RT Journal Article
SR Electronic
T1 SAT0122 Efficacy of addition, or continuation, of adalimumab in patients who did not achieve stable low disease activity with methotrexate or adalimumab plus methotrexate in the optima study
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 511
OP 512
DO 10.1136/annrheumdis-2012-eular.3069
VO 71
IS Suppl 3
A1 A. Kavanaugh
A1 R. Fleischmann
A1 P. Emery
A1 R. van Vollenhoven
A1 S. Florentinus
A1 J.W. Shaw
A1 S. Santra
A1 H. Kupper
A1 L. Redden
A1 J. Smolen
YR 2013
UL http://ard.bmj.com/content/71/Suppl_3/511.3.abstract
AB Background Guidelines for rheumatoid arthritis (RA) recommend adjusting treatment every 3-6 months to the desired state of disease activity. Patients (pts) treated with adalimumab (ADA) plus methotrexate (MTX) may have delayed responses without major radiographic consequences1. Objectives To determine outcomes after introduction of ADA in pts who did not achieve a stable low disease activity (LDA) target with MTX alone compared with pts continuing ADA+MTX who did not achieve the target. Methods MTX-naïve pts ≥18 yrs with RA <1 yr, active disease [DAS28(CRP)>3.2, ESR≥28 mm/hr or CRP≥1.5 mg/dL], and >1 erosion, RF+, or anti-CCP+ were randomized to ADA+MTX or placebo (PBO)+MTX for 26 wks. Pts who did not achieve a stable LDA target (DAS28<3.2 at wks 22 & 26) were offered open-label ADA+MTX for 52 wks. Categorical responses were analyzed using non-responder imputation and radiographic outcomes by multiple imputation. Predictors of rapid radiographic progression (RRP, ΔmTSS>1.5 in 26 wks) were assessed. Results Among pts who completed 26 wks, 76% (348/460) PBO+MTX and 56% (259/466) ADA+MTX did not achieve the stable LDA target (inadequate response [IR]). Introduction of ADA enhanced responses among PBO+MTX[IR] pts. Improvements were also observed among ADA+MTX[IR] pts who continued ADA+MTX despite no adjustment of concomitant medications (Table). Significantly more damage occurred in PBO+MTX[IR] pts: mean ΔmTSS from wk 0-26 was 1.2 compared with 0.3 for ADA+MTX[IR] (P<.001). RRP occurred in 18% PBO+MTX[IR] pts, compared with 5% ADA+MTX[IR] pts. Baseline erosions were a strong predictor of RRP. Addition of ADA halted radiographic progression in PBO+MTX[IR] pts: mean ΔmTSS from wk 0-78 was 1.3; radiographic inhibition was sustained in ADA+MTX[IR] pts: mean ΔmTSS from wk 0-78 was 0.4. View this table:Table 1. Outcomes (% pts) after IR to ADA+MTX (N=259) or PBO+MTX (N=348) Conclusions Introduction of ADA to pts who failed to achieve a stable LDA target with MTX alone decreased disease activity and halted radiographic progression; however, pts with baseline erosions may be candidates for earlier treatment intensification. Continued ADA+MTX treatment yielded ongoing improvements with little radiographic progression, demonstrating the disconnect between control of disease activity and inhibition of damage with ADA. Keystone et al. ACR 2011 P1102 Disclosure of Interest A. Kavanaugh Grant/Research support from: Abbott, Amgen, Astra-Zeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB, Consultant for: Abbott, Amgen, Astra-Zeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB, R. Fleischmann Consultant for: Abbott, P. Emery Consultant for: Pfizer Inc, Merck, Abbott, Roche, BMS, UCB, R. van Vollenhoven Grant/Research support from: Abbott, Glaxo Smithkline, Merck, Pfizer, Roche, UCB Pharma, Consultant for: Abbott, Glaxo Smithkline, Merck, Pfizer, Roche, UCB Pharma, S. Florentinus Shareholder of: Abbott, Employee of: Abbott, J. Shaw Shareholder of: Abbott, Employee of: Abbott, S. Santra Shareholder of: Abbott, Employee of: Abbott, H. Kupper Shareholder of: Abbott, Employee of: Abbott, L. Redden Shareholder of: Abbott, Employee of: Abbott, J. Smolen Grant/Research support from: Abbott, Amgen, Astra-Zeneca, BMS, Celgene Centocor-Janssen, Glaxo, Lilly, Pfizer (Wyeth), MSD (Schering-Plough), Novo-Nordisk, Roche, Sandoz, UCB, Consultant for: Abbott, Amgen, Astra-Zeneca, BMS, Celgene Centocor-Janssen, Glaxo, Lilly, Pfizer (Wyeth), MSD (Schering-Plough), Novo-Nordisk, Roche, Sandoz, UCB