scholarly journals Real-world discontinuation rate of teriflunomide and dimethyl fumarate in multiple sclerosis

2021 ◽  
Vol 7 (2) ◽  
pp. 205521732110220
Author(s):  
Hilde Norborg ◽  
Trond Riise ◽  
Kjell-Morten Myhr ◽  
Nina Grytten ◽  
Stig Wergeland

Background For patients with MS, medication switches increase the risk of disease reactivation. Objective Compare discontinuation rates due to treatment failure or side effects between teriflunomide and dimethyl fumarate, and investigate clinical variables affecting discontinuation rates. Methods All patients who received teriflunomide or dimethyl fumarate at Haukeland University Hospital from 2013 until 2018 were identified. Clinical and demographic variables were extracted from the Norwegian MS Registry. Cause-specific Cox regression models estimated the rate of discontinuation due to treatment failure or side effects. Results We included 354 patients treated with either dimethyl fumarate ( n = 185) or teriflunomide ( n = 169). We found 38% lower risk of discontinuation because of treatment failure for patients using dimethyl fumarate compared to teriflunomide ( p < 0.05). In a treatment-naive subgroup ( n = 183), we found a 38% reduced risk of discontinuation for any reason among patients using dimethyl fumarate ( p < 0.05). There was no significant difference between treatment groups in discontinuation rate due to side effects, although more patients reported side effects when treated with dimethyl fumarate. Conclusion Our findings suggests that dimethyl fumarate has a lower risk of discontinuation because of treatment failure among both treatment-experienced and treatment-naive patients.

2020 ◽  
Author(s):  
Say Tat Ooi ◽  
Purnima Parthasarathy ◽  
Yi Lin ◽  
Valliammai Nallakaruppan ◽  
Shereen Ng ◽  
...  

Background: Coronavirus disease 2019 (COVID-19) is associated with severe pneumonia, respiratory failure and death. We aim to evaluate the efficacy of adjunctive corticosteroids in the management of COVID-19. Methods: This is a retrospective cohort study of hospitalized adults (≥18 years) who were diagnosed with COVID-19 and were given treatment. Treatment included hydroxycholoroquine and lopinavir-ritonavir. Corticosteroids were included as adjunctive therapy in mid-April, 2020. We compared composite outcomes of clinical progression and invasive mechanical ventilation (MV) or death between group that received treatment only (Group A) versus group that received adjunctive corticosteroids (Group B). Entropy balancing was used to generate stabilized weight for covariates between treatment groups. Unweighted Kaplan-Meir curves, weighted and adjusted Cox regression analysis were used to estimate effect of adjunctive corticosteroids on composite outcomes. Subgroup analysis was performed on those with pneumonia. Results: Of 1046 patients with COVID-19, 57 received treatment alone (Group A) and 35 received adjunctive corticosteroids in addition to treatment (Group B). Median day of illness at treatment initiation was 5 day. There were 44 patients with pneumonia; 68.9% of them were not requiring supplemental oxygen at treatment initiation. Overall, 17 (18.5%) of 92 patients had clinical progression including 13 (22.8%) of 57 patients in Group A versus 4 (11.4%) of 35 patients in Group B (p=0.172). Unweighted Kaplan-Meier estimates showed no significant difference in the proportion of patients who had clinical progression or invasive MV or death between the 2 treatment groups. However in those with pneumonia, there were lower proportions of patients in Group B with clinical progression (11.1% , 95% CI 0.0 - 22.2 versus 58.8%, 95% CI 27.3 - 76.7, log rank p<0.001 ); and invasive MV or death (11.3%, 95% CI 0.0 - 22.5 versus 41.2%, 95% CI 12.4. - 60.5, log rank p=0.016). In weighted and adjusted cox regression analysis, patients in Group B were less likely to have clinical progression, (adjusted HR [aHR] 0.08, 95% CI 0.01-0.99, p=0.049) but there was no statistical significant difference in risk of requiring invasive MV or death (aHR 0.22, 95%CI 0.02 - 2.54, p=0.22). In subgroup with pneumonia, patients in Group B were significantly at lower risk of clinical progression (aHR 0.15, 95% CI 0.06 - 0.39, p<0.001) and requiring invasive MV compared to Group A (aHR 0.30, 0.10-0.87, p=0.029). Conclusions: Use of adjunctive corticosteroids is associated with lower risk of clinical progression and invasive MV or death, especially in those with pneumonia. Concurrent use of antivirals and corticosteroids should be considered in the management of COVID-19 related pneumonia.


