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6 results on '"Behm, B."'

1. First-dose anaphylaxis to infliximab: a case of mammalian meat allergy.

Author

Chitnavis M, Stein DJ, Commins S, Schuyler AJ, and Behm B

Subjects
Anaphylaxis blood, Anaphylaxis diagnosis, Anaphylaxis immunology, Crohn Disease diagnosis, Crohn Disease immunology, Cross Reactions, Drug Hypersensitivity blood, Drug Hypersensitivity diagnosis, Drug Hypersensitivity immunology, Female, Food Hypersensitivity blood, Food Hypersensitivity diagnosis, Gastrointestinal Agents administration & dosage, Humans, Immunoglobulin E blood, Infliximab administration & dosage, Middle Aged, Risk Factors, Treatment Outcome, Anaphylaxis chemically induced, Crohn Disease drug therapy, Disaccharides immunology, Drug Hypersensitivity etiology, Food Hypersensitivity immunology, Gastrointestinal Agents adverse effects, Immunoglobulin E immunology, Infliximab adverse effects, Meat adverse effects
Published
2017
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2. Tumor necrosis factor-alpha antibody for maintenance of remission in Crohn's disease.

Author

Behm BW and Bickston SJ

Subjects
Adalimumab, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Humanized, Certolizumab Pegol, Humans, Immunoglobulin Fab Fragments therapeutic use, Infliximab, Polyethylene Glycols therapeutic use, Randomized Controlled Trials as Topic, Remission Induction, Anti-Inflammatory Agents therapeutic use, Crohn Disease drug therapy, Tumor Necrosis Factor-alpha antagonists & inhibitors
Abstract

Background: Crohn's disease may be refractory to conventional treatments including corticosteroids and immunosuppressives. Recent studies suggest TNF-alpha blocking agents may be effective in maintaining remission in Crohn's disease., Objectives: To conduct a systematic review of the evidence for the effectiveness of TNF-alpha blocking agents in the maintenance of remission in patients with Crohn's disease., Search Strategy: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the IBD/FBD Review Group Specialized Trials Register were searched for relevant studies published between 1966-2007. Manual searches of references from potentially relevant papers were performed to identify additional studies. Experts in the field and study authors were contacted to identify unpublished data., Selection Criteria: Randomized controlled trials involving patients > 18 years with Crohn's disease who had a clinical response or clinical remission with a TNF-alpha blocking agent, or patients with Crohn's disease in remission but unable to wean corticosteroids, who were then randomized to maintenance of remission with a TNF-alpha blocking agent or placebo, Data Collection and Analysis: Two independent authors performed data extraction and assessment of the methodological quality of each trial. Outcome measures reported in the primary studies included clinical remission, clinical response, and steroid-sparing effects., Main Results: Nine studies met all inclusion criteria. Four different anti-TNF-alpha agents were evaluated (infliximab in 3 studies, CDP571 in 3 studies, adalimumab in 2 studies, and certolizumab in 1 study). There is evidence from three randomized controlled trials that infliximab maintains clinical remission (RR 2.50; 95% CI 1.64 to 3.80), maintains clinical response (RR 1.66; 95% CI 1.00 to 2.76), has corticosteroid-sparing effects (RR 3.13; 95% CI 1.25 to 7.81), and maintains fistula healing (RR 1.87; 95% CI 1.15 to 3.04) in patients with Crohn's disease with a response to infliximab induction therapy. There were no significant differences in remission rates between infliximab doses of 5 mg/kg or 10 mg/kg. There is evidence from two randomized controlled trials that adalimumab maintains clinical remission (RR 2.86; 95% CI 2.01 to 4.02), maintains clinical response (RR 2.69; 95% CI 1.88 to 3.86), and has corticosteroid-sparing effects (RR 2.81, 95% CI 1.46 to 5.43) in patients with Crohn's disease who have responded or entered remission with adalimumab induction therapy. There were no significant differences in remission rates between adalimumab 40 mg weekly or every other week. There is evidence from one randomized controlled trial that certolizumab pegol maintains clinical remission (RR 1.68; 95% CI 1.30 to 2.16) and maintains clinical response (RR 1.74; 95% CI 1.41 to 2.13) in patients who have responded to certolizumab induction therapy. There is no evidence to support the use of CDP571 for the maintenance of remission in Crohn's disease., Authors' Conclusions: Infliximab 5 mg/kg or 10 mg/kg, given every 8 weeks, is effective for the maintenance of remission and maintenance of fistula healing in patients who have responded to infliximab induction therapy. Adalimumab 40 mg weekly or every other week is effective for the maintenance of remission in patients who have responded to adalimumab induction therapy. Certolizumab pegol 400 mg every 4 weeks is effective for the maintenance of remission in patients who have responded to certolizumab induction therapy. No comparative trials have evaluated the relative efficacy of these agents. Adverse events are similar in the infliximab, adalimumab, and certolizumab groups compared with placebo, but study size and duration generally are insufficient to allow an adequate assessment of serious adverse events associated with long-term use.

