scholarly journals Infliximab switching from reference product to biosimilar: a review of evidence regarding the clinical efficacy, safety profile and immunogenicity

2021 ◽  
Author(s):  
Ahmad Zainal Abidin ◽  
Centaine L. Snoswell ◽  
Leila Shafiee Hanjani ◽  
Gavin Callaghan ◽  
Michelle Edmonds
Keyword(s):  
Clinical Efficacy ◽  
Safety Profile ◽  
Reference Product

scholarly journals An Overview on the Ongoing Clinical Trials of COVID-19 Vaccines

2020 ◽  
Vol V (I) ◽  
pp. 39-48
Author(s):  
Syeda Komal Fatima ◽  
Ameena Tur Rasool ◽  
Ayesha Sabir ◽  
Gul Shahnaz
Keyword(s):  
Clinical Trials ◽  
Antimicrobial Resistance ◽  
Adverse Events ◽  
Clinical Efficacy ◽  
Safety Profile ◽  
Clinical Endpoint ◽  
Phase 3 ◽  
Research Reporting ◽  
Development Of Resistance ◽  
Global Pandemic

COVID-19 has posed a great threat to mankind, there is a dire need to introduce a vaccine to combat this global pandemic. Several vaccines are underway to complete their phase 3 clinical trials. This article highlights events surrounding the ongoing clinical trials of vaccines effective against COVID-19, and different procedures and formalities the vaccine will have to endure to get EUA. Clinical trials are discussed stepwise along with the clinical endpoint desired at the end of these trials. In line with antimicrobial resistance, vaccine resistance has also emerged in this era and needs focused consideration, and the probability of development of resistance in these vaccines is discussed. This article specifically covers the latest research reporting clinical efficacy, safety profile, and adverse events following the administration of doses to patients and concerns regarding the rushed approval of vaccines. Four vaccines have been discussed in detail; BNT162b2, mRNA-1273, Sputnik V, ChAdOx1.

scholarly journals Dexpramipexole as an oral steroid-sparing agent in hypereosinophilic syndromes

Blood ◽  
2018 ◽  
Vol 132 (5) ◽  
pp. 501-509 ◽  
Author(s):  
Sandhya R. Panch ◽  
Michael E. Bozik ◽  
Thomas Brown ◽  
Michelle Makiya ◽  
Calman Prussin ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Safety Profile ◽  
Oral Steroid ◽  
Key Points ◽  
Excellent Safety Profile ◽  
Treatment Alternatives ◽  
Steroid Sparing

Key Points GC-sparing treatment alternatives are a critical need for patients with HESs. The orally bioactive drug dexpramipexole demonstrated clinical efficacy with an excellent safety profile in a subset of patients with HESs.

scholarly journals Clinical Efficacy and Safety Profile of Prucalopride in Chronic Idiopathic Constipation

Cureus ◽  
2019 ◽  
Author(s):  
Asim Tameez Ud Din ◽  
Ameer H Khan ◽  
Hamza Bajwa ◽  
Muhammad Haisum Maqsood ◽  
Mustafa N Malik
Keyword(s):  
Clinical Efficacy ◽  
Safety Profile ◽  
Efficacy And Safety ◽  
Idiopathic Constipation ◽  
Chronic Idiopathic Constipation

Clinical efficacy and safety following dose tapering of ciclosporin in cats with hypersensitivity dermatitis

2016 ◽  
Vol 18 (11) ◽  
pp. 898-905 ◽  
Author(s):  
Elizabeth S Roberts ◽  
Tiffany Tapp ◽  
Ann Trimmer ◽  
Linda Roycroft ◽  
Stephen King
Keyword(s):  
Adverse Events ◽  
Clinical Response ◽  
Clinical Efficacy ◽  
Safety Profile ◽  
Therapeutic Response ◽  
Clinical Pathology ◽  
Efficacy And Safety ◽  
Dosing Frequency ◽  
Dosing Regimens ◽  
Physical Examinations

Objectives This study was designed to evaluate the efficacy and safety of reducing ciclosporin (CsA) dosing frequency from daily to every other day (EOD) or twice a week (TW) according to clinical response in cats with hypersensitivity dermatitis (HD) and treated with CsA. Methods One hundred and ninety-one cats with HD were given 7 mg/kg CsA daily for at least 4 weeks. Depending on clinical response, the dosing frequency was tapered from daily to EOD over the next 4 weeks and further to TW for an additional 4 weeks. Safety was evaluated through physical examinations, clinical pathology and the monitoring of adverse events (AEs). Results The majority of cats were able to have their dose of CsA tapered to either EOD (15.5%) or TW (62.9%) according to the clinical response. Observed AEs were most frequently mild and self-limiting vomiting and diarrhea. A higher percentage of AEs occurred with daily administration (73%) compared with other dosing regimens (27%). Conclusions and relevance Following 4 weeks of daily dosing at 7 mg/kg, CsA may be tapered to EOD or TW while maintaining the desired therapeutic response in cats with HD. Additionally, CsA appears to be well tolerated with fewer AEs at EOD or TW dosing. Establishing the lowest effective dosing frequency of CsA improves the drug’s safety profile.

