scholarly journals SAT-418 Finding the Needles in the Haystack: Harnessing the Electronic Health Record to Find Thyroid Immune Related Adverse Events

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Zoe Quandt ◽  
Laura Trupin ◽  
Michael Evans ◽  
Gabriela Schmajuk ◽  
Mark Stuart Anderson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Electronic Health Record ◽  
Real World ◽  
Immune Checkpoint ◽  
Thyroid Disease ◽  
Thyroid Dysfunction ◽  
Health Record ◽  
The Real ◽  
New Onset

Abstract Background: Immune checkpoint inhibitors (CPIs) are being used to effectively treat a growing number of cancers but can cause immune related adverse events (irAE). Thyroid dysfunction is the most common endocrine irAE. A meta-analysis of clinical trials estimated that following CPI exposure, 6.6% will become hypothyroid and 2.9% will have hyperthyroidism1. It is unclear if this reflects the real-world incidence of these irAEs. We used electronic health record (EHR) data to identify patients who developed thyroid dysfunction after CPI to estimate the real-world incidence of these irAEs. Methods: Data were derived from the EHR of a large U.S. academic center. We identified subjects treated with CPIs between 2012 and 2018 and excluded those with thyroid cancer or pre-existing thyroid disease. Thyroid dysfunction was identified as either a TSH > 10, an abnormal free T4 or a prescription for thyroid hormone replacement or anti-thyroid medication. Those with thyroid dysfunction were then categorized as having pre-existing disease or a new-onset thyroid irAE based on the timing of CPI initiation. Logistic regression was used to evaluate the association of thyroid irAE with age, gender, CPI and type of cancer. Results: In total, 1146 individuals without pre-existing thyroid disease that received CPIs were assessed. Pembrolizumab was the most common treatment (45%), followed by nivolumab (20%). Less than 10% of subjects received atezolizumab, durvalumab, ipilimumab monotherapy, combined ipilimumab/nivolumab, or other combinations of CPIs. Melanoma was the most common cancer treated (32%), followed by non-small cell lung cancer (13%). The prevalence of any other cancer was < 10% each. Overall, 19% developed thyroid irAEs. After adjustment for gender and age, the type of cancer was significantly associated with new onset thyroid dysfunction (p=0.01). The rates of thyroid irAEs ranged from 10% in glioblastoma to 40% in renal cell cancer. Although there was no significant association between irAEs and specific CPIs in the overall analysis, thyroid irAEs were more common in subjects who received combined ipilimumab/ nivolumab (31%) compared to pembrolizumab (18%, p=0.03), nivolumab (18%, p<0.01) and ipilimumab (15%, p=0.02). Conclusion: Thyroid irAEs are much more common in real world practice than in clinical trials and there is emerging evidence that certain cancer types incur a higher risk of thyroid irAEs even after adjustment for CPI exposure. Clinicians and patients should be educated about these risks. Future work should focus on exploring the reasons underlying the differing rates of thyroid irAEs among different cancers including effect on cancer outcomes. 1Barroso-Sousa et al. Incidence of Endocrine Dysfunction Following the Use of Different Immune Checkpoint Inhibitor Regimens. JAMA Oncol. 2017; 02215: 1–10.

scholarly journals Analysis of Adjuvant Endocrine Therapy in Practice From Electronic Health Record Data of Patients With Breast Cancer

2017 ◽  
pp. 1-8 ◽  
Author(s):  
Morgan Harrell ◽  
Daniel Fabbri ◽  
Mia Levy
Keyword(s):  
Breast Cancer ◽  
Adverse Events ◽  
Electronic Health Record ◽  
Endocrine Therapy ◽  
Real World ◽  
Adjuvant Endocrine Therapy ◽  
Endocrine Treatment ◽  
Health Record ◽  
Treatment Practice

