scholarly journals A Compositive Strategy to Study the Pharmacokinetics of TCMs: Taking Coptidis Rhizoma, and Coptidis Rhizoma-Glycyrrhizae Radix et Rhizoma as Examples

Molecules ◽  
2018 ◽  
Vol 23 (8) ◽  
pp. 2042 ◽  
Author(s):  
Qiao Li ◽  
Yan Yang ◽  
Ting Zhou ◽  
Rui Wang ◽  
Na Li ◽  
...  
Keyword(s):  
Area Under The Curve ◽  
Simple Calculation ◽  
Systemic Circulation ◽  
Pharmacokinetic Studies ◽  
Sufficient Information ◽  
Blood Concentrations ◽  
Glycyrrhizae Radix ◽  
Pharmacokinetic Properties ◽  
Coptidis Rhizoma

Pharmacokinetic studies are crucial for elucidating the effective constituents and formula compatibility of traditional Chinese medicines (TCMs). However, studies have usually been limited to single dosages and detection of systemic blood concentrations. To obtain comprehensive pharmacokinetic information, here we propose a multi-dosage and multi-sampling (blood from portal vein or systemic circulation, and liver) strategy to comparatively study the pharmacokinetics of multi-form TCMs, i.e., pure constituents, TCMs, or TCM formula extracts. Based on this strategy, we studied the pharmacokinetics of pure berberine, berberine in Coptidis Rhizoma (CRE), and berberine in Coptidis Rhizoma-Glycyrrhizae Radix et Rhizoma extracts (CR-GRE). After simple calculation and comparison of the obtained area under the curve (AUC) values, the results revealed the drastically different pharmacokinetic properties of pure berberine compared to CRE and CR-GRE. The results contribute to explaining the pharmacological loss of berberine activity after purification and the compatibility of the CR-GR drug pair. The results also innovatively showed that it was intestinal absorption that differentiated the pharmacokinetics of CRE and pure berberine, and CRE and CR-GRE. In conclusion, we propose a composite strategy to comparatively study the pharmacokinetics of TCMs, which could provide sufficient information to obtain a comprehensive view, before follow-up mechanism-of-action studies.

A correlation study of fluorouracil pharmacodynamics with clinical efficacy and toxicity

2018 ◽  
Vol 104 (3) ◽  
pp. 157-164 ◽  
Author(s):  
Ece Esin ◽  
Tugba Akin Telli ◽  
Deniz Yuce ◽  
Suayib Yalcin
Keyword(s):  
Clinical Efficacy ◽  
Plasma Levels ◽  
Odds Ratio ◽  
Logistic Regression Model ◽  
Area Under The Curve ◽  
Correlation Study ◽  
Potential Toxicity ◽  
Standard Dosage ◽  
Pharmacokinetic Properties

Purpose: Plasma 5-fluorouracil (5-FU) concentrations vary greatly between individuals who have received standard dosage. Pharmacokinetic adjusted doses have been hypothesized to overcome the possibility of potential toxicity and ineffectiveness related to inappropriate plasma levels of 5-FU. In this study, we prospectively investigated the clinical benefit and toxicity of 5-FU in relation to its pharmacokinetic properties. Methods: Pharmacokinetics, effectiveness, and toxicity of 5-FU were investigated in 101 patients. The 5-FU pharmacokinetics were measured on day 2 of chemotherapy infusions. Clinicodemographic characteristics are outlined. Results: All 101 patients who received adjuvant chemotherapy were alive at the end of a median 45 months of the follow-up period. At least one grade 1 adverse event (AE) was observed in 69.3% of the patients and grade two AEs were observed in 10.1% of the patients. The 5-FU levels ranged between 103 and 4311 µg/L and area under the curve (AUC) measurements ranged between 4.5 and 189.7 mg min/L. Pharmacokinetic measurements were not significantly correlated with clinical efficacy (log-rank p = 0.21). However, higher AUC levels were positively correlated with toxicity (p = 0.02) and with the severity of adverse events. The risks of mucositis (odds ratio [OR] 1.45; p = 0.042) and neurotoxicity (OR 2.01; p = 0.009) were significantly increased in a logistic regression model. Conclusions: There is no clear evidence that increased plasma levels or pharmacokinetic adjusted doses of 5-FU were related to better efficacy. However, toxicity might be closely associated with increased plasma levels of 5-FU. Toxicities can be deferred via dose adjustments without any expense in efficacy.

