Date: Sunday, October 21, 2018
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
The superiority of a treat to target strategy over conventional treatment with fixed csDMARD and corticosteroids: a multi-centre randomized controlled trial in RA patients with inadequate response to conventional synthetic DMARDs, and a new therapy with certolizumab pegol.
Ruediger B. Mueller1,2, Michael Spaeth3, Cord von Restorff4, Christoph Ackermann5, Johannes von Kempis1
1 Division of Rheumatology and Immunology, Kantonsspital St. Gallen, St. Gallen, Switzerland
2 Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig-Maximilians-University Munich
3 Division of Rheumatology, Spital Linth, Uznach, Switzerland
4 Private rheumatologic practice, Männedorf, Switzerland
5 Private rheumatologic practice, Triesen, Liechtenstein
Background/Purpose: Treatment of rheumatoid arthritis (RA) includes the use of conventional (cs), biologic (b) disease-modifying anti-rheumatic drugs (DMARDs) and oral or intraarticular (IA-) glucocorticoids (GCs).
To analyse 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 in RA patients improves effectivity in RA patients.
Methods: 43 patients with active RA (≥ 6 tender, ≥ 6 swollen joints, ESR ≥ 20mm/h or CRP ≥ 7mg/l) despite csDMARD treatment for ≥ 3 months and naïve to bDMARDs were randomized to CZP (200mg/2 weeks after loading with 400mg at weeks 0-2-4) 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=>20=>25mg/week, depending on the initial dose) => leflunomide (20mg/d) => sulfasalazine (2x1000mg/d) plus (2) oral GCs (20-15-12.5-10-7.5-5-2.5-0mg/d tapered every 5 days) and (3) injections of ≤5 affected joints with triamcinolone. DMARD modification and an addition of oral GCs were initiated depending on the achievement of low disease activity (DAS28 <3.2). The primary objective was defined as the ACR50 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, resp.). The adverse event rate was similar for both groups (T2T n=51; fixed regimen n=55).
Conclusion: Treat to target management with 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.
UCB Pharma funded this study. Gebro Pharmaceuticals provided the csDMARDs and GCs for the study.
To cite this abstract in AMA style:Mueller R, Spaeth M, von Restorff C, Ackermann C, von Kempis J. The Superiority of a Treat to Target Strategy over Conventional Treatment with Fixed Csdmard and Corticosteroids: A Multi-Centre Randomized Controlled Trial in RA Patients with Inadequate Response to Conventional Synthetic Dmards, and a New Therapy with Certolizumab Pegol [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/the-superiority-of-a-treat-to-target-strategy-over-conventional-treatment-with-fixed-csdmard-and-corticosteroids-a-multi-centre-randomized-controlled-trial-in-ra-patients-with-inadequate-response-to/. Accessed December 8, 2019.
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