Published
2008
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3. Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease

Author

Sandborn, Wj, Feagan, Bg, Rutgeerts, P, Hanauer, S, Colombel, Jf, Sands, Be, Lukas, M, Fedorak, Rn, Lee, S, Bressler, B, Fox, I, Rosario, M, Sankoh, S, Xu, J, Stephens, K, Milch, C, Parikh, A, Bampton P, GEMINI 2 Study G. r. o. u. p., Borody, T, Chung, A, Debinski, H, Florin, T, Hetzel, D, Jakobovits, S, Lawrance, I, Leong, R, Macrae, F, Mitchell, B, Moore, G, Pavli, P, Samuel, D, Weltman, M, Haas, T, Reinisch, W, Vogel, W, Baert, F, De Maeyer, M, De Vos, M, Dewit, O, D'Haens, G, Louis, E, Muls, V, Van Assche, G, Krastev, Z, Nikolovska, D, Petrov, P, Petrov, A, Stoinov, S, Tchernev, K, Vasileva, G, Aumais, G, Axler, J, Bailey, R, Bernstein, C, Bitton, A, Bourdages, R, Cohen, A, Devroede, G, Dhalla, S, Feagan, B, Fedorak, R, Green, D, Greenberg, G, Jones, J, Larkai, E, Macintosh, D, Panaccione, R, Ponich, T, Singh, R, Sy, R, Wiesinger, H, Albin, A, Douda, L, Horny, I, Stehlik, J, Stuksa, J, Volfova, M, Vyhnalek, P, Zadorova, Z, Andersen, V, Bendtsen, F, Fallingborg, J, Rannem, T, Maelt, A, Margus, B, Salupere, R, Allez, M, Des Varennes SB, Desreumaux, P, Dupas, Jl, Grimaud, Jc, Hebuterne, X, Lerebours, E, Picon, L, Zerbib, F, Aldinger, V, Baumgart, D, Buening, C, Dollinger, M, Hoffmann, P, Howaldt, S, Klaus, J, Konturek, Jw, Krummenerl, T, Malfertheiner, P, Schmidt, W, Schreiber, S, Seidler, U, Stallmach, A, Stremmel, W, Zeitz, M, Mantzaris, G, Triantafyllou, K, Ng, C, Bene, L, Fazekas, I, Fejes, R, Gall, J, Horvat, G, Hunyady, B, Salamon, A, Toth, T, Tulassay, Z, Varga, E, Varga, M, Varga Szabo, L, Vincze, A, Oddsson, E, Örvar, K, Ahuja, V, Amarapurkar, D, Chandra, A, Koshy, A, Krishna, P, Ramakrishna, K, Reddy, N, Thorat, V, Patchett, S, Ryan, B, Ben Horin, S, Fishman, S, Lavy, A, Rachmilewitz, D, Ardizzone, S, Corazziari, E, Danese, S, Fries, Walter, Gasbarrini, A, Kohn, A, Sturniolo, Gc, Danilans, A, George, Am, Hilmi, In, Engels, Lg, Ponsioen, Cy, van der Woude CJ, Gearry, R, Haines, M, Schultz, M, Wallace, I, Wyeth, J, Florholmen, J, Jahnsen, J, Lygren, I, Röseth, A, Ciecko Michalska, I, Gonciarz, M, Horynski, M, Huk, J, Jamrozik Kruk, Z, Janke, A, Klupinska, G, Marecik, J, Paradowski, L, Rudzinski, J, Rydzewska, G, Han, Ds, Hong, Sp, Kim, Hj, Kim, Js, Kim, Ko, Kim, Yh, Yang, Sk, Gheorghe, Ls, Voiosu, Rm, Alexeeva, O, Baranovsky, A, Bunkova, E, Burnevich, E, Dolgikh, O, Grinevich, V, Lakhin, A, Tarabar, D, Ling, Kl, Bunganic, I, Cernok, S, Gregus, M, Coetzer, T, Grundling, H, Moola, Sa, Wright, Jp, Ziady, C, Bermejo, F, Calvet, X, Herrerias, Jm, Perez Calle JL, Perez Gisbert, J, Hertervig, E, Karlen, P, Michetti, P, Rogler, G, Seibold, F, Wu, Dc, Atug, O, Kurdas, Oo, Datsenko, O, Dorofyeyev, A, Dudar, L, Golovchenko, O, Klyarits'Ka, I, Skrypnyk, I, Hawthorne, Ab, Middleton, S, Abreu, M, Bala, N, Becker, S, Behm, B, Braun, R, Bukhari, M, Chen, S, Coates, A, Dar, S, Dassopoulos, T, De Villiers, W, Desautels, S, Desta, T, Dimitroff, J, Dryden, G, Duvall, A, Farraye, F, Fein, S, Liu, Bf, Gatof, D, Geenen, D, Ginsburg, P, Glombicki, A, Glover, S, Gordon, G, Grisolano, S, Hanson, J, Hardi, R, Hoffman, B, Isaacs, K, Kim, C, Koval, G, Lashner, B, Lawitz, E, Leman, B, Levine, J, Loftus, E, Mahadevan, U, Mannon, P, Marcet, J, Matsuyama, R, Matusow, G, Mccabe, R, Mirkin, K, Murphy, M, Mushahwar, A, Mutlu, E, Nagrani, M, Nguyen, D, Nichols, M, Nieves Ramirez, A, Oubre, B, Pace, S, Pandak, W, Perera, L, Quadri, A, Quallich, L, Rajapakse, R, Randall, C, Regueiro, M, Safdi, A, Sandborn, W, Sands, B, Saubermann, L, Scherl, E, Schwartz, D, Sedghi, S, Shafran, I, Shepard, R, Siegel, C, Stein, L, Tatum, H, Triebling, A, Vasudeva, R, Winston, B, Wolf, D, Younes, Z, Jewell, D, Mahon, J, Rothstein, R, Snydman, D, Massaro, J, Clifford, D, Berger, J, Major, E, Provenzale, J, Lev, M., GEMINI 2 Study