scholarly journals ASSESSING ANTI-TNF TROUGH LEVELS AND ITS APPLICABILITY IN DAILY PRACTICE IN SPONDYLOARTHRITIS PATIENTS

2016 ◽  
Vol 25 (3) ◽  
pp. 127-135
Author(s):  
Claudia Deaconu ◽  
◽  
Daniela Opris ◽  
Ruxandra Ionescu ◽  
◽  
...  
Keyword(s):  
Disease Activity ◽  
Drug Level ◽  
Daily Practice ◽  
Serum Levels ◽  
Antibody Detection ◽  
Therapeutic Drug ◽  
Study Cohort ◽  
Serum Drug Level ◽  
One Year ◽  
Trough Levels

Objective. The purpose of the present study was to assess the relevance of therapeutic drug monitoring in spondyloarthritis patients, by determining drug serum levels and anti-drug antibodies and estimating cut-off values for three TNF inhibitors. Methods. Over one year, we enrolled 100 patients with SpA, under consequent treatment with adalimumab (ADL), etanercept (ETA) or infliximab (IFX). Demographic, clinical (BASDAI, ASDAS) and laboratory (ESR, CRP) data was collected together with drug serum level and anti-drug antibodies using the ELISA technique. The statistical analysis was performed using the SPSS software, version 20.0 with the aid of Student t-test, Spearman and Pearson tests. Results. Out of the study cohort, 35% were on ADL, 33% on IFX, and 32% under ETA treatment. Undetectable drug levels correlated to the presence of anti-drug antibodies and to disease activity scores. There were no identified anti-ETA antibodies. For this study lot trough levels are estimated between 2 and 4 μg/mL for an ASDAS-CRP under 2.1. Conclusion. Serum drug level measurement and anti-drug antibody detection can be used as a completion to a clinician’s tools in assessing disease activity, leading to an optimal and personalized manner of patient management.

PRESCRIBING AND MONITORING OF GENTAMICIN IN NEONATES

2016 ◽  
Vol 101 (9) ◽  
pp. e2.65-e2 ◽  
Author(s):  
Nicola Staton
Keyword(s):  
Blood Culture ◽  
Neonatal Intensive Care ◽  
Drug Level ◽  
Neonatal Infection ◽  
Blood Cultures ◽  
Therapeutic Drug ◽  
Before And After ◽  
National Patient ◽  
Trough Levels ◽  
Selection Of

AimTo evaluate the implementation of the National Institute for Health and Care Excellence (NICE) clinical guideline1 with regards to the prescribing, exposure and therapeutic drug level monitoring of gentamicin in early onset neonatal infection.MethodA selection of drug charts for babies who were prescribed gentamicin within 72 hrs of birth were reviewed. The number of doses of gentamicin administered, C-reactive protein (CRP) results, blood culture results and gentamicin trough levels were recorded. A new gentamicin prescription chart was developed based on the NICE clinical guideline1 and the National Patient Safety Agency (NPSA) alert2 on the safer use of gentamicin for neonates, and was launched on the Neonatal Intensive Care Unit (NICU). A number of months after the new gentamicin prescription chart was introduced, and had therefore had time to become embedded into practice, a selection of babies' drug charts were reviewed and the same information as previously was documented. The information obtained before and after the introduction of the new gentamicin prescription chart was compared.ResultsPrior to the new gentamicin prescription chart 16 prescriptions for gentamicin were reviewed, and in total 47 doses of gentamicin were administered. Blood cultures were negative after five days in all 16 patients. In total 9 gentamicin trough levels were taken with only one level being >2 mg/L. Following the introduction of the new prescription chart another 16 prescriptions for gentamicin were reviewed, and in total 38 doses of gentamicin were administered. Again blood cultures were negative after five days in all 16 patients. In total 14 gentamicin trough levels were taken with two levels being >2 mg/L. Prior to the new gentamicin prescription chart 50% of babies received more than one dose of gentamicin despite having two CRP results <10. This is compared to 31% of babies following the introduction of the new gentamicin prescription chart.ConclusionIt can be concluded that the new gentamicin prescription chart has resulted in a reduction in the exposure of babies to gentamicin, as all babies now have it administered at 36 hourly intervals. There has also been an increase in blood monitoring of trough gentamicin levels, as they are now taken prior to the second dose rather than the third dose. Therefore the new gentamicin prescription chart is safer as toxic levels are identified sooner, which reduces the risk of babies suffering adverse effects.Since the introduction of the new gentamicin prescription chart 31% of babies received more than the necessary number of gentamicin doses, as dictated by the CRP results and blood culture result at 36 hrs. This is a learning point which will be highlighted to the medical and nursing staff on NICU.

scholarly journals P582 Adalimumab therapeutic drug monitoring: Does time of testing matter?