2011 ◽  
Vol 2011 ◽  
pp. 1-4 ◽  
Author(s):  
Mohamad Javad Yazdanpanah ◽  
Mahnaz Banihashemi ◽  
Fakhrozaman Pezeshkpoor ◽  
Mohammad Khajedaluee ◽  
Sororozaman Famili ◽  
...  

The purpose of this study was to investigate comparison between oral zinc sulfate and meglumine antimoniate in the treatment of cutaneous leishmaniasis (CL). So 100 patients with CL were included and randomly divided into two groups. The first group was treated with oral zinc sulfate (10 mg/kg/day during 45 days period), and the second group was treated with systemic meglumine antimoniate (20 mg/kg/day intramuscularly for 20 days). Acceptable cure after completing 45 days of followup occurred in 30.2% of lesions in first group, while this was 35.5% for the second group. There is not any significant difference between the two treatment groups (P=0.42). Serious side effects resulting in treatment discounting occurred in only meglumine antimoniate group. Although cure rate of systemic meglumine antimoniate group was better the treatment with zinc sulfate is much easier, cheaper, more convenient in consumption, safer, and nearly close cure percentage to systemic meglumine antimoniate injections without serious side effect.


2020 ◽  
Vol 7 (2) ◽  
pp. e660
Author(s):  
Lara Diem ◽  
Ariadne Daponte ◽  
Oliver Findling ◽  
Andrei Miclea ◽  
Myriam Briner ◽  
...  

ObjectiveDespite frequent use of fingolimod (FTY) and dimethyl fumarate (DMF), studies comparing clinical efficacy and withdrawal rates of DMF and FTY concerning different pretreatment situations are rare. The aim of our study was to compare relapse occurrence and withdrawal rates of DMF and FTY in different pretreatment situations.MethodsPatients from 4 European centers were retrospectively identified and followed until the 1st relapse after treatment start or if no relapse occurred for a maximum of 2 years. Cox regression analyses adjusted for relapsing-remitting MS (RRMS) disease duration, sex, and region were performed for the following pretreatment situations: treatment naive or injectables or DMF/FTY or natalizumab.ResultsSeven hundred thirty-two patients with RRMS (female/male: 2.4:1.0; DMF n = 409, FTY n = 323) were analyzed. Compared with FTY-treated patients, DMF-treated patients discontinued treatment more frequently mainly because of side effects (DMF/FTY: 29.3%/20.7%). Clinical relapses occurred in 24.5% of the patients within 24 months. Survival analysis demonstrated that compared with FTY treatment, DMF treatment was associated with an adjusted hazard ratio (aHR) for occurrence of relapse of 1.9 (95% CI 1.4–2.6, p < 0.001, n = 732). Stratification into pretreatment groups unmasked a higher relapse risk in DMF patients pretreated with natalizumab (aHR [95% CI] 4.5 [1.9–10.8], p = 0.001, n = 122) or to a lesser extend also in treatment-naive patients (aHR [95% CI] 1.9 [1.01–3.6], p = 0.045, n = 230). No differences were observed in patients pretreated with injectables or the respective other oral drug (injectables: p > 0.05, n = 341; other oral: p > 0.05, n = 39).ConclusionsDMF treatment was associated with higher clinical disease activity compared with FTY treatment. A subgroup analysis suggested beneficial effects of FTY in treatment-naive and patients pretreated with natalizumab.


