Trimethoprim use in early pregnancy and the risk of miscarriage: a register-based nationwide cohort study

2012 ◽  
Vol 141 (8) ◽  
pp. 1749-1755 ◽  
Author(s):  
J. T. ANDERSEN ◽  
M. PETERSEN ◽  
E. JIMENEZ-SOLEM ◽  
K. BROEDBAEK ◽  
E. W. ANDERSEN ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Cohort Study ◽  
Folic Acid ◽  
First Trimester ◽  
Induced Abortion ◽  
Time Dependent ◽  
Proportional Hazard ◽  
Acid Cycle ◽  
Cox Proportional Hazard ◽  
Cox Proportional Hazard Regression

SUMMARYThe antibiotic trimethoprim acts as a folate antagonist. Since trophoblasts are very sensitive to drugs that interfere with the folic acid cycle and thereby inhibit DNA synthesis, use of trimethoprim during the first trimester could be associated with miscarriage. A nationwide cohort study including all women in Denmark with a registered pregnancy between 1997 and 2005 was conducted. We used nationwide registers to identify all women giving birth, having a record of miscarriage or induced abortion. Data on exposure to trimethoprim were obtained from the National Prescription Register. Cox proportional hazard regression analysis with exposure to trimethoprim as a time-dependent variable was used to estimate the risk of miscarriage. The adjusted hazard ratio of having a miscarriage after exposure to trimethoprim in the first trimester compared to non-exposure was 2·04 (95% confidence interval 1·43–2·91). Our results indicate that trimethoprim exposure in the first trimester is associated with a doubling of the hazard of miscarriage.

scholarly journals The Associations of Lipid Profiles With Cardiovascular Diseases and Death in a 10-Year Prospective Cohort Study

2021 ◽  
Vol 8 ◽  
Author(s):  
Jiayi Dong ◽  
Song Yang ◽  
Qian Zhuang ◽  
Junxiang Sun ◽  
Pengfei Wei ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Cohort Study ◽  
Cardiovascular Diseases ◽  
Cox Regression ◽  
Density Lipoprotein ◽  
Proportional Hazard ◽  
Cox Regression Analysis ◽  
Cox Proportional Hazard ◽  
Cox Proportional Hazard Regression ◽  
Preventative Interventions

Background: Dyslipidemia is one of the modifiable risk factors for cardiovascular diseases (CVD). Identifying subjects with lipid abnormality facilitates preventative interventions.Objectives: To evaluate the effects of lipid indices on the risks of ischemic stroke (IS), coronary heart disease (CHD), CVD, all-cause death, and CVD death.Methods: The cohort study of 4,128 subjects started in May 2009 and followed up to July 2020. Restricted cubic spline (RCS) regression analysis was used to explore the dose-response relationship between lipid indices with outcomes. Cox proportional hazard regression analysis was used to estimate the association with a hazard ratio (HR) and 95% CI.Results: RCS analysis showed that there were significant linear associations of TG with IS, non-high-density lipoprotein cholesterol (HDL-C), apolipoprotein B (ApoB), and total cholesterol (TC)/HDL-C ratio with all-cause death, non-HDL-C and RC with CVD death, and significant non-linear associations of ApoB with IS and CVD, TC, LDL-C, ApoAI, and TC/HDL-C ratio with CHD, and TC with all-cause death (all P <0.1). Cox regression analysis revealed that subjects with TC <155 mg/dl (vs. 155–184 mg/dl), > 185 mg/dl (vs. 155–184 mg/dl), and ApoB <0.7 g/l (vs. ≥0.7 g/l) had higher risks of CHD (P < 0.05), the adjusted HRs (95% CIs) were 1.933 (1.248–2.993), 1.561 (1.077–2.261), and 1.502 (1.01–2.234), respectively. Subjects with ApoAI > 2.1 g/l (vs. 1.6–2.1 g/l) and TG <80 mg/dl (vs. 80–177 mg/dl) had higher risks of CVD and all-cause death (P < 0.05), the adjusted HRs (95% CIs) were 1.476 (1.031–2.115) and 1.234 (1.002–1.519), respectively.Conclusions: Lower or higher levels of TC, higher level of ApoAI, and lower level of ApoB were associated with increased risks of CVD, and lower level of TG was associated with increased all-cause death. Maintaining optimal lipid levels would help to prevent CVD and reduce mortality.

