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Abstract Number: 1238

Low Patient Global Assessment of Disease Activity and Negative Rheumatoid Factor Are Strongly Associated with Likelihood of Maintaining Remission Following Tapering of Therapy in Patients with Rheumatoid Arthritis

Jeffrey Curtis1, Paul Emery2, Boulos Haraoui3, Greg Kricorian4, Priscilla Yen4, David Collier5 and Vivian Bykerk6, 1Division of Clinical Immunology and Rheumatology, Department of Medicine, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, 2Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and Leeds NIHR Biomedical Research Centre, Leeds, United Kingdom, 3Institut de Rhumatologie de Montréal, Montréal, QC, Canada, 4Amgen Inc., Thousand Oaks, CA, 5Amgen Inc., Simi Valley, CA, 6Hospital for Special Surgery, New York, NY

Meeting: ACR Convergence 2021

Keywords: rheumatoid arthritis

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Session Information

Date: Monday, November 8, 2021

Session Title: RA – Treatments Poster II: PROs, Biomarkers, & Systemic Inflammation (1223–1256)

Session Type: Poster Session C

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

Background/Purpose: According to ACR and EULAR recommendations, patients with rheumatoid arthritis (RA) who persist in remission (REM) should consider tapering RA therapy. Identification of clinical factors that are associated with a patient remaining in REM following tapering is of value. Since low disease activity (LDA) is an acceptable disease state, we utilized multivariate logistic regression to assess baseline (BL) factors associated with remaining in REM or LDA during methotrexate (MTX) monotherapy, etanercept (ETN) monotherapy, or combination therapy (combo).

Methods: SEAM-RA was a phase 3, multicenter, randomized withdrawal, double-blind, controlled study in patients with RA on MTX + ETN (combo) who had very good disease control for 6 months prior to study entry. If REM (primary endpoint, Simplified Disease Activity Index [SDAI] ≤3.3) was sustained through a 24-week open-label period, patients then entered a 48-week, double-blind period and were randomized 2:2:1 to receive MTX monotherapy, ETN monotherapy, or combo therapy. We evaluated >60 covariates in a step-wise approach to identify BL factors associated with REM or LDA at the end of 48 weeks without disease-worsening. A P value of ≤0.25 was required to enter the regression model, and covariates remained in the multivariate model if P ≤ 0.15 or if commonly of clinical interest in studying RA. Interaction terms for all covariates per treatment arm were also assessed during variable selection to consider varying magnitudes of association by treatment arm. Score selection with best subset was used to confirm the model.

Results: In total, 253 patients with RA were included in the analysis. BL rheumatoid factor (RF) and Patient Global Assessment of Disease Activity (PtGA) showed strong association with SDAI REM or LDA (Table 1). After adjusting for other factors, patients with a 1-point higher PtGA (0-100 scale) at BL were 0.93 times more likely to maintain SDAI REM/LDA at Week 48. RF-positive patients were less than half as likely (OR, 0.46) as RF-negative patients to remain in REM/LDA at Week 48. Longer RA duration in the MTX arm and shorter duration of ETN treatment strongly decreased the odds of SDAI REM/LDA (Tables 1 and 2). An association was also found between lower CRP at BL and REM/LDA (Table 1). There was a trend for non-obese patients to be more likely to remain in REM than obese patients, although significance was not achieved. In addition, MTX and ETN patients with higher magnesium levels at BL had lower odds of maintaining REM/LDA, with an especially strong association within ETN monotherapy (Table 2). The area under the curve for the receiver operating characteristic of the model was 0.78.

Conclusion: These findings indicate patients with overall lower disease activity are more likely to remain in SDAI REM/LDA after tapering RA therapy. RF-negative status and lower PtGA scores in particular were strongly associated with likelihood of remaining in REM/LDA with MTX or ETN monotherapy. The role of magnesium in disease control warrants further exploration.


Disclosures: J. Curtis, AbbVie, 2, Amgen, 2, 5, Bristol-Myers Squibb, 2, Janssen, 2, Eli Lilly, 2, Myriad, 2, Pfizer Inc, 2, 5, Roche/Genentech, 2, UCB, 2, CorEvitas, 2, 5, Crescendo Bio, 5; P. Emery, Abbvie, 2, 5, 6, Sanofi, 2, 6, BMS, 2, 5, 6, Novartis, 2, 6, Gilead, 2, 6, Samsung, 2, 5, 6, Celltrion, 2, 6, Eli Lilly, 2, 5, 6, MSD, 2, 6, Pfizer, 2, 6, Roche, 2, 6, Amgen Inc., 2, 6, Sandoz, 2, UCB, 1, 5, 6, Boehringer Ingelheim, 1, 5, 6, Merck, 1, 5, 6; B. Haraoui, Amgen Inc., 2, 6, AbbVie, 2, 6, Bristol-Myers Squibb, 2, 6, Eli Lilly, 2, 6, Janssen, 2, 6, Merck, 2, 6, UCB, 2, 6, Celgene, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, Roche, 2, 6, Sandoz, 2, 6, Sanofi-Genzyme, 2, 6; G. Kricorian, Amgen Inc., 3, 11; P. Yen, Amgen Inc., 3, 11; D. Collier, Amgen Inc., 3, 11; V. Bykerk, Amgen Inc., 2, 6, Bristol Myers Squibb, 2, 6, Gilead, 2, 6, Pfizer, 2, 6, Regeneron, 2, 6, Sanofi-Genzyme, 2, 6, UCB, 2, 6.

To cite this abstract in AMA style:

Curtis J, Emery P, Haraoui B, Kricorian G, Yen P, Collier D, Bykerk V. Low Patient Global Assessment of Disease Activity and Negative Rheumatoid Factor Are Strongly Associated with Likelihood of Maintaining Remission Following Tapering of Therapy in Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/low-patient-global-assessment-of-disease-activity-and-negative-rheumatoid-factor-are-strongly-associated-with-likelihood-of-maintaining-remission-following-tapering-of-therapy-in-patients-with-rheumat/. Accessed January 27, 2023.
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