Efficacy and Safety of Infliximab in Intestinal Behçet's Disease: A Multicenter, Phase 3 Study (BEGIN).

Background/Aims: To date, there is no prospective study that specifically investigated the efficacy of infliximab in intestinal Behçet's disease (BD). This study evaluated the efficacy of infliximab in patients with moderate-to-severe active intestinal BD that are refractory to conventional therapies. Methods: This phase 3, interventional, open-label, single-arm study evaluated clinical outcomes of infliximab treatment in patients with moderate-to-severe intestinal BD. The coprimary endpoints were clinical response, decrease in disease activity index for intestinal BD (DAIBD) score ≥20 from weeks 0 to 8 for the induction therapy and week 32 for the maintenance therapy. Results: A total of 33 patients entered the induction therapy and were treated with infliximab 5 mg/kg intravenously at weeks 0, 2, and 6. The mean DAIBD score changed from 90.8±40.1 at week 0 to 40.3±36.4 at week 8, with a significant mean change of 50.5±36.4 (95% confidence interval, 37.5 to 63.4; p<0.001). Thirty-one (93.9%) continued to receive 5 mg/kg infliximab every 8 weeks during the maintenance therapy. The mean change in the DAIBD score after the maintenance therapy was statistically significant (61.5±38.5; 95% confidence interval, 46.0 to 77.1; p<0.001, from weeks 0 to 32). The proportion of patients who maintained a clinical response was 92.3% at week 32. No severe adverse reactions occurred during the induction and maintenance therapies. Conclusions: This study provided evidence that infliximab 5 mg/kg induction and maintenance therapies are efficacious and well-tolerated in patients with moderate-to-severe active intestinal BD. (ClinicalTrials.gov identifier: NCT02505568).

Differences in Clinical Responses to Ustekinumab Treatment among Body Regions: Results from a Real-World Prospective, Observational, and Multi-Center Study in Korea.

BACKGROUND: In psoriasis treatment, not all body regions improve simultaneously after clinical interventions. OBJECTIVE: This study was aimed at evaluating clinical responses across body regions, which may differentially influence patient treatment plans. METHODS: This prospective, observational, and multi-center study was conducted in Koreans who adhered to ustekinumab treatment based on criteria per local label and reimbursement guidelines. A total of 581 were included in this analysis. RESULTS: The mean (±standard deviation) psoriasis area severity index (PASI) score at baseline, age, disease duration, and body surface area (%) were 18.9±9.69, 44.2±13.29 years, 11.3±9.65 years, and 27.8±17.83, respectively. Across the head and neck, upper extremities, trunk, and lower extremities, the correlation between the PASI sub-scores for the upper and lower extremities was the highest (r=0.680). The mean PASI sub-score for the lower extremities was the highest at baseline. PASI90 and PASI100 scores were the highest for the head and neck region, indicating the highest response rates, while those for the lower extremities were consistently low at all visits. CONCLUSION: We found differences in regional ustekinumab responses, with the lower extremities being the most difficult to treat. These findings should be considered in psoriasis treatment.

Efficacy and safety of guselkumab compared with placebo and adalimumab in Korean patients with moderate-to-severe psoriasis: post-hoc analysis from the phase III, double-blind, placebo- and active-comparator-controlled VOYAGE 1/2 trials.

BACKGROUND: The phase 3 studies, VOYAGE 1 and 2, were conducted to assess guselkumab in the treatment of patients with moderate-to-severe psoriasis. OBJECTIVES: To investigate the efficacy and safety of guselkumab in Korean patients. METHODS: The Korean sub-population of VOYAGE 1 and 2 study patients were included in this analysis. Efficacy and safety were evaluated through Weeks 24 and 28, respectively. RESULTS: Of 126 randomized Korean patients, 30, 63, and 33 received placebo, guselkumab, and adalimumab, respectively. At Week 16, guselkumab was superior to placebo in achieving an Investigator's Global Assessment (IGA) score of 0 or 1 (cleared or minimal; 90.5 vs. 20.0%, p<.001) and a Psoriasis Area and Severity Index (PASI) 90 response (71.4 vs. 3.3%, p<.001). At week 24, a significantly higher proportion of guselkumab-treated patients achieved PASI 75 and IGA 0 (clear skin) responses compared to adalimumab-treated patients (PASI 75: 93.7 vs. 66.7%, p<.001; IGA 0: 52.4 vs. 21.2%, p=.004). Through Week 28, guselkumab and adalimumab showed comparable safety profiles. CONCLUSION: The efficacy and safety of guselkumab in Korean psoriasis patients through 28 weeks were consistent with findings for the overall VOYAGE 1 and 2 study population.