Group, Bampton, P., Borody, T., Chung, A., Debinski, H., Florin, T., Hetzel, D., Jakobovits, S., Lawrance, I., Leong, R., Macrae, F., Mitchell, B., Moore, G., Pavli, P., Samuel, D., Weltman, M., Haas, T., Reinisch, W., Vogel, W., Baert, F., De Maeyer, M., De Vos, M., Dewit, O., D'Haens, G., Louis, E., Muls, V., Van Assche, G., Krastev, Z., Nikolovska, D., Petrov, P., Petrov, A., Stoinov, S., Tchernev, K., Vasileva, G., Aumais, G., Axler, J., Bailey, R., Bernstein, C., Bitton, A., Bourdages, R., Bressler, B., Cohen, A., Devroede, G., Dhalla, S., Feagan, B., Fedorak, R., Green, D., Greenberg, G., Jones, J., Larkai, E., MacIntosh, D., Panaccione, R., Ponich, T., Singh, R., Sy, R., Wiesinger, H., Albin, A., Douda, L., Horny, I., Lukas, M., Stehlik, J., Stuksa, J., Volfova, M., Vyhnalek, P., Zadorova, Z., Andersen, V., Bendtsen, F., Fallingborg, J., Rannem, T., Maelt, A., Margus, B., Salupere, R., Allez, M., Des Varennes SB., Desreumaux, P., Dupas, JL., Grimaud, JC., Hebuterne, X., Lerebours, E., Picon, L., Zerbib, F., Aldinger, V., Baumgart, D., Buening, C., Dollinger, M., Hoffmann, P., Howaldt, S., Klaus, J., Konturek, JW., Krummenerl, T., Malfertheiner, P., Schmidt, W., Schreiber, S., Seidler, U., Stallmach, A., Stremmel, W., Zeitz, M., Mantzaris, G., Triantafyllou, K., Ng, C., Bene, L., Fazekas, I., Fejes, R., Gall, J., Horvat, G., Hunyady, B., Salamon, A., Toth, T., Tulassay, Z., Varga, E., Varga, M., Varga-Szabo, L., Vincze, A., Oddsson, E., Örvar, K., Ahuja, V., Amarapurkar, D., Chandra, A., Koshy, A., Krishna, P., Ramakrishna, K., Reddy, N., Thorat, V., Patchett, S., Ryan, B., Ben Horin, S., Fishman, S., Lavy, A., Rachmilewitz, D., Ardizzone, S., Corazziari, E., Danese, S., Fries, W., Gasbarrini, A., Kohn, A., Sturniolo, GC., Danilans, A., George, AM., Hilmi, IN., Engels, LG., Ponsioen, CY., van der Woude CJ., Gearry, R., Haines, M., Schultz, M., Wallace, I., Wyeth, J., Florholmen, J., Jahnsen, J., Lygren, I., Röseth, A., Ciecko-Michalska, I., Gonciarz, M., Horynski, M., Huk, J., Jamrozik-Kruk, Z., Janke, A., Klupinska, G., Marecik, J., Paradowski, L., Rudzinski, J., Rydzewska, G., Han, DS., Hong, SP., Kim, HJ., Kim, JS., Kim, KO., Kim, YH., Yang, SK., Gheorghe, LS., Voiosu, RM., Alexeeva, O., Baranovsky, A., Bunkova, E., Burnevich, E., Dolgikh, O., Grinevich, V., Lakhin, A., Tarabar, D., Ling, KL., Bunganic, I., Cernok, S., Gregus, M., Coetzer, T., Grundling, H., Moola, SA., Wright, JP., Ziady, C., Bermejo, F., Calvet, X., Herrerias, JM., Perez Calle JL., Perez Gisbert, J., Hertervig, E., Karlen, P., Michetti, P., Rogler, G., Seibold, F., Wu, DC., Atug, O., Kurdas, OO., Datsenko, O., Dorofyeyev, A., Dudar, L., Golovchenko, O., Klyarits'ka, I., Skrypnyk, I., Hawthorne, AB., Middleton, S., Abreu, M., Bala, N., Becker, S., Behm, B., Braun, R., Bukhari, M., Chen, S., Coates, A., Dar, S., Dassopoulos, T., De Villiers, W., Desautels, S., Desta, T., Dimitroff, J., Dryden, G., Duvall, A., Farraye, F., Fein, S., Liu, BF., Gatof, D., Geenen, D., Ginsburg, P., Glombicki, A., Glover, S., Gordon, G., Grisolano, S., Hanauer, S., Hanson, J., Hardi, R., Hoffman, B., Isaacs, K., Kim, C., Koval, G., Lashner, B., Lawitz, E., Lee, S., Leman, B., Levine, J., Loftus, E., Mahadevan, U., Mannon, P., Marcet, J., Matsuyama, R., Matusow, G., McCabe, R., Mirkin, K., Murphy, M., Mushahwar, A., Mutlu, E., Nagrani, M., Nguyen, D., Nichols, M., Nieves Ramirez, A., Oubre, B., Pace, S., Pandak, W., Perera, L., Quadri, A., Quallich, L., Rajapakse, R., Randall, C., Regueiro, M., Safdi, A., Sandborn, W., Sands, B., Saubermann, L., Scherl, E., Schwartz, D., Sedghi, S., Shafran, I., Shepard, R., Siegel, C., Stein, L., Tatum, H., Triebling, A., Vasudeva, R., Winston, B., Wolf, D., Younes, Z., Feagan, BG., Colombel, JF., Rutgeerts, P., Sandborn, WJ., Sands, BE., Jewell, D., Mahon, J., Rothstein, R., Snydman, D., Massaro, J., Clifford, D., Berger, J., Major, E., Provenzale, J., Lev, M., and Medical Microbiology & Infectious Diseases

