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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

Ruediger B Mueller, Michael Spaeth, Cord Von Restorff, Christoph Ackermann, Hendrik Schulze-Koops & Johannes Von Kempis

abstract

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 (≥6 tender, ≥6 swollen joints, ESR ≥ 20 mm/h or CRP ≥ 7mg/L) despite csDMARD treatment for ≥ 3 months and naïve to bDMARDs were randomized to CZP (200 mg/2 weeks after loading with 400 mg at weeks 0⁻2⁻4) plus a treat-to-target strategy (T2T, = 21), or to CZP added to the established csDMARD therapy (fixed regimen, = 22). The T2T strategy consisted of changing the baseline csDMARD therapy (1) SC-methotrexate (dose: 15 ≥ 20 ≥ 25 mg/week, depending on the initial dose) ≥ leflunomide (20 mg/d) ≥ sulphasalazine (2 × 1000 mg/d) plus (2) oral GCs (prednisolone 20⁻15⁻12.5⁻10⁻7.5⁻5⁻2.5⁻0 mg/d tapered every five 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 (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 ( = 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 ( = 0.045 and = 0.010, respectively). The adverse event rate was similar for both groups (T2T = 51; fixed regimen = 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.
   
citation Mueller R B, Spaeth M, von Restorff C, Ackermann C, Schulze-Koops H, von Kempis J. 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. J Clin Med 2019; 8:.
   
type journal paper/review (English)
date of publishing 03-03-2019
journal title J Clin Med (8/3)
ISSN print 2077-0383
PubMed 30832414
DOI 10.3390/jcm8030302