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Systemic Lupus Erythematosus
Published in Vincenzo Berghella, Maternal-Fetal Evidence Based Guidelines, 2022
Maria A. Giraldo-Isaza, Bettina F. Cuneo
Certolizumab pegol: Likely safe in pregnancy. No increased risk of birth defects or adverse outcomes with the use of Certolizumab. Certolizumab does not cross the placenta as it does not have the antibody FC-region that facilitates the passage of immunoglobulins through the placenta. Therefore, its use appears to be acceptable during the entire pregnancy [50, 51].
The science of biotechnology
Published in Ronald P. Evens, Biotechnology, 2020
Pegylation is a process in which polyethylene glycol (PEG) molecules are added to the protein structure. It has been done for eight different types of molecules: interferons (e.g., interferon-2a), a growth factor (e.g., filgrastim), all liposomes (e.g., doxorubicin), three enzymes (e.g., pegasparaginase, pegademase, and pegloticase), three coagulation proteins (e.g., Jivi), a hormone (e.g., pegvisomant), an aptamer (e.g., pegaptanib), and an antibody (e.g., certolizumab pegol). Figure 5.6 presents a diagram of a pegylated molecule, peg-filgrastim compared to its original molecule, filgrastim.
Small Bowel Crohn’s Disease
Published in Peter Sagar, Andrew G. Hill, Charles H. Knowles, Stefan Post, Willem A. Bemelman, Patricia L. Roberts, Susan Galandiuk, John R.T. Monson, Michael R.B. Keighley, Norman S. Williams, Keighley & Williams’ Surgery of the Anus, Rectum and Colon, 2019
Barry Salky, Naif Alenazi, André D’Hoore, Michael R.B. Keighley
Approximately 75% of patients with CD will require surgical intervention at some point in their disease course. This rate is even higher in small bowel disease. After first intestinal resection surgery, the rate for reoperation is as high as 70% after 20 years of disease. In the past decade, there has been great advancements in medical treatment of CD with an increase in the use of immunomodulators (thiopurines and methotrexate), and anti-tumour necrosis factor (TNF) drugs such as infliximab, adalimumab and certolizumab pegol. In spite of these advances, analysis of the National Hospital Discharge Survey between 1990 and 2003 found that the intestinal resection surgery rates did not change over time and patients continue to have a need for surgery mainly due to stricturing and penetrating complications.7
Abicipar pegol: an investigational anti-VEGF agent for the treatment of wet age-related macular degeneration
Published in Expert Opinion on Investigational Drugs, 2020
Lorenzo Ferro Desideri, Carlo Enrico Traverso, Massimo Nicolò
A preclinical study examined abicipar pegol pharmacodynamic features by using in vivo and in vitro assays. It was revealed that abicipar pegol had a high binding affinity (Kd) for human VEGF-A165 (394 fM), by adopting a kinetic exclusion assay (KinExA). Moreover, the binding affinities for VEGF-A189, VEGF-A121, and VEGF-A110, which represent other splice variants of human VEGF-A, were all in the picomolar range. Abicipar pegol was proven to display a high binding affinity also for murine VEGF-A164. In the same study, abicipar pegol showed a high binding affinity for human VEGF-A165, which was comparable to aflibercept one (486 fM and 200 fM, respectively). By contrast, these affinities were found to be almost 100-fold higher than those of ranibizumab and bevacizumab. The VEGF-A165 abicipar pegol association rate was 7.94 × 106 M − 1 s − 1, while it was 9.02 × 106 M − 1 s − 1 for aflibercept; both of these 2 drugs binded VEGF-A165 30- to 100-fold faster on-rates than ranibizumab (8.25 × 104 M − 1 s − 1) and bevacizumab (2.55 × 105 M − 1 s − 1). Moreover, mean potencies (IC50 values) referred were 101.9 pM for ranibizumab, 97.4 pM for bevacizumab, 13.8 pM for aflibercept, and 24.8 pM for abicipar, showing a significant difference between this latter and both ranibizumab and bevacizumab (p = 0.001).
How is safety of dermatology drugs assessed: trials, registries, and spontaneous reporting
Published in Expert Opinion on Drug Safety, 2020
Leila Asfour, Zenas Z.N. Yiu, Richard B. Warren
Pregnancy exposure registries are the main source of early information on medicines safety. However, these studies are typically statistically underpowered and can only demonstrate strong associations between exposure and rare outcomes such as major birth defects[90]. An adverse event registry had suggested potential teratogenic risk associated with exposure to anti-Tumor Necrosis Factor (TNF) therapy, in particular a collection of congenital anomalies Vertebral defects, Anal atresia, Cardiac abnormalities, Trachea-esophageal fistular, esophageal atresia, Renal abnormalities and preaxial Limb abnormalities (known as the acronym VACTERL)[91]. This was subsequently disputed as a different group demonstrated that the distribution of specific congenital malformations was similar to that of the general population-based database[92]; therefore, VACTERL group of anomalies was less likely to be associated with anti- TNF therapy[93]. Until recently, avoidance of biologics has been common in psoriasis during the third trimester and lactation. However, data can be generated during pregnancy and lactation that can improve our understanding of drug safety in this scenario. For example, the development of the pegylated targeted treatment Certolizumab pegol, that does not cross the placenta or get transferred via lactation, has created a safer option for these women[94].
Institute for clinical and economic review (ICER) psoriasis update 2018: what it means for dermatologists treating moderate-to-severe plaque psoriasis
Published in Journal of Dermatological Treatment, 2019
Erica B. Lee, Deeti J. Pithadia, Kelly A. Reynolds, Jashin J. Wu
Ultimately, they found that that initiating biologic therapy with an IL-17 inhibitor or guselkumab results in the greatest improvement of QALYs, and initiating therapy with apremilast, etanercept, or infliximab leads to the least. However, the IL-17 inhibitors, guselkumab, and certolizumab pegol were associated with the highest total costs over 10 years, while apremilast, etanercept, and infliximab are associated with lower costs. The analysis also suggested that in spite of its high discontinuation rate, initiation of target therapy with infliximab has a good economic value due to its high initial response and lower pricing. Additionally, this report indicates that neither etanercept nor adalimumab provide good long-term value as the initial biologic, as their costs outweigh their effectiveness. Initiation with ustekinumab or certolizumab pegol is also not recommended as many patients will require the higher and therefore costlier dosing.