Outcomes In Asian Patients Research Articles

FDA analysis of outcomes in Asian patients (pts) with metastatic non-small cell lung cancer (mNSCLC) receiving immune checkpoint inhibitors (ICI).

e20690 Background: Asian pts tend to be well-represented in mNSCLC clinical trials, and drug development in Asia is growing. We sought to investigate outcomes of Asian pts enrolled in clinical trials testing ICI in mNSCLC. Methods: We identified 11 ICI mNSCLC randomized trials submitted to FDA 2014-2018. We divided the trials into 3 groups: 1st-line monotherapy (1L-M), 1st-line combination with chemotherapy [chemo] (1L-C), and 2nd-line monotherapy (2L-M). Overall survival (OS) and progression-free survival (PFS) were evaluated with Kaplan-Meier methodology. We performed meta-analyses to assess if treatment effect is consistent across Asian and non-Asian populations. Results: There were 3399 patients enrolled in five 2L-M trials, 1579 in two 1L-M trials, and 2500 in four 1L-C trials. Most Asian pts were located geographically in Asia (90%). Asians comprised 15% of patients enrolled in 2L-M trials, 27% in 1L-M, and 11% in 1L-C. Compared to non-Asians, a higher proportion of Asians were never-smokers (32% vs. 13%) and EGFR-mutated (13% vs. 4%). Asian pts had better unadjusted and adjusted OS than non-Asian pts for each treatment in each line of therapy. The 3 covariates with greatest prognostic impact on OS in 2L-M were race, performance status, and histology. The magnitude of ICI treatment effect relative to chemo was similar for Asian and non-Asian pts. Conclusions: Asians appear to have better prognosis than non-Asians; no uniquely better or worse benefit was observed from ICI when compared to chemotherapy. [Table: see text]

Poor outcomes for osteoporotic patients undergoing conversion total hip arthroplasty following prior failed dynamic hip screw fixation: a nationwide retrospective cohort study.

ObjectivesThis study was performed to compare the long-term clinical and radiological outcomes of conversion total hip arthroplasty (CTHA) following prior failed InterTan nail (IT) fixation or dynamic hip screw (DHS) fixation in Asian patients with osteoporotic intertrochanteric hip fractures (IHFs) and to clarify which implant tends to be more favourable for CTHA.MethodsRecords of consecutive Asian patients with osteoporosis who underwent conversion of failed primary unilateral IT or DHS fixation to THA from 2010 to 2013 were extracted from the comprehensive database of the China Pacific Insurance Company Ltd. All consecutive procedures were managed by high-volume surgeons. The primary endpoint was the clinical outcome. The secondary endpoint was the radiological outcome.ResultsIn total, 447 Asian patients with osteoporotic IHFs (DHS, n = 223; IT, n = 224) were assessed during a median follow-up of 46 months (range, 39–53 months). The two groups showed a significant difference in the Harris hip score at final follow-up and in the orthopaedic complication rate (DHS, 20.2%; IT, 9.8%).ConclusionConversion to THA following prior failed DHS fixation tends to be associated with poorer clinical and radiological outcomes in Asian patients with osteoporotic IHFs than that following prior failed IT fixation.

Empagliflozin and kidney outcomes in Asian patients with type2 diabetes and established cardiovascular disease: Results from the EMPA-REG OUTCOME® trial.