scholarly journals Using advanced analysis of multifocal visual-evoked potentials to evaluate the risk of clinical progression in patients with radiologically isolated syndrome

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
J. M. Miguel ◽  
M. Roldán ◽  
C. Pérez-Rico ◽  
M. Ortiz ◽  
L. Boquete ◽  
...  
Keyword(s):  
Evoked Potentials ◽  
Visual Evoked Potentials ◽  
Area Under The Curve ◽  
Multifocal Visual Evoked Potentials ◽  
Radiologically Isolated Syndrome ◽  
Advanced Analysis ◽  
The Time Domain ◽  
Visual Evoked

AbstractThis study aimed to assess the role of multifocal visual-evoked potentials (mfVEPs) as a guiding factor for clinical conversion of radiologically isolated syndrome (RIS). We longitudinally followed a cohort of 15 patients diagnosed with RIS. All subjects underwent thorough ophthalmological, neurological and imaging examinations. The mfVEP signals were analysed to obtain features in the time domain (SNRmin: amplitude, Latmax: monocular latency) and in the continuous wavelet transform (CWT) domain (bmax: instant in which the CWT function maximum appears, Nmax: number of CWT function maximums). The best features were used as inputs to a RUSBoost boosting-based sampling algorithm to improve the mfVEP diagnostic performance. Five of the 15 patients developed an objective clinical symptom consistent with an inflammatory demyelinating central nervous system syndrome during follow-up (mean time: 13.40 months). The (SNRmin) variable decreased significantly in the group that converted (2.74 ± 0.92 vs. 4.07 ± 0.95, p = 0.01). Similarly, the (bmax) feature increased significantly in RIS patients who converted (169.44 ± 24.81 vs. 139.03 ± 11.95 (ms), p = 0.02). The area under the curve analysis produced SNRmin and bmax values of 0.92 and 0.88, respectively. These results provide a set of new mfVEP features that can be potentially useful for predicting prognosis in RIS patients.

scholarly journals Saliva RNA biomarkers predict concussion duration and detect symptom recovery: a comparison with balance and cognitive testing

2021 ◽  
Author(s):  
Gregory Fedorchak ◽  
Aakanksha Rangnekar ◽  
Cayce Onks ◽  
Andrea C. Loeffert ◽  
Jayson Loeffert ◽  
...  
Keyword(s):  
Test Performance ◽  
Area Under The Curve ◽  
Prediction Rule ◽  
Cognitive Testing ◽  
Cognitive Test ◽  
Clinical Tool ◽  
Post Injury ◽  
Symptom Recovery ◽  
Cognitive Test Performance

Abstract Objective The goals of this study were to assess the ability of salivary non-coding RNA (ncRNA) levels to predict post-concussion symptoms lasting ≥ 21 days, and to examine the ability of ncRNAs to identify recovery compared to cognition and balance. Methods RNA sequencing was performed on 505 saliva samples obtained longitudinally from 112 individuals (8–24-years-old) with mild traumatic brain injury (mTBI). Initial samples were obtained ≤ 14 days post-injury, and follow-up samples were obtained ≥ 21 days post-injury. Computerized balance and cognitive test performance were assessed at initial and follow-up time-points. Machine learning was used to define: (1) a model employing initial ncRNA levels to predict persistent post-concussion symptoms (PPCS) ≥ 21 days post-injury; and (2) a model employing follow-up ncRNA levels to identify symptom recovery. Performance of the models was compared against a validated clinical prediction rule, and balance/cognitive test performance, respectively. Results An algorithm using age and 16 ncRNAs predicted PPCS with greater accuracy than the validated clinical tool and demonstrated additive combined utility (area under the curve (AUC) 0.86; 95% CI 0.84–0.88). Initial balance and cognitive test performance did not differ between PPCS and non-PPCS groups (p > 0.05). Follow-up balance and cognitive test performance identified symptom recovery with similar accuracy to a model using 11 ncRNAs and age. A combined model (ncRNAs, balance, cognition) most accurately identified recovery (AUC 0.86; 95% CI 0.83–0.89). Conclusions ncRNA biomarkers show promise for tracking recovery from mTBI, and for predicting who will have prolonged symptoms. They could provide accurate expectations for recovery, stratify need for intervention, and guide safe return-to-activities.

