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4. Ustekinumab as induction and maintenance therapy for Crohn's disease

Author

Feagan, Bg, Sandborn, Wj, Gasink, C, Jacobstein, D, Lang, Y, Friedman, Jr, Blank, Ma, Johanns, J, Gao, Ll, Miao, Y, Adedokun, Oj, Sands, Be, Hanauer, Sb, Vermeire, S, Targan, S, Ghosh, S, de Villiers WJ, Colombel, Jf, Tulassay, Z, Seidler, U, Salzberg, Ba, Desreumaux, P, Lee, Sd, Loftus EV Jr, Dieleman, La, Katz, S, Rutgeerts, P, Bampton, P, Chung, A, Connor, S, Debinski, H, Leong, R, Macrae, F, Pavli, P, Sorrentino, D, van den Bogaerde, J, Vogel, W, Vogelsang, H, Louis, E, Mana, F, Zaltman, C, Aumais, G, Bernstein, C, Bressler, B, Dhalla, S, Dieleman, L, Feagan, B, Marshall, J, Panaccione, R, Ropeleski, M, Stehlik, J, Volfova, M, Brynskov, J, Glerup, H, Abitbol-Selinger, V, Allez, M, Beaugerie, L, Bourreille, A, Cadiot, G, Dupas, J, Grimaud, J, Laharie, D, Lerebours, E, Moreau, J, Baumgart, D, Brand, S, Ebert, M, Ehehalt, R, Hasselblatt, P, Howaldt, S, Klaus, J, Krummenerl, P, Kucharzik, T, Lügering, A, Mudter, J, Preiss, J, Schreiber, S, Stallmach, A, Stein, J, Strauch, U, Salamon, A, Patchett, S, Lahat-Zok, A, Rachmilewitz, D, Annese, V, Bossa, F, Guidi, L, Kohn, A, Rocca, R, Ando, A, Ashida, T, Hanai, H, Ishida, T, Ito, H, Matsumoto, T, Motoya, S, Nakamura, S, Sameshima, Y, Suzuki, Y, Watanabe, K, Yamagami, H, Yamamoto, T, Yao, K, Kim, H, Kim, Y, D'Haens, G, Pierik, M, van Bodegraven, A, van der Woude CJ, Gearry, R, Ciecko-Michalska, I, Malecka-Panas, E, Jojic, N, Aboo, N, Wright, J, Arranz, M, Viso, L, Ahmad, T, Bloom, S, Campbell, S, Creed, T, Cummings, F, Hawthorne, B, Iqbal, T, Ireland, A, Parkes, M, Pollok, R, Shaw, I, Shonde, A, Smith, M, Steel, A, Subramanian, S, Travis, S, Tremelling, M, Aberra, F, Abraham, B, Barish, C, Behm, B, Birbara, C, Bochner, R, Bologna, S, Brant, S, Charles, R, Cohen, N, de