Farmaci Biologici: gamma completa

Farmaci Biologici: gamma completa

TNF alpha (Infliximab-Remicade®, Infliximab-Remsima®, Adalimumab-Humira®, Etanercept-Enbrel®, Golimumab-Simponi®), Abatacept (Orencia®), Avelumab (Bavencio®), Atezolizumab (Tecentriq®), Aflibercept (Eylea®), Bevacizumab (Avastin®), Canakinumab (Ilaris®), Certolizumab (Cimzia®), Cetuximab (Erbitux®), Daratumumab (Darzalex®), Denosumab (Prolia®), Durvalumab (Imfinzi®), Filgrastim (Accofil®, Granulokine®, Nivestim®), Ipilimumab (Yervoy®), Omalizumab (Xolair®), Natalizumab (Tysabri®), Nivolumab (Opdivo®), Pembrolizumab (Keytruda®), Ramucirumab (Cyramza®), Ranibizumab (Lucentis®), Rituximab (Rituxan®, Mabthera®), Trastuzumab (Herceptin®, Herclon®), Tocilizumab (Actemra®), Ustekinumab (Stelara®), Vedolizumab (Entyvio®) e anti HAHA e anti HAMA.

Li StarFish propone una serie di kit per il dosaggio dei farmaci biologici utilizzati principalmente nella cura delle patologie reumatologiche, psoriasi, patologie infiammatorie e gastrointestinali (morbo di Crohn), oncologia, etc.

Inoltre questi test permettono di valutare gli anticorpi preesistenti o indotti dall’utilizzo dei farmaci biologici in terapia che possono alterare l’efficacia terapeutica.

 

TNF ALPHA

Determinazione quantitativa dei TNF blocker, Anti-TNF blocker (Infliximab-Remicade®, Infliximab-Remsima®, Adalimumab-Humira®, Etanercept-Enbrel®, Golimumab-Simponi®), Human TNFa e TNF receptor II.

INFLIXIMAB:

MAT-INF-FD-REMI Q-INFLIXI Enzyme immunoassay for the quantitative determination of free Infliximab (Remicade®) in serum and plasma CE/IVD

MAT-INF-QNS-REMI Q-ATI Enzyme immunoassay for the quantitative determination of specific antibodies to infliximab in human serum and plasma with confirmation CE/IVD

MAT-INF-QNFT-REMI Q-ATI DUO Enzyme immunoassay for the semi-quantitative determination (screening) of total and free antibodies to infliximab (Remicade®) in serum and plasma CE/IVD

AFI-EL-1611-091 Infliximab (Remicade) Pharmacokinetic ELISA

REMSIMA:

MAT-INF-FD-REMS Q-REMS Enzyme immunoassay for the quantitative determination of free Infliximab (Remsima®) in serum and plasma CE/IVD

MAT-INF-QNS-REMS S-AIR Enzyme immunoassay for the quantitative determination of antibodies to Infliximab Remsima in serum and plasma CE/IVD

MAT-INF-QNT-REMS S-AIR Enzyme immunoassay for the semi-quantitative determination (screening) of total antibodies to Infliximab biosimilar (Remsima®) in serum and plasma CE/IVD

ADALIMUMAB:

MAT-ADA-FD-HUM Q-ADA Enzyme immunoassay for the quantitative determination of free adalimumab (Humira®) in serum and plasma CE/IVD

MAT-ADA-QNS-HUM S-ATA Enzyme immunoassay for the quantitative determination of antibodies to adalimumab (Humira®) in serum and plasma with confirmation CE/IVD

MAT-ADA-QNFT-HUM S-ATA DUO Enzyme immunoassay for the semi-quantitative determination (screening) of total and free antibodies to adalimumab (Humira®) in serum and plasma CE/IVD

AFI-EL-1611-011 Adalimumab (Humira) Pharmacokinetic ELISA

ETANERCEPT:

MAT-ETA-FD-ENB Q-ETA Enzyme immunoassay for the quantitative determination of free Etanercept (Enbrel) in serum and plasma CE/IVD

MAT-ETA-QLS-ENB S-ATE Enzyme immunoassay for the qualitative determination of antibodies to etanercept in serum and plasma CE/IVD