scholarly journals Impact of Grade Groups on Prostate Cancer-Specific and Other-Cause Mortality: Competing Risk Analysis from a Large Single Institution Series

Cancers ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1963
Author(s):  
Daimantas Milonas ◽  
Tomas Ruzgas ◽  
Zilvinas Venclovas ◽  
Mindaugas Jievaltas ◽  
Steven Joniau
Keyword(s):  
Clinical Decision Making ◽  
Area Under The Curve ◽  
Clinical Decision ◽  
Competing Risk ◽  
Grade Group ◽  
Tertiary Center ◽  
Stable Performance ◽  
Cancer Specific Mortality ◽  
Risk Of Cancer

Objective: To assess the risk of cancer-specific mortality (CSM) and other-cause mortality (OCM) using post-operative International Society of Urological Pathology Grade Group (GG) model in patients after radical prostatectomy (RP). Patients and Methods: Overall 1921 consecutive men who underwent RP during 2001 to 2017 in a single tertiary center were included in the study. Multivariate competing risk regression analysis was used to identify significant predictors and quantify cumulative incidence of CSM and OCM. Time-depending area under the curve (AUC) depicted the performance of GG model on prediction of CSM. Results: Over a median follow-up of 7.9-year (IQR 4.4-11.7) after RP, 235 (12.2%) deaths were registered, and 52 (2.7%) of them were related to PCa. GG model showed high and stable performance (time-dependent AUC 0.88) on prediction of CSM. Cumulative 10-year CSM in GGs 1 to 5 was 0.9%, 2.3%, 7.6%, 14.7%, and 48.6%, respectively; 10-year OCM in GGs was 15.5%, 16.1%, 12.6%, 17.7% and 6.5%, respectively. The ratio between 10-year CSM/OCM in GGs 1 to 5 was 1:17, 1:7, 1:2, 1:1, and 7:1, respectively. Conclusions: Cancer-specific and other-cause mortality differed widely between GGs. Presented findings could aid in personalized clinical decision making for active treatment.

scholarly journals A novel predictor of clinical progression in patients on active surveillance for prostate cancer

2019 ◽  
Vol 13 (8) ◽  
Author(s):  
Guan Hee Tan ◽  
Antonio Finelli ◽  
Ardalan Ahmad ◽  
Marian Wettstein ◽  
Alexandre Zlotta ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Cox Regression ◽  
Area Under The Curve ◽  
Progression Free Survival ◽  
Roc Curves ◽  
Standard Of Care ◽  
Low Risk ◽  
Clinical Progression

Introduction: Active surveillance (AS) is standard of care in low-risk prostate cancer (PC). This study describes a novel total cancer location (TCLo) density metric and aims to determine its performance in predicting clinical progression (CP) and grade progression (GP).     Methods: This was a retrospective study of patients on AS after confirmatory biopsy (CBx). We excluded patients with Gleason ≥7 at CBx and <2 years follow-up. TCLo was the number of locations with positive cores at diagnosis (DBx) and CBx. TCLo density was TCLo / prostate volume (PV). CP was progression to any active treatment while GP occurred if Gleason ≥7 was identified on repeat biopsy or surgical pathology. Independent predictors of time to CP or GP were estimated with Cox regression. Kaplan-Meier analysis compared progression-free survival curves between TCLo density groups. Test characteristics of TCLo were explored with receiver operating characteristic (ROC) curves.     Results: We included 181 patients who had CBx between 2012-2015, and met inclusion criteria. The mean age of patients was 62.58 years (SD=7.13) and median follow-up was 60.9 months (IQR=23.4). A high TCLo density score (>0.05) was independently associated with time to CP (HR 4.70, 95% CI: 2.62-8.42, p<0.001), and GP (HR 3.85, 95% CI: 1.91-7.73, p<0.001). ROC curves showed TCLo density has greater area under the curve than number of positive cores at CBx in predicting progression.     Conclusion: TCLo density is able to stratify patients on AS for risk of CP and GP. With further validation, it could be added to the decision-making algorithm in AS for low-risk localized PC.

scholarly journals Gait Speed as a Predictor for Diabetes Incidence in People with or at Risk of Knee Osteoarthritis: A Longitudinal Analysis from the Osteoarthritis Initiative

