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infliximab serum

Canna Ghia, Shashank Akerkar, Shailaja Sabnis, Urk Rao, Gautam Rambhad
BACKGROUND / OBJECTIVES: Biologic anti-TNFs in India have improved the patient management. Significant proportions of patients lose response over time or do not respond. Possible explanations are suboptimal trough anti-TNFa concentrations or antibodies to anti-TNFs. The aim of this project was to set up and standardize an independent laboratory to test immunogenicity of anti-TNF biologics (infliximab and etanercept). METHODS: Three rheumatologists piloted this project approved by independent ethics committee and carried out in compliance with ICH/GCP guidelines...
September 2016: Journal of the Association of Physicians of India
Satoko Hayashi, Katsuya Suzuki, Keiko Yoshimoto, Masaru Takeshita, Takahiko Kurasawa, Kunihiro Yamaoka, Tsutomu Takeuchi
INTRODUCTION: Early prognostic factors for the clinical response in patients with rheumatoid arthritis (RA) after 1 year of treatment with infliximab (IFX) as part of routine clinical practice were investigated. METHODS: Thirty-five patients with RA with an inadequate response to methotrexate were enrolled and administered IFX (3-9 mg/kg, every 4-8 weeks). Serum trough levels of IFX and levels of 9 cytokines were measured at baseline and at 3, 6 months, and 1 year...
June 2016: Rheumatol Ther
Marla C Dubinsky, Becky L Phan, Namita Singh, Shervin Rabizadeh, Diane R Mould
Standard of care (SOC; combination of 5-10 mg/kg and an interval every 6-8 weeks) dosing of infliximab (IFX) is associated with significant loss of response. Dashboards using covariates that influence IFX pharmacokinetics (PK) may be a more precise way of optimizing anti-TNF dosing. We tested a prototype dashboard to compare forecasted dosing regimens with actual administered regimens and SOC. Fifty IBD patients completing IFX induction were monitored during maintenance (weeks 14-54). Clinical and laboratory data were collected at each infusion; serum was analyzed for IFX concentrations and anti-drug antibodies (ADA) at weeks 14 and 54 (Prometheus Labs, San Diego)...
October 13, 2016: AAPS Journal
Yana Davidov, Bella Ungar, Haggai Bar Yoseph, Dan Carter, Ola Haj-Natour, Miri Yavzori, Yehuda Chowers, Rami Eliakim, Shomron BenHorin, Uri Kopylov
BACKGROUND: The association of infliximab (IFX) trough levels with clinical and endoscopic outcomes in inflammatory bowel disease is well established. However there is scarce data regarding the association of perianal fistula response with IFX. The aim of the study was to establish whether early induction infliximab levels and anti-infliximab antibodies (ATI) are associated with perianal fistula response. METHODS: Consecutive CD patients with perianal fistulae that were treated with IFX between 2008 and 2016 were included in the study...
October 4, 2016: Journal of Crohn's & Colitis
B Hernández-Breijo, M Chaparro, D Cano-Martínez, I Guerra, M Iborra, J L Cabriada, L Bujanda, C Taxonera, V García-Sánchez, I Marín-Jiménez, M Barreiro-de Acosta, I Vera, M D Martín-Arranz, F Mesonero, L Sempere, F Gomollón, J Hinojosa, J P Gisbert, L G Guijarro
BACKGROUND: The availability of a quantitative method to measure anti-infliximab (IFX) antibodies (ATI) would facilitate the implementation of therapeutic drug monitoring in clinical decision-making. Our aim was to standardize the homogeneous mobility shift assay (HMSA) used in the measure of ATI levels. METHODS: In this prospective longitudinal multicenter study, 50 IFX-treated Crohn's disease (CD) patients were followed up for 54weeks. During this period 360 human serum samples were analysed...
