scholarly journals Omalizumab serum levels predict treatment outcomes in patients with chronic spontaneous urticaria: A three months prospective study

2021 ◽  
Author(s):  
Misbah Noshela Ghazanfar ◽  
Ewa Anna Bartko ◽  
Nicolai Skovbjerg Arildsen ◽  
Lars Poulsen K ◽  
Bettina Jensen ◽  
...  
Keyword(s):  
Life Quality ◽  
Peak Level ◽  
Serum Levels ◽  
Chronic Spontaneous Urticaria ◽  
Patient Specific ◽  
High Dose ◽  
Life Questionnaire ◽  
Patient Reported ◽  
Trough Concentrations ◽  
Specific Factors

Aim: To examine the association between serum levels and effectiveness of omalizumab in patients with chronic spontaneous urticaria (CSU), and explore patient-specific factors associated with omalizumab pharmacokinetics. Methods: Patients with CSU, who were refractory to high-dose antihistamines and who initiated treatment with omalizumab (300 mg every four weeks) were eligible for the study. Treatment was evaluated every 4 week during 12 weeks of treatment with urticaria activity score in the past week (UAS7) as primary outcome and urticaria control test (UCT), Chronic Urticaria Quality of Life Questionnaire (CU QoL) and dermatology life quality index (DLQI) as secondary outcomes. Serum drug level of omalizumab was measured before (trough level) and at day seven (peak level) after each injection. Results: A total of 23 patients were included. After 12 weeks of treatment with omalizumab, an improvement of 16.8 UAS7 points (95% CI 10.8-22.8), p<0.001 was seen. The omalizumab trough and peak levels were 7.0-33.1 µg/mL and 11.4-54.0 µg/mL and reached a plateau (steady state) after 8-12 weeks of treatment. Among the patient-specific factors measured at baseline (age, sex, body mass index (BMI), angioedema, basophil histamine release (HR) test, blood basophils and eosinophils, and serum total IgE), BMI was the only significant predictor of omalizumab peak concentrations during the study (difference -2.75, p<0.05), whereas omalizumab trough concentrations were significantly associated with UAS7 scores (difference -0.82, p<0.001). The same was observed for UCT, DLQI, and CU QoL. Conclusion: In patients with CSU initiating treatment with omalizumab, a higher BMI predicts lower peak concentrations of omalizumab during treatment, whereas lower trough concentrations of omalizumab are associated with a poorer response on UAS7 and other patient reported outcomes.

scholarly journals Outcomes of Meniscal Repair versus Meniscectomy in Patients with Concomitant ACL and Bucket Handle Meniscus Tears (200)

2021 ◽  
Vol 9 (10_suppl5) ◽  
pp. 2325967121S0030
Author(s):  
Laura Keeling ◽  
Alexandra Galel ◽  
Cooper Ehlers ◽  
David Wang ◽  
Edward Chang
Keyword(s):  
Meniscal Repair ◽  
Meniscus Tear ◽  
Patient Specific ◽  
Surgical Decision ◽  
Meniscus Tears ◽  
Patient Reported ◽  
Specific Factors ◽  
Surgical Decision Making ◽  
Bucket Handle

