BACKGROUND Inflammatory bowel disease(IBD)is a chronic inflammatory condition of the gastrointestinal tract,with tumor necrosis factor(TNF)-αplaying a key role in its pathogenesis.Etanercept,a decoy receptor for TNF,...BACKGROUND Inflammatory bowel disease(IBD)is a chronic inflammatory condition of the gastrointestinal tract,with tumor necrosis factor(TNF)-αplaying a key role in its pathogenesis.Etanercept,a decoy receptor for TNF,is used to treat inflammatory conditions.The secretome derived from adipose-derived stem cells(ASCs)has anti-inflammatory effects,making it a promising therapeutic option for IBD.AIM To investigate the anti-inflammatory effects of the secretome obtained from ASCs synthesizing etanercept on colon cells and in a dextran sulfate sodium(DSS)-induced IBD mouse model.METHODS ASCs were transfected with etanercept-encoding mini-circle plasmids to create etanercept-producing cells.The secretory material from these cells was then tested for anti-inflammatory effects both in vitro and in a DSS-induced IBD mouse model.RESULTS This study revealed promising results indicating that the group treated with the secretome derived from etanercept-synthesizing ASCs[Etanercept-Secretome(Et-Sec)group]had significantly lower expression levels of inflammatory mediators,such as interleukin-6,Monocyte Chemoattractant Protein-1,and TNF-α,when compared to the control secretome(Ct-Sec).Moreover,the Et-Sec group exhibited a marked therapeutic effect in terms of preserving the architecture of intestinal tissue compared to the Ct-Sec.CONCLUSION These results suggest that the secretome derived from ASCs that synthesize etanercept has potential as a therapeutic agent for the treatment of IBD,potentially enhancing treatment efficacy by merging the anti-inflam-matory qualities of the ASC secretome with etanercept's targeted approach to better address the multifaceted pathophysiology of IBD.展开更多
AIM: To evaluate the effects of etanercept on the expression of Fas, tumor necrosis factor-alpha(TNF-α) and caspase-8 in the early stage of the apoptotic pathway in diabetic rats, and to explore the therapeutic effec...AIM: To evaluate the effects of etanercept on the expression of Fas, tumor necrosis factor-alpha(TNF-α) and caspase-8 in the early stage of the apoptotic pathway in diabetic rats, and to explore the therapeutic effect of etanercept on diabetic retinopathy.METHODS: A total of 60 Sprague-Dawley(SD) rats were randomly and evenly divided into 3 groups with 20 rats each, including control group, and diabetic groups with or without treatment. Streptozotocin(STZ)-induced diabetic rats were established for diabetic groups. Blood glucose and body weight were measured weekly. All the rats were sacrificed at the 12 wk after treatment. The expressions of Fas, TNF-α and caspase-8 in rat retina were quantitatively detected by PCR and Western blot. The leakage of Evan blue was adopted to measure the retinal vascular leakage quantitatively, and to compare it among different groups. TUNEL method was used to compare the amount of apoptotic bodies quantitatively in rat retina ganglion cells under electron microscope.RESULTS: The expressions of Fas, TNF-α and caspase-8 in each group were compared via PCR and Western blot, in which the diabetic group with treatment was lower than those without treatment(P<0.01), but all the diabetic groups were higher than the control group(P<0.01). Evans blue leakage in the diabetic treatment group was lower than those without treatment(P<0.01), but those in the control group was the lowest compared with the other two groups(P<0.01). TUNEL method showed that the apoptoticbodies of retina in the diabetic treatment group was lower than those without treatment(P<0.01), while those in the control group was the lowest compared with the other two groups(P<0.01). CONCLUSION: Etanercept can effectively reduce the expression of Fas, TNF-α and caspase-8, as well as the retinal leakage and retinal cell apoptosis in diabetic rats.展开更多
