Safety of Infliximab Treatment in Patients with Rheumatoid Arthritis in a Real-world Clinical Setting: Description and Evaluation of Infusion Reactions

2012 ◽  
Vol 39 (8) ◽  
pp. 1539-1545 ◽  
Author(s):  
JOHN KELSALL ◽  
PAMELA ROGERS ◽  
GRISELDA GALINDO ◽  
MARY A. De VERA
Keyword(s):  
Inflammatory Arthritis ◽  
Reaction Rate ◽  
Chart Review ◽  
Primary Outcome ◽  
Retrospective Chart Review ◽  
Infusion Reaction ◽  
Secondary Outcome ◽  
Infliximab Treatment ◽  
Infusion Reactions ◽  
Acute Reaction

Objective.To describe acute and delayed infusion reactions in a large cohort of patients with inflammatory arthritis, treated with infliximab (IFX).Methods.We conducted a retrospective chart review of patients treated with IFX at the Mary Pack Arthritis Centre between 2000 and 2008. The primary outcome was the occurrence of acute infusion reactions during infusions or 1–2 hours after each infusion, and secondary outcome was the occurrence of delayed infusion reactions 1–14 days after an infusion. Descriptive analyses were conducted to summarize study outcomes and identify trends over followup.Results.Since 2000, 376 patients were referred to the Mary Pack IFX clinic and 200 received 4399 IFX infusions over a mean 140 ± 132 weeks of followup. Of these, 135 were patients with RA who received 2977 IFX infusions over mean followup of 138 ± 132 weeks. In total 258 episodes of acute reactions were observed for an overall acute reaction rate of 5.8%. Acute infusion reactions were mostly mild (42.6%) and moderate (43.8%) and commonly affected sites were head and neck (31.5%) and cutaneous (21.1%). A total of 37 delayed infusion reaction episodes were observed (0.9% rate); reactions were also mostly mild (16.2%) and moderate (64.9%).Conclusion.These clinical data from 200 patients treated with IFX demonstrate that acute and delayed infusion reactions occur infrequently and are mostly mild to moderate in presentation.

System intervention in community pharmacy setting: Leading to better patient care through reducing harm associated with coprescribing benzodiazepines and opioids

2021 ◽  
Vol 17 (6) ◽  
pp. 445-453
Author(s):  
Angelina Vascimini, PharmD ◽  
Kevin Duane, PharmD ◽  
Stacey Curtis, PharmD
Keyword(s):  
Chart Review ◽  
Primary Outcome ◽  
Community Pharmacists ◽  
Retrospective Chart Review ◽  
Secondary Outcome ◽  
Post Intervention ◽  
Improvement Project ◽  
System Intervention ◽  
Secondary Outcomes ◽  
Pharmacy Setting

Objective: The opioid epidemic is frequently discussed including the staggering numbers involved with coprescribing opioids and benzodiazepines associated with death. Community pharmacists, with the help of a system intervention, have a unique opportunity to help reduce the coprescribing of benzodiazepines and opioids and reduce the associated risk of death.Design: A single center retrospective chart review was conducted after a system intervention was placed, as a quality improvement project, from November 2019 to May 2020.Setting: Independent community pharmacy.Patients/participants: Data included demographics, dosing of each medication pre- and post-intervention, and naloxone status.Main outcome(s) measures: The primary outcome evaluated was reduction in dose/discontinuation of these prescriptions. The secondary outcome evaluated was the number of naloxone prescriptions ordered per protocol and picked up.Results: The primary outcome did not show statistical difference; however, the secondary outcomes showed statistical significance.Conclusion: In conclusion, community pharmacists, with the help of evolving technologies, can reduce harm associated with the coprescribing of benzodiazepines and opioids.

Assessment of Safety of Remdesivir in Covid −19 Patients with Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min per 1.73 m^2

2021 ◽  
pp. 088506662110705
Author(s):  
Shan Wang ◽  
Christy Huynh ◽  
Shahidul Islam ◽  
Brian Malone ◽  
Naveed Masani ◽  
...  
Keyword(s):  
Chart Review ◽  
Primary Outcome ◽  
Therapeutic Option ◽  
Kidney Injury ◽  
Retrospective Chart Review ◽  
Secondary Outcome ◽  
Oxygen Requirement ◽  
End Of Treatment ◽  
Review Study ◽  
T1 And T2

