An updated review of infliximab biosimilar, CT-P13, in the treatment of immune-mediated inflammatory diseases

Immunotherapy ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 609-623
Author(s):  
Seung Wook Hong ◽  
Yong-Gil Kim ◽  
Byong Duk Ye
Keyword(s):  
Clinical Trials ◽  
Clinical Outcomes ◽  
Real World ◽  
Inflammatory Diseases ◽  
European Medicines Agency ◽  
Immune Mediated ◽  
The Us ◽  
Us Fda ◽  
The Cost

The introduction of anti-TNFs, such as infliximab (IFX), has revolutionized the treatment of immune-mediated inflammatory diseases. Anti-TNF agents have shown outstanding efficacy and long-term improvement of clinical outcomes, but the cost has been relatively high. Out of this concern, several ‘biosimilar’ drugs of anti-TNF agents have been developed. CT-P13, the first biosimilar of reference IFX, was approved by the European Medicines Agency and licensed by the US FDA for use in all indications of IFX. This updated review summarizes all aspects of CT-P13, including pharmacology and pharmacokinetics, and evaluates its efficacy, safety and immunogenicity for all indications based on the results of the latest clinical trials as well as on real-world experiences.

scholarly journals Extended storage of SARS-CoV-2 nasopharyngeal swabs does not negatively impact results of molecular-based testing across three clinical platforms

2020 ◽  
pp. jclinpath-2020-206738
Author(s):  
Karin A Skalina ◽  
D Y Goldstein ◽  
Jaffar Sulail ◽  
Eunkyu Hahm ◽  
Momka Narlieva ◽  
...  
Keyword(s):  
Real World ◽  
Nasopharyngeal Swab ◽  
Molecular Testing ◽  
Clinical Tests ◽  
Ambient Conditions ◽  
Long Term Stability ◽  
The Us ◽  
Us Fda ◽  
World Environment

With the global outbreak of COVID-19, the demand for testing rapidly increased and quickly exceeded the testing capacities of many laboratories. Clinical tests which receive CE (Conformité Européenne) and Food and Drug Administration (FDA) authorisations cannot always be tested thoroughly in a real-world environment. Here we demonstrate the long-term stability of nasopharyngeal swab specimens for SARS-CoV-2 molecular testing across three assays recently approved by the US FDA under Emergency Use Authorization. This study demonstrates that nasopharyngeal swab specimens can be stored under refrigeration or even ambient conditions for 21 days without clinically impacting the results of the real-time reverse transcriptase-PCR testing.

A review of secukinumab in psoriasis treatment

Immunotherapy ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 201-216
Author(s):  
Scott H Berg ◽  
Esther A Balogh ◽  
Rima I Ghamrawi ◽  
Steven R Feldman
Keyword(s):  
Psoriatic Arthritis ◽  
Severity Index ◽  
European Medicines Agency ◽  
Real World Data ◽  
Igg1 Monoclonal Antibody ◽  
Pubmed Database ◽  
The Us ◽  
Human Igg1 ◽  
Us Fda

Psoriasis is a systemic immunologic disorder associated with decreased quality of life and numerous co-morbidities, including psoriatic arthritis and cardiovascular disease. Secukinumab, a fully human IgG1 monoclonal antibody, selectively binds IL-17A and is approved by the US FDA and European Medicines Agency for moderate-to-severe plaque psoriasis and psoriatic arthritis. This review examines the efficacy and safety of secukinumab for the treatment of psoriasis using the literature retrieved from the PubMed database. In clinical trials, treatment with secukinumab led to rapid and sustained improvement in Psoriasis Area and Severity Index (PASI) scores, with PASI 90 response rates up to 68.5% at 5 years. Long-term clinical trial and real-world data have established secukinumab as a safe and effective treatment for psoriasis.

Luspatercept in the treatment of lower-risk myelodysplastic syndromes

2021 ◽  
Author(s):  
Onyee Chan ◽  
Rami S Komrokji
Keyword(s):  
Clinical Trials ◽  
Myelodysplastic Syndromes ◽  
Transforming Growth Factor Beta ◽  
Transforming Growth Factor ◽  
Safety Data ◽  
Erythroid Differentiation ◽  
Fda Approval ◽  
The Us ◽  
Us Fda ◽  
Terminal Erythroid Differentiation

Transforming growth factor beta (TGF-β) signaling pathway is key to hematopoiesis regulation. Increased activation of this pathway contributes to ineffective terminal erythroid differentiation in myelodysplastic syndromes (MDS). Luspatercept is a novel fusion protein that traps TGF-β ligands preventing them from binding to Type II TGF-β receptors, thereby decreasing phosphorylated SMAD2/3 resulting in the downstream effect of promoting erythropoiesis. Seminal clinical trials using luspatercept, PACE-MD and MEDALIST, demonstrated impressive efficacy in the treatment of transfusion-dependent anemia in intermediate risk or lower MDS had led to the US FDA approval for this indication. This review summarizes luspatercept mechanisms of action, efficacy/safety data supporting its use and ongoing clinical trials in MDS.

