We aimed to evaluate the safety and effectiveness of darunavir (DRV) in the treatment of human immunodeficiency virus-1 (HIV-1) infection in Korea. From October 29, 2010, 225 eligible patients with HIV-1 infection receiving DRV were enrolled. DRV was administered with other antiretroviral agents, and followed for 24 weeks. The primary objective was safety evaluation, and effectiveness was assessed by viral load and CD4 T cell counts after 12 weeks and 24 weeks. Adverse drug reactions occurred in 18 patients (9.2%); diarrhea was the most common. Viral load was controlled (<400 copies/mL) in 90.9% of patients. CD4 T cell counts were increased 45.0/mm3 significantly at Week 12 (P = 0.0002), and 70.5/mm3 at Week 24 (P <0.0001). DRV safety and effectiveness was consistent with previous studies.

We aimed to evaluate the safety and effectiveness of darunavir (DRV) in the treatment of human immunodeficiency virus-1 (HIV-1) infection in Korea. From October 29, 2010, 225 eligible patients with HIV-1 infection receiving DRV were enrolled. DRV was administered with other antiretroviral agents, and followed for 24 weeks. The primary objective was safety evaluation, and effectiveness was assessed by viral load and CD4 T cell counts after 12 weeks and 24 weeks. Adverse drug reactions occurred in 18 patients (9.2%); diarrhea was the most common. Viral load was controlled (<400 copies/mL) in 90.9% of patients. CD4 T cell counts were increased 45.0/mm3 significantly at Week 12 (P = 0.0002), and 70.5/mm3 at Week 24 (P <0.0001). DRV safety and effectiveness was consistent with previous studies.

Background/Aims: Improving quality of life has been gaining importance in ulcerative colitis (UC) management. The aim of this study was to investigate changes in health-related quality of life (HRQL) and related factors in patients with moderate-to-severe UC. Methods: A multicenter, hospital-based, prospective study was performed using a Moderateto-Severe Ulcerative Colitis Cohort in Korea (the MOSAIK). Changes in HRQL, evaluated using the 12-Item Short Form Health Survey (SF-12) and Inflammatory Bowel Disease Questionnaire (IBDQ), were analyzed at the time of diagnosis and 1 year later. Results: In a sample of 276 patients, the mean age was 38.4 years, and the majority of patients were male (59.8%). HRQL tended to increase in both the IBDQ and SF-12 1 year after diagnosis. A higher partial Mayo score was significantly related to poorer HRQL on the IBDQ and SF-12 in a linear mixed model (p<0.01). Inflammatory markers such as C-reactive protein (CRP) or erythrocyte sedimentation rate also showed a negative correlation on HRQL (p<0.05). Patients whose IBDQ score improved by 16 or more (71.2%) in 1 year were younger, tended to be nonsmokers, and had a lower partial Mayo score and CRP than those whose IBDQ score did not. There was no significant association between HRQL and disease extent, treatments at diagnosis, or the highest treatment step during the 1-year period. Conclusions Optimally controlled disease status improves HRQL in patients with moderate-tosevere UC. The partial Mayo score and inflammatory markers may be potential indicators reflecting the influence of UC on patient`s daily lives.

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)

Background/Aims: Golimumab has been used for patients with ulcerative colitis (UC) since 2013. However, there is limited data on the effectiveness and safety of the real-world use of golimumab in Asian patients. Methods: This was a multicenter, prospective, observational study. We enrolled patients with moderate-to-severe UC who were administered subcutaneous golimumab at 46 medical centers between May 2014 and November 2019. The primary outcome was the effectiveness and safety of golimumab at week 22. Clinical outcomes and adverse events were assessed according to partial Mayo score at weeks 0, 2, 6, 14, and 22. Results: A total of 130 patients were included (mean age: 45.7±16.0 years). The clinical response/ remission rates at weeks 2, 6, 14, and 22 were 40.4%/22.9%, 56.0%/35.8%, 70.6%/49.5%, and 67.9%/48.6%, respectively. Based on full Mayo score at week 14, clinical response and remission rates were 84.2% and 39.5%, respectively. Mucosal healing rate was 65.8%. In multivariate analysis with logistic regression, longer disease duration was significantly associated with a higher clinical response rate (adjusted odds ratio [aOR], 1.136; 95% confidence interval [CI], 1.006 to 1.282; p=0.040 at week 6; aOR, 1.256; 95% CI, 1.049 to 1.503; p=0.013 at week 22). A higher baseline Mayo endoscopic subscore was significantly associated with a lower clinical response rate at week 6 (aOR, 0.248; 95% CI, 0.089 to 0.692; p=0.008). The incidence of adverse drug reactions was 4.6% (6/130, nine events). No serious unexpected adverse drug reactions or deaths were reported. Conclusions Golimumab was effective and safe as an induction and maintenance treatment for Korean patients with moderate-to-severe UC.