Aims/IntroductionIn the EMPA‐REG OUTCOME® trial, empagliflozin added to standard of care improved clinically relevant kidney outcomes by 39%, slowed progression of chronic kidney disease, and reduced albuminuria in patients with type 2 diabetes and established cardiovascular disease. This exploratory analysis investigated the effects of empagliflozin on the kidneys in Asian patients.Materials and MethodsParticipants in the EMPA‐REG OUTCOME® trial were randomized (1:1:1) to empagliflozin 10 mg, 25 mg or a placebo. In patients of Asian race, we analyzed incident or worsening nephropathy (progression to macroalbuminuria, doubling of serum creatinine, initiation of renal‐replacement therapy or renal death) and its components, estimated glomerular filtration rate (eGFR) and urine albumin‐to‐creatinine ratio changes, and renal safety.ResultsOf 7,020 treated patients, 1,517 (26.1%) were Asian. In this subgroup, consistent with the overall trial population, empagliflozin reduced the risk of incident or worsening nephropathy (hazard ratio 0.64, 95% confidence interval 0.49–0.83), progression to macroalbuminuria (hazard ratio 0.64, 95% confidence interval 0.49–0.85) and the composite of doubling of serum creatinine, initiation of renal‐replacement therapy or renal death (hazard ratio 0.48, 95% confidence interval 0.25–0.92). Furthermore, empagliflozin‐treated participants showed slower eGFR decline versus placebo, and showed rapid urine albumin‐to‐creatinine ratio reduction at week 12, maintained through week 164, with effects most pronounced in those with baseline microalbuminuria or macroalbuminuria. The kidney safety profile of empagliflozin in the Asian subgroup was similar to the overall trial population.ConclusionsIn Asian patients from the EMPA‐REG OUTCOME® trial, empagliflozin improved kidney outcomes, slowed eGFR decline and lowered albuminuria versus placebo, consistent with the overall trial population findings.

Heart failure with reduced ejection fraction: comparison of patient characteristics and clinical outcomes within Asia and between Asia, Europe and the Americas.

AimsNearly 60% of the world's population lives in Asia but little is known about the characteristics and outcomes of Asian patients with heart failure with reduced ejection fraction (HFrEF) compared to other areas of the world.Methods and resultsWe pooled two, large, global trials, with similar design, in 13 174 patients with HFrEF (patient distribution: China 833, India 1390, Japan 209, Korea 223, Philippines 223, Taiwan 199 and Thailand 95, Western Europe 3521, Eastern Europe 4758, North America 613, and Latin America 1110). Asian patients were younger (55.0–63.9 years) than in Western Europe (67.9 years) and North America (66.6 years). Diuretics and devices were used less, and digoxin used more, in Asia. Mineralocorticoid receptor antagonist use was higher in China (66.3%), the Philippines (64.1%) and Latin America (62.8%) compared to Europe and North America (range 32.8% to 49.6%). The rate of cardiovascular death/heart failure hospitalization was higher in Asia (e.g. Taiwan 17.2, China 14.9 per 100 patient‐years) than in Western Europe (10.4) and North America (12.8). However, the adjusted risk of cardiovascular death was higher in many Asian countries than in Western Europe (except Japan) and the risk of heart failure hospitalization was lower in India and in the Philippines than in Western Europe, but significantly higher in China, Japan, and Taiwan.ConclusionPatient characteristics and outcomes vary between Asia and other regions and between Asian countries. These variations may reflect several factors, including geography, climate and environment, diet and lifestyle, health care systems, genetics and socioeconomic influences.

Clinical Characteristics and Outcomes in Asian Patients With Premature Coronary Artery Disease: Insight From the FOCUS Registry.

Premature coronary artery disease (PCAD) is increasingly common in Asian countries; however, less is known regarding its characteristics and clinical outcomes. This study aims to describe clinical characteristics and investigate clinical outcomes in real-world Asian patients with PCAD. A total of 4700 Asian patients undergoing drug-eluting stent implantation were included in our study and divided into PCAD group and mature CAD (MCAD) group according to their onset age. All patients were followed up for 3 years to observe their clinical outcomes. Patients with PCAD were more likely to be associated with acute coronary syndrome (ACS; P = .03) and acute occlusive lesion ( P < .001). Reference diameter ( P < .001) and lesion diameter stenosis ( P = .001) were significantly greater in PCAD group. Conversely, the MCAD group was more likely to be associated with left main disease, severe calcification lesion and small vessel involvement. The cumulative incidences of major adverse cardiovascular event (MACE; P = .007), cardiovascular death ( P < .001), and all cause death ( P < .001) were significantly lower in PCAD group than those in MCAD group. Although more often manifested as ACS, PCAD is associated with lower risks of MACE and cardiovascular death than MCAD in real-world Asian population.

A New Technique for Augmentation Rhinoplasty Using Hybrid Autologous Grafts with Septal Extension Grafts in Asian Patients.