scholarly journals AB0292 EFFICACY AND SAFETY OF TWO BIOSIMILAR ETANERCEPT AFTER THE SWITCH FROM THEIR CORRESPONDING ORIGINATOR IN THE TREATMENT OF PATIENTS WITH AUTOIMMUNE ARTHRITIS; A RETROSPECTIVE ANALYSIS IN A REAL LIFE SETTING

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1445.1-1445
Author(s):  
F. Girelli ◽  
A. Ariani ◽  
M. Bruschi ◽  
A. Becciolini ◽  
L. Gardelli ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Disease Duration ◽  
Retention Rate ◽  
Real Life ◽  
Autoimmune Arthritis ◽  
Proportional Hazard ◽  
Hazard Regression ◽  
Cox Proportional Hazard ◽  
Real Life Setting ◽  
Cox Proportional Hazard Regression

Background:The available biosimilars of etanercept are as effective and well tolerated as their bio originator molecule in the naive treatment of chronic autoimmune arthritis. More data about the switching from the bio originator are needed.Objectives:To compare the clinical outcomes of the treatment with etanercept biosimilars (SB4 and GP2015) naïve and after the switch from their corresponding originator in patients affected by autoimmune arthritis in a real life settingMethods:We retrospectively analyzed the baseline characteristics and the retention rate in a cohort of patients who received at least a course of etanercept (originator or biosimilar) in our Rheumatology Units from January 2000 to January 2020. We stratified the study population according to biosimilar use. Descriptive data are presented by medians (interquartile range [IQR]) for continuous data or as numbers (percentages) for categorical data. Drug survival distribution curves were computed by the Kaplan-Meier method and compared by a stratified log-rank test. A Cox proportional hazards regression analysis stratified by indication, drug, age, disease duration, sex, treatment line, biosimilar use and prescription year was performed. P values≤0.05 were considered statistically significant.Results:477 patients (65% female, median age 56 [46-75] years, median disease duration 97 [40.25-178.75] months) treated with etanercept were included in the analysis. 257 (53.9%) were affect by rheumatoid arthritis, 139 (29.1%) by psoriatic arthritis, and 81 (17%) by axial spondylarthritis. 298 (62.5%) were treated with etanercept originator, 97 (20.3%) with SB4, and 82 (17.2%) with GP2015. Among the biosimilars 90/179 (50.3%) patients were naïve to etanercept treatment. Among the 89 switchers we observed 8 treatment discontinuations: one due to surgical infection complication, three due to disease flare, two due to subjective worsening and one due to remission. The overall 6- and 12-month retentions rate were 92.8% and 80.2%. The 6- and 12-month retention rate for etanercept, SB4 and GP2015 were 92.7%, 93.4% and 90.2%, and 82%, 74.5% and 88.1% respectively, without significant differences among the three groups (p=0.374). Patients switching from originator to biosimilars showed and overall higher treatment survival when compared to naive (12-month retention rate 81.2% vs 70.8%, p=0.036). The Cox proportional hazard regression analysis highlighted that the only predictor significantly associated with an overall higher risk of treatment discontinuation was the year of prescription (HR 1.08, 95% CI 1.04 to 1.13; p<0.0001).Conclusion:In our retrospective study etanercept originator and its biosimilars (SB4 and GP2015) showed the same effectiveness. Patients switching from originator to biosimilar showed an significant higher retention rate when compared to naive. The only predictor of treatment discontinuation highlighted by the Cox proportional hazard regression analysis was the year of treatment prescription.Disclosure of Interests:Francesco Girelli: None declared, Alarico Ariani: None declared, Marco Bruschi: None declared, Andrea Becciolini Speakers bureau: Sanofi-Genzyme, UCB and AbbVie, Lucia Gardelli: None declared, Maurizio Nizzoli: None declared

Association between Preoperative Monocyte-to-Lymphocyte Ratio and Late Arteriovenous Fistula Dysfunction in Hemodialysis Patients: A Cohort Study

