ozanimod as induction and maintenance therapy for ulcerative colitis
Mult Scler 2014;20:471-480, 13. Macular edema occurred in 3 patients receiving ozanimod; all cases resolved after treatment discontinuation (, Presented at the Annual Meeting of the European Committee for Treatment and Research in Multiple Sclerosis, Presented at the Triennial Joint Meeting of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (MSVirtual2020), Case Records of the Massachusetts General Hospital, Talquetamab, a T-CellRedirecting GPRC5D Bispecific Antibody for Multiple Myeloma, A Covid-19 Milestone Attained A Correlate of Protection for Vaccines, A Step toward Interoperability of Health IT, Breakthrough Infections after Postexposure Vaccination against Mpox, Tumor-Infiltrating Lymphocyte Therapy or Ipilimumab in Advanced Melanoma, Case 37-2022: A 55-Year-Old Man with Fatigue, Weight Loss, and Pulmonary Nodules, Brief Report: In Utero Enzyme-Replacement Therapy for Infantile-Onset Pompes Disease, NEJM Catalyst Innovations in Care Delivery, Time since diagnosis of ulcerative colitis yr, Had a primary nonresponse no./total no. 2021 Sep 30;385(14):1280-1291. Ozanimod as induction and maintenance therapy for ulcerative colitis. A 7-day period of dose escalation with ozanimod starting at 0.25 mg on days 1 to 4 and progressing to 0.5 mg on days 5 to 7 and to 1 mg thereafter was incorporated to minimize the risk of bradycardia that has been reported with some S1P modulators within the first few hours after administration.17,18. Careers. Unable to load your collection due to an error, Unable to load your delegates due to an error, Collaborators, Lancet Neurol 2016;15:373-381. Figueroa, Gabriela; Forster, Erin . and Lee, {Ji Hwan} and Lorna Charles and Denesh Chitkara and Keith Usiskin and Colombel, {Jean Frederic} and Loren Laine and Silvio Danese". 14. The multicenter, double-blind phase 3 True North trial evaluated ozanimod as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis. The primary efficacy end point was the percentage of patients with clinical remission at week 10 (for the induction period) and at week 52 (for the maintenance period), assessed on the basis of the three-component Mayo score. This trial was not large enough or of sufficiently long duration to assess safety. The most advanced way to teach, practice, and assess clinical reasoning skills. Maintenance of remission was defined as clinical remission at 52 weeks in the subgroup of patients with remission at week 10. In this phase 2 trial involving patients with moderately or severely active ulcerative colitis, treatment with ozanimod at a once-daily oral dose of 1 mg resulted in slightly higher rates of clinical remission at week 8 than those with placebo (16% vs. 6%, P=0.048). Patients with clinically significant cardiovascular disease, including those with bradycardia and those taking medications that affect the cardiac conduction system, were excluded from the trial, so our findings cannot be extrapolated to these patient populations. All the patients had documented presence of varicellazoster virus IgG antibody or complete varicellazoster vaccination at screening. TA828: Ozanimod for treating moderately to severely active ulcerative colitis The formulary will reflect the TAG - ICB is the responsible commissioner. The increases in the proportions of patients with clinical remission and with histologic remission at week 32, as compared with week 8, raise the possibility that extended treatment may be associated with enhanced efficacy. Endoscopic and histologic end points were determined by one central reader who used blinded videos of endoscopic procedures and preserved biopsy samples, respectively. In the 10-week induction period, patients in cohort 1 were assigned to receive oral ozanimod hydrochloride at a dose of 1 mg (equivalent to 0.92 mg of ozanimod) or placebo once daily in a double-blind manner, and patients in cohort 2 received open-label ozanimod at the same daily dose. Treatment with ozanimod led to significant improvements, as compared with placebo, in the incidence of clinical remission (primary end point) and in all key secondary clinical, endoscopic, and histologic end points at weeks 10 and 52. abstract = "BACKGROUND Ozanimod, a selective sphingosine-1-phosphate receptor modulator, is under investigation for the treatment of inflammatory bowel disease. The immunosuppressant FTY720 down-regulates sphingosine 1-phosphate G-protein-coupled receptors. (%), Laboratory assessments no./total no. Zeposia reduces the capacity of lymphocytes to exit from lymph nodes, reducing the number of circulating lymphocytes in peripheral blood. 