Real-World Safety and Effectiveness of Golimumab in Rheumatic Diseases: Post-Marketing Surveillance in Korea.

INTRODUCTION: Golimumab is a human monoclonal antibody that inhibits tumor necrosis factor-α (TNF-α). Inhibition of TNF-α by golimumab inhibits the inflammatory response, thereby modulating the immune response in immune-mediated inflammatory diseases. Although the efficacy of golimumab has been demonstrated in randomized controlled trials (RCTs), various patient populations, such as those at high risk of infection, including those with latent tuberculosis and various comorbidities, or on co-administered medications, were excluded from the RCTs. Therefore, safety cannot be sufficiently evaluated by RCTs in the patient group with heterogenous characteristics. The aim of this study was to assess the safety and effectiveness of golimumab in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondyloarthritis (AS) in a real-world setting in Korea. METHODS: We conducted an open-label, prospective, non-interventional study as post-marketing surveillance. Safety was evaluated by collecting and recording adverse events, and effectiveness was evaluated by assessing disease activity using DAS28-CRP, DAS28-ESR, ACR20, and ASAS20 outcome measures. Multiple logistic regression was performed to identify factors associated with the incidence of adverse events, and changes in disease activity scores from baseline were analyzed using the Wilcoxon signed-rank test. RESULTS: A total 673 patients were enrolled, of whom 621 were included in the safety analysis. During the study, 97 adverse drug reactions (ADRs) were reported in 62 patients (10.0%). The most frequently reported ADRs were related to infection, including nasopharyngitis (0.8%), upper respiratory tract infection (0.6%), and herpes zoster (0.5%). The mean (± standard deviation) changes from baseline in global disease activity at weeks 12 and 24 were - 3.37 ± 2.529 and - 3.68 ± 2.404, respectively, with statistical significance. In those patients with RA, 72.5 and 47.0% of individuals had a good response based on DAS28-CRP and DAS28-ESR outcomes at week 24. At week 24, 71.4% of patients with PsA had an ACR20 response and 72.9% of patients with AS had an ASAS20 response. CONCLUSION: In the real-world setting, golimumab was safe and effective in Korean patients with RA, PsA, and AS.

Clinical outcomes in adult patients with plaque psoriasis treated with ustekinumab under real-world practice in Korea: A prospective, observational, multi-center, postmarketing surveillance study.

Postmarketing surveillance is conducted to establish drug safety and effectiveness under real-world practice. We aimed to validate the effectiveness and safety of ustekinumab in the treatment of adult Korean patients with plaque psoriasis under real-world practice. This was a prospective, observational, and multi-center study. Subjects aged 18 years or older who were treated with ustekinumab for plaque psoriasis were enrolled. We enrolled 977 patients; 654 (66.9%) were men, with mean body surface area (BSA, ± standard deviation) of 27.0 ± 18.3% and mean psoriasis area severity index (PASI) score of 18.1 ± 9.7. The effectiveness analysis was performed in 581 patients who had at least one follow-up assessment and met treatment criteria per local label and reimbursement guidelines. Of these patients, 287 had effectiveness data for visit 6 at 53.7 ± 2.1 weeks. At visit 6, 91.6% (263/287), 51.2% (147/287), and 9.4% (27/287) patients achieved PASI 75, 90, and 100 responses, respectively. Adverse events (AEs) occurred in 112 of the 977 (11.5%) patients with an incidence rate of 21.5 per 100 patient-years (PYs). Serious AEs occurred in eight (0.8%) patients with an incidence rate of 1.2 per 100 PYs. The estimated 1-year drug survival rate was 87.7%. The multiple logistic regression analysis showed that higher baseline PASI score and no prior biologic exposure were significant predictors for PASI 90 response at visit 6. Ustekinumab was effective and safe, and displayed a high survival rate in the treatment of adult Korean patients with plaque psoriasis in real-world practice.