AFI-EL-1611-051 Etanercept (Enbrel) Pharmacokinetic ELISA

GOLIMUMAB-SIMPONI:

MAT-GOL-FD-SIM Q-GOL Enzyme immunoassay for the quantitative determination of free Golimumab (Simponi®) in serum and plasma CE/IVD

MAT-GOL-QLS-SIM S-ATG Enzyme immunoassay for the qualitative determination of antibodies to Golimumab in serum and plasma CE/IVD

ABATACEPT

Abatacept (Orencia®) è un farmaco antinfiammatorio che viene utilizzato in combinazione con metotressato (un altro farmaco che agisce sul sistema immunitario) nel trattamento dell’artrite reumatoide attiva da moderata a grave in pazienti adulti.

MAT-ABA-FD-ORE Shikari® (Q-ABA) Abatacept (Orencia®) Free drug Serum/Plasma ELISA CE/IVD

MAT-ABA-QLS-ORE Shikari® (S-ATAB) Abatacept (Orencia®) Antibody screening – Qualitative Serum/Plasma ELISA CE/IVD

AVELUMAB

Avelumab è un anticorpo monoclonale umano IgG1 diretto contro il ligando del recettore di morte cellulare programmata (Programmed cell Death,PD) PD-L1, ed è prodotto in cellule ovariche di criceto cinese tramite la tecnologia del DNA ricombinante.

E’ indicato in monoterapia per il trattamento di pazienti adulti affetti da carcinoma a cellule di Merkel (Merkel Cell Carcinoma,MCC) metastatico.

MAT-AVE-FD-BAV Q-AVE Enzyme immunoassay for the quantitative determination of specific Avelumab(Bavencio®) in human serum and plasma CE/IVD

MAT-AVE-QLS-BAV S-ATAV Enzyme immunoassay for the qualitative determination of specific anibodies to Avelumab in serum and plasma CE/IVD

ATEZOLIZUMAB

Atezolizumab è un farmaco a base di anticorpi monoclonali usato per trattare il carcinoma uroteliale, il cancro del polmone, il cancro al seno triplo negativo e il carcinoma epatocellulare.

MAT-ATE-FD-TEC  Shikari® (Q-ATE) Atezolizumab (Tecentriq®) Free drug Serum/Plasma ELISA CE/IVD

MAT-ATE-QLS-TEC Shikari® (S-ATAT) Atezolizumab (Tecentriq®) Antibody screening – Qualitative Serum/Plasma ELISA CE/IVD

AFLIBERCEPT

Aflibercept, prodotto mediante tecnologia del DNA ricombinante, si lega in modo specifico ai fattori di crescita dell’endotelio vascolare A e B (VEGF-A e VEGF-B) e al fattore di crescita placentare (PlGF). E’ usato per il trattamento della degenerazione maculare umida e del carcinoma del colon-retto metastatico.

MAT-AFL-FD-EYL Shikari® (Q-AF) Aflibercept (Eylea®) Free drug Serum/Plasma ELISA CE/IVD

MAT-AFL-QLS-EYL Shikari® (S-ATAF) Aflibercept (Eylea®) Antibody screening – Qualitative Serum/Plasma ELISA CE/IVD

BEVACIZUMAB

Il Bevacizumab, in commercio con il nome Avastin, è un farmaco che blocca la crescita di nuovi vasi sanguigni.

È usato per il trattamento di varie forme tumorali, tra cui quelli del colon-retto, del polmone e del rene, e in alcune malattie degli occhi.

MAT-BEV-FD-AVA Q-BEVA Enzyme immunoassay for the quantitative determination of Bevacizumab (Avastin®) in serum and plasma CE/IVD

MAT-BEV-QNS-AVA S-ATB Enzyme immunoassay for the quantitative determination of antibodies to Bevacizumab (Avastin®) in serum and plasma CE/IVD

AFI-EL-1611-021 Bevacizumab (Avastin) Pharmacokinetic ELISA

CANAKINUMAB

Il Canakinumab è un anticorpo monoclonale di tipo umano che è stato studiato per il trattamento di patologie quali artrite reumatoide, artrite idiopatica giovanile sistemica, BPCO, diabete tipo 1 e 2, e alcune malattie oculari.

