Effectiveness of methotrexate with step-down glucocorticoid remission induction (COBRA Slim) versus other intensive treatment strategies for early rheumatoid arthritis in a treat-to-target approach: 1-year results of CareRA, a randomised pragmatic open-label superiority trial

Annals of the Rheumatic Diseases

Volumn 76, Issue 3, 2017, Pages 511-520

  Verschueren, Patrick ^a,b   De Cock, Diederik ^a,b   Corluy, Luk ^c,d   Joos, Rik ^e   Langenaken, Christine ^c,d   Taelman, Veerle ^f   Raeman, Frank ^e   Ravelingien, Isabelle ^g   Vandevyvere, Klaas ^h   Lenaerts, Jan ^c,d   Geens, Elke ^e   Geusens, Piet ^i,j   Vanhoof, Johan ⁱ   Durnez, Anne ^h   Remans, Jan ^k   Vander Cruyssen, Bert ^g   Van Essche, Els ^l   Sileghem, An ^m   De Brabanter, Griet ⁿ   Joly, Johan ^b   Meyfroidt, Sabrina ^a   Van Der Elst, Kristien ^a,b   Westhovens, Rene ^a,b   more..

^a SKELETAL BIOLOGY AND ENGINEERING RESEARCH CENTER   (Belgium)

^b UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^c Reuma Instituut   (Belgium)

^d Jessa Ziekenhuis   (Belgium)

^e ZNA Jan Palfijn Antwerpen   (Belgium)

^f Heilig Hart Ziekenhuis   (Belgium)

^g OLV HOSPITAL   (Belgium)

^h AZ GROENINGE   (Belgium)

ⁱ ReumaClinic Genk and UHasselt   (Belgium)

^j MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^k Reuma instituut Genk   (Belgium)

^l IMELDA HOSPITAL   (Belgium)

^m ReumaClinic Hasselt   (Belgium)

ⁿ AZ Sint Lucas Brugge   (Belgium)

more..

Author keywords

Corticosteroids; DMARDs (synthetic); Early Rheumatoid Arthritis; Methotrexate; Treatment

Indexed keywords

C REACTIVE PROTEIN; CYCLIC CITRULLINATED PEPTIDE ANTIBODY; DISEASE MODIFYING ANTIRHEUMATIC DRUG; GLUCOCORTICOID; LEFLUNOMIDE; METHOTREXATE; PREDNISONE; RHEUMATOID FACTOR; SALAZOSULFAPYRIDINE; ANTIRHEUMATIC AGENT; ISOXAZOLE DERIVATIVE;

ADULT; APPETITE DISORDER; ARTICLE; BIOLOGICAL THERAPY; CONTROLLED STUDY; DAS28; DIABETES MELLITUS; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HAIR LOSS; HEALTH ASSESSMENT QUESTIONNAIRE; HIGH RISK PATIENT; HUMAN; INFECTION; INFLAMMATION; KIDNEY DYSFUNCTION; LIVER DYSFUNCTION; LOW RISK PATIENT; MAJOR CLINICAL STUDY; MALAISE; MALE; MIDDLE AGED; MONOTHERAPY; OPEN STUDY; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; REMISSION; RHEUMATOID ARTHRITIS; VISUAL IMPAIRMENT; ADVERSE EFFECTS; AGED; ARTHRITIS, RHEUMATOID; BLOOD; COMBINATION DRUG THERAPY; COMPARATIVE STUDY; METABOLISM; PROGNOSIS; RISK FACTOR; SEVERITY OF ILLNESS INDEX;

ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; C-REACTIVE PROTEIN; DRUG THERAPY, COMBINATION; FEMALE; GLUCOCORTICOIDS; HUMANS; ISOXAZOLES; MALE; METHOTREXATE; MIDDLE AGED; PREDNISONE; PROGNOSIS; REMISSION INDUCTION; RISK FACTORS; SEVERITY OF ILLNESS INDEX; SULFASALAZINE;

EID: 84978732533     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2016-209212     Document Type: Article

References (34)