2020 ◽  
Vol 31 (6) ◽  
pp. 774-780
Author(s):  
Kohei Hachiro ◽  
Takeshi Kinoshita ◽  
Tomoaki Suzuki ◽  
Tohru Asai

Abstract OBJECTIVES To compare postoperative outcomes in patients with diabetic nephropathy receiving haemodialysis and undergoing isolated coronary artery bypass grafting (CABG) using bilateral or single skeletonized internal thoracic artery (ITA). METHODS Among 1441 consecutive patients undergoing isolated CABG between 2002 and 2019 at our university hospital, we retrospectively analysed data for 107 patients with diabetic nephropathy receiving haemodialysis. After inverse probability of treatment weighting, we found no statistically significant differences regarding patients’ preoperative characteristics. RESULTS All patients underwent myocardial revascularization using the off-pump technique. There was no statistical significance in postoperative deep sternal wound infection (P = 0.902) and 30-day mortality (P = 0.755). However, the bilateral ITA group had a lower rate of postoperative stroke versus the single group (0% vs 5.5%, respectively; P = 0.021). Follow-up was completed in 95.3% (102/107) of the patients, and the mean follow-up duration was 3.3 years. Thirty-eight deaths occurred in the bilateral ITA group and 18 in the single ITA group. There was no significant difference in all-cause death (P = 0.558) and cardiac death rates (P = 0.727). Multivariable Cox regression models showed that the independent predictors of all-cause death were age [hazard ratio (HR) 1.031; P = 0.010], previous percutaneous intervention (HR 1.757; P = 0.009) and gastroepiploic artery grafting (HR 0.582; P = 0.026). CONCLUSIONS Bilateral ITA grafting in patients with diabetic nephropathy receiving haemodialysis did not improve mid-term outcomes.


Author(s):  
Rita D. ◽  
V. Haripriya

Background: Tocolytic agents are used to reduce preterm deliveries. Very few studies documenting the comparison of tocolytic agents viz. nifedipine, nitroglycerin dermal patches and isoxsuprine. Other drugs are not used due to their adverse effects. Objective was to study and compare the safety efficacy of nifedipine, nitroglycerin dermal patches and isoxsuprine as tocolytic agents in suppression of preterm labour 1 year study.Methods: This was a prospective case control study was conducted for a period of 1 year. Total 90 cases selected to study were randomly distribute in to three treatment groups viz. A, B, and C nifedipine, nitroglycerin and isoxsuprine respectively. Subjects in all three groups were evaluated for maternal pulse rate, palpitation uterine contractions and fetal heart rate in order to assess efficacy of each drug under investigation.Results: There was no statistically significant difference in age of woman’s in three different groups. Among (100%) subjects, majority of the cases i.e. (27.8%) primi gravida followed by multi (72.2%). Side effects of nifedipine was less when compared to nitroglycerine dermal patch and isoxsuprine i/v/o of headache (8.9%), nausea (1.1%), vomiting (1.1%), tachycardia (3.3%), palpitation (3.3%), hypotension (1.1%). side effects were statistically significant different between the treatment groups. There was no statistically significant difference with respect to APGAR score at 1 minute and 5 minutes.Conclusions: Oral nifedipine was found to be superior and efficacious as tocolytic agent as compared to transdermal nitroglycerin and intravenous isoxsuprine.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3974-3974
Author(s):  
Aleksandar Radujkovic ◽  
Sascha Dietrich ◽  
Alwin Krämer ◽  
Tilmann Bochtler ◽  
Anthony D. Ho ◽  
...  