AIM: To evaluate the safety and efficacy of intravitreal etanercept in the inhibiting of proliferative vitreoretinopathy(PVR) in a model of penetrating ocular injury. METHODS: Penetrating ocular injury on the retina o...AIM: To evaluate the safety and efficacy of intravitreal etanercept in the inhibiting of proliferative vitreoretinopathy(PVR) in a model of penetrating ocular injury. METHODS: Penetrating ocular injury on the retina of rabbit was induced, which was subsequently treated using 0.1 mL of sterile water or 0.1 m L of 12.5 mg/mL etanercept. The development of PVR was evaluated by fundus images, the B-scan, and the histopathology. The mRNA and protein expressions of tumor necrosis factor-α(TNF-α), transforming growth factor β(TGF-β) as well as connective tissue growth factor(CTGF) were examined at various time points after the etanercept injection with the reverse transcriptase-polymerase chain reaction(RT-PCR) and Western blotting, respectively. The safety of etanercept was evaluated by injection of 12.5 mg/mL etanercept into a normal rabbit eye without penetrating trauma. RESULTS: Clinical assessment and grading clearly demonstrated that the PVR formation was prevented in etanercept-treated animals, which was confirmed via fundus images, B-scan and histopathology. The RT-PCR and Western blotting showed increased mRNA and protein expression of TNF-α, TGF-β as well as CTGF in the retina of rabbits following penetrating ocular injury, and these factors were dramatically mitigated by ocular etanercept treatment. In addition, there was no adverse effect of etanercept intravitreal injection in normal eyes without penetrating trauma, it showed normal structure and histology. CONCLUSION: The etanercept is a potential therapy for inhibiting PVR development. To assess the clinic application of the etanercept in preventing PVR, further clinical studies are required.展开更多
Etanercept has been shown to be effective for the treatment of moderate-to-severe plaque psoriasis. Since most clinical trials examined etanercept in combination with other drugs, the efficacy and safety of etanercept...Etanercept has been shown to be effective for the treatment of moderate-to-severe plaque psoriasis. Since most clinical trials examined etanercept in combination with other drugs, the efficacy and safety of etanercept monotherapy for moderate-to-severe plaque psoriasis have not been well established. This prospective study enrolled 61 Chinese patients with moderate-to-severe plaque psoriasis to explore the efficacy and safety of etanercept monotherapy. These patients were treated with etanercept at a subcutaneous dose of 25 mg, twice a week, for 12 weeks. All the 61 patients completed the treatment and showed significant improvement in psoriasis area and severity index（PASI） scores. At 4, 8, and 12 weeks after treatment, the response rates（PASI75） were 0%, 21.31%, and 40.98%, respectively. It was concluded that etanercept monotherapy is efficacious and safe for patients with moderate-to-severe plaque psoriasis.展开更多
Etanercept, a recombinant human tumor necrosis factor (TNF)-receptor fusion protein, is FDA approved for psoriasis and psoriatic arthritis. TNFαincreases the synthesis of proin-flammatory cytokines and leads to the a...Etanercept, a recombinant human tumor necrosis factor (TNF)-receptor fusion protein, is FDA approved for psoriasis and psoriatic arthritis. TNFαincreases the synthesis of proin-flammatory cytokines and leads to the activation of multiple signaling pathways, including nuclear factor kappa B (NF-κB). The Rel/NF-κB transcription factors play a central role in numerous cellular processes, including the stress response and keratinocyte proliferation and differentiation. Utilizing a phosphorylation-specific antibody, we examined the expression of active nuclear NF-κB/RelA via immunohistochemistry in normal skin, non-lesional psoriatic skin, lesional psoriatic skin, and lesional skin from patients treated with etanercept. There was no expression of active nuclear NF-κB in the normal epidermis, whereas a basal level of constitutive active phosphorylated NF-κB/RelA was present in uninvolved epidermis from psoriasis patients. There was also significant upregulation of active phosphorylated NF-κB/RelA in the epidermis from psoriatic plaques. Serial biopsies from psoriasis patients treated with etanercept at 1, 3, and 6 mo demonstrated a significant downregulation of phosphorylated NF-κB/RelA, which correlated with decreases in epidermal thickness, restoration of normal markers of keratinocyte differentiation, and clinical outcomes. These data suggest that activation of NF-κB plays a significant role in the pathogenesis of psoriasis and that a potential mechanism of action for TNF-targeting agents is downregulation of NF-κB transcriptional activity.展开更多
