Serum concentrations of cis(Z)-flupentixol in patients under maintenance treatment with cis(Z)-flupentixol decanoate: (Fluanxol® Depot, Depixol® inj.)

1984 ◽  
Vol 38 (5) ◽  
pp. 493-495 ◽  
Author(s):  
Lars Kirk ◽  
Annelise Bilde ◽  
Jens Aage Stauning ◽  
Børge Ahrensburg ◽  
Erik Petersen ◽  
...  
1982 ◽  
Vol 77 (1) ◽  
pp. 58-65 ◽  
Author(s):  
A. J�rgensen ◽  
J. Andersen ◽  
N. Bj�rndal ◽  
S. J. Dencker ◽  
L. Lundin ◽  
...  

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S056-S057
Author(s):  
C Chen ◽  
M Rosario ◽  
D Polhamus ◽  
N Dirks ◽  
W Zhang ◽  
...  

Abstract Background The exposure–efficacy relationship and immunogenicity rates of the new vedolizumab subcutaneous (SC) formulation have been established for maintenance treatment of ulcerative colitis (UC).1 Here, we report vedolizumab SC exposure–efficacy and immunogenicity in Crohn’s disease (CD). Methods VISIBLE 2 (NCT02611817; EudraCT 2015-000481-58) was a pivotal, phase 3, randomised, double-blind, placebo-controlled trial evaluating the efficacy and safety of vedolizumab SC (108 mg every 2 weeks) as maintenance treatment in patients with moderately to severely active CD. Following intravenous (IV) vedolizumab (300 mg Week 0 and 2) induction, patients with a clinical response at Week 6 (≥70-point decrease in CD activity index [CDAI] from Week 0) were randomised to blinded maintenance treatment and included in the analyses. Vedolizumab serum concentrations were measured prior to dosing using an enzyme-linked immunosorbent assay. Immunogenicity was assessed with a drug-tolerant electrochemiluminescence assay. Predicted vedolizumab trough concentrations at Week 52 were grouped by quartiles (Q), and Week 52 efficacy outcome rates calculated for each Q. Missing efficacy outcome data were imputed as failures. Efficacy outcomes were clinical remission (CDAI ≤150) and enhanced clinical response (≥100-point decrease in CDAI from Week 0 at Week 52). Results Following vedolizumab IV induction (N = 644), patients with a clinical response were randomised and received vedolizumab SC (N = 275) or placebo (N = 134) as maintenance treatment. At Week 52, patients on vedolizumab SC maintenance had a positive exposure–efficacy relationship for clinical remission (Q1: 37.7%; Q4: 50.7%) and enhanced clinical response (Q1: 37.7%; Q4: 53.6%; Figures 1 and 2). Overall, 7/275 (2.5%) patients on vedolizumab SC (following vedolizumab IV induction) developed anti-vedolizumab antibodies (AVAs): 3/7 patients were persistently AVA positive and 4/7 had neutralising antibodies. Five of 7 AVA-positive patients on vedolizumab SC did not achieve clinical remission and enhanced clinical response at Week 52; 2 of those patients were persistently AVA-positive. Immunogenicity was not associated with injection-site reactions or hypersensitivity reactions. Conclusion These preliminary results suggest a trend for higher vedolizumab SC serum concentrations with greater efficacy in CD, but the association was less pronounced than was reported in UC. (1) The AVA rate was similar to what was observed in prior vedolizumab IV studies. (2) In this study, vedolizumab immunogenicity appeared to be associated with clinical outcome. References


Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2724-2724
Author(s):  
Michael A Fridrik ◽  
Richard Greil ◽  
Georg Hopfinger ◽  
Christine Mannhalter ◽  
Wilhelm Oberaigner ◽  
...  

Abstract Abstract 2724 Poster Board II-700 Introduction: Rituximab in combination with chemotherapy achieves the best result in follicular lymphoma. Only limited data are available with rituximab as maintenance in first line setting. Materials and methods: We conducted a prospective multicenter trial in patients with previously untreated follicular lymphoma stage III or IV, which required therapy. Primary endpoint was conversion of BCL2/IgH PCR positivity to negativity. BCL2/IgH was centrally measured by a two-step qualitative PCR in peripheral blood and bone marrow before and after induction therapy, after maintenance treatment and yearly thereafter. Induction therapy (R-FM) consisted of 6 cycles of rituximab 375 mg/qm i.v. day 1, mitoxantrone 10 mg/qm i.v. day 1, fludarabine 25 mg/qm i.v. days 2-4 recyling every 28 days for 6 cycles. I.v. Fludarabine could be substituted by 30 mg/qm p.o. days 2-4 at the discretion of the investigator. Patients not progressing during induction therapy received maintenance rituximab 375 mg/qm every 8 weeks for 12 doses. Results: Twenty-seven patients were entered in the study. Median age was 55 years, (range 32-73 years). Rituximab serum concentrations were measured before and after rituximab infusion during induction and maintenance. Mean rituximab trough serum concentrations before maintenance cylce 1, 2, 4, and 6 were 46, 32, 38, and 37 ng/ml, respectively. Induction R-FM resulted in 16 (59.3%) complete (CR) and 11 (40.7%) partial remissions (PR). During maintenance rituximab 3 patients with PR converted to CR and another 2 progressed. After a median observation period of 33 months 3 year event free and overall survival are 79% (95% CI: .5322; .9168) and 86% (95% CI: .6355; .9544), respectively. In all 19 patients in whom samples were available after the end of R-FM induction BCL2/IgH was negative. During rituximab maintenance therapy 2 of 12 samples became positive for BCL2/IgH. One at relapse on maintenance and the other after completion of maintenance still in clinical CR. Conclusion: With R-FM a high rate of stable remissions can be achieved. Rituximab through serum concentrations were within an effective range. All analyzed BCL2/IgH samples where negative already after induction with R-FM, even though the quality of the remission was improving in some patients during maintenance treatment. The additional effect of rituximab maintenance in first remission remains unclear. The results of randomized trials will elucidate the role of rituximab maintenance treatment in first remission of follicular lymphoma. Disclosures: Fridrik: Bayer: Honoraria, Speakers Bureau; Roche Austria: Honoraria, Research Funding, Speakers Bureau. Off Label Use: Rituximab maintenance in first remission of follicular lymphoma. Greil:Roche: Honoraria, Research Funding. Hopfinger:Roche: Speakers Bureau; Mundipharm: Speakers Bureau. Jaeger:Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Travel grants.