Villers, W, Dryden, G, Duvall, A, Flasar, M, Fleisher, M, Florez, D, Fogel, R, Gagneja, H, Gross, C, Hamilton, J, Hanauer, S, Hanson, J, Hardi, R, Higgins, P, Isaacs, K, Katz, J, Kaur, N, Khan, N, Lee, S, Leman, B, Levenson, S, Lichtiger, S, Loftus, E, Malik, P, Mcnair, A, Melmed, G, Miner, P, Nichols, M, Noar, M, Oikonomou, I, Oubre, B, Peterson, K, Pruitt, R, Quirk, D, Safdi, A, Safdi, M, Salzberg, B, Sandborn, W, Saubermann, L, Scherl, E, Schwartz, D, Schwarz, R, Sedghi, S, Selby, L, Shafran, I, Siegel, C, Sninsky, C, Stern, M, Stockwell, D, Stone, C, Swaminath, A, Swoger, J, Taormina, M, Williams, E, Winstead, N, Wolf, D, Wolosin, J, Yacyshyn, B, Yajnik, V, Yen, E, Hetzel, D, Muls, V, Bafutto, M, Francesconi, C, Sipahi, A, Steinwurz, F, Churchev, J, Kotzev, I, Marinova, I, Penchev, P, Spassova, Z, Stoinov, S, Takov, D, Vassileva, G, Fowler, S, Greenberg, G, Jones, J, Saibil, F, Salh, B, Banić, M, Duvnjak, M, Stimac, D, Goujon, G, Pelletier, A, Peyrin-Biroulet, L, Aldinger, V, Bokemeyer, B, Büning, C, Konturek, J, Krummenerl, T, Ochsenkuehn, T, Altorjay, I, Kis, J, Pecsi, G, Székely, A, Varga, M, Vincze, A, Wacha, J, Oddsson, E, Orvar, K, Avni-Biron, I, Fishman, S, Fraser, G, Konikoff, F, Melzer, E, Oren, R, Shirin, H, Danese, S, Marino, M, Sturniolo, Gc, Horiki, N, Iijima, H, Iwabuchi, M, Kanai, T, Kunisaki, R, Maemoto, A, Matsuoka, K, Osada, T, Sugimoto, K, Tanaka, S, Cheon, Jh, Han, Ds, Jang, Bi, Kim, Hj, Kim, Js, Kim, Yh, Park, Sj, Yang, Sk, Arnold, M, Claydon, A, Haines, M, Hill, J, Rowbotham, D, Schultz, M, Wallace, I, Bochenek, A, Niezgoda, K, Szura, M, Arutyunov, G, Baranovsky, A, Khalif, I, Osipenko, M, Milinic, N, Bloch, H, Kruger, Fc, Prins, M, Watermeyer, G, Ziady, C, Calvo, Xc, Domínguez-Muñoz, Je, Gisbert, Jp, Arsenescu, R, Beaulieu, D, Bedford, R, Behrend, C, Cleavinger, P, Cohen, J, Ertan, A, Freilich, B, Friedenberg, K, Glover, S, Gordon, G, Gunaratnam, N, Gupta, N, Holbrook, R, Jones, M, Kaufman, B, Khan, Nh, Khurana, S, Legnani, P, Mutlu, E, Phillips, R, Rai, R, Reichelderfer, M, Ritter, T, Safdi, Ma, Sands, B, Schulman, M, Smith, J, Suiter, D, Taylor, D, Vasudeva, R, Winstead, T, Zwick, A, Savoye, G, Atreya, R, Ochsenkuhn, T, Ott, C, Goldin, E, Motohiro, E, Takanori, K, Park, S, James, B, Cummings, J, Tariq, A, Willert, R, Allan, M, Bulat, R, Devilliers, W, Eaker, E, Hou, J, Mendu, S, Nicols, M, Proctor, D, Thosani, N, Zhang, C, and UNITI-IM-UNITI Study Group

