scholarly journals A retrospective, real world experienced of perampanel monotherapy in patient with first new onset focal seizure: A Thailand experience

2021 ◽  
Author(s):  
Yotin Chinvarun
Keyword(s):  
Real World ◽  
Focal Seizure ◽  
New Onset

Clinical profile and etiological evaluation of new onset focal seizure in adults

2019 ◽  
Vol 12 (3) ◽  
pp. 69-73
Author(s):  
Sachin S Bangar ◽  
◽  
Akshay B Shinde ◽  
Keyword(s):  
Focal Seizure ◽  
Clinical Profile ◽  
New Onset

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 P179 Glucocorticoid exposure and link to serious adverse events in patients with ANCA-associated vasculitis

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Philip Spearpoint ◽  
Cormac Sammon ◽  
Antonio Ramirez de ◽  
Arellano Serna ◽  
Peter Rutherford
Keyword(s):  
Cardiovascular Disease ◽  
Adverse Events ◽  
Renal Disease ◽  
Real World ◽  
Low Dose ◽  
Remission Induction ◽  
High Dose ◽  
Anca Associated Vasculitis ◽  
Increased Risk ◽  
New Onset

Abstract Background Remission induction in ANCA-associated vasculitis (AAV) is with high dose glucocorticoids (GC) and immunosuppressants. Patients are exposed to high GC dose and/or prolonged low dose. EULAR/EDTA guidelines target 7.5-10mg at 3 months but acknowledge this is often achieved later. This study used UK real world practice data to examine the scale of GC exposure and associated clinical risks in AAV. Methods The study utilised the Clinical Practice Research Datalink (CPRD) - Hospital Episode Statistics (HES) linked database. AAV patients were identified using specific READ and ICD codes and followed between 01/01/1997 and 01/01/2018. GP prescriptions were used to describe periods of continuous GC use, stop and restart and when high dose (> 30mg/day) and low dose (<30mg/day) was prescribed. Diagnostic codes indicative of infections and adverse events linked to GCs were used to estimate rates in the AAV population using a generalized linear model with a Poisson distribution. Results 450 AAV patients with at least one GC prescription were analysed. The median dose decreased to 9.3 mg (IQR 5.0 - 17.0) at 6 months and 5.1 mg (0.00 - 10.0) at 12 months,50% patients were taking > 10mg at 5 months and 25% were still > 10mg at 12 months. However, within 6 months of achieving 10mg/day, 50% relapse to needing dose >10mg, 75% within 2 years and 90% within 6 years. In adjusted Poisson model (age, gender, year of diagnosis before/after 2013) the rate of infection in AAV patients taking high dose was 2.59 times (CI95 1.95, 3.45) that of those on low dose and lower in those not taking GCs (IRR 0.27 (0.22-0.34)). Increased risk of new onset cardiovascular disease (IRR 2.55 (0.92, 7.04)) and new onset renal disease (IRR 3.4 (1.29-8.96)) were higher in patients receiving high dose. Conclusion AAV patients have significant exposure to high dose GCs and in real world practice, GC dose remains higher than recommended in current clinical guidelines. High dose GCs are associated with high risk of infection and new cardiovascular disease and renal disease. This creates a significant patient burden and has implications for healthcare resource use. Disclosures P. Spearpoint: Corporate appointments; Employee of Vifor Pharma. C. Sammon: Corporate appointments; Employee of PHMR. A. Ramirez de Arellano Serna: Corporate appointments; Employee of Vifor Pharma. P. Rutherford: Corporate appointments; Employee of Vifor Pharma. Shareholder/stock ownership; Vifor Pharma.

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 Elevated Triglycerides (≥150 mg/dL) and High Triglycerides (200–499 mg/dL) Are Significant Predictors of Hospitalization for New-Onset Kidney Disease: A Real-World Analysis of High-Risk Statin-Treated Patients

2019 ◽  
Vol 9 (6) ◽  
pp. 400-407 ◽  
Author(s):  
Peter P. Toth ◽  
Sephy Philip ◽  
Michael Hull ◽  
Craig Granowitz
Keyword(s):  
High Risk ◽  
Kidney Disease ◽  
Real World ◽  
Density Lipoprotein ◽  
Cox Proportional Hazards Model ◽  
Lipoprotein Cholesterol ◽  
Administrative Claims ◽  
Atherosclerotic Cardiovascular Disease ◽  
Research Database ◽  
New Onset

