Tofacitinib or Adalimumab versus Placebo in Rheumatoid Arthritis
| Autor: | van Vollenhoven, R.F., Fleischmann, R., Cohen, S., Lee, E.B., García Meijide, J.A., Wagner, S., Forejtova, Zwillich, S.H., Gruben, D., Koncz, T., Wallenstein, G.V., Krishnaswami, S., Bradley, J.D., Wilkinson, B., Čikeš, Nada, Martinović Kaliterna, Dušanka |
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| Rok vydání: | 2012 |
| Předmět: |
musculoskeletal diseases
medicine.medical_specialty Tofacitinib business.industry Arthritis General Medicine Placebo medicine.disease tofacitinib adalimuab rheumatoid arthritis Rheumatology law.invention Randomized controlled trial law Internal medicine Rheumatoid arthritis medicine Physical therapy Adalimumab skin and connective tissue diseases business Janus kinase inhibitor medicine.drug |
| Zdroj: | New England Journal of Medicine. 367:508-519 |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa1112072 |
| Popis: | Tofacitinib (CP-690, 550) is a novel oral Janus kinase inhibitor that is being investigated for the treatment of rheumatoid arthritis. In this 12-month, phase 3 trial, 717 patients who were receiving stable doses of methotrexate were randomly assigned to 5 mg of tofacitinib twice daily, 10 mg of tofacitinib twice daily, 40 mg of adalimumab once every 2 weeks, or placebo. At month 3, patients in the placebo group who did not have a 20% reduction from baseline in the number of swollen and tender joints were switched in a blinded fashion to either 5 mg or 10 mg of tofacitinib twice daily ; at month 6, all patients still receiving placebo were switched to tofacitinib in a blinded fashion. The three primary outcome measures were a 20% improvement at month 6 in the American College of Rheumatology scale (ACR 20) ; the change from baseline to month 3 in the score on the Health Assessment Questionnaire-Disability Index (HAQ-DI) (which ranges from 0 to 3, with higher scores indicating greater disability) ; and the percentage of patients at month 6 who had a Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate (DAS28-4[ESR]) of less than 2.6 (with scores ranging from 0 to 9.4 and higher scores indicating greater disease activity). At month 6, ACR 20 response rates were higher among patients receiving 5 mg or 10 mg of tofacitinib (51.5% and 52.6%, respectively) and among those receiving adalimumab (47.2%) than among those receiving placebo (28.3%) (P |
| Databáze: | OpenAIRE |
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