1. Deighton C, O'Mahony R, Tosh J, et al. Management of rheumatoid arthritis: summary of NICE guidance. BMJ 2009;338:b702.
2. Singh JA, Furst DE, Bharat A, 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.
3. Smolen JS, Landewé R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 2014;73:492-509.
4. Boers M, Verhoeven AC, Markusse HM, et al. Randomised comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone in early rheumatoid arthritis. Lancet 1997;350:309-18.
5. Mottonen T, Hannonen P, Leirisalo-Repo M, et al. Comparison of combination therapy with single-drug therapy in early rheumatoid arthritis: a randomised trial. FIN-RACo trial group. Lancet 1999;353:1568-73.
6. Calgüneri M, Pay S, Caliskaner Z, et al. Combination therapy versus monotherapy for the treatment of patients with rheumatoid arthritis. Clin Exp Rheumatol 1999;17:699-704.
7. Hetland ML, Stengaard-Pedersen K, Junker P, et al. Combination treatment with methotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis: an investigator-initiated, multicenter, randomized, double-blind, parallel-group, placebo-controlled study. Arthritis Rheum 2006;54:1401-9.
8. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, et al. Comparison of treatment strategies in early rheumatoid arthritis: a randomized trial. Ann Intern Med 2007;146:406-15.
9. Verschueren P, Esselens G, Westhovens R. Daily practice effectiveness of a step-down treatment in comparison with a tight step-up for early rheumatoid arthritis. Rheumatology (Oxford) 2008;47:59-64.
10. Choy EH, Smith CM, Farewell V, et al. Factorial randomised controlled trial of glucocorticoids and combination disease modifying drugs in early rheumatoid arthritis. Ann Rheum Dis 2008;67:656-63.
11. Bakker MF, Jacobs JW, Welsing PM, et al. Low-dose prednisone inclusion in a methotrexate-based, tight control strategy for early rheumatoid arthritis: a randomized trial. Ann Intern Med 2012;156:329-39.
12. De Cock D, Van der Elst K, Meyfroidt S, et al. The optimal combination therapy for the treatment of early rheumatoid arthritis. Expert Opin Pharmacother 2015;16:1615-25.
13. van Tuyl LH, Plass AM, Lems WF, et al. Why are Dutch rheumatologists reluctant to use the COBRA treatment strategy in early rheumatoid arthritis?. Ann Rheum Dis 2007;66:974-6.
14. Meyfroidt S, van Hulst L, De Cock D, et al. Factors influencing the prescription of intensive combination treatment strategies for early rheumatoid arthritis. Scand J Rheumatol 2014;43:265-72.
15. van Vollenhoven RF, Ernestam S, Geborek P, et al. Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in patients with early rheumatoid arthritis (Swefot trial): 1-year results of a randomised trial. Lancet 2009;374:459-66.
16. O'Dell JR, Mikuls TR, Taylor TH, et al. Therapies for active rheumatoid arthritis after methotrexate failure. N Engl J Med 2013;369:307-18.
17. De Cock D, Vanderschueren G, Meyfroidt S, et al. Two-year clinical and radiologic follow-up of early RA patients treated with initial step up monotherapy or initial step down therapy with glucocorticoids, followed by a tight control approach: lessons from a cohort study in daily practice. Clin Rheumatol 2014;33:125-30.
18. De Cock D, Vanderschueren G, Meyfroidt S, et al. The performance of matrices in daily clinical practice to predict rapid radiologic progression in patients with early RA. Semin Arthritis Rheum 2014;43:627-31.
19. Duru N, van der Goes MC, Jacobs JW, et al. EULAR evidence-based and consensus-based recommendations on the management of medium to high-dose glucocorticoid therapy in rheumatic diseases. Ann Rheum Dis 2013;72:1905-13.
20. Meyfroidt S, Van der Elst K, De Cock D, et al. Patient experiences with intensive combination-treatment strategies with glucocorticoids for early rheumatoid arthritis. Patient Educ Couns 2015;98:384-90.
21. Nam JL, Ramiro S, Gaujoux-Viala C, et al. Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis 2014;73:516-28.
22. Smolen JS, Nash P, Durez P, et al. Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial. Lancet 2013;381:918-29.
23. Durez P, Malghem J, Nzeusseu Toukap A, et al. Treatment of early rheumatoid arthritis: a randomized magnetic resonance imaging study comparing the effects of methotrexate alone, methotrexate in combination with infliximab, and methotrexate in combination with intravenous pulse methylprednisolone. Arthritis Rheum 2007;56:3919-27.
24. Ma MH, Kingsley GH, Scott DL. A systematic comparison of combination DMARD therapy and tumour necrosis inhibitor therapy with methotrexate in patients with early rheumatoid arthritis. Rheumatology (Oxford) 2010;49:91-8.
25. van den Hout WB, Goekoop-Ruiterman YP, Allaart CF, et al. Cost-utility analysis of treatment strategies in patients with recent-onset rheumatoid arthritis. Arthritis Rheum 2009;61:291-9.
26. Verschueren P, De Cock D, Corluy L, et al. Patients lacking classical poor prognostic markers might also benefit from a step-down glucocorticoid bridging scheme in early Rheumatoid Arthritis: week 16 results from the randomized multicenter CareRA trial. Arthritis Res Ther 2015;17:97.
27. Verschueren P, De Cock D, Corluy L, et al. Methotrexate in combination with other DMARDs is not superior to methotrexate alone for remission induction with moderate-to-high-dose glucocorticoid bridging in early rheumatoid arthritis after 16 weeks of treatment: the CareRA trial. Ann Rheum Dis 2015;74:27-34.
28. de Jong PH, Hazes JM, Barendregt PJ, et al. Induction therapy with a combination of DMARDs is better than methotrexate monotherapy: first results of the tREACH trial. Ann Rheum Dis 2013;72:72-8.
29. de Jong PH, Hazes JM, Han HK, et al. Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial. Ann Rheum Dis 2014;73:1331-9.
30. den Uyl D, ter Wee M, Boers M, et al. A non-inferiority trial of an attenuated combination strategy ('COBRA-light') compared to the original COBRA strategy: clinical results after 26 weeks. Ann Rheum Dis 2014;73:1071-8.
31. Grigor C, Capell H, Stirling A, 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.
32. Van der Elst K, Meyfroidt S, De Cock D, et al. Unraveling patient-preferred health and treatment outcomes in early rheumatoid arthritis: a longitudinal qualitative study. Arthritis Care Res (Hoboken) 2015. doi:10.1002/acr.22824 [Epub ahead of print 29 Dec 2015].
33. Felson DT, Smolen JS, Wells G, et al. American College of Rheumatology/European League against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Ann Rheum Dis 2011;70:404-13.
34. Barra L, Pope JE, Orav JE, et al. Prognosis of seronegative patients in a large prospective cohort of patients with early inflammatory arthritis. J Rheumatol 2014;41:2361-9.