2021 ◽  
Vol 18 (9) ◽  
pp. 4414
Author(s):  
Aqeel M. Alenazi ◽  
Bader A. Alqahtani ◽  
Vishal Vennu ◽  
Mohammed M. Alshehri ◽  
Ahmad D. Alanazi ◽  
...  
Keyword(s):  
At Risk ◽  
Gait Speed ◽  
Area Under The Curve ◽  
Incident Diabetes ◽  
Future Research ◽  
Cutoff Score ◽  
Diabetes Incidence ◽  
Knee Oa ◽  
Osteoarthritis Initiative

Background: This study examined the association between baseline gait speed with incident diabetes mellitus (DM) among people with or at elevated risk for knee OA. Materials and Methods: Participants from the Osteoarthritis Initiative, aged 45 to 79 years, where included. Participants with or at risk of knee OA from baseline to the 96-month visit were included. Participants with self-reported DM at baseline were excluded. DM incidence was followed over the 4-time points. Gait speed was measured at baseline using a 20-m walk test. Generalized estimating equations with logistic regression were utilized for analyses. Receiver operator characteristic curves and area under the curve were used to determine the cutoff score for baseline speed. Results: Of the 4313 participants included in the analyses (58.7% females), 301 participants had a cumulative incidence of DM of 7.0% during follow-up. Decreased gait speed was a significant predictor of incident DM (RR 0.44, p = 0.018). The threshold for baseline gait speed that predicted incident DM was 1.32 m/s with an area under the curve of 0.59 (p < 0.001). Conclusions: Baseline gait speed could be an important screening tool for identifying people at risk of incident diabetes, and the determined cutoff value for gait speed should be examined in future research.

scholarly journals Analysis of serum levels of titanium and aluminium ions in patients with early onset scoliosis operated upon using the magnetic growing rod—a single centre study of 14 patients

2021 ◽  
Author(s):  
Mandar Deepak Borde ◽  
Sarang Sapare ◽  
Emile Schutgens ◽  
Chadi Ali ◽  
Hilali Noordeen
Keyword(s):  
Early Onset ◽  
Serum Levels ◽  
Early Onset Scoliosis ◽  
Ion Concentration ◽  
Long Term Effects ◽  
Blood Concentrations ◽  
Growing Rod ◽  
Rod System ◽  
Rod Breakage

Abstract Study design A cross-sectional retrospective Level 3 study. Objective To study the serum levels of Titanium and Aluminium ions in patients operated using the magnetically controlled growing rod (MCGR) system. Summary of background data 14 consecutive patients of early onset scoliosis with varying etiology managed with MCGR system with a minimum follow-up of 24 months were selected for the study. The group consisted of two boys (14.3%) and 12 girls (85.7%). The average age of the patients at the time of surgery was 10.4 years (5–15 years). The average period of follow-up was 43.7 months (28–79 months). After informed consent of the subjects and their caretakers, serum levels of titanium and aluminium were measured. These levels were then assessed with regards to the number of screws used, number of distractions and complications. Methods The concentration of titanium and aluminium ions in the serum was measured using high resolution inductively coupled plasma mass spectrometry. Results For the sake of ease of assessment, patients were divided into three etiology-based groups—idiopathic (n = 6), neuromuscular (n = 2) and syndromic (n = 6). The mean serum titanium level was 15.9 μg/L (5.1–28.2 μg/L) while that of aluminium was 0.1 μmol/L (0.1–0.2 μmol/L). Of the 14 patients, 2 (14.2%) patients had mechanical failure (actuator pin dysfunction), 3 (21.4%) had rod breakage requiring revision surgery and one patient (7.1%) had surgical site infection managed with appropriate antibiotics. Patients undergoing revision for rod breakage did not show any metallosis of the tissues during surgery. Conclusion Analysis of patients with scoliosis operated using the magnetic growing rod system concludes that it is accompanied by presence of titanium in the blood but whether clinically significant or not needs to be ascertained by comparison of preoperative and postoperative blood concentrations of the titanium ions in individual subjects. The aluminium ion concentration remains within normal limits. Though implant malfunction may raise the titanium levels in the blood, its clinical significance needs to be determined. The aluminium levels are not affected irrespective to the presence or absence of complications. The long-term effects of raised titanium levels in the blood also warrant further prospective studies designed for precise and deeper analyses.