Abstract Introduction Azacitidine (AZA) treatment has been shown to be superior to conventional care regimens including low dose cytarabine (LD-Ara-C) in acute myeloid leukemia (AML) patients with low bone marrow (BM) blast counts (20-30%). In contrast, data on efficacy of AZA in patients with blast counts exceeding 30% are scarce. Here we present a retrospective, single center analysis, comparing the efficacy and toxicity of AZA versus LD-Ara-C in AML patients with high BM blast counts (≥30%) prior to treatment. Patients and Methods Twenty-seven patients receiving AZA and 38 patients receiving LD-Ara-C met the eligibility criteria for the analysis (age ≥18 years, documented BM blast count ≥30% prior to start of treatment and administration of at least one complete therapy cycle). Patients who underwent allogeneic transplantation following AZA treatment or received stem cell support following LD-Ara-C therapy were excluded from this analysis. Overall survival (OS) was estimated using the method of Kaplan and Meier. Comparison of OS between the AZA and LD-Ara-C group was done using the logrank test and by Cox regression adjusting for known confounders. Results Patient (age, ECOG status) and diseases characteristics (type of AML, cytogenetics, pretreatment, number of treatment cycles) did not differ significantly between the treatment groups, except for BM blast count (median 44% vs. 60% in the AZA and LD-Ara-C group, respectively; p=0.03) and peripheral blood blast count (median 6% vs. 56% in the AZA and LD-Ara-C group, respectively; p<0.01). Response rates to AZA treatment according to international working group (IWG) criteria were low with two patients achieving a complete remission (CR) and one patient showing partial remission (PR) after AZA treatment. In the LD-Ara-C cohort no CR was observed and two patients experienced a PR. Hematologic improvement (HI) rates according to IWG criteria did not differ between both treatment groups (any type of HI 33% vs. 24% in the AZA and LD-Ara-C group, respectively; p=0.41). In both cohorts, most common non-hematologic toxicities (CTCAE grade≥3) included febrile neutropenia, pneumonia and bleedings without significant differences regarding frequencies. As expected, skin involvement was more commonly observed in the AZA group (19% vs. 3%, p=0.04). One year survival rates were only 15% (95% CI 8-22%) and 13% (95% CI 7-19%) in the AZA and LD-Ara-C group, respectively. There was no statistically significant difference between the treatment groups (HR 1.2, p=0.41). Furthermore, there was no difference in hospitalization time (total days spent in hospital during treatment per patient-year of follow-up 29.4 vs. 27.2 in the AZA and LD-Ara-C group, respectively; RR 1.07 95% CI 0.95-1.21, p=0.23). In a multivariate analysis with OS as endpoint adverse cytogenetics (HR 2.24 95% CI 1.17-4.70, p<0.02) were significantly associated with inferior survival, whereas the treatment had no impact (AZA vs. LD-Ara-C HR 1.27 95% CI 0.67-2.40, p=0.46). Conclusion In our center, treatment with AZA showed limited efficacy and no superiority to LD-Ara-C treatment in AML patients with BM blasts ≥30%. Disclosures: Dreger: Riemser Pharma : Consultancy, Honoraria, Research Funding.


2003 ◽  
Vol 31 (03) ◽  
pp. 475-480 ◽  
Author(s):  
Yongsuk Kim ◽  
Chang-Whan Kim ◽  
Keon-Sik Kim

We studied the effect of auricular acupuncture on postoperative nausea and vomiting (PONV). One hundred female patients undergoing transabdominal hysterectomy were entered into the study. The patients were divided into two groups (auricular acupuncture treatment group and non-treatment group) in order to test the effectiveness of auricular acupuncture. There was no significant difference in age, weight, height or duration of anesthesia among the two groups of patients. There was a significant difference between the control and auricular acupuncture treatment groups in the incidence of vomiting 12 hours after surgery (68% and 30%, respectively, p < 0.01). No noteworthy side effects from treatment were observed. Auricular acupuncture is effective in reducing vomiting following transabdominal hysterectomy in female patients.