MAT-CAN-FD-ILA  Shikari® (Q-CAN) Canakinumab (Ilaris®) Free drug Serum/Plasma ELISA CE/IVD

MAT-CAN-QLS-ILA Shikari® (S-ATCAN) Canakinumab (Ilaris®) Antibody screening – Qualitative Serum/Plasma ELISA CE/IVD

CERTOLIZUMAB

Certolizumab pegol è un frammento Fab di un anticorpo ricombinante umanizzato diretto contro il fattore di necrosi tumorale (TNF alfa) coniugato con polietilenglicole (PEG). E’ utilizzato nel trattamento dell’artrite reumatoide (AR). La FDA statunitense ha approvato il farmaco per il trattamento del morbo di Crohn grave.

MAT-CER-FD-CIM Q-CERT Enzyme immunoassay for the quantitative determination of Certolizumab in human serum and plasma CE/IVD

CETUXIMAB

Il Cetuximab, comunemente noto con il nome commerciale di Erbitux®, è indicato per il trattamento di pazienti affetti da carcinoma metastatico del colon-retto con espressione del recettore per il fattore di crescita epidermico (EGFR) e senza mutazioni di RAS (wild- type).

MAT-CET-FD-ERB Q-CET Enzyme immunoassay for the quantitative determination of free Cetuximab (Erbitux®) in serum and plasma CE/IVD

MAT-CET-QNS-ERB S-ATC Enzyme immunoassay for the quantitative determination of antibodies to cetuximab in serum and plasma CE/IVD

AFI-EL-1611-031 Cetuximab (Erbitux) Pharmacokinetic ELISA

DARATUMUMAB

Daratumumab è un medicinale antitumorale utilizzato in monoterapia per il trattamento di pazienti adulti con mieloma multiplo (un tumore del midollo osseo).

MAT-DAR-FD-DAR Shikari® (Q-DAR) Daratumumab (Darzalex®) Free drug Serum/Plasma ELISA CE/IVD

MAT-DAR-QLS-DAR Shikari® (S-ATDAR) Daratumumab (Darzalex®) Antibody screening – Qualitative Serum/Plasma ELISA CE/IVD

DENOSUMAB

Denosumab (PROLIA®) è un anticorpo monoclonale IgG2 umanizzato con affinità e specificità per RANKL. Inibisce RANKL dall’attivare il suo recettore, diminuendo in tal modo il riassorbimento osseo. Applicazione nel trattamento dell’osteoporosi.

MAT-DEN-FD-PRO Q-DEN Enzyme immunoassay for the quantitative determination of Denosumab (Prolia®)in serum and plasma CE/IVD

MAT-DEN-QLS-PRO S-ATD Enzyme immunoassay for the qualitative determination of antibodies to Denosumab in serum and plasma CE/IVD

DURVALUMAB

Durvalumab è un farmaco immunoterapico che agisce inibendo PD-L1, il ligando del recettore PD-1. Agisce stimolando le cellule del sistema immunitario a sviluppare una risposta immunitaria contro le cellule del tumore. E’ indicato in monoterapia per il trattamento del carcinoma polmonare non a piccole cellule (NSCLC) localmente avanzato.

MAT-DUR-FD-IMF Shikari® (Q-DUR) Durvalumab (Imfinzi®) Free drug Serum/Plasma ELISA CE/IVD

MAT-DUR-QLS-IMF Shikari® (S-ATDUR) Durvalumab (Imfinzi®) Antibody screening – Qualitative Serum/Plasma ELISA CE/IVD

FILGRASTIM

Filgrastim è utilizzato per ridurre la durata della neutropenia (basso numero di globuli bianchi) in corso di terapie con farmaci citotossici o mielotosssici, per eutropenia cronica grave o in pazienti con infezione da HIV. E’ inoltre impiegato nella preparazione al trapianto di midollo osseo e nella mobilizzazione cellule staminali dal sangue periferico.

MAT-FIL-QNS-FIL Q-AFA Enzyme immunoassay for the quantitative determination of specific anibodies to Filgrastim in serum and plasma CE/IVD

IPILIMUMAB

Ipilimumab è un anticorpo monoclonale anti-CTLA-4, che attiva il sistema immunitario stimolando la proliferazione delle cellule-T, le quali sviluppano una risposta immune più attiva contro le cellule tumorali.

