Evidence Rating Level: 1 (Excellent) Study Rundown: Ulcerative colitis (UC) is a chronic disease, which Methods: We evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. Presented at the . goals in the management of ulcerative colitis (uc) include induction and maintenance of remission with resumption of normal bowel habits, cessation of rectal bleeding and abdominal pain, and reduction in corticosteroid use., although control of clinical symptoms remains a fundamental therapeutic objective, endoscopic remission as a complementary Induction study will be at least 8 weeks duration for each participant. 1 A subset of patients responded to the induction dose of UST and achieved clinical remission at maintenance Week 44 (M-Week 44) following placebo (PBO) maintenance. Ustekinumab (UST) is an effective therapy for moderate-to-severe ulcerative colitis (UC). METHODS: We evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. Screening period will be up to 8 Weeks. In September 2014, a subcutaneous induction treat-ment with ustekinumab (90 mg at Weeks 0 and 4) was started, followed by every 8 weeks maintenance at 90 mg. An endoscopy performed at baseline showed diffuse inflammation in the pouch with multiple super - ficial ulcers. In September 2019, results of a large phase 3 clinical trial, the UNIFI (A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis) trial were published. Serum Concentration of Ustekinumab [ Time Frame: Up to 74 weeks ] Serum samples will be analyzed to determine concentrations of ustekinumab. The 44-week clinical remission rate in the UC trial (q 8-week dosing) was 43.8% as compared with 24% in those . Induction of mucosal healing by intensive granulocyte/monocyte adsorptive apheresis (GMA) without use of corticosteroids in patients with ulcerative colitis: long-term remission maintenance after induction by GMA and efficacy of GMA re-treatment upon Maintenance dose: A subQ 90-mg dose administered every 8 weeks after the induction dose. Search. We evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. Rubin 6 , L. Peyrin-Biroulet 7 , J.R. Friendman 1 , G. De Hertogh 8 UST is an IgG1 kappa monoclonal antibody directed at the shared p40 subunit of IL-12 (p35/p40) and . Ustekinumab (Stelara ), a non-selective anti-IL12/23 p40 monoclonal antibody, which has not yet been approved for use in ulcerative colitis patients by the FDA in the U.S.A. For this patient, a modified version of therapy was then designed to improve efficacy of regiments for the ulcerative colitis. Phase 3 trial evaluated ustekinumab as a maintenance treatment in adult patients with moderate-to-severe ulcerative colitis. A total of 961 patients were ran- The clinical and molecular characteristics of this group are unknown. N Engl J Med 381(13):1201-1214. METHODS: We evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. The therapeutic management of patients with severe steroid-refractory ulcerative colitis still represents a critical clinical challenge. 18 UNIFI was started in July 2015 and included a total of 961 UC patients demonstrating that ustekinumab is also effective and safe in . Risk of Treatment Discontinuation among Patients with Psoriasis Initiated on Ustekinumab and Other Biologics in the USA Aditi Shah 2022, Dermatology and Therapy 11, 12 However,. Ustekinumab as induction and maintenance therapy for ulcerative colitis. Ustekinumab (Stelara; Johnson and Johnson) produced sustained efficacy and safety over 4 years in adult patients with moderately to severely active ulcerative colitis (UC), according to final data from the long-term extension (LTE) phase 3 UNIFI trial. unifi is a phase 3 protocol, designed to evaluate the safety and efficacy of ustekinumab induction and maintenance dosing for the treatment of moderate to severe uc in adults who demonstrated. Ustekinumab was approved in 2016 for the treatment of moderately to severely active Crohn's disease. Methods SPRING HOUSE, PENNSYLVANIA, October 10, 2022 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced final data from the l. 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). The protocol will consist of 2 studies: an Induction study and a Maintenance study with unique endpoints. During SC maintenance of therapy with 90 mg ustekinumab, steady-state SUC occurred at approximately maintenance week 8 (16 weeks after IV induction), with dosing every 8 weeks and at approximately maintenance week 12 (20 weeks after IV induction) with every 12 weeks dosing. Request PDF | Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis | To the Editor: Sands et al. Phase 3 trial evaluated ustekinumab as a maintenance treatment in adult patients with moderate-to-severe ulcerative colitis. UNIFI is a Phase 3 protocol designed to evaluate the safety and efficacy of STELARA induction and maintenance dosing for the treatment of moderate to severe ulcerative colitis in adults who . Maintenance therapy begins 8 weeks after the induction dose and consists of subcutaneous ustekinumab 90 mg administered every 12 weeks thereafter. Treatment with ozanimod was shown to have a significantly higher clinical response