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Ann Rheum Dis. 2017 Oct;76(10):1716-1722. doi: 10.1136/annrheumdis-2017-211169. Epub 2017 Jun 12.

Long-term outcomes after disease activity-guided dose reduction of TNF inhibition in rheumatoid arthritis: 3-year data of the DRESS study - a randomised controlled pragmatic non-inferiority strategy trial.

Author information

1
Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands.
2
Department of Rheumatology, Radboud University Medical Centre, Nijmegen, The Netherlands.
3
Department of Clinical Immunology and Rheumatology, Academic Medical Center, Amsterdam, The Netherlands.
4
Department of Rheumatology, VU University Medical Centre, Amsterdam, The Netherlands.
5
Department of Rheumatology & Clinical Immunology, Utrecht University Medical Centre, Utrecht, The Netherlands.

Abstract

OBJECTIVE:

Tumour necrosis factor inhibitors (TNFi) are effective in rheumatoid arthritis (RA), but disadvantages include adverse events (AEs) and high costs. This can be improved by disease activity-guided dose reduction (DR). We aimed to assess long-term outcomes of TNFi DR in RA by using 3-year data from the DRESS study (Dose REduction Strategy of Subcutaneous TNF inhibitors study).

METHODS:

In the intervention phase (month 0-18) of the DRESS study (Dutch trial register, NTR 3216), patients were randomised to DR or usual care (UC). In the extension phase (month 18-36), treatment strategies in both groups converged to continuation of protocolised tight control and allowed dose optimisation. Intention-to-treat analyses were done on flare, disease activity (28 joint count-based disease activity score with C reactive protein (DAS28-CRP)), functioning (health assessment questionnaire-disability index (HAQ-DI)), quality of life (Euroqol 5 dimensions 5 levels questionnaire (EQ5D-5L)), medication use, radiographic progression (Sharp van der Heijde score (SvdH)) and AE.

RESULTS:

172/180 patients included in the DRESS study were included in the extension phase. Cumulative incidences of major flare were 10% and 12% (-2%, 95% CI -8 to 15) in DR and UC groups in the extension phase, and 17% and 14% (3%, 95% CI -9 to 13) from 0 to 36 months. Cumulative incidences of short-lived flares were 43% (33 to 52%)%) and 35% (23 to 49%)%) in DR and UC groups in the extension phase, and 83% (75 to 90%)%) and 44% (31 to 58%)%) from 0 to 36 months. Mean DAS28-CRP, HAQ-DI, EQ5D-5L and SvdH remained stable and not significantly different between groups. TNFi use remained low in the DR group and decreased in the UC group. Cumulative incidences of AE were not significantly different between groups.

CONCLUSIONS:

Safety and efficacy of disease activity guided TNFi DR in RA are maintained up to 3 years, with a large reduction in TNFi use, but no other benefits. Implementation of DR would vastly improve the cost-effective use of TNFi.

KEYWORDS:

TNF inhibitor; flare; rheumatoid arthritis; treatment optimization

PMID:
28606961
DOI:
10.1136/annrheumdis-2017-211169
[Indexed for MEDLINE]

Conflict of interest statement

Competing interests: HB received grants and personal fees from Pfizer and AbbVie during the conduct of the study; grants and personal fees from Roche, BMS, MSD, UCB, all outside the submitted work. RFvV received grants from AbbVie, Amgen, BMS, GSK, Pfizer, Roche, UCB and personal fees from AbbVie, Biotest, BMS, Celgene, Crescendo, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, UCB, Vertex, outside the submitted work. JF received a research grant from BMS. AAdB received congress invitations from Roche and Abvie and an expert witness fee from Amgen. The other authors declare that they have no conflicts of interest.

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