Methotrexate in rheumatology – efficacy and safety of the therapy

2020 ◽  
Vol 13 (3) ◽  
pp. 314-319
Author(s):  
Tomasz Kosakowski
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Time Frame ◽  
Chronic Arthritis ◽  
Gastrointestinal Disorders ◽  
Efficacy And Safety ◽  
Everyday Clinical Practice ◽  
Elevated Transaminase ◽  
Health Complications ◽  
Significant Health

Methotrexate is currently the safe and effective drug used in chronic arthritis and other rheumatic diseases. Avoiding the use of methotrexate in everyday rheumatic treatment can lead to significant health complications. There is no time frame for the use of methotrexate, the drug can be used successfully for many years. The therapeutic dose of the drug is usually 25–30 mg/week. The most common side effects are gastrointestinal disorders and elevated transaminase levels. The efficacy and safety of methotrexate have been confirmed in many clinical trials and in everyday clinical practice.

scholarly journals Real-world efficacy and safety of eribulin in advanced and pretreated HER2-negative breast cancer in a Spanish comprehensive cancer center

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Milana Bergamino Sirvén ◽  
Adela Fernández-Ortega ◽  
Agostina Stradella ◽  
Idoia Morilla ◽  
Catalina Falo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Central Nervous System ◽  
Nervous System ◽  
Clinical Practice ◽  
Objective Response ◽  
Comprehensive Cancer Center ◽  
Special Focus ◽  
Efficacy And Safety ◽  
Everyday Clinical Practice ◽  
Prognosis Factors

Abstract Background Eribulin improves survival in pre-treated HER2-negative advanced breast cancer (ABC). However, limited data exist on co-morbidities and central nervous system (CNS) efficacy. The purpose of this study was to review eribulin’s efficacy and safety in everyday clinical practice with special focus on age, body mass index (BMI) and central nervous system (CNS) activity. Methods An observational study was conducted in a series of HER2-negative ABC patients treated from January’14-December’17 outside a clinical trial. Objective Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS), and association of clinical and pathological variables with outcome were evaluated. Results Ninety-five women were treated with at least one cycle of eribulin. Median age was 57 (33–83), and 18% were obese. Median number of prior chemotherapies for ABC was 3 (2–5) and 76% of patients had visceral metastases, including 21% with CNS involvement. Most tumors were estrogen receptor-positive (79%). ORR and stable disease (SD) at 6 months were 26.2 and 37.5%, respectively. Remarkably, relevant CNS efficacy was observed with eribulin: 20% of patients obtained partial response and 25% SD. Treatment was generally well tolerated and manageable, with 29% grade 3 and 10.9% grade 4 toxicities. Median PFS and OS were 4.1 months (CI95% 3.2–4.9) and 11.1 months (CI95% 9.5–14.7), respectively. Triple-negative disease, > 2organs involved and being younger than 70 years old were independent prognosis factors for worse OS in multivariate analysis. Most patients (75%) progressed in pre-existing metastases sites. Conclusion In everyday clinical practice, eribulin’s efficacy seems similar to pivotal trials. CNS-efficacy was observed. TNBC, > 2 organs involved and being younger than 70 years old were independent prognosis factors for worse OS. Remarkably, less incidence of grade 4-toxicity compared to previous studies was found.

scholarly journals An observational study «FOLLITROPIN» comparing the efficacy of follitropin alpha biosimilar: the real-world data

2021 ◽  
Vol 15 (1) ◽  
pp. 5-21
Author(s):  
D. P. Kamilova ◽  
M. M. Ovchinnikova ◽  
E. Sh. Ablyaeva ◽  
M. M. Leviashvili ◽  
N. S. Stuleva ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Observational Study ◽  
Clinical Efficacy ◽  
Real World ◽  
Ovarian Stimulation ◽  
Successful Implementation ◽  
Efficacy And Safety ◽  
The Real ◽  
Real Clinical Practice