2022 May;18(5):265-271. Evidence Rating Level: 1 (Excellent) Absolute lymphocyte counts in blood decreased by a mean of 32% from baseline to week 8 in patients who received 0.5 mg of ozanimod and by 49% in patients who received 1 mg of ozanimod. Tran JQ, Zhang P, Surapaneni S, Selkirk J, Yan G, Palmisano M. Absorption, metabolism, and excretion, in vitro pharmacology, and clinical pharmacokinetics of ozanimod, a novel sphingosine 1-phosphate receptor agonist. For the secondary outcome of change in the Mayo Clinic score from baseline, as well as for the analyses of change from baseline in the concentrations of C-reactive protein, calprotectin, and lactoferrin, missing values were replaced by the last observation carried forward. Marsolais D, Rosen H. Chemical modulators of sphingosine-1-phosphate receptors as barrier-oriented therapeutic molecules. Safety was also assessed. At week 32, the rate of clinical remission was 21% in the group that received 1 mg of ozanimod, 26% in the group that received 0.5 mg of ozanimod, and 6% in the group that received placebo; the rate of clinical response was 51%, 35%, and 20%, respectively. Bradycardia, cardiac conduction abnormalities (second-degree and higher atrioventricular block), macular edema, cancer, serious or opportunistic infection, pulmonary effects, and hepatic effects were examined as adverse events of special interest on the basis of previous associations with S1P receptor modulation.21,22 Clinical laboratory measurements were performed at a central laboratory. In the current case, we aim to describe a successful long . The authorized source of trusted medical research and education for the Chinese-language medical community. Vedolizumab as induction and maintenance therapy for ulcerative colitis. Please enable it to take advantage of the complete set of features! The incidence of infection (of any severity) with ozanimod was similar to that with placebo during induction and higher than that with placebo during maintenance. Mandala S, Hajdu R, Bergstrom J, et al. A total of 645 patients entered cohort 1 and were randomly assigned to receive either ozanimod (429 patients) or placebo (216 patients) in a double-blind manner; 367 patients received open-label ozanimod in cohort 2 (Figure 1). Ozanimod, a selective sphingosine-1- phosphate receptor modulator . 2021 Sep 30;385 (14):1280-1291. doi: 10.1056/NEJMoa2033617. journal = "New England Journal of Medicine". In the 10-week induction period, patients in cohort 1 were assigned to receive oral ozanimod hydrochloride at a dose of 1 mg (equivalent to 0.92 mg of ozanimod) or placebo once daily in a double-blind manner, and patients in cohort 2 received open-label ozanimod at the same daily dose. Ozanimod, a selective sphingosine-1-phosphate receptor modulator, is under investigation for the treatment of inflammatory bowel disease. Four patients who received ozanimod (one patient who received 0.5 mg and three who received 1 mg) had an increase in the alanine aminotransferase level of more than 3 times the upper limit of the normal range during treatment. Patients were assessed on day 1 (baseline), at weeks 4 and 8 (during the induction period), and at weeks 20 and 32 (during the maintenance period). ZEPOSIA (ozanimod) is indicated for the treatment of: 1. Ustekinumab as induction and maintenance therapy for ulcerative colitis. Introduction. Safety and efficacy of the selective sphingosine 1-phosphate receptor modulator ozanimod in relapsing multiple sclerosis (RADIANCE): a randomised, placebo-controlled, phase 2 trial. From the University of California, San Diego, La Jolla (W.J.S. Mucosal healing was defined as endoscopic improvement plus histologic remission (i.e., a Geboes score of <2.0 [on a scale from 0 to 5.4, with higher scores indicating more severe inflammation] and an absence of neutrophils in the epithelial crypts or lamina propria and no increase in eosinophils, no crypt destruction, and no erosions, ulcerations, or granulation tissue). Curr Opin Pharmacol 2006;6:244-250, 14. All other key secondary end points were significantly improved with ozanimod as compared with placebo in both periods. Greater reductions from