Effects of tapering conventional synthetic disease-modifying antirheumatic drugs to drug-free remission versus stable treatment in rheumatoid arthritis (ARCTIC REWIND): 3-year results from an open-label, randomised controlled, non-inferiority trial

Kjørholt, KE; Sundlisæter, NP; Aga, AB; Sexton, J; Olsen, IC; Fremstad, H; Spada, C; Madland, TM; Høili, CA; Bakland, G; Lexberg, Å; Hansen, IJW; Hansen, IM; Haukeland, H; Ljoså, MA; Moholt, E; Uhlig, T; Kvien, TK; Solomon, DH; van der Heijde, D; Haavardsholm, EA; Lillegraven, S

doi:10.1016/s2665-9913(24)00021-3

Rheumatoid arthritis

Effects of tapering conventional synthetic disease-modifying antirheumatic drugs to drug-free remission versus stable treatment in rheumatoid arthritis (ARCTIC REWIND): 3-year results from an open-label, randomised controlled, non-inferiority trial

Lancet RheumatolPublished 4 Apr 2024Randomised controlled trial

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Authors' conclusion

Two conventional synthetic DMARD tapering strategies were associated with significantly lower rates of flare-free survival compared with stable conventional synthetic DMARD treatment, and the data do not support non-inferiority.

Study context

Population: Patients aged 18–80 years with RA in sustained remission for at least 1 year on stable csDMARD therapy, ten hospitals in Norway155 per-protocol
Participants: 160 patients

Comparison: Half-dose csDMARDs, or half-dose csDMARDs for 1 year then withdrawal, vs stable csDMARDs
Stable-dosen = 80reference
Half-dosen = 42
Half-dose tapering to withdrawaln = 38
Primary endpoint: Disease flare over 3 years, analysed as flare-free survival and risk difference in the per-protocol population
Follow-up: 3 years

Methodological detailsopen-label, non-inferiority, multicentre (ten hospitals in Norway), randomised 2:1:1 with centre stratification

Open-label
Non-inferiority
Multicentre (ten hospitals in Norway)
Randomised 2:1:1 with centre stratification

Primary result

As reported in the abstract

Flare-free over 3 years

Stable-dose80%95% CI 69–88%

Half-dose57%95% CI 41–71%

Half-dose tapering to withdrawal38%95% CI 22–53%

Each group vs stable-doseRisk difference of flare (95% CI)P value

Half-dose

23%(6–41%)

P = 0.010

Half-dose tapering to withdrawal

40%(22–58%)

P < 0.0001

Further findings

Death — Stable-dose: 1 events

Death: sudden death considered unlikely related to the study medication

Safety

Adverse events

Stable-dose83%

Half-dose90%

Half-dose tapering to withdrawal97%

Reference

Authors: Kjørholt KE, Sundlisæter NP, Aga AB, Sexton J, Olsen IC, Fremstad H, et al.
All 22 authors
Kjørholt KE, Sundlisæter NP, Aga AB, Sexton J, Olsen IC, Fremstad H, Spada C, Madland TM, Høili CA, Bakland G, Lexberg Å, Hansen IJW, Hansen IM, Haukeland H, Ljoså MA, Moholt E, Uhlig T, Kvien TK, Solomon DH, van der Heijde D, Haavardsholm EA, Lillegraven S
Journal: The Lancet Rheumatology
Published: 4 Apr 2024
DOI: 10.1016/s2665-9913(24)00021-3
PubMed: 38583450
Registration: NCT01881308

Topic: Rheumatoid arthritis

Intervention details

Stable-dose: stable conventional synthetic disease-modifying antirheumatic drugs (DMARDs)
Half-dose: half-dose conventional synthetic DMARDs
Half-dose tapering to withdrawal: half-dose conventional synthetic DMARDs for 1 year followed by withdrawal of all conventional synthetic DMARDs

Key notes

Per-protocol population
Non-inferiority margin of 20%

More notes

Non-inferiority not shown

Original publication

Effects of tapering conventional synthetic disease-modifying antirheumatic drugs to drug-free remission versus stable treatment in rheumatoid arthritis (ARCTIC REWIND): 3-year results from an open-label, randomised controlled, non-inferiority trial. Lancet Rheumatol. Published 4 April 2024. doi:10.1016/s2665-9913(24)00021-3

Read the original article ↗

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