Abstract

AimThis study examined the degree of gastrointestinal (GI) risk and patient‐reported outcomes including GI‐related symptoms, adherence to non‐steroidal anti‐inflammatory drugs (NSAIDs), disease activity and quality of life (QoL) in patients with ankylosing spondylitis (AS).MethodsCross‐sectional, observational study conducted at six nationwide, university‐based hospitals of Korea. AS patients treated with NSAIDs for at least 2 weeks were included between March and September 2016. Demographic and clinical data were gathered through a medical chart review and patient survey. GI risk was estimated using Standardized Calculator of Risk for Events (SCORE). NSAIDs adherence was investigated with Morisky Medication Adherence Scale‐8 (MMAS‐8). Disease activity and QoL were examined with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and EuroQol‐3L (EQ‐5D, EQ‐visual analog scale [EQ‐VAS]), respectively. Path analysis was implemented to estimate pathways of GI risk, GI symptoms and NSAIDs adherence to QoL.ResultsA total of 596 patients (age: 38.9 ± 12.6 years, male: 82.1%) participated in the study, of which 33.2% experienced GI symptoms during NSAID treatment, and 34.2% of them showed ongoing GI symptoms upon enrollment. According to SCORE, 37.1% of patients showed moderate to very high GI risk. No patient showed high adherence according to MMAS‐8, so 55.3% of patients with moderate adherence were considered adherent. BASDAI and QoL of the total patients were 3.5 ± 2.0, 0.6 ± 0.3 (EQ‐5D), and 67.4 ± 19.8 (EQ‐VAS), respectively. From path analyses, higher GI risk significantly lowered QoL.ConclusionThis study suggests timely therapeutic strategies should be implemented to manage GI risk during NSAID treatment in order to effectively manage AS.

Highlights

  • Ankylosing spondylitis (AS) is an inflammatory arthritis affecting approximately fewer than 1% of the worldwide population.1{Braun, 1998 #1662} According to the 2016 update of the Assessment in Ankylosing Spondylitis International Society (ASAS) and European League Against Rheumatism (EULAR) management recommendations for AS, non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as a first-line treatment option up to its maximum dose in AS patients with pain and stiffness.[2]

  • We investigated the degree of GI risk and patient-reported outcomes (PROs) in a large number of AS patients in Korea

  • The assessment of GI risk among NSAID users has been widely studied using a variety of risk measurement tools in multiple populations

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Summary

Introduction

Ankylosing spondylitis (AS) is an inflammatory arthritis affecting approximately fewer than 1% of the worldwide population.1{Braun, 1998 #1662} According to the 2016 update of the Assessment in Ankylosing Spondylitis International Society (ASAS) and European League Against Rheumatism (EULAR) management recommendations for AS, non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as a first-line treatment option up to its maximum dose in AS patients with pain and stiffness.[2]. Gastrointestinal side effects have been associated with NSAID use, which may be minor, such as nausea, dyspepsia, anorexia, and abdominal pain, or life-threatening complications such as GI bleeding and perforation.[8]. This gastrointestinal risk among NSAID users is known to differ as per demographic and clinical characteristics of each individual patient,[9] and known factors include long-term use and/or high doses of NSAIDs (≥3 months), old age (≥65 years), heavy smoking, heavy drinking, current health status, co-morbidity (cardiovascular, renal and liver diseases, diabetes, hypertension), diagnosis of rheumatoid arthritis, aspirin use, anticoagulant use, corticosteroid use, use of selective serotonin reuptake inhibitor, Helicobacter pylori infection, history of GI symptoms, and history of hospitalization due to GI complications.[10]. A systematic treatment approach which considers each patient-specific feature should be implemented to minimize GI risk while on a NSAIDs prescription

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