Fifty-one rheumatoid arthritis (RA) patients were enrolled to assess the gene expression of tumor necrosis factor-alpha (TNF-α) by reverse transcription quantitative polymerase chain reaction (qRT-PCR) in etanercept-...Fifty-one rheumatoid arthritis (RA) patients were enrolled to assess the gene expression of tumor necrosis factor-alpha (TNF-α) by reverse transcription quantitative polymerase chain reaction (qRT-PCR) in etanercept-treated RA patients, with some emphasis on clinical and biological markers of disease. The results revealed that the ΔCt mean range in total, male and female RA patients and controls was 1.286 ± 1.226 - 4.023 ± 0.856 and the differences were not. Laboratory and clinical findings in subgroups of patients also showed no significant variations in the distribution of 2-ΔΔCt means, with the exception of anti-cyclic citrullinated peptide (ACCP) antibodies. The lowest expression was observed in moderate positive patients (1.566 ± 1.104) compared to low and high positive patients (4.061 ± 1.366 and 9.668 ± 3.518, respectively) for ACCP antibodies, and the difference was significant (p = 0.043). Inspecting the 2-ΔΔCt means in duration of disease and gender revealed that male patients recorded a lower mean than female patients (0.827 ± 0.550 vs. 4.143 ± 1.317) at 10 years duration of disease, female patients showed a lower mean than male patients (1.242 ± 0.372 vs. 5.607 ± 3.334). However, both differences were not significant. It is concluded that etanercept was effective in normalizing the TNF gene expression, but variations that were related to gender, duration of disease and some biological markers of disease, were observed.展开更多
Tumor necrosis factor-alpha (TNF-α) is a potent inflammatory cytokine and its exaggerated production has been implicated in acute, chronic and autoimmune inflammatory diseases. Proteinaceous and non-proteinaceous ant...Tumor necrosis factor-alpha (TNF-α) is a potent inflammatory cytokine and its exaggerated production has been implicated in acute, chronic and autoimmune inflammatory diseases. Proteinaceous and non-proteinaceous anti-TNF-α agents have been developed to reduce its circulating levels either by neutralizing, binding or inhibiting the de novo synthesis with the aim of achieving desirable therapeutic effects. In the present study, we compared the effects of a protein-based anti-TNF-α drug, etanercept, and a non-protein-based anti-TNF-α small molecule, 5-ethyl-1-phenyl-2-(1H) pyridone (5-EPP), on the LPS-stimulated secretion of TNF-α in the medium and TNF-α associated with the THP-1 cells in vitro. Both drugs had marked concentration-dependent inhibitory effects on the LPS-stimulated secretion of TNF-α. However, their effects on the LPS-stimulated cell-associated TNF-α were diametrically opposed to each other. For instance, etanercept further increased the level by up to 12-fold, whereas 5-EPP inhibited the level in a dose dependent manner. In addition, 5-EPP caused a significant reduction in the elevated level of cell associated TNF-α caused by LPS + etanercept. The differences in the levels of cell-associated TNF-α as reported in the present study may partly explain the adverse effects of some protein-based anti-TNF-α drugs including etanercept as opposed to a non-protein-based anti-TNF-α drug such as pirfenidone, a structural analogue of 5-EPP, for treatment of some TNF-α mediated diseases. It was concluded from the findings of this study that drugs which elevate the levels of cell associated-TNF-α will potentially have more adverse events even after reducing the secreted levels of TNF-α than the drugs which reduce both the secreted and cell-associated TNF-α levels.展开更多
