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25. 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

27. Chronic urticaria and blastocystis hominis infection: a case report

Author

Pasqui, A. L., Savini, E., Saletti, M., Guzzo, C., LUCA PUCCETTI, and Auteri, A.

Subjects
Urticaria, Gastrointestinal Diseases, Paromomycin, Blastocystis Infections, Middle Aged, Drug Administration Schedule, Diagnosis, Differential, Drug Hypersensitivity, Feces, Italy, Metronidazole, Chronic Disease, Animals, Humans, Blastocystis hominis, Female, Food Hypersensitivity
Abstract

We report a case of a 45 year old woman which fulfilled the criteria of chronic urticaria (remitting and relapsing bouts of erythematous and pruriginuos lesions without angioedema, lasted four months). Cutaneous manifestations were not related to a specific inducing factor, had no benefit from antihystamine and steroid drugs and were associated sometimes with mild gastroentric disorders. Patient was submitted to extensive clinical, laboratory and intrumental investigations which permit to exclude many conditions: allergy to inhalants, food, insects and drug adverse reactions, autoimmune urticaria, autoimmune diseases, neoplastic and infectious diseases. Finally coprocolture disclosed the presence of Blastocystis hominis in stool samples thus permitting to associate urticaria to parasitic infection. Both cutaneous manifestations and mild abdomen disturbs disappeared after appropriate treatment. Despite the high diffusion the aetiopathogenesis of chronic urticaria remains often undefined. A large number of parasites have been correlated with urticaria but few data exist as regards Blastocystis hominis infection; then our findings may add evidence to the role of this parasite in inducing chronic urticaria. Considering that Blastocystis hominis is a modest pathogen for humans, the mechanism is probably the typical one of cutaneous allergic hypersensitivity; antigen parasites induce the activation of specific clones of Th2 lymphocytes, the release of related cytokines and the consequent IgE production.

Published
2004

28. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis.

Author

Griffiths, C.E., Strober, B.E., Kerkhof, P.C.M. van de, Ho, V., Fidelus-Gort, R., Yeilding, N., Guzzo, C., Xia, Y., Zhou, B., Li, S., Dooley, L.T., Goldstein, N.H., Menter, A., Griffiths, C.E., Strober, B.E., Kerkhof, P.C.M. van de, Ho, V., Fidelus-Gort, R., Yeilding, N., Guzzo, C., Xia, Y., Zhou, B., Li, S., Dooley, L.T., Goldstein, N.H., and Menter, A.

Abstract

Contains fulltext : 89832.pdf (publisher's version ) (Closed access), BACKGROUND: Biologic agents offer a range of new therapeutic options for patients with psoriasis; however, the relative benefit-risk profiles of such therapies are not well known. We compared two biologic agents, ustekinumab (an interleukin-12 and interleukin-23 blocker) and etanercept (an inhibitor of tumor necrosis factor alpha), for the treatment of psoriasis. METHODS: We randomly assigned 903 patients with moderate-to-severe psoriasis to receive subcutaneous injections of either 45 or 90 mg of ustekinumab (at weeks 0 and 4) or high-dose etanercept (50 mg twice weekly for 12 weeks). The primary end point was the proportion of patients with at least 75% improvement in the psoriasis area-and-severity index (PASI) at week 12; a secondary end point was the proportion with cleared or minimal disease on the basis of the physician's global assessment. Assessors were unaware of the treatment assignments. The efficacy and safety of a crossover from etanercept to ustekinumab were evaluated after week 12. RESULTS: There was at least 75% improvement in the PASI at week 12 in 67.5% of patients who received 45 mg of ustekinumab and 73.8% of patients who received 90 mg, as compared with 56.8% of those who received etanercept (P=0.01 and P<0.001, respectively). Similarly, 65.1% of patients who received 45 mg of ustekinumab and 70.6% of patients who received 90 mg of ustekinumab had cleared or minimal disease according to the physician's global assessment, as compared with 49.0% of those who received etanercept (P<0.001 for both comparisons). Among patients who did not have a response to etanercept, 48.9% had at least 75% improvement in the PASI within 12 weeks after crossover to ustekinumab. One or more adverse events occurred through week 12 in 66.0% of patients who received 45 mg of ustekinumab and 69.2% of patients who received 90 mg of ustekinumab and in 70.0% who received etanercept; 1.9%, 1.2%, and 1.2%, respectively, had serious adverse events. Safety patterns were simila

Published
2010

30. P225 Impact of subcutaneously administered golimumab on disease specific and generic health-related quality of life in patients with moderately to severely active ulcerative colitis: Results from PURSUIT-SC induction

