scholarly journals P631 Predictors of vedolizumab treatment persistence in bio-naïve ulcerative colitis patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S523-S524
Author(s):  
T E Ritter ◽  
H E Sarles ◽  
S A Mehta ◽  
L J Van Anglen
Keyword(s):  
Ulcerative Colitis ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Maintenance Therapy ◽  
Clinical Response ◽  
Disease Duration ◽  
Biologic Therapy ◽  
First Line ◽  
Treatment Persistence ◽  
Oral Agents

Abstract Background Vedolizumab (VDZ) is increasingly being positioned as first-line biologic therapy for the treatment of inflammatory bowel disease (IBD) in adults, particularly for ulcerative colitis (UC). Identifying a certain subset of bio-naïve UC patients most likely to benefit from VDZ and remain on long-term maintenance therapy is important. The purpose of this study was to evaluate predictors of VDZ treatment persistence at 12 months in real-world clinical practice. Methods We performed a retrospective review of all adult (≥18 years) bio-naïve UC patients started on VDZ at US gastroenterology physician office infusion centres. Data collection included baseline demographics, VDZ therapy, concomitant oral agents, disease severity, and disease activity scores using the partial Mayo score (pMayo). Disease severity was characterised by prior IBD-related surgery and IBD-related healthcare resource utilisation within 1 year of VDZ initiation. Clinical response was assessed at baseline, 6 weeks, and 14 weeks and defined as a pMayo reduction of ≥2 points. Patients were divided into two cohorts, those persisting on VDZ at 12 months and those discontinuing VDZ prior to 12 months. Logistic regression analysis was used to determine predictors associated with persistence. Results A total of 141 UC patients receiving VDZ as first-line biologic therapy were identified: mean age 44 ± 14.5 years, male gender 82 (58%), median disease duration 5.5 (IQR 1.6–13.3) years. VDZ treatment persistence at 12 months was observed in 102 (72%) patients (Figure 1). The remaining 39 patients discontinued VDZ within the first 12 months. Amongst those who discontinued VDZ, reasons included lack or loss of response in 35 (90%), antibodies in 3 (8%), and intolerance in 1 (3%). In the logistic regression analysis, the only factor associated with VDZ treatment persistence was clinical response at 14 weeks (OR 6.5 [95% CI 2.9–14.5]). No other variables (age, gender, smoking status, disease duration, concomitant oral agents, or severity of illness) influenced persistence at 12 months. Conclusion Almost three-fourths of bio-naïve UC patients treated with vedolizumab experienced treatment persistence at 12 months. Our data suggest that response to induction may be used to predict those who will remain on maintenance therapy.

scholarly journals P333 Endoscopic severity and CRP predict failure of medical rescue therapy in patients with acute severe ulcerative colitis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S357-S357
Author(s):  
P Kakkadasam Ramaswamy ◽  
D Subhaharan ◽  
L Willmann ◽  
J Edwards ◽  
D Shukla ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Cyclosporin A ◽  
Corticosteroid Therapy ◽  
Disease Duration ◽  
Rescue Therapy ◽  
Multivariable Analysis ◽  
Severe Ulcerative Colitis ◽  
Intravenous Corticosteroid

Abstract Background The efficacy of Infliximab and Cyclosporin A as medical rescue therapy in patients with corticosteroid refractory acute severe ulcerative colitis (ASUC) is well established. We aimed to identify predictors of failure of medical rescue therapy and colectomy during the same admission in this population. Methods Patients hospitalized with ASUC who received infliximab or cyclosporin A after failing intravenous corticosteroid therapy between 1st January 2013 to 31stJuly, 2020 at two Australian tertiary IBD centres were retrospectively analysed. Patients who underwent colectomy during the same admission after medical rescue therapy were defined as non-responders. Logistic regression analysis was performed to identify predictors of colectomy during same admission. Results 226 episodes of ASUC [110 (48.7%) female, median disease duration 2 years] were analysed. 104 (46%) episodes required rescue therapy [94 episodes received medical rescue (16 cyclosporine/78 Infliximab) and 10 underwent direct colectomy]. In patients receiving medical rescue therapy, 16 (17%) underwent colectomy during same admission and 28 (29.8%) underwent colectomy by 12 months. On multivariable analysis, UCEIS score at admission [Coef 0.100 (0.02-0.17), p 0.011] and CRP on Day 3 post-rescue therapy [Coef 0.004 (0.0007-0.007), p 0.018] were significant for predicting colectomy during the same admission. A score with 1 point for each variable (UCEIS score ≥ 7 and CRP value of ≥ 22 mg/L on day 3 post medical rescue therapy) was developed. A score of 2 points had sensitivity 57%, specificity 97%, PPV 80%, NPV 91%, accuracy 89% for predicting colectomy during the same admission and sensitivity 33%, specificity 94%, PPV 80%, NPV 67%, accuracy 69% for predicting colectomy at 12 months. Conclusion UCEIS and CRP on day 3 after rescue therapy are predictors of non-response to medical rescue therapy and need for colectomy during the admission for the ASUC episode. Combination of UCEIS ≥ 7 and CRP ≥ 22mg/L on day 3 post medical rescue therapy has a PPV of 80% for colectomy during same admission and at 12 months. The score can be used to make decisions about colectomy or further medical rescue therapy.

