Background The window of opportunity for optimal outcomes in rheumatoid arthritis (RA) treatment is hypothesised to be very early in the disease. At the time of symptom onset, radiographic progression may be rapid and early treatment to slow or prevent irreversible damage is essential. TNF inhibitors have been shown to slow or halt radiographic progression.
Objectives This posthoc analysis examines responses to 52 weeks (wks) of etanercept (ETN)/methotrexate (MTX) based on modified Total Sharp Scores (mTSS) at baseline (BL) in patients (pts) with early RA (symptom onset ≤12 months) in the PRIZE study (NCT00913458).
Methods Pts received ETN50/MTX for 52 wks. In this posthoc analysis, pts were stratified by mTSS at BL (≤3 vs. >3) and by radiographic progression at wk 52 (ΔmTSS ≤0 vs. >0) and were then examined for efficacy, looking at DAS28ESR, CDAI, SDAI, ACR 20/50/70and ΔmTSS. LOCF imputation, chi-square and CMH tests were used; mTSS was extrapolated to wk 52.
Results At BL, similar subpopulations (N=269) had mTSS >3 (n=141, mean mTSS=13.8) and ≤3 (n=128, mean mTSS=1.5); pts with mTSS>3 had higher age, serum CRP, symptom duration and lower percent of females (mean 54 yrs, 18 mg/L, 6.9 mo, 59%) than those with mTSS ≤3 (45 yrs, 14 mg/L, 6.1 mo, 77%, P<0.05). At week 52, pts with mTSS >3 at BL achieved better improvement than those with mTSS ≤3 in DAS28ESR, CDAI, CRP and ESR (P<0.05 for all). For endpoints at week 52, nominally more pts with BL mTSS≤3 x wk 52 ΔmTSS>0 and pts with BL mTSS>3 x wk 52 ΔmTSS≤0 achieved ACR50/70 and CDAI/SDAI remission than other pts (table).
Conclusions Regardless of the amount of joint damage at baseline, disease states improved after 52 weeks for ΔmTSS for all clinical outcomes examined. A large percent of patients achieved remission which may have impacted relationships between progression and outcomes. More research is needed on the predictive value of mTSS for outcomes of RA treatment.
Quinn, M.A. and P. Emery, Clin Exp Rheumatol, 2003. 21(5 Suppl 31): p. S154–7. 2. Bruynesteyn, K., et al., Arthritis Rheum, 2002. 46(4): p. 913-20.
Acknowledgements The PRIZE study (ClinicalTrials.gov, NCT00913458) was sponsored by Pfizer Inc. The authors would like to thank Thomas Jones, Andrew S. Koenig and Eustratios Bananis of Pfizer Inc for thoughtful reviews of this abstract. Medical writing support was provided by Patricia McChesney of UBC Scientific Solutions and funded by Pfizer Inc.
Disclosure of Interest P. Emery Consultant for: Abbott, Bristol-Myers Squibb, Merck, Novartis, Pfizer Inc, Roche-Chugai, UCB Pharma Ltd, A. Szumski Employee of: Pfizer Inc, H. Jones Shareholder of: Pfizer Inc, Employee of: Pfizer Inc