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  • 1
    Online Resource
    Online Resource
    Clinical outcomes in adult patients with plaque psoriasis treated with ustekinumab under real‐world practice in Korea: A prospective, observational, multi‐center, postmarketing surveillance study
    Wiley ; 2021
    In:  The Journal of Dermatology Vol. 48, No. 6 ( 2021-06), p. 778-785
    Details
    In: The Journal of Dermatology, Wiley, Vol. 48, No. 6 ( 2021-06), p. 778-785
    Abstract: Postmarketing surveillance is conducted to establish drug safety and effectiveness under real‐world practice. We aimed to validate the effectiveness and safety of ustekinumab in the treatment of adult Korean patients with plaque psoriasis under real‐world practice. This was a prospective, observational, and multi‐center study. Subjects aged 18 years or older who were treated with ustekinumab for plaque psoriasis were enrolled. We enrolled 977 patients; 654 (66.9%) were men, with mean body surface area (BSA, ± standard deviation) of 27.0 ± 18.3% and mean psoriasis area severity index (PASI) score of 18.1 ± 9.7. The effectiveness analysis was performed in 581 patients who had at least one follow‐up assessment and met treatment criteria per local label and reimbursement guidelines. Of these patients, 287 had effectiveness data for visit 6 at 53.7 ± 2.1 weeks. At visit 6, 91.6% (263/287), 51.2% (147/287), and 9.4% (27/287) patients achieved PASI 75, 90, and 100 responses, respectively. Adverse events (AEs) occurred in 112 of the 977 (11.5%) patients with an incidence rate of 21.5 per 100 patient‐years (PYs). Serious AEs occurred in eight (0.8%) patients with an incidence rate of 1.2 per 100 PYs. The estimated 1‐year drug survival rate was 87.7%. The multiple logistic regression analysis showed that higher baseline PASI score and no prior biologic exposure were significant predictors for PASI 90 response at visit 6. Ustekinumab was effective and safe, and displayed a high survival rate in the treatment of adult Korean patients with plaque psoriasis in real‐world practice.
    Type of Medium: Online Resource
    ISSN: 0385-2407 , 1346-8138
    URL: Issue
    URL: Article
    DOI: 10.1111/jde.v48.6
    DOI: 10.1111/1346-8138.15670
    RVK:
    XA 53120
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2222121-9
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  • 2
    Online Resource
    Online Resource
    Clinical factors predicting the therapeutic response to ustekinumab in patients with moderate to severe chronic plaque psoriasis
    Wiley ; 2017
    In:  The Journal of Dermatology Vol. 44, No. 5 ( 2017-05), p. 560-566
    Details
    In: The Journal of Dermatology, Wiley, Vol. 44, No. 5 ( 2017-05), p. 560-566
    Abstract: While ustekinumab has been widely used as an effective biologic for the treatment of chronic plaque psoriasis, no prospective studies have specifically investigated the clinical factors that may influence treatment outcomes with ustekinumab. This post‐hoc analysis aimed to identify specific clinical factors that may influence treatment outcomes with ustekinumab in psoriasis patients. In the MARCOPOLO study, 102 Korean patients with moderate to severe psoriasis were analyzed to assess the influence of baseline characteristics as clinical factors on clinical response (improvement in P soriasis A rea and S everity I ndex by ≥75%/90% [ PASI 75/ PASI 90]) to ustekinumab. In addition, differences in PASI 75 and PASI 90 responses between the responder group and non‐responders were evaluated at weeks 28 and 52. Multiple logistic regression analysis was used to determine adjusted clinical factors predicting treatment outcomes among patient characteristics. At week 28, there was a significant difference in PASI 75/ PASI 90 response based on prior biologic experience, although the difference did not persist at week 52. In addition, after adjusting for the effects of relevant clinical factors, biologic experience was significantly associated with less PASI 75 (odds ratio [ OR ] = 0.14, P = 0.001) and PASI 90 ( OR = 0.22, P = 0.036) responses at week 28. The presence of comorbidities was higher among non‐responders than among PASI 75/ PASI 90 responders at both weeks 28 and 52, but was not statistically significant. Previous biologic use was the only clinical factor predicting less response at week 28, although it did not influence the clinical response after week 52. Further studies are warranted to investigate the association between presence of comorbidities and clinical response.