scholarly journals Risk factors for tissue expander infection in scar reconstruction: a retrospective cohort study of 2374 consecutive cases

2020 ◽  
Vol 8 ◽  
Author(s):  
Chen Dong ◽  
Minhui Zhu ◽  
Luguang Huang ◽  
Wei Liu ◽  
Hengxin Liu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Treatment Failure ◽  
Logistic Regression Analysis ◽  
Disease Duration ◽  
Multivariate Logistic Regression Analysis ◽  
Tissue Expansion ◽  
Multivariate Logistic Regression ◽  
Hematoma Evacuation

Abstract Background Tissue expansion is used for scar reconstruction owing to its excellent clinical outcomes; however, the complications that emerge from tissue expansion hinder repair. Infection is considered a major complication of tissue expansion. This study aimed to analyze the perioperative risk factors for expander infection. Methods A large, retrospective, single-institution observational study was carried out over a 10-year period. The study enrolled consecutive patients who had undergone tissue expansion for scar reconstruction. Demographics, etiological data, expander-related characteristics and postoperative infection were assessed. Univariate and multivariate logistic regression analysis were performed to identify risk factors for expander infection. In addition, we conducted a sensitivity analysis for treatment failure caused by infection as an outcome. Results A total of 2374 expanders and 148 cases of expander infection were assessed. Treatment failure caused by infection occurred in 14 expanders. Multivariate logistic regression analysis identified that disease duration of ≤1 year (odds ratio (OR), 2.07; p < 0.001), larger volume of expander (200–400 ml vs <200 ml; OR, 1.74; p = 0.032; >400 ml vs <200 ml; OR, 1.76; p = 0.049), limb location (OR, 2.22; p = 0.023) and hematoma evacuation (OR, 2.17; p = 0.049) were associated with a high likelihood of expander infection. Disease duration of ≤1 year (OR, 3.88; p = 0.015) and hematoma evacuation (OR, 10.35; p = 0.001) were so related to high risk of treatment failure. Conclusions The rate of expander infection in patients undergoing scar reconstruction was 6.2%. Disease duration of <1 year, expander volume of >200 ml, limb location and postoperative hematoma evacuation were independent risk factors for expander infection.

scholarly journals POS0455 EFFECT OF ANTI-Ro/SSA ANTIBODIES FOR TREATMENT RESPONSE TO METHOTREXATE IN RHEUMATOID ARTHRITIS: A RETROSPECTIVE MULTICENTER OBSERVATIONAL STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 458.1-458
Author(s):  
R. Yokochi ◽  
H. Tamai ◽  
T. Kido ◽  
Y. Yagyu ◽  
D. Waki ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Disease Activity ◽  
Clinical Response ◽  
Logistic Regression Analysis ◽  
Age At Onset ◽  
Treat To Target ◽  
Low Disease Activity ◽  
Target Strategy