scholarly journals New screening approach to detecting congenital syphilis in China: a retrospective cohort study

2020 ◽  
pp. archdischild-2020-320549
Author(s):  
Fang Hu ◽  
Shuai-Jun Guo ◽  
Jian-Jun Lu ◽  
Ning-Xuan Hua ◽  
Yan-Yan Song ◽  
...  
Keyword(s):  
Predictive Value ◽  
Congenital Syphilis ◽  
Area Under The Curve ◽  
Diagnostic Tools ◽  
Operating Characteristics ◽  
Loss To Follow Up ◽  
Sensitivity Specificity ◽  
Mother To Child ◽  
Rule Out

BackgroundDiagnosis of congenital syphilis (CS) is not straightforward and can be challenging. This study aimed to evaluate the validity of an algorithm using timing of maternal antisyphilis treatment and titres of non-treponemal antibody as predictors of CS.MethodsConfirmed CS cases and those where CS was excluded were obtained from the Guangzhou Prevention of Mother-to-Child Transmission of syphilis programme between 2011 and 2019. We calculated sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) using receiver operating characteristics (ROC) in two situations: (1) receiving antisyphilis treatment or no-treatment during pregnancy and (2) initiating treatment before 28 gestational weeks (GWs), initiating after 28 GWs or receiving no treatment for syphilis seropositive women.ResultsAmong 1558 syphilis-exposed children, 39 had confirmed CS. Area under the curve, sensitivity and specificity of maternal non-treponemal titres before treatment and treatment during pregnancy were 0.80, 76.9%, 78.7% and 0.79, 69.2%, 88.7%, respectively, for children with CS. For the algorithm, ROC results showed that PPV and NPV for predicting CS were 37.3% and 96.4% (non-treponemal titres cut-off value 1:8 and no antisyphilis treatment), 9.4% and 100% (non-treponemal titres cut-off value 1:16 and treatment after 28 GWs), 4.2% and 99.5% (non-treponemal titres cut-off value 1:32 and treatment before 28 GWs), respectively.ConclusionsAn algorithm using maternal non-treponemal titres and timing of treatment during pregnancy could be an effective strategy to diagnose or rule out CS, especially when the rate of loss to follow-up is high or there are no straightforward diagnostic tools.

scholarly journals Simultaneous Determination of 5 Active Components of Periploca forrestii Schltr Extract in Rat Plasma by UPLC-MS and Its Application to Pharmacokinetic Studies in Normal and Adjuvant-Induced Arthritis Model Rats

2020 ◽  
Vol 15 (12) ◽  
pp. 1934578X2098143
Author(s):  
Hui Liu ◽  
Hao Chen ◽  
Xiaoli Qin ◽  
Xue Ma ◽  
Zipeng Gong ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Chlorogenic Acid ◽  
Intravenous Administration ◽  
Area Under The Curve ◽  
Pharmacokinetic Studies ◽  
Active Components ◽  
Arthritis Model ◽  
Adjuvant Induced Arthritis ◽  
Neochlorogenic Acid

Periploca forrestii Schltr ( P. forrestii) is a herb used in traditional Chinese medicine for its anti-rheumatoid arthritis effect. The aim of this study was to compare the pharmacokinetic properties of the 5 active components of this plant: neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, isochlorogenic acid C, and periplocin between normal rats and adjuvant-induced arthritis model rats. After the intravenous administration (177.78 mg/kg) of P. forrestii extract, samples were analyzed by ultra-performance liquid chromatography-tandem mass spectrometry. Compared with normal rats, the area under the curve [(AUC)(0-t), AUC(0-∞)], mean residence time [(MRT)(0-t), MRT(0-∞)] of neochlorogenic acid-treated rats decreased significantly, and drug clearance (CL) and apparent volume of distribution (V) increased significantly; the V of chlorogenic acid-treated rats decreased significantly, and MRT(0-t) significantly increased; the AUC(0-t) and AUC(0-∞) of cryptochlorogenic acid-treated rats decreased significantly, and CL and V increased significantly; the AUC(0-t) and MRT(0-t) of isochlorogenic acid C-treated rats decreased significantly, and V increased significantly; the AUC(0-t) and AUC(0-∞) of periplocin-treated rats increased significantly, and MRT(0-t), MRT(0-∞), CL, and V decreased significantly in model rats. The disease condition of rheumatoid arthritis in rats had a significant effect on the in vivo pharmacokinetics of P. forrestii after the intravenous administration.

