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Rheumatoid arthritis
Original article
Factors influencing the use of tocilizumab as monotherapy in patients with rheumatoid arthritis in a real-life setting: results at 1 year of the ACT-SOLO study
  1. René-Marc Flipo1,
  2. Jean-Francis Maillefert2,
  3. Pascal Chazerain3,
  4. Isabelle Idier4,
  5. Mathieu Coudert5 and
  6. Jacques Tebib6
  1. 1Department of Rheumatology, University Hospital, Lille, France
  2. 2Department of Rheumatology, University Hospital, Dijon, France
  3. 3Department of Rheumatology and Internal Medicine, Croix Saint Simon Hospital, Paris, France
  4. 4Medical Department, Chugai Pharma, Paris, France
  5. 5Department of Clinical Operations, Roche, Boulogne-Billancourt, France
  6. 6Department of Rheumatology, Lyon Sud hospital, Lyon, France
  1. Correspondence to Dr René-Marc Flipo; Rene-Marc.FLIPO{at}chru-lille.fr

Abstract

Introduction Using a biologic disease-modifying antirheumatic drug (bDMARD) as monotherapy in clinical practice for patients with rheumatoid arthritis (RA) is common and recognised by health authorities although current guidelines recommend to combine them with conventional synthetic (cs)DMARDs. This study mainly aimed to search for real-life factors influencing the use of tocilizumab as MONO or in combination (COMBO).

Methods In this non-interventional, prospective, national, multicentre study, data were collected every 3 months over a 12-month period in RA patients starting tocilizumab. The proportion of monotherapy patients was described, together with significant explicative factors.

Results Among the 577 analysed patients recruited from January 2012 to August 2013 (228 monotherapy patients; 40%), 79% were women, mean RA duration was 11±9 years, previous RA treatments included bDMARDs and csDMARDs in 75% of cases and mean Disease Activity Score 28 joints-Erythrocyte Sedimentation Rate (DAS28-ESR) was 5.2±1.3 at inclusion. Explicative factors for monotherapy were at least 65 years (OR=1.47, p=0.0485), no methotrexate within the two last years (OR=5.96, p<0.0001), past severe infection (OR=1.99, p=0.0272) and higher baseline DAS28-ESR (OR=1.22, p=0.0086). Regarding clinical results (DAS28-ESR, Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) low disease activity and remission; ACR20/50/70 and European League Against Rheumatism (EULAR) response; Health Assessment Questionnaire Disability Index (HAQ-DI) score), no relevant differences between monotherapy and combination patients were observed at 1 year. A total of 23 tocilizumab-treated patients (4%) experienced serious infections; no new safety signals were noted with no differences between groups.

Conclusions ACT-SOLO confirms the high proportion of RA patients receiving tocilizumab as MONO in clinical practice. The study also showed that clinical results at 1 year were similar between MONO and COMBO patients in a real-life setting.

Trial registration number NCT01474291.

  • Rheumatoid Arthritis
  • DMARDs (biologic)
  • Epidemiology

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/rmdopen-2016-000340

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    Footnotes

    • Contributors All authors contributed to the conception or design of the work, data analysis and interpretation, critical revision of the article and final approval of the version to be published. R-MF, J-FM and JT were involved in the study design and participated in the interpretation of study results. R-MF, J-FM, JT and PC were investigators, involved in the study data collection and in the critical revision and approval of the final version of the manuscript.

    • Funding This study was funded by Roche SAS and Chugai Pharma France. Roche SAS and Chugai Pharma France were involved in the study design, data collection, data analysis and preparation of the manuscript.

    • Competing interests R-MF, J-FM and JT were the scientific committee of the study. R-MF is member of the medical board and consultant for Roche Chugai France.

    • Ethics approval The study was approved by Comité Consultatif sur le Traitement de l'Information en Matière de Recherche dans le Domaine de la Santé (Consultative Committee on Information Processing for Research in the Field of Health) and was validated by the Commission Nationale de l'Informatique et des Libertés (Independent Administrative Authority Protecting Privacy and Personal Data).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Clinical Study Report may be requested by email. at idier@chugai-pharm.fr