Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Mar;6(1):61-75.
doi: 10.1007/s40744-018-0138-y. Epub 2019 Jan 10.

Tocilizumab Effectiveness After Switching from Intravenous to Subcutaneous Route in Patients with Rheumatoid Arthritis: The RoSwitch Study

Jean Darloy  1 , Nicolas Segaud  2 , Jean-Hugues Salmon  3 , Jean-Paul Eschard  3 , Vincent Goëb  4 , Xavier Deprez  5 , Marie-Hélène Guyot  5   6 , Eric Houvenagel  7 , Nicolas Lecuyer  8 , Laurent Marguerie  9 , Samuel Gally  10 , David Pau  10 , Isabelle Idier  11 , Guy Baudens  12 , René-Marc Flipo  2
Affiliations

Tocilizumab Effectiveness After Switching from Intravenous to Subcutaneous Route in Patients with Rheumatoid Arthritis: The RoSwitch Study

Jean Darloy et al. Rheumatol Ther. 2019 Mar.

Abstract

Introduction: The main objective of this work was to assess the maintenance of effectiveness of subcutaneous tocilizumab 6 months after switching from intravenous to subcutaneous formulation in patients with rheumatoid arthritis (RA) in a real-world setting. Secondary objectives aimed to describe the characteristics of patients and disease, the effectiveness at 12 months after switching, the therapeutic maintenance, and to search for predictive factors of switching.

Methods: We analyzed all the RA patients of the shared medical file "RIC Nord de France", treated with tocilizumab, switching or not from intravenous to subcutaneous tocilizumab, between April 2015 and January 2016. The primary effectiveness endpoint was the proportion of patients remaining in their DAS28-ESR category remission/low disease activity (LDA) or moving to an inferior DAS28-ESR category at 6 months. Since RoSwitch was an observational study, without randomization, a propensity score was built in a sensitivity analysis to balance on RA and patients' characteristics at inclusion between switching and no-switching groups.

Results: An improvement of initial DAS28-ESR category or maintenance in DAS28-ESR remission/LDA at 6 months was shown in 203 of the 285 patients with an evaluation for the primary criterion (71.2%, 95% CI [65.6-76.4%]) without differences between groups (73.3%, 95% CI [63.0-82.1%] vs. 70.3%, 95% CI [63.3-76.6%]). The RoSwitch study showed the maintenance of effectiveness at 6 and 12 months. Similar therapeutic maintenance rates were observed for switch and no-switch patients. No clinical factor was associated with the switch in patients in remission/LDA at inclusion.

Conclusions: The RoSwitch study showed the maintenance of effectiveness at 6 months in RA patients switching from intravenous (IV) to subcutaneous (SC) tocilizumab.

Funding: Roche SAS and Chugai Pharma France.

Keywords: Administration route; Rheumatoid arthritis; Subcutaneous; Switch; Tocilizumab.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Flowchart—analysis populations from the extracted database. CRP C-reactive protein, DAS28 disease activity score in 28 joints, EMR electronic medical records, ESR erythrocyte sedimentation rate, IV intravenous, RA rheumatoid arthritis, RIC “rhumatismes inflammatoires chroniques” chronic inflammatory rheumatism, SC subcutaneous, TCZ tocilizumab
Fig. 2
Fig. 2
DAS28-ESR evolution over the study period, according to switch and no-switch patients of the main population. DAS28-ESR disease activity score in 28 joints using the erythrocyte sedimentation rate
Fig. 3
Fig. 3
Maintenance of TCZ treatment according to switch and no-switch patients. Kaplan–Meier curve of the main population. SC subcutaneous, TCZ tocilizumab
See this image and copyright information in PMC

References

    1. Guillemin F, Saraux A, Guggenbuhl P, et al. Prevalence of rheumatoid arthritis in France: 2001. Ann Rheum Dis. 2005;64(10):1427–1430. doi: 10.1136/ard.2004.029199. - DOI - PMC - PubMed
    1. Gabriel SE, Crowson CS, Kremers HM, et al. Survival in rheumatoid arthritis: a population-based analysis of trends over 40 years. Arthritis Rheum. 2003;48:54–58. doi: 10.1002/art.10705. - DOI - PubMed
    1. Fautrel B, Gaujoux-Viala C. Aspects médico-économiques de la polyarthrite Rhumatoïde. Bull Acad Natle Méd. 2012;196(7):1295–1306. - PubMed
    1. Srirangan S, Choy EH. The role of interleukine 6 in the pathophysiology of rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2010;2(5):247–256. doi: 10.1177/1759720X10378372. - DOI - PMC - PubMed
    1. Emery P, Keystone E, Tony HP, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008;67(11):1516–1523. doi: 10.1136/ard.2008.092932. - DOI - PMC - PubMed

LinkOut - more resources