Augmentation rhinoplasty is commonly performed to raise the nasal dorsum in Asian individuals. However, materials used for dorsal augmentation are associated with various surgical challenges and complications. In this article, the authors present a novel dorsal augmentation technique combining hybrid autologous costal grafts with septal extension grafts. The records of 28 patients (19 women and 9 men; mean age: 27 years; range: 18-43 years) who underwent augmentation rhinoplasty (primary or revision) with our novel technique from December 2007 to December 2016 were retrospectively reviewed. Our technique included septal extension grafts for nasal tip projection and hybrid costal cartilage grafts, with a solid boat-shaped portion for bony dorsum augmentation and a fascia-wrapped diced cartilage graft for cartilaginous dorsum augmentation. Objective and subjective outcomes and complications were evaluated. Anthropometric parameters were measured on facial photographs to evaluate surgical outcomes in the 15 primary cases. Objective anthropometric measurements revealed successful augmentation of all nasal parameters. The nasal tip was mobile and comfortable in all patients. Among the 28 patients, 12 (42.9%) were very satisfied, 10 (35.7%) were satisfied, and 6 (21.4%) were unsatisfied with surgical results and required revision surgery. No immediate postoperative complications occurred. Ten (35.7%) patients experienced graft-related complications, including visibility or warping of the solid graft, supratip depression, and caudal deviation of the septal extension graft. None of these complications was serious. Augmentation rhinoplasty using hybrid autologous costal grafts with septal extension grafts allows dorsal augmentation with suitable graft material for each recipient site and can achieve successful outcomes in Asian patients.

Impact of type D personality on clinical outcomes in Asian patients with stable coronary artery disease

Some personality types are associated with cardiovascular (CV) diseases and may be related to clinical outcomes in coronary artery disease (CAD). This study investigates the association between type D personality and clinical outcomes in stable CAD patients in an Asian cohort. Stable CAD patients were enrolled and prospectively followed up for at least 1 year in Taiwan. The inclusion criteria were at least one successful percutaneous coronary intervention (PCI) and stable medical treatment for at least 1 month before enrollment. Vulnerability to psychological distress was measured by the Type D Personality Scale (DS14) after enrollment. The end point was the occurrence of total CV events. Cox regression models of CV events were used to investigate the role of type D personality in clinical outcomes. The study included 777 patients, among which 122 (15.77%) had type D personality. Forty-two CV events were identified: 3 cardiac deaths, 5 nonfatal myocardial infarctions, 1 stroke, 4 congestive heart failures (CHF), 6 peripheral arterial occlusive disorder cases, and 23 readmissions for angina/revascularization treatment. Patients with type D personality had significantly higher incidence of future CV events (9.84% vs. 4.58%, p=0.018%) and admission for angina/revascularization (5.74% vs. 2.44%, p=0.049). Patients with subsequent CV events were more likely to have type D personality (28.57% vs. 14.97%, p=0.018). After proportional Cox regression analysis, type D personality remained an independent predictor of future CV events (HR: 3.21, 95% CI: 1.06-9.69). In subgroup analyses, type D personality was especially associated with higher risk of total CV events among females, the elderly, hypertension patients, diabetes patients, and non-smokers. Type D personality was an independent predictor of CV outcomes in an Asian cohort of stable CAD patients. This personality type may be identified in risk stratification for secondary prevention after PCI.

Transarterial chemoembolization plus sorafenib for the management of unresectable hepatocellular carcinoma: a systematic review and meta-analysis

