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1. Efficacy and safety of intravenous ustekinumab re-induction therapy in Crohn’s disease patients with secondary loss of response during ustekinumab maintenance therapy: week 16 results from the phase 3b POWER trial

Author

Schreiber, S., additional, Lee, S., additional, Van der Woude, C. J., additional, Marín-Jiménez, I., additional, Wolf, D., additional, Schnoy, E., additional, Salzberg, B., additional, Busse, C., additional, Nazar, M., additional, Langholff, W., additional, Borghorst, S., additional, Gasink, C., additional, Baker, T., additional, Godwin, B., additional, and Feagan, B., additional

Published
2023
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5. Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial

Author

Sands, B.E., Irving, P.M., Hoops, T., Izanec, J.L., Gao, L.L., Gasink, C., Greenspan, A., Allez, M., Danese, S., Hanauer, S.B., Jairath, V., Kuehbacher, T., Lewis, J.D., Loftus, E.V., Jr., Mihaly, E., Panaccione, R., Scherl, E., Hoentjen, F., Shchukina, O.B., Sandborn, W.J., Sands, B.E., Irving, P.M., Hoops, T., Izanec, J.L., Gao, L.L., Gasink, C., Greenspan, A., Allez, M., Danese, S., Hanauer, S.B., Jairath, V., Kuehbacher, T., Lewis, J.D., Loftus, E.V., Jr., Mihaly, E., Panaccione, R., Scherl, E., Hoentjen, F., Shchukina, O.B., and Sandborn, W.J.

Abstract

Item does not contain fulltext, BACKGROUND: Active-comparator trials are important to inform patient and physician choice. We aimed to evaluate the efficacy and safety of monotherapy with either ustekinumab or adalimumab in biologic-naive patients with moderately to severely active Crohn's disease. METHODS: We conducted a randomised, double-blind, parallel-group, active-comparator, phase 3b trial (SEAVUE) at 121 hospitals or private practices in 18 countries. We included biologic-naive patients aged 18 years or older with moderately to severely active Crohn's disease and a Crohn's Disease Activity Index (CDAI) score of 220-450, who had not responded to or were intolerant to conventional therapy (or were corticosteroid dependent) and had at least one ulcer of any size at baseline endoscopic evaluation. Eligible patients were randomly assigned (1:1; via an interactive web response system) to receive ustekinumab (approximately 6 mg/kg intravenously on day 0, then 90 mg subcutaneously once every 8 weeks) or adalimumab (160 mg on day 0, 80 mg at 2 weeks, then 40 mg once every 2 weeks, subcutaneously) through week 56. Study treatments were administered as monotherapy and without dose modifications. Patients, investigators, and study site personnel were masked to treatment group assignment. The primary endpoint was the proportion of patients who were in clinical remission (CDAI score <150) at week 52 in the intention-to-treat population (ie, all patients who were randomly assigned to a treatment group). This trial is registered with ClinicalTrials.gov, NCT03464136, and EudraCT, 2017-004209-41. FINDINGS: Between June 28, 2018, and Dec 12, 2019, 633 patients were assessed for eligibility and 386 were enrolled and randomly assigned to receive ustekinumab (n=191) or adalimumab (n=195). 29 (15%) of 191 patients in the ustekinumab group and 46 (24%) of 195 in the adalimumab group discontinued study treatment before week 52. There was no significant difference between the ustekinumab and adalimumab groups in th

Published
2022

14. P377 Impact of moderate-to-severe endoscopic disease criteria on endoscopic response, endoscopic remission, and deep remission in patients receiving ustekinumab or adalimumab in the SEAVUE study

Author

Allez, M, primary, Lewis, J D, additional, Hanauer, S B, additional, Danese, S, additional, Irving, P M, additional, Gasink, C, additional, Hoops, T, additional, Izanec, J L, additional, Ma, T, additional, Loftus, E V, additional, Scherl, E J, additional, Panaccione, R, additional, Sandborn, W J, additional, and Sands, B E, additional