Objectives: Bucket handle meniscus tears often present concurrently with tears of the anterior cruciate ligament (ACL). However, little is known regarding the influence of demographic factors on surgical decision-making, or on outcomes following treatment of bucket handle meniscus tears in ACL-deficient patients. Furthermore, no study has compared outcomes in this population between patients undergoing meniscectomy versus repair. The purpose of this study was therefore to determine if there is a difference in outcomes between patients presenting with concomitant ACL and bucket handle meniscus tears treated with meniscal repair versus meniscectomy. A secondary aim of this study was to discover if there is an association between the decision to perform a meniscus repair or meniscectomy based on demographic factors. Methods: In this institutional review board-approved retrospective study, we evaluated 62 patients presenting with ACL tear who were found to have a bucket handle meniscus tear preoperatively or at the time of ACL reconstruction. Of those, 30 patients underwent partial meniscectomy, while 32 underwent meniscal repair. Primary outcome measures included ACL and meniscal retear rates, as well as patient-reported outcome measures (PROMs). Documented PROMs included the International Knee Documentation Committee (IKDC), Single Assessment Numeric Evaluation (SANE), and ACL-Return to Sport after Injury (ACL-RSI) scores. Demographic and patient-specific factors evaluated included age, body mass index (BMI), smoking status, and location of meniscus tear. Results: Of 62 patients presenting for ACL reconstruction with concomitant bucket handle meniscus tear, a total of 34 patients with greater than one year (mean 22.4 month) follow-up were included. 14 patients underwent repair, and 20 underwent meniscectomy. No significant differences were noted in IKDC (p = 0.36), delta IKDC (p = 0.18), SANE (p = 0.61), or ACL-RSI (p = 0.67) scores between the repair and meniscectomy groups at final follow-up. No significant differences were found in ACL (p = 1.00) or meniscus (p = 0.49) retear rates between the two groups. Younger age, lower BMI, and tear location (red-red zone) were significantly associated with the decision to perform meniscal repair over meniscectomy (p < 0.05). Conclusions: Among patients presenting with concomitant ACL and bucket handle meniscus tears, we found no difference in patient-reported outcomes or retear rates in patients undergoing meniscal repair versus meniscectomy. Demographic and patient-specific factors including age, BMI, and tear location may influence surgical decision-making when determining the optimal treatment of bucket handle meniscus tears in this population.

Patient-Specific Factors Predictive of Warfarin Dosage Requirements

2002 ◽  
Vol 36 (10) ◽  
pp. 1512-1517 ◽  
Author(s):  
Randall K Absher ◽  
M Elisabeth Moore ◽  
Mary H Parker
Keyword(s):  
Logistic Regression ◽  
Vitamin K ◽  
Assessment Tool ◽  
Validation Cohort ◽  
Patient Specific ◽  
High Dose ◽  
Study Cohort ◽  
Warfarin Dosage ◽  
Specific Factors ◽  
American Ethnicity

OBJECTIVE: To identify patient-specific factors predictive of maintenance warfarin dosage requirements >5 mg/d. METHODS: One hundred forty-six adults taking warfarin were identified from a community hospital and an outpatient anticoagulation clinic. Patient demographics and data on warfarin doses, laboratory results, and medication use were obtained by abstracting patient records. Estimates of vitamin K intake were obtained using a questionnaire and structured interview. Multiple logistic regression was used to identify patient characteristics independently predictive of warfarin maintenance requirements >5 mg/d. An assessment tool for estimating an individual patient's likelihood of requiring warfarin maintenance doses >5 mg/d was derived from the logistic regression model and was assessed in both the study cohort and a separate historical validation cohort of 125 patients. RESULTS: Five factors were independently associated with warfarin requirements >5 mg/d: age <55 years, male gender, African American ethnicity, vitamin K intake >400 μg/d, and body weight ≥91 kg. The assessment tool derived from these factors correctly classified semiquantitative warfarin requirements as non—high-dose in 84 of 93 study cohort patients and 71 of 78 validation cohort patients, and correctly classified requirements as high-dose in 10 of 13 study cohort patients and 11 of 15 validation cohort patients. CONCLUSIONS: African American ethnicity is a newly identified predictor of warfarin requirements >5 mg/d and is independent of dietary vitamin K intake. An assessment tool incorporating this and other predictors can estimate a patient's likelihood of requiring such dosages.

scholarly journals Administration of a Single Low Dose of Recombinant Human Thyrotropin Significantly Enhances Thyroid Radioiodide Uptake in Nontoxic Nodular Goiter1