BackgroundTransarterial chemoembolization (TACE) is the recommended treatment for hepatocellular carcinoma (HCC) patients at Barcelona Clinic Liver Cancer (BCLC) B-stage, whereas sorafenib is an orally administered small molecule target drug for BCLC C-stage. This updated systemic review and meta-analysis focuses on identifying the efficacy of the combination of TACE with sorafenib, which remains controversial despite years of exploration.MethodsPubMed, EMBASE, Scopus and the Cochrane Library were systematically reviewed to search for studies published from January 1990 to May 2017. Studies focusing on the efficacy of combination therapy for unresectable HCC were eligible. The hazard ratio (HR) with 95% confidence intervals (95% CIs) for time to progression (TTP), overall survival (OS), disease control rate (DCR) and aetiology were collected. The data were then analysed through fixed/random effects meta-analysis models with STATA 13.0. The incidence and severity of treatment-related adverse events (AEs) were also evaluated.ResultsTwenty-seven studies were included. Thirteen non-comparative studies reported median OS (ranging from 18.5 to 20.4 months), median TTP (ranging from 7 to 13.9 months) and DCR (ranging from 18.4 to 95%). Fourteen comparative studies provided median OS (ranging from 7.0 to 29.7 months) and median TTP (ranging from 2.6 to 10.2 months). Five comparative studies provided DCR (ranging from 32 to 97.2%). Forest plots showed that combination therapy significantly improved TTP (HR = 0.66, 95% CI 0.50–0.81, P = 0.002) rather than OS (HR = 0.63, 95% CI 0.55–0.71, P = 0.058), compared to TACE alone. DCR increased significantly in the combination therapy group (OR = 2.93, 95% CI 1.59–5.41, P = 0.005). Additional forest plots were drawn and no significant differences were observed with regard to survival outcome among various aetiologies. Forest plots for separate analysis of regions showed the HR for TTP was 0.62 (95% CI 0.45–0.79, P = 0.002) in the Asian countries group, and 0.82 (95% CI 0.59–1.05, P = 0.504)) in western countries. The HR for OS was 0.61 (95% CI 0.48–0.75, P = 0.050) in the Asian countries group and was 0.88 (95% CI 0.56–1.20, P = 0.845) in western countries. These data may indicate positive TTP outcome in Asian patients but not in European patients while no positive findings regarding OS were observed in either region. The most common AEs included fatigue, hand-foot skin reaction, diarrhoea and hypertension.ConclusionsCombination therapy may benefit unresectable HCC patients in terms of prolonged TTP and DCR. More well-designed studies are needed to investigate its superiority for OS.

Hepatocellular Carcinoma Outcome Is Predicted by Expression of Neuronal Calcium Sensor 1.

Background: Hepatocellular carcinoma (HCC) is the second leading cause of cancer-related death worldwide. There is an urgent demand for prognostic biomarkers that facilitate early tumor detection, as the incidence of HCC has tripled in the United States in the last three decades. Biomarkers to identify populations at risk would have significant impact on survival. We recently found that expression of Neuronal Calcium Sensor 1 (NCS1), a Ca2+-dependent signaling molecule, predicted disease outcome in breast cancer, but its predictive value in other cancer types is unknown. This protein is potentially useful because increased NCS1 regulates Ca2+ signaling and increased Ca2+ signaling is a hallmark of metastatic cancers, conferring cellular motility and an increasingly aggressive phenotype to tumors.Methods: We explored the relationship between NCS1 expression levels and patient survival in two publicly available liver cancer cohorts and a tumor microarray using data mining strategies.Results: High NCS1 expression levels are significantly associated with worse disease outcome in Asian patients within these cohorts. In addition, a variety of Ca2+-dependent and tumor growth-promoting genes are transcriptionally coregulated with NCS1 and many of them are involved in cytoskeleton organization, suggesting that NCS1 induced dysregulated Ca2+ signaling facilitates cellular motility and metastasis.Conclusions: We found NCS1 to be a novel biomarker in HCC. Furthermore, our study identified a pharmacologically targetable signaling complex that can influence tumor progression in HCC.Impact: These results lay the foundation for using NCS1 as a prognostic biomarker in prospective cohorts of HCC patients and for further functional assessment of the characterized signaling axis. Cancer Epidemiol Biomarkers Prev; 27(9); 1091-100. ©2018 AACR.

A STAT4 variant increases liver fibrosis risk in Caucasian patients with chronic hepatitis B.

