The burden of RA, PsA, and AS on patients, their caregivers, and society as a whole is significant. Chronic inflammation leads to pain, stiffness, joint erosions, ankylosing features, and impaired mobility, which can result in functional disability, increased health care costs, and reduced employability. These factors and the strategies patients use to cope with disease burden contribute to an impaired HRQoL for affected patients. In this study, we directly compared the HRQoL of patients with three inflammatory rheumatic diseases. The distribution of baseline PCS scores for all three diseases were shifted to the left of the distribution for the general United States population. These results demonstrate that these patients had greatly impaired physical HRQoL relative to the general population.
The data used in this analysis were from patients who participated in clinical trials of the anti-tumor necrosis factor-α (TNFα) agent infliximab. To be eligible for these studies, patients must have had moderate-to-severe disease activity at baseline. The comparison of the mean baseline PCS, as well as scores for the individual scales, showed that patients with PsA and those with AS had similarly impaired HRQoL relative to patients with RA. This finding is different from the reports of previous studies in which patients with RA had lower physical SF-36 summary scores compared with those with AS [3] or PsA [4].
One potential explanation for this discrepancy is the disease severity of patients in each of the cohorts. In the Toronto study that compared the quality of life of patients with RA to that of patients with PsA [4], the mean number of active joints in patients with PsA was 6, while the baseline mean number of tender and swollen joints for patients in the IMPACT II study was 25 and 14 joints, respectively [10]. Similarly, the mean number of active joints in patients with RA in the Toronto study was lower (6) than the mean number of tender and swollen joints for patients in ATTRACT (32 and 22 joints, respectively) and START (24 and 17 joints, respectively). In the analysis of patients with RA or AS in a Dutch study [3], the mean baseline Bath Ankylosing Spondylitis Disease Activity score was 3.9 compared with a mean score of 6.4 for patients in the ASSERT trial [9]. Disease activity assessments for patients with RA in the Dutch study were different from those used in ATTRACT or START studies; however, the mean baseline SF-36 physical component summary score in the RA cohort of the present study (29) was lower than those of patients with RA in the Dutch study (35.7 in men and 34.3 in women).
Results of the present analysis also demonstrate the significant improvement in HRQoL after treatment with the TNFα inhibitor infliximab. After adjustment for age, sex, and disease duration, patients in all the disease cohorts who received infliximab demonstrated significantly greater improvement from baseline in PCS than those who received placebo. Role physical and bodily pain were the domains that had the greatest magnitude of change in each disease cohort. Early improvement was evident at the first assessment point, which ranged from week 6 to week 14 depending on the study design. The magnitude of the difference in the change from baseline in PCS between the infliximab and placebo groups was comparable among the three diseases.
Patients with RA and PsA treated with infliximab also showed greater improvement in MCS than those treated with placebo, although the improvement in MCS between infliximab and placebo groups was not statistically significant in the AS cohort.
Improvements in PCS persisted throughout the placebo-controlled period of each study. The longest placebo-controlled period was in the ATTRACT study, in which improvements in mean PCS were sustained and increased slightly through week 54.
We observed several notable differences in the changes in the placebo group across diseases. Changes in PCS in the placebo group were lower in the PsA and AS cohorts compared with the RA cohort. All patients in the RA cohort, including those in the placebo group, were incomplete responders to MTX at baseline and received concomitant MTX throughout the study. However, eligibility for the trials was determined using clinical signs and symptoms criteria, not quality of life measurements.
There are some potential limitations of this retrospective study, and the results should be interpreted with caution. Although the SF-36 is robust for comparisons across diseases [14], each study assessed quality of life at different time points according to the study design. Thus, the first quality of life assessment ranged from week 6 in START to week 14 in IMPACT II. Moreover, each study had different selection criteria, study design, and infliximab dosages, making comparisons of HRQoL difficult. Although all 3 rheumatic diseases evaluated were immune-mediated inflammatory disorders that share some pathophysiological characteristics, comparisons of patients with different diseases should always be interpreted with caution. In the analysis, we adjusted SF-36 scores for age, sex, and disease duration, to attempt to control for potentially confounding factors.