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001-es BibID:	BIBFORM072422
Első szerző:	Feagan, Brian
Cím:	Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease / Feagan B. G., Sandborn W. J., Gasink C., Jacobstein D., Lang Y., Friedman J. R., Blank M. A., Johanns J., Gao L. L., Miao Y., Adedokun O. J., Sands B. E., Hanauer S. B., Vermeire S., Targan S., Ghosh S., de Villiers W. J., Colombel J. F., Tulassay Z., Seidler U., Salzberg B. A., Desreumaux P., Lee S. D., Loftus E. V. Jr., Dieleman L. A., Katz S., Rutgeerts P., UNITI-IM-UNITI Study Group
Dátum:	2016
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban ustekinumab, Crohn's disease
Megjelenés:	The New England journal of medicine 375 : 20 (2016), p. 1946-1960. -
További szerzők:	Sandborn, William J. Gasink, C. Jacobstein, D. Lang, Y. Friedman, J. Blank, Marion Johanns, Jewel Gao, L. L. Miao, Y. Adedokun, Omoniyi J. Sands, Bruce E. Hanauer, Stephen B. Vermeire, S. Targan, Stephan Ghosh, Subrata de Villiers, W. J. Colombel, J. F. Tulassay Zsolt (1944-) (belgyógyász, gasztroenterológus) Seidler, U. Salzberg, B. A. Desreumaux, P. Lee, S. D. Loftus, Edward V. Dieleman, L. A. Katz, Seymour Rutgeerts, Paul Altorjay István (1954-) (belgyógyász, gasztroenterológus, onkológus) UNITI-IM-UNITI Study Group
Internet cím:	DOI Intézményi repozitóriumban (DEA) tárolt változat
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001-es BibID:	BIBFORM036076
035-os BibID:	PMID:19637334
Első szerző:	Reinisch, Walter
Cím:	Fontolizumab in moderate to severe Crohn's disease: a phase 2, randomized, double-blind, placebo-controlled, multiple-dose study / Walter Reinisch, Williem de Villiers, László Bene, László Simon, István Rácz, Seymour Katz, István Altorjay, Brian Feagan, Dennis Riff, Charles N. Bernstein, Daniel Hommes, Paul Rutgeerts, Antoine Cortot, Michael Gaspari, May Cheng, Tillman Pearce, Bruce E. Sands
Dátum:	2010
ISSN:	1078-0998
Megjegyzések:	BACKGROUND: The safety and efficacy of fontolizumab, a humanized anti-interferon gamma antibody, was investigated in patients with Crohn's disease (CD). Elevated gut mucosal levels of interferon gamma, a key cytokine involved in the inflammatory process of CD, are associated with disease symptoms. METHODS: A total of 201 patients with Crohn's Disease Activity Index (CDAI) scores between 250 and 450 were randomized to receive an initial intravenous dose of 1.0 or 4.0 mg/kg fontolizumab or placebo, followed by up to 3 subcutaneous doses of 0.1 or 1.0 mg/kg fontolizumab or placebo every 4 weeks. Clinical response at day 29, the primary efficacy endpoint, was defined as a decrease in the CDAI of at least 100 points from baseline levels. RESULTS: Of 201 patients, 135 (67%) completed the study. Day 29 response rates were similar in all treatment groups (31%-38%). At subsequent timepoints a significantly greater proportion of patients in the 1.0 mg/kg intravenous / 1.0 mg/kg subcutaneous fontolizumab group had clinical response and significantly greater improvement in the CDAI score compared with patients who received placebo. All fontolizumab groups had significant improvement in C-reactive protein levels. The overall frequency of adverse events was similar in all groups (58%-75%); most events were related to exacerbation of CD. There was a low frequency (5.2%) of neutralizing antibodies to fontolizumab. CONCLUSIONS: Although a strong clinical response to fontolizumab was not observed, significant decreases in C-reactive protein levels suggest a biological effect. Fontolizumab was well tolerated, and further studies to assess its efficacy are warranted.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban külföldön készült közlemény
Megjelenés:	Inflammatory Bowel Diseases 16 : 2 (2010), p. 233-42. -
További szerzők:	Villiers, Williem de Bene László (Budapest) Simon László (orvos Szekszárd) Rácz István (orvos Győr) Katz, Seymour Altorjay István (1954-) (belgyógyász, gasztroenterológus, onkológus) Feagan, Brian Riff, Dennis Bernstein, Charles N. Hommes, Daniel Rutgeerts, Paul Cortot, Antoine Gaspari, Michael Cheng, May Pearce, Tillman Sands, Bruce E.