Host genetic modifiers of the natural history of chronic hepatitis B (CHB) remain poorly understood. Recently, a genome-wide association study (GWAS)-identified polymorphism in the STAT4 gene that contributes to the risk for hepatocellular carcinoma (HCC) was shown to be associated with the full spectrum of hepatitis B virus (HBV) outcomes in Asian patients. However, the functional mechanisms for this effect are unknown and the role of the variant in modulating HBV disease in Caucasians has not been investigated. To determine whether STAT4 genetic variation is associated with liver injury in Caucasian patients with CHB and to investigate potential mechanisms mediating this effect. STAT4 rs7574865 was genotyped in 1085 subjects (830 with CHB and 255 healthy controls). STAT4 expression in liver, PBMCs and NK cells, STAT4 phosphorylation and secretion of interferon-gamma (IFN-γ) according to STAT4 genetic variation was examined. STAT4 rs7574865 genotype was independently associated with hepatic inflammation (OR: 1.42, 95% CI: 1.07-2.06, P=0.02) and advanced fibrosis (OR: 1.83, 95% CI: 1.19-2.83, P=0.006). The minor allele frequency of rs7574865 was significantly lower than that in healthy controls. rs7574865 GG risk carriers expressed lower levels of STAT4 in liver, PBMCs and in NK cells, while NK cells from patients with the risk genotype had impaired STAT4 phosphorylation following stimulation with IL-12/IL-18 and a reduction in secretion of IFN-γ. Genetic susceptibility to HBV persistence, hepatic inflammation and fibrosis in Caucasians associates with STAT4 rs7574865 variant. Downstream effects on NK cell function through STAT4 phosphorylation-dependent IFN-γ production likely contribute to these effects.

Clinical correlates and pharmacological management of Asian patients with concomitant diabetes mellitus and heart failure.

Asia is the center of convergence of the twin epidemics of diabetes mellitus (DM) and heart failure (HF). The regional and ethnic diversity across Asia, along with a high prevalence of a young, lean diabetic phenotype, emphasizes the importance of targeted public health strategies that address the unique needs of Asian patients with DM and HF. This review discusses the epidemiology, clinical correlates, pharmacological management, and outcomes of Asian patients with concomitant DM and HF.

Early Functional, Radiological Outcomes and Satisfaction Rates of Total Ankle Arthroplasty in an Asian Population.

Few studies have outlined the outcomes and complications in Asians undergoing total ankle arthroplasty. This study reports the functional, radiological outcomes and satisfaction rates in our Asian population. Patients who underwent primary total ankle arthroplasty from 2007 to 2013 were recruited. Outcomes evaluated were the AOFAS Ankle-Hindfoot Score (AHS), Visual Analogue Scale (VAS), and the Short Form 36 (SF-36)questionnaire. Outcome scores were collected prospectively up to 2 years. Patient satisfaction was evaluated on a 6-point scale based on North American Spine Society Low Back Pain Instrument and classified as satisfied or unsatisfied. Forty-one patients underwent primary total ankle arthroplasty. All patients experienced improvements in AHS, VAS, and Mental Component Summary score of the SF-36 at both 6-month and 2-year postoperative interval. The mean AHS score improved from 35 ± 19 points preoperatively to 64 ± 24 at 6 months (P<.001) and 72 ± 26 at 24 months (P <.001). VAS scores improved from 7 ± 2 preoperatively to 3 ± 3 (P < .001) at 6 and 24 months. The Physical Component Summary (PCS) of the SF-36 has an established minimum clinically important difference (MCID) of 5. The mean improvement in PCS in our cohort met this MCID for the PCS; 63% and 71% of patients were satisfied with the procedure at 6 months and 2 years postoperatively, respectively. Revision rate in this series was 9.7%. Total ankle arthroplasty has good patient satisfaction rates, with favorable early clinical outcome in Asian patients. Therapeutic, Level II.

Asian patients with Hinchey Ia acute diverticulitis: a condition for the ambulatory setting?