2000 ◽  
Vol 85 (10) ◽  
pp. 3592-3596 ◽  
Author(s):  
Dyde A. Huysmans ◽  
Willy-Anne Nieuwlaat ◽  
Ronald J. Erdtsieck ◽  
Andries P. Schellekens ◽  
Jo W. Bus ◽  
...  
Keyword(s):  
Low Dose ◽  
Nodular Goiter ◽  
Peak Level ◽  
Serum Levels ◽  
High Dose ◽  
Free T4 ◽  
Contrast Administration ◽  
Recombinant Human Thyrotropin ◽  
Serum Tsh ◽  
Tsh Levels

Radioiodine (131I) is increasingly used as treatment for volume reduction of nontoxic, nodular goiter. A high dose of 131I is often needed because of low thyroid radioiodide uptake (RAIU). We investigated whether pretreatment with a single, low dose of recombinant human TSH (rhTSH; Thyrogen, Genzyme Transgenics Corp.) enhances RAIU in 15 patients with nontoxic, nodular goiter (14 women and 1 man; aged 61 ± 11 yr). Four patients were studied twice, and 1 patient was studied 3 times. RAIU was measured both under basal conditions and after pretreatment (im) with rhTSH, given either 2 h (0.01 mg; n = 7) or 24 h[ 0.01 mg (n = 7) or 0.03 mg (n = 7)] before 131I administration (20–40 μCi). Serum levels of TSH, free T4 (FT4), and total T3 were measured at 2, 5, 8, 24, 48, 72, 96, and 192 h after rhTSH administration. After administration of 0.01 mg rhTSH, serum TSH rose from 0.7 ± 0.5 to a peak level of 4.4 ± 1.1 mU/L (P &lt; 0.0001), FT4 rose from 16.0 ± 2.6 to 18.5 ± 3.7 pmol/L (P &lt; 0.0001), and T3 rose from 2.10 ± 0.41 to 2.63 ± 0.66 nmol/L (P &lt; 0.0001). After administration of 0.03 mg rhTSH, TSH rose from 0.6± 0.4 to 15.8 ± 2.3 mU/L (P &lt; 0.0001), FT4 rose from 15.2 ± 1.5 to 21.7 ± 2.9 pmol/L (P &lt; 0.0001), and T3 rose from 1.90 ± 0.43 to 3.19 ± 0.61 nmol/L (P &lt; 0.0001). Peak TSH levels were reached at 5–8 h and peak FT4 and T3 levels at 8–96 h after rhTSH administration. Administration of 0.01 mg rhTSH 2 h before 131I increased 24-h RAIU from 30 ± 11% to 42 ± 10% (P &lt; 0.02), 0.01 mg rhTSH administered 24 h before 131I increased 24-h RAIU from 29 ± 10% to 51 ± 10% (P &lt; 0.0001), and 0.03 mg rhTSH administered 24 h before 131I increased 24-h RAIU from 33 ± 11% to 63 ± 9% (P &lt; 0.0001). After administration of 0.01 mg rhTSH 2 h before 131I, 24-h RAIU did not increase in 1 patient, whereas the increase in 24-h RAIU was less than 10% in 2 other patients. In contrast, administration of rhTSH 24 h before 131I increased 24-h RAIU by more than 10% in all 14 patients (by &gt;20% in 10 and by&gt; 30% in 6). In conclusion, pretreatment with a single, low dose of rhTSH in patients with nontoxic, nodular goiter increased RAIU considerably. Our observations hold promise that administration of rhTSH before 131I therapy for nontoxic, nodular goiter will allow treatment with lower doses of 131I in these patients.

scholarly journals A novel and dynamic prediction engine for practicing precision medicine to prevent chemotherapy-induced nausea and vomiting

2015 ◽  
Author(s):  
◽  
Abu Saleh Mohammad Mosa
Keyword(s):  
Social Life ◽  
Treatment Plan ◽  
Life Quality ◽  
The United States ◽  
Nausea And Vomiting ◽  
Patient Specific ◽  
Dynamic Prediction ◽  
Personal Experiences ◽  
Specific Factors ◽  
Chemotherapy Patients