Purpose Safety of remdesivir in patients with renal impairment is unknown. Incidence of liver injury secondary to remdesivir is also unknown. The objective of this study is to assess the incidence of acute kidney injury (AKI) and to trend the liver enzymes during remdesivir treatment and change in eGFR from baseline to end of treatment as well as 48 h post completion of remdesivir therapy. Methods This is a retrospective chart review study including adult patients admitted with COVID-19 receiving remdesivir with a baseline eGFR < 30 ml/min per 1.73 m^2 from December 2020 to May 2021. The primary outcome was to assess the incidence of AKI and hepatic injury. The secondary outcome was to assess the efficacy of remdesivir defined by change in oxygen requirement. Results Seventy-one patients were included in the study. Patients experienced an improvement in eGFR from baseline (T0) to end of remdesivir treatment (T1), as well as 48 h after the end of the treatment (T2) ( + 30.3% and + 30.6% respectively, P < .0001). Creatinine reduced from baseline (T0) to T1 and T2 (-20.9% and −20.5% respectively, P < .0001). Creatinine clearance improved from baseline to T1 and T2 ( + 26.6% and + 26.2% respectively, p < .0001). Elevation of aminotransferase (AST) was observed at T1 ( + 2.5%, P  =  .727), however, AST reduction was seen at T2 (-15.8%, P  =  .021). Elevation in alanine transaminase (ALT) was observed at T1 and T2 ( + 25% and + 12%, P  =  .004 and P  =  .137 respectively). Both direct and total bilirubin remained stable and were not significantly changed from baseline. Conclusion Our study showed that remdesivir use in renally-impaired patients with eGFR < 30 ml/min is safe. Remdesivir may be considered as a therapeutic option in this population with COVID-19 infection.

scholarly journals Intermediate outcomes of ab externo circumferential trabeculotomy and canaloplasty in POAG patients with prior incisional glaucoma surgery

2020 ◽  
Author(s):  
Huaizhou Wang ◽  
Chen Xin ◽  
Ying Han ◽  
Yan Shi ◽  
Sarah Ziaei ◽  
...  
Keyword(s):  
Chart Review ◽  
Primary Outcome ◽  
Open Angle Glaucoma ◽  
Retrospective Chart Review ◽  
Glaucoma Surgery ◽  
Secondary Outcome ◽  
Filtering Surgery ◽  
Intermediate Outcomes ◽  
Topical Medications

Abstract Background: To compare the efficacy and safety of ab externo circumferential trabeculotomy (ECT) and canaloplasty on primary open angle glaucoma (POAG) patients with failed filtering surgery and intact schlemm’s canal (SC). Methods : We conducted a retrospective chart review of POAG patients with failed filtering surgery and intact SC, who further received ECT and canaloplasty. The primary outcome measures were intraocular pressure (IOP) and the number of topical medications at each follow-up point.The secondary outcome compared the quantified success rate at1-year follow-up between the groups. Results: Twenty-nine eyes were recruited in the ECT group and 19 eyes in canaloplasty group. The postoperative IOP and the number of topical medications decreased significantly in both groups(p<0.001). The IOP at 3-month and 6-monthwas significantly lower in the ECT group (p=0.039, p=0.001) than in the canaloplasty group. Although the IOP at 12-mon was similar between the two groups, the number of topical medications was less in the ECP group (p=0.040). Hyphema (72.4%) and ciliary body detachment (27.6%), which mainly resolve spontaneously, were two leading complications in the ECT group. The prevalence of hyphema was higher in ECT than in canaloplasty group (p<0.001). Conclusion: For POAG with failed filtering surgery and intact SC, canaloplasty may be safer, whereas ECT presented better IOP control.

scholarly journals Intermediate Outcomes of ab Externo Circumferentialtrabeculotomy and Canaloplastyin POAG Patients with Prior Incisional Glaucoma Surgery

2020 ◽  
Author(s):  
Huaizhou Wang ◽  
Chen Xin ◽  
Ying Han ◽  
Yan Shi ◽  
Sarah Ziaei ◽  
...  
Keyword(s):  
Chart Review ◽  
Primary Outcome ◽  
Open Angle Glaucoma ◽  
Retrospective Chart Review ◽  
Glaucoma Surgery ◽  
Secondary Outcome ◽  
Filtering Surgery ◽  
Intermediate Outcomes ◽  
Topical Medications

