SKIN INFECTION; SKIN TOXICITY; STANDARDIZED MORTALITY RATIO; STEP UP COMBINATION THERAPY; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; DISEASE COURSE; SURVIVAL ANALYSIS;

ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DISEASE PROGRESSION; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFLIXIMAB; MALE; MIDDLE AGED; PREDNISONE; REMISSION INDUCTION; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 84964527094     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/M15-0919     Document Type: Article

References (39)

1. Möttönen T, Hannonen P, Leirisalo-Repo M, Nissilä M, Kautiainen H, Korpela M, et al. Comparison of combination therapy with singledrug therapy in early rheumatoid arthritis: a randomised trial. FINRACo trial group. Lancet. 1999; 353:1568-73. [PMID: 10334255]
2. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, van Zeben D, Kerstens PJ, Hazes JM, et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum. 2005; 52:3381-90. [PMID: 16258899]
3. Boers M, Verhoeven AC, Markusse HM, van de Laar MA, Westhovens R, van Denderen JC, et al. Randomised comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone in early rheumatoid arthritis. Lancet. 1997; 350:309-18. [PMID: 9251634]
4. O'Dell JR, Haire CE, Erikson N, Drymalski W, Palmer W, Eckhoff PJ, et al. Treatment of rheumatoid arthritis with methotrexate alone, sulfasalazine and hydroxychloroquine, or a combination of all three medications. N Engl J Med. 1996; 334:1287-91. [PMID: 8609945]
5. Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, et al; Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. 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; 343:1594-602. [PMID: 11096166]
6. Klareskog L, van der Heijde D, de Jager JP, Gough A, Kalden J, Malaise M, et al; TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) study investigators. 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; 363:675-81. [PMID: 15001324]
7. Heimans L, Wevers-de Boer KV, Visser K, Goekoop RJ, van Oosterhout M, Harbers JB, et al. A two-step treatment strategy trial in patients with early arthritis aimed at achieving remission: the IMPROVED study. Ann Rheum Dis. 2014; 73:1356-61. [PMID: 23716067] doi:10.1136/annrheumdis-2013-203243
8. Grigor C, Capell H, Stirling A, McMahon AD, Lock P, Vallance R, et al. Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet. 2004; 364:263-9. [PMID: 15262104]
9. Bakker MF, Jacobs JW, Verstappen SM, Bijlsma JW. Tight control in the treatment of rheumatoid arthritis: efficacy and feasibility. Ann Rheum Dis. 2007; 66 Suppl 3:iii56-60. [PMID: 17934098]
10. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988; 31:315-24. [PMID: 3358796]
11. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, van Zeben D, Kerstens PJ, Hazes JM, et al. Comparison of treatment strategies in early rheumatoid arthritis: a randomized trial. Ann Intern Med. 2007; 146:406-15. [PMID: 17371885]
12. van der Heijde DM, van 't Hof M, van Riel PL, van de Putte LB. Development of a disease activity score based on judgment in clinical practice by rheumatologists. J Rheumatol. 1993; 20:579-81. [PMID: 8478878]
13. Ritchie DM, Boyle JA, McInnes JM, Jasani MK, Dalakos TG, Grieveson P, et al. Clinical studies with an articular index for the assessment of joint tenderness in patients with rheumatoid arthritis. Q J Med. 1968; 37:393-406. [PMID: 4877784]
14. van Gestel AM, Prevoo ML, van 't Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. 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. [PMID: 8546736]
15. Prevoo ML, van Gestel AM, van T Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Remission in a prospective study of patients with rheumatoid arthritis. American Rheumatism Association preliminary remission criteria in relation to the disease activity score. Br J Rheumatol. 1996; 35:1101-5. [PMID: 8948296]
16. Siegert CE, Vleming LJ, Vandenbroucke JP, Cats A. Measurement of disability in Dutch rheumatoid arthritis patients. Clin Rheumatol. 1984; 3:305-9. [PMID: 6488708]
17. van der Heijde D. How to read radiographs according to the Sharp/van der Heijde method. J Rheumatol. 1999; 26:743-5. [PMID: 10090194]
18. Molenberghs G, Kenward M. Missing Data in Clinical Studies. New York: J Wiley; 2007: 529.
19. Rothman KJ, Greenland S, Lash TL. Modern Epidemiology. 3rd ed. Philadelphia: Lippincott Williams & Wilkins; 2008:776.
20. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010; 152:726-32. [PMID: 20335313] doi:10.7326/0003-4819-152-11-201006010-00232
21. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010; 340:c869. [PMID: 20332511] doi:10.1136/bmj.c869
22. Pope JE, Khanna D, Norrie D, Ouimet JM. The minimally important difference for the health assessment questionnaire in rheumatoid arthritis clinical practice is smaller than in randomized controlled trials. J Rheumatol. 2009; 36:254-9. [PMID: 19132791] doi:10.3899/jrheum.080479