September 21, 2016: Biochemical Pharmacology
Yolanda Braun-Moscovici, Marius Braun, Tarek Saadi, Doron Markovits, Menahem A Nahir, Alexandra Balbir-Gurman
BACKGROUND: Immunosuppressive agents may induce hepatitis B flares. The minimal corticosteroid dose and duration of therapy leading to HBV reactivation is unknown. OBJECTIVE: To assess whether short-term corticosteroid therapy for rheumatologic diseases induces HBV reactivation. METHODS: The records of all HBsAg or HBcore antibodies positive, anti-HBs negative patients who were hospitalized in the rheumatology department during 2001-2014 and treated with corticosteroids were reviewed...
October 2016: Journal of Clinical Rheumatology: Practical Reports on Rheumatic & Musculoskeletal Diseases
Yuki Ishikawa, Takao Fujii, Seiko Kondo Ishikawa, Naoichiro Yukawa, Motomu Hashimoto, Moritoshi Furu, Hiromu Ito, Koichiro Ohmura, Tsuneyo Mimori
Besides anti-drug antibodies, anti-nuclear antibodies and anti-DNA antibodies are often induced in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors. We examined the association between immunogenicity, autoantibody production, and serum cytokine profiles in patients with rheumatoid arthritis treated with infliximab. Japanese patients with rheumatoid arthritis (n = 57) were retrospectively examined. Serum trough levels of infliximab, anti-drug antibody, anti-nuclear antibody, and anti-DNA (Farr), anti-single-stranded DNA and anti-double-stranded DNA antibodies were measured...
2016: PloS One
Christopher R Heier, Alyson A Fiorillo, Ellen Chaisson, Heather Gordish-Dressman, Yetrib Hathout, Jesse M Damsker, Eric P Hoffman, Laurie S Conklin
OBJECTIVE: Serum biomarkers may serve to predict early response to therapy, identify relapse, and facilitate drug development in inflammatory bowel disease (IBD). Biomarkers are particularly important in children, in whom achieving early remission and minimizing procedures are especially beneficial. METHODS: We profiled protein and micro RNA (miRNA) in serum from patients pre- and post-therapy, to identify molecular markers of pharmacodynamic effect. Serum was obtained from children with IBD before and after treatment with either corticosteroids (prednisone; n=12) or anti-tumor necrosis factor-α biologic (infliximab; n=7)...
2016: Clinical and Translational Gastroenterology
Eran Zittan, Raquel Milgrom, Grace W Ma, Nathalie Wong-Chong, Brenda OʼConnor, Robin S McLeod, Helen M MacRae, Gordon R Greenberg, Geoffrey C Nguyen, Kenneth Croitoru, A Hillary Steinhart, Zane Cohen, Mark S Silverberg
BACKGROUND: There are conflicting data regarding the effect of previous exposure to anti-tumor necrosis factor (anti-TNF) therapy on complication rates after pelvic pouch surgery for patients with ulcerative colitis (UC). In particular, there is concern surrounding the rates of pouch leaks and infectious complications, including pelvic abscesses, in anti-TNF-treated subjects who require ileal pouch-anal anastomosis (IPAA) surgery. METHODS: A retrospective study was performed in UC subjects who underwent IPAA between 2002 and 2013...
October 2016: Inflammatory Bowel Diseases
Joseph C Marini, Jocelyn Sendecki, Freddy Cornillie, John W Popp, Shawn Black, Marion Blank, Ann Gils, Thomas Van Stappen, Dörte Hamann, Theo Rispens, Lina Thérien, Kelly Chun, Gopi Shankar
Monitoring infliximab (IFX) concentrations and antibodies-to-IFX (ATI) titers during inflammatory bowel disease treatment may allow more informed decisions in assessing exposure/response and determining appropriate dosing. To aid in interpreting results from different commercial tests in the context of Janssen's published Remicade® results, the reliability of Janssen's IFX and ATI assays was compared with commercial assays from KU Leuven, Sanquin, Dynacare, and LabCorp. Test results were independently reported to Janssen...