Author

Feagan, B., primary, Gibson, P., additional, Marano, C., additional, Strauss, R., additional, Han, C., additional, Johanns, J., additional, Zhang, H., additional, Guzzo, C., additional, Colombel, J.-F., additional, Reinisch, W., additional, Collins, J., additional, Jarnerot, G., additional, Rutgeerts, P., additional, and Sandborn, W., additional

Published
2013
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31. P142 Subcutaneously administered golimumab induction therapy improves health states measured by EQ-5D in patients with moderately to severely active ulcerative colitis: results from PURSUIT-SC

Author

Gibson, P., primary, Feagan, B., additional, Marano, C., additional, Strauss, R., additional, Han, C., additional, Johanns, J., additional, Zhang, H., additional, Guzzo, C., additional, Colombel, J.-F., additional, Reinisch, W., additional, Collins, J., additional, Jarnerot, G., additional, Rutgeerts, P., additional, and Sandborn, W., additional

Published
2013
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33. P300 Health related quality of life results through week 22 from the CERTIFI study, a multicenter, randomized, double-blind, placebo-controlled Phase2b study of ustekinumab in patients with moderately to severely active Crohn's disease

Author

Feagan, B., primary, Gasink, C., additional, Gao, L.-L., additional, Blank, M., additional, Johanns, J., additional, Guzzo, C., additional, Chiou, C.-F., additional, Sandborn, W., additional, Hanauer, S.B., additional, Targan, S., additional, Rutgeerts, P., additional, Ghosh, S., additional, De Villiers, W., additional, Panaccione, R., additional, Greenberg, G., additional, Schreiber, S., additional, Lichtiger, S., additional, and Sands, B., additional

Published
2012
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34. Health related quality of life results through week 22 from the CERTIFI study, a multicenter, randomized, double-blind, placebo-controlled phase2b study of Ustekinumab in patients with moderately to severely active Crohnʼs disease

Author

Sands, BE, primary, Gasink, C, additional, Gao, L-L, additional, Blank, MA, additional, Johanns, J, additional, Guzzo, C, additional, Chiou, C-F, additional, Sandborn, WJ, additional, Hanauer, SB, additional, Targan, S, additional, Rutgeerts, P, additional, Ghosh, S, additional, de Villiers, W, additional, Panaccione, R, additional, Greenberg, G, additional, Schreiber, S, additional, Lichtiger, S, additional, and Feagan, BG, additional

Published
2011
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35. A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Study of Ustekinumab, a Human Monoclonal Antibody to Il-12/23p40, in Patients with Moderately to Severely Active Crohnʼs Disease: Results through Week 36 from the CERTIFI Trial: 2011 ACG Presidential Poster

Author

Feagan, Brian, primary, Gasink, C., additional, Gao, L., additional, Blank, M., additional, Johanns, J., additional, Guzzo, C., additional, Sands, B., additional, Hanauer, Stephen, additional, Targan, S., additional, Rutgeerts, P., additional, Ghosh, S., additional, de Villiers, W., additional, Panaccione, R., additional, Greenberg, G., additional, Schreiber, S., additional, Lichtiger, S., additional, and Sandborn, William, additional

Published
2011
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48. Phosphate-induced hypocalcaemia and experimental digitalis intoxication.

Author

ABITBOL, A., ABATE, C. D., ARIAS, A., CUSIMANO, L., and GUZZO, C.

Abstract

The effects of inorganic phosphate-induced hypocalcaemia on experimental digitalis intoxication were studied in 75 dogs. In the control digitalized group four animals died of ventricular fibrillation, eight remained with frank signs of intoxication at the end of the 180 min period, and in three animals the ECG returned to normal. Intravenous infusion of inorganic disodium monopotassium phosphate induced a return to normal of the ECG, in all cases, in 38·5 ± 22 min. Infusions of a buffered glucose or a potassium chloride solution were ineffective. In the phosphate treated group, a marked decrease in serum calcium was observed; in the other groups changes in serum Ca were not significant. Potassium, pH, and HCO3− changes were not significant in any group. [ABSTRACT FROM PUBLISHER]

Published
1974

49. Some Considerations Regarding the Sacrifical Precincts at Tas-Silġ

Author

Ciasca, Antonia, Schembri, Anthony, Frendo, Anthony J., Guzzo, C., and Scardocci, M.

Abstract

On-going studies on the Phoenician and Punic sanctuary at Tas-Silġ, to which the University of Rome, ‘La Sapienza’ had dedicated eight seasons of excavation, link up with recent courses of enquiry in interdisciplinary research which involves archaeologists, enigraphists, historians of religions, and those dealing with problems relating to places of cult in the ancient Mediterranean. This paper proposes an evaluation of the distributions of areas of the sanctuary, and a formal, cultural, and religious reconstruction of the series of altars in its temenos.

Published
1993

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