Session Information
Date: Tuesday, November 10, 2015
Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment Poster III: Therapy
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: Clinical trial results have demonstrated benefits of anti-TNF therapy in improving clinical outcomes, including overall health-related quality of life (HRQoL) in patients with ankylosing spondylitis (AS)1. We aimed to understand how consistency of anti-TNF use in the real-world impacts patient-reported outcomes, including measures of disease activity, functional impairment, depression, HRQoL, and work productivity.
Methods: A prospective Patient Reported Outcomes Survey of Employment in Patients with AS (PROSE-AS) was conducted at rheumatologists’ practices in Canada, the Netherlands, the United Kingdom, and the United States. Patients ≥18 years of age completed surveys assessing sociodemographic and clinical characteristics, drug use, and several patient reported outcomes at 3 month intervals (12 months follow-up; 5 visits total). Anti-TNF history prior to the baseline visit was not assessed. Disease activity and functional impairment were assessed using the Bath AS Disease Activity Index (BASDAI) and Bath AS Functional Index (BASFI) scales, respectively; depression with the Center for Epidemiological Studies Depression (CES-D) scale; overall HRQoL with the Short Form 36 Health Survey (SF-36) and AS Quality of Life (ASQoL) questionnaires; and work outcomes with the Work Productivity and Activity Impairment (WPAI) questionnaire. Associations between anti-TNF use (occasional vs intermittent or continuous; defined as use in 1–2, 3–4, and 5 of 5 visits, respectively) and outcomes at 12 months were assessed with multivariable regression analyses, after controlling for baseline characteristics.
Results: Of 555 patients enrolled, 227 who had ≥1 visit with anti-TNF use during study period (20 occasional, 63 intermittent, and 144 continuous) were included in the analysis. Mean age was 46 years, 93.4% were white, and 30.8% were female. At baseline, mean AS duration was 14 years; mean BASDAI and BASFI scores were both 4.4; and mean SF-36 Physical Component Summary (PCS) and ASQoL scores were 37.3 and 8.2, respectively. Of the 227 anti-TNF users, 182 (8 occasional, 30 intermittent, and 144 continuous) were on anti-TNFs at baseline. Among 149 (65.6%) patients who were employed at baseline, 30 (20.1%) reported baseline absenteeism. At month 12, patients with intermittent or continuous anti-TNF use reported significantly better BASDAI, BASFI, SF-36 PCS, and ASQOL scores than patients with occasional use; they were also significantly less likely to be depressed and to report absenteeism (Table). Improvements were generally greater with increasing anti-TNF use.
Conclusion: In this real-world, multi-country, prospective study of patients with AS, continuous and intermittent vs occasional use of anti-TNF medication was associated with better clinical, psychological, and HRQoL outcomes, and lower absenteeism.
Reference:
- van der Heijde D et al, Rheumatology (Oxford). 2014 Dec 25. pii: keu438.
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Association Between anti-TNF Use Category and Outcome Variables at 12 Monthsa |
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Outcome Variables (Continuous) |
Intermittent vs Occasional (β, 95% CI) |
Continuous vs Occasional (β, 95% CI) |
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BASDAI Score (n=227, scale 0–10) |
-1.33 (-2.27 to -0.39)b |
-1.68 (-2.58 to -0.78)b |
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BASFI Score (n=227, scale 0–10) |
-0.96 (-1.85 to -0.06)b |
-1.09 (-1.95 to -0.23)b |
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SF-36 |
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(a) PCS Score (n=227, scale 0–100) |
4.14 (-0.05 to 8.33) |
5.87 (1.88 to 9.86) |
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(b) MCS Score (n=227, scale 0–100) |
2.94 (-1.97 to 7.84) |
2.96 (-1.67 to 7.6) |
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ASQoL Score (n=227, scale 0–18) |
-3.17 (-5.05 to -1.3)b |
-2.9 (-4.68 to -1.12)b |
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Outcome Variables (Categorical) |
Intermittent vs Occasional (OR, 95% CI) |
Continuous vs Occasional (OR, 95% CI) |
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CES-D (scale 0–60) |
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Depressed (≥16, n=85) vs not depressed (<16, n=142) |
0.11 (0.02 to 0.49) |
0.11 (0.02 to 0.46) |
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WPAI |
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(a) Absenteeism (n=30) vs no absenteeism (n=117) |
0.05 (0.004 to 0.82)
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0.06 (0.004 to 0.78)
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(b) Presenteeism (n=121) vs no presenteeism (n=26)
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0.23 (0.01 to 5.50)
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0.14 (0.01 to 2.88)
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(c) Overall work impairment (n=120) vs no overall work impairment (n=25)
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0.23 (0.01 to 5.51)
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0.14 (0.01 to 3.04)
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(d) Activity impairment (n=206) vs no activity impairment (n=21) |
1.09 (0.07 to 17.34) |
0.56 (0.04 to 7.29) |
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aResults from multivariate regression adjusted for age, sex, race, country, education, number of comorbidities, use of NSAIDs and non-biologic DMARDs, AS duration, and outcome at baseline. bLower score indicates better outcome. CI, confidence interval; DMARD, disease-modifying antirheumatic drug; MCS, Mental Component Summary; NSAID, non-steroidal antiinflammatory drug; OR, odds ratio; PCS, Physical Component Summary; β, regression coefficient. |
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To cite this abstract in AMA style:
Maksymowych W, Boonen A, Marzo-Ortega H, Magrey MN, Mittal M, Halpern M, Renaud J, Bao Y, Joshi AD. Real-World Impact of Anti-TNF Medication Use on Patient Reported Outcomes in a Prospective Cohort of Patients with Ankylosing Spondylitis [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/real-world-impact-of-anti-tnf-medication-use-on-patient-reported-outcomes-in-a-prospective-cohort-of-patients-with-ankylosing-spondylitis/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/real-world-impact-of-anti-tnf-medication-use-on-patient-reported-outcomes-in-a-prospective-cohort-of-patients-with-ankylosing-spondylitis/