Effect of a treat-to-target strategy based on methotrexate and intra-articular betamethasone with or without additional cyclosporin on MRI-assessed synovitis, osteitis, tenosynovitis, bone erosion, and joint space narrowing in early rheumatoid arthritis: results from a 2-year randomized double-blind placebo-controlled trial (CIMESTRA)

• Published in: Scandinavian journal of rheumatology 2017-09, Vol.46 (5), p.335-345
• Main Authors: Møller-Bisgaard, S, Ejbjerg, BJ, Eshed, I, Hørslev-Petersen, K, Hetland, ML, Jurik, AG, Thomsen, H, Torfing, T, Stengaard-Pedersen, K, Junker, P, Krogh, NS, Lottenburger, T, Ellingsen, T, Andersen, LS, Skjødt, H, Svendsen, AJ, Tarp, U, Hansen, IT, Pødenphant, J, Pedersen, JK, Lindegaard, H, Hanson, LG, Vestergaard, A, Glinatsi, D, Østergaard, M
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antirheumatic Agents - administration & dosage; Arthritis, Rheumatoid - diagnosis; Arthritis, Rheumatoid - physiopathology; Betamethasone - administration & dosage; Bone Diseases - drug therapy; Bone Diseases - etiology; Cyclosporine - administration & dosage; Double-Blind Method; Drug Administration Routes; Drug Delivery Systems - methods; Drug Monitoring - methods; Drug Therapy, Combination; Female; Humans; Magnetic Resonance Imaging - methods; Male; Methotrexate - administration & dosage; Middle Aged; Patient Acuity; Synovitis - drug therapy; Synovitis - etiology; Tendinopathy - drug therapy; Tendinopathy - etiology; Treatment Outcome
• ISSN: 0300-9742; 1502-7732
• DOI: 10.1080/03009742.2016.1209550

Objectives: To investigate whether a treat-to-target strategy based on methotrexate (MTX) and intra-articular (IA) betamethasone suppresses magnetic resonance imaging (MRI)-determined measures of disease activity and reduces joint destruction in early rheumatoid arthritis (eRA) patients, and to investigate whether concomitant cyclosporin A (CyA) provides an additional effect. Method: In the 2-year randomized, double-blind, treat-to-target trial CIMESTRA, 160 patients with eRA (< 6 months) were randomized to MTX, intra-articular betamethasone and CyA, or placebo CyA. A total of 129 patients participated in the MRI substudy, and had contrast-enhanced MR images of the non-dominant hand at months 0, 6, 12, and 24. MR images were evaluated for osteitis, synovitis, tenosynovitis, bone erosion, and joint space narrowing (JSN), using validated scoring methods. Results: Significant reductions were seen at 6 months in all inflammatory parameters [synovitis, mean change -1.6 (p