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S488-S488
Author(s):  
S Shields ◽  
J P Seenan ◽  
A Dunlop ◽  
P Galloway ◽  
J Macdonald
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Drug Level ◽  
Drug Dose ◽  
Therapeutic Drug ◽  
Drug Levels ◽  
Clinical Scenarios ◽  
Serum Drug Level ◽  
Inflammatory Bowel ◽  
Fourth Quartile

Abstract Background Whilst anti-TNF drugs such as adalimumab (ADL) have revolutionised the management of inflammatory bowel disease treatment outcomes are not universally favourable with 30% primary non-response (PNR) and 46% secondary loss of response (SLOR) rates reported.1,2 Therapeutic drug monitoring (TDM)—the measurement of serum drug levels and anti-drug antibodies—has become popular with clinicians who use it to optimise biologic therapy through serum drug-level guided dose adjustment. Conventionally TDM is based on the interpretation of trough drug levels (DL) which are obtained by drawing a blood sample immediately prior to the next drug dose. Obtaining an ADL trough DL can be challenging as the drug is administered as a subcutaneous injection usually in the patient’s own home. The aim of this project was to determine the current use of non-trough ADL TDM in clinical practice and determine whether timing of ADL TDM in relation to the next planned dose is clinically important. Methods All ADL DLs performed in 2018 in the Scottish Biologic TDM service3 were identified. DLs were included for patients in sustained clinical remission (SCR), on 40mg every other week dosing, and if the time from the last dose was ≤14 days. TDM performed during induction and for PNR or SLOR were excluded, as were patients on nonstandard dosing or with missing data on dose and interval. Results were analysed by quartile according to time from the last drug dose. Results 338 DLs were included. Median DL is 8µg/ml (range &lt;0.4–36). Median time from last dose is 12 (range 0–14) days. The first quartile (n = 83, median 5 (range 0–7) days) had a median DL of 8.2µg/ml (&lt;0.4–28.1). The second quartile (n = 90, median 11 (8–12) days) had a median DL of 7.9µg/ml (&lt;0.4–36). The third quartile (n = 80, 13 days from last dose) had a median DL of 8µg/ml (&lt;0.4 – 28.1). fourth quartile samples (n = 85, 14 days from last dose – true trough DLs) had a median DL of 8 µg/ml (&lt;0.4–34.8). No relationship was identified between observed DL and the time of DL testing (ρ= -0.3162, p = 0.23). Conclusion It is not necessary to use trough DLs when performing ADL TDM for individuals in SCR. These data should give clinicians the confidence to use opportunistic ADL TDM testing in a clinical setting. Further work should be undertaken on non-trough testing of ADL DLs in other clinical scenarios. Disclosure Biogen GmbH contributed funding for this research. Authors had full editorial control and approval of all content. References

scholarly journals Clinical Relevance of Anti-TNF Antibody Trough Levels and Anti-Drug Antibodies in Treating Inflammatory Bowel Disease Patients

2020 ◽  
pp. 1-10
Author(s):  
Ilana Reinhold ◽  
Sena Blümel ◽  
Jens Schreiner ◽  
Onur Boyman ◽  
Jan Bögeholz ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Clinical Disease ◽  
Therapeutic Drug ◽  
Real World Data ◽  
Significant Treatment ◽  
Infusion Reactions ◽  
Inflammatory Bowel ◽  
Trough Levels