23. van den Hout WB, Goekoop-Ruiterman YP, Allaart CF, de Vries-Bouwstra JK, Hazes JM, Kerstens PJ, et al. Cost-utility analysis of treatment strategies in patients with recent-onset rheumatoid arthritis. Arthritis Rheum. 2009; 61:291-9. [PMID: 19248130] doi:10.1002/art.24169
24. Humphreys JH, Warner A, Chipping J, Marshall T, Lunt M, Symmons DP, et al. Mortality trends in patients with early rheumatoid arthritis over 20 years: results from the Norfolk Arthritis Register. Arthritis Care Res (Hoboken). 2014; 66:1296-301. [PMID: 24497371] doi: 10.1002/acr.22296
25. Humphreys JH, van Nies JA, Chipping J, Marshall T, van der Helm-van Mil AH, Symmons DP, et al. Rheumatoid factor and anticitrullinated protein antibody positivity, but not level, are associated with increased mortality in patients with rheumatoid arthritis: results from two large independent cohorts. Arthritis Res Ther. 2014; 16: 483. [PMID: 25471696] doi:10.1186/s13075-014-0483-3
26. de Vries-Bouwstra JK, Goekoop-Ruiterman YP, Verpoort KN, Schreuder GM, Ewals JA, Terwiel JP, et al. Progression of joint damage in early rheumatoid arthritis: association with HLA-DRB1, rheumatoid factor, and anti-citrullinated protein antibodies in relation to different treatment strategies. Arthritis Rheum. 2008; 58:1293-8. [PMID: 18438829] doi:10.1002/art.23439
27. van den Broek M, Dirven L, Klarenbeek NB, Molenaar TH, Han KH, Kerstens PJ, et al. The association of treatment response and joint damage with ACPA-status in recent-onset RA: a subanalysis of the 8-year follow-up of the BeSt study. Ann Rheum Dis. 2012; 71: 245-8. [PMID: 22110122] doi:10.1136/annrheumdis-2011-200379
28. Verstappen SM, Jacobs JW, van der Veen MJ, Heurkens AH, Schenk Y, ter Borg EJ, et al; Utrecht Rheumatoid Arthritis Cohort study group. Intensive treatment with methotrexate in early rheumatoid arthritis: aiming for remission. Computer Assisted Management in Early Rheumatoid Arthritis (CAMERA, an open-label strategy trial). Ann Rheum Dis. 2007; 66:1443-9. [PMID: 17519278]
29. Leirisalo-Repo M, Kautiainen H, Laasonen L, Korpela M, Kauppi MJ, Kaipiainen-Seppänen O, et al; NEO-RACo Study Group. Infliximab for 6 months added on combination therapy in early rheumatoid arthritis: 2-year results from an investigator-initiated, randomised, double-blind, placebo-controlled study (the NEO-RACo Study). Ann Rheum Dis. 2013; 72:851-7. [PMID: 22753402] doi:10.1136/annrheumdis-2012-201365
30. de Punder YM, Fransen J, Kievit W, Houtman PM, Visser H, van de Laar MA, et al. The prevalence of clinical remission in RA patients treated with anti-TNF: results from the Dutch Rheumatoid Arthritis Monitoring (DREAM) registry. Rheumatology (Oxford). 2012; 51: 1610-7. [PMID: 22539487] doi:10.1093/rheumatology/kes078
31. ter Wee MM, den Uyl D, Boers M, Kerstens P, Nurmohamed M, van Schaardenburg D, et al. Intensive combination treatment regimens, including prednisolone, are effective in treating patients with early rheumatoid arthritis regardless of additional etanercept: 1-year results of the COBRA-light open-label, randomised, non-inferiority trial. Ann Rheum Dis. 2015; 74:1233-40. [PMID: 24818633] doi:10.1136/annrheumdis-2013-205143
32. Smolen JS, LandewéR, Breedveld FC, Buch M, Burmester G, Dougados M, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological diseasemodifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014; 73:492-509. [PMID: 24161836] doi:10.1136/annrheumdis-2013-204573
33. Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012; 64:625-39. [PMID: 22473917] doi:10.1002/acr.21641
34. Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010; 69: 1580-8. [PMID: 20699241] doi:10.1136/ard.2010.138461
35. Radovits BJ, Fransen J, Al Shamma S, Eijsbouts AM, van Riel PL, Laan RF. Excess mortality emerges after 10 years in an inception cohort of early rheumatoid arthritis. Arthritis Care Res (Hoboken). 2010; 62:362-70. [PMID: 20391482] doi:10.1002/acr.20105
36. van Nies JA, de Jong Z, van der Helm-van Mil AH, Knevel R, Le Cessie S, Huizinga TW. Improved treatment strategies reduce the increased mortality risk in early RA patients. Rheumatology (Oxford). 2010; 49:2210-6. [PMID: 20696679] doi:10.1093/rheumatology/keq250
37. Gonzalez A, Maradit Kremers H, Crowson CS, Nicola PJ, Davis JM 3rd, Therneau TM, et al. The widening mortality gap between rheumatoid arthritis patients and the general population. Arthritis Rheum. 2007; 56:3583-7. [PMID: 17968923]
38. van der Heijde D, LandewéR, Klareskog L, Rodríguez-Valverde V, Settas L, Pedersen R, et al. Presentation and analysis of data on radiographic outcome in clinical trials: experience from the TEMPO study. Arthritis Rheum. 2005; 52:49-60. [PMID: 15641062]
39. LandewéR, van der Heijde D. Presentation and analysis of radiographic data in clinical trials and observational studies. Ann Rheum Dis. 2005; 64 Suppl 4:iv48-51. [PMID: 16239387]