baseline in fecal calprotectin levels were also observed with ozanimod than with placebo in both the induction and maintenance periods (Table S7). PDF Ozanimod for the treatment of relapsing remitting multiple sclerosis Ludwig Rasche, F. Paul Biology, Psychology For end points that were not included in the hierarchies, point estimates and 95% confidence intervals are reported, without P values. Data were compiled by the sponsor; Pharmaceutical Product Development provided assistance with statistical programming. A total of 199 patients were randomly assigned to the trial groups, of whom 197 received placebo or ozanimod (Fig. The eighth and ninth authors, both employees of the sponsor, vouch for the completeness and accuracy of the data, and the eighth author vouches for the adherence of the trial to the protocol. Wolf DC, Colombel J-F, Ponich T, et al. Liver events were mostly mild or moderate in severity and led to the discontinuation of the trial regimen in less than 1% of the patients. Authors Background: Panel C shows the percentage of patients with mucosal healing (endoscopy subscore of 1 point) at week 8. Predictors and outcomes of histological remission in ulcerative colitis treated to endoscopic healing. *The final safety follow-up visit was scheduled to occur 90 days (within a window of 10 days) after the final dose of ozanimod or placebo. Aim: The relative treatment effects of filgotinib and adalimumab, golimumab, infliximab, tofacitinib, ustekinumab and vedolizumab were estimated using a network meta-analysis (NMA). Ozanimod for Ulcerative Colitis and Multiple Sclerosis. The purpose of this study is to evaluate the efficacy and safety of ozanimod compared with placebo in participants with ulcerative colitis (UC) in mainland China and Taiwan. Glucocorticoid doses were maintained unchanged through week 8, after which time the doses could be tapered at the discretion of the investigator. 2022 Nov 29;15:17562848221138160. doi: 10.1177/17562848221138160. 29. Early mucosal healing with infliximab is associated with improved long-term clinical outcomes in ulcerative colitis. Multiple sclerosis treatment with fingolimod: profile of non-cardiologic adverse events. N Engl J Med 2010;362:402-415, 10. The changes in the Mayo Clinic score from baseline to week 8 and to week 32 were analyzed with the use of analysis of covariance models with treatment group, status with respect to previous TNF-antagonist therapy, and baseline value of the corresponding outcome included as covariates. The most common reasons for ineligibility were disease criteria not met (in 18.1% of the patients who underwent screening), a lack of documentation of varicellazoster virus IgG antibodies or vaccination (in 5.7%), inability to provide informed consent or to comply with protocol assessments (in 4.6%), and presence of Clostridium difficile or other stool pathogens (in 3.7%). Brinkmann V, Baumruker T. Pulmonary and vascular pharmacology of sphingosine 1-phosphate. Furthermore, clinical remission was reached by 19.3% at this timepoint. (%), Had received vedolizumab previously no./total no. Editorial assistance was funded by Bristol Myers Squibb. Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis. Sandborn WJ1, Feagan BG1, Wolf DC1, D'Haens G1, Vermeire S1, Hanauer SB1, Ghosh S1, Smith H1, Cravets M1, Frohna PA1, Aranda R1, Gujrathi S1, Olson A1, TOUCHSTONE Study Group Collaborators (101) Sparrow M, Vermeire S, Churchev J, Kotzev I, Takov D, Dragomirov B, Vladimirov B, Bookshelf The Mayo Clinic score was used to measure disease activity on a scale from 0 to 12, with higher scores indicating more severe disease; subscores range from 0 to 3, with higher scores indicating more severe disease. Prepare to become a physician, build your knowledge, lead a health care organization, and advance your career with NEJM Group information and services. Table 1. Blood samples were obtained at each visit for clinical chemical and hematologic studies and for the measurement of the C-reactive protein concentration. USA: A recent study in the New England Journal of Medicine reported ozanimod to be more effective than placebo for the treatment of patients with moderately to severely active ulcerative colitis. Safety Findings through the Final Safety Visit in the Induction and Maintenance Periods.*. Treatment of acute severe colitis remains a clinical challenge, and although many patients respond to cyclosporine therapy, there remains a relative paucity of maintenance options. 