Step-down strategy of spacing TNF-blocker injections for established rheumatoid arthritis in remission: Results of the multicentre non-inferiority randomised open-label controlled trial (STRASS: Spacing of TNF-blocker injections in Rheumatoid ArthritiS Study)

Annals of the Rheumatic Diseases

Volumn 75, Issue 1, 2016, Pages 59-67

  Fautrel, Bruno ^a   Pham, Thao ^b,c   Alfaiate, Toni ^d,e   Gandjbakhch, Frédérique ^a   Foltz, Violaine ^a   Morel, Jacques ^f   Dernis, Emmanuelle ^g   Gaudin, Philippe ^h   Brocq, Olivier ⁱ   Solau Gervais, Elisabeth ^j,k   Berthelot, Jean Marie ^l,m   Balblanc, Jean Charles ⁿ   Mariette, Xavier ^o,p   Tubach, Florence ^b,q  

^a SORBONNE UNIVERSITÉ   (France)

^b AIX MARSEILLE UNIVERSITY   (France)

^c HÔPITAL SAINTE MARGUERITE   (France)

^d BICHAT HOSPITAL   (France)

^e INSERM   (France)

^f UNIV MONTPELLIER   (France)

^g CENTRE HOSPITALIER DU MANS   (France)

^h UNIV GRENOBLE ALPES   (France)

ⁱ Princess Grace Health Centre   (Monaco)

^j UNIVERSITÉ DE POITIERS   (France)

^k POITIERS UNIVERSITY HOSPITAL   (France)

^l UNIVERSITÉ DE NANTES   (France)

^m HÔTEL DIEU   (France)

ⁿ GESC Dept   (France)

^o UNIVERSITÉ PARIS SACLAY   (France)

^p BICÊTRE HOSPITAL   (France)

^q UNIVERSITÉ PARIS DESCARTES   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ETANERCEPT; ANTIRHEUMATIC AGENT; TUMOR NECROSIS FACTOR ALPHA;

ADULT; ARTICLE; CONTROLLED STUDY; DISEASE COURSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG RESPONSE; FEMALE; HUMAN; INTERMETHOD COMPARISON; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; NEURITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RELAPSE; RHEUMATOID ARTHRITIS; TREATMENT OUTCOME; URINARY TRACT INFECTION; AGED; ANTAGONISTS AND INHIBITORS; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; COMPARATIVE STUDY; DRUG ADMINISTRATION; MAINTENANCE CHEMOTHERAPY; PROCEDURES; RADIOGRAPHY; RECURRENT DISEASE; SEVERITY OF ILLNESS INDEX;

ADALIMUMAB; ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DRUG ADMINISTRATION SCHEDULE; ETANERCEPT; FEMALE; HUMANS; MAINTENANCE CHEMOTHERAPY; MALE; MIDDLE AGED; RECURRENCE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84955198252     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2014-206696     Document Type: Article

References (47)