Introduction. The efficacy and safety of biosimilar follitropin alpha have been demonstrated in randomized blinded prospective clinical trials of phases I and III. Unfortunately, there is a gap between the clinical trials and real clinical practice data. The real-world patient data helps to create an evidence-based background for successful implementation of medicine at everyday practice in a nonselected population.Aim: to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.Materials and Methods. A retrospective observational anonymized cohort study of follitropin alpha biosimilar (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included: monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application for at least 5 days.Results. The overall clinical efficacy of ovarian stimulation cycles (N = 5484) was: oocytes retrieved - 9.5 ± 7.2, mature (MII) - 6.8 ± 6.6, fertilized (2PN) - 6.1 ± 5.8, clinical pregnancy per ET (PR) - 38.4 %. Mixed gonadotropin protocols (N = 2625) vs. monotherapy with Primapur® (N = 2859): oocytes retrieved - 8.6 ± 6.8 vs. 10.3 ± 7.4 (p < 0.001), mature (MII) - 6.7 ± 6.2 vs. 7.7 ± 6.9 (p < 0.001), fertilized (2PN) - 5.8 ± 5.2 vs. 7.2 ± 6.2 (p < 0.001). There were statistically significant differences between oocyte yields in mixed vs. monotherapy protocols due to subgroup differences, including age, body mass index (BMI) and IVF/ICSI attempts. No statistically significant differences were found for PR: 39.3 % vs. 37.6 % (p = 0.314). Monotherapy protocols with GnRH antagonist OS (N = 2183) vs. GnRH agonist (N = 676) revealed: oocytes retrieved - 10.5 ± 7.5 vs. 9.6 ± 7.0 (p = 0.032), mature (MII) - 7.6 ± 6.9 vs. 6.7 ± 5.7 (p < 0.001), fertilized (2PN) - 7.3 ± 6.3 vs. 5.7 ± 5.0 (p < 0.001). There were statistically significant differences between BMI and IVF/ICSI attempts. No statistically significant differences were found for PR: 37.9 % vs. 35.9 % (p = 0.482). All medicines were well tolerated and no serious adverse reactions were reported.Conclusion. This was the largest retrospective observational study conducted in the field of fertility in Russia and involved 5484 ovarian stimulation protocols at 35 IVF clinics. The obtained results demonstrated similar clinical efficacy for follitropin alpha biosimilar Primapur® in different OS protocols in real clinical practice. 

Pembrolizumab for advanced nonsmall cell lung cancer: Efficacy and safety in everyday clinical practice

Lung Cancer ◽  
2019 ◽  
Vol 133 ◽  
pp. 110-116 ◽  
Author(s):  
Doran Ksienski ◽  
Elaine S. Wai ◽  
Nicole Croteau ◽  
Ashley T. Freeman ◽  
Angela Chan ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Practice ◽  
Cell Lung Cancer ◽  
Nonsmall Cell Lung Cancer ◽  
Efficacy And Safety ◽  
Everyday Clinical Practice

Generalisability of recent clinical trials in idiopathic pulmonary fibrosis to everyday clinical practice

2015 ◽  
Author(s):  
Lisa Nicol ◽  
Pauline McFarlane ◽  
Catriona Graham ◽  
David McAllister ◽  
William Wallace ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Everyday Clinical Practice

Efficacy and Safety of Lamotrigine in Pediatric Patients

2002 ◽  
Vol 17 (2_suppl) ◽  
pp. 2S34-2S42 ◽  
Author(s):  
John Messenheimer
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Pediatric Patients ◽  
Efficacy And Safety ◽  
Controlled Clinical Trials ◽  
Regulatory Authorities ◽  
Treatment Of Epilepsy

Accumulating data suggest that lamotrigine, which has been available for adult use in epilepsy for more than a decade in clinical practice, also confers effective, well-tolerated control of a range of childhood epilepsies. Lamotrigine is currently approved for the treatment of epilepsy by regulatory authorities in 93 countries, more than 70 of which have approved its use in pediatric patients on the basis of data from well-controlled clinical trials. The controlled clinical trials data have been supplemented over the years by clinical practice data, primarily from uncontrolled studies, confirming or demonstrating additional efficacy of lamotrigine for a range of seizure types. This article reviews the data from well-controlled clinical trials and studies conducted in clinical practice to present an updated perspective on the efficacy and safety of lamotrigine in pediatric patients. (J Child Neurol 2002;17:2S34—2S42).