Subjects
030203 arthritis & rheumatology, Adult, Male, Infusions, Medicine (all), Remission Induction, Crohn Disease, Female, Humans, Induction Chemotherapy, Infusions, Intravenous, Maintenance Chemotherapy, Middle Aged, Ustekinumab, General Medicine, Orvostudományok, Klinikai orvostudományok, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Intravenous
Abstract

Ustekinumab, a monoclonal antibody to the p40 subunit of interleukin-12 and interleukin-23, was evaluated as an intravenous induction therapy in two populations with moderately to severely active Crohn's disease. Ustekinumab was also evaluated as subcutaneous maintenance therapy.We randomly assigned patients to receive a single intravenous dose of ustekinumab (either 130 mg or approximately 6 mg per kilogram of body weight) or placebo in two induction trials. The UNITI-1 trial included 741 patients who met the criteria for primary or secondary nonresponse to tumor necrosis factor (TNF) antagonists or had unacceptable side effects. The UNITI-2 trial included 628 patients in whom conventional therapy failed or unacceptable side effects occurred. Patients who completed these induction trials then participated in IM-UNITI, in which the 397 patients who had a response to ustekinumab were randomly assigned to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 8 weeks or every 12 weeks) or placebo. The primary end point for the induction trials was a clinical response at week 6 (defined as a decrease from baseline in the Crohn's Disease Activity Index [CDAI] score of ≥100 points or a CDAI score150). The primary end point for the maintenance trial was remission at week 44 (CDAI score150).The rates of response at week 6 among patients receiving intravenous ustekinumab at a dose of either 130 mg or approximately 6 mg per kilogram were significantly higher than the rates among patients receiving placebo (in UNITI-1, 34.3%, 33.7%, and 21.5%, respectively, with P≤0.003 for both comparisons with placebo; in UNITI-2, 51.7%, 55.5%, and 28.7%, respectively, with P0.001 for both doses). In the groups receiving maintenance doses of ustekinumab every 8 weeks or every 12 weeks, 53.1% and 48.8%, respectively, were in remission at week 44, as compared with 35.9% of those receiving placebo (P=0.005 and P=0.04, respectively). Within each trial, adverse-event rates were similar among treatment groups.Among patients with moderately to severely active Crohn's disease, those receiving intravenous ustekinumab had a significantly higher rate of response than did those receiving placebo. Subcutaneous ustekinumab maintained remission in patients who had a clinical response to induction therapy. (Funded by Janssen Research and Development; ClinicalTrials.gov numbers, NCT01369329 , NCT01369342 , and NCT01369355 .).

Published
2016

6. Distribution of the entomopathogenic fungus Entomophaga maimaiga (Entomophthorales: Entomophthoraceae) at the northern edge of its range in Europe.

Author

Zúbrik, M., Špilda, I., Pilarska, D., Hajek, A. E., Takov, D., Nikolov, C., Kunca, A., Pajtík, J., Lukášová, K., and Holusa, J.

Subjects
ENTOMOPHAGA maimaiga, LYMANTRIA dispar, GRISELINIA littoralis, OAK diseases & pests, FUNGAL translocation
Abstract

Abstract: The gypsy moth Lymantria dispar is a serious economic pest in European broadleaf forests. However, the entomopathogenic fungus Entomophaga maimaiga, which has a great potential to regulate gypsy moth numbers, has recently spread in the Central and Eastern European area of the moth's range. In the current study, 39 plots in oak forests in the Slovak Republic and the Czech Republic were monitored for E. maimaiga from 2014 to 2016. These plots were located along the northern edge of the E. maimaiga range where gypsy moth outbreaks have occurred in the past. The fungus was detected in 16 of the 39 plots. The results thus confirm that E. maimaiga is quite widespread along the northern edge of its range in Europe and can be considered to be established in that area. [ABSTRACT FROM AUTHOR]

Published
2018
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11. 446 TIMING AND FREQUENCY OF DEPRESSION DURING HCV-TREATMENT WITH CONTROLLED-RELEASE-IFNA2B (CR2B) VS. PEGYLATED-IFNA2B (PEG2B): RESULTS FROM SELECT-2, A RANDOMIZED-OPEN-LABEL-72-WEEK-COMPARISON IN 116 TREATMENT-NAIVE PATIENTS WITH GENOTYPE-1 HCV

Author

Long, W.A., primary, Younossi, Z., additional, Lawitz, E., additional, Kotsev, I., additional, Takov, D., additional, Tchernev, K., additional, Rigney, A., additional, Ghalib, R., additional, Stoinov, S., additional, Balabanska, R., additional, Mehra, P., additional, and Krastev, Z., additional

Published
2011
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13. 2010 Q2WEEK CONTROLLED-RELEASE-INTERFERON-ALPHA2B + RIBAVRIN REDUCES FLU-LIKE SYMPTOMS >50% AND PROVIDES EQUIVALENT EFFICACY IN COMPARISON TO WEEKLY PEGYLATED-INTERFERON-ALPHA2B + RIBAVIRIN IN TREATMENT-NAIVE-GENOTYPE-1-CHRONIC-HEPATITIS-C: RESULTS FROM EMPOWER, A RANDOMIZED-OPEN-LABEL-12-WEEK-COMPARISON IN 133 PATIENTS

Author

Long, W.A., primary, Takov, D., additional, Tchernev, K., additional, Kotzev, I., additional, Rigney, A., additional, Krastev, Z., additional, Stoynov, S., additional, Balabanska, R., additional, Lawitz, E., additional, Younossi, Z., additional, Ghalib, R., additional, Zuckerman, E., additional, Safadi, R., additional, Tur-Kaspa, R., additional, Assy, N., additional, and Lurie, Y., additional

Published
2010
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22. Phytophagous larvae occurring in Central and Southeastern European oak forests as a potential host of Entomophaga maimaiga (Entomophthorales: Entomophthoraceae) - A field study.

