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Abstract Number: 0829

Tapering and Withdrawal of Biologics or Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Patients with Inflammatory Arthritis: A Systematic Review and Meta-Analyses of Randomised Trials

Line Uhrenholt1, Robin Christensen2, Wilfred K Dinesen3, Caroline Liboriussen3, Stine Andersen3, Lene Dreyer1, Annette Schlemmer4, Ellen-Margrethe Hauge5, Conni Skrubbeltrang6 and Salome Kristensen1, 1Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark, 2Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen & Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Copenhagen, Denmark, 3Department of Clinical Medicine, Aalborg University, Aalborg, Denmark, 4Department of Rheumatology, Randers Regional Hospital, Randers, Denmark, 5Aarhus University Hospital, Aarhus, Denmark, 6Medical Library, Aalborg University Hospital, Aalborg, Denmark

Meeting: ACR Convergence 2021

Keywords: Ankylosing spondylitis (AS), Biologicals, meta-analysis, rheumatoid arthritis, spondyloarthritis

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Session Information

Date: Sunday, November 7, 2021

Session Title: RA – Treatments Poster I: Comparative Effectiveness, Biosimilars, Withdrawal, & the Real World (0813–0845)

Session Type: Poster Session B

Session Time: 8:30AM-10:30AM

Background/Purpose: Tapering and withdrawal of biological or targeted synthetic disease-modifying antirheumatic drugs (bDMARDs or tsDMARDs) in patients with inflammatory arthritis (IA) in remission or low disease activity (LDA) are a topic of great interest. This systematic review aimed to assess the risk of flare after tapering or withdrawing b- or tsDMARDs compared to continuation of standard dosage.

Methods: The protocol was registered at PROSPERO (CRD42019136905). Predefined search terms identified relevant articles in Cochrane Library, EMBASE, PubMed, and Web of Science (search date: 13-14/06/2019, rerun 11/01/2021). Congress abstracts from ACR and EULAR after 01/01/2017 was evaluated for eligibility. Randomized trials comparing tapering or withdrawal of b- or tsDMARDs in patients with IA with continuation of standard dosage were included. Random-effects meta-analyses were performed to combine the risk ratio (RR) with 95% confidence interval (95%CI) for data on flare after either A) Tapering or B) Withdrawal of b- or tsDMARDs compared to continuation of standard dosage stratified by diagnosis. In trials with >1 tapering strategy, data for the different tapering strategies were combined initially before meta-analysis.

Results: 14,861 references were screened, and 22 trials were included in the meta-analyses of flare risk with data on 3,942 patients with RA and 828 patients with axSpA (Figure 1). An increased risk for developing flare(s) was demonstrated in the meta-analysis on 15 trials tapering of b- or tsDMARDs, RR = 1.45 (95%CI: 1.19 to 1.77; Figure 2). This corresponds to an absolute effect of number needed to treat (NNT [harm]) of 10 patients. Moreover, in 11 trials testing the effect of (abrupt) withdrawal of tumour necrosis factor inhibitors (TNFis), a highly evident increased risk was demonstrated, RR = 2.28 (95%CI: 1.78 to 2.93; Figure 2) with an absolute effect of NNT (harm) of 3 patients. As presented in Figure 2, no significant difference in the risk for flare was observed in subgroup meta-analyses when stratifying by diagnosis (i.e. axSpA or RA).

In summary, 431 patients (32.7%) in the tapering group had a flare and 888 patients (67.3%) did not whereas 830 patients (55.3%) in the withdrawal group experienced a flare and 670 patients (44.7%) did not. Thus, even though an increased risk for flare was demonstrated in the meta-analyses it is noteworthy that the proportion of patients with no flare was larger in the tapering group (67.3%) compared to the withdrawal group (44.7%).

Conclusion: Patients with IA who taper or withdraw their b- or tsDMARDs compared to continuation of standard dosage have an increased risk of flare with no significant risk difference between patients with axSpA or RA. However, a complete withdrawal was associated with a substantially increased flare risk; thus, the most favorable approach to reduce b- or tsDMARDs dose seems to be tapering.

Figure 1: Flow diagram of study selection

Figure 2: Meta-analysis of risk ratio with 95% confidence interval (95%CI) for flare by diagnosis (i.e. RA or axSpA) who A) Taper or B) Withdraw b- or tsDMARDs compared to continuation of standard dosage.


Disclosures: L. Uhrenholt, None; R. Christensen, None; W. Dinesen, None; C. Liboriussen, None; S. Andersen, None; L. Dreyer, BMS, 5, Galderma, 6, Eli Lilly, 6, Janssen, 6; A. Schlemmer, None; E. Hauge, AbbVie, 6, Sanofi, 6, Sobi, 6, SynACT Pharma, 6, Novo Nordic Foundation, 5, Roche, 5, Novartis, 5; C. Skrubbeltrang, None; S. Kristensen, None.

To cite this abstract in AMA style:

Uhrenholt L, Christensen R, Dinesen W, Liboriussen C, Andersen S, Dreyer L, Schlemmer A, Hauge E, Skrubbeltrang C, Kristensen S. Tapering and Withdrawal of Biologics or Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Patients with Inflammatory Arthritis: A Systematic Review and Meta-Analyses of Randomised Trials [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/tapering-and-withdrawal-of-biologics-or-targeted-synthetic-disease-modifying-antirheumatic-drugs-in-patients-with-inflammatory-arthritis-a-systematic-review-and-meta-analyses-of-randomised-trials/. Accessed January 27, 2023.
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