scholarly journals COVID-19 and rheumatology: A year later

2021 ◽  
Vol 59 (1) ◽  
pp. 31-36
Author(s):  
B. S. Belov ◽  
A. M. Lila
Keyword(s):  
Clinical Trials ◽  
General Population ◽  
Severe Acute Respiratory Syndrome ◽  
Inflammatory Diseases ◽  
Controlled Clinical Trials ◽  
Antirheumatic Drugs ◽  
The Past ◽  
Immune Mediated ◽  
Great Hope ◽  
Blind Spots

An enormous body of evidence on various aspects of the coronavirus disease 2019, COVID-19 associated with the SARS-CoV-2 virus (severe acute respiratory syndrome coronavirus-2) has been accumulated over the past year. Meanwhile, investigated relationship between COVID-19 and rheumatic immune-mediated inflammatory diseases (IMIDs) and certain identified similarities were of paramount importance. It was shown that the incidence of COVID-19 in patients with rheumatic diseases does not significantly differ from that in general population. The risk of severe course and unfavorable COVID-19 outcomes in patients with rheumatic IMIDs is significantly associated with older age and comorbidities – as in general population, and is not aggravated by preceding use of the majority of antirheumatic drugs. Gaining better insights into pathogenesis of COVID-19 provided sound prerequisites for anti-rheumatic drugs repurposing and substantiated their use for treatment of COVID-19 infection. Under current COVID-19 pandemic circumstances, accelerated development and invention of various COVID-19 vaccines offers a great hope to curb the tide of pandemic. However, the efficacy, immunogenicity, and safety of these vaccines in patients with rheumatic IMIDs must be studied in controlled clinical trials. Generally speaking, there are still numerous blind spots in our knowledge of rheumatological aspects of such a versatile and polymorphous condition as COVID-19 infection.

Abstract 16784: Under-Enrollment of Real-World Heart Failure With Preserved Ejection Fraction Patients in Major HFpEF Clinical Trials

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Joban Vaishnav ◽  
Lisa R Yanek ◽  
Virginia S Hahn ◽  
Eunice Yang ◽  
Rishi Trivedi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Outcomes ◽  
Real World ◽  
Loop Diuretic ◽  
Nyha Class ◽  
Clinic Visit ◽  
Inclusion Criteria ◽  
Pulmonary Capillary ◽  
Number Of Patients ◽  
Wedge Pressure

Introduction: Inclusion criteria for enrollment in HFpEF clinical trials vary considerably and often exclude patients with co-morbidities such as obesity. We tested the hypotheses that: 1) a large number of patients with clinical and hemodynamic evidence of HFpEF are excluded from major HFpEF clinical trials; and 2) there is no difference in clinical outcomes between patients excluded versus those who met enrollment criteria by evaluating reasons for exclusion from HFpEF clinical trials and comparing clinical outcomes in a real-world HFpEF cohort. Methods: Patients referred to the Johns Hopkins HFpEF Clinic with clinical and hemodynamic evidence of HFpEF (pulmonary capillary wedge pressure [PCWP] ≥ 12 mmHg on a loop diuretic or PCWP ≥ 15 mmHg) were assessed for inclusion into 4 major HFpEF trials (TOPCAT, I-PRESERVE, PARAGON-HF, and RELAX). Cumulative hazard of HF hospitalization or death at 2 years from index clinic visit was compared between patients included and excluded by each trial. Results: Of 132 HFpEF patients, the median PCWP was 19 mmHg (IQR: 15-22 mmHg). Forty-four (33%) of patients met enrollment criteria for TOPCAT, 39 (29%) for I-PRESERVE, 21 (16%) for PARAGON-HF, and 50 (38%) for RELAX. The top 5 criteria that would have excluded patients included low natriuretic peptide level, obesity, elevated blood pressure, young age, and low hemoglobin (Figure 1A) . There was no difference in HF burden (hospitalizations, diuretic dosing, or NYHA class), or in clinical outcomes including HF hospitalization or death between patients who did or did not meet inclusion criteria for each clinical trial (Figure 1B ). Conclusion: We demonstrate that in a real-world cohort of hemodynamically-proven HFpEF few patients would have met criteria for enrollment in major HFpEF clinical trials, yet HF burden and outcomes were no different. Given the lack of proven therapies in HFpEF, consideration should be given to unifying and broadening enrollment criteria in HFpEF clinical trials.

Long-term clinical outcomes of patients treated with elosulfase alfa: Five-year real-world results from the Morquio A Registry Study (MARS)

2020 ◽  
Vol 129 (2) ◽  
pp. S112
Author(s):  
John Mitchell ◽  
Uma Ramaswami ◽  
Nicola Longo ◽  
Yin-Hsiu Chien ◽  
Nathalie Guffon ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Real World ◽  
Registry Study ◽  
Morquio A ◽  
Elosulfase Alfa
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