Ipilimumab è approvato per pazienti con melanoma in stadio III non operabile o in stadio IV.

MAT-IPI-FD-YER Q-IPI Enzyme immunoassay for the quantitative determination of specific Ipilimumab(Yervoy®) in human serum and plasma CE/IVD

MAT-IPI-QLS-YER S-ATI Enzyme immunoassay for the qualitative determination of specific anibodies to Ipilimumab in serum and plasma CE/IVD

OMALIZUMAB

Omalizumab (Xolair®) è un anticorpo monoclonale IgG1κ umanizzato da DNA ricombinante che si lega selettivamente alle immunoglobuline E (IgE) umane.

NATALIZUMAB

Il Natalizumab è un anticorpo monoclonale che impedisce la migrazione dei leucociti attraverso la barriera ematoencefalica e può arrestare la cascata infiammatoria nella sclerosi multipla.

MAT-NAT-FD-TYS Shikari® (Q-NAT) Natalizumab (Tysabri®) Free drug Serum/Plasma ELISA CE/IVD

MAT-NAT-QLS-TYS Shikari® (S-ATNAT) Natalizumab (Tysabri®) Antibody screening – Qualitative Serum/Plasma ELISA CE/IVD

AFI-EL-1611-141  Natalizumab (Tysabri) Pharmacokinetic ELISA

NIVOLUMAB

Nivolumab (Opdivo®) è un anticorpo monoclonale anti-PD-1 che attiva il sistema immunitario agendo sulle cellule-T, le quali intervengono con una risposta immune contro le cellule tumorali.

Approvato per il trattamento del tumore del polmone, del tumore del rene e del Linfoma di Hodgkin.

MAT-NIV-FD-OPD Q-NIVO Enzyme immunoassay for the quantitative determination of Nivolumab (Opdivo®) in serum and plasma CE/IVD

MAT-NIV-QLS-OPD S-ATN Enzyme immunoassay for the qualitative determination of antibodies to Nivolumab in serum and plasma CE/IVD

PEMBROLIZUMAB

Pembrolizumab (Keytruda®) è un anticorpo monoclonale anti-PD-1, che attiva il sistema immunitario stimolando la proliferazione delle cellule T, le quali montano una risposta immune più attiva contro le cellule tumorali.

Pembrolizumab è approvato per pazienti con melanoma in stadio III non operabile o in stadio IV, indipendentemente dalla presenza della mutazione di BRAF.

MAT-PEM-FD-KEY Q-PEM Enzyme immunoassay for the quantitative determination of Pembrolizumab (Keytruda®) in serum and plasma CE/IVD

MAT-PEM-QLS-KEY S-ATP Enzyme immunoassay for the qualitative determination of antibodies to Pembrolizumab in serum and plasma CE/IVD

AFI-EL-1611-161 Pembrolizumab (Keytruda) Pharmacokinetic ELISA

RAMUCIRUMAB

Ramucirumab (Cyramza) è un medicinale antitumorale usato nel trattamento di pazienti adulti con carcinoma gastrico di stadio avanzato o con tumore localizzato nel tratto in cui l’esofago si unisce allo stomaco. Ramucirumab è usato in associazione a un altro medicinale, paclitaxel, quando la malattia è peggiorata nonostante il trattamento con medicinali a base di platino e fluoropirimidine.

MAT-RAM-FD-CYR Q-RAM Enzyme immunoassay for the quantitative determination of free Ramucirumab in serum and plasma CE/IVD

MAT-RAM-QLS-CYR S-ATRAM Enzyme immunoassay for the qualitative determination of antibodies to Ramucirumab in serum and plasma CE/IVD

RANIBIZUMAB

Il Ranibizumab nome commerciale Lucentis è un anticorpo monoclonale frammento derivato dall’anticorpo similare murino bevacizumab (Avastin).

Ha attività antiangiogenica ed è stato approvato per il trattamento della Degenerazione maculare età correlata (AMD) che è una comune causa di cecità nell’anziano.

Il ranibizumab si lega ed inibisce una serie di sottotipi del fattore di crescita vascolare endoteliale A (VEGF-A).

