Safety and effectiveness of tofacitinib in Korean adult patients with rheumatoid arthritis: A post-marketing surveillance study.

OBJECTIVES: The aim of this article is to assess the safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in routine clinical settings in Korea. METHODS: This is a prospective, multi-centre post-marketing surveillance study. Data were prospectively collected within 6 months after the start of tofacitinib therapy. Safety was evaluated based on the presence of adverse events (AEs) observed in patients who received at least one dose of tofacitinib. Effectiveness was assessed according to the proportion of patients who achieved low disease activity and remission, American College of Rheumatology 20 criteria (ACR20), European League Against Rheumatism (EULAR) response, and change of Disease Activity Score in 28 Joints (DAS28). RESULTS: The incidence rates [patients with events per 100 patient-years (PY)] of AEs and serious AEs were 56.92 and 10.69, respectively. Regarding AEs of special interest, the incidence rates were 4.33 per 100 PY for serious infections and infestations, 5.78 per 100 PY for herpes zoster, no event of tuberculosis, 0.29 per 100 PY for malignancy, 0.29 per 100 PY for venous thromboembolism (one event of deep vein thrombosis and no event of pulmonary embolism), 0.87 per 100 PY for major adverse cardiovascular event, and 0.58 per 100 PY for mortality. Moreover, ∼40.48% and 21.60% of patients achieved low disease activity and remission of DAS28-erythrocyte sedimentation rate. The EULAR response was classified as good responders with 39.12% in the DAS28-erythrocyte sedimentation rate. CONCLUSIONS: The benefit/risk profile of tofacitinib in adult patients with rheumatoid arthritis in routine clinical settings in Korea was similar to long-term clinical trial data.

Treatment pattern, satisfaction, and productivity loss of patients with ankylosing spondylitis treated with tumor necrosis factor inhibitors in Korea: A multicenter cross-sectional observational study.

AIM: To provide in-depth understanding of real-world tumor necrosis factor inhibitor (TNFi) treatment patterns in patients with ankylosing spondylitis (AS) and treatment satisfaction, productivity loss, and associated factors. METHODS: This was a multicenter observational hybrid retrospective chart review and cross-sectional survey study. Disease activity and physical functioning were measured using the Bath AS Disease Activity Index and Bath AS Functional Index, respectively. Treatment satisfaction was determined with the Treatment Satisfaction Questionnaire for Medication (TSQM). Productivity loss was evaluated using the Korean version of the World Health Organization-Health and Work Performance Questionnaire. RESULTS: A total of 497 patients were enrolled (mean age 40.3 years, 85.3% male, mean AS duration 10 years). The mean duration of TNFi treatment was 6.2 years. Among the four TNFi considered, adalimumab (39.6%) and etanercept (23.5%) were most commonly used at study enrollment. The TSQM convenience domain score was lower than scores in the effectiveness, adverse effects, and global satisfaction domains. Subcutaneous syringe-type injection and intravenous injection were associated with lower patient convenience satisfaction than subcutaneous pen-type injection. Increased costs of lost productivity time were associated with female sex, unemployed status, and higher disease activity. CONCLUSIONS: The most frequently prescribed TNFi was adalimumab, followed by etanercept. Etanercept was used for the longest duration. More convenient treatment options may enhance overall treatment satisfaction. Considerable loss in productivity due to AS was observed in this study. To reflect patients' perspectives, further attention should be paid to factors associated with treatment satisfaction and productivity loss when selecting treatment options.

[The relationship between ineffective esophageal motility and gastro-esophageal reflux disease].

BACKGROUND/AIMS: Ineffective esophageal motility (IEM) is a distinct manometric entity characterized by a hypocontractile esophagus. Recently, IEM replaced the nonspecific esophageal motility disorder (NEMD), and its associations with gastro-esophageal reflux disease (GERD) and respiratory symptoms are well known. We evaluated the relationship of IEM with GERD, and the diagnostic value of IEM for GERD. METHODS: We retrospectively analyzed recent 3-year (Jan. 1998-Sep. 2002) datas of esophageal manometry, acid perfusion test and simultaneous 24 hr-ambulatory pH-metry with manometry studies in 270 consecutive patients with esophageal and/or GERD symptoms. The prevalence of IEM in GERD group and non-GERD group, and the variables of pH-metry and manometry among esophageal motility disorders were compared. In addition, the sensitivity, specificity, positive predictive value, negative predictive value of IEM, esophageal symptom, and acid perfusion test for GERD were calculated. RESULTS: There was no significant difference in IEM prevalence rate between GERD group and non-GERD group. In addition, there was no significant difference in GERD prevalence rate and esophageal acid clearance in variety of motility disorder groups. Total percent time of pH <4 in IEM group did not show any difference when compared with other groups except in the achalasia group. In regard of diagnostic value to detect GERD, all positive results showed high specificity (97%) in IEM with esophageal symptom and positive acid perfusion test. CONCLUSIONS: The diagnosis of IEM using esophageal manometry in patients with various esophageal symptoms does not strongly suggest on association with GERD. However, IEM with concomitant esophageal symptoms and positive acid perfusion test has diagnostic values for GERD.