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Testing treat-to-target outcomes with initial methotrexate monotherapy compared with initial tumour necrosis factor inhibitor (adalimumab) plus methotrexate in early rheumatoid arthritis

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Kavanaugh A1, van Vollenhoven RF2, Fleischmann R3, Emery P4,5, Sainsbury I6, Florentinus S6, Chen S6, Guérette B6, Kupper H7, Smolen JS8. Ann Rheum Dis. 2018 Feb;77(2):289-292. doi: 10.1136/annrheumdis-2017-211871. Epub 2017 Nov 16.


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1 Division of Rheumatology, Allergy and Immunology, School of Medicine, University of California at San Diego, La Jolla, California, USA.

2 Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, The Netherlands.

3 University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, Texas, USA.

4 Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Leeds, UK.

5 NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.

6 AbbVie Inc., North Chicago, Illinois, USA.

7 AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.

8 Medical University of Vienna and Hietzing Hospital, Vienna, Austria.


OBJECTIVES: To compare responses in patients with early rheumatoid arthritis (RA) initially treated with the tumour necrosis factor inhibitor (TNFi) adalimumab+methotrexate (MTX) versus MTX monotherapy who may have continued receiving MTX or switched to adalimumab rescue therapy after inadequate response to MTX.

METHODS: OPTIMA enrolled MTX-naive patients with active RA for <1 year. This post hoc analysis determined the proportion of patients, stratified by initial treatment, who achieved 28-joint modified Disease Activity Score based on C reactive protein <3.2, normal function and/or no radiographic progression at weeks 26, 52 and 78.

RESULTS: Significantly greater proportions of patients initially treated with adalimumab+MTX (n=466) compared with MTX monotherapy (n=460) achieved good clinical (53% vs 30%), functional (45% vs 33%) and radiographic (87% vs 72%) outcomes at week 26. From weeks 26 to 78, adalimumab rescue patients achieved similar clinical and functional outcomes versus patients initially treated with adalimumab+MTX. However, significantly more patients initially treated with adalimumab+MTX had no radiographic progression at weeks 52 and 78 versus patients initially treated with MTX (both timepoints: 86% vs 72%).

CONCLUSIONS: In early RA, starting with MTX monotherapy and adding TNFi after 26 weeks yields similar longer term clinical results as starting with TNFi+MTX combination therapy but allows a small but significant accrual of radiographic damage.