2021 ◽  
pp. 1-7
Author(s):  
Shouliang Hu ◽  
Dan Wang ◽  
Tean Ma ◽  
Fanli Yuan ◽  
Yong Zhang ◽  
...  
Keyword(s):  
Cohort Study ◽  
Arteriovenous Fistula ◽  
Vessel Diameter ◽  
Transluminal Angioplasty ◽  
Proportional Hazard ◽  
Clinical Value ◽  
Hazard Regression ◽  
Lymphocyte Ratio ◽  
Cox Proportional Hazard ◽  
Cox Proportional Hazard Regression

<b><i>Background:</i></b> Inflammation appears to be at the biological core of arteriovenous fistula (AVF) dysfunction, and the occurrence of AVF dysfunction is related to high death and disability in hemodialysis (HD) patients. Despite several studies on the correlations between AVF dysfunction and inflammatory indicators, how AVF dysfunction is related to the monocyte-to-lymphocyte ratio (MLR) is much unclear. We hypothesize that preoperative MLR is associated with AVF dysfunction in Chinese HD patients. <b><i>Methods:</i></b> In this single-center retrospective cohort study, totally 769 adult HD patients with a new AVF created between 2011 and 2019 were included. Association of preoperative MLR with AVF dysfunction (thrombosis or decrease of normal vessel diameter by &#x3e;50%, requiring either surgical revision or percutaneous transluminal angioplasty) was assessed by multivariable Cox proportional hazard regression. <b><i>Results:</i></b> The patients were aged 55.8 ± 12.2 years and were mostly males (55%). During the average 32-month follow-up (maximum 119 months), 223 (29.0%) patients had permanent vascular access dysfunction. In adjusted multivariable Cox proportional hazard regression analyses, the risk of AVF dysfunction was 4.32 times higher with 1 unit increase in MLR (hazard ratio [HR]: 5.32; 95% confidence interval [CI]: 3.1–9.11). Compared with patients with MLR &#x3c;0.28, HRs associated with an MLR of 0.28–0.41 and ≥0.41 are 1.54 (95% CI: 1.02–2.32) and 3.17 (2.18–4.62), respectively. <b><i>Conclusions:</i></b> A higher preoperative MLR is independently connected with a severer risk of AVF dysfunction in HD patients. Its clinical value should be determined in the future.

scholarly journals Computer-assisted quantification of tumor-associated collagen signatures to improve the prognosis prediction of breast cancer

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Gangqin Xi ◽  
Lida Qiu ◽  
Shuoyu Xu ◽  
Wenhui Guo ◽  
Fangmeng Fu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Regression Analysis ◽  
Cancer Patients ◽  
Validation Cohort ◽  
Proportional Hazard ◽  
Breast Cancer Patients ◽  
Cox Proportional Hazard ◽  
Clinical Center ◽  
Microscopic Features ◽  
Cox Proportional Hazard Regression

Abstract Background Collagen fibers play an important role in tumor initiation, progression, and invasion. Our previous research has already shown that large-scale tumor-associated collagen signatures (TACS) are powerful prognostic biomarkers independent of clinicopathological factors in invasive breast cancer. However, they are observed on a macroscale and are more suitable for identifying high-risk patients. It is necessary to investigate the effect of the corresponding microscopic features of TACS so as to more accurately and comprehensively predict the prognosis of breast cancer patients. Methods In this retrospective and multicenter study, we included 942 invasive breast cancer patients in both a training cohort (n = 355) and an internal validation cohort (n = 334) from one clinical center and in an external validation cohort (n = 253) from a different clinical center. TACS corresponding microscopic features (TCMFs) were firstly extracted from multiphoton images for each patient, and then least absolute shrinkage and selection operator (LASSO) regression was applied to select the most robust features to build a TCMF-score. Finally, the Cox proportional hazard regression analysis was used to evaluate the association of TCMF-score with disease-free survival (DFS). Results TCMF-score is significantly associated with DFS in univariate Cox proportional hazard regression analysis. After adjusting for clinical variables by multivariate Cox regression analysis, the TCMF-score remains an independent prognostic indicator. Remarkably, the TCMF model performs better than the clinical (CLI) model in the three cohorts and is particularly outstanding in the ER-positive and lower-risk subgroups. By contrast, the TACS model is more suitable for the ER-negative and higher-risk subgroups. When the TACS and TCMF are combined, they could complement each other and perform well in all patients. As expected, the full model (CLI+TCMF+TACS) achieves the best performance (AUC 0.905, [0.873–0.938]; 0.896, [0.860–0.931]; 0.882, [0.840–0.925] in the three cohorts). Conclusion These results demonstrate that the TCMF-score is an independent prognostic factor for breast cancer, and the increased prognostic performance (TCMF+TACS-score) may help us develop more appropriate treatment protocols.

scholarly journals Patient flow dynamics in hospital systems during times of COVID-19: Cox proportional hazard regression analysis.