Diverticulitis in Asians is a different disease entity from Western counterparts. Few Asian studies have evaluated the management of acute Hinchey Ia diverticulitis with consideration for outpatient management. The purpose of this study was to evaluate the outcomes of Asian patients with Hinchey Ia acute diverticulitis. A retrospective review of all patients who were treated for Hinchey Ia acute colonic diverticulitis between 2012 and 2014 was performed. All patients were diagnosed on computed tomography (CT). There were 129 patients with Hinchey Ia acute diverticulitis. Fifty-five (42.6%) patients were male, and the median age was 54years (range, 30-86). Eighty-seven (67.4%) patients had right-sided diverticulitis. Most patients were treated empirically with intravenous ceftriaxone and metronidazole (89.1%). They were then discharged with oral antibiotics. Only 6.1% of patients had a positive blood culture. The median length of stay in the hospital was 4 (range, 3-4) days. Only three (2.3%) patients were readmitted for acute diverticulitis within 30days. They were managed with antibiotics and discharged well. The repeated CT scans reconfirmed Hinchey Ia diverticulitis. No patients required emergency surgery, and there were no 30-day mortalities. Asian patients with Hinchey Ia diverticulitis recovered well with conservative management and could be amenable to outpatient therapy. Future prospective studies should be performed amongst Asians to evaluate managing this condition in an ambulatory setting.

Lifetime Risks, Projected Numbers, and Adverse Outcomes in Asian Patients With Atrial Fibrillation: A Report From the Taiwan Nationwide AF Cohort Study

Most data on the clinical epidemiology of atrial fibrillation (AF) come from Western populations, and data for Asians are limited. We investigated the lifetime risk and projected number of AF among Asians. The annual risks of adverse events among patients with AF, time trends, and the risks compared with patients without AF were analyzed. Between 2000 and 2011, 289,559 patients aged≥ 20 years experienced new-onset AF in Taiwan. The incidence, prevalence, and lifetime risk of AF were calculated. The risk of adverse events among patients with AF were analyzed and compared with that of age- and sex-matched patients without AF. The incidence of AF in year 2011 was 1.51 per 1,000 person-years, with a lifetime risk of AF being appropriately 1 in 7 for subjects aged > 20 years. The prevalence of AF is estimated to be 4.01%in 2050. Compared with patients without AF, AF was associated with an increased risk of mortality (adjusted hazard ratio [aHR], 2.61), heart failure (aHR, 3.31), ischemic stroke (aHR, 3.34), dementia (aHR, 1.56), sudden cardiac death (aHR, 1.83), and myocardial infarction (aHR, 1.62); all P< .01. The risks of ischemic stroke, heart failure, and mortality were especially higher compared with patients without AF in the initial period (approximately 6months) after AF was first diagnosed. The burden of AF among Asian patients is increasing, with a lifetime risk of AF being 1 in 7. Optimized management of any associated comorbidities should be part of the holistic management approach for AF.

Long-term follow-up and survivorship of single-radius, posterior-stabilized total knee arthroplasty.

We sought to determine the 10-year survivorship of single-radius, posterior-stabilized total knee arthroplasty (TKA) in Asian patients. We also aimed to determine whether the long-term clinical and radiographic results differed between patients with and without patellar resurfacing. This retrospective study included 148 (115 patients) consecutive single-radius, posterior-stabilized TKAs. Ten-year survivorship analysis was performed using the Kaplan-Meier method with additional surgery for any reason as the end-point. Furthermore, long-term clinical and radiographic results of 109 knees (74%; 84 patients) with more than 10-year follow-up were analyzed. Ten-year survivorship and long-term outcomes after surgery were determined, and outcomes were compared between patients with and without patellar resurfacing. The cumulative survival rate of the single-radius posterior-stabilized TKA of 148 knees was 97.7% (95% confidence interval, 93.1%-99.3%) at 10 years after surgery. Three knees required additional surgery during the 10-year follow-up because of one case of instability and two cases of periprosthetic infections. Mean postoperative Knee Society knee score and function score were 97 points and 75 points, respectively. There were no cases of aseptic loosening of the prosthesis, even though a non-progressive radiolucent line was found in 10 (9%) knees. There were no differences in postoperative scores and degree of patellar tilt and displacement between patients with and without patellar resurfacing. Single-radius, posterior-stabilized TKA showed satisfactory long-term clinical and radiographic outcomes in Asian patients regardless of patellar resurfacing, with comparable survivorship to that reported in westerners.

P4614Lifetime risks, projected numbers and adverse outcomes in asian patients with atrial fibrillation

P4614Lifetime risks, projected numbers and adverse outcomes in asian patients with atrial fibrillation

Early anti-TNF/immunomodulator therapy is associated with better long-term clinical outcomes in Asian patients with Crohn's disease with poor prognostic factors.

