scholarly journals P002 Real-world experiences of biologic tapering

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Zoe Rutter-locher ◽  
Yik Long Man ◽  
Lydia Marsh ◽  
Scott Mercer ◽  
Bina Menon ◽  
...  
Keyword(s):  
Real World ◽  
Biologic Therapy ◽  
Small Sample Size ◽  
Significant Proportion ◽  
Small Sample ◽  
Patient Choice ◽  
Treat To Target ◽  
Improvement Project ◽  
Real World Setting

Abstract Background/Aims  Biologic therapy and treat to target have significantly improved patient outcomes and we now have a proportion of patients on biologic therapy who remain in clinical remission. NICE guidance suggests “cautiously reducing drug doses or stopping drugs in those who have maintained the treatment target”. Despite this guidance, little is known about current clinical practice of biologic tapering in UK rheumatology centres. We aimed to illustrate current practice and success rates in biologic tapering in a real-world setting in patients with rheumatoid arthritis (RA), psoriatic arthritis (PSA) and ankylosing spondylitis (AS). Methods  We identified patients who were potentially suitable for biologic tapering 1 week prior to their follow up appointment using the following criteria - any anti-TNFα biologic ≥ 1 year, RA patients (DAS28 CRP<3.2, CRP normal), PSA patients (no swollen joints, CRP normal, no extra-articular manifestations), AS patients (BASDAI<4, CRP normal). We then analysed how many patients were successfully tapered at one year. Tapering schedule was decided by the supervising rheumatologist. Results  From December 2018 to February 2019, 66 patients were identified as being suitable for biologic tapering. 3 patients did not attend and were excluded from further analysis. Tapered group: 20 (32%) patients were tapered. Based on the retrospective review of clinic letters, the “tapering schedule” was inconsistent and the information provided to patients if they flared was also inconsistent - 9 (45%) patients were advised to return to their normal dose and only 1 (5%) patient was advised to contact the helpline. After 12 months of follow up, 11 (55%) patients remained on the tapered dose, 7 (35%) patients returned to their prior dose and 2 (10%) patients were lost to follow up. Non-tapered group: 43 (68%) patients were not tapered. The reasons for not tapering were divided into 6 broad categories: active disease (n = 15, 35%), patient choice (n = 5, 12%), DMARD was tapered instead (n = 5, 12%), discuss at next visit (n = 3, 7%), reason not mentioned (n = 12, 28%), other (n = 3, 7%) Conclusion  This Quality Improvement Project has highlighted the inconsistencies in biologic tapering in a UK real-world setting. In response to this inconsistency, we have developed a departmental guideline which provides stringent criteria to identify patients at lowest risk of flaring and standardises a tapering schedule and clinical pathway. We also created a patient information leaflet that could be distributed. Only half of the patients remained on the tapered dose after 1 year, suggesting a significant proportion of patients flare following dose reduction. However, our findings may be limited by small sample size. National guidance and a thorough audit based on this guidance is welcomed. Disclosure  Z. Rutter-locher: None. Y. Long Man: None. L. Marsh: None. S. Mercer: None. B. Menon: None. A. Cope: None.

scholarly journals Assessing Biomarkers of Breast Cancer Risk in Underserved Women in a Midwestern County

2021 ◽  
Vol 12 ◽  
pp. 215013272110177
Author(s):  
Marla A. DeWitt ◽  
Ivana T. Croghan ◽  
Celine M. Vachon ◽  
Thomas D. Thacher ◽  
Marcia R. Venegas Pont ◽  
...  
Keyword(s):  
Vitamin D ◽  
Mammographic Density ◽  
Small Sample Size ◽  
Vitamin D Insufficiency ◽  
Screening Mammography ◽  
Small Sample ◽  
Vitamin D Status ◽  
Small Pilot Study ◽  
Unexpected Findings

