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Abstract Number: L08

Tapering of Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs in Rheumatoid Arthritis Patients in Sustained Remission: Results from a Randomized Controlled Trial

Siri Lillegraven1, Nina Sundlisater 2, Anna-Birgitte Aga 3, Joe Sexton 1, Inge Christoffer Olsen 4, Hallvard Fremstad 5, Cristina Spada 6, Tor Magne Madland 7, Christian Høili 8, Gunnstein Bakland 9, Åse Lexberg 10, Inger Johanne Widding Hansen 11, Inger Myrnes Hansen 12, Hilde Haukeland 13, Maud-Kristine Aga Ljoså 14, Ellen Moholt 15, Till Uhlig 16, Daniel Solomon 17, Désirée van der Heijde 18, Tore Kvien 16 and Espen A Haavardsholm 15, 1Diakonhjemmet Hospital, Dept. of Rheumatology, Oslo, Norway, 2Diakonhjemmet Hospital, Department of Rheumatology, Oslo, Norway, 3Diakonhjemmet Hospital, Department of Rheumatology, Oslo, Oslo, Norway, 4Oslo University Hospital, Oslo, Norway, 5Ålesund Hospital, Helse Møre og Romsdal, Ålesund, Norway, 6Lillehammer Hosptial for Rheumatic Diseases, Lillehammer, Norway, 7Haukeland University Hospital, Bergen, Norway, 8Hospital Østfold HF, Moss, Norway, 9University Hospital of North Norway, Tromsø, Norway, 10Drammen Hospital, Vestre Viken HF, Drammen, Norway, 11Sørlandet Hospital HF, Kristiansand, Norway, 12Helgelandssykehuset Mo i Rana, Mo i Rana, Norway, 13Martina Hansens Hospital, Bærum, Norway, 14Ålesund Hospital Helse Møre og Romsdal HF, Ålesund, Norway, 15Diakonhjemmet Hospital, Oslo, Norway, 16Diakonhjemmet Hospital, Dept. of Rheumatology / University of Oslo, Faculty of Medicine, Oslo, Norway, 17Brigham and Women´s Hospital, Div. of Rheumatology, Immunology and Allergy, Boston, MA, 18Leiden University Medical Center, Leiden, Netherlands

Meeting: 2019 ACR/ARP Annual Meeting

Date of first publication: October 23, 2019

Keywords: DMARDs, Late-Breaking 2019, remission

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Session Information

Date: Tuesday, November 12, 2019

Title: Late-Breaking Abstracts ePoster

Session Type: Late-Breaking Abstract Poster Session

Session Time: 9:00AM-11:00AM

Background/Purpose: Sustained remission is the goal of rheumatoid arthritis (RA) care, and more patients reach and maintain this state on conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) after the implementation of treat-to-target strategies. The knowledge about whether csDMARDs can be tapered in RA remission is limited. The primary objective of the study was to assess the effect of tapering of csDMARDs on the risk of flares in RA patients in sustained clinical remission.

Methods: In the non-inferiority ARCTIC REWIND trial, RA patients in clinical remission for at least 12 months on stable csDMARD therapy were randomly assigned to continued stable csDMARD or half dose csDMARD, with visits every four months. Patients had to be in DAS remission at inclusion with no swollen joints (of 44 assessed). The primary endpoint was the proportion of patients with a disease flare during the 12-month study period (a combination of DAS > 1.6, a change in DAS > 0.6 and at least 2 swollen joints, or both the physician and patient agreed that a clinically significant flare had occurred). The non-inferiority margin was 20%, with a predefined superiority test if non-inferiority was not shown. The inferiority null-hypothesis was tested in the per-protocol population using mixed effect logistic regression. Radiographic joint damage at 0 and 12 months was scored by van der Heijde modified Sharp score (progression: ≥1 unit change/year). Clinicaltrials.gov number NCT01881308.

Results: We enrolled 160 patients, 155 received the allocated treatment strategy. Baseline characteristics were overall well balanced in the two arms (Table 1). 61/78 (78.2%) patients in the stable csDMARD arm and 65/78 (84.4%) in the half-dose csDMARD arm were methotrexate monotherapy users. In the primary analysis, 5/78 (6.4%) of patients in the stable csDMARD arm experienced a flare during the 12 months, compared to 19/77 (24.7%) in the half-dose csDMARD arm, giving a risk difference (95% confidence interval [CI]) of 18.3% (7.2% to 29.3%, Figure 1). Non-inferiority could not be claimed as the confidence interval crossed the non-inferiority margin. However, the confidence interval did not include the null, showing superiority of the stable arm over the half-dose arm, with similar results in methotrexate monotherapy users. In the stable arm, 2/5 (40.0%) adjusted DMARD medication following the flares, compared to 18/19 (94.7%) in the half-dose arm. No progression of radiographic joint damage was observed in 79.5% of patients on stable DMARDs and 62.7% in the half-dose arm, difference (95% CI) -17.7% ( -33.0%, -2.3%, Figure 2E). At 12 months, 67 (91.8%) patients in the stable arm and 63 (85.1%) patients in the half-dose arm were in DAS remission (Figure 2), with similar results for other remission definitions. We observed 75 adverse events in the stable arm and 53 in the tapered arm, with serious adverse events in 2 (2.6%) of patients in the stable arm and in 4 (5.1%, including two serious infections) of patients in the tapered arm.