Cancer remains the second major cause of death in the United States over the last decade. Chemotherapy is a core component of nearly every cancer treatment plan. Chemotherapy-Induced Nausea and Vomiting (CINV) are the two most dreadful and unpleasant side-effects of chemotherapy for cancer patients. The consequences of CINV include: (1) impaired life quality, (2) poor social life, (3) burden on economy due to loss of workdays, (4) increased healthcare cost, and (5) denial of chemotherapy due to unendurable CINV. There are three clinical guidelines (ASCO, NCCN, and MASCC/ESMO) for the management of CINV. Several patient-specific factors affect the risk of CINV. However, none of the guidelines consider those factors. Not all of patients have the similar emetic risk of CINV. Despite the improvements in CINV management, as many as two-thirds of chemotherapy patients still experience some degree of CINV. As a result, physicians use their personal experiences for CINV treatment, which leads to inconsistent managements of CINV. The overall objective of this study is to improve the prevention of CINV using precise, personalized and evidence-based antiemetic treatment before chemotherapy. Physicians receive feedback about CINV risks of patients from a CINV decision support system based on patient-specific factors. This objective was achieved by accomplishing clinical innovations through the discovery of combined relationships of various patient-specific factors for causing CINV, and informatics innovations through the development of a novel, precise and dynamic prediction engine for practicing precision and personalized medicine in CINV prevention. The approach presented in this dissertation can be applied to any other clinical predictions.

scholarly journals Does Mesh Augmentation of the Hiatal Repair with Gore Bio-A® Improve Symptomatic Outcomes in Laparoscopic Fundoplication?

2020 ◽  
Vol 14 (1) ◽  
Author(s):  
Christodoulidou M ◽  
Kosai NR ◽  
Rajan R ◽  
Hassan S ◽  
Das S ◽  
...  
Keyword(s):  
Hiatus Hernia ◽  
Laparoscopic Fundoplication ◽  
Patient Specific ◽  
Symptom Improvement ◽  
Life Questionnaire ◽  
Mesh Augmentation ◽  
Significant Difference ◽  
Patient Reported ◽  
Large Hiatus Hernia ◽  
Hiatal Repair

Introduction: Laparoscopic fundoplication is performed for the management of symptomatic hiatus hernias and gastro-oesophageal reflux disease (GORD) refractory to medical therapy. We adopted the use of Gore Bio-A® for selected laparoscopic hiatus hernia repairs in 2011 and with this case series aimed to establish whether mesh augmentation affects symptomatic outcomes. Methods: A retrospective review of prospectively collected data from all laparoscopic fundoplications performed by a single surgeon between October 2011 and January 2013 was performed. Patient specific data were entered into a proforma and analysed using Microsoft ExcelTM. Patient reported outcomes were assessed with a system specific quality of life questionnaire (GORD-HRQL) both pre and post-operatively. Results: Twenty-three patients underwent laparoscopic fundoplication during the study period. Gore Bio-A® re-enforcement of the hiatal repair was used in 14 patients and was the preferred option for those with pre-operative evidence of a large hiatus hernia. Whilst overall there was a statistically significant difference between pre and post-operative scores (21 vs 0, p=<0.0001, Mann-Whitney U test), there was no clear difference observed in pre-operative scores (22 vs 20, p=0.21, Mann-Whitney U test), postoperative scores (0 vs 0, p=0.92, Mann-Whitney U test) or symptom improvement (21 vs 20, p=0.24, MannWhitney U test) between the mesh and non-mesh groups. Conclusions: Augmentation of the hiatal repair with biosynthetic mesh is safe, feasible and may contribute to improved symptomatic outcomes in selected cases with a large hiatus hernia. We suggest a further assessment with a larger randomised sample and long term follow-up for definitive evaluation.

