Department of Orthopedics and Physical Rehabilitation
Immune System Diseases | Musculoskeletal Diseases | Rheumatology | Therapeutics
INTRODUCTION: Controlled clinical studies have shown that the efficacy of tocilizumab (TCZ) monotherapy is superior to that of tumor necrosis factor inhibitor (TNFi) monotherapy and comparable to that of TCZ plus methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). This study compared the real-world effectiveness of TCZ monotherapy vs. TNFis plus MTX in US patients with RA.
METHODS: TCZ-naive patients from the Corrona RA registry with prior exposure to > /= 1 TNFi who initiated TCZ monotherapy or TNFi + MTX were included. Outcomes included mean change in Clinical Disease Activity Index (CDAI), achievement of low disease activity (LDA; CDAI < /= 10), achievement of modified American College of Rheumatology (mACR) 20/50 responses, and mean change in modified Health Assessment Questionnaire (mHAQ) at 6 months. Patients initiating TNFi + MTX were grouped by MTX dose ( < /= 10 mg; > 10 to < /= 15 mg; > 15 to < /= 20 mg; > 20 mg); outcomes in each group were compared with TCZ monotherapy using trimmed populations (excluding patients outside the propensity score distribution overlap).
RESULTS: Patients in all groups experienced improvement in CDAI at 6 months (mean change, - 6.9 to - 9.7), with no significant differences between the TCZ monotherapy and TNFi + MTX groups. Achievement of LDA and mACR responses at 6 months were comparable between the TCZ monotherapy and TNFi + MTX groups; overall, 26.8-38.0% of patients achieved LDA, 24.3-37.6% achieved mACR20 response and 13.2-20.8% achieved mACR50 response. The mean change in mHAQ at 6 months was - 0.1 in all groups.
CONCLUSIONS: In this real-world population of US patients with RA who had prior TNFi exposure, there was no evidence of a difference in the effectiveness of TCZ monotherapy compared with that of TNFi + MTX, regardless of MTX dose, at 6 months for improving RA disease activity.
FUNDING: Corrona, LLC. Plain language summary available for this article.
Biological therapy, Comparative effectiveness research, Interleukin-6, Methotrexate, Monotherapy, Registries, Rheumatoid arthritis, Tocilizumab, Tumor necrosis factor inhibitors
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Copyright The Author(s) 2018. Open Access: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
DOI of Published Version
Rheumatol Ther. 2018 Dec;5(2):507-523. doi: 10.1007/s40744-018-0127-1. Epub 2018 Oct 6. Link to article on publisher's site
Rheumatology and therapy
Harrold LR, Reed GW, Best J, Zlotnick S, Kremer JM. (2018). Real-world Comparative Effectiveness of Tocilizumab Monotherapy vs. Tumor Necrosis Factor Inhibitors with Methotrexate in Patients with Rheumatoid Arthritis. Open Access Articles. https://doi.org/10.1007/s40744-018-0127-1. Retrieved from https://escholarship.umassmed.edu/oapubs/3632
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This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License