The research work was carried out using Ultraviolet (UV)—visible spectroscopy and Reverse Phase-Ultra Fast Liquid Chromatography (RP-UFLC) for establishing novel methods for the analysis and quantification of Biosimi...The research work was carried out using Ultraviolet (UV)—visible spectroscopy and Reverse Phase-Ultra Fast Liquid Chromatography (RP-UFLC) for establishing novel methods for the analysis and quantification of Biosimilar drug, Etanercept. The maximum absorbance of Etanercept was found to be 215 nm and it obeyed Beer-Lamberts law in the range of 5 to 200 μg/ml and 1 to 32 μg/ml for UV and RP-UFLC, respectively. The correlation coefficient (r<sup>2</sup>) value was found to be between 0.999 and 0.9995. All the validation parameters like linearity, accuracy, and precision, Limit of Detection (LOD), Limit of Quantitation (LOQ) and Robustness were found to be within acceptance criteria as per ICH guidelines. The results of accuracy studies (99.0% to 100.38%) indicated the methods to be accurate. The RSD % for interday and intraday precision studies was found to be less than 2%. Robustness and ruggedness were expressed in terms of RSD % which were also in the specified limits. LOD and LOQ of proposed method was calculated and found to be 1.257 and 3.809 μg/ml by UV, and 0.1073 μg/ml and 0.3251 μg/ml by RP-UFLC method, respectively. The developed methods were observed to be simple, rapid and cost-efficient. It can be easily applied for the estimation of Etanercept in the marketed formulations and for routine analysis of the Biosimilar drug.展开更多
Psoriasis is a chronic, immune-mediated, inflammatory disease with a high prevalence in the general population (2%). The anti-tumor necrosis factor receptor etanercept is Food and Drug Administration (FDA) approved fo...Psoriasis is a chronic, immune-mediated, inflammatory disease with a high prevalence in the general population (2%). The anti-tumor necrosis factor receptor etanercept is Food and Drug Administration (FDA) approved for the treatment of moderate-to-severe plaque psoriasis. Both continuous and interrupted etanercept therapy is effective and well-tolerated. This report <strong>aims</strong> to document a new case presentation of psoriasis on intermittent etanercept injection throughout 36 weeks with long-lasting sustained efficacy and no risk factor. <strong>Case Report</strong>: A 39-year-old adult male patient with long-standing chronic plaque psoriasis for 15 years duration without joint involvement started loading dose treatment of etanercept injection in whom due to his work circumstances not taken maintenance therapy and showed-up at the clinic after 36 weeks from first induction therapy when partial relapse of psoriatic lesions appear in last week with continued improvement when reintroducing loading treatment on followed-up over the next 36 weeks. <strong>Conclusion</strong>: Intermittent etanercept therapy considers effective for 36 weeks with prolonging sustained efficacy and without adverse effect.展开更多
基金Supported by the National Research Foundation of Korea(NRF)grant funded by the Korea government(MSIT),No.NRF-2021R1F1A1064566.
文摘BACKGROUND Inflammatory bowel disease(IBD)is a chronic inflammatory condition of the gastrointestinal tract,with tumor necrosis factor(TNF)-αplaying a key role in its pathogenesis.Etanercept,a decoy receptor for TNF,is used to treat inflammatory conditions.The secretome derived from adipose-derived stem cells(ASCs)has anti-inflammatory effects,making it a promising therapeutic option for IBD.AIM To investigate the anti-inflammatory effects of the secretome obtained from ASCs synthesizing etanercept on colon cells and in a dextran sulfate sodium(DSS)-induced IBD mouse model.METHODS ASCs were transfected with etanercept-encoding mini-circle plasmids to create etanercept-producing cells.The secretory material from these cells was then tested for anti-inflammatory effects both in vitro and in a DSS-induced IBD mouse model.RESULTS This study revealed promising results indicating that the group treated with the secretome derived from etanercept-synthesizing ASCs[Etanercept-Secretome(Et-Sec)group]had significantly lower expression levels of inflammatory mediators,such as interleukin-6,Monocyte Chemoattractant Protein-1,and TNF-α,when compared to the control secretome(Ct-Sec).Moreover,the Et-Sec group exhibited a marked therapeutic effect in terms of preserving the architecture of intestinal tissue compared to the Ct-Sec.CONCLUSION These results suggest that the secretome derived from ASCs that synthesize etanercept has potential as a therapeutic agent for the treatment of IBD,potentially enhancing treatment efficacy by merging the anti-inflam-matory qualities of the ASC secretome with etanercept's targeted approach to better address the multifaceted pathophysiology of IBD.