Subjects
Adult, Male, Integrins, medicine.medical_specialty, HUMAN POLYOMAVIRUSES, JC, Antibodies/blood, Antibodies, Monoclonal, Humanized/adverse effects, Antibodies, Monoclonal, Humanized/immunology, Crohn Disease/drug therapy, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Glucocorticoids/therapeutic use, Humans, Immunosuppressive Agents/therapeutic use, Induction Chemotherapy, Infusions, Intravenous/adverse effects, Integrins/antagonists & inhibitors, Integrins/immunology, Maintenance Chemotherapy, Middle Aged, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY, Antibodies, Monoclonal, Humanized, Placebo, Gastroenterology, Inflammatory bowel disease, Antibodies, Vedolizumab, CERTOLIZUMAB PEGOL, Natalizumab, Crohn Disease, Maintenance therapy, HUMANIZED ANTIBODY, Internal medicine, Ustekinumab, medicine, Certolizumab pegol, Infusions, Intravenous, Glucocorticoids, NATALIZUMAB, business.industry, Induction chemotherapy, General Medicine, medicine.disease, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY, RELAPSING MULTIPLE-SCLEROSIS, INFLAMMATORY-BOWEL-DISEASE, HUMAN POLYOMAVIRUSES, HUMANIZED ANTIBODY, CERTOLIZUMAB PEGOL, ULCERATIVE-COLITIS, RANDOMIZED-TRIAL, NATALIZUMAB, JC, RANDOMIZED-TRIAL, digestive system diseases, Surgery, ULCERATIVE-COLITIS, RELAPSING MULTIPLE-SCLEROSIS, business, Immunosuppressive Agents, INFLAMMATORY-BOWEL-DISEASE, medicine.drug
Abstract