Author

Zúbrik M, Pilarska D, Kulfan J, Barta M, Hajek AE, Bittner TD, Zach P, Takov D, Kunca A, Rell S, Hirka A, and Csóka G

Subjects
Animals, Europe, Forests, Quercus parasitology, Entomophthorales, Larva parasitology, Moths parasitology, Pest Control, Biological methods
Abstract

We evaluated the presence and impact of Entomophaga maimaiga on both target and non-target phytophagous larvae. All six study plots, with low gypsy moth population density, were situated in Central and Southeastern European oak forests and E. maimaiga had previously been reported from these plots. Totally, 45 of 4,045 (1.13%) collected non-target larvae died due to fungal infections. No non-target insect specimen was infected by E.maimaiga, although the presence of the pathogen could not be fully excluded in three cadavers. Out of 1,780L.dispar larvae collected, 15individuals (0.84%) were infected by E.maimaiga., (Copyright © 2018. Published by Elsevier Inc.)

Published
2018
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23. Natural occurrence of microsporidia infecting Lepidoptera in Bulgaria.

Author

Pilarska D, Takov D, Hyliš M, Radek R, Fiala I, Solter L, and Linde A

Subjects
Animals, Bulgaria, Host-Parasite Interactions, Microsporidia classification, Microsporidia genetics, Phylogeny, Lepidoptera parasitology, Microsporidia physiology
Abstract

We examined 34 lepidopteran species belonging to 12 families to determine presence and prevalence of microsporidian pathogens. The insects were collected from May 2009 to July 2012 from 44 sites in Bulgaria. Nosema species were isolated from Archips xylosteana, Tortrix viridana, Operophtera brumata, Orthosia cerasi, and Orthosia cruda. Endoreticulatus sp. was isolated from Eilema complana. The prevalence of all isolates in their hosts was low and ranged from 1.0% to 5.3%. Phylogenetic analyses of the new isolates based on SSU rDNA are presented.

Published
2017
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24. [What do we know and what do we not know about peptic ulcer].

Author

Mechkov G and Takov D

Subjects
Gastric Mucosa metabolism, Helicobacter Infections complications, Helicobacter Infections microbiology, Helicobacter pylori pathogenicity, Humans, Mucus physiology, Prostaglandins physiology, Receptors, Cell Surface physiology, Peptic Ulcer etiology, Peptic Ulcer microbiology, Peptic Ulcer physiopathology
Published
1991

25. [The importance of endoscopy in the diagnosis of malignant non-Hodgkin's lymphoma of the stomach].

Author

Takov D, Danev K, Rauinov Iu, and Gigov I

Subjects
Adult, Biopsy, Diagnosis, Differential, Female, Humans, Lymphatic Metastasis, Lymphoma, Non-Hodgkin pathology, Male, Middle Aged, Stomach pathology, Stomach Neoplasms pathology, Gastroscopy, Lymphoma, Non-Hodgkin diagnosis, Stomach Neoplasms diagnosis
Abstract

Four patients with non-Hodgkin lymphoma of the stomach are presented. In 3 of the patients the localization of the lymphoma was considered primary and in the fourth patient it was considered secondary. The diagnosis was made on clinical, laboratory and instrumental data and had been confirmed histologically and in 3 of the patients also surgically. The importance of endoscopy for the diagnosis of gastric malignant lymphomas is emphasized and the most frequent changes of the gastric mucosa which direct the attention toward the disease are pointed out. Most important for the timely diagnosis of gastric malignant lymphoma are the gastroscopic follow-up of patients presenting with atypical macroscopic changes, the guided biopsies and the close collaboration between endoscopists and pathomorphologists.

Published
1989

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