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AB0481 Demonstrated, quantifiable benefits in patient reported outcomes supporting a “treat to target” paradigm for infliximab-treated RA patients previously inadequately responsive to prior anti-TNF treatment
  1. M. Ingham1,
  2. L. Tang2,
  3. D. Decktor3,
  4. R. Bolce3,
  5. J. Wang2
  1. 1Janssen Scientific Affairs, LLC
  2. 2Janssen R&D, LLC
  3. 3Janssen Services, Horsham, United States


Background ACR and EULAR jointly released Treat-to-target (T2T) recommendations in 2010. Clinical Disease Activity Index (CDAI) has been recommended for use in practice, if thresholds are applied. CDAI cut points have been previously published.

Objectives Quantify the relative difference in improvement in pt reported outcomes between RA pts achieving different T2T-related goals vs. those who do not.

Methods This is a post hoc analysis of the RESTART trial, where mean (SD) CDAI at baseline was 40.1 (12.38) and 95% of pts had a baseline CDAI>22. RESTART is an active switch study. Pts were treated with IFX for 22 wks and clinicians allowed to dose escalate at fixed intervals to achieve a EULAR response. In this analysis, multiple analytical subgroups were defined using published CDAI thresholds. Given the relatively high baseline CDAI scores, subgroup definitions included goals of low or moderate disease activity, with or without significant improvement in CDAI. Subgroup response thresholds at Wk 26 included published specific cut points of: CDAI≤22 (Subgroup A); CDAI≤22 and CDAI reduction of at least 16.1 points (Subgroup B); CDAI≤10 (Subgroup C). Within each sub group, responder vs non-responder cohorts were then compared on HAQ scores and all domains of the SF-36 health status questionnaire. Missing data were not imputed. Descriptive statistics and a non-parametric Wilcoxon test were used to compare the change from baseline to Wk 26 in HAQ or SF-36 domains between cohorts.

Results Responders in Subgroups A to C typically experienced at least twice the level of absolute improvement from baseline to Wk 26, in 7 of 8 SF-36 domains vs. non-responders, and 2 to 6 times greater improvement in HAQ. Pts attaining low disease activity (Subgroup C) experienced the greatest differences. For Subgroup B (Table 1), where cohorts had the most comparable baseline scores, results were statistically significant for HAQ (p=0.0079) and 5 of 8 SF-36 domains (p<0.05 except, general health, role-emotional and mental health domains).

Response Sub-group definition = CDAI≤22 AND change in CDAI ≥16.1

Conclusions Pts able to attain T2T-related response achieved significantly greater absolute improvement in health status vs. non-responders, in HAQ and 5 of 8 SF-36 domains. There may be additional value in adding change scores to threshold values in current T2T objectives for severe pts and consideration of pt functionality may be warranted.

  1. Smolen JS et al. Ann Rheum Dis; 69:631-637.

  2. Aletaha D et al. EULAR/ACR collaborative recommendations, 2008. Ann Rheum Dis; 67:1360-64. Fleischmann R, et al. ACR 2010. Abstract 420

Disclosure of Interest None Declared

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