Early course of newly diagnosed moderate-to-severe ulcerative colitis in Korea: Results from a hospital-based inception cohort study (MOSAIK).

BACKGROUND AND AIM: No inception cohort study has ever evaluated the early course of moderate-to-severe ulcerative colitis (UC) within 1 year of diagnosis in the non-Caucasian population. We aimed to investigate the early clinical course of moderate-to-severe UC patients in terms of remission, relapse, UC-related hospitalizations, colectomy, mortality, and overall use of medications. METHODS: In the MOSAIK inception cohort, which is an ongoing multicenter, prospective, hospital-based, observational cohort, 354 patients with moderate-to-severe UC were followed up for 1 year. Main outcomes of UC and predictive factors for medication use over the course of 1 year were evaluated. RESULT: Among 354 patients, 276 (78.0%) patients were followed up for 1 year. The rates of remission, relapse, UC-related hospitalizations, and proximal disease extension were 95.3%, 39.6%, 15.2%, and 12.3%, respectively. Systemic corticosteroids, thiopurines, and biologics were administered to 61.2%, 30.4%, and 10.5% of patients, respectively, throughout 1 year. One year after, 58.2% patients experienced remission or mild endoscopic activity. Overall disease courses did not show much difference according to moderate or severe disease activity at baseline. In addition, no colectomy and mortality were observed for 1 year. Predictive factors for medication use included disease severity, disease extent, endoscopic severity, and presence of periappendiceal inflammation at baseline for corticosteroid, disease extent and initial corticosteroid use for thiopurine, and only initial corticosteroid use for biologics. CONCLUSION: Korean patients with moderate-to-severe UC may have more favorable early outcomes than Western patients. However, outcomes of them need to be further looked into for a longer time.

Knowledge, behaviors and prevalence of reproductive tract infections: a descriptive study on rural women in hunchun, china.

PURPOSE: The aim of the study was to assess the prevalence, knowledge and behavior about reproductive tract infections (RTIs) among rural Chinese women in Hunchun, China. METHODS: The study employed a cross-sectional research design with a convenience sample of 190 participants who had received microfinancing. Data were collected by trained research staff, utilizing face to face interviews and physical examinations. RESULTS: About 1 in 5 participants (20.3%) had had more than 5 pregnancies and 26.7% had had 3 or more abortions. More than half (57.3%) of study participants had an RTI at the time of examination, and 92.3% reported having had at least one RTI symptom. Nearly half (49.6%) of the women who exhibited RTI symptoms reported no utilization of any healthcare services. Age, number of pregnancies, RTI knowledge, and behavior were found to be significant correlates in the sample. CONCLUSIONS: The prevalence of RTI among low-income rural Chinese women were extremely high, indicating the urgent need for effective and culturally sensitive health education, particularly targeted to the poor rural population.

The effect of cognitive-behavioral group therapy on the self-esteem, depression, and self-efficacy of runaway adolescents in a shelter in South Korea.