How to assess response to immune therapy

2016 ◽  
Vol 4 (3) ◽  
pp. 47-51
Author(s):  
Judith Michels ◽  
Emilie Lanoy ◽  
Caroline Caramella ◽  
Christian Marth
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Tumor Microenvironment ◽  
Renal Cancer ◽  
Immune Therapy ◽  
Treatment Decisions ◽  
Response Criteria ◽  
Everyday Clinical Practice ◽  
Biological Analysis

Immunotherapy is already a mainstay in treating melanoma, lung cancer and renal cancer and shows compelling promise in many different tumors. However, responses to immunotherapy may be present despite apparent initial progression of the tumor. This underlines the importance of defining accurate tumor assessments and response criteria for immunotherapy. The RECIST criteria have therefore been modified to adhere to requirements of immunotherapy. In line with that, this review will focus on the current imaging tools, the statistical evaluations in clinical trials and the biological analysis of the tumor microenvironment that will in the future effectively guide treatment decisions in everyday clinical practice.

scholarly journals Eltrombopag in immune thrombocytopenia: efficacy review and update on drug safety

2018 ◽  
Vol 9 (6) ◽  
pp. 263-285 ◽  
Author(s):  
Jose Ramon Gonzalez-Porras ◽  
Jose Maria Bastida
Keyword(s):  
Risk Factors ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Immune Thrombocytopenia ◽  
Autoimmune Disorder ◽  
Efficacy And Safety ◽  
First Line ◽  
Platelet Production ◽  
Thrombopoietin Receptor ◽  
Current Guidelines

Immune thrombocytopenia (ITP) is an autoimmune disorder that induces a decrease in the number of circulating platelets due to spleen destruction and inability of megakaryocytes to restore normal counts. Immunosuppressive therapy with glucocorticoid drugs constitutes the first line of treatment. However, lack of response to these agents is not uncommon, and the management of refractory patients is a matter of controversy. In fact, day-to-day clinical practice shows that, in spite of the current guidelines, splenectomy, which is currently considered a suitable second-choice therapy, is being replaced by treatment with thrombopoietin receptor agonists. These boost platelet production by megakaryocytes. The use of one of these, namely eltrombopag, has been permitted for ITP patients refractory to first-line drugs or splenectomy, for the last 10 years. This review summarizes the experience reported using eltrombopag in ITP, paying attention to efficacy and safety. Results from clinical trials will be discussed, and studies performed in the course of daily clinical practice will also be reviewed, as these are useful to assess the potential of the drug in real-world settings. The management of adverse events and the use of eltrombopag in particular situations will also be covered. The experience reported so far permits us to suggest that eltrombopag efficiently induces recovery of platelet counts. Furthermore, recent papers have demonstrated that a sustained response after discontinuation, initially thought to be problematic, may be possible in a nonnegligible number of cases. The safety profile is satisfactory, although patients presenting with thromboembolism risk factors should be treated with caution until the eltrombopag-associated prothrombotic risk is fully established. In summary, although larger studies are still needed to clarify some issues, eltrombopag may be a useful alternative tool for ITP patients refractory to conventional medical management or splenectomy.

scholarly journals Everolimus treatment for neuroendocrine tumors: latest results and clinical potential

2017 ◽  
Vol 9 (3) ◽  
pp. 183-188 ◽  
Author(s):  
Sara Pusceddu ◽  
Elena Verzoni ◽  
Natialie Prinzi ◽  
Alessia Mennitto ◽  
Daniela Femia ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Signaling Pathway ◽  
Neuroendocrine Tumors ◽  
Efficacy And Safety ◽  
Mtor Signaling Pathway ◽  
Current Role ◽  
Clinical Potential ◽  
Heterogeneous Class

Neuroendocrine tumors (NETs) are a heterogeneous class of diseases characterized by challenging management. Preclinical evidence shows that the PI3K/AKT/mTOR signaling pathway plays a central role in the pathogenesis and progression of NETs. Everolimus is a direct inhibitor of this pathway, and therefore this molecule appears to be a well-grounded strategy for the treatment of NETs, capable of changing clinical practice. The efficacy and safety of everolimus was demonstrated in the RADIANT trials. In this work, we comment on the results of the RADIANT trials, and other recent key evidence from fully published clinical trials on everolimus, and we discuss the current role of everolimus in the treatment of NETs.

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