Conclusion: In RA patients in sustained remission on csDMARDs, continued csDMARD therapy with stable doses led to significantly fewer disease activity flares and less frequent radiographic joint damage progression than tapered csDMARD treatment. 

Figure 1: Non-inferiority plot of stable vs half-dose csDMARD treatment in per protocol set, full analysis set and in patients treated by methotrexate monotherapy, with the proportion of patients with a disease flare during the 12-month study period as outcome

Figure 2 – Secondary endpoints. Panel A shows the cumulative percentage of patients who have experienced flares. Panel B shows the Disease Activity Score. Panel C shows the percentage of patients in Disease Activity Score remission. Panel D shows the PROMIS physical function score. Panel E Panel F shows the cumulative probability plot for radiographic joint damage, scored by van der Heijde Sharp score. Panel F shows the Disease Activity Score at the visit before a flare occurred, at the flare visit and at visits after flare in the half-dose arm.


Disclosure: S. Lillegraven, AbbVie, 2, MSD, 2, Norwegian Research Council, 2, Norwegian South-Eastern Health Region, 2, Pfizer, 2, Roche, 2, UCB, 2; N. Sundlisater, None; A. Aga, AbbVie, 2, 8, Eli Lilly, 8, MSD, 2, Norwegian Research Council, 2, Norwegian Rheumatism Association, 2, Norwegian South-Eastern Health Region, 2, Norwegian Women's Public Health Association, 2, Novartis, 8, Pfizer, 2, 8, Roche, 2, UCB, 2, 8; J. Sexton, None; I. Olsen, None; H. Fremstad, None; C. Spada, None; T. Madland, None; C. Høili, None; G. Bakland, Novartis, 1; Å. Lexberg, None; I. Hansen, None; I. Hansen, None; H. Haukeland, Novartis, 1; M. Ljoså, None; E. Moholt, None; T. Uhlig, None; D. Solomon, AbbVie, 2, Abbvie, 2, Amgen, 2, AstraZeneca, 2, Corrona, 2, Genentech, 2, Janssen, 2, Lilly, 2, Pfizer, 2; D. van der Heijde, AbbVie, 5, AbbVie, Amgen, Astellas, AstraZeneca, BMS, 5, Amgen, 5, Astellas, 5, 9, Astellas Pharma, 5, AstraZeneca, 5, BMS, 5, Boehringer Ingelheim, 5, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, GSK, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB, 5, Boehringer-Ingelheim, 5, Bristol-Myers Squibb, 5, Celgene, 5, Daiichi, 5, 9, Daiichi Sankyo, 5, Director of Imaging Rheumatology, 6, Director of Imaging Rheumatology bv, 9, Eli Lilly, 5, Eli Lilly and Company, 5, Eli-Lilly, 5, Galapagos, 5, Gilead, 5, Gilead Sciences, Inc., 5, GlaxoSmithKline, 5, Glaxo-Smith-Kline, 5, GSK, 5, 8, Imaging Rheumatology bv, 9, Imaging Rheumatology BV, 9, Imaging Rheumatology bv., 9, Janssen, 5, 8, Janssen Pharmaceutica, 5, Merck, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Pfizer Inc, 5, Regeneron, 5, 8, Rheumatology bv, 4, 9, Roche, 5, 8, Sanofi, 5, 8, Takeda, 5, 8, Takeda Pharmaceutical Company, 5, UCB, 5, 8, UCB Pharma, 5; T. Kvien, AbbVie, 2, 8, Biogen, 5, 8, Biogen, Egis, Eli Lilly, Hikma, Mylan, Novartis/Sandoz, Oktal, Hospira/Pfizer, Sanofi and UCB, 5, BMS, 8, Celltrion, 8, Egis, 5, 8, Eli Lilly, 5, 8, Hikma, 5, 8, Hospira/Pfizer, 2, 5, 8, MSD, 2, 8, Mylan, 5, 8, Novartis, 8, Novartis/Sandoz, 5, 8, Oktal, 5, 8, Orion Pharma, 8, Roche, 2, 8, Sandoz, 8, Sanofi, 5, 8, UCB, 5, 8; E. Haavardsholm, None.

To cite this abstract in AMA style:

Lillegraven S, Sundlisater N, Aga A, Sexton J, Olsen I, Fremstad H, Spada C, Madland T, Høili C, Bakland G, Lexberg Å, Hansen I, Hansen I, Haukeland H, Ljoså M, Moholt E, Uhlig T, Solomon D, van der Heijde D, Kvien T, Haavardsholm E. Tapering of Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs in Rheumatoid Arthritis Patients in Sustained Remission: Results from a Randomized Controlled Trial [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/tapering-of-conventional-synthetic-disease-modifying-anti-rheumatic-drugs-in-rheumatoid-arthritis-patients-in-sustained-remission-results-from-a-randomized-controlled-trial/. Accessed .
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