Abstract Background: To compare the efficacy and safety of ab externo circumferential trabeculotomy (ECT) and canaloplasty on primary open angle glaucoma (POAG) patients with failed filtering surgery and intact schlemm’s canal (SC).Methods: We conducted a retrospective chart review of POAG patients with failed filtering surgery and intact SC, who further received ECT and canaloplasty. The primary outcome measures were intraocular pressure (IOP) and the number of topical medications at each follow-up point.The secondary outcome compared the quantified success rate at1-year follow-up between the groups. Results:Twenty-nine eyes were recruited in the ECT group and 19 eyes in canaloplasty group. The postoperative IOP and the number of topical medications decreased significantly in both groups(p<0.001). The IOP at 3-month and 6-monthwas significantly lower in the ECT group (p=0.039, p=0.001) than in the canaloplasty group. Although the IOP at 12-mon was similar between the two groups, the number of topical medications was less in the ECP group (p=0.040). Hyphema (72.4%) and ciliary body detachment (27.6%), which mainly resolve spontaneously, were two leading complications in the ECT group. The prevalence of hyphema was higher in ECT than in canaloplasty group (p<0.001). Conclusion: For POAG with failed filtering surgery and intact SC, canaloplasty may be safer, whereas ECT presented better IOP control.Translational Relevance:

scholarly journals Intermediate outcomes of ab externo circumferential trabeculotomy and canaloplasty in POAG patients with prior incisional glaucoma surgery

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Huaizhou Wang ◽  
Chen Xin ◽  
Ying Han ◽  
Yan Shi ◽  
Sarah Ziaei ◽  
...  
Keyword(s):  
Chart Review ◽  
Primary Outcome ◽  
Open Angle Glaucoma ◽  
Retrospective Chart Review ◽  
Glaucoma Surgery ◽  
Secondary Outcome ◽  
Filtering Surgery ◽  
Intermediate Outcomes ◽  
Topical Medications

Abstract Background To compare the efficacy and safety of ab externo circumferential trabeculotomy (ECT) and canaloplasty on primary open angle glaucoma (POAG) patients with failed filtering surgery and intact schlemm’s canal (SC). Methods We conducted a retrospective chart review of POAG patients with failed filtering surgery and intact SC, who further received ECT and canaloplasty. The primary outcome measures were intraocular pressure (IOP) and the number of topical medications at each follow-up point. The secondary outcome compared the quantified success rate at1-year follow-up between the groups. Results Twenty-nine eyes were recruited in the ECT group and 19 eyes in canaloplasty group. The postoperative IOP and the number of topical medications decreased significantly in both groups (p < 0.001). The IOP at 3-month and 6-monthwas significantly lower in the ECT group (p = 0.039, p = 0.001) than in the canaloplasty group. Although the IOP at 12-mon was similar between the two groups, the number of topical medications was less in the ECT group (p = 0.040). Hyphema (72.4%) and ciliary body detachment (27.6%), which mainly resolve spontaneously, were two leading complications in the ECT group. The prevalence of hyphema was higher in ECT than in canaloplasty group (p < 0.001). Conclusion For POAG with failed filtering surgery and intact SC, canaloplasty may be safer, whereas ECT presented better IOP control. Translational Relevance: Suggestions for surgical choice for POAG with failed filtering surgery.

scholarly journals O26 Testing an intervention to reduce fatigue impact in inflammatory arthritis: design and outcomes of a single-arm feasibility study

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Susan Bridgewater ◽  
Joe Lomax ◽  
Bryan Abbott ◽  
Jo Adams ◽  
Alice Berry ◽  
...  
Keyword(s):  
Feasibility Study ◽  
Inflammatory Arthritis ◽  
Primary Outcome ◽  
Time Frame ◽  
Secondary Outcome ◽  
Control Group ◽  
Regression To The Mean ◽  
Intervention Delivery ◽  
Cognitive Behavioural ◽  
One To One