基金Supported by National Natural Science Foundation of China(No.81270999)the Key Project of Miaopu of Fujian Medical University(No.2015MP004)the Qihang Funds of Fujian Medical University(No.2018QH1063)
文摘AIM: To evaluate the effects of etanercept on the expression of Fas, tumor necrosis factor-alpha(TNF-α) and caspase-8 in the early stage of the apoptotic pathway in diabetic rats, and to explore the therapeutic effect of etanercept on diabetic retinopathy.METHODS: A total of 60 Sprague-Dawley(SD) rats were randomly and evenly divided into 3 groups with 20 rats each, including control group, and diabetic groups with or without treatment. Streptozotocin(STZ)-induced diabetic rats were established for diabetic groups. Blood glucose and body weight were measured weekly. All the rats were sacrificed at the 12 wk after treatment. The expressions of Fas, TNF-α and caspase-8 in rat retina were quantitatively detected by PCR and Western blot. The leakage of Evan blue was adopted to measure the retinal vascular leakage quantitatively, and to compare it among different groups. TUNEL method was used to compare the amount of apoptotic bodies quantitatively in rat retina ganglion cells under electron microscope.RESULTS: The expressions of Fas, TNF-α and caspase-8 in each group were compared via PCR and Western blot, in which the diabetic group with treatment was lower than those without treatment(P<0.01), but all the diabetic groups were higher than the control group(P<0.01). Evans blue leakage in the diabetic treatment group was lower than those without treatment(P<0.01), but those in the control group was the lowest compared with the other two groups(P<0.01). TUNEL method showed that the apoptoticbodies of retina in the diabetic treatment group was lower than those without treatment(P<0.01), while those in the control group was the lowest compared with the other two groups(P<0.01). CONCLUSION: Etanercept can effectively reduce the expression of Fas, TNF-α and caspase-8, as well as the retinal leakage and retinal cell apoptosis in diabetic rats.
基金Supported by National Natural Science Foundation of China (No.91442124 No.81670865)
文摘AIM: To evaluate the safety and efficacy of intravitreal etanercept in the inhibiting of proliferative vitreoretinopathy(PVR) in a model of penetrating ocular injury. METHODS: Penetrating ocular injury on the retina of rabbit was induced, which was subsequently treated using 0.1 mL of sterile water or 0.1 m L of 12.5 mg/mL etanercept. The development of PVR was evaluated by fundus images, the B-scan, and the histopathology. The mRNA and protein expressions of tumor necrosis factor-α(TNF-α), transforming growth factor β(TGF-β) as well as connective tissue growth factor(CTGF) were examined at various time points after the etanercept injection with the reverse transcriptase-polymerase chain reaction(RT-PCR) and Western blotting, respectively. The safety of etanercept was evaluated by injection of 12.5 mg/mL etanercept into a normal rabbit eye without penetrating trauma. RESULTS: Clinical assessment and grading clearly demonstrated that the PVR formation was prevented in etanercept-treated animals, which was confirmed via fundus images, B-scan and histopathology. The RT-PCR and Western blotting showed increased mRNA and protein expression of TNF-α, TGF-β as well as CTGF in the retina of rabbits following penetrating ocular injury, and these factors were dramatically mitigated by ocular etanercept treatment. In addition, there was no adverse effect of etanercept intravitreal injection in normal eyes without penetrating trauma, it showed normal structure and histology. CONCLUSION: The etanercept is a potential therapy for inhibiting PVR development. To assess the clinic application of the etanercept in preventing PVR, further clinical studies are required.