<b><i>Background and Aims:</i></b> The majority of patients treated with anti-tumor necrosis factor (TNF) therapy develop anti-drug antibodies (ADAs), which might result in loss of treatment efficacy. Strict guidelines on measuring trough levels (TLs) and ADA in clinical routine do not exist. To provide real-world data, we took advantage of our tertiary inflammatory bowel disease (IBD) center patient cohort and determined indicators for therapeutic drug monitoring (TDM) and actual consequences in patient care. <b><i>Methods:</i></b> We retrospectively collected clinical data of 104 IBD patients treated with infliximab or adalimumab in our IBD clinic. Patients with TL and ADA measurements between June 2015 and February 2018 were included. <b><i>Results:</i></b> The main reason for determining TL was increased clinical disease. Subtherapeutic TLs were found in 33 patients, therapeutic TLs in 33 patients, and supratherapeutic TLs in 38 patients. Adjustments in anti-TNF therapy occurred more frequently (<i>p</i> = 0.01) in patients with subtherapeutic TL (24 of 33 patients; 73%) as compared to patients with therapeutic and supratherapeutic TLs (26 of 71 patients; 37%). No correlation could be found between TL and disease activity (<i>p</i> = 0.16). Presence of ADA was found in 16 patients, correlated with the development of infusion reactions (OR: 10.6, RR: 5.4, CI: 2.9–38.6), and was associated with subtherapeutic TL in 15 patients (93.8%). Treatment adaptations were based on TL and/or ADA presence in 36 of 63 patients. <b><i>Conclusions:</i></b> TDM showed significant treatment adaptations in patients with subtherapeutic TL. Conversely, in patients with therapeutic and supratherapeutic TLs, reasons for adaptations were based on considerations other than TL, such as clinical disease activity. Further studies should focus on decision-making in patients presenting with supratherapeutic TL in remission.

scholarly journals Vitamin D and disease activity in rheumatoid arthritis patients: a retrospective study in a Romanian cohort

2020 ◽  
Author(s):  
Elena Sirbu ◽  
Florina Buleu ◽  
Anca Tudor ◽  
Simona Dragan
Keyword(s):  
Vitamin D ◽  
Disease Activity ◽  
White Blood Cells ◽  
Hypovitaminosis D ◽  
Serum Levels ◽  
Study Cohort ◽  
Healthy Controls ◽  
25 Hydroxy Vitamin D ◽  
Retrospective Comparative Study ◽  
The Relationship

Background. The relationship between the serum levels of Vitamin D and the severity of RA is a subject of great interest for the future therapeutic strategies. Although the evidence on the relationship between hypovitaminosis D and early RA is contradictory, preliminary data suggest that the serum levels of vitamin D are inversely associated with the disease activity. Aim: the main objectives of this study include: (1) to analyze the serum levels of vitamin D in patients with RA in comparison to healthy controls; (2) to investigatea possible correlation with disease activity. Materials and Methods. This was a retrospective, comparative study conducted on 37 subjects suffering from RA and a group of 21 healthy matched controls. The following were determined in all studied subjects: erythrocyte sedimentation rate (ESR), white blood cells (WBC), hemoglobin (Hb), platelets (PLT), serum calcium (Ca), serum phosphorus (Phos), and serum 25 hydroxy-vitamin D. Moreover, in the RA group the IgM-Rhematoid Factor (RF) and anti-citrullinated protein antibodies (ACPA) (immune-enzymatic method) were assessed. The Disease Activity Score of 28 joints (DAS28) was calculated for the RA patients. Results. We observed that vitamin D deficiency is more common in RA patients than in healthy controls. No significant correlation between 25OHvitD and DAS28-ESR was found in our study cohort. Conclusions. There is no significant association of serum 25(OH)D with disease severity in a Western Romanian cohort with RA. However, this result could have implications for the disease management, as patients with RA could be supplemented with vitamin D even in the absence of disease activity.

scholarly journals Appropriate vancomycin use in a Malaysian tertiary hospital based on current HICPAC recommendations

2014 ◽  
Vol 8 (10) ◽  
pp. 1267-1271 ◽  
Author(s):  
Farida Islahudin ◽  
Hui-Yeah Ong
Keyword(s):  
Serum Levels ◽  
Tertiary Hospital ◽  
High Rate ◽  
Therapeutic Drug ◽  
Appropriate Use ◽  
Inappropriate Use ◽  
Significant Difference ◽  
Vancomycin Resistant ◽  
High Level ◽  
Trough Levels