scholarly journals Cardiomyocyte-Specific Circulating Cell-Free Methylated DNA in Esophageal Cancer Patients Treated with Chemoradiation

2021 ◽  
Vol 3 (3) ◽  
pp. 100-112
Author(s):  
Sarah Martinez Roth ◽  
Eveline E. Vietsch ◽  
Megan E. Barefoot ◽  
Marcel O. Schmidt ◽  
Matthew D. Park ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Cardiac Toxicity ◽  
Amplicon Sequencing ◽  
Neoadjuvant Chemoradiation ◽  
Patient Specific ◽  
High Dose ◽  
Specific Cell ◽  
Methylated Dna ◽  
Bisulfite Treatment ◽  
Dose Radiation

Thoracic high-dose radiation therapy (RT) for cancer has been associated with early and late cardiac toxicity. To assess altered rates of cardiomyocyte cell death due to RT we monitored changes in cardiomyocyte-specific, cell-free methylated DNA (cfDNA) shed into the circulation. Eleven patients with distal esophageal cancer treated with neoadjuvant chemoradiation to 50.4 Gy (RT) and concurrent carboplatin and paclitaxel were enrolled. Subjects underwent fasting blood draws prior to the initiation and after completion of RT as well as 4–6 months following RT. An island of six unmethylated CpGs in the FAM101A locus was used to identify cardiomyocyte-specific cfDNA in serum. After bisulfite treatment this specific cfDNA was quantified by amplicon sequencing at a depth of >35,000 reads/molecule. Cardiomyocyte-specific cfDNA was detectable before RT in the majority of patient samples and showed some distinct changes during the course of treatment and recovery. We propose that patient-specific cardiac damages in response to the treatment are indicated by these changes although co-morbidities may obscure treatment-specific events.

scholarly journals Implementation of pharmacogenomic testing in oncology care (PhOCus): study protocol of a pragmatic, randomized clinical trial

2020 ◽  
Vol 12 ◽  
pp. 175883592097411
Author(s):  
Natalie Reizine ◽  
Everett E. Vokes ◽  
Ping Liu ◽  
Tien M. Truong ◽  
Rita Nanda ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Drug Effects ◽  
Dose Intensity ◽  
Progression Free Survival ◽  
Clinical Decision ◽  
Drug Dose ◽  
Patient Specific ◽  
Drug Dosing ◽  
Patient Reported ◽  
Dose Modifications

Background: Many cancer patients who receive chemotherapy experience adverse drug effects. Pharmacogenomics (PGx) has promise to personalize chemotherapy drug dosing to maximize efficacy and safety. Fluoropyrimidines and irinotecan have well-known germline PGx associations. At our institution, we have delivered PGx clinical decision support (CDS) based on preemptively obtained genotyping results for a large number of non-oncology medications since 2012, but have not previously evaluated the utility of this strategy for patients initiating anti-cancer regimens. We hypothesize that providing oncologists with preemptive germline PGx information along with CDS will enable individualized dosing decisions and result in improved patient outcomes. Methods: Patients with oncologic malignancies for whom fluoropyrimidine and/or irinotecan-inclusive therapy is being planned will be enrolled and randomly assigned to PGx and control arms. Patients will be genotyped in a clinical laboratory across panels that include actionable variants in UGT1A1 and DPYD. For PGx arm patients, treating providers will be given access to the patient-specific PGx results with CDS prior to treatment initiation. In the control arm, genotyping will be deferred, and dosing will occur as per usual care. Co-primary endpoints are dose intensity deviation rate (the proportion of patients receiving dose modifications during the first treatment cycle), and grade ⩾3 treatment-related toxicities throughout the treatment course. Additional study endpoints will include cumulative drug dose intensity, progression-free survival, dosing of additional PGx supportive medications, and patient-reported quality of life and understanding of PGx. Discussion: Providing a platform of integrated germline PGx information may promote personalized chemotherapy dosing decisions and establish a new model of care to optimize oncology treatment planning.