BACKGROUND: The efficacy of vedolizumab, an α4β7 integrin antibody, in Crohn's disease is unknown. METHODS: In an integrated study with separate induction and maintenance trials, we assessed intravenous vedolizumab therapy (300 mg) in adults with active Crohn's disease. In the induction trial, 368 patients were randomly assigned to receive vedolizumab or placebo at weeks 0 and 2 (cohort 1), and 747 patients received open-label vedolizumab at weeks 0 and 2 (cohort 2); disease status was assessed at week 6. In the maintenance trial, 461 patients who had had a response to vedolizumab were randomly assigned to receive placebo or vedolizumab every 8 or 4 weeks until week 52. RESULTS: At week 6, a total of 14.5% of the patients in cohort 1 who received vedolizumab and 6.8% who received placebo were in clinical remission (i.e., had a score on the Crohn's Disease Activity Index [CDAI] of ≤150, with scores ranging from 0 to approximately 600 and higher scores indicating greater disease activity) (P=0.02); a total of 31.4% and 25.7% of the patients, respectively, had a CDAI-100 response (≥100-point decrease in the CDAI score) (P=0.23). Among patients in cohorts 1 and 2 who had a response to induction therapy, 39.0% and 36.4% of those assigned to vedolizumab every 8 weeks and every 4 weeks, respectively, were in clinical remission at week 52, as compared with 21.6% assigned to placebo (P

Published
2013

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

5. Ustekinumab induction and maintenance therapy in refractory Crohn's disease

Author

Sandborn, Wj, Gasink, C, Gao, Ll, Blank, Ma, Johanns, J, Guzzo, C, Sands, Be, Hanauer, Sb, Targan, S, Rutgeerts, P, Ghosh, S, de Villiers WJ, Panaccione, R, Greenberg, G, Schreiber, S, Lichtiger, S, Feagan, Bg, Haas, T, Kaser, A, Vogelsang, H, Brown, S, Florin, T, Gibson, Pg, Hetzel, D, Leong, R, Pavli, P, Radford-Smith, G, Sparrow, M, Baert, F, D'Haens, G, D'Heygere, F, Franchimont, D, Louis, E, Mana, F, Moreels, T, Vermeire, S, Anderson, F, Axler, J, Greenbloom, S, Bitton, A, Fedorak, Rn, Larkai, E, Marshall, J, Singh, R, Abitbol, V, Allez, M, Lemann, M, Bonaz, B, Colombel, Jf, Dupas, Jl, Hebuterne, X, Laharie, D, Lerebours, E, Moreau, J, Bokemeyer, B, Holler, B, Howaldt, Sp, Krummenerl, T, Kucharzik, T, Ochsenkühn, T, Raedler, A, Schiefke, I, Seidler, U, Sturm, A, Zeitz, M, Eliakim, A, Fishman, S, Konikoff, Fm, Lavy, A, Niv, Y, Nussinson, E, Rachmilewitz, D, Andriulli, A, Annese, V, Biancone, L, Corazza, Gr, Danese, S, Sturniolo, Gc, Terrosu, G, Sorrentino, D, Hommes, Dw, Jansen, Jm, Otten, Mh, Pierik, M, Ponsioen, Cy, Stokkers, P, van Bodegraven AA, Van der Woude, J, Calvet Calvo, X, Casellas, F, Garcia López, S, Garcia-Planella, E, Ginard-Vincens, D, López San Román, A, Muñoz Nuñez, F, Pérez Gisbert, J, Vera, Mi, Rodrigo, J, Riestra-Menendez, S, Arnott, I, Bloom, S, Campbell, Ss, Harbord, Mw, Mansfield, Jc, Nwokolo, C, Parkes, M, Probert, Cs, Aberra, Fn, Abraham, Bp, Abreu, Mt, Amontree, Js, Barish, Cf, Barto, Ae, Behm, B, Birbara, Ca, Bologna, S, Dryden GW Jr, Eisner, Ms, Ertan, A, Fogel, R, Gagneja, Hk, Ginsburg, P, Goff, Js, Gordon, G, Hamilton, Jw, Hanson, Js, Hardi, R, Hemaidan, A, Higgins, P, Holderman, W, Hornbuckle, K, Ibegbu, E, Isaacs, Kl, Katz, Ja, Katz, S, Kaufman, Bp, Kavanaugh, Af, Khurana, Sk, Lashner, B, Lawrence, S, Hansen, Rn, Lee, S, Leighton, Ja, Leman, Bi, Levenson, Sd, Lowe, Je, Marcuard, Sp, Matsuyama, Rm, Mcnair, Ae, Melmed, G, Miller, Km, Miner PB Jr, Mutlu, Ea, Keshavarzian, A, Narayen, V, Noar, Md, Patel, Ph, Patrick, Tj, Peck, A, Peterson, Ka, Phillips, Rw, Picco, Mf, Randall, C, Richards, Rj, Safdi, Ma, Scherl, Eh, Schwartz, Da, Schwartz, Hi, Schwartz, Jl, Sedghi, S, Shafran, I, Siegel, Ca, Sninsky, Ca, Stern, M, Suiter, D, Swaminath, A, Terdiman, Jp, Mahadevan, U, Thomson, C, Valentine, J, Vasudeva, R, Vecchio, Ja, Wolf, Dc, Yajnik, V, Yabkowski, J, Yen, E., AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and Hepatology, and Other departments