文摘Etanercept has been shown to be effective for the treatment of moderate-to-severe plaque psoriasis. Since most clinical trials examined etanercept in combination with other drugs, the efficacy and safety of etanercept monotherapy for moderate-to-severe plaque psoriasis have not been well established. This prospective study enrolled 61 Chinese patients with moderate-to-severe plaque psoriasis to explore the efficacy and safety of etanercept monotherapy. These patients were treated with etanercept at a subcutaneous dose of 25 mg, twice a week, for 12 weeks. All the 61 patients completed the treatment and showed significant improvement in psoriasis area and severity index（PASI） scores. At 4, 8, and 12 weeks after treatment, the response rates（PASI75） were 0%, 21.31%, and 40.98%, respectively. It was concluded that etanercept monotherapy is efficacious and safe for patients with moderate-to-severe plaque psoriasis.
文摘Etanercept, a recombinant human tumor necrosis factor (TNF)-receptor fusion protein, is FDA approved for psoriasis and psoriatic arthritis. TNFαincreases the synthesis of proin-flammatory cytokines and leads to the activation of multiple signaling pathways, including nuclear factor kappa B (NF-κB). The Rel/NF-κB transcription factors play a central role in numerous cellular processes, including the stress response and keratinocyte proliferation and differentiation. Utilizing a phosphorylation-specific antibody, we examined the expression of active nuclear NF-κB/RelA via immunohistochemistry in normal skin, non-lesional psoriatic skin, lesional psoriatic skin, and lesional skin from patients treated with etanercept. There was no expression of active nuclear NF-κB in the normal epidermis, whereas a basal level of constitutive active phosphorylated NF-κB/RelA was present in uninvolved epidermis from psoriasis patients. There was also significant upregulation of active phosphorylated NF-κB/RelA in the epidermis from psoriatic plaques. Serial biopsies from psoriasis patients treated with etanercept at 1, 3, and 6 mo demonstrated a significant downregulation of phosphorylated NF-κB/RelA, which correlated with decreases in epidermal thickness, restoration of normal markers of keratinocyte differentiation, and clinical outcomes. These data suggest that activation of NF-κB plays a significant role in the pathogenesis of psoriasis and that a potential mechanism of action for TNF-targeting agents is downregulation of NF-κB transcriptional activity.
文摘Fifty-one rheumatoid arthritis (RA) patients were enrolled to assess the gene expression of tumor necrosis factor-alpha (TNF-α) by reverse transcription quantitative polymerase chain reaction (qRT-PCR) in etanercept-treated RA patients, with some emphasis on clinical and biological markers of disease. The results revealed that the ΔCt mean range in total, male and female RA patients and controls was 1.286 ± 1.226 - 4.023 ± 0.856 and the differences were not. Laboratory and clinical findings in subgroups of patients also showed no significant variations in the distribution of 2-ΔΔCt means, with the exception of anti-cyclic citrullinated peptide (ACCP) antibodies. The lowest expression was observed in moderate positive patients (1.566 ± 1.104) compared to low and high positive patients (4.061 ± 1.366 and 9.668 ± 3.518, respectively) for ACCP antibodies, and the difference was significant (p = 0.043). Inspecting the 2-ΔΔCt means in duration of disease and gender revealed that male patients recorded a lower mean than female patients (0.827 ± 0.550 vs. 4.143 ± 1.317) at 10 years duration of disease, female patients showed a lower mean than male patients (1.242 ± 0.372 vs. 5.607 ± 3.334). However, both differences were not significant. It is concluded that etanercept was effective in normalizing the TNF gene expression, but variations that were related to gender, duration of disease and some biological markers of disease, were observed.