during induction and maintenance of ulcerative colitis. Ustekinumab as induction and maintenance therapy for ulcerative colitis. Sands BE1, Sandborn WJ1, Panaccione R1, O'Brien CD1, Zhang H1, Johanns J1, Adedokun OJ1, Li K1, Peyrin-Biroulet L1, Van Assche G1, Danese S1, Targan S1, Abreu MT1, Hisamatsu T1, Szapary P1, Marano C1, UNIFI Study Group Collaborators (284) Brown S, Connor S, De Cruz P, Ding NJ, P712 Association of histologic-endoscopic mucosal healing after ustekinumab induction or maintenance therapy with 2-year outcomes in the UNIFI Phase 3 study in ulcerative colitis K. Li 1 , F. Yang 1 , C. Marano 1 , H. Zhang 2 , W.J. 55.2 percent of induction responder patients treated with STELARA at the start of maintenance were in symptomatic remission approximately four years later (at week 200), 96.4 percent without corticosteroids Overall, 79.1 percent of patients treated with STELARA in the long-term extension (LTE) who were receiving corticosteroids at maintenance baseline were no longer receiving corticosteroids . Select search scope, currently: articles+ all catalog, articles, website, & more in one search; catalog books, media & more in the Stanford Libraries' collections; articles+ journal articles & other e-resources He was symptom free at Week 4. 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. 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 beneficial effect of ustekinumab on clinical response, mucosal healing and clinical remission was observed in induction and in maintenance both in patients who failed conventional therapy but not a biologic therapy, as well as in those who had failed at least one prior TNF antagonist therapy including in patients with a primary non-response to TNF antagonist therapy. STELARA PIVOTAL STUDIES IN ULCERATIVE COLITIS Get details about the pivotal trials of STELARA as induction and maintenance therapy for the treatment of adults with moderately to severely active ulcerative colitis featured in The New England Journal of Medicine . "We see this as a missed opportunity to get the dosing right during that critical induction phase, and during maintenance. 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. 1. Feagan 5 , D.T. Sands 4 , B.G. 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). 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. It almost always involves the rectum, and may extend in a proximal and continuous fashion to involve other portions of the colon. Gut Liver 13(6):604-616 Dorset The Dorset Formulary has been developed in associations with NHS Dorset Dorset County Hospital NHS Foundation Trust Dorset Healthcare University NHS Foundation . Lancet. The efficacy of ustekinumab (UST) over placebo for UC has been demonstrated in the UNIFI trials. 13 the pivotal unifi (ustekinumab as induction and maintenance therapy for ulcerative colitis) Spotlight. vs 71.8% @44wks. Practice Pearls Women's Health Zoster At Week 12 he was in clin - while in biologic-nave patients (67.2% @200wk. Shots: The P-III (UNIFI) study evaluating Stelara (90mg, q8w or q12w, IV) as induction & maintenance in adult patients with active UC; The results showed that induction responder patients treated with Stelara at the start of maintenance were in symptomatic remission (55.2% @200wks. The primary outcome was persistence to ustekinumab 16 weeks after treatment initiation. *Induction dose: A single IV infusion using a weight-based dosage regimen: STELARA 260 mg (weight 55 kg), STELARA 390 mg (weight >55 kg to 85 kg), STELARA 520 mg (weight >85 kg). In the maintenance phase, we typically rely on the drug to maintain the remission that was induced in the initial induction phase. 2. Induction study will be at least 8 weeks duration for each participant. The Efficacy and Safety of Guselkumab Induction Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: Phase 2b QUASAR Study Results Through Week 12 (OP23). In this setting, cyclosporin is an effective and rapidly act. The clinical remission rates at 8 and 44 weeks after UST treatment were superior to those of the placebo group. The ongoing UNIFI long-term extension evaluates subcutaneous ustekinumab for moderate-to-severe ulcerative colitis (UC) from weeks 44 through 220. Which induction therapy you will be given to treat your IBD will depend on a range of different things, including the type of IBD you have, it's severity and your age. Ustekinumab (Stelara, Janssen Biotech) is a monoclonal antibody to the p40 subunit of interleukin-12 and interleukin-23. 2. Sands BE, Sandborn WJ, Panaccione R et al (2019) Ustekinumab as induction and maintenance therapy for ulcerative colitis. Therefore, the ideal treatment for UC is the early induction and long-term maintenance of remission. Summary; That's why we did this study." Dr. Abraham says she hopes the study results help correct the clinical underutilization of therapeutic drug monitoring for ustekinumab, which was approved for use in Crohn's disease in 2016 and ulcerative colitis in 2019. 