scholarly journals Synovial Tissue Proteins and Patient-Specific Variables as Predictive Factors for Temporomandibular Joint Surgery

Diagnostics ◽  
2020 ◽  
Vol 11 (1) ◽  
pp. 46
Author(s):  
Mattias Ulmner ◽  
Rachael Sugars ◽  
Aron Naimi-Akbar ◽  
Nikolce Tudzarovski ◽  
Carina Kruger-Weiner ◽  
...  
Keyword(s):  
Temporomandibular Joint ◽  
Synovial Tissue ◽  
Surgical Outcome ◽  
Clinical Decision Making ◽  
Protein Profile ◽  
Strong Association ◽  
Tissue Inhibitor Of Metalloproteinase ◽  
Patient Specific ◽  
Disc Displacement ◽  
Patient Reported

Our knowledge of synovial tissues in patients that are scheduled for surgery as a result of temporomandibular joint (TMJ) disorders is limited. Characterising the protein profile, as well as mapping clinical preoperative variables, might increase our understanding of pathogenesis and forecast surgical outcome. A cohort of 100 patients with either disc displacement, osteoarthritis, or chronic inflammatory arthritis (CIA) was prospectively investigated for a set of preoperative clinical variables. During surgery, a synovial tissue biopsy was sampled and analysed via multi-analytic profiling. The surgical outcome was classified according to a predefined set of outcome criteria six months postoperatively. Higher concentrations of interleukin 8 (p = 0.049), matrix metalloproteinase 7 (p = 0.038), lumican (p = 0.037), and tissue inhibitor of metalloproteinase 2 (p = 0.015) were significantly related to an inferior surgical outcome. Several other proteins, which were not described earlier in the TMJ synovia, were detected but not related to surgical outcome. Bilateral masticatory muscle palpation pain had strong association to a poor outcome that was related to the diagnoses disc displacement and osteoarthritis. CIA and the patient-reported variable TMJ disability might be related to an unfavourable outcome according to the multivariate model. These findings of surgical predictors show potential in aiding clinical decision-making and they might enhance the understanding of aetiopathogenesis in TMJ disorders.

Sudden Sensorineural Hearing and Vestibular Loss in a Case of Relapsing Polychondritis

2021 ◽  
pp. 000348942110059
Author(s):  
Özge Akdoğan ◽  
Smirnov Exilus ◽  
Bryan K. Ward ◽  
Justin C. McArthur ◽  
Charles C. Della Santina ◽  
...  
Keyword(s):  
Cochlear Implantation ◽  
Pure Tone ◽  
Relapsing Polychondritis ◽  
Sensorineural Hearing ◽  
High Dose ◽  
Left Auricle ◽  
Vestibular Loss ◽  
Patient Reported ◽  
Loss Of Hearing ◽  
Hearing Outcomes

Objectives: To report a case of profound bilateral sensorineural hearing and vestibular loss from relapsing polychondritis and hearing outcomes after cochlear implantation. Methods: Case report and literature review. Results: A 43 year-old woman developed sudden loss of hearing and balance that progressed over several weeks to bilateral, profound hearing and vestibular loss. Steroid treatments were ineffective. She underwent vestibular physical therapy and left cochlear implantation. About 10 months after her initial presentation, she developed erythema, warmth, swelling, and pain of the left auricle sparing the lobule, flattening of the bridge of her nose, and right ankle swelling, warmth, and skin erythema. A biopsy of the left auricle revealed histopathologic findings consistent with relapsing polychondritis. She was treated with high dose prednisolone. The ear inflammation resolved, however, despite excellent auditory response to pure tone thresholds, the patient reported no improvement in speech perception after cochlear implantation. Conclusions: Relapsing polychondritis can present with rapidly progressive, profound loss of hearing and vestibular function. Hearing outcomes after cochlear implantation can include poor speech discrimination despite good pure tone detection thresholds.

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