THU0259 10 Years of Treat-To-Target Therapy in Rheumatoid Arthritis Patients (The Best Study): Clinical and Radiographic Outcomes:

Abstract

Background Long term studies with treat-to-target therapy are essential to guide treatment strategies. Objectives To compare clinical and radiographic outcomes of 4 treatment strategies in early rheumatoid arthritis (RA) patients after 10 years. Methods The BeSt study enrolled 508 patients with early RA. Patients were randomized to: 1 sequential monotherapy, 2 step-up therapy, 3 initial combination with prednisone, 4 initial combination with infliximab. Treatment adjustments were based on 3-monthly disease activity score (DAS) measurements (DAS>2.4: next step; DAS≤2.4 for ≥6 months: taper to maintenance dose, next if DAS<1.6 for ≥6 months: stop last drug). Functional ability (Health Assessment Questionnaire, HAQ) over time was analyzed with a linear mixed model (LMM). Annual X-rays were scored ine one session by 2 blinded readers with the Sharp van der Heijde Score (SHS). SHS progression was categorized per year into “no” (<0.5), “little” (≥0.5 - ≤5) and “much” (>5) and analyzed over time with a generalized LMM. Results 10 year follow-up was completed by 313 patients (62%). Drop-out rates were lowest in arm 4. Mean age of completers was 61 years and 67% were female. Mean (SD) DAS was 1.6 (0.8) and mean (SD) HAQ was 0.6 (0.6). 82% had a DAS≤2.4, 53% had a DAS<1.6, 15% were in drug-free remission (DFR) with a mean (median) duration of 52 (58) months. After 10 years, 38% were still on the initial treatment step, others had changed medication at least once. Toxicity was similar in all arms. Table 1 shows outcomes per treatment arm. The initial functional improvement achieved during year 1 was maintained during 10 years. Over time HAQ was significantly lower in arm 4 than in arm 2 (0.52 vs 0.70, p=0.03, other differences non-significant). Ten year progression rates were low in all arms. Over time, patients in arm 3 less often developed progression compared to arm 1 (p=0.03, other comparisons non-significant). If progression was present, estimates were 8, 11, 8 and 5 SHS progression in 10 years in arm 1 to 4, respectively. At t=10 years Arm 1 Arm 2 Arm 3 Arm 4 p N=126 N=121 N=133 N=128 DAS, mean ± SD* 1.7±0.7 1.7±0.8 1.5±0.8 1.6±0.8 0.333 HAQ, mean ± SD* 0.6±0.6 0.7±0.6 0.5±0.5 0.5±0.6 0.121 DAS≤2.4, n (%)* 61 (85) 43 (71) 59 (84) 75 (84) 0.102 DAS<1.6, n (%)* 36 (50) 28 (46) 40 (57) 50 (56) 0.507 DFR, n (%)* 11 (14) 11 (15) 12 (15) 13 (13) 0.604 On initial treatment, n (%)* 21 (28) 13 (19) 33 (42) 52 (58) <0.001 Current infliximab use, n (%)* 14 (18) 8 (12) 9 (12) 23 (25) 0.075 Drop out, n (%) 50 (40) 54 (45) 55 (41) 36 (28) 0.041 Patients with SAE, n (%) 62 (49) 51 (42) 61 (46) 66 (52) 0.473 ΔSHS, median (IQR)* 2.0 (0.0–11.0) 2.5 (0.0–13.5) 3.0 (0.3–11.3) 1.5 (0.0–6.0) 0.390 ΔSHS >5, n (%)* 24 (38) 23 (42) 27 (42) 21 (27) 0.190 ΔSHS >10, n (%)* 16 (25) 16 (29) 18 (28) 12 (15) 0.196 *Completers analysis. Conclusions 10 year follow-up in the BeSt study shows the benefit of continued treat-to-target therapy, steering at low disease activity. After initial improvement...

New Guidelines for the Management of Rheumatoid Arthritis (Eular, 2013): The Place of Glucocorticoids

“…Через 10 лет наблю-дения у 53% пациентов имела место ремиссия, а у 15% -ремиссия без лекарств. При этом достоверных различий в отношении клинической эффективности лечения в за-висимости от первоначальной стратегии фармакотерапии, не отмечено [45].…”

New Recommendations for the Management of Rheumatoid Arthritis (Eular, 2013): The Role of Methotrexate

“…Через 10 лет наблюдения у 53% пациентов имела место ремиссия, а у 15% -безлекарственная ремиссия. При этом достовер-ных различий в отношении клинической эффективности лечения в зависимости от первоначальной стратегии фар-макотерапии не отмечено [64].…”

New Recommendations for the Management of Rheumatoid Arthritis (Eular, 2013): The Role of Methotrexate

“…Че рез 10 лет на блю де ния у 53% па ци ен тов име ла ме с то ре мис сия, а у 15% -без ле кар ст вен ная ре мис сия. При этом до с то вер-ных раз ли чий в от но ше нии кли ни че ской эф фе к тив но сти ле че ния в за ви си мо сти от пер во на чаль ной стра те гии фар-ма ко те ра пии не от ме че но [64].…”