Background:Several previous observational studies have suggested that patients with anti-Ro/SSA antibody-positive rheumatoid arthritis (RA) may respond poorly to treatment, including tumor necrosis factor inhibitors1. However, its influence on methotrexate (MTX) treatment, which is the anchor drug of treat-to-target strategy in RA treatment, remains unclear.Objectives:We compared the clinical response to MTX in both anti-Ro/SSA antibody-positive and -negative patients with MTX-naiive RA and investigated the reasons for the difference in response.Methods:We recruited 210 consecutive patients with RA who were newly started on MTX in this retrospective cohort study. The effect of the presence of anti-Ro/SSA antibodies on achieving low disease activity (LDA) of DAS28-CRP at six months after initiating MTX was investigated by using logistic regression analysis. CDAI, SDAI, concomitant using DMARDs and painkillers, patient’s and evaluator’s VAS, tender joint counts, and swollen joint counts at six months were also compared between the anti-Ro/SSA-positive patients and -negative patients. Missing data were imputed by using multiple imputations before multivariate analysis.Results:32 anti-Ro/SSA antibody-positive patients and 178 anti-Ro/SSA antibody-negative patients were included. The rate of achieving DAS28-LDA at six months was significantly lower in the anti-Ro/SSA antibody-positive patients than those in the anti-Ro/SSA antibody-negative patients (56.2% versus 75.8%, P=0.03). in the logistic regression analysis, the presence of anti-Ro/SSA antibodies was an independent negative predictor for achieving DAS-28-LDA at six months (OR:0.431, 95%CI: 0.190-0.978, P=0.044) (Table1). Anti-Ro/SSA antibody-positive patients had significantly higher patient’s VAS at six months (median [IQR]: 22 [15-41] vs 19 [5-30], P=0.038), and prescribed NSAIDs (37.5% vs 18.0%, P=0.018). CDAI and SDAI after six months were not significantly different between the group.Conclusion:The presence of anti-Ro/SSA antibodies might be one of the predictive factors for the insufficient response to treat to target strategy in RA treatment. Residual pain was suspected as one of the mechanisms contributing to the lesser clinical response of MTX in anti-Ro antibody-positive RA.References:[1]Ran Matsudaira wt al. J Rheumatol 2011;38(11):2346-54Table 1.Logistic regression analysis for the rate of achieving DAS28 low disease activity at six months.Risk factor Odds ratio95%CIP valueAge at onset0.9930.968-1.0180.586Sex (woman)0.6430.300-1.3840.258RF-positive1.9620.853-4.5110.112ACPA-positive0.5520.225-1.3510.192Anti-Ro/SSA antibody-positive0.4310.190-0.9780.044Disclosure of Interests:None declared

scholarly journals Dynamic evolution of osseous structure in osteonecrosis of the femoral head and dynamic collapse risks: a preliminary CT image study

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Zeqing Huang ◽  
Biao Tan ◽  
Hengli Ye ◽  
Fanyu Fu ◽  
Rongtian Wang ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Regression Analysis ◽  
Soft Tissue ◽  
Femoral Head ◽  
Roc Analysis ◽  
Disease Duration ◽  
Radiographic Progression ◽  
Dynamic Evolution ◽  
Sclerotic Bone ◽  
Osseous Structure

Abstract Background Collapse risk of osteonecrosis of the femoral head (ONFH) is estimated mainly based on static indicators, including lesion size and lesion location, but bone repairing is a dynamic process that lasts for years. The present study attempted to analyze the dynamic evolution of the osseous structure and its correlation with radiographic progression. Methods This retrospective study included 50 hips with ONFH from 50 patients. Participants were divided into the non-collapse group (n = 25) and the collapse group (n = 25). Original files of the initial computed tomography (CT) images were imported into imaging processing software for morphology analysis. The volume of sclerotic bone, the volume of soft tissue, and bone mineral density (BMD) were calculated. The linear correlations between the aforementioned indicators and the disease duration were estimated. The logistic regression analysis was conducted to evaluate the correlation of these indicators with the radiographic progression. Receiver operating characteristic (ROC) analysis was used to evaluate these indicators’ prediction performance. Results The volume of sclerotic bone and the BMD grew with disease duration, but the volume of soft tissue decrease. The logistic regression analysis found that the volume of sclerotic bone and the BMD were statistically associated with radiographic progression. The ROC analysis found that the regression model, which integrated the volume of sclerotic bone and the BMD, had satisfactory performance in predicting radiographic progression. Conclusion The present study suggested a dynamic evolution of the osseous structure and a dynamic variation trend of the collapse risk in ONFH. The volume of sclerotic bone and the BMD might serve as further prognostic indicators when estimating the collapse risk.

Clinical Factors Associated With Response to Fecal Diversion in Crohn’s Disease

2020 ◽  
Vol 86 (10) ◽  
pp. 1277-1280
Author(s):  
Hassan Buhulaigah ◽  
Adam Truong ◽  
Karen Zaghiyan ◽  
Phillip Fleshner
Keyword(s):  
Logistic Regression ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Disease Duration ◽  
Binary Logistic Regression ◽  
Fecal Diversion ◽  
Age At Diagnosis ◽  
Perianal Disease ◽  
Perineal Pain