Internet cím:	Szerző által megadott URL DOI Intézményi repozitóriumban (DEA) tárolt változat
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001-es BibID:	BIBFORM083110
Első szerző:	Sands, Bruce E.
Cím:	Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis / Sands Bruce E., Sandborn William J., Panaccione Remo, O'Brien Christopher D., Zhang Hongyan, Johanns Jewel, Adedokun Omoniyi J., Li Katherine, Peyrin-Biroulet Laurent, Van Assche Gert, Danese Silvio, Targan Stephan, Abreu Maria T., Hisamatsu Tadakazu, Szapary Philippe, Marano Colleen, UNIFI Study Group
Dátum:	2019
ISSN:	0028-4793
Megjegyzések:	BACKGROUND The efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown. METHODS We evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. A total of 961 patients were randomly assigned to receive an intravenous induction dose of ustekinumab (either 130 mg [320 patients] or a weight-range?based dose that approximated 6 mg per kilogram of body weight [322]) or placebo (319). Patients who had a response to induction therapy 8 weeks after administration of intravenous ustekinumab were randomly assigned again to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 12 weeks [172 patients] or every 8 weeks [176]) or placebo (175). The primary end point in the induction trial (week 8) and the maintenance trial (week 44) was clinical remission (defined as a total score of ?2 on the Mayo scale [range, 0 to 12, with higher scores indicating more severe disease] and no subscore >1 [range, 0 to 3] on any of the four Mayo scale components). RESULTS The percentage of patients who had clinical remission at week 8 among patients who received intravenous ustekinumab at a dose of 130 mg (15.6%) or 6 mg per kilogram (15.5%) was significantly higher than that among patients who received placebo (5.3%) (P<0.001 for both comparisons). Among patients who had a response to induction therapy with ustekinumab and underwent a second randomization, the percentage of patients who had clinical remission at week 44 was significantly higher among patients assigned to 90 mg of subcutaneous ustekinumab every 12 weeks (38.4%) or every 8 weeks (43.8%) than among those assigned to placebo (24.0%) (P = 0.002 and P<0.001, respectively). The incidence of serious adverse events with ustekinumab was similar to that with placebo. Through 52 weeks of exposure, there were two deaths (one each from acute respiratory distress syndrome and hemorrhage from esophageal varices) and seven cases of cancer (one each of prostate, colon, renal papillary, and rectal cancer and three nonmelanoma skin cancers) among 825 patients who received ustekinumab and no deaths and one case of cancer (testicular cancer) among 319 patients who received placebo. CONCLUSIONS Ustekinumab was more effective than placebo for inducing and maintaining remission in patients with moderate-to-severe ulcerative colitis. (Funded by Janssen Research and Development; UNIFI ClinicalTrials.gov number, NCT02407236.)
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban colitis ulcerative colitis ustekinumab
Megjelenés:	New England Journal Of Medicine. - 381 : 13 (2019), p. 1201-1214. -
További szerzők:	Sandborn, William J. Panaccione, Remo O'Brien, Christopher D. Zhang, Hongyan Johanns, Jewel Adedokun, Omoniyi J. Li, Katherine Peyrin-Biroulet, Laurent Van Assche, Gert Danese, Silvio Targan, Stephan Abreu, Maria T. Hisamatsu, Tadakazu Szapary, Philippe Marano, Colleen Altorjay István (1954-) (belgyógyász, gasztroenterológus, onkológus) UNIFI Study Group
Internet cím:	Szerző által megadott URL DOI Intézményi repozitóriumban (DEA) tárolt változat
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001-es BibID:	BIBFORM083108
Első szerző:	Sands, Bruce E.