Abstract Background/Aims  Patients with inflammatory arthritis report that fatigue can be a challenging symptom to manage, with little support available. In response, we developed a brief one-to-one cognitive-behavioural manualised intervention, delivered by rheumatology health professionals (RHPs), to help patients manage their fatigue. Methods  We designed a single-arm feasibility study called FREE-IA (Fatigue - Reducing its Effects through individualised support Episodes in Inflammatory Arthritis). Patients were eligible if they were ≥18 years, had a clinician confirmed diagnosis of inflammatory arthritis, scored ≥6/10 on the BRAF NRS Fatigue Impact with fatigue that they considered recurrent, frequent, and/or persistent, and were not accessing support for their fatigue. Following training, RHPs delivered 2-4 one-to-one sessions to participants. The initial two core sessions were delivered face-to-face in clinic; participants then had the option of up to two further sessions, either in clinic, by telephone or online. We proposed delivering sessions 1 and 2 within two weeks of each other, and sessions 3 and 4 in the following two weeks. Baseline data were collected before the first session (T0), and outcomes at six weeks (T1) and six months (T2). The primary outcome was fatigue impact (BRAF NRS Fatigue Effect), collected by telephone. Secondary outcomes included fatigue severity, fatigue coping, multi-dimensional impact of fatigue, disease impact and disability and measures of therapeutic mechanism (self-efficacy, and perceived confidence and autonomy to manage health). These outcomes were collected by post. This study allowed us to test the feasibility and acceptability of RHP training, study design and materials, intervention delivery and outcome collection, ahead of a possible RCT to determine intervention effectiveness. Results  Eight RHPs at five hospitals delivered 113 sessions to 46 participants. Four sessions were delivered by phone and none online. Session 2 was only delivered within the two-week time frame for 37% of participants attending both core sessions. Out of a potential 138 primary and secondary outcome responses at T0, T1 and T2, there were 13 missing primary outcome responses and 27 missing secondary outcome responses. Results indicated improvements in all measures except disability at either T1 or T2, or both, with confidence intervals supporting an interpretation of improvement. Conclusion  We were able to design and deliver FREE-IA training to RHPs, deliver FREE-IA sessions to patients, and collect outcomes at three time points with low levels of attrition. Outcomes in all measures except disability were in a direction to suggest improvement at T1, T2, or both. Study numbers were small, there was no control group and regression to the mean was a possibility. However, outcomes were in the direction to cautiously suggest benefit, and there is evidence of promise of the intervention. A definitive RCT is the next step to test clinical and cost effectiveness of the intervention. Disclosure  S. Bridgewater: None. J. Lomax: None. B. Abbott: None. J. Adams: None. A. Berry: None. S. Creanor: None. P. Ewings: None. S. Hewlett: None. L. McCracken: None. M. Ndosi: None. J. Thorn: None. M. Urban: None. E. Dures: None.

scholarly journals Real-World Experience With Acute Infusion Reactions to Ustekinumab at 2 Large Tertiary Care Centers

2020 ◽  
Vol 2 (2) ◽  
Author(s):  
Elizabeth A Spencer ◽  
Jami Kinnucan ◽  
Julie Wang ◽  
Marla C Dubinsky
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Tertiary Care ◽  
Retrospective Chart Review ◽  
Infusion Reaction ◽  
Large Tertiary Care ◽  
Infusion Reactions ◽  
Tertiary Care Centers

Abstract Background Ustekinumab is approved for Crohn’s disease and Ulcerative colitis with acute infusion reactions reported at a rate of 0.9%–4.5%. Methods A retrospective chart review was conducted on inflammatory bowel disease (IBD) patients experiencing an acute infusion reaction to ustekinumab at 2 large institutions. Results Acute ustekinumab infusion reactions occurred in 16 patients with Crohn’s disease (CD) and Ulcerative colitis (UC), at a rate of 0.8%–3%. Patients were all naïve to ustekinumab, receiving their initial IV induction. Ninety-three percent subsequently tolerated the injection without issues. Conclusions In this large, real-world study of acute infusion reactions to ustekinumab, the rate was similar to that seen in clinical trials—0.8%–3%.

scholarly journals GP.04 Prevalence and determinants of seizure action plans in a pediatric epilepsy population

2019 ◽  
Vol 46 (s1) ◽  
pp. S7
Author(s):  
M Chiu ◽  
S Peinhof ◽  
M Borhani ◽  
C DeGuzman ◽  
C Siu ◽  
...  
Keyword(s):  
Mobile Application ◽  
Chart Review ◽  
Primary Outcome ◽  
Action Plan ◽  
Univariate Analysis ◽  
Male Gender ◽  
Secondary Outcome ◽  
Pediatric Epilepsy ◽  
History Of ◽  
Timely Treatment