This study examined the effects of cognitive-behavioral group therapy (CBT) on the self-esteem, depression, and self-efficacy of runaway adolescents residing in a shelter in Seoul, South Korea. The study used a control group pretest-posttest design. The experimental group and the control group consisted of 14 and 13 male subjects, respectively, with subjects having been randomly assigned to these groups. The experimental group participated in a CBT that consisted of eight sessions over an 8-week period; the control group did not participate in the program. To examine the effects of the CBT on dependent variables, the Wilcoxon signed rank test was used. The scores on depression decreased significantly (z = -2.325, p = .02) and those on self-efficacy increased significantly (z = -2.098, p = .03) after the intervention in the experimental group. There was no significant change on self-esteem (z = -1.19, p = .23). In the control group, the scores on depression, self-esteem, and self-efficacy did not change significantly after the intervention period. The CBT developed in this study consisted of structured and specific content that could be usefully applied to runaway adolescents residing in a shelter.

Large-scale and effective screening of Korean medicinal plants for inhibitory activity on matrix metalloproteinase-9.

Matrix metalloproteinase-9 (MMP-9) degrades type IV collagen constituting the major structural component of the basement membrane and extra cellular membrane. The enzymatic activity is found to be elevated in tumor tissues. With the aim of finding novel MMP-9 inhibitors from natural products, 87 extracts of oriental medicinal herbs, which are used as prescriptions for cancer treatment in traditional Korean medicine, were screened for their inhibitory activities towards MMP-9. It was found that most of the hexane and chloroform fractions as well as water extracts showed a weak inhibitory effect on MMP-9 activity at a concentration of 100mug/ml. However, a strong inhibition was found in the butanol fractions of Cinnamomum cassia PRESL, Magnolia obovata THUEB., Magnolia officinalis REHD. et WILS., Magnolia officinalis REHD. et WILS. var. biloba REHD. et WILS., and Euonymus alatus (THUNB.) SIEB. with inhibitory activity (>90%) at a concentration of 100 microg/ml.

Effects of egg yolk proteins on the longitudinal bone growth of adolescent male rats.

Hen egg is a nutritional store for a new life. We examined the effect of egg yolk proteins on longitudinal bone growth in the rat. Protein fractions from egg yolk were tested. Milk protein, casein, was used as a control. The bone growth rate was significantly increased by yolk water-soluble protein (YSP, 100 mg/kg) administration for 5 d. The bone morphogenetic protein-2 immunostaining of growth plate was also increased. Considering the results, YSP can be used as a growth-promoting factor.

[Effects of taping therapy on the deformed angle of the foot and pain in hallux valgus patients].

PURPOSE: This study was to examine the effects of Taping therapy on the deformed angle of the foot and pain in hallux valgus patients. METHOD: The subjects were 24 feet from 15 patients who were diagnosed withhallus valgus at the orthopedic department of K University Hospital in Seoul. Taping therapy was conducted 15 times overall during a four-week period. Data was analyzed using descriptive statistics and t-test. RESULT: The deformed angle of the foot of the hallus valgus patients significantly improved from 21.95 (4.38) to 18.75 (4.80) after Taping therapy. Pain significantly decreased from 4.73 (1.56) to 3.45 (2.21) after Taping therapy. CONCLUSION: The result shows that Taping therapy is effective in improving the deformed angle of the foot and in decreasing pain in the hallux valgus patients.

[Trends of nursing science inquiry in doctoral dissertations].

PURPOSE: The purpose of this study was to identify the theoretical characteristics and direction of inquiry in the discipline of nursing by analyzing doctoral dissertations. METHOD: The materials used in this study were 277 doctoral dissertations from five universities in Korea. The framework for the study was derived from Kim's(1993) alternative linkage among philosophy, theory, and method in nursing science. RESULT: Of the 277 dissertations it was found that there were 13 types of linkages out of a possible 54 types. Most of the dissertations (128 of 277) were done within the linkage of realism/etic/quantitative/explanatory knowledge type. Of the 218 dissertations within scientific realism, 42 were within relativism, and 17 within practicism. There were 134 dissertations of the explanatory knowledge type, 112 descriptive ones, and 31 prescriptive ones. Studies done within the etic quantitative methodology included 209 dissertations and within the emic perspective, 43 with qualitative methodology, and 7 with quantitative. CONCLUSION: The results show that it is necessary to develop more alternative linkages for nursing practice and this will lead to expanding nursing knowledge.