Objective: The primary aim of this study was to evaluate the feasibility of collecting risk factor information and accessing digitized mammographic data in a medically marginalized population. A secondary aim was to examine the association between vitamin D status and mammographic density. Methods: Breast-screening examinations were provided for age-appropriate patients, and a referral for no-cost screening mammography was offered. Study participants were asked to undergo 25-hydroxyvitamin D testing at mammography and 1-year follow-up. Results: Of 62 women approached, 35 (56%) consented to participate. Of 32 participants who had baseline mammography, the median mammographic density measured by VolparaDensity (Volpara Solutions Limited) was 5.7%. After 1 year, 9 women obtained follow-up mammograms, with a median density of 5.7%. Vitamin D status was measured for 31 participants at baseline and 13 participants in the following year. Insufficient vitamin D status (<30 ng/mL) was noted in 77% at each time point. Mammographic density was not significantly correlated with vitamin D status ( P = .06). Conclusions: On the basis of this small pilot study, vitamin D insufficiency is common in this study population. Owing to the small sample size, an association between vitamin D insufficiency and breast density was not clear. Additional unexpected findings included substantial barriers in initial access to care and longitudinal follow-up in this population. Further study of these issues is needed.

scholarly journals Real-World Clinical Outcomes Associated with Canagliflozin in Patients with Type 2 Diabetes Mellitus in Spain: The Real-Wecan Study

2020 ◽  
Vol 9 (7) ◽  
pp. 2275
Author(s):  
Juan J. Gorgojo-Martínez ◽  
Manuel A. Gargallo-Fernández ◽  
Alba Galdón Sanz-Pastor ◽  
Teresa Antón-Bravo ◽  
Miguel Brito-Sanfiel ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Real World ◽  
Primary Outcome ◽  
Baseline Hba1c ◽  
Real World Setting ◽  
Antihyperglycemic Therapy ◽  
The Mean ◽  
Hba1c Levels

The aims of this multicentric retrospective study were to assess in a real-world setting the effectiveness and safety of canagliflozin 100 mg/d (CANA100) as an add-on to the background antihyperglycemic therapy, and to evaluate the intensification of prior sodium–glucose co-transporter type 2 inhibitor (SGLT-2i) therapy by switching to canagliflozin 300 mg/d (CANA300) in patients with T2DM. One cohort of SGLT2i-naïve patients with T2DM who were initiated on CANA100 and a second cohort of patients with prior background SGLT-2i therapy who switched to CANA300 were included in the study. The primary outcome of the study was the mean change in HbA1c over the follow-up time. In total, 583 patients were included—279 in the cohort of CANA100 (HbA1c 8.05%, weight 94.9 kg) and 304 in the cohort of CANA300 (HbA1c 7.51%, weight 92.0 kg). Median follow-up periods in both cohorts were 9.1 and 15.4 months respectively. CANA100 was associated to significant reductions in HbA1c (−0.90%) and weight (−4.1 kg) at the end of the follow-up. In those patients with baseline HbA1c > 8% (mean 9.25%), CANA100 lowered HbA1c levels by 1.51%. In the second cohort, patients switching to CANA300 experienced a significant decrease in HbA1c (−0.35%) and weight (−2.1 kg). In those patients with baseline HbA1c > 8% (mean 8.94%), CANA300 lowered HbA1c levels by 1.12%. There were significant improvements in blood pressure in both cohorts. No unexpected adverse events were reported. In summary, CANA100 (as an add-on therapy) and CANA300 (switching from prior SGLT-2i therapy) significantly improved several cardiometabolic parameters in patients with T2DM.

