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adalimumab serum

Spyridon Gkalpakiotis, Monika Arenbergerova, Petra Gkalpakioti, Jana Potockova, Petr Arenberger, Pavel Kraml
Psoriasis is a chronic systemic immune-mediated inflammatory dermatosis associated with several comorbidities. Psoriasis patients are at increased risk of developing cardiovascular diseases (CVD), namely, coronary heart disease, stroke or peripheral vascular disease, and psoriasis seems to be an independent cardiovascular risk factor. Antipsoriatic systemic therapy, especially anti-tumor necrosis factor (TNF)-α, seems to exert a beneficial effect on these comorbidities. The purpose of this study was: (i) to measure the level of cardiovascular serum markers in psoriasis patients in comparison with healthy volunteers; and (ii) to compare the serum level of the same markers in patients before and 3 months after adalimumab therapy...
October 24, 2016: Journal of Dermatology
Miguel Cordero-Coma, Sara Calleja-Antolín, Irene Garzo-García, Ana M Nuñez-Garnés, Carolina Álvarez-Castro, Manuel Franco-Benito, Jose G Ruiz de Morales
PURPOSE: To evaluate the rate of immunogenicity induced by adalimumab and its relationship with drug serum levels and clinical responses in patients with noninfectious uveitis. DESIGN: Prospective observational study. PARTICIPANTS: Consecutive patients from 1 referral center who initiated treatment with adalimumab for active noninfectious uveitis resistant to conventional therapy. METHODS: All patients received 40 mg adalimumab every other week...
September 27, 2016: Ophthalmology
Maria Sole Chimenti, Paola Triggianese, Alessandra Narcisi, Barbara Marinari, Miriam Teoli, Sara Faleri, Annalisa Arcese, Roberto Perricone, Antonio Costanzo
OBJECTIVES: An observational study to evaluate the relationship between serum concentrations of adalimumab and disease activity in patients receiving long-term adalimumab treatment for psoriatic arthritis. METHODS: Serum adalimumab and adalimumab antidrug antibodies were quantified by enzyme linked immunosorbent assay. Disease activity was assessed using Disease Activity Score (44 joint measures). Serum C-reactive protein was quantified using standard methods. RESULTS: A total of 30 patients were recruited...
September 2016: Journal of International Medical Research
S Krabbe, R Bolce, C H Brahe, U M Døhn, B J Ejbjerg, M L Hetland, E H Sasso, D Chernoff, M S Hansen, L S Knudsen, A Hansen, O R Madsen, M Hasselquist, J Møller, M Østergaard
OBJECTIVES: To investigate the multi-biomarker disease activity (MBDA) score by comparison with imaging findings in an investigator-initiated rheumatoid arthritis (RA) trial (HURRAH trial, NCT00696059). METHOD: Fifty-two patients with established RA initiated adalimumab treatment and had magnetic resonance imaging (MRI), ultrasonography (US), computed tomography (CT), and radiography performed at weeks 0, 26, and 52. Serum samples were analysed using MBDA score assays and associations between clinical measures, MBDA score, and imaging findings were investigated...
September 28, 2016: Scandinavian Journal of Rheumatology
Qiang Wu, Yunxin Wang, Qiuying Wang, Dan Yu, Yuyang Wang, Liying Song, Zhihang Liu, Xianlong Ye, Pengfei Xu, Hongxue Cao, Deshan Li, Guiping Ren
Rheumatoid arthritis (RA) is a chronic, systemic and autoimmune disease with overexpression inflammation cytokines. The biological therapy targeting these inflammatory cytokines has been applied for the clinic. Drugs aimed at a single target are ineffective in some patients with RA. However, double-target and multi-target drugs have huge advantages in therapy. Interleukin-1β (IL-1β) and Interleukin-17A (IL-17A) are the keys to inflammatory factors in RA. The bispecific antibody(BsAb)against both human IL-1β and human IL-17A was formed and expressed in E...
September 8, 2016: Immunology Letters
Bart V J Cuppen, Marzia Rossato, Ruth D E Fritsch-Stork, Arno N Concepcion, Yolande Schenk, Johannes W J Bijlsma, Timothy R D J Radstake, Floris P J G Lafeber
BACKGROUND: In rheumatoid arthritis, prediction of response to TNF-alpha inhibitor (TNFi) treatment would be of clinical value. This study aims to discover miRNAs that predict response and aims to replicate results of two previous studies addressing this topic. METHODS: From the observational BiOCURA cohort, 40 adalimumab- (ADA) and 40 etanercept- (ETN) treated patients were selected to enter the discovery cohort and baseline serum profiling on 758 miRNAs was performed...