2020 ◽  
Vol 120 (03) ◽  
pp. 384-391 ◽  
Author(s):  
Katarina Waldén ◽  
Anders Jeppsson ◽  
Salmir Nasic ◽  
Martin Karlsson

Abstract Background We investigated whether fibrinogen concentrate administration to bleeding patients is associated with an increased risk of thromboembolic complications and death. Methods All consecutive patients who underwent first-time cardiac surgery at Sahlgrenska University Hospital from 2009 to 2014 were included. Patients, who had received fibrinogen concentrate, were compared with those who had not received fibrinogen concentrate. The primary endpoint was a composite of thromboembolic complications and death within 1 year after surgery. Secondary endpoints included the composite and mortality within 30 days and mortality within 1 year after surgery. Multivariable logistic regression and Cox regression models were used to compare the groups. Propensity score (PS)-matched models were used for sensitivity analyses. Results A total of 5,408 patients were included in the present study, of which 564 (10.4%) received fibrinogen concentrate. The composite endpoint occurred in 3.5% of patients at 30 days and 10.5% at 1 year. There was no significant difference between the groups in the composite endpoint at 1 year (adjusted hazard ratio [HR]: 1.11, 95% confidence interval [CI]: 0.84–1.46, p = 0.45) or in the secondary endpoints, that is, mortality at 1 year (adjusted HR: 1.38, 95% CI: 0.93–2.04, p = 0.11), composite at 30 days (adjusted odds ratio [OR]: 1.07, 95% CI: 0.64–1.81, p = 0.79) and mortality at 30 days (adjusted OR: 1.00, 95% CI: 0.51–1.96, p = 0.50). The results of the sensitivity analyses were consistent with those of main analyses. Conclusion Perioperative administration of fibrinogen concentrate to bleeding cardiac surgery patients is not associated with an increased risk of thromboembolic complications or death.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 107-108
Author(s):  
M. Movahedi ◽  
D. Choquette ◽  
L. Coupal ◽  
A. Cesta ◽  
X. LI ◽  
...  