September 6, 2016: AAPS Journal
Pieter Hindryckx, Vipul Jairath, Geert D'Haens
Ulcerative colitis is a common chronic inflammatory disease of the colon and rectum, resulting from a dysregulated immune response towards intraluminal antigens in a genetically predisposed host. The disease has a varying extent and severity. Approximately 20% of patients with ulcerative colitis experience a severe flare during the course of their disease, requiring hospitalization. Acute severe ulcerative colitis (ASUC) is potentially a life-threatening condition that requires early recognition, hospitalization, correction of body fluids and electrolytes, and nutritional support if needed...
September 1, 2016: Nature Reviews. Gastroenterology & Hepatology
Monique Wei Meng Lee, Susan Connor, Watson Ng, Catherine Mei-Ling Toong
The monitoring of infliximab drug levels aids in the management of several autoimmune diseases, notably inflammatory bowel disease. Several commercial kits are now available and approved by the Therapeutic Goods Administration (TGA) for the measurement of infliximab levels, but there have been limited verification or comparison studies to date. Finding an assay that most accurately measures infliximab is essential for optimal drug titration and patient management. We performed this study to compare the performance of the Grifols Promonitor, Theradiag Lisatracker and R-Biopharm Ridascreen enzyme linked immunosorbent assay (ELISA) kits...
October 2016: Pathology
Sundaram G Veerappan, Martin Healy, Bernard Walsh, Colm A O'Morain, Jacqueline S Daly, Barbara M Ryan
OBJECTIVES: Infliximab (IFX) treatment has shown potentially beneficial effects on bone metabolism in inflammatory bowel disease (IBD) patients. We aimed to prospectively evaluate the impact of IFX treatment on bone metabolism in antitumour necrosis factor (TNF)-α-naive IBD patients using established bone metabolism markers and an in-vitro osteoblast model. MATERIALS AND METHODS: A total of 37 anti-TNFα-naive IBD patients and 20 healthy controls were included...
November 2016: European Journal of Gastroenterology & Hepatology
J Afonso, S Lopes, R Gonçalves, P Caldeira, P Lago, H Tavares de Sousa, J Ramos, A R Gonçalves, P Ministro, I Rosa, A I Vieira, C C Dias, F Magro
BACKGROUND: Therapeutic drug monitoring is a powerful strategy known to improve the clinical outcomes and to optimise the healthcare resources in the treatment of autoimmune diseases. Currently, most of the methods commercially available for the quantification of infliximab (IFX) are ELISA-based, with a turnaround time of approximately 8 h, and delaying the target dosage adjustment to the following infusion. AIM: To validate the first point-of-care IFX quantification device available in the market - the Quantum Blue Infliximab assay (Buhlmann, Schonenbuch, Switzerland) - by comparing it with two well-established methods...
October 2016: Alimentary Pharmacology & Therapeutics
Piotr Eder, Katarzyna Korybalska, Liliana Łykowska-Szuber, Kamila Stawczyk-Eder, Iwona Krela-Kaźmierczak, Joanna Łuczak, Natasza Czepulis, Krzysztof Linke, Janusz Witowski
BACKGROUND: Soluble tumour necrosis factor-α (sTNF-α) has been reported to increase in the course of anti-TNF-α therapy for rheumatoid and skin diseases. AIMS: To assess changes in sTNF-α and clinical efficacy of anti-TNF-α agents in Crohn's disease (CD). METHODS: Sixty-four patients on infliximab or adalimumab were analyzed. Clinical outcomes were assessed by using CD Activity Index after the induction therapy and at week 52. sTNF-α was measured before and after the induction therapy with high-sensitivity immunoassay...
