Session: (1862–1894) Imaging of Rheumatic Diseases Poster II
1868: Long-term Efficacy of a 2-year MRI Treat-to-target Strategy on Radiographic Joint Damage Progression in Rheumatoid Arthritis Patients in Clinical Remission – Five Year Follow-up of the IMAGINE-RA Randomized Clinical Trial
Rigshospitalet, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases Glostrup, Denmark
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Signe Møller-Bisgaard1, Kim Hørslev-Petersen2, Lykke Ørnbjerg1, Bo Ejbjerg3, Merete L Hetland1, Jakob Moeller4, Robin Christensen5, Sabrina Mai Nielsen6, Daniel Glinatsi7, Mikael Boesen8, Kristian Stengaard-Pedersen9, Ole Rintek Madsen10, Bente Jensen11, Jan Alexander Villadsen2, Ellen-Margrethe Hauge9, Oliver Hendricks2, Hanne Merete Lindegaard12, Niels Steen Krogh13, Anne Grethe Jurik9, Henrik Thomsen4 and Mikkel Østergaard14, 1Copenhagen Center for Arthritis Research, Rigshospitalet, Copenhagen, Denmark, 2Danish Hospital for Rheumatic Diseases, Sønderborg, Denmark, 3Slagelse Hospital, Slagelse, Denmark, 4Herlev-Gentofte Hospital, Herlev, Denmark, 5Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen, Denmark, 6The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark, 7Copenhagen Center for Arthritis Research, Rigshospitalet, Copenhagen, Sweden, 8Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital, Naerum, Denmark, 9Aarhus University Hospital, Aarhus, Denmark, 10Herlev-Gentofte Hospital, Gentofte, Denmark, 11Bispebjerg-Frederiksberg Hospital, Frederiksberg, Denmark, 12Odense Hospital, Odense, Denmark, 13ZiteLab ApS, Frederiksberg, Denmark, 14Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet; University of Copenhagen, Copenhagen, Denmark
Background/Purpose: Radiographic joint damage progresses in 20-30% of rheumatoid arthritis (RA) patients despite fulfilling clinical remission criteria (1). Osteitis assessed on MRI is a well known predictor of subsequent radiographic bone damage progression (2). Therefore, targeting absence of osteitis combined with clinical remission may improve long-term radiographic outcomes. The purpose of the study was therefore: To investigate whether a 2-year MRI treat-to-target (MRI T2T) strategy targeting absence of osteitis combined with clinical remission, compared to a conventional T2T strategy targeting clinical remission only, could reduce radiographic joint damage progression over 5 years in RA patients.
Methods: IMAGINE-more was designed as a 3-year observational extension study of the 2-year IMAGINE-RA randomized clinical trial (3). IMAGINE-RA included 200 RA patients in clinical remission (DAS28-CRP< 3.2 and no swollen joints), with erosive disease (bone erosion on conventional radiography),and treated with conventional synthetic DMARDs (csDMARDs). The objective was to investigate whether a 2-year MRI T2T strategy targeting absence of osteitis combined with clinical remission (DAS28-CRP≤3.2 and no swollen joints) as compared to a conventional T2T strategy, targeting clinical remission only, could improve remission rates and prevent radiographic joint damage progression. If treatment target was not met, treatment was intensified stepwise starting with increment in csDMARDs and subsequently adding biologics. Participants in the IMAGINE-more extension study were managed in routine clinical practice in outpatient clinics. Clinical examinations and radiographs of hands and feet (also obtained at baseline, year 1 and 2 in IMAGINE-RA) were done year 3, 4 and 5. The primary endpoint was the proportion of patients with no radiographic progression (increase in total van der Heijde-modified Sharp score (vdHSS) ≤0) from baseline to year 5. Secondary endpoints were changes from baseline to 5 years in total vdHSS, vdHSS erosion and joint space narrowing (JSN) scores. Dichotomous endpoints were estimated by logistic regression, while median differences were calculated for the continuous outcome measures.