2020 ◽  
Author(s):  
Sudhir Bhandari ◽  
Amit Tak ◽  
Sanjay Singhal ◽  
Jyotsna Shukla ◽  
Bhoopendra Patel ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Survival Rate ◽  
Hospital Stay ◽  
Cox Model ◽  
Patient Flow ◽  
Proportional Hazard ◽  
Age And Gender ◽  
Cox Proportional Hazard ◽  
And Gender ◽  
Cox Proportional Hazard Regression

Abstract Objectives: The present study is aimed at estimating patient flow dynamical parameters and requirement of hospital beds. Secondly, the effects of age and gender on parameters were evaluated. Patients and Methods: In this retrospective cohort study, 987 COVID-19 patients were enrolled from SMS Medical College, Jaipur (Rajasthan, India). The survival analysis was carried out from 29 Feb to 19 May 2020 for two hazards – ‘Hazard 1’ was hospital discharge and ‘Hazard 2’ was hospital death. The starting point for survival analysis of the two hazards was considered to be hospital admission . The survival curves were estimated and additional effects of age and gender were evaluated using Cox proportional hazard regression analysis. Results: The Kaplan Meier estimates of lengths of hospital stay (Median =10 days, IQR =10 days) and median survival rate ( more than 60 days due to large amount of censored data) were obtained. The Cox Model for ‘Hazard 1’ showed no significant effect of age and gender on duration of hospital stay. Similarly, the Cox Model 2 showed no significant difference of gender on survival rate. The case fatality rate 8.1 % , recovery rate 78.8% , mortality rate 0.10 per 100 person--days and hospital admission rate 0.35 per 105 person-days were estimated.Conclusion : The study estimates hospital bed requirement based on patient flow dynamic parameters. Furthermore, study concludes that average length of hospital stay were similar for patients of both genders and all age groups.

scholarly journals Factors That Affect Time to Switch From Warfarin to a Direct Oral Anticoagulant After Change in the Reimbursement Criteria in Patients With Atrial Fibrillation

2019 ◽  
Vol 25 (1) ◽  
pp. 57-64
Author(s):  
Susin Park ◽  
Nam Kyung Je
Keyword(s):  
Atrial Fibrillation ◽  
Regression Analysis ◽  
Oral Anticoagulant ◽  
Proportional Hazard ◽  
Direct Oral Anticoagulant ◽  
Hazard Regression ◽  
Cox Proportional Hazard ◽  
History Of ◽  
Cox Proportional Hazard Regression ◽  
Prior Stroke

Background: Anticoagulation therapy is recommended for stroke prevention in high-risk patients with atrial fibrillation (AF). This study aimed to estimate the time to switch from warfarin to a direct oral anticoagulant (DOAC) and identify the factors associated with it. Methods: By using claims data, we studied 7111 warfarin-using patients with nonvalvular AF who were aged ≥65 years. The Kaplan-Meier analysis was performed to estimate the time to switch from warfarin to a DOAC, and Cox proportional hazard regression analysis was used to estimate the influencing factors. Results: Approximately one-third of the patients (2403, 33.8%) switched from warfarin to a DOAC during the study period. Female sex, aged between 75 and 79 years, having a Medical Aid or Patriots and Veterans Insurance, hypertension, and history of prior stroke, and transient ischemic attack or thromboembolism (prior stroke/TIA/TE) were associated with a significantly shorter time to switch. The odds of switching to a DOAC were increased by approximately 1.2-fold in the women and 1.4-fold in the patients with prior stroke/TIA/TE. Conclusions: Approximately one-third of the warfarin-using patients switched from warfarin to a DOAC within 6 months after the change in the DOAC reimbursement criteria. In the Cox proportional hazard regression analysis, the factors that affected anticoagulant switching from warfarin to a DOAC were female sex and history of prior stroke/TIA/TE.

