Patients receiving nonsteroidal anti-inflammatory drugs (NSAIDs) for ankylosing spondylitis (AS) may be at elevated risk for gastrointestinal (GI) events, according to study results published in International Journal of Rheumatic Diseases.
Investigators conducted a cross-sectional observational study at 6 university-based hospitals in South Korea. Patients with AS receiving treatment with NSAIDs were included in the study. Between March and September 2016, researchers collected demographic and clinical data by a medical chart review and patient survey. They measured disease activity and NSAID adherence using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Morisky Medication Adherence Scale-8, respectively. Investigators assessed quality of life of patients using 2 components of the EuroQol (EQ) tool: the EQ-5 dimensions descriptive scale (EQ-5D) and the EQ-visual analog scale (EQ-VAS). Researchers used the Standardized Calculator of Risk for Events (SCORE) to compute GI risk level according to 6 predictors, including age, current health status, diagnosis of rheumatoid arthritis, duration of corticosteroid use, GI symptoms (such as bleeding or ulcers), and hospitalization history due to GI symptoms while receiving NSAIDs.
Researchers then stratified patient data into 4 risk groups according to SCORE value: low (<10 points), moderate (11-15 points), high (16-20 points), and very high risk (>20 points). They conducted path analysis to evaluate the pathways of GI risk, GI symptoms, and NSAID adherence to quality of life.
The study included data of 591 patients (82.1% men), with mean age of 38.9±12.6 years and mean AS duration at enrollment of 51.8±46.8 years. Of the total cohort, 16.1% of patients were diagnosed with GI-related diseases and 11.3% showed GI-related symptoms at enrollment. A total of 196 (33.2%) patients reported a history of GI symptoms with NSAID intake. According to SCORE calculations, 158 patients (26.7%) had moderate GI risk, 53 (9.0%) had high risk, and 8 (1.4%) had very high risk. The remaining 372 patients (62.9%) were classified as low-risk. A total of 55.3% of patients were classified as adherent to their NSAIDs regimens; 44.5% reported suboptimal adherence. Mean BASDAI, EQ-5D, and EQ-VAS scores were 3.5±2.0, 0.6±0.3, and 67.4±19.8, respectively. Among patients with suboptimal NSAID adherence, higher GI risk was directly associated with lower EQ-5D scores (P =.015). Higher GI risk also indirectly affected both EQ-5D and EQ-VAS through history of GI-related symptoms.
Results from this study highlighted the risk for GI events among patients receiving NSAIDs for AS. Given the cross-sectional study design, causality cannot be inferred for the relationship between GI risk and quality of life in AS. Prospective studies are necessary to explore trends in GI risk among patients with AS.
“[T]he results clearly provide practical evidence to suggest timely therapeutic strategies be implemented in order to manage GI risk during NSAIDs treatment in [patients with AS],” the investigators concluded.
Disclosure: This study was sponsored by Pfizer Pharmaceuticals Korea Ltd.
Lee S-H, Park Y-W, Choe J-Y, et al. Gastrointestinal risk factors and patient-reported outcomes of ankylosing spondylitis in Korea [published online December 29, 2019]. Int J Rheum Dis. doi:10.1111/1756-185X.13758