Role of multiparametric MRI in long-term surveillance following focal laser ablation of prostate cancer

2021 ◽  
pp. 20210414
Author(s):  
Mark Paxton ◽  
Eitan Barbalat ◽  
Nathan Perlis ◽  
Ravi J Menezes ◽  
Mark Gertner ◽  
...  
Keyword(s):  
Laser Ablation ◽  
Recurrent Disease ◽  
Small Sample Size ◽  
Focal Therapy ◽  
Outcome Data ◽  
Small Sample ◽  
Restricted Diffusion ◽  
Treatment Site ◽  
Imaging Characteristics

Objective: Determine the multiparametric magnetic resonance imaging (mpMRI) appearance of the prostate following focal laser ablation (FLA) for PCa and to identify imaging characteristics associated with recurrent disease. Methods: Retrospective analysis of patients who underwent FLA for low-intermediate risk PCa between 2010 and 2014 was performed. Early (median 4 months) and late mpMRI (median 49 months) follow-up were qualitatively assessed for T2-weighted, dynamic contrast enhanced (DCE) and diffusion weighted imaging (DWI) appearances and also compared to corresponding PSA values and biopsy results. Results: 55 cancers were treated in 54 men (mean age 61.0 years). Early mpMRI was performed in 30 (54.5%) patients while late follow-up mpMRI in 42 (84%). Ill-defined scarring with and without atrophy at the treatment site were the most common appearances. In patients with paired MRI and biopsy, one of four patients with clinically significant PCa on biopsy (≥GG2 or≥6 mm GG1) showed hyperenhancement or restricted diffusion at early follow-up. At late follow-up, positive biopsies were seen in 5/8 (63%) cases with hyperenhancement and 5/6 (83%) cases with restricted diffusion at the treatment site. PSA change was not associated with biopsy results at either time point. Conclusion: mpMRI is able to document the morphological and temporal changes following focal therapy. It has limited ability to detect recurrent disease in early months following treatment. Late-term mpMRI is sensitive at identifying patients with recurrent disease. Small sample size is, however, a limitation of the study. Advances in knowledge: Implementing MRI in follow-up after FT may be useful in predicting residual or recurrent PCa and therefore provide reliable outcome data.

scholarly journals Retrospective, observational study on usage of evogliptin in T2DM patients: A real-World experience in Indian patients

2021 ◽  
Vol 8 (3) ◽  
pp. 205-207
Author(s):  
Abhijit Trailokya ◽  
Amol Aiwale ◽  
Roshan Pawar ◽  
Suhas Erande
Keyword(s):  
Real World ◽  
Small Sample Size ◽  
Small Sample ◽  
Hypoglycemic Agents ◽  
P Value ◽  
Base Line ◽  
Oral Hypoglycemic Agents ◽  
Naive Patient ◽  
Indian Patients ◽  
Treatment Naïve

This study aimed to assess effectiveness and safety of Evogliptin 5 mg in patients with T2DM who were prescribed Evogliptin alone or with other oral hypoglycemic agents in real world scenario. Overall 20 patients who received Evogliptin as routine clinical practice in management of T2DM were analyzed retrospectively from single center. Data collected from past medical records. Primary endpoint was mean changes in HbA1c from baseline to weeks 24 and secondary endpoints were Change in HbA1c from baseline to weeks 12 Change from baseline in FPG & PPG at weeks 12 & 24.Significant reduction in HbA1c at the end of 12 and 24 weeks of Evogliptin therapy was - 0.9% and -1.45% respectively from the baseline of HbA1c 8.6% (p value &#60;0.001). At the end of 12 and 24 weeks of addition of Evogliptin, significant reduction in FBG were seen i.e -49.5 mg/dl and -90.7mg/dl respectively from base line of 182 mg/dl and reduction in PPG was -79.4mg/dl and -116.6mg/dl respectively from base line 277 mg/dl (p value &#60;0.001). Evogliptin was found to be effective when added to the patients who were uncontrolled on dual / triple oral anti-diabetic medications and even in treatment naïve patient. It effectively showed reduction in HbA1c, FBG and PPG and the end of 12 and 24 weeks when added to existing anti-diabetic medications & well tolerated in type 2 diabetes Indian patients.Small sample size and retrospective study