2007 ◽  
Vol 20 (3) ◽  
pp. 647-650 ◽  
Author(s):  
N. Cassano ◽  
A. Puglisi Guerra ◽  
C. Malara ◽  
F. Loconsole ◽  
A. Galluccio ◽  
...  

Infliximab is an anti-tumour necrosis factor-alpha chimeric monoclonal antibody which is highly effective in psoriasis, as well as in other indications. In clinical practice, some patients may require dose escalation to overcome a reduction of the extent and/or duration of response during regular maintenance treatment, possibly due to the loss of stable serum concentrations of the drug. Common strategies of dose escalation are the increase of dose per infusion and the decrease of interval between infusions. Here we report the results of re-induction therapy with infliximab used as a dose escalation strategy in 9 patients whose psoriasis relapsed during maintenance treatment with infliximab 5 mg/kg every 8 weeks. Re-induction was well tolerated and capable of restoring response in 8 of these patients.


2016 ◽  
Vol 267 (1) ◽  
pp. 33-40 ◽  
Author(s):  
Rilana Schuster ◽  
Alexandra Kleimann ◽  
Marie-Kathrin Rehme ◽  
Leonie Taschner ◽  
Alexander Glahn ◽  
...  

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S590-S590
Author(s):  
M Carrillo Palau ◽  
I Alonso-Abreu ◽  
L Ramos-Lopez ◽  
G N Fernando ◽  
N Hernandez Alvarez-Buylla ◽  
...  

Abstract Background Anti-TNF drugs are effective treatments for the management of inflammatory bowel disease (IBD) but treatment failure is common. The aim of this study was to investigate the association between inflammatory biomarkers, serum concentrations of IFX and antiIFX antibody concentration during induction and maintenance treatment and to investigate the association with disease activity and response to treatment in our patients from 2017 to 2019. Methods Retrospective observational study. We enrolled patients receiving IFX from March 2017 until March 2019. Demographic data, disease characteristics, previous medical treatments and surgeries were recorded. Clinical Activity Index (Harvey Index and Parcial Mayo Score) and CRP, faecal calprotectine (FC) and endoscopy or radiological activity were recorded at baseline, and at 6, 12 and 24 months of treatment. IFX serum concentrations and anti-IFX antibody concentration were measured at the end of induction (week 8) and during follow-up (6, 12 and 24 months). Results One hundred and eighty-one IBD patients were treated during the study period, and 175 patients were included: 128 (73.1%) Crohn’s disease (CD), 46 (26.3%) ulcerative colitis (UC) and 1 (0.6%) indeterminated colitis (IC). 95 male, 85 female, mean age 45 years (±15); 93% were naive to IFX. 73.6% started IFX combined with inmunomodulator treatment. At week 0, 80% had an active disease (Global Physician Assessment), 58.8% had CRP >5 μg/dl and 62% had FC > 150 mg/kg. At 12 months, 126 patients continued under IFX, and 68% had an stable disease and 44% were intensified. Thirty-six per cent had CRP > 5 μg/dl and 37% FC>150 mg/kg. At 24 months, 90 patients continued with IFX, from which 80% were stable and 43% were intensified.38% had CRP >5 μg/dl and 26% FC >150 mg/kg. Patients with post-induction (week 8) serum IFX concentration >7 μg/ml had more stable disease (p: 0.04) at that moment and IFX serum concentration > 3 μg/ml at 18 months was corelationated with no inflammation at endoscopy or radiology (p: 0.025). In the multivariate analysis stenosant phenotype and CRP < 5 mg/dl at 6 months were relationated with early stop of IFX treatment (<1 year). Conclusion Our study shows that IFX levels >7 μg/ml correlates with a better clinical response. Disease phenotype and inflammatory parameters could influence in long time maintenance treatment. Drug-level monitoring and measurement of baseline inflammatory parameters may improve the management of IBD.


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