Results: Informed consent to participation in IMAGINE-more was obtained from 131 patients (59 from the originalMRI T2T group). Of these, 14 patients (24%) in the MRI T2T group and 19 patients (26%) in the conventional T2T group had no radiographic progression from baseline to year 5 (OR 0.70 [0.28 to 1.71]). As illustrated in the Table and Figure, the median progression in total vdHSS from baseline to 5 years was low, with no differences between treatment groups.
Conclusion: A 2-year combined MRI T2T and clinical T2T strategy, compared with a conventional clinical T2T strategy alone, did not result in reduced radiographic progression in the long term over 5 years in RA patients with erosive disease in clinical remission. In accordance with the primary results from the IMAGINE-RA trial, these findings do not support systematic use of MRI to guide treatment in RA patients in remission.
References: 1. Lillegraven et al. Ann Rheum Dis 2012 2. Brown et al. Arthritis Rheum 2008 3. Møller-Bisgaard et al. JAMA 2019
Group contrasts are presented as No. (%) for dichotomous data and medians [IQR] for continuous data. OR (95%CI) were estimated from logistic regression adjusted for a propensity score and with non-responder imputation. For endpoints with continuous data median differences (95%CI) were calculated based on the ITT population (no manual imputation) *In addition to the radiographic endpoints, the full IMAGINE-more study includes a clinical co-primary endpoint, and several secondary endpoints.
Illustrates the change in total vdHSS from baseline to 60 months (i.e., 5 years) based on the ITT population (no manual imputation done), as well as the proportions with no radiographic progression (delta total vdHSS<0) in each group from baseline to 60 months, with non-responder imputation.
S. Møller-Bisgaard: None; K. Hørslev-Petersen: None; L. Ørnbjerg: Novartis, 5; B. Ejbjerg: None; M. Hetland: AbbVie/Abbott, 1, 5, Bristol-Myers Squibb(BMS), 5, Danbio, 12, MLH has chaired the steering committee of the Danish Rheumatology Quality Registry (DANBIO, DRQ), which receives public funding from the hospital owne, Eli Lilly, 5, MEDAC, 6, Novartis, 5, Pfizer, 5, 6, Sandoz, 5, 6; J. Moeller: None; R. Christensen: None; S. Nielsen: None; D. Glinatsi: Eli Lilly, 1, 6; M. Boesen: AbbVie, 2, 5, 6, Celgene, 2, 5, 6, Eli Lilly, 2, 6, Image Analysis Group, 2, 6, 11, Novartis, 2, 5, 6, Pfizer, 2, 6, UCB, 2, 6; K. Stengaard-Pedersen: None; O. Madsen: None; B. Jensen: None; J. Villadsen: None; E. Hauge: AbbVie/Abbott, 2, 5, 6, Danish Regions Medicine Grants, 5, Danish Rheumatism Association, 5, Galapagos, 5, Novartis, 2, 6, Novo Nordic, 2, 5, 6, Sanofi, 2, 6, Sobi, 2, 6; O. Hendricks: AbbVie/Abbott, 4, 6, Eli Lilly, 6, Novartis, 6, Pfizer, 6; H. Lindegaard: None; N. Krogh: None; A. Jurik: None; H. Thomsen: None; M. Østergaard: AbbVie, 2, 5, 6, Amgen, 5, Boehringer-Ingelheim, 2, 6, Bristol-Myers Squibb(BMS), 2, 5, 6, Celgene, 2, 5, 6, Eli Lilly, 2, 6, Galapagos, 2, 6, Gilead, 2, 6, Hospira, 2, 6, Janssen, 2, 6, MEDAC, 6, Merck, 2, 5, 6, Novartis, 2, 5, 6, Novo Nordisk, 2, 6, Orion, 2, 6, Pfizer, 2, 6, Regeneron, 2, 6, Roche, 2, 6, Sandoz, 2, 6, Sanofi, 2, 6, UCB, 2, 6.