Up to 80% of Crohn’s disease (CD) patients require surgery. Fecal diversion is used selectively in CD proctocolitis refractory to medical treatment or advanced perianal disease. This study examines associations between clinical features in predicting clinical response (CR) to fecal diversion in CD. Charts of CD patients undergoing fecal diversion for medically refractory disease or perianal disease were reviewed. Clinical response was assessed focusing on improvements in urgency, abdominal and perineal pain, decreased anal fistula drainage, and weight gain. Univariate binary logistic regression and multivariate forward-stepwise modeling analysis were used to determine associations with CR. The study cohort comprised 79 patients. After a median follow-up of 36 (3-192) months, 40 (51%) patients achieved a CR. Binary logistic regression analysis revealed both age at diagnosis (hazard ratio [HR] 1.05; confidence interval [CI] 1.01-1.09; P = .007) and disease duration (HR .91; CI .86-.96; P = .001) to be significantly associated with CR. Later age of onset (HR 1.05; CI 1.01-1.10; P = .002) and shorter disease duration (HR .91; CI .86-.97; P = .02) remained significant on multivariate analysis. This largest reported series of fecal diversion for refractory CD in the biologic drug era revealed that young age at diagnosis and long disease duration are associated with a lower CR.

Efficacy of taxanes followed by anthracyclines as neoadjuvant therapy in HER2-negative breast cancer (BC): Analysis of everyday clinical practice.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12112-e12112
Author(s):  
Enrique Alanya Rodríguez ◽  
Catalina Falo Zamora ◽  
Miguel J. Gil Gil ◽  
Petit Anna ◽  
Raul Ortega ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Regression Analysis ◽  
Clinical Response ◽  
Logistic Regression Analysis ◽  
Histological Grade ◽  
Menopausal Status ◽  
Multivariate Logistic Regression Analysis ◽  
Dose Intensity ◽  
Complete Response ◽  
Reverse Sequence

e12112 Background: Pathological complete response (pCR) after neoadjuvant chemotherapy for BC has been related with survival, and the sequence of anthracyclines followed by taxanes (AT) has been the strategy to achieve this response. Some studies suggest that the reverse sequence (TA) might improve cancer outcomes. The aim of our study was to compare clinical response, toxicity and efficacy in terms of pCR rate (ypT0/pTis, ypN0) between both sequences Methods: A retrospective cohort study was designed. TA cohort received Docetaxel (100 mg/m2) x 4, followed by AC (60/600 mg/m2) x 4. AT cohort received the reverse sequence at the same doses. To be included, it was necessary to have received at least one cycle in the planned sequence. Logistic regression analysis was performed to obtain a model adjusted by age, menopausal status, tumor size, nodal status, grade, estrogen receptor (ER), progesterone receptor, and Ki67 Results: From June 2008 to December 2015, 135 consecutive patients with stage II – III HER2 negative BC were treated: TA (n = 48) and AT (n = 87). No significant differences in patient characteristics between groups were found, except for histological grade 3 (63.2% to AT vs. 35.4% to TA), and ER negative (41.4% to AT vs. 22.9% to TA). The pCR rate for TA was 16.7% (8 of 40) vs. 14.9% (13 of 74) for AT. Multivariate logistic regression analysis found OR = 3.65 to achieve pCR for TA (95%CI 1.03 – 12.94; p = .045). We also performed the same analysis for two clinical parameters of response: Neoadjuvant response index (NRI) with cut-off > 0.5 (OR 3.96, 95%CI 1.42-11.08; p = .009) and Clinical response (CR) > 50% (OR 3.65, 95%CI 1.03 – 12.94; p = .045). These parameters were correlated in our series with DFS (p = .011 to NRI and p = .00023 to CR) and OS (p = .034 to NRI and p = .0014 to CR) using the Kaplan-Meier method. No significant differences between rates of either, hospitalizations, neutropenia or dose intensity were found Conclusions: Sequence of T followed by A was slightly significantly more effective to achieve pCR as well as better clinical outcomes in our series of HER2 negative BC than classical sequence of A followed by T, and support the design of large prospective studies to confirm these results

scholarly journals Weight Loss in Parkinson’s Disease: The Relationship with Motor Symptoms and Disease Progression

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Maria G. Cersosimo ◽  
Gabriela B. Raina ◽  
Luis A. Pellene ◽  
Federico E. Micheli ◽  
Cristian R. Calandra ◽  
...  
Keyword(s):  
Weight Loss ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Disease Progression ◽  
Logistic Regression Analysis ◽  
Disease Duration ◽  
Multivariable Logistic Regression Analysis ◽  
Single Session ◽  
Multivariable Logistic Regression ◽  
The Relationship