Published
2022
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16. OP02 Ustekinumab versus adalimumab for induction and maintenance therapy in Moderate-to-Severe Crohn’s Disease: The SEAVUE study

Author

Irving, P M, primary, Sands, B E, additional, Hoops, T, additional, Izanec, J L, additional, Gao, L L, additional, Gasink, C, additional, Greenspan, A, additional, Allez, M, additional, Danese, S, additional, Hanauer, S B, additional, Jairath, V, additional, Kuehbacher, T, additional, Lewis, J D, additional, Loftus, E V, additional, Mihaly, E, additional, Panaccione, R, additional, Scherl, E, additional, Shchukina, O, additional, and Sandborn, W J, additional

Published
2021
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20. Long-term efficacy and safety of ustekinumab for Crohn's disease through the second year of therapy

Author

Sandborn, W. J., primary, Rutgeerts, P., additional, Gasink, C., additional, Jacobstein, D., additional, Zou, B., additional, Johanns, J., additional, Sands, B. E., additional, Hanauer, S. B., additional, Targan, S., additional, Ghosh, S., additional, de Villiers, W. J. S., additional, Colombel, J.-F., additional, and Feagan, B. G., additional

Published
2018
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21. 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, L-L, Miao, Y, Adedokun, OJ, Sands, BE, Hanauer, SB, Vermeire, S, Targan, S, Ghosh, S, de Villiers, WJ, Colombel, J-F, Tulassay, Z, Seidler, U, Salzberg, BA, Desreumaux, P, Lee, SD, Loftus, EV, Dieleman, LA, Katz, S, and Rutgeerts, P

Abstract

BACKGROUND\ud Ustekinumab, a monoclonal antibody to the p40 subunit of interleukin-12 and inter-leukin-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.\ud METHODS\ud 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 \ud 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 score

Published
2016

32. P281 Combined clinical and biological response (concomitant CRP and faecal calprotectin reductions) in induction and maintenance from the phase 3 ustekinumab Crohn’s disease studies

Author

Colombel, J -F, primary, Gasink, C, additional, Oortwijn, A, additional, van Kruchten, R, additional, Sloan, S, additional, Laliman, V, additional, Rutgeerts, P, additional, Ghosh, S, additional, Sandborn, W, additional, Feagan, B, additional, and Sands, B, additional

Published
2018
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35. LONG-TERM EFFICACY AND SAFETY OF USTEKINUMAB FOR CROHN’S DISEASE: RESULTS FROM IM-UNITI LONG-TERM EXTENSION THROUGH 2 YEARS

Author

Sandborn, W., primary, Rutgeerts, P., additional, Gasink, C., additional, Jacobstein, D., additional, Gao, L., additional, Johanns, J., additional, Sands, B., additional, Hanauer, S., additional, Targan, S., additional, Ghosh, S., additional, Villiers, W., additional, Colombel, J., additional, Feagan, B., additional, and Silva, Bruno, additional

Published
2017
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36. OC-043 Long term efficacy and safety of ustekinumab for crohn’s disease: results from im-uniti long-term extension through 2 years

Author

Sandborn, WJ, primary, Rutgeerts, P, additional, Gasink, C, additional, Jacobstein, D, additional, Gao, L, additional, Johanns, J, additional, Sands, B, additional, Hanauer, S, additional, Targan, S, additional, Ghosh, S, additional, Villiers, WJS de, additional, Colombel, JF, additional, and Feagan, BG, additional

Published
2017
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39. OC-005 A Multicenter, Double-Blind, Placebo (PBO)-Controlled Ph3 Study of Ustekinumab (UST), A Human IL-12/23P40 MAB, in Moderate-Severe Crohn’s Disease (CD) Refractory to anti-TNFΑ: UNITI-1

