Current Issue : January-March Volume : 2024 Issue Number : 1 Articles : 5 Articles
Objective: Biosimilars represent a new opportunity for inflammatory bowel disease (IBD) treatment and economic sustainability of therapies. This study aimed to evaluate the efficacy and long-term safety of the adalimumab biosimilar ABP 501 in biologic-naïve vs. biologic-switched IBD patients. Methods: A retrospective observational study was conducted using a database of patients with IBD treated with ABP 501, biologic-naïve or switched from the original, at eight IBD centers. We included adult patients with at least one year of follow-up. The primary objective of this study was to assess the efficacy (persistence) and safety (adverse event rate) of ABP 501 therapy. Results: A total of 118 patients with IBD were included in the analysis: 84 patients with Crohn’s disease (CD) (39 women, 45 men, mean age 40.4 ± 14.3 years; 33% biologic-naïve) and 34 patients with ulcerative Colitis (UC) (16 women, 18 men, mean age 38.9 ± 14.9 years; 61.8% biologic-naïve). Regarding the primary endpoint, no difference was observed in the efficacy between biologic-naïve patients and patients with Adalimumab (ADA) originator replacement for nonmedical reasons in terms of long-term persistence. However, ABP 501 showed a higher percentage of sustained clinical remission at 2 years in patients with CD (64 patients, 77%) than in those with UC (15 patients, 45.5%; p=0.00091). Nine patients (six with CD and three with UC) experienced adverse events that led to drug discontinuation in three. Conclusions: APB 501 showed a good safety and efficacy profile in maintaining clinical response at 2 years in patients with IBD, both as a treatment-naïve and as a replacement for ADA originator for non-medical reasons....
Objective: Adalimumab (ADA) is an effective treatment for inflammatory bowel disease (IBD), both ulcerative colitis (UC) and Crohn’s disease (CD). The equal effect between the original ADA and biosimilars from Europe and the United States has been shown. However, the biosimilar of ADA is different in China. The effectiveness and safety data of ADA biosimilar (HS016) in China have yet to be discovered. Patients and methods: 91 patients (75 CD, 16 UC) received HS016 treatment and were enrolled in this study. Therapeutic response and safety profiles were analyzed. Therapeutic drug monitoring (TDM) was also carried out among nonresponse patients. After being considered as “nonresponse” (after three or 6 months of treatment), 20 patients’ serum TNFα concentrations were measured and correlated to their disease severity. Results: Among active CD patients (n = 61), 75.4% (46/61) at 12 w, 73.8% (45/61) at 26 w, 50.8% (31/61) at 52 w achieved the clinical response, respectively; 55.7% (34/61) at 12 w, 65.6% (40/61) at 26 w, and 45.9% (28/61) at 52 w achieved clinical remission. The maintained remission rates of CD (n = 14) in clinical remission were 100% (14/14) at 12 w, 78.6% (11/14) at 26 w, and 63.6% (7/11) at 52 w, respectively. Among active UC patients, 37.5% (6/16) at 12 w and 50% (8/16) at 26 w achieved clinical response. Total adverse event rates were 5.5% (5/91) during 52-week visits. Due to the inadequate serum drug concentration, 30.4% (7/23) of patients had poor clinical responses. Elevations of serum anti-drug antibodies occurred in one additional patient (4.3%). Conclusion: ADA biosimilar HS016 had good efficacy and safety in Chinese IBD patients....
(1) Background: GP2017 is one of the biosimilar drugs of adalimumab, one of the anti-TNF agents used for inflammatory bowel disease (IBD). To date, there is little real-world data about the use of GP2017 in IBD patients. The aim of our study was to evaluate the effectiveness and safety of this biosimilar in an IBD population. (2) Methods: This is an observational retrospective study including patients that were all treated with GP2017 as a first step or as a switch from the originator or other biosimilars. The clinical activity was evaluated at baseline and after 6 and 12 months of therapy. The therapy discontinuation and side effects were also evaluated. (3) Results: a total of 72 patients were included (65 with Crohn’s disease and 7 with ulcerative colitis). Of the 29 patients starting GP2017 as a first adalimumab therapy, clinical remission was achieved in 58.6%. Of the patients starting GP2017 as a switch from the originator (33 patients) or other biosimilars (10 patients), clinical remission was maintained in 78.8% and in 70%, respectively. Regarding the safety, only 11 patients experienced non-serious side effects. During the follow-up, nine patients suspended treatment mainly due to side effects or secondary failure. (4) Conclusions: GP2017 is an effective and safe therapy for IBD patients....
Canine mammary carcinomas (CMC) are associated with major aggressive clinical behavior and high mortality. The current standard of care is based on surgical resection, without an established effective treatment scheme, highlighting the urgent need to develop novel effective therapies. Vascular endothelial growth factor (VEGF) is a key regulator of tumor angiogenesis and progression in the majority of solid cancers, including human and canine mammary carcinomas. The first therapy developed to target VEGF was bevacizumab, a recombinant humanized monoclonal antibody, which has already been approved as an anticancer agent in several human cancers. The goal of this work was to establish the therapeutic value of MB02 bevacizumab biosimilar in CMC. First, through different in silico approaches using the MUSCLE multiple-sequence alignment tool and the FoldX protein design algorithm, we were able to predict that canine VEGF is recognized by bevacizumab, after showing an extremely high sequence similarity between canine and human VEGF. Further, by using an ELISA-based in vitro binding assay, we confirmed that MB02 biosimilar was able to recognize canine VEGF. Additionally, canine VEGF-induced microvascular endothelial cell proliferation was inhibited in a concentration-dependent manner by MB02 biosimilar. These encouraging results show a high potential for MB02 as a promising therapeutic agent for the management of CMC....
Polyphenols have attracted attention for their anti-inflammatory, antidiabetic, and anticancer properties. Due to the antioxidant and anti-inflammatory potential of these molecules, they are also proposed as a potential therapeutic tool to prevent complications of cancer and decrease the secondary effects of conventional chemotherapeutic drugs. Nonetheless, polyphenols such as flavonoids and phenolic acids have low bioavailability, as they are highly metabolized. Thus, administration strategies have been developed to enhance the anticancer properties of polyphenols. Most of these strategies involve different encapsulation techniques, such as nanoencapsulation, nanoemulsion, and the use of other polymeric matrixes. These techniques can increase the activity of these compounds after going through the gastrointestinal process and improve their solubility in an aqueous medium. This review comprises recent studies regarding encapsulation techniques to enhance the bioactivity of polyphenols against cancer and their current state in clinical studies. Overall, micro- and nanoencapsulation techniques with different polymers enhanced the anticancer properties of polyphenols by inhibiting tumor growth, modulating the expression of genes related to metastasis and angiogenesis, decreasing the expression of pro-inflammatory biomarkers....
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