Subjects
Male, Oncology, MONOCLONAL-ANTIBODY, Drug Resistance, Disease, Severity of Illness Index, Crohn Disease, Maintenance therapy, IL-23, Adult, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Double-Blind Method, Female, Humans, Induction Chemotherapy, Maintenance Chemotherapy, Middle Aged, Remission Induction, Tumor Necrosis Factors, Ustekinumab, Monoclonal, Humanized, Settore MED/12 - Gastroenterologia, Crohn's disease, EXPERIMENTAL COLITIS, General Medicine, medicine.drug, medicine.medical_specialty, MONOCLONAL-ANTIBODY, RANDOMIZED-TRIAL, EXPERIMENTAL COLITIS, CERTOLIZUMAB PEGOL, INFLAMMATION, IL-23, INTERLEUKIN-12, ADALIMUMAB, INFLIXIMAB, DISCOVERY, Antibodies, CERTOLIZUMAB PEGOL, INFLAMMATION, Refractory, Internal medicine, INFLIXIMAB, medicine, business.industry, Induction chemotherapy, medicine.disease, RANDOMIZED-TRIAL, INTERLEUKIN-12, Clinical trial, DISCOVERY, Immunology, Tumor Necrosis Factor Inhibitors, business, ADALIMUMAB
Abstract

BACKGROUND In patients with Crohn's disease, the efficacy of ustekinumab, a human monoclonal antibody against interleukin-12 and interleukin-23, is unknown. METHODS We evaluated ustekinumab in adults with moderate-to-severe Crohn's disease that was resistant to anti-tumor necrosis factor (TNF) treatment. During induction, 526 patients were randomly assigned to receive intravenous ustekinumab (at a dose of 1, 3, or 6 mg per kilogram of body weight) or placebo at week 0. During the maintenance phase, 145 patients who had a response to ustekinumab at 6 weeks underwent a second randomization to receive subcutaneous injections of ustekinumab (90 mg) or placebo at weeks 8 and 16. The primary end point was a clinical response at 6 weeks. RESULTS The proportions of patients who reached the primary end point were 36.6%, 34.1%, and 39.7% for 1, 3, and 6 mg of ustekinumab per kilogram, respectively, as compared with 23.5% for placebo (P = 0.005 for the comparison with the 6-mg group). The rate of clinical remission with the 6-mg dose did not differ significantly from the rate with placebo at 6 weeks. Maintenance therapy with ustekinumab, as compared with placebo, resulted in significantly increased rates of clinical remission (41.7% vs. 27.4%, P = 0.03) and response (69.4% vs. 42.5%, P < 0.001) at 22 weeks. Serious infections occurred in 7 patients (6 receiving ustekinumab) during induction and 11 patients (4 receiving ustekinumab) during maintenance. Basal-cell carcinoma developed in 1 patient receiving ustekinumab. CONCLUSIONS Patients with moderate-to-severe Crohn's disease that was resistant to TNF antagonists had an increased rate of response to induction with ustekinumab, as compared with placebo. Patients with an initial response to ustekinumab had significantly increased rates of response and remission with ustekinumab as maintenance therapy. (Funded by Janssen Research and Development; CERTIFI ClinicalTrials.gov number, NCT00771667.)