2016: Arthritis Research & Therapy
N M Mostafa, A M Nader, P Noertersheuser, M Okun, W M Awni
BACKGROUND: Adalimumab is a tumour necrosis factor-alpha antibody approved for treatment of moderate to severe chronic plaque psoriasis. OBJECTIVE: To characterise population pharmacokinetics of adalimumab 40 mg every other week dosing regimen and impact of immunogenicity on pharmacokinetics, efficacy and safety in psoriasis patients. METHODS: Patients were enrolled in a Phase 3 study comprising a 16-week double-blind, placebo-controlled period, a 17-week open-label period for Week 16 Psoriasis Area and Severity Index (PASI) 75 responders, and a 19-week double-blind, placebo-controlled period for Week 33 PASI 75 responders...
August 22, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
Takashi K Kishimoto, Joseph D Ferrari, Robert A LaMothe, Pallavi N Kolte, Aaron P Griset, Conlin O'Neil, Victor Chan, Erica Browning, Aditi Chalishazar, William Kuhlman, Fen-Ni Fu, Nelly Viseux, David H Altreuter, Lloyd Johnston, Roberto A Maldonado
The development of antidrug antibodies (ADAs) is a common cause for the failure of biotherapeutic treatments and adverse hypersensitivity reactions. Here we demonstrate that poly(lactic-co-glycolic acid) (PLGA) nanoparticles carrying rapamycin, but not free rapamycin, are capable of inducing durable immunological tolerance to co-administered proteins that is characterized by the induction of tolerogenic dendritic cells, an increase in regulatory T cells, a reduction in B cell activation and germinal centre formation, and the inhibition of antigen-specific hypersensitivity reactions...
October 2016: Nature Nanotechnology
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
Primal Kaur, Vincent Chow, Nan Zhang, Michael Moxness, Arunan Kaliyaperumal, Richard Markus
OBJECTIVE: To demonstrate pharmacokinetic (PK) similarity of biosimilar candidate ABP 501 relative to adalimumab reference product from the USA and European Union (EU) and evaluate safety, tolerability and immunogenicity of ABP 501. METHODS: Randomised, single-blind, single-dose, three-arm, parallel-group study; healthy subjects were randomised to receive ABP 501 (n=67), adalimumab (USA) (n=69) or adalimumab (EU) (n=67) 40 mg subcutaneously. Primary end points were area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) and the maximum observed concentration (Cmax)...
July 27, 2016: Annals of the Rheumatic Diseases
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
Ioana Mărgineanu, Radu Crişan, Traian Mihăescu
After the introduction of anti-TNFα medication for treatment of autoimmune conditions, clinicians have investigated not only other possible uses for the drugs, but also less common side-effects and interactions with other pathologies. Despite some succes registered with Adalimumab as an antiinflammatory agent in severe asthma, there have been case reports of patients developing asthma or asthma-like symptoms following anti-TNFα therapy. The case presents a patient without previous family or personal history of respiratory or atopic conditions that developed bronchospasm immediately after the initiation of Adalimumab and Methotrexate treatment for rheumatoid arthritis...
October 2015: Pneumologia: Revista Societății Române de Pneumologie
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
Haydar Celik, Mete Karatay, Yavuz Erdem, Ali Erdem Yildirim, Idris Sertbas, Eylem Karatay, Halil Kul, Yahya Guvenc, Ismet Koksal, Guner Menekse, Fatih Alagoz, Huseyin Hayri Kertmen, Muzaffer Caydere
AIM: To evaluate the neuroprotective effects of adalimumab in an experimental spinal cord injury model and compare them with those of the widely-used methylprednisolone. MATERIAL AND METHODS: Forty male Wistar rats were divided into 5 as the sham, trauma, adalimumab, methylprednisolone, and adalimumab+methylprednisolone groups. Only laminectomy was performed in the sham group. Laminectomy and trauma was performed to the trauma group but no treatment was given. A single dose of 40 mg/kg subcutaneous adalimumab was administered after the laminectomy and trauma to group 3...