scholarly journals Clinical efficacy of the rituximab biosimilar Acellbia® 600 mg in patients with active rheumatoid arthritis in clinical practice

2019 ◽  
Vol 56 (6) ◽  
pp. 703-708
Author(s):  
D. A. Kusevich ◽  
A. S. Avdeeva ◽  
V. V. Rybakova ◽  
N. V. Chichasova ◽  
E. L. Nasonov
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clinical Efficacy ◽  
Safety Profile ◽  
Active Rheumatoid Arthritis ◽  
Activity Index ◽  
Disease Activity Index ◽  
Eular Response ◽  
American College Of Rheumatology ◽  
Remission Criteria

Objective: to evaluate the clinical efficacy of the rituximab biosimilar Acellbia® at a dose of 600 mg intravenously at a 2-week interval in patients with active rheumatoid arthritis (RA) 12 and 24 weeks after initiation of treatment.Subjects and methods. Examinations were made in 20 active seropositive RA patients who had not been previously treated with biological agents (BAs), but received two infusions of the rituximab biosimilar Acellbia® at a dose of 600 mg intravenously at a 2-week interval during stable therapy with methotrexate (MT) and glucocorticoids (GCs). The European League Against Rheumatism (EULAR) response criteria (Disease Activity Score 28 (DAS28), Clinical Disease Activity Index (CDAI), and Simplified Disease Activity Index) and the American College of Rheumatology (ACR) criteria were used to evaluate the efficiency of Acellbia® therapy. Disease remission was identified by DAS28 and 2011 ACR/EULAR criteria. The safety profile (the frequency of all reported adverse events) corresponds to the data on the safety of rituximab (MabThera®).Results and discussion. At the time of inclusion, median DAS28 was 5.6 [4.9; 6.8], SDAI – 27.1 [23.0; 39.9], and CDAI – 26.6 [22.2; 37.0]. At week 12 after initiation of Acellbia® therapy, they decreased to 4.2 [3.24; 4.75], 14.4 [8.5; 20.7], and 13.2 [7.9; 19.0] respectively, which remained at 24-week follow-up (p<0.01). At week 12, the frequencies of ACR 20%, 50%, 70% improvements were 70, 55, and 5%; at week 24, these were 75, 45, and 15%, respectively. A good or moderate EULAR response at week 24 was observed in 25 and 60% of patients, respectively. At week 24, DAS28, SDAI, and CDAI remissions were achieved by 4 (20%), 2 (10%), and 1 (5%); low disease activity – by 4 (20%), 5 (25%), and 6 (30%) patients, respectively; high disease activity as measured by SDAI and CDAI remained in 3 (15%) patients. Two patients (10%) met the 2011 ACR/EULAR remission criteria at 24 weeks.Conclusion. The rituximab biosimilar Acellbia® 600 mg used in patients with active seropositive RA is clinically effective and comparable in the safety profile as shown in investigations of the brand-name MabThera® (F. Hoffman-La Roche Ltd., Switzerland) at a low dose (500 mg), as well as the first BA.

scholarly journals A RANDOMIZED ACTIVE CONTROLLED CLINICAL STUDY TO EVALUATE EFFICACY AND SAFETY OF RESVERATROL AS AN ADJUVANT THERAPY IN PATIENTS WITH HYPERTENSION

2016 ◽  
Vol 10 (1) ◽  
pp. 376
Author(s):  
Rakesh Ojha ◽  
Kulkarni Pranesh ◽  
Vyas Bhavin
Keyword(s):  
Essential Hypertension ◽  
Adjuvant Therapy ◽  
Clinical Efficacy ◽  
Safety Profile ◽  
Gold Standard ◽  
Standard Therapy ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Hypertensive Patients