Published
2012

6. Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn’s Disease After Ileocolonic Resection

Author

Silvio Danese, V. Yajnik, P. Gionchetti, Brian G. Feagan, Richard N. Fedorak, O. Dewit, D. Sorrentino, V. F. Annese, W J Sandborn, Michael Chiorean, G. Radford-Smith, S Plevy, I. Lawrance, Jane E. Onken, Simon Campbell, Jewel Johanns, Peter L. Lakatos, G R D’Haens, Denis Franchimont, J. C. Preiss, Giovanni Terrosu, Áron Vincze, Torsten Kucharzik, Charles Randall, I. Stein, Edward V. Loftus, L. Sauberman, X. Li, I. Oikonomou, Frank Zerbib, H. G. Lamprecht, R. Kottoor, J. Vecchio, Severine Vermeire, Daniel Rachmilewitz, J. R. Lachance, J.L. Dupas, W. H. Holderman, Michael Safdi, T. Haas, J.-F. Colombel, Richard B. Gearry, Russell S. Walmsley, R. P. Phillips, Miguel Regueiro, A. B. Hawthorne, David T. Rubin, J. W. Hamilton, G. D'Haens, M Parkes, Jean-Marie Reimund, Fabrizio Bossa, Walter Reinisch, K. A. Peterson, M. Ropeleski, S. Fishman, Marc Chevrier, Hans H Herfarth, Stephen B. Hanauer, Timothy H. Florin, Walter Fries, D. J. Hetzel, D. E. Elliott, János Banai, B. W. Behm, S. Sedghi, Remo Panaccione, Peter D.R. Higgins, Jean-Paul Achkar, Ziad Younes, Raja Atreya, Harald Vogelsang, M. Noar, S. S. Dhalla, U. Boecker, Raymond Bourdages, Ellen Scherl, Eran Goldin, T. Ritter, S. Gassner, Stefanie Howaldt, M. Ricci, Paolo Gionchetti, B. I. Leman, Marion Blank, D. Grunkmeier, Livia Biancone, J. Mudter, N. Chiba, Paolo Usai, R. Hardi, I. P. Beales, István Altorjay, W. J S Devilliers, J. Hill, Daniel C. Baumgart, Jason M. Swoger, Charles A. Sninsky, B. Singh Salh, L. D. Wruble, G. Bramkamp, Dario Sorrentino, Paul Rutgeerts, Stephen J. Bickston, S. Schreiber, D. J. Helper, Eric Lerebours, Jaroslaw Regula, M. D. Kreines, M. Strasser, C. Antoni, Giovanni Maconi, Freddy Cornillie, Laurent Peyrin-Biroulet, J. S. Hanson, Ewa Małecka-Panas, David Rowbotham, Jean-Charles Grimaud, Gerald Fraser, Ursula Seidler, C. Bünning, C. Berg, G. Reicht, Martin Lukas, John W. Popp, Edouard Louis, D. Laharie, Xavier Hébuterne, K. J. Brown, Márta Varga, L. Paradowski, Robert Ehehalt, Sandro Ardizzone, Stephanie Viennot, S. B. Hanauer, Charles N. Bernstein, Milan Lukas, H. Debinski, R. P. Schwarz, Simon Travis, D. I. Weinberg, D. Wallace, R. S. Stubbs, Bin Zou, A. Sloss, John Wyeth, Irit Avni-Biron, Peter Bossuyt, Ira Shafran, Matthieu Allez, Pierre Desreumaux, Michael Schultz, W. Reinisch, William J. Sandborn, APH - Amsterdam Public Health, 10 Public Health & Methodologie, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and Hepatology, AII - Amsterdam institute for Infection and Immunity, Intensive Care Medicine, UCL - SSS/IREC-Institut de recherche expérimentale et clinique, UCL - SSS/IREC/GAEN-Pôle d'Hépato-gastro-entérologie, UCL - (SLuc) Service de gastro-entérologie, Regueiro, M, Feagan, Bg, Zou, B, Johanns, J, Blank, Ma, Chevrier, M, Plevy, S, Popp, J, Cornillie, Fj, Lukas, M, Danese, S, Gionchetti, P, Hanauer, Sb, Reinisch, W, Sandborn, Wj, Sorrentino, D, Rutgeerts, P, Regueiro, Miguel, Feagan, Brian G., Zou, Bin, Johanns, Jewel, Blank, Marion A., Chevrier, Marc, Plevy, Scott, Popp, John, Cornillie, Freddy J., Lukas, Milan, Danese, Silvio, Gionchetti, Paolo, Hanauer, Stephen B., Reinisch, Walter, Sandborn, William J., Sorrentino, Dario, Rutgeerts, Paul, Debinski, H., Florin, T., Hetzel, D., Lawrance, I., Radford Smith, G., Sloss, A., Sorrentino, D., Gassner, S., Haas, T., Reicht, G., Reinisch, W., Strasser, M., Vogelsang, H., Bossuyt, P., Dewit, O., D'Haens, G., Franchimont, D., Louis, E., Vermeire, S., Bernstein, C. N., Bourdages, R., Chiba, N., Dhalla, S. S., Feagan, B. G., Fedorak, R. N., Lachance, J. R., Panaccione, R., Ropeleski, M., Singh Salh, B., Lukas, M., Colombel, J. F., Allez, M., Desreumaux, P., Dupas, J. L., Grimaud, J. C., Hebuterne, X., Laharie, D., Lerebours, E., Peyrin Biroulet, L., Reimund, J. M., Viennot, S., Zerbib, F., Antoni, C., Atreya, R., Baumgart, D. C., Berg, C., Boecker, U., Bramkamp, G., Bünning, C., Ehehalt, R., Howaldt, S., Kucharzik, T., Lamprecht, H. G., Mudter, J., Preiss, J. C., Schreiber, S., Seidler, U., Altorjay, I., Banai, J., Lakatos, P. L., Varga, M., Vincze, A., Avni Biron, I., Fishman, S., Fraser, G. M., Goldin, E., Rachmilewitz, D., Annese, V., Ardizzone, S., Biancone, L., Bossa, F., Danese, S., Fries, W., Gionchetti, P., Maconi, G., Terrosu, G., Usai, P., D'Haens, G. R., Gearry, R. B., Hill, J., Rowbotham, D. S., Schultz, M., Stubbs, R. S., Wallace, D., Walmsley, R. S., Wyeth, J., Malecka Panas, E., Paradowski, L., Regula, J., Beales, I. P., Campbell, S., Hawthorne, A. B., Parkes, M., Travis, S. P., Achkar, J. P., Behm, B. W., Bickston, S. J., Brown, K. J., Chiorean, M. V., Devilliers, W. J. S., Elliott, D. E., Grunkmeier, D., Hamilton, J. W., Hanauer, S. B., Hanson, J. S., Hardi, R., Helper, D. J., Herfarth, H., Higgins, P. D. R., Holderman, W. H., Kottoor, R., Kreines, M. D., Leman, B. I., Li, X., Loftus, E. V., Noar, M., Oikonomou, I., Onken, J., Peterson, K. A., Phillips, R. P., Randall, C. W., Ricci, M., Ritter, T., Rubin, D. T., Safdi, M., Sandborn, W. J., Sauberman, L., Scherl, E., Schwarz, R. P., Sedghi, S., Shafran, I., Sninsky, C. A., Stein, I., Swoger, J., Vecchio, J., Weinberg, D. I., Wruble, L. D., Yajnik, V., and Younes, Z.