Purpose Adjuvant endocrine therapy is a long-term drug therapy prescribed to prevent recurrence of hormone receptor–positive breast cancer. Data on adjuvant endocrine therapy are reported though clinical trials, which may differ from treatment practice and outcomes in the general population of patients with breast cancer. With secondary use of electronic health record (EHR) data, we summarize adjuvant endocrine treatment practice and outcomes in real-world settings. Methods We analyzed treatment data derived from EHR data on 1,587 patients with stage I to III breast cancer at a National Cancer Institute–designated comprehensive cancer center to learn the frequencies of real-world adjuvant endocrine drug switches and discontinuation and to explore the potential cause for drug switches and discontinuation from medical records. We measured rates of drug use, drug switches, early drug discontinuation, adverse events, recurrence, and death. We also measured adverse events and change in menopause status as potential causes for drug switch and discontinuation. Results Within the study population, approximately 49% of patients were lost to follow-up or did not complete adjuvant treatment through 5 years. Fifty-two percent of patients switched to a different endocrine therapy drug during their treatment. We found that age is correlated with drug switches and that adverse events are correlated with drug switches and discontinuation. We also found that patients who switched to an alternative endocrine therapy during treatment were more likely to complete 5 years of treatment. Conclusion This study describes long-term adjuvant endocrine treatment in real-world settings and demonstrates the ability to leverage longitudinal EHR data to characterize oral medication treatment patterns in patients with cancer.

scholarly journals AB0649 REAL WORLD EFFICACY OF SECUKINUMAB: A SINGLE CENTRE EXPERIENCE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1619-1620
Author(s):  
G. Kasavkar ◽  
T. Blake ◽  
N. Gullick
Keyword(s):  
Clinical Trial ◽  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Adverse Events ◽  
Real World ◽  
Certolizumab Pegol ◽  
Tender Joint Count ◽  
Inadequate Response ◽  
Technology Appraisal ◽  
New Onset

Background:Secukinumab was approved by NICE for patients with active Ankylosing Spondylitis and Psoriatic Arthritis in 2017. Clinical trial data suggests secukinumab is a useful treatment option in both conditions, but often real world experience differs greatly from clinical trial results. In addition, patients with more refractory disease are often excluded from clinical trials.Objectives:To assess the response to secukinumab in patients with seronegative spondyloarthropathy receiving treatment at University Hospital Coventry and WarwickshireMethods:Patients starting secukinumab at UHCW were identified from the Blueteq funding database. Medical notes were reviewed retrospectively to assess response rates using BASDAI responses in Ankylosing spondylitis and PsARC responses in PsA. Patients who had previously had inadequate response to TNF inhibitors (PsA only) and severe psoriasis received 300mg secukinumab monthly; the remainder were prescribed 150mg monthly.Results:146 patients commenced secukinumab between June 2017 and January 2020 and had outcome data recorded. 73 patients (50%) had received previous biologic agents prior to secukinumab exposure. Patients with Ankylosing spondylitis had high BASDAI (6.8±1.4) and spinal pain (7.5±1.4). 48 patients had an initial response to treatment as per outcome measures done before and after Secukinumab inception. Secukinumab was effective in 89 patients (94%), and 87 (91%) continued treatment.In psoriatic arthritis, despite high levels of activity at baseline (mean tender joint count 10±8; swollen joint count 6±3) and 65% prior biologic exposure; high rates of response were seen. The majority of patients have continued treatment. Secukinumab was well tolerated in both patient groups with low rates of discontinuation due to adverse events (8 patients, 5%). Adverse events included recurrent infection (3), rash (1), mouth ulcers (1), vertigo (1), new onset cancer (1) and new onset Crohn’s (1) although rates were low overall. Patients with pre-existing uveitis did not develop exacerbations but low numbers of patients with prior uveitis were treated.PsA (n=51)AS (n=95)Age in years, mean (SD)53 (13)49(12)Male sex, n (%)21 (41)62 (65)Disease duration in years, mean (SD)8 (8)10.9 (9.2)Previous biologic exposure, n (%)30 (65)43 (48)Number of prior biologics, median (range)1 (1-4)1 (1-4)Responder, n (%)37 (72)*89 (93)Discontinuation, n(%)12 (24)8 (8.5)Adverse events62Lack of efficacy64Other02*Response could not be assessed in 3/51 PsA patients due to insufficient clinical data; these patients have been recorded as non respondersConclusion:Secukinumab demonstrates high levels of efficacy even in a cohort of patients with longstanding PSA and AS with high rates of inadequate responses to other biologics.Secukinumab is well tolerated with low rates of discontinuation due to adverse events.References:Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs Technology appraisal guidance [TA445]Secukinumab for active ankylosing spondylitis after treatment with non-steroidal anti-inflammatory drugs or TNF-alpha inhibitors Technology appraisal guidance [TA407]Disclosure of Interests:None declared

scholarly journals Alemtuzumab in the long-term treatment of relapsing-remitting multiple sclerosis: an update on the clinical trial evidence and data from the real world