Background/Aims: Limited data are available regarding psychosocial distress at the time of diagnosis of ulcerative colitis (UC). We investigated the psychosocial burden and factors related to poor health-related quality of life (HRQL) among patients newly diagnosed with moderate-to-severe UC who were affiliated with the nationwide prospective cohort study. Methods: Within the first 4 weeks of UC diagnosis, all patients were assessed using the Hospital Anxiety and Depression Scale (HADS), Work Productivity and Activity Impairment questionnaire, Inflammatory Bowel Disease Questionnaire (IBDQ), and 12-Item Short Form (SF-12) health survey. A multiple linear regression model was used to identify factors associated with HRQL. Results: Between August 2014 and February 2017, 355 patients completed questionnaires. Significant mood disorders requiring psychological interventions, defined by a HADS score ≥11, were identified in 16.7% (anxiety) and 20.6% (depression) of patients. Patients with severe disease were more likely to have presenteeism, loss of work productivity, and activity loss than those with moderate disease (all p<0.05). Significant mood disorders had the strongest negative relationship with total IBDQ score, which indicates disease-specific HRQL (β coefficient: –22.1 for depression and –40.0 for anxiety, p<0.001). The scores of all SF-12 dimensions, which indicate general HRQL, were remarkably decreased in the study population compared indirectly with previously reported scores in the general population. The Mayo score, C-reactive protein level, and white blood cell count showed significant negative associations with the IBDQ score (p<0.05). Conclusions Psychosocial screening and timely interventions should be incorporated into the initial care of patients newly diagnosed with UC.

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.

Background/Aims: We previously reported that patients with moderate-to-severe ulcerative colitis (UC) often experience common mental disorders (CMDs) such as anxiety and depression, necessitating immediate psychological interventions within the first 4 weeks of diagnosis. In this 3-year follow-up study of the MOSAIK cohort in Korea, we examined the effects of CMDs at initial diagnosis on clinical outcomes and health-related quality of life (HRQoL). Methods: We examined differences in clinical outcomes (evaluated based on clinical response, relapse, hospitalization, and medication use) and HRQoL (assessed using the Inflammatory Bowel Disease Questionnaire [IBDQ] and Short Form 12 [SF-12]) according to Hospital Anxiety and Depression Scale (HADS) scores at diagnosis. Results: In a study involving 199 UC patients, 47.7% exhibited significant psychological distress (anxiety and/or depression) at diagnosis. Clinical follow-up showed no major differences in outcomes, including remission rates, response rates, or hospitalization rates, between patients with anxiety or depression at diagnosis and patients without anxiety or depression at diagnosis. The HRQoL at the end of follow-up was notably lower in those with baseline CMDs, particularly anxiety, across all domains of the IBDQ and SF-12. Linear mixed-effect models revealed that higher HADS scores, as well as higher Mayo scores, were independently associated with lower IBDQ scores and both summary domains of the SF-12. Additionally, regular attendance at follow-up visits during the study period was also related to improvements in HRQoL (all p<0.05). Conclusions While CMDs present at the time of UC diagnosis did not influence long-term clinical outcomes, they persistently impaired HRQoL. Our findings support the routine incorporation of psychological interventions into the long-term management of moderate-to-severe UC.

Background/Aims: We previously reported that patients with moderate-to-severe ulcerative colitis (UC) often experience common mental disorders (CMDs) such as anxiety and depression, necessitating immediate psychological interventions within the first 4 weeks of diagnosis. In this 3-year follow-up study of the MOSAIK cohort in Korea, we examined the effects of CMDs at initial diagnosis on clinical outcomes and health-related quality of life (HRQoL). Methods: We examined differences in clinical outcomes (evaluated based on clinical response, relapse, hospitalization, and medication use) and HRQoL (assessed using the Inflammatory Bowel Disease Questionnaire [IBDQ] and Short Form 12 [SF-12]) according to Hospital Anxiety and Depression Scale (HADS) scores at diagnosis. Results: In a study involving 199 UC patients, 47.7% exhibited significant psychological distress (anxiety and/or depression) at diagnosis. Clinical follow-up showed no major differences in outcomes, including remission rates, response rates, or hospitalization rates, between patients with anxiety or depression at diagnosis and patients without anxiety or depression at diagnosis. The HRQoL at the end of follow-up was notably lower in those with baseline CMDs, particularly anxiety, across all domains of the IBDQ and SF-12. Linear mixed-effect models revealed that higher HADS scores, as well as higher Mayo scores, were independently associated with lower IBDQ scores and both summary domains of the SF-12. Additionally, regular attendance at follow-up visits during the study period was also related to improvements in HRQoL (all p<0.05). Conclusions While CMDs present at the time of UC diagnosis did not influence long-term clinical outcomes, they persistently impaired HRQoL. Our findings support the routine incorporation of psychological interventions into the long-term management of moderate-to-severe UC.