Although early treatment of Crohn’s disease (CD) patients with anti-tumor necrosis factor (TNF) agents or immunomodulators (IMs) may improve long-term outcomes, especially those with poor prognostic factors, their effectiveness in Asians remains unclear. In this study, Korean patients with CD naïve to both intestinal surgery and intestinal complications, and with at least two risk factors for progression (diagnosis at age <40 years, systemic corticosteroid treatment <3 months after diagnosis, and perianal fistula at diagnosis) were retrospectively analyzed. Patients were classified into those who started anti-TNFs, or IMs but not anti-TNFs, within 2 years of diagnosis, and those who started anti-TNFs and/or IMs later. Their probabilities of intestinal surgery and intestinal complications were compared. A total of 670 patients were enrolled, 79 in the early anti-TNF, 286 in the early IM, and 305 in the late treatment group. Kaplan-Meier analysis with the log-rank test showed that from starting anti-TNFs/IMs, times to intestinal surgery (P < 0.001), stricturing complications (P = 0.002), and penetrating complications (P < 0.001) were significantly longer in the early anti-TNF/IM groups than in the late treatment group. Multivariate Cox regression analysis showed that, from starting anti-TNFs/IMs, late anti-TNF/IM treatment was independently associated with higher risks of intestinal surgery (adjusted hazard ratio [aHR] 2.321, 95% confidence interval [CI] 1.503–3.584, P < 0.001), behavioral progression (aHR 2.001, 95% CI 1.449–2.763, P < 0.001), stricturing complications (aHR 1.736, 95% CI 1.209–2.493, P = 0.003), and penetrating complications (aHR 3.315, 95% CI 2.094–5.249, P < 0.001) than early treatment. In conclusion, treatment of Asian CD patients having poor prognostic factors with anti-TNFs/IMs within 2 years of diagnosis is associated with better clinical outcomes than later treatment.

97 - Early Anti-TNF/Immunomodulator Therapy is Associated with Better Clinical Outcomes in Asian Patients with Crohn's Disease with Poor Prognostic Factors

97 - Early Anti-TNF/Immunomodulator Therapy is Associated with Better Clinical Outcomes in Asian Patients with Crohn's Disease with Poor Prognostic Factors

P482 Early anti-TNF/immunomodulator therapy is associated with better clinical outcomes in Asian patients with Crohn's disease with poor prognostic factors

P482 Early anti-TNF/immunomodulator therapy is associated with better clinical outcomes in Asian patients with Crohn's disease with poor prognostic factors

The Modified Z-Epicanthoplasty-A Stepwise and Individualized Design.

To describe a medial epicanthoplasty technique using a stepwise, customized design and to review the outcome in Asian patients after the treatment of medial epicanthal fold. Retrospective, noncomparative and interventional case series with the introduction of a new surgical technique. Forty-eight consecutive Asian patients with primary medial epicanthal fold. Patient charts were reviewed from patients (mean age, 24.6 ± 3.8 years; range, 19-40 years) with a stepwise z-epicanthoplasty. The intercanthal distance (ICD), interpupillary distance (IPD), and scar visibility were evaluated at regular intervals (preoperative, immediate postoperative, 3 months, 6 months, and 1 year after the operation). The ratio of the ICD to IPD (ICD ratio) was calculated, and the visibility of the surgical scar assessed. Postoperative improvement in ICD ratio and scar quality. The preoperative median ICD ratio was 0.60 (range, 0.57-0.66) and decreased to 0.57 (range, 0.52-0.60) postoperatively. The median ICD ratio reduction was 5.6% (range, 2.6-14.1%; P < 0.001, Wilcoxon signed-rank test). Forty patients (83.3%) had no visible scarring or scarring only visible under close inspection. Eight patients (16.7%) experienced a more apparent scar, but none of them developed a severe scar requiring revision. The modified z-epicanthoplasty using a stepwise design is a customized and effective technique for the treatment of the epicanthal fold. This method has a short learning curve, is widely applicable to various types of epicanthal fold, and has a high satisfaction rate with a stable long-term result.