文摘Tumor necrosis factor-alpha (TNF-α) is a potent inflammatory cytokine and its exaggerated production has been implicated in acute, chronic and autoimmune inflammatory diseases. Proteinaceous and non-proteinaceous anti-TNF-α agents have been developed to reduce its circulating levels either by neutralizing, binding or inhibiting the de novo synthesis with the aim of achieving desirable therapeutic effects. In the present study, we compared the effects of a protein-based anti-TNF-α drug, etanercept, and a non-protein-based anti-TNF-α small molecule, 5-ethyl-1-phenyl-2-(1H) pyridone (5-EPP), on the LPS-stimulated secretion of TNF-α in the medium and TNF-α associated with the THP-1 cells in vitro. Both drugs had marked concentration-dependent inhibitory effects on the LPS-stimulated secretion of TNF-α. However, their effects on the LPS-stimulated cell-associated TNF-α were diametrically opposed to each other. For instance, etanercept further increased the level by up to 12-fold, whereas 5-EPP inhibited the level in a dose dependent manner. In addition, 5-EPP caused a significant reduction in the elevated level of cell associated TNF-α caused by LPS + etanercept. The differences in the levels of cell-associated TNF-α as reported in the present study may partly explain the adverse effects of some protein-based anti-TNF-α drugs including etanercept as opposed to a non-protein-based anti-TNF-α drug such as pirfenidone, a structural analogue of 5-EPP, for treatment of some TNF-α mediated diseases. It was concluded from the findings of this study that drugs which elevate the levels of cell associated-TNF-α will potentially have more adverse events even after reducing the secreted levels of TNF-α than the drugs which reduce both the secreted and cell-associated TNF-α levels.
文摘The research work was carried out using Ultraviolet (UV)—visible spectroscopy and Reverse Phase-Ultra Fast Liquid Chromatography (RP-UFLC) for establishing novel methods for the analysis and quantification of Biosimilar drug, Etanercept. The maximum absorbance of Etanercept was found to be 215 nm and it obeyed Beer-Lamberts law in the range of 5 to 200 μg/ml and 1 to 32 μg/ml for UV and RP-UFLC, respectively. The correlation coefficient (r<sup>2</sup>) value was found to be between 0.999 and 0.9995. All the validation parameters like linearity, accuracy, and precision, Limit of Detection (LOD), Limit of Quantitation (LOQ) and Robustness were found to be within acceptance criteria as per ICH guidelines. The results of accuracy studies (99.0% to 100.38%) indicated the methods to be accurate. The RSD % for interday and intraday precision studies was found to be less than 2%. Robustness and ruggedness were expressed in terms of RSD % which were also in the specified limits. LOD and LOQ of proposed method was calculated and found to be 1.257 and 3.809 μg/ml by UV, and 0.1073 μg/ml and 0.3251 μg/ml by RP-UFLC method, respectively. The developed methods were observed to be simple, rapid and cost-efficient. It can be easily applied for the estimation of Etanercept in the marketed formulations and for routine analysis of the Biosimilar drug.
文摘Psoriasis is a chronic, immune-mediated, inflammatory disease with a high prevalence in the general population (2%). The anti-tumor necrosis factor receptor etanercept is Food and Drug Administration (FDA) approved for the treatment of moderate-to-severe plaque psoriasis. Both continuous and interrupted etanercept therapy is effective and well-tolerated. This report <strong>aims</strong> to document a new case presentation of psoriasis on intermittent etanercept injection throughout 36 weeks with long-lasting sustained efficacy and no risk factor. <strong>Case Report</strong>: A 39-year-old adult male patient with long-standing chronic plaque psoriasis for 15 years duration without joint involvement started loading dose treatment of etanercept injection in whom due to his work circumstances not taken maintenance therapy and showed-up at the clinic after 36 weeks from first induction therapy when partial relapse of psoriatic lesions appear in last week with continued improvement when reintroducing loading treatment on followed-up over the next 36 weeks. <strong>Conclusion</strong>: Intermittent etanercept therapy considers effective for 36 weeks with prolonging sustained efficacy and without adverse effect.
