title: 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.
authors.affiliation: Centocor Research and Development, Inc, 200 Great Valley Parkway, Malvern, Pennsylvania 19355, USA. chan3@cntus.jnj.com
authors.forename: Chenglong
authors.initials: C
authors.lastname: Han
authors.forename: Josef S
authors.initials: JS
authors.lastname: Smolen
authors.forename: Arthur
authors.initials: A
authors.lastname: Kavanaugh
authors.forename: Désirée
authors.initials: D
authors.lastname: van der Heijde
authors.forename: Jürgen
authors.initials: J
authors.lastname: Braun
authors.forename: René
authors.initials: R
authors.lastname: Westhovens
authors.forename: Ning
authors.initials: N
authors.lastname: Zhao
authors.forename: Mahboob U
authors.initials: MU
authors.lastname: Rahman
authors.forename: Daniel
authors.initials: D
authors.lastname: Baker
authors.forename: Mohan
authors.initials: M
authors.lastname: Bala
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000639:trends; D015331:Cohort Studies; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000639:trends; D011788:Quality of Life / Q000523:psychology*; D012216:Rheumatic Diseases / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000069285:Infliximab