Utility of chemotherapy given before and/or after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for appendiceal adenocarcinoma with peritoneal metastases.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16276-e16276
Author(s):  
Tyler Friedrich ◽  
Junxiao Hu ◽  
Robert William Lentz ◽  
Alexis Diane Leal ◽  
Sunnie S. Kim ◽  
...  
Keyword(s):  
Intraperitoneal Chemotherapy ◽  
Cytoreductive Surgery ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Small Sample Size ◽  
Peritoneal Metastases ◽  
Small Sample ◽  
Histologic Grade ◽  
Low Grade ◽  
Appendiceal Adenocarcinoma

e16276 Background: Appendiceal adenocarcinoma is relatively rare and often diagnosed incidentally during operations for acute appendicitis. It is commonly associated, either at time of initial presentation or upon recurrence, with peritoneal metastases. A typical treatment strategy for patients with peritoneal disease includes cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC). Extrapolating largely from literature in colorectal cancer, chemotherapy is frequently given before and/or after CRS/HIPEC though high-level evidence to support this is lacking. We sought to evaluate the effect of systemic chemotherapy on survival. Methods: Utilizing a database of CRS/HIPEC procedures at University of Colorado Hospital from 2008 to present we retrospectively reviewed cases of appendiceal adenocarcinoma. Data collected included staging, histologic grade, chemotherapy given, surgical outcomes, and time to disease recurrence. Patients without adequate information regarding treatment, or without at least 1 year of clinical follow-up, were excluded. Associations between administration of chemotherapy or histologic grade and 1-year DFS were analyzed using Fisher’s exact test, and logistic regression was used to assess whether 1-year DFS were different in chemotherapy-treated patients when adjusted for histologic grade. Results: In total, 117 cases reviewed indicated an appendiceal pathology. Of these, 54 cases in a total of 51 patients met the specified criteria for pathology and completeness and length of follow-up information. The average age was 58 years (range 26-81 years). Adenocarcinoma was graded as low in 15 (28%) cases, intermediate in 18 (33%) cases, and high in 21 (39%) cases. 23 (43%) patients received no chemotherapy while 31 (57%) received chemotherapy before and/or after surgery. In the overall population, there was no significant effect of chemotherapy on survival, with 1-year DFS demonstrated in 74.2% of patients receiving some chemotherapy and 70% in patients not receiving chemotherapy (p = 0.765). One-year DFS was achieved in 86% of low-grade cases, 61% of intermediate-grade cases, and 71% of high-grade cases, though this was also not statistically significant (p = 0.254). Furthermore, when 1-year DFS between chemotherapy and non-chemotherapy patients was adjusted for grade, there was again no significant interaction (odds ratio = 0.48, 95% C.I. (0.13-1.64), p = 0.763). Conclusions: In this small, single-institution experience of patients with peritoneal appendiceal adenocarcinoma, there was no significant effect of chemotherapy administration on 1-year DFS. These findings are likely affected by significant confounding with the small sample size and retrospective nature of the data. Further investigation on a larger scale is warranted.

Long-term follow-up of patients undergoing decompressive hemicraniectomy for malignant stroke: Quality of life and caregiver’s burden in a real-world setting

2020 ◽  
Vol 197 ◽  
pp. 106168
Author(s):  
Pedro Tadao Hamamoto Filho ◽  
Lucas Braz Gonçalves ◽  
Nicholas Falcomer Koetz ◽  
Aline Maria Lara Silvestrin ◽  
Aderaldo Costa Alves Júnior ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Real World ◽  
Decompressive Hemicraniectomy ◽  
Real World Setting ◽  
Long Term Follow Up

scholarly journals TCT-350 Safety and Performance of the Resorbable Magnesium Scaffold, Magmaris in a Real World Setting - First 400 Subjects at 12-month Follow-up of the BIOSOLVE-IV Registry

2018 ◽  
Vol 72 (13) ◽  
pp. B142-B143
Author(s):  
Michael Lee ◽  
Adrian Wlodarczak ◽  
Johan Bennett ◽  
Jan Torzewski ◽  
Michael Haude ◽  
...  
Keyword(s):  
Real World ◽  
Real World Setting ◽  
And Performance

scholarly journals Usefulness of mycophenolate mofetil in Indian patients with C3 glomerulopathy