October 2016: Digestive and Liver Disease
Wilhelmina M C Timmermans, Jan A M van Laar, Tim B van der Houwen, Lieke S J Kamphuis, Sophinus J W Bartol, King H Lam, Rob J Ouwendijk, Miles P Sparrow, Peter R Gibson, P Martin van Hagen, Menno C van Zelm
BACKGROUND: B-cell depletion can improve a variety of chronic inflammatory diseases, but does not appear beneficial for patients with Crohn's disease. OBJECTIVE: To elucidate the involvement of B cells in Crohn's disease, we here performed an 'in depth' analysis of intestinal and blood B-cells in this chronic inflammatory disease. METHODS: Patients with Crohn's disease were recruited to study B-cell infiltrates in intestinal biopsies (n = 5), serum immunoglobulin levels and the phenotype and molecular characteristics of blood B-cell subsets (n = 21)...
2016: PloS One
Tsutomu Mizoshita, Satoshi Tanida, Keiji Ozeki, Takahito Katano, Takaya Shimura, Yoshinori Mori, Eiji Kubota, Hiromi Kataoka, Takeshi Kamiya, Takashi Joh
There is little evidence regarding the maintenance of long-term clinical remission by adalimumab (ADA) therapy in Crohn's disease (CD) patients naïve to anti-tumor necrosis factor treatment (naïve CD patients), since most CD patients are treated with ADA after infliximab (IFX) therapy. The long-term clinical response to ADA was retrospectively analyzed in 17 naïve CD patients for at least 24 months, and the serum trough IFX levels were evaluated in patients switching from ADA to IFX. Of the 17 naïve CD patients, 14 (82...
May 2016: Case Reports in Gastroenterology
Kornelius Schulze, Nadine Koppka, Frederik Lutter, Gunnar Brandhorst, Stefan Schreiber, Ulf Helwig
The approval of infliximab biosimilars Remsima™ and Inflectra™ (CT-P13) for patients with inflammatory bowel disease (IBD) is a promising step to reduce treatment costs. Since monitoring of Remicade™ serum trough levels and anti-Remicade™ immunogenicity hold an important significance in treatment modalities, no data about monitoring of drug serum trough levels or anti-drug antibody levels in IBD patients treated with Remsima™ or Inflectra™ are present to date. Therefore, in this study we applied a Remicade™-validated ELISA to determine drug serum levels of Remsima™ or Inflectra™...
September 2016: Biologicals: Journal of the International Association of Biological Standardization
Masahito Koiwa, Susumu Goto, Kenji Takahashi, Toshikazu Kamada, Shinro Takai, Hiroshi Nakamura
BACKGROUND: Disease activity of rheumatoid arthritis (RA) is evaluated by composite measures, such as Disease Activity Score (DAS). Recently, much attention has been paid to a neutrophil-lymphocyte (N/L) ratio to evaluate the prognosis and the efficacy of intervention in various diseases. To determine whether the N/L ratio is a prognostic marker or a surrogate marker of response to biologics, this study investigated the N/L ratio in RA patients treated with biological agents. METHODS: The medical records were reviewed of 358 patients with RA in routine care who were treated with infliximab (144 patients), etanercept (120 patients), adalimumab (25 patients), tocilizumab (41 patients), or abatacept (28 patients)...
2016: Journal of Nippon Medical School, Nippon Ika Daigaku Zasshi
Konstantinos Papamichael, Filip Baert, Sophie Tops, Gert Van Assche, Paul Rutgeerts, Severine Vermeire, Ann Gils, Marc Ferrante
BACKGROUND AND AIMS: Mucosal healing is associated with favourable therapeutic outcomes in patients with ulcerative colitis [UC]. We investigated whether adalimumab concentrations during induction therapy are associated with short-term mucosal healing [STMH] in UC patients. METHODS: This was a retrospective, single-centre study including consecutive UC patients treated with adalimumab from June 2005 to May 2014, who underwent an endoscopy both at baseline and after induction therapy [weeks 8-14] and at least one serum sample available at week 2 and/or week 4...
July 11, 2016: Journal of Crohn's & Colitis
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