BENEFITS IN PATIENT REPORTED OUTCOMES SUPPORTING A ” TREAT TO TARGET” PARADIGM FOR INFLIXIMAB -TREATED RA PATIENTS PREVIOUSLY INADEQUATELY RESPONSIVE TO PRIOR ANTI-TNF TREATMENT
Author(s)
Ingham M1, Tang L2, Decktor D3, Bolce R3, Wang J21Janssen Scientific Affairs, LLC, Horsham, PA, USA, 2Janssen Research & Development, LLC, Horsham, PA, USA, 3Janssen Services, LLC, Horsham, PA, USA
Presentation Documents
OBJECTIVES: Quantify the relative difference in improvement in patient-reported outcomes between rheumatoid arthritis (RA) patients achieving different T2T-related goals versus those who do not. METHODS: This is a post hoc analysis of the RESTART trial, an active switch study, where patients were treated with IFX for 22 weeks and clinicians allowed to dose escalate at fixed intervals to achieve a EULAR response. In this analysis, multiple analytical sub-groups were defined using real-world CDAI thresholds. Given high baseline Clinical Disease Activity Index (CDAI) scores, sub-group definitions included goals of low or moderate disease activity, with or without significant improvement in CDAI. Sub-group response thresholds at Week 26 included real-world specific cut points of: CDAI≤19.6 (Sub-group A); CDAI≤19.6 AND CDAI reduction of at least 10 points (Sub-group B); CDAI≤7.6 (Sub-group C). Within each sub-group, responder versus non-responder cohorts were compared on HAQ scores and all domains of the SF-36. Descriptive statistics and a non-parametric Wilcoxon test were used to compare cohorts. RESULTS: Responders in Sub-groups A to C typically experienced 2 to 3 times the level of absolute improvement from baseline to week 26, in 7 of 8 SF-36 domains, versus non-responders, and 2 to 8 times greater improvement in HAQ. Patients attaining low disease activity (Sub-group C) experienced the greatest differences. For Sub-group B, where cohorts had the most comparable baseline scores, results were statistically significant for HAQ (p=0.0012) and 6 of 8 SF-36 domains (p<0.01 except role-emotional and mental health domains). CONCLUSIONS: Patients able to attain T2T-related response achieved significantly greater absolute improvement in health status versus non-responders, in HAQ and 6 of 8 SF-36 domains. There may be additional value in adding change scores to threshold values in current T2T objectives for severe patients and consideration of patient functionality may be warranted.
Conference/Value in Health Info
2012-06, ISPOR 2012, Washington, D.C., USA
Value in Health, Vol. 15, No. 4 (June 2012)
Code
PMS50
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Musculoskeletal Disorders