2018 ◽  
Vol 12 (4) ◽  
pp. 483-487 ◽  
Author(s):  
Joyita Bharati ◽  
Karalanglin Tiewsoh ◽  
Ashwani Kumar ◽  
Ritambhra Nada ◽  
Manish Rathi ◽  
...  
Keyword(s):  
Mycophenolate Mofetil ◽  
Small Sample Size ◽  
Initial Response ◽  
Immunosuppressive Agent ◽  
Small Sample ◽  
C3 Glomerulopathy ◽  
Standardized Treatment ◽  
Stage Renal Disease ◽  
End Stage

Abstract Background C3 glomerulopathy (C3G) is a heterogeneous disease caused by alternative complement pathway abnormalities without any standardized treatment. An immunosuppressive agent, mycophenolate mofetil (MMF), has been recently shown to be useful in treating C3G, mainly in studies from the west. We report the clinical outcome of 17 Indian C3G patients treated with MMF with or without steroids. Methods The clinical and histology details of the C3G patients treated with MMF for at least 6 months with a follow-up of at least 12 months were retrieved from the medical records of our center. Results The median serum creatinine and proteinuria at presentation were 0.8 mg/dL and 3.7 g/day, respectively, with the majority (88.2%) presenting as nephrotic syndrome. The mean dose of MMF was 1.65 (±0.56) g/day, and the median duration of MMF therapy was 18 months. Two-thirds (64%) of the patients responded to the treatment, with complete remission in 4 (23%) and partial remission in 7 (41%) (median time: 9 months). Three patients progressed to end-stage renal disease (ESRD) on follow-up. Of the three patients, one (33%) had an initial response in proteinuria to MMF but did not respond after a relapse and subsequently progressed to ESRD and two (67%) other patients were nonresponsive to MMF from the start of the therapy. Conclusion Despite a small sample size and lack of a control arm, this study describes the effectiveness of MMF in treating C3G patients from Asia and forms a basis for future randomized trials.

Improved Postoperative Survival for Intraductal- Growth Subtype of Intrahepatic Cholangiocarcinoma

2016 ◽  
Vol 82 (11) ◽  
pp. 1133-1139 ◽  
Author(s):  
Laura L. Dover ◽  
Rojymon Jacob ◽  
Thomas N. Wang ◽  
Joseph H. Richardson ◽  
David T. Redden ◽  
...  
Keyword(s):  
Intrahepatic Cholangiocarcinoma ◽  
Small Sample Size ◽  
Tumor Stage ◽  
Small Sample ◽  
Postoperative Survival ◽  
Rank Test ◽  
Intraductal Growth ◽  
Kaplan Meier ◽  
Disease Free

Intrahepatic cholangiocarcinoma (ICC) is classified according to the following subtypes: mass-forming (MF), periductal infiltrating (PI), and intraductal growth (IG). The aim of this study is to measure the association between ICC subtypes and patient survival after surgical resection. Data were abstracted on all patients treated with definitive resections of ICC at a single institution between 2000 and 2011 with at least three years follow-up. Survival estimates were quantified using Kaplan-Meier curves and compared using the log-rank test. There were 37 patients with ICC treated with definitive partial hepatectomies with a median survival of 33.5 months. Tumor stage (P < 0.0001), satellitosis (P < 0.001), lymphovascular space invasion (P = 0.003), and macroscopic subtype (P = 0.003) were predictive of postoperative survival. Disease-free survivals for MF, PI, and IG subtypes, respectively, were 30 per cent, 0 per cent, and 57 per cent (P = 0.017). Overall survivals among ICC macroscopic subtypes were as follows: MF 37 per cent, PI 0 per cent, and IG 71 per cent (P = 0.003). Although limited by the small sample size of this rare cancer, this study demonstrates significant differences among macroscopic subtypes of ICC in both disease-free survivals and overall survivals after definitive partial hepatectomy.

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