MAT-RAN-FD-LUC Q-RAN Enzyme immunoassay for the quantitative determination of free Ranibizumab in aqueous humour CE/IVD

TRASTUZUMAB

Il Trastuzumab, nome commerciale Herceptin, è un anticorpo monoclonale umanizzato utilizzato per contrastare il carcinoma mammario avanzato, recidivante o diffuso ad altri organi (carcinoma mammario secondario).

MAT-TRA-FD-HH Q-TRAS Enzyme immunoassay for the quantitative determination of Trastuzumab (Herceptin®, Herclon®) CE/IVD

MAT-TRA-QNS-HH S-ATT Enzyme immunoassay for the quantitative determination of antibodies to Trastuzumab (Herceptin®, Herclon®) in serum and plasma CE/IVD

AFI-EL-141-201 Trastuzumab (Herceptin) Immunogenicity ELISA

AFI-EL-1611-201 Trastuzumab (Herceptin) Pharmacokinetic ELISA

TOCILIZUMAB

Il Tocilizumab, o atlizumab, è un anticorpo monoclonale umanizzato posto in vendita con i nomi commerciali di Tocilizumab, Actemra e RoActemra.

È un farmaco immunosoppressore, studiato soprattutto per il trattamento dell’artrite reumatoide e dell’artrite idiopatica giovanile sistemica, una grave forma di artrite reumatoide dei bambini.

Il tocilizumab è attivo contro il recettore dell’interleuchina-6 (IL-6R).

L’interleuchina-6 (IL-6) è una citochina che gioca un ruolo importante nella risposta immunitaria ed è implicata nella patogenesi di molte malattie, quali le malattie autoimmuni, il mieloma multiplo e il cancro della prostata.

USTEKINUMAB

Ustekinumab è un anticorpo monoclonale IgG interamente umano prodotto in una linea cellulare di mieloma murino, usando la tecnica del DNA ricombinante. E’ stato registrato tramite procedura centralizzata europea nel trattamento della psoriasi a placche di grado da moderato a severo in pazienti non responders o intolleranti ad altre terapie sistemiche.

MAT-UST-FD-STE Q-UST Enzyme immunoassay for the quantitative determination of Ustekinumab in human serum and plasma CE/IVD

MAT-UST-QLS-STE S-ATU Enzyme immunoassay for the qualitative determination of antibodies to Ustekinumab in human serum and plasma CE/IVD

VEDOLIZUMAB

Il Vedolizumab, nome commerciale Entyvio, è impiegato per il trattamento, negli adulti, del Morbo di Crohn (moderato-severo) e della Colite Ulcerosa.

IMM-KM9600 Vedolizumab drug level LC-MS/MS Kit for the in vitro determination of free vedolizumab
concentration (e. g. Entyvio®) in EDTA plasma and serum.

MAT-VED-FD-ENT Q-VEDO Enzyme immunoassay for the quantitative determination of Vedolizumab in human serum and plasma CE/IVD

MAT-VED-QLS-ENT S-ATV Enzyme immunoassay for the qualitative determination of antibodies to Vedolizumab in human serum and plasma CE/IVD

HAMA e HAHA

Questi test  permettono di rivelare la presenza di auto anticorpi HAMA, HAHA e MAHA  che possono influenzare la diagnosi e il trattamento con farmaci biologici nei pazienti.

EPI-KT806 HAHA (Human Anti-human Antibody) ELISA Kit, CE/IVD

EPI-KT805 HAMA (Human Anti- Mouse Antibody) ELISA Kit, CE/IVD

EPI-KT807 MAHA (Mouse Anti-human Antibody) ELISA Kit

Letteratura:

1 Lombardi S, Bernardoni C, Bertolucci D, et al. Biologic therapies in rheumatic diseases: drug and anti-drug antibody levels and clinical efficacy. Journal of Autoimmunity and Cell Responses, Volume 4, Article 1, 2017.**

2 Gregoritza M, Messmann V, Abstiens K, Brandl FP, Göpferich AM, Controlled antibody release from degradable thermoresponsive hydrogels cross-linked by Diels-Alder chemistry, Biomacromolecules, Just Accepted Manuscript, 22 Jun 2017.