1. Saleem B, Nizam S, Emery P. Can remission be maintained with or without further drug therapy in rheumatoid arthritis? Clin Exp Rheumatol 2006;24(6 Suppl 43): S-33-6.
2. Combe B, Landewe R, Lukas C, et al. EULAR recommendations for the management of early arthritis: report of a task force of the European Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 2007;66:34-45.
3. Smolen JS, Aletaha D, Bijlsma JW, et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis 2010;69:631-7.
4. Burmester GR. RA in 2011: advances in diagnosis, treatment and definition of remission. Nat Rev Rheumatol 2012;8:65-6.
5. Gaujoux-Viala C, Nam J, Ramiro S, et al. Efficacy of conventional synthetic disease-modifying antirheumatic drugs, glucocorticoids and tofacitinib: a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis 2014;73:510-15.
6. Listing J, Gerhold K, Zink A. The risk of infections associated with rheumatoid arthritis, with its comorbidity and treatment. Rheumatol Oxf 2012;52:53-61.
7. 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.
8. Bongartz T, Sutton AJ, Sweeting MJ, et al. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA 2006;295:2275-85.
9. Lopez-Olivo MA, Tayar JH, Martinez-Lopez JA, et al. Risk of malignancies in patients with rheumatoid arthritis treated with biologic therapy: a meta-analysis. JAMA 2012;308:898-908.
10. Mariette X, Matucci-Cerinic M, Pavelka K, et al. Malignancies associated with tumour necrosis factor inhibitors in registries and prospective observational studies: a systematic review and meta-analysis. Ann Rheum Dis 2011;70:1895-904.
11. Mariette X, Reynolds AV, Emery P. Updated meta-analysis of non-melanoma skin cancer rates reported from prospective observational studies in patients treated with tumour necrosis factor inhibitors. Ann Rheum Dis 2012;71:e2.
12. Pavelka K, Jarosova K, Suchy D, et al. Increasing the infliximab dose in rheumatoid arthritis patients: a randomised, double blind study failed to confirm its efficacy. Ann Rheum Dis 2009;68:1285-9.
13. Fautrel B, Verstappen SM, Boonen A. Rheumatoid arthritis: Economic consequences and potential benefits. Best Pr Res Clin Rheumatol 2011;25:607-24.
14. 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.
15. Van der Bijl AE, Goekoop-Ruiterman YP, de Vries-Bouwstra JK, et al. Infliximab and methotrexate as induction therapy in patients with early rheumatoid arthritis. Arthritis Rheum 2007;56:2129-34.
16. Klarenbeek NB, van der Kooij SM, Guler-Yuksel M, et al. Discontinuing treatment in patients with rheumatoid arthritis in sustained clinical remission: exploratory analyses from the BeSt study. Ann Rheum Dis 2011;70:315-19.
17. Kavanaugh A, Fleischmann RM, Emery P, et al. Clinical, functional and radiographic consequences of achieving stable low disease activity and remission with adalimumab plus methotrexate or methotrexate alone in early rheumatoid arthritis: 26-week results from the randomised, controlled OPTIMA study. Ann Rheum Dis 2013;72:64-71.
18. Detert J, Bastian H, Listing J, et al. Induction therapy with adalimumab plus methotrexate for 24 weeks followed by methotrexate monotherapy up to week 48 versus methotrexate therapy alone for DMARD-naive patients with early rheumatoid arthritis: HIT HARD, an investigator-initiated study. Ann Rheum Dis 2013;72:844-50.
19. Nawata M, Saito K, Nakayamada S, et al. Discontinuation of infliximab in rheumatoid arthritis patients in clinical remission. Mod Rheumatol 2008;18:460-4.
20. Brocq O, Millasseau E, Albert C, et al. Effect of discontinuing TNFalpha antagonist therapy in patients with remission of rheumatoid arthritis. Joint Bone Spine 2009;76:350-5.
21. Tanaka Y, Takeuchi T, Mimori T, et al. Discontinuation of infliximab after attaining low disease activity in patients with rheumatoid arthritis: RRR (remission induction by Remicade in RA) study. Ann Rheum Dis 2010;69:1286-91.
22. Van der Maas A, Kievit W, van den Bemt BJ, et al. Down-titration and discontinuation of infliximab in rheumatoid arthritis patients with stable low disease activity and stable treatment: an observational cohort study. Ann Rheum Dis 2012;71:1849-54.
23. Nishimoto N, Amano K, Hirabayashi Y, et al. Drug free REmission/low disease activity after cessation of tocilizumab (Actemra) Monotherapy (DREAM) study. Mod Rheumatol 2014;24:17-25.
