Tocilizumab Inhibits Structural Joint Damage and Improves Physical Function in Patients with Rheumatoid Arthritis and Inadequate Responses to Methotrexate: LITHE Study 2-year Results
| Autor: | Anne-Marie Halland, Rubén Burgos-Vargas, Marek Brzosko, Christopher M Mela, Roy Fleischmann, Emma Vernon, Joel M. Kremer |
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| Rok vydání: | 2013 |
| Předmět: |
Male
musculoskeletal diseases medicine.medical_specialty Health Status Immunology Arthritis Antibodies Monoclonal Humanized Severity of Illness Index law.invention Arthritis Rheumatoid Disability Evaluation chemistry.chemical_compound Tocilizumab Double-Blind Method Rheumatology Randomized controlled trial law Neoplasms Sickness Impact Profile Surveys and Questionnaires Internal medicine Severity of illness medicine Humans Immunology and Allergy skin and connective tissue diseases business.industry Area under the curve Middle Aged medicine.disease Surgery Radiography Clinical trial Methotrexate Treatment Outcome chemistry Antirheumatic Agents Rheumatoid arthritis Disease Progression Drug Therapy Combination Female Joints business medicine.drug |
| Zdroj: | The Journal of Rheumatology. 40:113-126 |
| ISSN: | 1499-2752 0315-162X |
| Popis: | Objective.To assess radiographic progression, physical function, clinical disease activity, and safety in patients with rheumatoid arthritis (RA) who had inadequate response to methotrexate (MTX) and who were treated with tocilizumab-MTX or MTX during Year 2 of a 2-year study.Methods.During Year 1, patients were randomized to placebo-MTX, 4 mg/kg tocilizumab-MTX, or 8 mg/kg tocilizumab-MTX. During Year 2, patients continued the initial double-blind treatment or switched to open-label 8 mg/kg tocilizumab-MTX. Co-primary endpoints at Week 104 were mean change from baseline in Genant-modified Total Sharp Score (GmTSS) and adjusted mean area under the curve (AUC) for change from baseline in the Health Assessment Questionnaire–Disability Index (HAQ-DI). Signs and symptoms of RA and safety were also evaluated.Results.At Week 104, mean change from baseline in GmTSS was significantly lower for patients initially randomized to tocilizumab-MTX 4 mg/kg (0.58; p = 0.0025) or 8 mg/kg (0.37; p < 0.0001) than for patients initially randomized to placebo-MTX (1.96). Adjusted mean AUC of change from baseline in HAQ-DI was also significantly lower in patients initially randomized to tocilizumab-MTX 4 mg/kg (–287.5; p < 0.0001) or 8 mg/kg (–320.8; p < 0.0001) than in patients initially randomized to placebo-MTX (–139.4). Signs and symptoms of RA were maintained or showed improvement. No new safety signals were noted.Conclusion.Compared with placebo-MTX, tocilizumab-MTX significantly inhibited structural joint damage and improved physical function in patients with RA who previously had inadequate response to MTX. An extension of this study is continuing and will provide additional longterm efficacy and safety data. National Clinical Trials registry NCT00106535. |
| Databáze: | OpenAIRE |
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