Session Information
Date: Sunday, October 21, 2018
Session Title: Rheumatoid Arthritis – Treatments Poster I: Strategy and Epidemiology
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose:
ACR and EULAR recommend bDMARD tapering in patients (pts) with rheumatoid arthritis (RA) who achieved stable clinical remission. Yet, there are limited systematically collected data on objective magnetic resonance imaging (MRI)-assessed levels of musculoskeletal inflammation, especially tenosynovitis, in RA pts in stable clinical remission with previous data derived from a range of cohorts with differing definitions of clinical remission.The purpose of the analysis was to evaluate within the PREDICTRA study the extent of disease control, in particular MRI inflammation, in RA pts in DAS28-based stable clinical remission attained on adalimumab (ADA) at the standard dosing of 40 mg every other week (eow).
Methods:
PREDICTRA is a multicenter, randomized, double-blind study generating data on pt and disease characteristics that may predict the clinical course of ADA dose-tapering for RA pts in stable clinical remission. RA pts with DAS28-CRP or -ESR <2.6 for ≥6 months following treatment with originator ADA 40 mg eow for ≥12 months in clinical practice were eligible to enter a 4-week (wk) open-label lead-in study period with continued standard ADA dosing. Pts must have had confirmed DAS28-ESR <2.6 at the beginning and end of the lead-in period and quality-verified MRI of the most affected or, if both equally affected, the dominant hand to be eligible for randomization. Study assessments included multiple measures of disease activity (SJC28 and 68, TJC28 and 68, DAS28, CDAI, SDAI, patient’s and physician’s global assessment of disease activity), physical function (HAQ-DI, SF-36 PCS), and OMERACT RAMRIS scores for synovitis, tenosynovitis, bone marrow edema and erosions. Data of the randomized pts at the end of the lead-in period are presented.
Results:
Of the 149 pts that entered the lead-in period, 122 (82%) were randomized. The randomized pts were 75% female, mean age 59.7±10.3 years, RA duration 12.8±9.8 years, prior ADA exposure 5.1±3.0 years, and DAS28 remission duration 2.2±2.1 years. Most pts received concomitant methotrexate (83.6%; mean dose 13.2 mg weekly) and few received concomitant corticosteroids (9.8%; mean dose 3.2 mg daily). Very low disease activity was observed in terms of clinical measures and MRI inflammation scores (synovitis [3.5±3.13], osteitis [1.0±2.01], tenosynovitis [2.7±2.7]). The mean MRI erosion score was low given the disease duration, and physical function scores were within normal ranges (Table).
Conclusion: Pts with long-standing RA randomized to the tapering phase of the PREDICTRA study based on sustained DAS28-based clinical remission on prior standard dose ADA therapy showed very low levels of clinical disease activity and normal physical function. This concurred with low MRI inflammation scores, especially for osteitis and tenosynovitis, the latter pathology being reported for the first time in RA clinical remission pts.
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Table: Summary of Patient Characteristics |
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Patient Characteristic (N=122) |
Mean (SD)* |
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Duration of prior adalimumab, years |
5.1 (3.0) |
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Duration of remission, years |
2.2 (2.0) |
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Concomitant csDMARDs dose, mg Methotrexate (weekly) Hydroxychloroquine (daily) Sulfasalazine (daily) |
13.2 (5.5) 228.6 (75.6) 750.0 (288.7) |
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Concomitant oral corticosteroids dose, mg (daily) |
3.2 (1.7) |
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Anti-cyclic citrullinated peptide (ACCP), Unit ACCP positive, n (%) |
286.6 (206.4) 63 (52.9) |
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Rheumatoid factor (RF), KU/L RF positive, n (%) |
139.5 (395.4) 90 (76.3) |
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C-reactive protein (CRP), mg/L |
5.3 (28.0) |
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Erythrocyte sedimentation rate (ESR), mm/hr |
11.4 (8.4) |
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Tender joint count (TJC) 68 |
0.3 (0.6) |
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Swollen joint count (SJC) 66 |
0.1 (0.3) |
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DAS28 (ESR) |
1.7 (0.6) |
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Clinical Disease Activity Index (CDAI) |
1.3 (1.4) |
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Simplified Disease Activity Index (SDAI) |
1.8 (3.0) |
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Patient’s Global Assessment of Disease Activity –VAS, 0-100 mm |
6.4 (8.9) |
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Physician’s Global Assessment of Disease Activity – VAS, 0-100 mm |
3.7 (5.0) |
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Pain – VAS, 0-100 mm |
8.5 (11.5) |
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HAQ-DI |
0.3 (0.4) |
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SF-36 MCS |
54.4 (7.7) |
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SF-36 PCS |
50.1 (7.8) |
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MRI OMERACT scores Synovitis, Range 0-24 Osteitis, Range 0-75 Tenosynovitis, Range 0-30 Erosion, Range 0-250 |
3.5 (3.1) 1.0 (2.0) 2.7 (2.7) 21.4 (26.9) |
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*All values are Mean (SD) unless otherwise specified ACCP = Anti-cyclic citrullinated peptide; CRP = C-reactive protein; ESR = Erythrocyte sedimentation rate; EAMs = extra-articular manifestations; HAQ-DI = Health Assessment Questionnaire – Disability Index; IBD = inflammatory bowel disease; MCS = mental component summary; OMERACT = Outcome Measures in Rheumatoogy; PCS = physical component summary; Pts = patients; RF = rheumatoid factor; SD = standard deviation; SF-36=Short form 36-item health survey; VAS = Visual Analogue Scale. |
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To cite this abstract in AMA style:
Emery P, Burmester GR, Naredo E, Lagunes Galindo I, Zhang Y, Wang X, Hojnik M, Conaghan PG. Low Inflammation on Magnetic Resonance Imaging in Patients with Rheumatoid Arthritis That Achieved Sustained Clinical Remission on Adalimumab [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/low-inflammation-on-magnetic-resonance-imaging-in-patients-with-rheumatoid-arthritis-that-achieved-sustained-clinical-remission-on-adalimumab/. Accessed April 13, 2021.« Back to 2018 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/low-inflammation-on-magnetic-resonance-imaging-in-patients-with-rheumatoid-arthritis-that-achieved-sustained-clinical-remission-on-adalimumab/