Tofacitinib versus methotrexate in rheumatoid arthritis
| Autor: | Lee, Eun Bong, Fleischmann, Roy, Hall, Stephen, Wilkinson, Bethanie, Bradley, John D, Gruben, David, Koncz, Tamas, Krishnaswami, Sriram, Wallenstein, Gene V, Zang, Chuanbo, Zwillich, Samuel H, van Vollenhoven, Ronald F, ORAL Start investigators, the, Van den Bosch, Filip |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
medicine.medical_specialty
CLINICAL-OUTCOMES Arthritis Context (language use) RECOMMENDATIONS DISEASE Etanercept DOUBLE-BLIND Internal medicine medicine Medicine and Health Sciences PLUS METHOTREXATE ETANERCEPT JOINT DAMAGE Janus kinase inhibitor Tofacitinib business.industry General Medicine medicine.disease Rheumatology RANDOMIZED-TRIAL COMBINATION THERAPY Rheumatoid arthritis Physical therapy MODIFYING ANTIRHEUMATIC DRUGS Methotrexate business medicine.drug |
| Zdroj: | NEW ENGLAND JOURNAL OF MEDICINE |
| ISSN: | 0028-4793 |
| Popis: | Background : Methotrexate is the most frequently used first-line antirheumatic drug. We report the findings of a phase 3 study of monotherapy with tofacitinib, an oral Janus kinase inhibitor, as compared with methotrexate monotherapy in patients with rheumatoid arthritis who had not previously received methotrexate or therapeutic doses of methotrexate. Methods : We randomly assigned 958 patients to receive 5 mg or 10 mg of tofacitinib twice daily or methotrexate at a dose that was incrementally increased to 20 mg per week over 8 weeks; 956 patients received a study drug. The coprimary end points at month 6 were the mean change from baseline in the van der Heijde modified total Sharp score (which ranges from 0 to 448, with higher scores indicating greater structural joint damage) and the proportion of patients with an American College of Rheumatology (ACR) 70 response (>= 70% reduction in the number of both tender and swollen joints and >= 70% improvement in three of five other criteria: the patient's assessment of pain, level of disability, C-reactive protein level or erythrocyte sedimentation rate, global assessment of disease by the patient, and global assessment of disease by the physician). Results : Mean changes in the modified total Sharp score from baseline to month 6 were significantly smaller in the tofacitinib groups than in the methotrexate group, but changes were modest in all three groups (0.2 points in the 5-mg tofacitinib group and |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|