2016: Turkish Neurosurgery
José Inciarte-Mundo, Julio Ramirez, Maria Victoria Hernández, Virginia Ruiz-Esquide, Andrea Cuervo, Sonia Raquel Cabrera-Villalba, Mariona Pascal, Jordi Yagüe, Juan D Cañete, Raimon Sanmarti
BACKGROUND: Serum levels of calprotectin, a major S100 leucocyte protein, are associated with disease activity in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients. Higher drug trough serum levels are associated with good response in patients treated with tumour necrosis factor inhibitors (TNFi). Power Doppler ultrasound (PDUS) synovitis is predictive of flare and progression of structural damage in patients in clinical remission. The purpose of this study was to analyse the accuracy of calprotectin and TNFi trough serum levels in detecting PDUS synovitis in RA and PsA patients in clinical remission or with low disease activity who were receiving TNFi...
July 8, 2016: Arthritis Research & Therapy
José L Hernández, Raquel López-Mejías, Ricardo Blanco, Trinitario Pina, Sheila Ruiz, Isabel Sierra, Begoña Ubilla, Verónica Mijares, Marcos A González-López, Susana Armesto, Alfonso Corrales, Enar Pons, Patricia Fuentevilla, Carmen González-Vela, Miguel Á González-Gay
Studies on trabecular bone score (TBS) in psoriasis are lacking. We aim to assess the association between TBS and inflammation, metabolic syndrome features, and serum adipokines in 29 nondiabetic patients with psoriasis without arthritis, before and after 6-month adalimumab therapy. For that purpose, adjusted partial correlations and stepwise multivariable linear regression analysis were performed. No correlation was found between TBS and disease severity. TBS was negatively associated with weight, BMI, waist perimeter, fat percentage, and systolic and diastolic blood pressure before and after adalimumab...
2016: Journal of Osteoporosis
Elizabeth Hyland, Tim Mant, Pantelis Vlachos, Neil Attkins, Martin Ullmann, Sanjeev Roy, Volker Wagner
AIMS: The aim of the study was to compare the pharmacokinetics (PK), safety and tolerability of the proposed adalimumab biosimilar MSB11022 (Merck) with Humira(®) (AbbVie), sourced from both the US (US reference product [US-RP]) and Europe (European reference medicinal product [EU-RMP]). METHODS: In this phase 1 double-blind, parallel group trial (EMR200588-001), 213 healthy volunteers were randomized 1 : 1 : 1 to receive a single dose (40 mg) of MSB11022, US-RP or EU-RMP in order to achieve 80% power assuming a 5% difference among groups and a 10% dropout rate...
October 2016: British Journal of Clinical Pharmacology
Mohamed G Elsakkar, Olla A Sharaki, Dina M Abdallah, Dalia K Mostafa, Fadia T Shekondali
Asthma is a chronic inflammatory heterogeneous disorder initiated by a dysregulated immune response which drives disease development in susceptible individuals. Though T helper 2 (TH2) biased responses are usually linked to eosinophilic asthma, other Th cell subsets induce neutrophilic airway inflammation which provokes the most severe asthmatic phenotypes. A growing evidence highlights the role of T regulatory (Treg) cells in damping abnormal Th responses and thus inhibiting allergy and asthma. Therefore, strategies to induce or augment Treg cells hold promise for treatment and prevention of allergic airway inflammation...
September 5, 2016: European Journal of Pharmacology
Giorgia Bodini, Edoardo G Giannini, Vincenzo Savarino, Lorenzo Del Nero, Gaia Pellegatta, Costanza De Maria, Isabella Baldissarro, Edoardo Savarino
OBJECTIVE: Few data are available on the relevance of adalimumab (ADA) trough serum levels and anti-ADA antibodies (AAA) during long-term follow-up of patients with Crohn's Disease (CD), and their association with disease outcome. In this study, our aim was to assess ADA trough serum levels and the presence of AAA according to disease activity and clinical response during long-term follow-up in a series of patients with CD treated with ADA monotherapy. MATERIAL AND METHODS: We prospectively evaluated 23 consecutive, infliximab-naïve CD patients who achieved clinical remission/response after induction and were in maintenance treatment with ADA, and who were followed-up for at least 72 weeks...
September 2016: Scandinavian Journal of Gastroenterology
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