Background:Tofacitinib (TOFA) is an oral, small molecule drug used for rheumatoid arthritis (RA) treatment as the first or an alternative option to biologic disease- modifying antirheumatic drugs (bDMARDs), including tumor necrosis factor inhibitors (TNFi). The similarity in retention of TNFi and TOFA was previously reported separately by the Ontario Best Practices Research Initiative (OBRI) and the Quebec cohort RHUMADATA®.Objectives:To increase the study power, we propose to evaluate the discontinuation rate (due to any reason) of TNFi compared to TOFA, using pooled data from both these registries.Methods:RA patients enrolled in the OBRI and RHUMADATA initiating their TOFA or TNFi between 1st June 2014 (TOFA approval date in Canada) and 31st Dec 2019 were included. Time to discontinuation was assessed using adjusted Kaplan-Meier (KM) survival and Cox regression models. To deal with confounding by indication, we estimated propensity scores for covariates with a standard difference greater than 0.1. Models were then adjusted using stratification and inverse probability of treatment weight (IPTW) methods. Multiple imputation (Imputation by Chained Equation method, N=20) was used to deal with missing data for covariates at treatment initiation.Results:A total of 1318 patients initiated TNFi (n=825) or TOFA (n=493) with mean (SD) disease duration of 8.9 (9.3) and 13.0 (10.1) years, respectively. In the TNFi group, 78.8% were female and mean age (SD) at treatment initiation was 57.6 (12.6) years. In the TOFA group, 84.6% were female and mean (SD) age at treatment initiation was 59.5 (11.5) years. The TNFi group was less likely to have prior biologic use (33.9%) than the TOFA group (66.9%). At treatment initiation, the mean (SD) CDAI was significantly (p<0.05) lower in the TNFi group [20.0 (11.7)] compared to the TOFA group [22.1(12.4)]. Physical function measured by HAQ-DI was also significantly lower (p<0.05) in the TNFi compared to the TOFA group (1.2 vs.1.3).Over a mean follow-up of 23.2 months, discontinuation was reported in 309 (37.5%) and 182 (36.9%) of all TNFi and TOFA patients, respectively. After adjusting for propensity score deciles across 20 imputed datasets, there was no significant difference in discontinuation between treatment groups (adjusted HRs: 0.96, 95% CI: 0.78-1.18; p=0.69). The results were similar for two propensity adjustment methods. Figure 1 shows IPTW adjusted KM survival curves comparing discontinuation rates in patients treated with TNFi and TOFA.Figure 1.Note: Propensity Score Weighted (IPTW) Survival Curves was performed using one imputed datasetConclusion:In this pooled real -world data study, we found that TNFi and TOFA retention is similar in patients with RA. In the next step we will analysis the data for specific reasons of dicontinutaion. We will also repeat analysis comparing discontinuation in the first users versus those after one or more biologic failure.Disclosure of Interests:Mohammad Movahedi: None declared, Denis Choquette Grant/research support from: Rhumadata® is supported by unrestricted grants from Abbvie Canada, Amgen Canada, Eli Lilly Canada, Novartis Canada, Pfizer Canada, Sandoz Canada and Sanofi Canada., Louis Coupal: None declared, Angela Cesta: None declared, Xiuying Li: None declared, Edward Keystone Grant/research support from: Amgen, Merck, Pfizer Pharmaceuticals, PuraPharm. Speaker Honoraria Agreements: AbbVie, Amgen, Bristol-Myers Squibb Company, Celltrion, Myriad Autoimmune, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, Sanofi-Genzyme, Samsung Bioepsis. Consulting Agreements/Advisory Board Membership: AbbVie, Amgen, Bristol-Myers Squibb Company, Celltrion, Myriad Autoimmune, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, Sanofi-Genzyme, Samsung Bioepsis, Claire Bombardier Grant/research support from: OBRI was funded by peer reviewed grants from CIHR (Canadian Institute for Health Research), Ontario Ministry of Health and Long-Term Care (MOHLTC), Canadian Arthritis Network (CAN) and unrestricted grants from: Abbvie, Amgen, Aurora, Bristol-Meyers Squibb, Celgene, Hospira, Janssen, Lilly, Medexus, Merck, Novartis, Pfizer, Roche, Sanofi, & UCB.Dr. Bombardier held a Canada Research Chair in Knowledge Transfer for Musculoskeletal Care and a Pfizer Research Chair in Rheumatology


Author(s):  
Annapurna V. T. ◽  
Nivedita Maity ◽  
Ravikumar T. V.

Background: The efficacy and safety of Pregabalin and Nortriptyline have been proved individually in low backache with radicular pain. However, there are limited number of studies comparing the efficacy of Pregabalin and Nortriptyline in Chronic Low Backache (CLBA) with radicular pain. Hence the present study was designed to determine the efficacy as well as tolerability of Pregabalin in comparison with that of Nortriptyline for reduction of pain in CLBA. The present study was an open label prospective observational study.Methods: Patients with CLBA, 15-60 years of age without specific cause and significant neurological deficit were included in the study. Severity of pain was assessed by Visual Analogue Scale (VAS). Patients were followed up at 2 and 4 weeks and their VAS scores and side effects were noted.Results: Both Pregabalin and Nortriptyline were effective in reducing pain, from baseline to 2 weeks and up to 4 weeks of treatment in chronic low backache with radicular pain, but there was no statistically significant difference between the two treatment groups. The incidences of side effects were less in the Nortriptyline treatment group as compared to Pregabalin.Conclusions: From the results of the present study it can be concluded that both Pregabalin and Nortriptyline were equally effective in the treatment of chronic low backache with radicular pain, but the incidence of adverse effects were more with Pregabalin as compared to Nortriptyline.


Sign in / Sign up

Export Citation Format

Share Document