ABSTRACTObjectives: No long-term clinical efficacy and safety study of resveratrol as adjuvant therapy along with gold standard therapy has been conductedin patients with essential hypertension. The aim of this study was to investigate the efficacy and safety of resveratrol as an adjuvant therapy in newlydiagnosed hypertensive patients.Methods: In this randomized active-controlled study, hypertensive patients (male/female) of 20-65 years aged were randomized (1:1) to receivetelmisartan 20 mg or telmisartan 20 mg plus resveratrol 1 g daily for 12 months. Efficacy variables included a change in systolic and diastolic bloodpressure (DBP) from baseline and were followed up for every 3 months. Treatment-emergent adverse events were assessed.Results: A total of 60 hypertensive patients were analyzed (telmisartan [n=30] and telmisartan plus resveratrol [n=30]). Resveratrol as an adjuvantwith telmisartan significantly reduced in systolic (p<0.001) and DBP (p<0.001) as compared to telmisartan monotherapy. Change in systolic and DBPfrom baseline was significantly higher in telmisartan plus resveratrol group than telmisartan (p<0.001) at all followed visits. Both the study drugshave similar safety profile and found well tolerable.Conclusions: Resveratrol plus Telmisartan was found to be superior over telmisartan monotherapy in reducing systolic and DBP in newly diagnosedhypertensive patients. Both the study drugs were effective with comparable safety profile. Our study supports the long-term clinical efficacy andsafety study of resveratrol along with gold standard therapy in essential hypertension.Keywords: Essential hypertension, Resveratrol, Systolic and diastolic blood pressure, Telmisartan.

scholarly journals P858 An open-label, multi-center trial of INO-5401 and INO-9012 delivered by electroporation (EP) in combination with cemiplimab in subjects with newly-diagnosed glioblastoma (GBM)

2020 ◽  
Vol 8 (Suppl 1) ◽  
pp. A8.1-A8
Author(s):  
Jeffrey Skolnik ◽  
David Reardon ◽  
Steven Brem ◽  
Arati Desai ◽  
Stephen Bagley ◽  
...  
Keyword(s):  
T Cell ◽  
Clinical Efficacy ◽  
Safety Profile ◽  
Wilms Tumor ◽  
List Type ◽  
Newly Diagnosed ◽  
Checkpoint Inhibition ◽  
New York University ◽  
Synthetic Dna ◽  
Mgmt Promoter

BackgroundGBM is one of the most deadly cancers and treatment is surgery, followed by radiation (RT) and temozolomide (TMZ) daily during RT followed by cycles of TMZ for select patients.1 New immunotherapies, such as checkpoint inhibition, may benefit patients with GBM. T cell-enabling therapies, in combination with checkpoint inhibition, may improve overall survival (OS). In this study, a novel antigen-specific T cell-generating therapy, INO-5401 (synthetic DNA plasmids encoding for human telomerase [hTERT], Wilms Tumor-1 [WT-1] and prostate specific membrane antigen [PSMA]), plus INO-9012 (synthetic DNA plasmid encoding for IL-12), with the PD-1 checkpoint inhibitor, cemiplimab, was given to patients with newly-diagnosed GBM to evaluate tolerability, immunogenicity and clinical efficacy of the combination.MethodsPhase I/II, single arm, two cohort study (A: MGMT Promoter Unmethylated, B: MGMT Promoter Methylated). The primary objective is to evaluate the safety of INO-5401 and INO-9012 followed by EP with CELLECTRA® 2000 in combination with cemiplimab. Secondary objectives include the evaluation of preliminary clinical efficacy and immunogenicity. Treatment is with 9 mg INO-5401 with 1 mg INO-9012 every three weeks (Q3W) for four doses, then Q9W; and cemiplimab (350 mg IV Q3W). RT is given as 40 Gy over three weeks; TMZ is given concurrent with radiation (Cohorts A and B), followed by maintenance TMZ (Cohort B).Results52 patients were enrolled onto this study; 32 in Cohort A and 20 in Cohort B. 18 were women (35%) and 47 were white (90%). The median age was 60 years (range 19-78 years). The most common Grade ≥3 adverse events were elevations in alanine or aspartate aminotransferase (ALT/AST; 5 patients), and tumor inflammation/edema (5 patients); there was one Grade 5 unrelated event of urosepsis. The only related SAE reported in more than one patient was pyrexia. 22 patients (42%) reported immune-related AEs, with the most common being elevations in ALT or AST (8 patients), and were reported most commonly within the first nine weeks of treatment. The safety profile was consistent with that of patients with GBM and of checkpoint inhibitors. ELISpot assessments performed to date demonstrated the majority of patients have T cell responses to INO-5401. PFS6 was 75% (95% CI 56.6, 88.5) in Cohort A (preliminary; Cohort B pending).ConclusionsINO-5401 + INO-9012 with cemiplimab has an acceptable safety profile, is immunogenic and is potentially efficacious in patients with newly-diagnosed GBM. This combination is promising; survival results will be updated next year.Trial RegistrationNCT03491683.Ethics ApprovalThis study was approved by New York University institution’s Ethics Board; approval number i17-00764.ReferencesStupp R, et al. (2009). Lancet Oncology 10(5): 459–466.

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