3 Aldrich MB, Velasquez FC, Kwon S, Lymphatic delivery of etanercept via nanotopography improves response to collagen-induced arthritis, et al., Arthritis Research & Therapy 19:116, 2017.**

4 Kolar M, Duricova D, Bortlik M, et al., Infliximab Biosimilar (Remsima TM ) in Therapy of Inflammatory Bowel Diseases Patients: Experience from One Tertiary Inflammatory Bowel Diseases Centre, Digestive Disease, 35:91–100, 2017.

5 Gibellini L, De Biasi S, Bianchini E, et al. Anti-TNF-α Drugs Differently Affect the TNFα-sTNFR System and Monocyte Subsets in Patients with Psoriasis. Richard Y, ed. PLoS ONE. 11(12), 2016.**

6 Julsgaard M, Christensen LA, Gibson PR, Gearry RB, Fallingborg J, Hvas CL,Bibby BM, Uldbjerg N, Connell WR, Rosella O, Grosen A, Brown SJ, Kjeldsen J,Wildt S, Svenningsen L, Sparrow MP, Walsh A, Connor SJ, Radford-Smith G, LawranceIC, Andrews JM, Ellard K, Bell SJ. Concentrations of Adalimumab and Infliximab in Mothers and Newborns, and Effects on Infection. Gastroenterology. Jul;151(1):110-9, 2016.**

7 Jonathan GG, Beatriz AÁ, Nazco C GJ, Norberto BL, Fernando GN. Plasma levels of trastuzumab in gastric cancer: Case report. J Oncol Pharm Pract. Sep 23, 2016.**

8 Choi SY, Kang B, Lee JH, Choe YH. Clinical Use of Measuring Trough Levels and Antibodies against Infliximab in Patients with Pediatric Inflammatory Bowel Disease. Gut Liver. Sep 9 2016.**

9 Chen L., et al., Efficient Production of a Bioactive Bevacizumab Monoclonal Antibody Using the 2A Self-cleavage Peptide in Transgenic Rice Callus. Frontiers in Plant Science August 2016 | Volume 7 | Article 1156.**

10 Farkas K., et al., Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis. Journal of Crohn’s and Colitis Advance Access published April 21, 2016.

11 Gutiérrez A, Zapater P, Juanola O, Sempere L, García M, Laveda R, Martínez A, Scharl M, González-Navajas JM, Such J, Wiest R, Rogler G, Francés R. Gut Bacterial DNA Translocation is an Independent Risk Factor of Flare at Short Term in Patients with Crohn’s Disease. Am J Gastroenterol. Apr;111(4):529-40, 2016.

12 Won Jae Song, Ben Kang, So Yoon Choi, and Yon Ho Choe. Adalimumab Treatment in Pediatric-Onset Crohn’s Disease Patients after Infliximab Failure: A Single Center Study. Pediatr Gastroenterol Hepatol Nutr. Jun; 19(2): 116–122, 2016.**

13 Hayashi S, et al., Early Prognostic Factors Associated with the Efficacy of Infliximab Treatment for Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate. Rheumatol Ther (2016) 3:155–166 **

14 Bortlik M., et al., Discontinuation of anti-tumor necrosis factor therapy in inflammatory bowel disease patients: a prospective observation. Scandinavian Journal of Gastroenterology, 2016 vol. 51, no. 2, 196–202.

15 Al-Karkhi M.A., et al., Correlation between Anti-infliximab and Anti-CCP Antibodies Development in Patients with Rheumatoid Arthritis Treated with Infliximab in Baghdad Teaching Hospital. IOSR Journal of Dental and Medical Sciences, Volume 14, Issue 11 Ver. IV (Nov. 2015), PP 95-100.**

16 Kui R, Gál B, Gaál M, Kiss M, Kemény L1, Gyulai R. Presence of antidrug antibodies correlates inversely with the plasma tumor necrosis factor (TNF)-α level and the efficacy of TNF-inhibitor therapy in psoriasis. J Dermatol. Sep;43(9):1018-23, 2016.**

17 Bodini G., Edoardo G. Giannini, Edoardo V. Savarino, and Vincenzo Savarino. Adalimumab Trough Levels and Response to Biological Treatment in Patients With Infl ammatory Bowel Disease: A Useful Cutoff in Clinical Practice. Am J Gastroenterol. Vol. 110, March, 2015.