Introduction: Antibiotic resistance is a rapidly emerging problem. A major concern is methicillin-resistant Staphylococcus aureus (MRSA), especially in developing countries where cost-effectiveness is imperative. Restriction of vancomycin usage is necessary to reduce the emergence of vancomycin-resistant organisms. The aim of this study was to look into the appropriate use of vancomycin based on the Healthcare Infection Control Practices Advisory Committee (HICPAC) guidelines and to investigate serum levels of vancomycin. Methodology: The study was performed retrospectively. Medical records of patients treated with vancomycin for the past year were identified and selected. Results: Overall, 118 patients were treated with vancomycin. Appropriate use of vancomycin was significantly higher than inappropriate use (p = 0.001). Approximately 85% (n = 100) of patients were given vancomycin for treatment, whereas the rest were given it for prophylaxis. Appropriate use of vancomycin was observed in 67% (n = 79) of patients. However, there was still a high rate of inappropriate vancomycin use for prophylaxis and treatment (n = 39, 33.1%). The most common reason for inappropriate use was non-neutropenic and non-line related sepsis (n = 36, 30.8%). Therapeutic drug monitoring of vancomycin was performed in 79 patients (67%). Most patients (n = 53, 67%) demonstrated sub-therapeutic levels during the first measurement. There was no significant difference between trough levels achieved with a higher (> 15 mg/kg) versus a lower dose (< 15 mg/kg). Conclusions: This study demonstrates that there was still a high level of inappropriate vancomycin use, which could potentially contribute to vancomycin resistance.

scholarly journals FRI0042 DISCREPANCIES BETWEEN RAPID3 AND DAS28 IN RHEUMATOID ARTHRITIS PATIENTS IN REMISSION OR LOW DISEASE ACTIVITY RECEIVING TNF INHIBITORS: WHAT IS THE ROLE OF THE INFLAMMATION BIOMARKERS?

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 596.1-596
Author(s):  
J. Inciarte-Mundo ◽  
R. Morlà ◽  
B. Frade-Sosa ◽  
J. Ramírez ◽  
R. Castellanos-Moreira ◽  
...  
Keyword(s):  
Disease Activity ◽  
Serum Levels ◽  
Target Group ◽  
Low Disease Activity ◽  
Factors Influencing ◽  
Trough Serum ◽  
Serum Trough ◽  
Trough Levels ◽  
Serum Trough Levels ◽  
Perception Of Disease

Background:Patients and Rheumatologist often differ in their perception of RA disease activity. Remission or low disease activity should be the treatment target in RA, patients should be included in treatment decisions.Objectives:To identify factors influencing patient’s self-reported disease activity by RAPID3 test.Methods:47 RA patients in remission or low disease activity by DAS28ESR (DAS28ESR ≤ 3.2) receiving TNFi (etanercept, adalimumab and infliximab) stratified their disease activity by RAPID3, then two patients’ groups were defined:target group(RAPID3 with remission 0-3 or low disease activity 3.1-6),non-target group(RAPID3 with moderate 6.1-12 or high disease activity >12). Demographic data, disease duration, autoantibody status, radiological data, concomitant csDMARD therapy was collected. Laboratory measurements included CRP, ESR, calprotectin serum levels, TNFi trough serum levels, and antidrug antibodies (enzyme-linked immunosorbent assay (ELISA) test kit (Calprolab™ Calpro AS, Oslo, Norway, and Promonitor®, Progenika SA, Spain, respectively) according to the manufacturers’ protocol. Pearson´s correlations coefficients were used to identify variables correlating with RAPID3 score. Mixed-effects analyses of covariance (ANCOVAs) models were used to identify factors influencing RAPID3 score.Results:Patients in “target group”have shown a significant lower TJC, pain by VAS 0-10mm, and calprotectin serum levels, but higher TNFi serum trough levels in comparison to “non-target group”. When patients were classified according to RAPID 3 categories, patients in “remission” have shown lower calprotectin serum levels than those classified as in “high disease activity” (0.94 (4.88-0.14) vs. 4.57 (7.97-1.25),p=0.001, respectively). Accordingly, when classified according to pain by VAS 0-10mm, patients with low levels of pain had lower calprotectin serum levels vs. those with severe pain (1.43 (6.33-10.14) vs. 5.16 (8.80-1.25),p=0.009, respectively). When distributed according to PGA (1=very good, 2=good, 3=regular, 4=bad, 5=very bad) patients in “very good” group had lower mean of calprotectin serum levels than those in “very bad” group (0.94 (4.88-0.14) vs. 4.57 (7.97-1.25),p=0.001, respectively). PGA and Pain VAS have shown a strong correlation with RAPID 3 (R20.978, and 0.834,p=0.001, respectively), while calprotectin and TNFi serum trough levels showed a moderate correlation (R20.311, and 0.372,p=0.005, respectively). The multivariate adjusted analysis showed a significant association between Pain and RAPID3 (p<0.001) according to the different covariates (age, gender, anti-CCP positivity, time in remission, SJC, TJC, DAS28ESR). In addition, calprotectin and TNFi trough serum levels were associated with RAPID 3 (p<0.005). Backward selection of variables did not substantially modify the association between RAPID 3 and pain, calprotectin and TNFi trough serum levels.Conclusion:61.7% of RA patients undergoing TNFi classified as in remission or low disease activity by DAS28ESR, self-reported their disease activity as moderate or high by RAPID3. The most significant factor influencing patient’s perception of disease activity is pain (pain VAS and TJC). However, inflammation markers (calprotectin, TNFi serum trough levels) remain statistically significant after fully adjustment by different confounders. Thus, therapies improving these three domains will have a larger impact in patient´s perception of disease activity.References:[1]Studenic P, et al. Arthritis Rheum. 2012;64:2814-23.Disclosure of Interests:Jose Inciarte-Mundo Employee of: Eli Lilly, Speakers bureau: Abbvie, Eli Lilly, BMS, Roche and Pfizer, Rosa Morlà Speakers bureau: Abbvie, Eli Lilly, BMS, Roche and Pfizer, Beatriz Frade-Sosa: None declared, Julio Ramírez Speakers bureau: Abbvie, Eli Lilly, BMS, Roche, Novartis and Pfizer, Raul Castellanos-Moreira Speakers bureau: Lilly, MSD, Sanofi, UCB, Virginia Ruiz Speakers bureau: Lilly, Pfizer, Juan de Dios Cañete: None declared, José Gomez Puerta Speakers bureau: Abbvie, Eli Lilly, BMS, Roche and Pfizer, Raimón Sanmartí Speakers bureau: Abbvie, Eli Lilly, BMS, Roche and Pfizer

