Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population
| Autor: | Roy Fleischmann, Michael E. Weinblatt, Maurizio Cutolo, O. Davies, Ronald F van Vollenhoven, Maxime Dougados, Tom W J Huizinga, Désirée van der Heijde, Benjamin Duncan, Paul Emery, Kristel Luijtens |
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| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Male
musculoskeletal diseases medicine.medical_specialty Time Factors Population Immunology Rheumatoid arthritis Anti-TNF DMARDs (biologic DMARDs (biologic DMARDs (biologic) Placebo law.invention Arthritis Rheumatoid Anti-TNF Randomized controlled trial Double-Blind Method Rheumatology law Predictive Value of Tests Internal medicine medicine Humans Immunology and Allergy Certolizumab pegol Rheumatoid arthritis education skin and connective tissue diseases Aged education.field_of_study medicine.diagnostic_test business.industry Middle Aged medicine.disease Surgery Treatment Outcome Nasopharyngitis Erythrocyte sedimentation rate Concomitant Antirheumatic Agents Certolizumab Pegol Population study Female Inflammation Mediators business medicine.drug Follow-Up Studies Research Article |
| Zdroj: | Arthritis Research & Therapy |
| ISSN: | 1478-6354 |
| Popis: | Introduction This 28-week, phase IIIb study assessed safety and maintenance of response to certolizumab pegol (CZP) in a diverse population of rheumatoid arthritis (RA) patients, stratified by prior anti-TNF exposure, concomitant methotrexate (MTX) use and disease duration. The ability to predict achievement of low disease activity (LDA) at week 28 from improvements in Disease Activity Score 28 (DAS28), erythrocyte sedimentation rate (ESR), swollen joint count (SJC) and Clinical Disease Activity Index (CDAI) up to week 12 was assessed. Methods The 28-week study population included all patients who completed the double-blind (DB) phase and entered the open-label (OL) phase, receiving 200 mg CZP every 2 weeks (Q2W) ≥16 weeks. In the 12-week DB period, patients with active RA and an inadequate response to ≥1 disease-modifying antirheumatic drug (DMARD) were randomized 4:1 to CZP (400 mg at weeks 0, 2 and 4 then 200 mg Q2W) or placebo (Q2W), stratified by prior anti-TNF use, concomitant use of MTX and disease duration ( |
| Databáze: | OpenAIRE |
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