Background In RA, direct comparisons of the quality of life effects associated with different therapies remain sparse.
Objectives To compare EuroQol 5-Dimensions (EQ-5D) utility and quality-adjusted life-years (QALYs) over 21 months in patients with active early RA despite ongoing methotrexate (MTX), randomised to addition of infliximab (IFX) or sulfasalazine and hydroxychloroquine (SSZ+HCQ).
Methods The SWEFOT trial enrolled RA-patients (symptoms<1y) in Sweden between 2002 and 2005 (van Vollenhoven RF, et al. Lancet 2009;374:459-466). After 3-4 months of MTX monotherapy, patients with a remaining DAS28>3.2 were randomised to addition of IFX or SSZ+HCQ and followed for 21 months. EQ-5D profiles were collected every 3 months, and between-group comparisons of utility change and accumulated QALYs were performed (UK EQ-5D tariff). Intention to treat (ITT) was applied, using last observation carried forward (LOCF) following protocol breach. Missing data were imputed by linear interpolation or LOCF (if no future measurements). Sensitivity analyses, using baseline observation carried forward (BOCF) or restricted to completers were also conducted. Completer status required data at both time points for utility change and at least every 7.5 months beyond randomisation for QALY assessment.
Results Of 487 patients initially enrolled, 128 and 130 were randomised to addition of IFX or SSZ+HCQ, respectively. The figure displays mean utility development (A. Observed data only; B. ITT LOCF analysis). Adjusting for age, sex, EQ-5D, DAS28 and HAQ at randomisation, differences between the IFX and SSZ+HCQ groups in utility change and accumulated QALYs were (95% CI; p-value; n[IFX/SSZ+HCQ] in the completer analyses): ITT LOCF 0.04 (-0.01, 0.09; 0.15) and 0.07 (-0.01, 0.14; 0.07); ITT BOCF 0.03 (-0.05, 0.10; 0.49) and 0.09 (-0.01, 0.18; 0.07); completers -0.03 (-0.11, 0.06; 0.53; 67/57) and -0.04 (-0.15, 0.08; 0.53; 63/51). Drop-out was higher in the SSZ+HCQ group (n[IFX/SSZ+HCQ]=38/56; Log rank test p=0.024).
Conclusions Comparing addition of IFX or SSZ+HCQ to MTX in active early RA, no statistically significant differences in utility or QALY gains could be detected over 21 months.
Disclosure of Interest None Declared
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