Treatment of varicose tributaries with sclerotherapy with polidocanol 0.5 % foam

VASA ◽  
2010 ◽  
Vol 39 (2) ◽  
pp. 169-174 ◽  
Author(s):  
Reich-Schupke ◽  
Weyer ◽  
Altmeyer ◽  
Stücker
Keyword(s):  
Scientific Evidence ◽  
Daily Practice ◽  
Severe Adverse Effect ◽  
Safe Procedure ◽  
Efficacy And Safety ◽  
Foam Sclerotherapy ◽  
History Of ◽  
One Year ◽  
Additional Therapy

Background: Although foam sclerotherapy of varicose tributaries is common in daily practice, scientific evidence for the optimal sclerosant-concentration and session-frequency is still low. This study aimed to increase the knowledge on foam sclerotherapy of varicose tributaries and to evaluate the efficacy and safety of foam sclerotherapy with 0.5 % polidocanol in tributaries with 3-6 mm in diameter. Patients and methods: Analysis of 110 legs in 76 patients. Injections were given every second or third day. A maximum of 1 injection / leg and a volume of 2ml / injection were administered per session. Controls were performed approximately 6 months and 12 months after the start of therapy. Results: 110 legs (CEAP C2-C4) were followed up for a period of 14.2 ± 4.2 months. Reflux was eliminated after 3.4 ± 2.7 injections per leg. Insufficient tributaries were detected in 23.2 % after 6.2 ± 0.9 months and in 48.2 % after 14.2 ± 4.2 months, respectively. Only 30.9 % (34 / 110) of the legs required additional therapy. In 6.4 % vein surgery was performed, in 24.5 % similar sclerotherapy was repeated. Significantly fewer sclerotherapy-sessions were required compared to the initial treatment (mean: 2.3 ± 1.4, p = 0.0054). During the whole study period thrombophlebitis (8.2 %), hyperpigmentation (14.5 %), induration in the treated region (9.1 %), pain in the treated leg (7.3 %) and migraine (0.9 %) occurred. One patient with a history of thrombosis developed thrombosis of a muscle vein (0.9 %). After one year there were just hyperpigmentation (8.2 %) and induration (1.8 %) left. No severe adverse effect occurred. Conclusions: Foam sclerotherapy with injections of 0.5 % polidocanol every 2nd or 3rd day, is a safe procedure for varicose tributaries. The evaluation of efficacy is difficult, as it can hardly be said whether the detected tributaries in the controls are recurrent veins or have recently developed in the follow-up period. The low number of retreated legs indicates a high efficacy and satisfaction of the patients.

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