18 Juanola O., et al., Anti-TNF-alpha loss of response is associated with a decreased percentage of FoxP3+ T cells and a variant NOD2 genotype in patients with Crohn’s disease. J Gastroenterol (2015) 50:758–768.

19 Fujita T, Murata Y, Hemmi S, Kajiwara M, Yabuki M, et al. (2015) Persistent Complement Activation is Associated with Insulin Resistance and Chronic Inflammation in Overweight Patients with Type 2 Diabetes with Dyslipidemia. Int J Immunol Immunother 2:007, 2015. **

20 Malíckova K, et al., Serum trough infliximab levels: A comparison of three different immunoassays for the monitoring of CT-P13 (infliximab) treatment in patients with inflammatory bowel disease, Biologicals 2015.

21 Farkas K. et al, Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis experiences from a single center. Expert Opin. Biol. Ther. 15:(9) 2015.

22 Lee Y.M. et al, Infliximab ‘‘Top-Down’’ Strategy is Superior to ‘‘Step-Up’’ in Maintaining Long-Term Remission in the Treatment of Pediatric Crohn Disease. JPGN 60: (737–743), 2015.

23 Al-Karkhi M.A., et al., Development of Antibodies against Infliximab in Iraqi Patients with Rheumatoid Arthritis. J Fac Med Baghdad, 57: (241-243), 2015.**

24 Bergen T.V., et al., Complementary effects of bevacizumab and MMC in the improvement of surgical outcome after glaucoma filtration surgery. Acta Ophthalmologica 2015, 667-678.**

25 Aydın C, AtaoÄŸlu H., Demonstration of β-1,2 Mannan Structures Expressed on the Cell Wall of Candida albicans Yeast Form But Not on the Hyphal Form by Using Monoclonal Antibodies Mikrobiyol Bul 49(1): 66-76, 2015.

26 Pallagi-Kunstár É. et al., Utility of serum TNF-a, infliximab trough level, and antibody titers in inflammatory bowel disease. World J Gastroenterol. 20(17): (5031-5035), 2014. **27 Khanna R., et al., Therapeutic Drug Monitoring of TNF Antagonists in Inflammatory Bowel Disease. Gastroenterology & Hepatology, August (478-489),2014. **

28 Krajcovicova A. et al., Delayed hypersensitivity reaction after initial dose of infliximab: a case report. European Journal of Gastroenterology& Hepatology 26:(485-487), 2014.

29 Erdemli Ö., et al, In vitro evaluation of effects of sustained anti-TNF release from MPEG-PCL-MPEG and PCL microspheres on human rheumatoid arthritis synoviocytes.2014. Journal of Biomaterials Application, 29(4):524-42, 2014. **

30 Avdeeva A.A., Aleksandrova E.N., Karateev D.E., Luchikhina E.L., Novikov A.A., Cherkasova M.V., Nasonov E.L. EFFICACY OF ADALIMUMAB IN EARLY RHEUMATOID ARTHRITIS IN RELATION TO ITS SERUM LEVEL AND THE PRESENCE OF ANTI-DRUG ANTIBODY. Rheumatology Science and Practice. 52(6):624–630. 2014 Russian, English abstract 

31 Bortlik M, et al, Impact of Anti-Tumor Necrosis Factor Alpha Antibodies Administered to Pregnant Women With Inflammatory Bowel Disease on Long-term Outcome of Exposed Children. Inflamm Bowel Dis 20 : (495-451), 2014.

32 Jung Y et al., “Temperature-modulated noncovalent interaction controllable complex for the long-term delivery of etanercept to treat rheumatoid arthritis”, J. Control. Release 2013.

33 Gutierrez A, et al, Genetic susceptibility to increased bacterial translocation influences the response to biological therapy in patients with Crohn’s disease, Gut 0:1–9, 2013. **

34 Grosen A., et al, Infliximab concentrations in the milk of nursing mothers with inflammatory bowel disease, J Crohns Colitis 2013. **

35 Romero G., et al, Poly(Lactide-co-Glycolide) Nanoparticles, Layer by Layer Engineered for the Sustainable Delivery of AntiTNF-α. Macromol. Biosci. 13: (903–912), 2013.

