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, 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 ≥ 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 (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.
BackgroundTreatment of rheumatoid arthritis (RA) includes the use of conventional (cs) or targeted synthetic (ts) and biologic disease-modifying anti-rheumatic drugs (DMARDs) and oral or subcutaneous (SC) glucocorticoids (GC).ObjectivesWe aimed to test the hypothesis that an improved outcome can be achieved by employing a treat to target (T2T) strategy optimising csDMARD, oral, and SC-GC treatment in parallel to a new onset certolizumab pegol (CZP) in RA patients with an incomplete response to csDMARD as compared to a conventional step up strategy with CZP.MethodsWe designed a randomised controlled trial in four specialised rheumatological units. 43 patients with active RA (≥6 tender,≥6 swollen joints, and ESR ≥20 mm/h or CRP ≥7 mg/L) despite csDMARD treatment for ≥3 months and naïve to biologic DMARDs were randomly allocated either to CZP plus a treat to target strategy (T2T group, n=21) or add on of CZP to a fixed dose of the already established csDMARD with or without established GCs (fixed dose group, n=22). Patients of both groups received 400 mg CZP at week 0, 2, and 4 (loading dose), followed by 200 mg every 2 weeks. The T2T strategy consisted in a step up in, or to, SC-methotrexate (dose: 15≥20≥25 mg/week), followed by leflunomide (20 mg/d) and then by sulfasalazine (2 × 1000 mg/d). In parallel, oral GCs were initiated in the T2T group at 20 mg/d and tapered every 5 days (15–12.5–10–7.5–5–2.5–0 mg/d). The decision to take the next step in the DMARD modification and addition of oral GCs was taken depending on the achievement of LDA (low disease activity: DAS28 <3.2) at the 4-weekly visits. Injections of up to five tender and/or swollen joints with triamcinolone (small joints 10 mg, intermediate 20 mg, and big joints 40 mg; max. 100 mg/visit) was allowed in the T2T group.The primary outcome measure was ACR 50 response after 24 weeks. The analysis was intention-to-treat.ResultsThree patients dropped out during the study (n=2 T2T, n=1 fixed dose). ACR 50 was achieved in 16 out 21 T2T patients (76.2%) as compared to 8 out of 22 fixed dose patients (36.4%; Chi2: 5.355, 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 dose patients, respectively (p=0.045 and p=0.010, resp.). Mean reduction in DAS28 were significantly and HAQ-DI markedly greater in the T2T group than in the fixed dose group (DAS28: −3.9 [SD 1.2] vs. −2.2 [SD 1.5], p<0.0006; HAQ-DI: −0.63 [SD 0.58] vs. 0.20 [SD 0.67], p<0.14). All but five of the T2T patients required only one modification of csDMARD and one additional course of oral GC. 10.2 joints (mean) were infiltrated with triamcinolone in the T2T group (av. dose 14.1 mg/injection). The adverse event rate was similar for both groups (T2T n=51; fixed dose n=55).ConclusionsTreat to target management with optimisation of csDMARDs, oral and intra-articular glucocorticoids of RA patients in parallel to additional CZP treatment was safe and substantially improves disease activity and the patient related outcome HAQ-DI in comparis...
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