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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)
  1. Bruno Fautrel1,2,
  2. Thao Pham3,4,
  3. Toni Alfaiate5,6,
  4. Frédérique Gandjbakhch1,2,
  5. Violaine Foltz1,2,
  6. Jacques Morel7,
  7. Emmanuelle Dernis8,
  8. Philippe Gaudin9,
  9. Olivier Brocq10,
  10. Elisabeth Solau-Gervais11,12,
  11. Jean-Marie Berthelot13,14,
  12. Jean-Charles Balblanc15,
  13. Xavier Mariette16,17,
  14. Florence Tubach3,18
  1. 1Pierre et Marie Curie University—Paris 6, Sorbonne Universités, GRC-08 (EEMOIS), Paris, France
  2. 2APHP, Rheumatology Department, Pitié Salpêtrière Hospital, Paris, France
  3. 3Aix-Marseille University, Marseille, France
  4. 4AP-HM, Rheumatology Department, Sainte Marguerite Hospital, Marseille, France
  5. 5APHP, Department of Epidemiology and Clinical Research, Hôpital Bichat, Paris, France
  6. 6INSERM CIC-EC 1425, Paris, France
  7. 7Rheumatology Department, Montpellier 1 University, Lapeyronie Hospital, Montpellier, France
  8. 8Rheumatology Department, Le Mans Hospital, Le Mans, France
  9. 9Rheumatology Department, Joseph Fourrier University, Sud Hospital, Grenoble, France
  10. 10Rheumatology Department, Princess Grace Health Centre, Monaco, Monaco
  11. 11University of Poitiers, Poitiers, France
  12. 12Rheumatology Department, La Miletrie Hospital, Poitiers, France
  13. 13University of Nantes, Nantes, France
  14. 14Rheumatology Department, Hotel-Dieu Hospital, Nantes, France
  15. 15Rheumatology Department, Belfort-Montbeliard Health Center, Belfort, France
  16. 16Paris Sud University—Paris 11, Le Kremlin Bicêtre, France
  17. 17AP-HP, Rheumatology Department, Bicêtre Hospital, Le Kremlin Bicêtre, France
  18. 18University Paris Diderot, Sorbonne Paris Cité, UMR 1123, Paris, France
  1. Correspondence to Professor Bruno Fautrel, Université Pierre & Marie Curie (UPMC)—Paris 6, AP-HP, Pitié-Salpêtrière Hospital, Dept of Rheumatology, 83 boulevard de l'Hôpital, Paris F- 75651, Cedex 13, France; bruno.fautrel{at}psl.aphp.fr

Abstract

Tumour necrosis factor (TNF)-blocker tapering has been proposed for patients with rheumatoid arthritis (RA) in remission.

Objective The trial aims to compare the effect of progressive spacing of TNF-blocker injections (S-arm) to their maintenance (M-arm) for established patients with RA in remission.

Methods The study was an 18-month equivalence trial which included patients receiving etanercept or adalimumab at stable dose for ≥1 year, patients in remission on 28-joint Disease Activity Score (DAS28) for ≥6 months and patients with stable joint damage. Patients were randomised into two arms: maintenance or injections spacing by 50% every 3 months up to complete stop. Spacing was reversed to the previous interval in case of relapse, and eventually reattempted after remission was reachieved. The primary outcome was the standardised difference of DAS28 slopes, based on a linear mixed-effects model (equivalence interval set at ±30%).

Results 64 and 73 patients were included in the S-arm and M-arm, respectively, which was less than planned. In the S-arm, TNF blockers were stopped for 39.1%, only tapered for 35.9% and maintained full dose for 20.3%. The equivalence was not demonstrated with a standardised difference of 19% (95% CI −5% to 46%). Relapse was more common in the S-arm (76.6% vs 46.5%, p=0.0004). However, there was no difference in structural damage progression.

Conclusions Tapering was not equivalent to maintenance strategy, resulting in more relapses without impacting structural damage progression. Further studies are needed to identify patients who could benefit from such a strategy associated with substantial cost savings.

Trial registration number: ClinicalTrials.gov: NCT00780793; EudraCT identifier: 2007-004483-41.

  • Rheumatoid Arthritis
  • Anti-TNF
  • Treatment

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