Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Bykerk, VP; Östör, AJ; Alvaro-Gracia, J; Pavelka, K; Román Ivorra, JA; Graninger, W; Bensen, W; Nurmohamed, MT; Krause, A; Bernasconi, C; Aassi, M; Sibilia, J.
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.
Clin Rheumatol. 2015; 34(3):563-571
Doi: 10.1007/s10067-014-2857-y
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- Co-authors Med Uni Graz
- Graninger Winfried
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- 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Aged -
- Antibodies, Monoclonal, Humanized - therapeutic use
- Antirheumatic Agents - therapeutic use
- Arthritis, Rheumatoid - drug therapy
- Drug Therapy, Combination -
- Female -
- Humans -
- Male -
- Middle Aged -
- Treatment Outcome -
- Find related publications in this database (Keywords)
- Disease activity
- DMARDs (biologic)
- DMARDs (synthetic)
- Monotherapy
- Open-label
- Rheumatoid arthritis
- Tocilizumab
- Tumor necrosis factor-alpha inhibitor