A Dynamic Prognostic Model To Predict Survival in Post-Polycythemia Vera Myelofibrosis.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2547-2547
Author(s):  
Francesco F. Passamonti ◽  
Elisa E. Rumi ◽  
Marianna M. Caramella ◽  
Chiara C. Elena ◽  
Luca L. Arcaini ◽  
...  
Keyword(s):  
Platelet Count ◽  
Prognostic Factors ◽  
Polycythemia Vera ◽  
Median Survival ◽  
Prognostic Model ◽  
Time Dependent ◽  
Proportional Hazard ◽  
Cox Proportional Hazard ◽  
Cox Proportional Hazard Regression

Abstract Polycythemia vera (PV) is a chronic myeloproliferative disorder with a propensity to develop myelofibrosis, a condition named post polycythemia vera myelofibrosis (post-PV MF). Survival and prognostic factors after transition to MF remain to be defined. We studied 68 patients with post-PV MF to define survival and prognostic factors for survival at diagnosis of post-PV MF. We also developed a dynamic prognostic model to predict survival at any time from diagnosis of post-PV MF. The median interval between the diagnosis of PV and that of post-PV MF was 13 years (range, 4–29.6 years). Patients with post-PV MF were observed for 181 person-years of follow-up. At diagnosis of post-PV MF, 43 (63%) of 68 patients had less than 65 years. During the follow-up, the incidence of thrombosis was 42 × 1000 person-years (95% CI: 19–93.5) and the incidence of leukemia was 50.3 × 1000 person-years (95% CI: 26–115). The median survival was 5.7 years. Multivariable Cox proportional hazard regression including age, hemoglobin value, platelet count, leukocyte count, and spleen size, showed that hemoglobin &lt; 10 g/dL (P &lt; .001) and platelet count &lt; 100 × 109/L (P= .026) were independent risk factors for survival. We stratified patients at diagnosis of post-PV MF, according to these factors, obtaining two risk groups with significantly different survival (P = .003): low risk (Hb &gt; 10 g/dL and platelet count &gt; 100 × 109/L) with a median survival of 7 years, and high risk (Hb &lt; 10 g/dL or platelet count &lt; 100 × 109/L) with a median survival of 2 years. The prognostic model retained significance after adjustment for age in a multivariable Cox proportional hazard regression (HR: 4.3, 95% CI: 1.6–11.4; P= .003). To assess whether this prognostic model may predict survival at any time from diagnosis of post-PV MF, we evaluated in a time-dependent analysis 64 patients who had longitudinal blood cell counts during follow-up. As first step, we evaluated univariate survival analysis with hemoglobin value &lt; 10 g/dL and platelet count &lt; 100 ×109/L as time-dependent covariates. Both time-dependent parameters affected survival (HR for hemoglobin 5.8, 95% CI: 2.2–15.2, P &lt; 0.001; HR for platelets 4.5, 95% CI: 1.67-12, P=.002). As second step, we evaluated the prognostic model assessed at diagnosis as time-dependent covariate, to define whether the acquisition of one risk factor during follow-up may affect survival. The HR was 7.5 (95% CI: 2.4-23.4; P &lt; .001). The time-dependent prognostic model retained statistical significance after adjustment for age (P &lt; .001). In conclusion, in patients developing post-PV myelofibrosis, a prognostic model based on hemoglobin level &lt; 10 g/dL and platelet count &lt; 100 × 109/L may predict survival at diagnosis of post-PV MF and at any time thereafter.

scholarly journals Decreased All-Cause and Liver-Related Mortality Risk in HIV/Hepatitis B Virus Coinfection Coinciding With the Introduction of Tenofovir-Containing Combination Antiretroviral Therapy

2020 ◽  
Vol 7 (7) ◽  
Author(s):  
Berend J van Welzen ◽  
Colette Smit ◽  
Anders Boyd ◽  
Faydra I Lieveld ◽  
Tania Mudrikova ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Hepatitis B Virus ◽  
Proportional Hazard ◽  
Combination Antiretroviral Therapy ◽  
Cox Proportional Hazard ◽  
B Virus ◽  
Specific Mortality ◽  
Cox Proportional Hazard Regression ◽  
Related Mortality