Background: Dyslipidemia in kidney disease (KD) involves increased levels of triglycerides (TG) and TG-rich lipoproteins, with only minor changes in low-density lipoprotein cholesterol. The increasing prevalence of diabetic KD and the shared atherogenic lipid profile between KD and diabetes underscore the importance of understanding dyslipidemia in these patients. Previous studies suggest an association between elevated TG and new-onset KD. Additional data are needed to better define the relationship between hypertriglyceridemia and new-onset KD. Objective: To evaluate the real-world impact of elevated and high TG on risk of KD in high-risk statin-treated patients. Methods: This retrospective administrative claims analysis of the Optum Research Database included statin-treated patients (age ≥45 years) with diabetes and/or atherosclerotic cardiovascular disease who were followed for ≥6 months. Cohorts included patients with elevated TG (≥150 mg/dL; n = 27,471) or high TG (200–499 mg/dL; subgroup of elevated TG cohort; n = 13,411), and a comparator cohort (TG <150 mg/dL and high-density lipoprotein cholesterol >40 mg/dL; n = 32,506). The probability of hospitalization for new-onset KD was calculated post hoc from multivariate analyses controlled for patient characteristics and comorbidities using a Cox proportional hazards model. Results: The rate of hospitalization for new-onset KD was 31% higher in the elevated-TG cohort (hazard ratio [HR], 1.311; 95% confidence interval [CI], 1.228–1.401; p < 0.001) and 45% higher in the high-TG cohort (HR, 1.451; 95% CI, 1.339–1.572; p < 0.001) compared with the respective comparator cohorts. Conclusions: In a real-world analysis of statin-treated patients with high cardiovascular risk, both elevated TG (≥150 mg/dL) and high TG (200–499 mg/dL) were significant predictors of hospitalization for new-onset KD, identifying hypertriglyceridemia as a potential KD risk factor.

scholarly journals New Onset Focal Seizure Following COVID-19 Vaccination: Case Report

2021 ◽  
Author(s):  
Chun Seng Phua ◽  
Shalini Bhaskar ◽  
Azman Ali Raymond
Keyword(s):  
Case Report ◽  
Side Effects ◽  
Focal Seizure ◽  
Seizure Threshold ◽  
Hippocampal Atrophy ◽  
Case Presentation ◽  
Mri Brain ◽  
Focal Seizures ◽  
Patient’S History ◽  
New Onset

Abstract IntroductionAs more novel COVID-19 vaccines are being rolled out in a frantic pace globally, any complication that might be related to COVID-19 vaccines should be highlighted, especially since COVID-19 vaccines are relatively new, and side effects may yet to be fully elucidated. We report a case of a healthy 18-year-old male who presented with new onset focal seizures 5 days after receiving 1st dose of Oxford/AstraZeneca COVID-19 vaccine. Case PresentationThe patient was treated with intravenous phenytoin and oral levetiracetam 250mg twice daily with no further events. There was no documented fever. CT venogram and EEG were unremarkable. MRI brain revealed generalised atrophy including mild bilateral hippocampal atrophy with no evidence of sclerosis. There was no predilection for seizures identified from the patient’s history. The patient was discharged the following day on levetiracetam and advised to proceed with the 2nd dose of Oxford/AstraZeneca COVID-19 vaccination in 3 months’ time.ConclusionSeizures following COVID-19 vaccination have only been reported in a handful of cases. COVID-19 vaccination could lower seizure threshold, or unmask an underlying predisposition for epilepsy. As most COVID-19 vaccines worldwide are given in 2 doses, clinicians should consider maintaining patients on anti-seizure drugs if vaccination was thought to be a provoking factor.

