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Comparison of tocilizumab as monotherapy or with add-on disease-modifying antirheumatic drugs in patients with rheumatoid arthritis and inadequate responses to previous treatments: an open-label study close to clinical practice

Comparison of tocilizumab as monotherapy or with add-on disease-modifying antirheumatic drugs in patients with rheumatoid arthritis and inadequate responses to previous treatments: an open-label study close to clinical practice

Data de publicació: 01/03/2015

Autors de IIS La Fe

José Andrés Román Ivorra

Autor

Autors aliens a IIS La Fe

Bykerk, VP
Ostor, AJK
Alvaro-Gracia, J
Pavelka, K
Graninger, W
Bensen, W
Nurmohamed, MT
Krause, A
Bernasconi, C
Aassi, M
Sibilia, J

Grups d'Investigació

Reumatología

Leader

José Andrés Román Ivorra

Abstract

This was an exploratory analysis comparing the safety and efficacy of tocilizumab monotherapy with those of tocilizumab in combination with disease-modifying anti-rheumatic drugs (DMARDs). Data were from a single-arm, nonrandomized, open-label, 24-week study in patients with rheumatoid arthritis in which patients with inadequate responses to DMARDs or tumor necrosis factor-alpha inhibitors received tocilizumab 8 mg/kg intravenously every 4 weeks plus methotrexate/other DMARD(s) combination therapy. If they were intolerant of methotrexate/other DMARD, patients received tocilizumab monotherapy. Effectiveness endpoints included American College of Rheumatology (ACR) responses (ACR20/50/70/90) and disease activity score using 28 joints (DAS28). Of 1,681 patients, 239 received tocilizumab monotherapy, and 1,442 received combination therapy. Methotrexate was the most common DMARD (79 %) used in combination therapy. The frequency of adverse events (AEs), serious AEs, and AEs leading to withdrawal were similar between tocilizumab monotherapy (82.4, 7.9, and 5.4 %, respectively) and combination therapy (76.6, 7.8, and 5.1 %, respectively). No differences in ACR20/50/70/90 responses were observed between treatment groups (66.9 %/43.5 %/23.8 %/10.0 % vs 66.9 %/47.2 %/26.8 %/8.5 %, respectively; p > 0.12 for all individual comparisons, including ACR50 propensity score analyses). The decrease in DAS28 was also similar between treatment groups (mean +/- standard deviation: -3.41 +/- 1.49 for tocilizumab monotherapy vs -3.43 +/- 1.43 for combination therapy; p > 0.33 all analyses, including propensity score analyses). Tocilizumab had a comparable safety profile, and was similarly effective, when used as monotherapy or in combination with DMARDs in a broad population of patients with rheumatoid arthritis.

Dades de la publicació

ISSN/ISSNe:: 0770-3198, 1434-9949
Tipus:: Article
Pàgines:: 563-571
DOI:: 10.1007/s10067-014-2857-y
PubMed:: 25604316
Factor d'Impacte:: 0,838 SCImago ℠
Quartil:: Q2 SCImago ℠

Documents

No hi ha documents

Mètriques

Filiacions

Bykerk, VP:: Hosp Special Surg, Inflammatory Arthrit Ctr, New York, NY 10021 USA

Mt Sinai Hosp, Dept Rheumatol, Toronto, ON M5G 1X5, Canada
Ostor, AJK:: Univ Cambridge, Cambridge, England
Alvaro-Gracia, J:: Hosp Univ La Princesa, IIS Princesa, Madrid, Spain
Pavelka, K:: Inst Rheumatol, Prague, Czech Republic
Ivorra, JAR:: Hosp Univ La Fe, Valencia, Spain
Graninger, W:: Med Univ Graz, Graz, Austria
Bensen, W:: McMaster Univ, St Josephs Hosp, Hamilton, ON, Canada
Nurmohamed, MT:: Vrije Univ Amsterdam, Med Ctr, Amsterdam, Netherlands
Krause, A:: Immanuel Hosp, Berlin, Germany
Bernasconi, C:: F Hoffmann La Roche, Basel, Switzerland
Aassi, M:: F Hoffmann La Roche, Basel, Switzerland
Sibilia, J:: CHU Hautepierre, F-67098 Strasbourg, France

Keywords

Disease activity; DMARDs (biologic); DMARDs (synthetic); Monotherapy; Open-label; Rheumatoid arthritis; Tocilizumab; Tumor necrosis factor-alpha inhibitor

Campos d'Estudi

Projectes associats

CON-CIENCIA-YV: PILDORAS DE SALUD

FCT-13-7457_FECYT_2013 . MINISTERIO DE ECONOMIA Y COMPETITIVIDAD; FUNDACIÓN PARA LA INVESTIGACIÓN DEL HOSPITAL UNIVERSITARIO LA FE DE LA COMUNIDAD VALENCIANA . 2013