Author

Rutgeerts, P, primary, Gasink, C, additional, Blank, M, additional, Lang, Y, additional, Johanns, J, additional, Gao, L-L, additional, Sands, B, additional, Hanauer, S, additional, Feagan, B, additional, Targan, S, additional, Ghosh, S, additional, de Villiers, W, additional, Colombel, J-F, additional, Lee, SD, additional, Desreumaux, P, additional, Loftus, EV, additional, Vermeire, S, additional, and Sandborn, WJ, additional

Published
2016
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40. OC-007 A Multicenter, Double-Blind, Placebo (PBO)-Controlled Ph3 Study of Ustekinumab (UST), A’Human MAB to IL-12/23P40, IN PTS with Moderately-Severely Active Crohn’s Disease (CD) Who are Naïve or not Refractory to anti-TNFΑ: UNITI-2: Abstract OC-007 Table 1

Author

Feagan, B, primary, Gasink, C, additional, Lang, Y, additional, Friedman, JR, additional, Johanns, J, additional, Gao, L-L, additional, Sands, B, additional, Hanauer, S, additional, Rutgeerts, P, additional, Targan, S, additional, Ghosh, S, additional, de Villiers, W, additional, Colombel, J-F, additional, Tulassay, Z, additional, Seidler, U, additional, and Sandborn, WJ, additional

Published
2016
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41. 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

45. 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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46. 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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47. 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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49. AODWE-006 Efficacy of ustekinumab for induction and maintenance of histological healing in patient’s with crohn’s disease

Author

Li, K, Chan, D, Pollack, P, Jacobstein, D, Brodmerkel, C, Gasink, C, Feagan, B, Sandborn, W, Rutgeerts, P, and Hertogh, G De

Abstract

IntroductionUstekinumab (UST) has been shown to induce and maintain clinical response and remission and to produce clinically meaningful endoscopic improvement in patients with moderate-severe Crohn’s disease (CD). Effects of UST on histologic CD activity were evaluated in a substudy of the induction (UNITI-1 and 2) and maintenance (IM-UNITI) Phase 3 studies.MethodBiopsies were taken at induction baseline(I-Wk0), Wk8(I-Wk8), and maintenance Wk44(M-Wk44) from 3 sites (ileum, splenic flexure, rectum) and blindly scored by an expert GI pathologist (GDH) using the Global Histology Activity Score (GHAS1). At I-Wk0, pts received a single IV dose (UST 130 mg, UST~6 mg/kg, or PBO). At I-Wk8, UST induction responders were re-randomised to subcutaneous (SC) PBO, UST 90 mg q12w or UST 90 mg q8w. Histology data from 251 substudy pts with simple endoscopic score for CD (SES-CD)≥3 at I-Wk0 were eligible for analysis. The relationship between GHAS and SES-CD was evaluated by Spearman correlation. Histologic improvements were assessed within groups (UST, PBO) and between groups (UST vs. PBO, at I-Wk0, I-Wk8 and M-Wk44).ResultsRegional and overall GHAS were moderately correlated with SES-CD at all timepoints (r~0.6, p<0.001). GHAS was significantly reduced at I-Wk8 in pts treated with UST (from 10.4 to 7.1, p<0.001) but not PBO (from 9.2 to 7.8). At M-Wk44 in the randomised population, a continued reduction in GHAS from I-Wk8 was observed with UST 90 mg SC q8w (from 7.39 to 6.07, p=0.07) but not UST 90 mg SC q12w (from 5.29 to 8.67) or PBO (from 9.19 to 10.85). In the pooled maintenance population (randomised and non-randomised), continued histologic improvement from I-Wk8 was observed with UST 90 mg q8w (7.14 to 5.19, p<0.0001), but not UST 90 mg q12w (from 6.14 to 7.18) or PBO (from 8.19 to 8.85). Consistent results are observed in between-group (UST vs. PBO) analyses, numerically greater GHAS reduction was observed for UST.ConclusionHistologic and endoscopic disease activities were moderately correlated. Consistent with previously reported results, statistically significant histologic improvements were observed in pts induced with UST, but not PBO. Trends for greater and continued histologic improvement were observed in pts who received UST 90 mg q8w maintenance.Disclosure of InterestK Li Conflict with: Janssen R and D, D Chan Conflict with: Janssen R and D, P Pollack Conflict with: Janssen R and D, D Jacobstein Conflict with: Janssen R and D, C Brodmerkel Conflict with: Janssen R and D, C Gasink Conflict with: Janssen R and D, B Feagan: None Declared, W Sandborn: None Declared, P Rutgeerts: None Declared, G De Hertogh: None Declared

