The impact of infliximab treatment on quality of life in patients with inflammatory rheumatic diseases

Abstract

In this study, we compare the health-related quality of life (HRQoL) of patients with moderate-to-severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), and study the effect of treatment with infliximab on the HRQoL of patients with these diseases. Short Form Health Survey-36 (SF-36) data from the placebo-controlled phases of 4 studies of infliximab in patients with inflammatory rheumatic diseases (n = 1990) were evaluated. Data came from the Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy (ATTRACT) (n = 428), the Safety Trial for Rheumatoid Arthritis with REMICADE Therapy (START) (n = 1083), the Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy (ASSERT) (n = 279), and the Infliximab Multinational Psoriatic Arthritis Clinical Trial II (IMPACT II) (n = 200). SF-36 assessments were made at weeks 0, 10, 30, and 54 in ATTRACT, weeks 0, 6, and 22 in START, weeks 0, 12, and 24 in ASSERT, and weeks 0 and 14 in IMPACT II. All patient populations had significantly impaired physical aspects of HRQoL at baseline relative to the general population of the United States, and the magnitude of impairment was similar across the diseases. Mean baseline physical component summary scores were 29 in the RA cohort, 32 in the PsA cohort, and 29 in the AS cohort. In all 3 diseases, patients who received infliximab showed significant improvement in physical component summary scores compared with those who received placebo. The magnitude of the difference of improvement (effect size, 95%CI) between infliximab and placebo groups was similar in the AS (10.1, 9.2-11.0), PsA (8.6, 7.8-9.4), and RA (10.1, 9.2-11.0) cohorts. Patients with RA and those with PsA treated with infliximab also showed greater improvement in the mental component summary score than those in the placebo group with an effect size of 4.6 (4.2-5.1) in RA and 2.7 (2.4-3.1) in PsA. Patients in large randomized controlled studies of infliximab in RA, PsA, and AS had similar impairment in physical aspects of HRQoL at baseline and showed significantly greater improvement in HRQoL after treatment with infliximab.

Figures

Figure 1

Health-related quality of life at baseline. Mean norm-based Short Form Health Survey-36 (SF-36) scales, mental component summary score (MCS), and physical component summary score (PCS) at baseline. Values were adjusted for age, gender, and disease duration. BP, bodily pain; GH, general health; MH, mental health; PF, physical functioning; RE, role emotional; RP, role physical; SF, social functioning; VT, vitality.

Figure 2

Frequency distribution of physical component summary scores. Frequency distribution of baseline physical component summary scores (PCS) for patients with rheumatoid arthritis (RA) (a), psoriatic arthritis (PsA) (b), and ankylosing spondylitis (AS) (c) in infliximab clinical trials.

Figure 3

Change in health-related quality of life after treatment. Mean changes from baseline to the first assessment time point in Short Form Health Survey-36 (SF-36) scales for patients with rheumatoid arthritis (RA) (a; change from baseline to week 6 or 10), patients with psoriatic arthritis (PsA) (b; change from baseline to week 14), and patients with ankylosing spondylitis (AS) (c; change from baseline to week 12). BP, bodily pain; GH, general health; MCS, mental component summary score; MH, mental health; PCS, physical component summary score; PF, physical functioning; RE, role emotional; RP, role physical; SF, social functioning; VT, vitality.

Figure 4

Clinically meaningful improvement in health-related quality of life. Percentage of patients who achieved a clinically meaningful improvement (≥5 points) from baseline to the first assessment time point (rheumatoid arthritis (RA): week 6 or 10, psoriatic arthritis (PsA): week 14, and ankylosing spondylitis (AS): week 12) in the physical (a) or mental (b) component summary scores of the SF-36.