THU0393 INFLAMMATORY BOWEL DISEASES AMONG SECUKINUMAB-TREATED PATIENTS: 24 CASES FROM THE MISSIL REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 431.1-431
Author(s):  
J. G. Letarouilly ◽  
B. Pariente ◽  
D. Staumont-Sallé ◽  
P. Goupille ◽  
P. Claudepierre ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Real World ◽  
Bowel Disease ◽  
Research Support ◽  
Real World Data ◽  
Pooled Data ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
New Onset

Background:An alert regarding about the tolerance of Interleukin 17 (IL-17) inhibitors has been issued from data of randomized controlled trials showing cases of de novo inflammatory bowel diseases (IBD). In a recent analysis of pooled data from 21 clinical trials, cases of IBD events (including Crohn’s disease (CD), ulcerative colitis (UC) and inflammatory bowel disease unclassified (IBDU)) were uncommon (1). Yet, real-world data are lacking.Objectives:To describe real-world data about patients treated by IL-17 inhibitors developing new onset IBD (CD or UC).Methods:A French national registry called MISSIL was started in February 2018 to collect the cases of patients treated by IL-17 inhibitors developing new onset IBD. This registry is conducted by rheumatologist, dermatologist and gastroenterologist learned societies specialized on immune-mediated inflammatory diseases. In France, secukinumab (SEK) has been granted market authorization since June 2016 and ixekizumab since April 2018.Results:24 cases under SEK were reported between February 2018 and January 2020: 3 patients with psoriasis and 21 patients with spondylwoarthritis. There were 20 patients with new onset CD and 4 with UC. Mean age was 51.7 ± 15.7 years old and 12/24 were female; 10 presented an axial spondyloarthritis, 5 a peripheral spondyloarthritis and 6 both,13/17 were HLA-B27 positive,7/19 had a radiographic sacroiliitis and 11/17 a MRI sacroiliitis. Only 2 were biological Disease-modifying antirheumatic drug (bDMARD)-naïve. Crohn’s disease was mainly located at the ileum, colon and rectum. The median time to onset of symptoms was 2 (1-6) months. The main symptoms were diarrhea, nausea and vomiting and loss of weight. Median CRP at the onset of symptoms was 68 mg/L (41-140.5); 21 patients underwent biopsies, 12 were in favor of CD. IL-17 inhibitors were consistently stopped. Patients were treated by corticosteroids (16/24), mesalazine (7/24), methotrexate (3/24), thiopurines (2/24), infliximab (9/243), adalimumab (3/24), golimumab (2/24), ustekinumab (5/24). The evolution was favorable under treatment with complete resolution (4/24), improvement (11/24) or stabilization (5/24). 3 patients worsened under treatment and 1 died (massive myocardial infarction).Conclusion:IBD flare in patients treated with IL-17 inhibitors are rare and lead to discuss the potential iatrogenic role of IL-17 inhibitor drugs. Further cases are needed to better characterize this complication. A case-control study will be conducted to identify patients at risk to develop IBD under IL-17 inhibitor.References:[1]Reich et al. Incidence rates of inflammatory bowel disease in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis treated with secukinumab: a retrospective analysis of pooled data from 21 clinical trials. Ann Rheum Dis. 2019;78:473-479Disclosure of Interests:Jean-Guillaume Letarouilly Grant/research support from: Research grant from Pfizer, Benjamin Pariente: None declared, Delphine Staumont-Sallé Speakers bureau: Lilly, Novartis, Philippe Goupille Grant/research support from: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Consultant of: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Speakers bureau: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Pascal Claudepierre Speakers bureau: Janssen, Novartis, Lilly, Stephane Varin: None declared, Sylvain Lanot: None declared, Emmanuelle Dernis Speakers bureau: Lilly, Novartis, Tristan Pascart Speakers bureau: Novartis, Lilly, Beatrice Banneville Speakers bureau: Lilly, Novartis, Pauline Baudart: None declared, Bruno Gombert: None declared, Elodie BAUER: None declared, Laurianne Plastaras: None declared, Sébastien Barbarot: None declared, Renaud FELTEN: None declared, Loïc Le Dantec: None declared, Nathalie Sultan-Bichat: None declared, Céline Girard: None declared, Arnaud Constantin Grant/research support from: Study was sponsored by Sanofi Genzyme, Consultant of: Consulting fees from Abbvie, BMS, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, Daniel Wendling: None declared, Philippe Gaudin Speakers bureau: Lilly, Denis Jullien Speakers bureau: Lilly, Novartis, Thao Pham Speakers bureau: Novartis, Janssen, Lilly, Rene-Marc Flipo Speakers bureau: Novartis, Janssen, Lilly

Sign in / Sign up

Export Citation Format

Share Document