scholarly journals Effectiveness and persistence of golimumab as a second biological drug in patients with spondyloarthritis

Medicine ◽  
2021 ◽  
Vol 100 (13) ◽  
pp. e25223
Author(s):  
Juan J. Alegre-Sancho ◽  
Xavier Juanola ◽  
José M. Rodríguez-Heredia ◽  
Javier Manero ◽  
Ignacio Villa-Blanco ◽  
...  
Keyword(s):  
Author(s):  
Qingqing Xiao ◽  
Xiaotong Li ◽  
Yi Li ◽  
Zhenfeng Wu ◽  
Chenjie Xu ◽  
...  

2016 ◽  
Vol 30 (2) ◽  
pp. 316-333 ◽  
Author(s):  
Alexis Mathian ◽  
Makoto Miyara ◽  
Fleur Cohen-Aubart ◽  
Julien Haroche ◽  
Miguel Hie ◽  
...  

Author(s):  
Robert I. Roth ◽  
Nicholas M. Fleischer

Recent years have seen the approvals, more so in the EU than the United States, of follow-on biological drugs. These products have been new formulations of recombinant therapeutic proteins, developed to compete with the marketed originator products. Intended to closely mimic the originator products in terms of chemistry and therapeutic properties, these so-called ‘biosimilar’ products were initially conceived to be developed according to abbreviated development programmes, presumably at a substantial cost savings to both the drug developer and the consumer. With several such products now recently approved, however, it has become clear that their development programmes have been quite extensive and not particularly abbreviated. Accordingly, cost savings to consumers appear to be relatively modest.


2021 ◽  
Vol 10 (3) ◽  
pp. 122-122
Author(s):  
Charles L Bennett

Biosimilars are biological drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety and efficacy. Biosimilar epoetin received US Food and Drug Administration (FDA) approval in 2018 [1]. The manufacturer received an FDA non-approval letter in 2017, despite receiving a favourable review by the FDA’s Oncologic Drugs Advisory Committee (ODAC) and an FDA non-approval letter in 2015 for an earlier formulation.


2020 ◽  
Vol 79 (9) ◽  
pp. 1203-1209 ◽  
Author(s):  
Raphael Micheroli ◽  
Christoph Tellenbach ◽  
Almut Scherer ◽  
Kristina Bürki ◽  
Karin Niederman ◽  
...  

ObjectiveTo compare effectiveness of treatment with secukinumab (SEC) with that of alternative tumour necrosis factor inhibitors (TNFis) in patients with axial spondyloarthritis (axSpA) after withdrawal from one or more TNFis.MethodsPatients diagnosed as having axSpA in the Swiss Clinical Quality Management cohort were included if they had initiated SEC (n=106) or an alternative TNFi (n=284) after experiencing TNFi failure. Drug retention was investigated with matching weights propensity score (PS) analyses and multiple adjusted Cox proportional hazards models. Matching weights PS-based analyses and multiple-adjusted logistic regression analyses were used to assess the proportion of patients reaching 50% reduction in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50) at 1 year.ResultsSEC was more often used as third-line or later-line biological drug (76% vs 40% for TNFi). Patients starting SEC had higher BASDAI, Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Metrology Index and C reactive protein levels. A comparable risk of drug discontinuation was found for SEC versus TNFi (HR 1.14, 95% CI 0.78 to 1.68 in the PS-based analysis and HR 1.16, 95% CI 0.79 to 1.71 in the multiple-adjusted analysis). No significant difference in BASDAI50 responses at 1 year was demonstrated between the two modes of biological drug action, with CI of estimates being, however, wide (OR for SEC vs TNFi 0.76, 95% CI 0.26 to 2.18 and 0.78, 95% CI 0.24 to 2.48 in the PS-based and the covariate-adjusted model, respectively).ConclusionOur data suggest a comparable effectiveness of SEC versus an alternative TNFi after prior TNFi exposure.


2020 ◽  
Vol 37 (10) ◽  
Author(s):  
V. Ashutosh Rao ◽  
Jennifer J. Kim ◽  
Dipti S. Patel ◽  
Kimberly Rains ◽  
Corey R. Estoll

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