scholarly journals FRI0234 A HIGH NEMO SCORE IN VIDEOCAPILLAROSCOPY IS PREDICTIVE OF FUTURE DEVELOPMENT OF DIGITAL ULCERS IN PATIENTS WITH SYSTEMIC SCLEROSIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 700.1-701
Author(s):  
N. Del Papa ◽  
F. Pignataro ◽  
W. Maglione ◽  
A. Minniti ◽  
D. Sambataro ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Future Development ◽  
Area Under The Curve ◽  
Subsequent Development ◽  
State Level ◽  
Receiver Operating Curve ◽  
Digital Ulcers ◽  
Cumulative Number ◽  
Predictive Values

Background:Nailfold videocapillaroscopy (NVC) is a feasible method that allows the observation and follow-up of the microvascular changes that mark the course of Systemic Sclerosis (SSc). In previous studies, we demonstrated that the NEMO score, namely the cumulative Number of microhaEMOrrhages and microthromboses, is a good indicator of the steady state level and over time changes of disease activity (DA) in SSc (1-3).Objectives:To verify whether a high NEMO score, and then a high level of active microvascular derangement in the fingers may be predictive of the subsequent development of ischemic digital ulcers (IDUs).Methods:The NEMO score was assessed at baseline (T0) in 98 patients affected by SSc, according to the ACR-EULAR criteria. Out of them, 90 were females, 48 had the limited form and 50 the diffuse cutaneous variant of SSc. ACA and anti-Scl-70 antibodies were positive in 42 and 50 patients, respectively. The NVC pattern was early, active and late in 16, 42 and 40 patients, respectively.Afterwards, patients were closely followed up for 3 years, and the appearance of new IDUs was recorded in any time of the follow up.The T0-NEMO score values of patients who developed IDUs were compared to those of patients who did not. A receiver operating curve (ROC) was constructed, and the area under the curve (AUC) calculated, by plotting the sensitivity and 1-specificity of the different NEMO score values in predicting the development of IDUs.Results:During the follow up, 38 out of 98 patients developed one or more DUs. The NEMO score at T0 was significantly higher in those who developed IDUs with respect to those who did not [median 14.5 (CI 11.0-21.5), and 4.5 (CI 4.0-6.0), respectively, p<.0001]. The AUC was 0.79 (CI 0.69-0.86, p<0.0001). A NEMO score of 12 or more had a sensitivity of 83.3 (CI 71.5-91.7), and a specificity of 63.2 (CI 46.0-78.2), with positive (P) and negative (N) predictive values (PV) of 59.1 (CI 44.9-72.3), and 85.6 (CI 71.7-94.3), respectively. A NEMO score of 16 or more had a sensitivity of 95.0 (CI 86.1-99.0), and a NPV of 93.3 (CI 77.4-99.2).Conclusion:NEMO score is not only a valid tool to assess the level of DA in the course of SSc, but this NVC parameter could also be used as a good predictor of the future development of IDUs in patients with this disease.References:[1]Sambataro et al. Arthritis Res Ther 2014;16:462-69[2]Andracco et al. Arthritis Res Ther 2017;19:133-41[3]Pignataro et al. Arthritis Res Ther. 2019;21(1):258Disclosure of Interests:Nicoletta Del Papa: None declared, Francesca Pignataro: None declared, Wanda Maglione: None declared, Antonina Minniti: None declared, Domenico Sambataro: None declared, Gianluca Sambataro: None declared, Gabriele Valentini Grant/research support from: BMS, MSD, NOVARTIS, LILLY, PFIZER, ABBVIE, CELGENE, Claudio Vitali: None declared, Roberto Caporali Consultant of: AbbVie; Gilead Sciences, Inc.; Lilly; Merck Sharp & Dohme; Celgene; Bristol-Myers Squibb; Pfizer; UCB, Speakers bureau: Abbvie; Bristol-Myers Squibb; Celgene; Lilly; Gilead Sciences, Inc; MSD; Pfizer; Roche; UCB

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