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Abstract Number: 2336

Literature Review of Patient Reported Outcome and Health Related Quality of Life Measures for Biologic Therapies in the Management of Psoriatic Arthritis and Ankylosing Spondylitis

Steffen Jugl1, Sultana Syeda2 and Gunda Praveen2, 1BF I&D GPA, Health Economics and Outcomes Research, Novartis Pharma AG, Basel, Switzerland, 2Novartis Healthcare Pvt. Ltd., Hyderabad, India, Hyderabad, India

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Ankylosing spondylitis (AS), Biologic drugs, Health outcome, patient outcomes and psoriatic arthritis

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Session Information

Date: Tuesday, November 10, 2015

Title: Health Services Research Poster III: Patient Reported Outcomes, Patient Education and Preferences

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Psoriatic arthritis (PsA) and ankylosing spondylitis (AS) are chronic progressive conditions with substantial humanistic burden on patients and care givers. A variety of instruments, both generic and disease specific have been used in PsA and AS clinical studies. These Patient Reported Outcome (PRO) instruments allow to compare and measure impact on patient’s quality of life and thus play an essential role in evaluating humanistic burden. Objective of this project was to review generic and disease specific PRO measures used in clinical studies for biologics in the management of PsA and AS.

Methods: A literature search review of literature in English language from 1996-2015 was conducted. Embase, MEDLINE®, Tuft’s Cost-effectiveness Analysis registry, National Health Services Economic Evaluation Databases were searched. Inclusion criteria for review and data extraction were at least one biologic DMARD intervention, at least one utility, quality of life or patient reported outcome measure mentioned. Clinical as well as non-RCTs, observational or retrospective trials were eligible for inclusion.

Results: The literature search retrieved 3,175 articles, whereof 124 were included. Maximum articles were obtained for AS (N=73), followed by PsA (N=46). In addition five articles were included that captured both conditions. Across studies, a wide variation was observed in baseline characteristics such as age (Years, PsA: 35.5–65.0; AS: 24.4–61.0), disease duration (Years, AS: 0.7–30.2; PsA: 1.7–22.2) and gender distribution (Females, AS: 0–70%, PsA: 25–88%). The Short Form health survey 36 (SF-36) was the most commonly used generic health related quality of life (HRQoL) measure (N=27 for PsA, N=55 for AS), followed by Euro QoL 5d (EQ-5d) (N=10 PsA, N=14 AS). Variation was seen with respect to the utilization and reporting of disease specific instruments. Health Assessment Questionnaire (HAQ)/HAQ-Disability Index (N=36) was the most common in PsA while Ankylosing Spondylitis QoL (ASQoL) (N=21) was common in AS. Other common instruments reported were measured by Visual Analogue Scale (total pain, nocturnal pain, fatigue, physician global assessment etc.). Measures like Fatigue-VAS (0-10), Stiffness severity (0-100), Nottingham Health Profile (NHP)-fatigue, NHP-pain were reported the least.

Conclusion: A large variety of generic and disease specific PROs are utilized increasingly in the recent years in PsA and AS studies to measure HRQoL. This also shows the complexity and the multidimensional impact of these conditions on HRQoL. As there is no gold standard established, new tools may be needed to measure this impact holistically and reduce complexity of various measures across trials.


Disclosure: S. Jugl, Novartis Pharma AG, 3,Novartis Pharma AG, 1; S. Syeda, Novartis Pharma AG, 3; G. Praveen, Novartis Pharma AG, 3.

To cite this abstract in AMA style:

Jugl S, Syeda S, Praveen G. Literature Review of Patient Reported Outcome and Health Related Quality of Life Measures for Biologic Therapies in the Management of Psoriatic Arthritis and Ankylosing Spondylitis [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/literature-review-of-patient-reported-outcome-and-health-related-quality-of-life-measures-for-biologic-therapies-in-the-management-of-psoriatic-arthritis-and-ankylosing-spondylitis/. Accessed .
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