2021; 397: 2372-2384. METHODS We evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. Prospectively recorded data were extracted from the SWIBREG. Overall, 399 responders to intravenous ustekinumab induction and who were randomised to maintenance therapy were treated in the long-term extension . Ozanimod treatment was shown to be more effective at inducing clinical remission than placebo for patients with ulcerative colitis. Amiot A, Filippi J, Abitbol V, et al. Ustekinumab is a monoclonal antibody targeting the shared p40 subunit of IL12/23, which has been widely used both in dermatology and IBD as in the systemic treatment of psoriasis. Participant with clinical response in the Induction study will be eligible for the Maintenance study. In patients with ulcerative colitis (UC) treated with ustekinumab, the achievement of histo-endoscopic mucosal healing after induction therapy is associated with lower disease activity at the end of maintenance therapy than either histologic or endoscopic improvement alone, according to the results of a study published in Gastroenterology. Background. The UNIFI trial is a phase 3 trial of ustekinumab that included patients with moderate-to-severe ulcerative colitis. Induction treatments in IBD are usually fast-acting to improve your symptoms quickly and taken for a short period of time (often 6-8 weeks). 1. The 12-week maintenance dosing interval may be reduced to 8 weeks by the attending physician if the patient shows reduced response to the treatment. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. Select search scope, currently: articles+ all catalog, articles, website, & more in one search; catalog books, media & more in the Stanford Libraries' collections; articles+ journal articles & other e-resources CD=Crohn's disease; IV=intravenous; subQ=subcutaneous; TNF=tumor necrosis factor; UC=ulcerative colitis. N Engl J Med. Results: Among all patients randomised in maintenance, symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively. vs 64.9% @44wks.) The induction phase is targeted to get as much of the drug into the patient as possible to rapidly eliminate the symptoms of inflammation and the severity of the disease. A Biblioteca Virtual em Sade uma colecao de fontes de informacao cientfica e tcnica em sade organizada e armazenada em formato eletrnico nos pases da Regio Latino-Americana e do Caribe, acessveis de forma universal na Internet de modo compatvel com as bases internacionais. Article CAS PubMed Google Scholar Na SY, Moon W (2019) Perspectives on current and novel treatments for inflammatory bowel disease. Clinical response in the ulcerative colitis induction trial to 130 mg IV was 51.3% at week 8 compared with a placebo rate of 31.3%. Introduction Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease of the large intestine. ), 72.9% in clinical remission . Ulcerative colitis (UC) is a chronic inflammatory condition of the large intestine that is limited to the mucosal layer of the colon. 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). MethodsWe evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. Adult ulcerative colitis patients without previous colectomy starting ustekinumab treatment up until 11 December 2020 were identified through the Swedish Inflammatory Bowel Disease Register (SWIBREG). abdominal pain. N Engl J Med 2019;381:1201-1214. Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial. 2019; 381: 1201-1214. . Effectiveness and safety of ustekinumab induction therapy for 103 patients with ulcerative colitis: a GETAID multicentre real-world cohort study. The protocol will consist of 2 studies: an Induction study and a Maintenance study with unique endpoints. Screening period will be up to 8 Weeks. Given the success of IL-12 and IL-23 blockade in psoriasis (Lancet 2008;371:1665-1674), and the emergence of ustekinumab (UST) as a promising new strategy for the treatment of Crohn's disease (CD), it has been assessed for the treatment of UC. Sandborn 3 , B.E. Aliment To assess efficacy (through week 92) . 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. VIEW ARTICLE View lasting remission demonstrated at 1 year with STELARA in CD Reactions temporally associated with an IV infusion (induction period) and SC injection-site reactions (maintenance period) will be reported. Sands BE, Sandborn WJ, Panaccione R, et al. ustekinumab, a human monoclonal antibody that targets the p40 subunit of interleukin (il)-12 and il-23, was fda approved for the treatment of crohn disease in september 2016 and for the treatment of moderately to severely active uc in october 2019. Aims. Participant with clinical response in the Induction study will be eligible for the Maintenance study. Ustekinumab is a monoclonal antibody against the p40 subunit of interleukin-12 and interleukin-23 and has proven efficacy in inducing and maintaining remission in adult patients with moderate-to-severe UC. (Sept. 26 issue) have reported the results from the UNIFI trial, a double . For UC is the early induction and maintenance therapy for ulcerative colitis and rapidly act rate. Effective and safe in sands et al ( 2019 ) ustekinumab as a maintenance study UNIFI trials large that... 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