    Type of Medium: Online Resource
    ISSN: 0385-2407 , 1346-8138
    URL: Issue
    URL: Article
    DOI: 10.1111/jde.2017.44.issue-5
    DOI: 10.1111/1346-8138.13681
    RVK:
    XA 53120
    Language: English
    Publisher: Wiley
    Publication Date: 2017
    detail.hit.zdb_id: 2222121-9
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  • 3
    Online Resource
    Online Resource
    Early course of newly diagnosed moderate‐to‐severe ulcerative colitis in Korea: Results from a hospital‐based inception cohort study (MOSAIK)
    Wiley ; 2021
    In:  Journal of Gastroenterology and Hepatology Vol. 36, No. 8 ( 2021-08), p. 2149-2156
    Details
    In: Journal of Gastroenterology and Hepatology, Wiley, Vol. 36, No. 8 ( 2021-08), p. 2149-2156
    Abstract: No inception cohort study has ever evaluated the early course of moderate‐to‐severe ulcerative colitis (UC) within 1 year of diagnosis in the non‐Caucasian population. We aimed to investigate the early clinical course of moderate‐to‐severe UC patients in terms of remission, relapse, UC‐related hospitalizations, colectomy, mortality, and overall use of medications. Methods In the MOSAIK inception cohort, which is an ongoing multicenter, prospective, hospital‐based, observational cohort, 354 patients with moderate‐to‐severe UC were followed up for 1 year. Main outcomes of UC and predictive factors for medication use over the course of 1 year were evaluated. Result Among 354 patients, 276 (78.0%) patients were followed up for 1 year. The rates of remission, relapse, UC‐related hospitalizations, and proximal disease extension were 95.3%, 39.6%, 15.2%, and 12.3%, respectively. Systemic corticosteroids, thiopurines, and biologics were administered to 61.2%, 30.4%, and 10.5% of patients, respectively, throughout 1 year. One year after, 58.2% patients experienced remission or mild endoscopic activity. Overall disease courses did not show much difference according to moderate or severe disease activity at baseline. In addition, no colectomy and mortality were observed for 1 year. Predictive factors for medication use included disease severity, disease extent, endoscopic severity, and presence of periappendiceal inflammation at baseline for corticosteroid, disease extent and initial corticosteroid use for thiopurine, and only initial corticosteroid use for biologics. Conclusion Korean patients with moderate‐to‐severe UC may have more favorable early outcomes than Western patients. However, outcomes of them need to be further looked into for a longer time.
    Type of Medium: Online Resource
    ISSN: 0815-9319 , 1440-1746
    URL: Issue
    URL: Article
    DOI: 10.1111/jgh.v36.8
    DOI: 10.1111/jgh.15435
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2006782-3
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  • 4
    Online Resource
    Online Resource
    A randomized phase l pharmacokinetic study comparing SB4 and etanercept reference product (Enbrel®) in healthy subjects
    Wiley ; 2016
    In:  British Journal of Clinical Pharmacology Vol. 82, No. 1 ( 2016-07), p. 64-73
    Details
    In: British Journal of Clinical Pharmacology, Wiley, Vol. 82, No. 1 ( 2016-07), p. 64-73
    Abstract: SB4 has been developed as a biosimilar of etanercept. The primary objective of the present study was to demonstrate the pharmacokinetic (PK) equivalence between SB4 and European Union ‐sourced etanercept (EU‐ETN), SB4 and United States‐sourced etanercept (US‐ETN), and EU‐ETN and US‐ETN. The safety and immunogenicity were also compared between the treatments. Methods This was a single‐blind, three‐part, crossover study in 138 healthy male subjects. In each part, 46 subjects were randomized at a 1:1 ratio to receive a single 50 mg subcutaneous dose of the treatments (part A: SB4 or EU‐ETN; part B: SB4 or US‐ETN; and part C: EU‐ETN or US‐ETN) in period 1, followed by the crossover treatment in period 2 according to their assigned sequences. PK equivalence between the treatments was determined using the standard equivalence margin of 80–125%. Results The geometric least squares means ratios of AUC inf , AUC last and C max were 99.04%, 98.62% and 103.71% (part A: SB4 vs . EU‐ETN); 101.09%, 100.96% and 104.36% (part B: SB4 vs . US‐ETN); and 100.51%, 101.27% and 103.29% (part C: EU‐ETN vs . US‐ETN), respectively, and the corresponding 90% confidence intervals were completely contained within the limits of 80–125 %. The incidence of treatment‐emergent adverse events was comparable, and the incidence of the antidrug antibodies was lower in SB4 compared with the reference products. Conclusions The present study demonstrated PK equivalence between SB4 and EU‐ETN, SB4 and US‐ETN, and EU‐ETN and US‐ETN in healthy male subjects. SB4 was well tolerated, with a lower immunogenicity profile and similar safety profile compared with those of the reference products.
    Type of Medium: Online Resource
    ISSN: 0306-5251 , 1365-2125
    URL: Issue
    URL: Article
    DOI: 10.1111/bcp.v82.1
    DOI: 10.1111/bcp.12929
    RVK:
    XA 33650
    Language: English
    Publisher: Wiley
    Publication Date: 2016
    detail.hit.zdb_id: 1498142-7
    SSG: 15,3
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