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 |
| |
Authors: | Bykerk Vivian P Östör Andrew J K Alvaro-Gracia José Pavelka Karel Ivorra José Andrés Román Graninger Winfried Bensen William Nurmohamed Michael T Krause Andreas Bernasconi Corrado Aassi Maher Sibilia Jean |
| |
Affiliation: | 1.Inflammatory Arthritis Center, Hospital for Special Surgery, 535 East 70th Street, New York, NY, 10021, USA ;2.Department of Rheumatology, Mount Sinai Hospital, Toronto, ON, Canada ;3.University of Cambridge, Cambridge, UK ;4.Hospital Universitario de la Princesa, IIS Princesa, Madrid, Spain ;5.Institute of Rheumatology, Prague, Czech Republic ;6.Hospital Universitario La Fe, Valencia, Spain ;7.Medical University of Graz, Graz, Austria ;8.St Joseph’s Hospital/McMaster University, Hamilton, ON, Canada ;9.VU University Medical Center, Amsterdam, Netherlands ;10.Immanuel Hospital, Berlin, Germany ;11.F. Hoffmann-La Roche, Basel, Switzerland ;12.CHU Hautepierre, Strasbourg, France ; |
| |
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-α 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. |
| |
Keywords: | |
本文献已被 SpringerLink 等数据库收录! |
|