2017 ◽  
Vol 10 (10) ◽  
pp. 343-359 ◽  
Author(s):  
Tjalf Ziemssen ◽  
Katja Thomas
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Mechanism Of Action ◽  
Real World ◽  
Continuous Treatment ◽  
The Real ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Alemtuzumab is a humanized monoclonal antibody approved for the treatment of relapsing-remitting multiple sclerosis (RRMS), given as two annual courses on five consecutive days at baseline and on three consecutive days 12 months later. Here we provide an update on the long-term efficacy and safety of alemtuzumab in RRMS, including real-world experience, and advances in our understanding of its mechanism of action. Recent data from the phase II/III extension study have demonstrated that alemtuzumab reduces relapse rates, disability worsening, and the rate of brain volume loss over the long term, with many patients achieving no evidence of disease activity. In high proportions of patients, preexisting disability remained stable or improved. Alemtuzumab is associated with a consistent safety profile over the long term, with no new safety signals emerging and the overall annual incidence of reported adverse events decreasing after the first year on treatment. Acyclovir prophylaxis reduces herpetic infections, and monitoring has been shown to mitigate the risk of autoimmune adverse events, allowing early detection and overall effective management. Data from clinical practice and ongoing observational studies are providing additional information on the real-world use of alemtuzumab. Recent evidence on the mechanism of action of alemtuzumab indicates that in addition to its previously known effects of inducing depletion and repopulation of T and B lymphocytes, it also results in a relative increase of cells with memory and regulatory phenotypes and a decrease in cells with a proinflammatory signature, and may further promote an immunoregulatory environment through an impact on other innate immune cells (e.g. dendritic cells) that play a role in MS. These effects may allow preservation of innate immunity and immunosurveillance. Together, these lines of evidence help explain the durable clinical efficacy of alemtuzumab, in the absence of continuous treatment, in patients with RRMS.

Real-world evaluation of weight loss in patients with T2DM treated with canagliflozin (CANA) – An electronic health-record (EHR)-based study

2016 ◽  
Vol 120 ◽  
pp. S118-S119
Author(s):  
Patrick Lefebvre ◽  
Wing Chow ◽  
Dominic Pilon ◽  
Bruno Emond ◽  
Marie-Hélène Lafeuille ◽  
...  
Keyword(s):  
Weight Loss ◽  
Electronic Health Record ◽  
Real World ◽  
Health Record ◽  
Electronic Health

scholarly journals Use of electronic health record data from diverse primary care practices to identify and characterize patients’ prescribed common medications

2018 ◽  
Vol 26 (1) ◽  
pp. 172-180 ◽  
Author(s):  
Allison M Cole ◽  
Kari A Stephens ◽  
Imara West ◽  
Gina A Keppel ◽  
Ken Thummel ◽  
...  
Keyword(s):  
Primary Care ◽  
Adverse Events ◽  
Electronic Health Record ◽  
Research Network ◽  
Health Record ◽  
Electronic Health Record Data ◽  
Record Data ◽  
Care Practices ◽  
Electronic Health ◽  
Primary Care Practices

We use prescription of statin medications and prescription of warfarin to explore the capacity of electronic health record data to (1) describe cohorts of patients prescribed these medications and (2) identify cohorts of patients with evidence of adverse events related to prescription of these medications. This study was conducted in the WWAMI region Practice and Research Network (WPRN)., a network of primary care practices across Washington, Wyoming, Alaska, Montana and Idaho DataQUEST, an electronic data-sharing infrastructure. We used electronic health record data to describe cohorts of patients prescribed statin or warfarin medications and reported the proportions of patients with adverse events. Among the 35,445 active patients, 1745 received at least one statin prescription and 301 received at least one warfarin prescription. Only 3 percent of statin patients had evidence of myopathy; 51 patients (17% of those prescribed warfarin) had a bleeding complication. Primary-care electronic health record data can effectively be used to identify patients prescribed specific medications and patients potentially experiencing medication adverse events.

scholarly journals An automated electronic health‐record derived frailty index is associated with adverse events after endoscopy

2021 ◽  
Author(s):  
Jared Rejeski ◽  
Ted Xiao ◽  
William Wheless ◽  
Nicholas M. Pajewski ◽  
Elizabeth Jensen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Electronic Health Record ◽  
Frailty Index ◽  
Health Record ◽  
Electronic Health
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