Abstract Background The development of efficacious combination antiretroviral therapy (cART) has led to a dramatic decrease in mortality in HIV-positive patients. Specific data on the impact in HIV/hepatitis B virus (HBV)–coinfected patients are lacking. In this study, all-cause and cause-specific mortality risks stratified per era of diagnosis are investigated. Methods Data were analyzed from HIV/HBV-coinfected patients enrolled in the ATHENA cohort between January 1, 1998, and December 31, 2017. Risk for (cause-specific) mortality was calculated using Cox proportional hazard regression analysis, comparing patients diagnosed before 2003 with those diagnosed ≥2003. Risk factors for all-cause and liver-related mortality were also assessed using Cox proportional hazard regression analysis. Results A total of 1301 HIV/HBV-coinfected patients were included (14 882 person-years of follow-up). One-hundred ninety-eight patients (15%) died during follow-up. The adjusted hazard ratio (aHR) for all-cause mortality in patients diagnosed in or after 2003 was 0.50 (95% CI, 0.35–0.72) relative to patients diagnosed before 2003. Similar risk reduction was observed for liver-related (aHR, 0.29; 95% CI, 0.11–0.75) and AIDS-related mortality (aHR, 0.44; 95% CI, 0.22–0.87). Use of a tenofovir-containing regimen was independently associated with a reduced risk of all-cause and liver-related mortality. Prior exposure to didanosine/stavudine was strongly associated with liver-related mortality. Ten percent of the population used only lamivudine as treatment for HBV. Conclusions All-cause, liver-related, and AIDS-related mortality risk in HIV/HBV-coinfected patients has markedly decreased over the years, coinciding with the introduction of tenofovir. Tenofovir-containing regimens, in absence of major contraindications, should be strongly encouraged in this population.

scholarly journals P06 Paternal exposure to methotrexate and the risk of miscarriage – a register based nationwide cohort study

2019 ◽  
Vol 104 (6) ◽  
pp. e19.3-e20
Author(s):  
J Andersen ◽  
B Askaa ◽  
TB Jensen ◽  
H Horwitz ◽  
C Vermehren ◽  
...  
Keyword(s):  
Cohort Study ◽  
First Trimester ◽  
Hazard Ratio ◽  
Adjusted Hazard Ratio ◽  
Birth Registry ◽  
Paternal Exposure ◽  
Cox Proportional Hazard ◽  
Increased Risk ◽  
First Trimester Of Pregnancy ◽  
Cox Proportional Hazard Regression

ObjectiveTo study the association between paternal exposure to methotrexate within three month before conception and during the first trimester of pregnancy and the risk of miscarriage.MethodsWe conducted a nationwide cohort study identifying all registered pregnancies in Denmark from 1997 to 2015. All births were identified using the Medical Birth Registry, and all records of induced abortion and miscarriage were from the National Hospital Register. Data on drug use were from the National Prescription Register. Cox proportional hazard regression models were used to calculate the hazard of miscarriage in women with a partner exposed to methotrexate. The study was approved by the Danish Data Protection Agency (2015-41-4309).ResultsWe identified 1,364,063 registered pregnancies with known paternity, of whom 520 fathers were exposure to methotrexate within the three months before conception to the end of the first trimester. Among these, 46 (8.9%) experienced a miscarriage compared to 122,926 (9.0%) among the unexposed.There was no increased risk of experiencing a miscarriage in pregnancies to men exposed to methotrexate before pregnancy compared to unexposed (adjusted hazard ratio 0.99 (CI95% 0.67- 1.46)). Furthermore, we found no increased risk of experiencing a miscarriage in pregnancies to men exposed to methotrexate during first trimester compared to unexposed (adjusted hazard ratio 0.90 (CI95% 0.61–1.32)).ConclusionWe found no association between paternal exposure to methotrexate before and during early pregnancy and miscarriage. Available data suggest that paternal methotrexate exposure should not be of major concern. Multinational recommendations could be changed accordingly.Disclosure(s)Nothing to disclose

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