Background: Status epilepticus (SE) is the most common pediatric neurological emergency. Timely treatment is crucial, yet administration of rescue medications is often delayed and under-dosed. We aim to improve SE management by ensuring that every child at risk of SE in our province has an individualized seizure action plan (SAP) outlining the steps that should be taken during SE. Methods: A survey was distributed to parents of epilepsy patients aged 1 month to 19 years. Primary outcome was percentage of patients with SAPs. Secondary outcome was parental interest in a SAP mobile application. Following chart review, univariate and multivariate analysis was performed to identify variables that predict whether patients have SAPs. Results: Of 192 participants, 61.5% have SAPs. On univariate analysis, history of prior SE and male gender increased likelihood of having a SAP. On logistic regression, Nagelkerke R2 was 0.204 and our model correctly predicted 82.2% of patients with SAPs. 83.3% of parents were interested in a SAP mobile application. Conclusions: This is one of the first studies to examine SAP prevalence in a pediatric epilepsy population. There is a need to increase the percentage of epilepsy patients with SAPs. Most parents would find a SAP mobile application valuable in their child’s management.

scholarly journals Perioperative Intravenous Acetaminophen in Pediatric Tonsillectomies

2018 ◽  
Vol 53 (5) ◽  
pp. 316-320 ◽  
Author(s):  
Brandi Bowman ◽  
Leslie Sanchez ◽  
Preeyaporn Sarangarm
Keyword(s):  
Chart Review ◽  
Primary Outcome ◽  
Pediatric Patients ◽  
Retrospective Chart Review ◽  
Descriptive Statistics ◽  
Pain Medications ◽  
Frequent Administration ◽  
Intravenous Acetaminophen ◽  
Sparing Effect ◽  
Opiate Administration

Purpose: This study investigated the effect of perioperative intravenous (IV) acetaminophen on opioid requirements in pediatric patients undergoing tonsillectomy at a single center. Methods: This retrospective chart review included patients who were less than 18 years old and underwent an outpatient tonsillectomy procedure. Patients who received non–Food and Drug Administration (FDA)-approved dosing of IV acetaminophen, without documented weights, and on chronic pain medications at the time of the procedure were excluded. The primary outcome was opioid requirements postoperatively prior to discharge measured as morphine equivalents per kilogram. Descriptive statistics were used to compare differences between groups. A multivariate analysis was performed, accounting for differences between groups in baseline and procedural characteristics. Results: In total, 157 patients were included in this study, of whom 55 had received IV acetaminophen and 102 had not. The average IV acetaminophen dose for was 14.5 mg/kg for patients weighing less than 50 kg (n = 22); the remaining patients received the maximum 1 g dose. Patients who received IV acetaminophen were less likely to be administered postoperative opiates as compared with those did not (45.5% vs 63.7%, odds ratio = 0.48, P = .036). There was a trend toward a decrease in total amount of opiates administered with IV acetaminophen (0 vs 0.033 µg/kg, P = .61). After adjusting for age and documented pain assessment, IV acetaminophen administration remained a significant factor for postoperative opiate administration. Conclusions: Perioperative administration of IV acetaminophen was associated with less frequent administration of symptom-directed opiates in pediatric tonsillectomies. This finding indicates that the agent may have an opioid-sparing effect in this patient population.

scholarly journals Pseudoseptic Arthritis: A Case Series and Review of the Literature

2011 ◽  
Vol 2011 ◽  
pp. 1-4 ◽  
Author(s):  
Brian P. Oppermann ◽  
Jonida K. Cote ◽  
Stephanie J. Morris ◽  
Thomas Harrington
Keyword(s):  
Rheumatoid Arthritis ◽  
Inflammatory Arthritis ◽  
Chart Review ◽  
Case Series ◽  
Retrospective Chart Review ◽  
Published Data ◽  
Inflammatory Condition ◽  
Gram Stain ◽  
Review Of The Literature ◽  
Pseudoseptic Arthritis

Purpose. Pseudoseptic arthritis is an acute inflammatory monoarthritis with a sterile synovial gram stain and culture. Pseudoseptic arthritis has been previously described in the literature in a variety of settings including rheumatoid arthritis and microcrystalline disease. Despite pseudoseptic arthritis being a described entity, there is little published data on this topic with no published reports since 1992.Methods. This paper was a retrospective chart review over a 20-year period that identified all rheumatology inpatient consultations at our tertiary rural hospital for pseudoseptic arthritis.Results. We identified 10 patients with pseudoseptic arthritis and presented 5 of those cases in this paper. Majority of these patients had known autoimmune inflammatory arthritis or microcrystalline inflammatory arthritis.Conclusion. Pseudoseptic arthritis is a syndrome that should be in the differential diagnosis with patients with long standing inflammatory condition who present with an acute monoarthritis with no known bacterial source for septic arthritis.

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