24. 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 [Internet] 2013;381:918-29.
25. Den Broeder AA, van der Maas A, van den Bemt BJ. Dose de-escalation strategies and role of therapeutic drug monitoring of biologics in RA. Rheumatol Oxf 2010;49:1801-3.
26. Van Vollenhoven RF. How to dose infliximab in rheumatoid arthritis: new data on a serious issue. Ann Rheum Dis 2009;68:1237-9.
27. Hansson L, Hedner T, Dahlof B. Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point. Blood Press 1992;1:113-19.
28. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315-24.
29. Prevoo ML, van't Hof MA, Kuper HH, et al. 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 1995;38:44-8.
30. Van der Heijde DM, van't Hof M, van Riel PL, et al. Development of a disease activity score based on judgment in clinical practice by rheumatologists. J Rheumatol 1993;20:579-81.
31. Smolen JS, Keystone EC, Emery P, et al. Consensus statement on the use of rituximab in patients with rheumatoid arthritis. Ann Rheum Dis 2007;66:143-50.
32. Fries JF, Spitz PW, Young DY. The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales. J Rheumatol 1982;9:789-93.
33. Van der Heijde D, Dankert T, Nieman F, et al. Reliability and sensitivity to change of a simplification of the Sharp/van der Heijde radiological assessment in rheumatoid arthritis. Rheumatol Oxf 1999;38:941-7.
34. Brown H, Prescott R. Applied Mixed Models in Medicine. 2nd edn. Chichester, UK: Wiley, 2006.
35. Kelley K. The effects of nonnormal distributions on confidence intervals for the standardized mean difference: Bootstrapping as an alternative to parametric confidence intervals. Educ Psychol Meas 2005;65:51-69.
36. Wells G, Becker J-C, Teng J, et al. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis 2009;68:954-60.
37. Tanaka Y, Hirata S, Kubo S, et al. Discontinuation of adalimumab after achieving remission in patients with established rheumatoid arthritis: 1-year outcome of the HONOR study. Ann Rheum Dis 2015;74:389-95.
38. Aguilar-Lozano L, Castillo-Ortiz JD, Vargas-Serafin C, et al. Sustained clinical remission and rate of relapse after tocilizumab withdrawal in patients with rheumatoid arthritis. J Rheumatol 2013;40:1069-73.
39. Hirata S, Saito K, Kubo S, et al. Discontinuation of adalimumab after attaining disease activity score 28-erythrocyte sedimentation rate remission in patients with rheumatoid arthritis (HONOR study): an observational study. Arthritis Res Ther 2013;15:R135.
40. Chatzidionysiou K, Turesson C, Teleman A, et al. A multicenter, randomized, controlled, open-label pilot study of the feasibility of discontinuation of adalimumab in rheumatoid arthritis patients in stable clinical remission. Arthritis Rheum 2012;64:S336.
41. Takeuchi T, Matsubara T, Ohta S, et al. Abatacept biologic-free remission study in established rheumatoid arthritis patients. ORION study. Arthritis Rheum 2012;64: S552.
42. Van Herwaarden N, den Broeder AA, Jacobs W, et al. Down-titration and discontinuation strategies of tumor necrosis factor-blocking agents for rheumatoid arthritis in patients with low disease activity. Cochrane Database Syst Rev 2014;9: CD010455.
43. van Vollenhoven RF, Ostergaard M, Leirisalo-Repo M, et al. Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis. Ann Rheum Dis 2016; 75:52-8.
44. Van Herwaarden N, van der Maas A, Minten MJM, et al. Disease activity guided dose reduction and withdrawal of adalimumab or etanercept compared with usual care in rheumatoid arthritis: open label, randomised controlled, non-inferiority trial. BMJ 2015;350:h1389.
45. Breban M, Ravaud P, Claudepierre P, et al. Maintenance of infliximab treatment in ankylosing spondylitis: results of a one-year randomized controlled trial comparing systematic versus on-demand treatment. Arthritis Rheum 2008; 58:88-97.
46. Kinney T, Rawlins M, Kozarek R, et al. Immunomodulators and "on demand" therapy with infliximab in Crohn's disease: clinical experience with 400 infusions. Am J Gastroenterol 2003;98:608-12.
47. Sieper J. Infliximab therapy for patients with ankylosing spondylitis: on-demand or continuous treatment? Nat Clin Pr Rheumatol 2008;4:398-9.