Published
2017
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50. OC-045 Efficacy & safety of dose adjustment & delayed response to ustekinumab in moderate–severe crohn’s disease patients: results from im-uniti maintenance study

Author

Sands, B, Gasink, C, Jacobstein, D, Gao, L, Johanns, J, Szapary, P, Colombel, J, Targan, S, Ghosh, S, and Sandborn, W

Abstract

IntroductionUstekinumab (UST) induced/maintained clinical response (CR) and remission (CRM) in mod-severe Crohn’s disease (CD) as shown in 2 induction (UNITI-1 and 2) and 1 maintenance (IM-UNITI) RCT, placebo (PBO) controlled phIII trials. We evaluated UST efficacy in 2 more grps in IM-UNITI: pts undergoing dose adjustment after loss of response (LOR) and pts without a CR to IV UST during induction and had an additional SC dose.MethodPts achieving CR after single dose IV induction randomised to SC PBO, UST 90 mg/q12w or q8w. Pts meeting LOR criteria (i.e. CDAI ≥220 and a≥100 point ←from baseline maintenance CDAI score, between wks 8–32 of IM-UNITI trial) underwent a single dose adjustment as follows: PBO→q8w, q12w→q8w, and q8w→q8w (no dose adjustment) and assessed for CR (≥100 point ↓in CDAI) and CRM (CDAI <150) 16 wks later. Separately, UST pts not in CR 8 wks after IV dose given SC UST 90 mg and if CR 8 wks later stayed on q8w.Results51 (39%), 29 (23%), and 28 (22%) pts in PBO, q12w and q8w grps, respectively, had dose adjustment after meeting LOR criteria. We observed CRM and CR in 39% and 71% of pts adjusting PBO→q8w (situation similar to drug holiday), 41%–55% in q12w→q8w grp and 32%–46% in q8w→q8w grp assessed 16 wks later respectively (Table 1). Median CDAI change after adjustment was −121,–141 and −78.5 in PBO→q8w, q12w→q8w and q8w→q8w grs, respectively. UST 467 pts not in response after IV dose,50.5%–28.9% had CR and CRM 8 wks after 1 extra UST dose (90 mg SC). Of 251 of these pts continued dosing at wk 8 of maintenance, 68.1% had CR and 50.2% CRM at wk 44. No ←or changes in AEs seen among dose adjustment pts.ConclusionPts meeting LOR criteria, dose adjustment from UST 90 mg/q12w to q8w had some additional clinical benefit vs pts remaining on UST 90 mg/q8w. Initial induction non-responders pts can benefit from continued treatment with at least 1 SC UST dose 8 wks after IV induction.Disclosure of InterestB. Sands: None Declared, C. Gasink Conflict with: Janssen R and D, LLC, D. Jacobstein Conflict with: Janssen R and D, LLC, L. Gao Conflict with: Janssen R and D, LLC, J. Johanns Conflict with: Janssen R and D, LLC, P. Szapary Conflict with: Janssen R and D, LLC, J. Colombel: None Declared, S. Targan: None Declared, S. Ghosh: None Declared, W. Sandborn: None Declared

Published
2017
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