Superiority of a Treat-to-Target Strategy over Conventional Treatment with Fixed csDMARD and Corticosteroids: A Multi-Center Randomized Controlled Trial in RA Patients with an Inadequate Response to Conventional Synthetic DMARDs, and New Therapy with Certolizumab Pegol
| Autor: | Hendrik Schulze-Koops, Ruediger B Mueller, Johannes von Kempis, Cord von Restorff, Christoph Ackermann, Michael Spaeth |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
musculoskeletal diseases
rheumatoid arthritis medicine.medical_specialty treat-to-target Triamcinolone acetonide lcsh:Medicine Gastroenterology Article law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine 0502 economics and business medicine Certolizumab pegol Adverse effect Leflunomide 030203 arthritis & rheumatology intra-articular injections DAS 28 glucocorticoids business.industry 05 social sciences lcsh:R ACR response General Medicine medicine.disease HAQ-DI certolizumab pegol Regimen Rheumatoid arthritis csDMARDs Prednisolone 050211 marketing business medicine.drug |
| Zdroj: | Journal of Clinical Medicine Volume 8 Issue 3 Journal of Clinical Medicine, Vol 8, Iss 3, p 302 (2019) |
| ISSN: | 2077-0383 |
| DOI: | 10.3390/jcm8030302 |
| Popis: | Background: Treatment of rheumatoid arthritis (RA) includes the use of conventional (cs), biologic (b) disease-modifying anti-rheumatic drugs (DMARDs) and oral, intramuscularly, intravenous, or intraarticular (IA) glucocorticoids (GCs). In this paper, we analysed whether a treat-to-target (T2T) strategy optimizing csDMARD, oral, and IA-GC treatment as an adjunct new therapy to a new certolizumab pegol (CZP) therapy improves the effectivity in RA patients. Methods: 43 patients with active RA (&ge 6 tender, &ge 6 swollen joints, ESR &ge 20 mm/h or CRP &ge 7mg/L) despite csDMARD treatment for &ge 3 months and naï ve to bDMARDs were randomized to CZP (200 mg/2 weeks after loading with 400 mg at weeks 0&ndash 2&ndash 4) plus a treat-to-target strategy (T2T, n = 21), or to CZP added to the established csDMARD therapy (fixed regimen, n = 22). The T2T strategy consisted of changing the baseline csDMARD therapy (1) SC-methotrexate (dose: 15 &ge 20 &ge 25 mg/week, depending on the initial dose) &ge leflunomide (20 mg/d) &ge sulphasalazine (2 × 1000 mg/d) plus (2) oral GCs (prednisolone 20&ndash 15&ndash 12.5&ndash 10&ndash 7.5&ndash 5&ndash 2.5&ndash 0 mg/d tapered every five days) and (3) injections of &le 5 affected joints with triamcinolone. DMARD modification and an addition of oral GCs were initiated, depending on the achievement of low disease activity (DAS 28 < 3.2). The primary objective was defined as the ACR 50 response at week 24. Results: ACR 50 was achieved in 76.2% of the T2T, as compared to 36.4% of the fixed regimen patients (p = 0.020). ACR 20 and 70 responses were achieved in 90.5% and 71.4% of the T2T patients and 59.1% and 27.3% of the fixed regimen patients, respectively (p = 0.045 and p = 0.010, respectively). The adverse event rate was similar for both groups (T2T n = 51 fixed regimen n = 55). Conclusion: Treat-to-target management with the optimization of csDMARDs, oral, and IA-GCs of RA patients in parallel to a newly established CZP treatment was safe and efficacious in comparison to a fixed regimen of csDMARDs background therapy. |
| Databáze: | OpenAIRE |
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