Objectives.To determine the prevalence of weight loss (WL) in PD patients, its relationship to the severity of motor manifestations and appetite changes.Methods.144 PD patients and 120 controls were evaluated in a single session. All subjects were asked about changes in body weight and appetite. PD patients were examined with the UPDRS-III and the Hoehn and Yahr (HY) scales. Subscores of tremor, bradykinesia /rigidity, and non-dopaminergic symptoms (NDS) were analyzed individually. Multivariable logistic regression analysis was used to determine an association between WL and PD motor manifestations.Results.48.6 % of PD patients presented WL compared to 20.8 % of controls (p < 0.001). Weight losers were significantly older and had longer disease duration, higher scores in HY stages, UPDRS-III, and NDS-subscore. Multivariable logistic regression analysis demonstrated that WL was associated with NDS-subscore (p= 0.002; OR: 1.33) and older age (p= 0.037; OR: 1.05). Appetite in PD cases losing weight was unchanged (35.7 %), decreased (31.4 %), or even increased (32.9).Conclusions.Our results showed that WL occurs in almost half of PD patients and it is largely the consequence of disease progression rather than involuntary movements or a decrease in food intake.

scholarly journals DOP55 A real-world comparison of the effectiveness and safety of vedolizumab and anti-TNF therapies in early treatment initiation with first-line biologic therapy in ulcerative colitis: Results from EVOLVE

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S092-S094
Author(s):  
G Mantzaris ◽  
B Bressler ◽  
U Kopylov ◽  
M Bassel ◽  
N Brett ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Real World ◽  
Early Treatment ◽  
Clinical Remission ◽  
Treatment Initiation ◽  
Clinical Effectiveness ◽  
Mucosal Healing ◽  
First Line

Abstract Background Evidence suggests that early treatment (Tx) with biologic agents in Crohn’s disease improves long-term clinical outcomes. However, there is less evidence in ulcerative colitis (UC), and data comparing early Tx with first-line biologic vedolizumab (VDZ) to anti-tumour necrosis factor (anti-TNF) in real-world settings is needed. This study compared the clinical effectiveness and safety of UC patients who initiated VDZ or an anti-TNF as a first-line biologic within 2 years following diagnosis. Methods This was a real-world, multi-country, retrospective chart review study in Canada, Greece and the United States where biologic-naïve UC patients (≥18 years old) were treated with VDZ or an anti-TNF (adalimumab, infliximab, golimumab) agent within 2 years following diagnosis (initiated Tx May 2014–March 2018). Clinical effectiveness and safety data were collected from Tx initiation to earliest of chart abstraction date, death, or 6 months post-Tx discontinuation (Canada only). Tx persistence was defined as the duration of time from treatment initiation to discontinuation. Analyses of cumulative rates of Tx persistence, clinical response, clinical remission and mucosal healing over 24 months were estimated using Kaplan–Meier analyses. Clinical response, remission and mucosal healing were assessed using pre-defined hierarchical algorithms of standard disease measures reported in the medical records. Analyses of incidence rates (per 100 person-years [PYs]) of disease exacerbations, disease-related surgeries, serious adverse events (SAEs) and serious infections (SIs) were performed. Adjusted analyses used inverse probability weighting to balance cohorts. Results This analysis included 176 UC patients (VDZ: 86; anti-TNF: 90) from 37 sites. Mean (SD) age at index date: VDZ, 41.4 (18.9); anti-TNF, 36.8 (15.6) years (p = 0.20) and the proportion male: VDZ, 58.1%; anti-TNF, 56.7% (p = 0.84). At 12 months, 72.9% and 58.1% continued VDZ and anti-TNF respectively (p = 0.03) (Figure 1A). Though there were no differences in clinical response, clinical remission or mucosal healing between VDZ and anti-TNF groups; VDZ patients were significantly less likely to experience disease exacerbations (HR = 0.47 [95% CI: 0.32–0.69]) and SAEs (HR = 0.37 [95% CI: 0.19–0.72]) (Figure 2). Adjusted outcomes (Figures 1C and D, and 2B) were similar to unadjusted outcomes. Conclusion EVOLVE is one of the first studies that compared early VDZ Tx to early anti-TNF Tx in biologic-naïve UC patients. Results showed VDZ was associated with higher persistence, lower likelihood of experiencing disease exacerbations and a more favourable safety profile. Thus, in early UC, Tx with VDZ may improve long-term clinical outcomes. Sample size limitations warrant further study.

Sign in / Sign up

Export Citation Format

Share Document