Cím:	Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis / Sands Bruce E., Peyrin-Biroulet Laurent, Loftus Edward V., Danese Silvio, Colombel Jean-Frédéric, Törüner Murat, Jonaitis Laimas, Abhyankar Brihad, Chen Jingjing, Rogers Raquel, Lirio Richard A., Bornstein Jeffrey D., Schreiber Stefan, VARSITY Study Group
Dátum:	2019
ISSN:	0028-4793
Megjegyzések:	BACKGROUND Biologic therapies are widely used in patients with ulcerative colitis. Head-to-head trials of these therapies in patients with inflammatory bowel disease are lacking. METHODS In a phase 3b, double-blind, double-dummy, randomized, active-controlled trial conducted at 245 centers in 34 countries, we compared vedolizumab with adalimumab in adults with moderately to severely active ulcerative colitis to determine whether vedolizumab was superior. Previous exposure to a tumor necrosis factor inhibitor other than adalimumab was allowed in up to 25% of patients. The patients were assigned to receive intravenous infusions of 300 mg of vedolizumab on day 1 and at weeks 2, 6, 14, 22, 30, 38, and 46 (plus injections of placebo) or subcutaneous injections of 40 mg of adalimumab, with a total dose of 160 mg at week 1, 80 mg at week 2, and 40 mg every 2 weeks thereafter until week 50 (plus infusions of placebo). Dose escalation was not permitted in either group. The primary outcome was clinical remission at week 52 (defined as a total score of ?2 on the Mayo scale [range, 0 to 12, with higher scores indicating more severe disease] and no subscore >1 [range, 0 to 3] on any of the four Mayo scale components). To control for type I error, efficacy outcomes were analyzed with the use of a hierarchical testing procedure, with the variables in the following order: clinical remission, endoscopic improvement (subscore of 0 to 1 on the Mayo endoscopic component), and corticosteroid-free remission at week 52. RESULTS A total of 769 patients underwent randomization and received at least one dose of vedolizumab (383 patients) or adalimumab (386 patients). At week 52, clinical remission was observed in a higher percentage of patients in the vedolizumab group than in the adalimumab group (31.3% vs. 22.5%; difference, 8.8 percentage points; 95% confidence interval [CI], 2.5 to 15.0; P = 0.006), as was endoscopic improvement (39.7% vs. 27.7%; difference, 11.9 percentage points; 95% CI, 5.3 to 18.5; P<0.001). Corticosteroid-free clinical remission occurred in 12.6% of the patients in the vedolizumab group and in 21.8% in the adalimumab group (difference, ?9.3 percentage points; 95% CI, ?18.9 to 0.4). Exposure-adjusted incidence rates of infection were 23.4 and 34.6 events per 100 patient-years in the vedolizumab group and adalimumab group, respectively, and the corresponding rates for serious infection were 1.6 and 2.2 events per 100 patient-years. CONCLUSIONS In this trial involving patients with moderately to severely active ulcerative colitis, vedolizumab was superior to adalimumab with respect to achievement of clinical remission and endoscopic improvement, but not corticosteroid-free clinical remission. (Funded by Takeda; VARSITY ClinicalTrials.gov number, NCT02497469; EudraCT number, 2015 - 000939 - 33.)
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban ulceratice colitis colitis vedolizumab adalimumab
Megjelenés:	New England Journal Of Medicine. - 381 : 13 (2019), p. 1215-1226. -
További szerzők:	Peyrin-Biroulet, Laurent Loftus, Edward V. Danese, Silvio Colombel, J. F. Törüner, Murat Jonaitis, Laimas Abhyankar, Brihad Chen, Jingjing Rogers, Raquel Lirio, Richard A. Bornstein, Jeffrey D. Schreiber, Stefan Altorjay István (1954-) (belgyógyász, gasztroenterológus, onkológus) VARSITY Study Group
Internet cím:	Szerző által megadott URL DOI Intézményi repozitóriumban (DEA) tárolt változat
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