THU0124 Low inflammation on magnetic resonance imaging in patients with rheumatoid arthritis that achieved sustained clinical remission on adalimumab: data from the predictra study
Authors: P. Emery, G. Burmester, E. Naredo, I. Lagunes, Y. Zhang, X. Wang, M. Hojnik, P.G. Conaghan
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> ACR and EULAR recommend bDMARD tapering in patients (pts) with rheumatoid arthritis (RA) who achieved stable clinical remission. However, 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. <h3>Objectives</h3> To evaluate within the PREDICTRA study, the extent of disease control, in particular MRI inflammation, in RA patients in DAS28-based stable clinical remission, attained on adalimumab (ADA) at the standard dosing of 40 mg every other week (eow). <h3>Methods</h3> PREDICTRA is a multicenter, randomised, 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&lt;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) lead-in study period with continued standard ADA dosing. Pts must have had confirmed DAS28-ESR&lt;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 oedema, and erosions. Data of the randomised pts at the end of the lead-in period are presented. <h3>Results</h3> Of the 149 pts that entered the lead-in period, 122 (82%) were randomised. The randomised pts were 75% female, mean age of 59.7±10.3 years, RA duration of 12.8±9.8 years, prior ADA exposure for 5.1±3.0 years, and DAS28 remission duration of 2.2±2.1 years. Most pts received concomitant methotrexate (83.6%; mean dose 13.2 mg) and few received concomitant corticosteroids (9.8%; mean dose 3.2 mg). All the clinical disease activity measures showed very low disease activity. There was very low disease activity also in terms of the 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 the physical function scores were within normal levels (table 1). <h3>Conclusions</h3> Pts with long-standing RA randomised 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. <h3>Acknowledgements</h3> AbbVie: study sponsor, study design, data collection, analysis, interpretation, writing, reviewing, and approval of the final version. Statistical support: Liang Chen; Med Writing Support: Siddharth Mukherjee, PhD, both from Abbvie. <h3>Disclosure of Interest</h3> P. Emery Grant/research support from: AbbVie, Bristol-Myers Squibb, Lilly, Merck, Novartis, Pfizer, Roche, Sandoz, and UCB, G. Burmester Grant/research support from: AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, and UCB, E. Naredo Consultant for: AbbVie, Roche, Bristol-Myers Squibb, Pfizer, UCB, Lilly, Novartis, Janssen, and Celgene GmbH, I. Lagunes Shareholder of: Abbvie, Employee of: Abbvie, Y. Zhang Shareholder of: Abbvie, Employee of: Abbvie, X. Wang Shareholder of: Abbvie, Employee of: Abbvie, M. Hojnik Shareholder of: Abbvie, Employee of: Abbvie, P. Conaghan Consultant for: AbbVie, Bristol-Myers Squibb, Lilly, Novartis, Pfizer, and Roche