Subjects
Adult, Male, musculoskeletal diseases, medicine.medical_specialty, Colon, medicine.medical_treatment, Colonoscopy, Klinikai orvostudományok, Placebo, law.invention, Anti-TNF, 03 medical and health sciences, 0302 clinical medicine, Crohn Disease, Double-Blind Method, Gastrointestinal Agents, Randomized controlled trial, Ileum, Recurrence, law, CDAI, Inflammatory Bowel Disease, PREVENT, Gastroenterology, Secondary Prevention, medicine, Clinical endpoint, Humans, Postoperative Period, Colectomy, Gastrointestinal agent, Hepatology, medicine.diagnostic_test, business.industry, Orvostudományok, Middle Aged, Crohn's Disease Activity Index, Infliximab, Surgery, Treatment Outcome, 030220 oncology & carcinogenesis, Female, 030211 gastroenterology & hepatology, business, medicine.drug
Abstract

Background & Aims Most patients with Crohn's disease (CD) eventually require an intestinal resection. However, CD frequently recurs after resection. We performed a randomized trial to compare the ability of infliximab vs placebo to prevent CD recurrence. Methods We evaluated the efficacy of infliximab in preventing postoperative recurrence of CD in 297 patients at 104 sites worldwide from November 2010 through May 2012. All study patients had undergone ileocolonic resection within 45 days before randomization. Patients were randomly assigned (1:1) to groups given infliximab (5 mg/kg) or placebo every 8 weeks for 200 weeks. The primary end point was clinical recurrence, defined as a composite outcome consisting of a CD Activity Index score >200 and a ≥70-point increase from baseline, and endoscopic recurrence (Rutgeerts score ≥i2, determined by a central reader) or development of a new or re-draining fistula or abscess, before or at week 76. Endoscopic recurrence was a major secondary end point. Results A smaller proportion of patients in the infliximab group had a clinical recurrence before or at week 76 compared with the placebo group, but this difference was not statistically significant (12.9% vs 20.0%; absolute risk reduction [ARR] with infliximab, 7.1%; 95% confidence interval: -1.3% to 15.5%; P =.097). A significantly smaller proportion of patients in the infliximab group had endoscopic recurrence compared with the placebo group (30.6% vs 60.0%; ARR with infliximab, 29.4%; 95% confidence interval: 18.6% to 40.2%; P

Published
2016

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