36 Cheong C, et al, Etanercept Attenuates Traumatic Brain Injury in Rats by Reducing Brain TNF-α Contents and by Stimulating Newly Formed Neurogenesis, Mediators of Inflammation, 2013; Volume 2013, Article ID 620837, 9 pages **

37 Bortlik M et al, “Pregnancy and newborn outcome of mothers with inflammatory bowel diseases exposed to anti-TNF-a therapy during pregnancy: three-center study”, Scandinavian Journal of Gastroenterology. 48: 951–958, 2013

38 Bortlik M, et al, Infliximab trough levelsmay predict sustained response to infliximab in patients with Crohn’s disease, Journal of Crohn’s and Colitis 2012. **

39 Malickova K, et al, Phosphatidylserine-dependent anti-prothrombin antibodies (aPS/PT) in infliximab-treated patients with inflammatory bowel diseases, Autoimmun Highlights, 2012. **

40 Takahashi H, et al, Plasma trough levels of adalimumab and infliximab in terms of clinical efficacy during the treatment of psoriasis, Journal of Dermatology 2012; 39: 1- 4. **

41 Seok Lee Y, et al, “Efficacy of Early Infliximab Treatment for Pediatric Crohn’s Disease: A Three-year Follow-up”, Pediatric Gastroenterology, Hepatology & Nutrition 2012; 15(4):243-249 **42 Molnar T, et al, “Importance of trough levels and antibody titers on the efficacy and safety of Infliximab therapy in inflammatory bowel disease”, Z Gastroenterol 2012; 50 – A5343 Kato S, et al, “Elevated Serum IgE Prior to Acute Severe Infusion Reaction During Infliximab Maintenance Therapy in a Crohn’s Disease Patient”, Crohn’s & Colitis Foundation of America 201144 Adisen E, et al, “Anti-infliximab antibody status and its relation to clinical response in psoriatic patients”: A pilot study, Journal of Dermatology 2010; 37: 708–713.

Poster:

1 Malickova K, et al,. Monitoring patients treated with infliximab: Assessing Anti-Infliximab antibodies, Czech Republic. EUROMEDLAB. Autoimmune diseases 2009. S1152 Malickova K, et al, Formation of antiphospholipid antibodies and antibodies to infliximab in anti-TNF-alpha antibody-treated patients with inflammatory bowel diseases, Charles University in Prague Czech Republic (2011).

2 Malickova K, et al, Relationship between serum trough infliximab levels, serum antibodies to infliximab, serum albumin levels and clinical response to infliximab treatment in patients with inflammatory bowel diseases, Charles University in Prague Czech Republic. (2011)

3 Lukas M, et al, Anti-infliximab antibodies in routine clinical practice is it worth to assess them, Czech Republic

4 Duricova D, et al, Predictors of sustained response to infliximab with Crohn’s disease: A single cohort study, Czech Republic

5 Bodini G, et al, Correlation between Adalimumab trough serum concentration, Anti-Adalimumab antibodies and TNF-Alpha levels with clinical outcome in patients affected by Crohn’s disease,. United European Gastroenterology. Italy 2013.

6 Julsgaard M, et al, Time since last drug exposure in pregnancy determines Adalimumab and Infliximab levels in neonates(Era Study), Italy 2014

7 Szepes Z., et al, Clinical utility of measuring serum TNF alpha level, anti TNF alpha levels and antibody titers in critical situations in inflammatory bowel disease and in psoriasis, ECCO 2014 Inflammatory Bowel Disease.

8 Julsgaard M., et al, Intra-uterine Exposure to Anti-TNF-alpha therapy(ERA study):Infliximab and adalimumab cord blood levels correlate with maternal levels at birth, ECCO 2014 Inflammatory Bowel Disease.

9 Goldberg R., et al, Predictors of sub-therapeutic infliximab oradalimumab trough levels and anti-drug antibodies and their influence on therapeutic decisions, ECCO 2014 Inflammatory Bowel Disease.

10 H. Akbulut, et al: The role of immune system on the efficacy of bevacizumab in patients with metastatic colorectal cancer (mCRC). Medical Oncology, Ankara University School of Medicine, Ankara, Turkey. 1553 P, Annals of Oncology, Volume 27, 2016, 7–11 October 2016, Copenhagen, Denmark.

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