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International Journal of Rheumatology
Volume 2018 (2018), Article ID 8721753, 9 pages
https://doi.org/10.1155/2018/8721753
Clinical Study

AC-CUTE: An Open-Label Study to Evaluate Progression of Structural Joint Damage and Inflammation in Subjects with Moderate to Severe Rheumatoid Arthritis

1University of New South Wales, Sydney, NSW, Australia
2Combined Rheumatology Practice, Kogarah, NSW, Australia
3Spire Sciences, Inc., Boca Raton, FL, USA
4Barwon Rheumatology Service, Geelong, VIC, Australia
5Roche Products Pty, Limited (Australia), Sydney, NSW, Australia
6Royal Prince Alfred Hospital, Camperdown, NSW, Australia
7Cabrini Medical Centre, Malvern, VIC, Australia

Correspondence should be addressed to Paul Bird; ua.moc.hcraesersumitpo@dribp

Received 13 November 2017; Revised 13 February 2018; Accepted 26 February 2018; Published 12 April 2018

Academic Editor: Tim Jansen

Copyright © 2018 Paul Bird et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Aim. Examine the efficacy of once-weekly subcutaneous tocilizumab (SC-TCZ) on joint damage at 24 weeks based on radiography of the hands and feet and magnetic resonance imaging (MRI) of the hand in subjects with moderate to severe rheumatoid arthritis (RA). Methods. In this Australian open-label, multicentre, prospective, single-arm study, subjects received 162 mg SC-TCZ weekly. Primary endpoint was change in radiographic Genant-modified Total Sharp Score (TSS) between baseline and Week 24. Secondary endpoints included change from baseline to Week 24 in RA MRI scoring (RAMRIS) of erosions, synovitis, and osteitis and Cartilage Loss Score (CARLOS) in the dominant hand and disease activity score 28 (DAS28). Results. 52 subjects were enrolled (80% female, mean (SD) age 57  (12) years). Radiography showed mild but not significant progression of joint damage (mean (SD) change in TSS 0.46 (1.29)). Synovitis reduced significantly on MRI; however, osteitis, erosion, and cartilage loss did not change significantly. DAS28 improved significantly by Week 24; 78% of subjects achieved DAS28 remission. SC-TCZ was generally well tolerated. Conclusion. Synovitis and DAS28 decreased significantly; however, no significant change in osteitis or joint damage was observed at Week 24. Trial registration. This trial is registered with Clinicaltrials.gov registration number NCT01951170 (ML28703).