Long Term Efficacy of a 2-year MRI Treat-to-target Treatment Strategy on Disease Activity, MRI Inflammation and Physical Function in Rheumatoid Arthritis Patients in Clinical Remission: Five Year Follow-up of the IMAGINE-RA Cohort

Background Targeting MRI remission in rheumatoid arthritis (RA) patients in clinical remission may improve long term clinical, functional and MRI outcomes. Objectives To investigate whether a 2-year treat-to-target (T2T) strategy, based on structured MRI assessments targeting absence of osteitis combined with clinical remission, compared with a conventional clinical T2T strategy targeting clinical remission only, improves disease activity, physical function and suppresses MRI-inflammation over 5 years in RA patients. Methods The IMAGINE-more trial was designed as an extension protocol to the 2-year IMAGINE-RA randomised controlled trial (RCT). IMAGINE-RA included 200 RA patients, in clinical remission (DAS28-CRP<3.2 and no swollen joints), who received conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and investigated whether an MRI T2T strategy targeting absence of osteitis in combination with clinical remission (DAS28-CRP≤3.2 and no swollen joints) could increase remission rates and prevent erosive progression compared with a conventional T2T strategy targeting clinical remission only. If target was not met, treatment was escalated according to a predefined treatment algorithm starting with increment in csDMARDs and then adding biologics. At the end of the study, participants were invited to participate in the IMAGINE-more follow-up study. Patients were managed in routine outpatient clinic and had three IMAGINE-more visits including clinical examination (year 3, 4 and 5) and contrast-enhanced MRI of the dominant wrist and 2 nd -5 th metacarpophalangeal joints (year 3 and 5). The primary clinical endpoint was the proportion of patients achieving DAS28-CRP remission (DAS28-CRP<2.6) at year 5. Predefined key secondary outcomes were disease activity (DAS28-CRP), and changes in MRI osteitis (OMERACT RA MRI scoring system (RAMRIS)) and functional level (Health Assessment Questionnaire (HAQ)) from baseline to 5-years follow up. Endpoints were analysed by logistic regression models and repeated measures mixed effects models adjusted for propensity scores corresponding to (remaining in) group allocation. Results Fifty-nine patients in the MRI T2T arm and 72 patients in conventional T2T arm consented to participate. Of these, 47 patients (80%) in the MRI T2T group and 54 patients (75%) in the conventional T2T group reached the primary clinical endpoint (p=0.161) (Table 1 and Figure 1). No statistically significant differences between treatment strategies in key secondary outcomes were seen. Table 1. Primary and key secondary outcomes at 5 years MRI T2T Conventional T2T Difference between groups P value N=59 N=72 Primary endpoint DAS28-CRP remission (DAS28-CRP<2.6), No. (%) 47 (80%) 54 (75%) 2.00 (0.76 to 5.28) 0.161 Key secondary endpoints DAS28-CRP 1.79 (0.08) 1.94 (0.08) -0.15 (-0.38 to 0.07) 0.176 Change from baseline in MRI osteitis (RAMRIS) -0.17 (0.58) 0.18 (0.54) -0.35 (-1.96 to 1.25) 0.663 Change from baseline in HAQ -0.02 (0.03) 0.05 (0.03) -0.07 (-0.15 to 0.01) 0.080 Group estimates are presented as No. (%) for dichotomous data and least squares means (SE) for continuous data. For the primary endpoint, adjusted odds ratio and 95%CI between groups were calculated from a logistic regression model including a fixed factor for treatment arm, and an adjustment for propensity score as a covariate. For endpoints with continuous data, least squares mean differences between groups were calculated based on repeated-measures mixed linear models adjusted for baseline values and propensity scores. Conclusion A 2-year MRI T2T strategy targeting absence of MRI osteitis combined with clinical remission as compared to a conventional clinical T2T strategy in RA patients had no effect on the long-term probability of achieving DAS28-CRP remission. These findnings do not support the use of an MRI-guided strategy for treating patients with RA. References [1]Møller-Bisgaard S et al : JAMA 2019, 321(5):461-472. Disclosure of Interests Signe Møller-Bisgaard Grant/research support from: AbbVie, Kim Hørslev-Petersen: None declared, Daniel Glinatsi: None declared, Bo Ejbjerg: None declared, Merete L. Hetland: None declared, Jakob Møllenbach Møller: None declared, Robin Christensen: None declared, Sabrina Mai Nielsen: None declared, Mikael Boesen: None declared, Kristian Stengaard-Pedersen: None declared, Ole Madsen: None declared, Bente Jensen: None declared, Jan Alexander Villadsen: None declared, Ellen Margrethe Hauge: None declared, Oliver Hendricks: None declared, Hanne Merete Lindegaard: None declared, Niels Steen Krogh: None declared, Anne Grethe Jurik: None declared, Henrik Thomsen: None declared, Mikkel Østergaard Speakers bureau: Abbvie, BMS, Celgene, Eli-Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Orion, Pfizer, Roche and UCB, Consultant of: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB, Grant/research support from: Abbvie, Amgen, BMS, Merck, Celgene and Novartis.