2,3 zeposia reduces the capacity of lymphocytes to migrate from lymphoid tissue, reducing the number of circulating lymphocytes in peripheral blood and lymphocyte migration into the intestines. Patients with clinical response at week 8 continued their blinded regimen during the maintenance period. Continued ozanimod treatment for the induction of non-responders in the phase 3 True North trial, induced symptomatic clinical response in nearly half of the patients with ulcerative colitis (UC) after 10 weeks in an open-label extension trial (OLE). Reductions in rectal bleeding and stool frequency were assessed in post hoc analyses, and changes in biomarkers such as fecal calprotectin and C-reactive protein levels were examined. Additional monitoring for adverse events that were considered to be potentially relevant to S1P-receptor modulation is described in the Supplementary Appendix. Nonserious infections were more common with ozanimod than with placebo during the maintenance phase of the trial. Feagan BG, Rutgeerts P, Sands BE, et al. Concise summaries and expert physician commentary that busy clinicians need to enhance patient care. 9. Tran JQ, Hartung JP, Peach RJ, et al. We conducted a double-blind, placebo-controlled phase 2 trial of ozanimod in 197 adults with moderate-to-severe ulcerative colitis. At 10 weeks, patients with a clinical response to ozanimod in either cohort underwent randomization again to receive double-blind ozanimod or placebo for the maintenance period (through week 52). Etrolizumab for maintenance therapy in patients with moderately to severely active ulcerative colitis (LAUREL): a randomised, placebo-controlled, double-blind, phase 3 study. Annu Rev Biochem 2009;78:743-768, 4. N Engl J Med. Rectal bleeding and stool frequency were reported by patients in an electronic diary. Ozanimod (RPC1063) is a potent sphingosine-1-phosphate receptor-1 (S1P1) and receptor-5 (S1P5) agonist with autoimmune disease-modifying activity. UR - http://www.scopus.com/inward/record.url?scp=85116386829&partnerID=8YFLogxK, UR - http://www.scopus.com/inward/citedby.url?scp=85116386829&partnerID=8YFLogxK, Powered by Pure, Scopus & Elsevier Fingerprint Engine 2022 Elsevier B.V, We use cookies to help provide and enhance our service and tailor content. The incidences of elevated alanine aminotransferase levels were higher among patients who received ozanimod than among those who received placebo. Five patients who had a clinical response did not enter the maintenance phase (Table S7 in the Supplementary Appendix). Sensitivity analyses were conducted for the primary and first key secondary end points with the use of an observed-cases analysis (assumption of data missing completely at random) and with the use of multiple imputation (assumption of data missing at random).23. Figure 2 shows the proportions of patients with clinical remission, clinical response, mucosal healing, and histologic remission at week 32. 6. Sandborn WJ, Feagan BG, D'Haens G, Wolf DC, Jovanovic I, Hanauer SB, Ghosh S, Petersen A, Hua SY, Lee JH, Charles L, Chitkara D, Usiskin K, Colombel JF, Laine L, Danese S; True North Study Group. The primary end point for both periods was the percentage of patients with clinical remission, as assessed with the three-component Mayo score. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. The eighth and ninth authors, both employees of the sponsor, vouch for the completeness and accuracy of the data, and the eighth author vouches for the adherence of the trial to the protocol. The confidence intervals were not adjusted for multiple comparisons and should not be used to infer definitive treatment effects. Other prespecified end points included histologic remission and clinical remission in subgroups defined according to demographic and disease-based characteristics. A complete list of investigators in the TOUCHSTONE trial is provided in the Supplementary Appendix, available at NEJM.org. Demographic and Clinical Characteristics of the Patients at Baseline in the Induction Period (Modified Intention-to-Treat Population).*. The content of this site is intended for health care professionals. N2 - BACKGROUND Ozanimod, a selective sphingosine-1-phosphate receptor modulator, is under investigation for the treatment of inflammatory bowel disease. 2021 Jul 5;15(7):1120-1129. doi: 10.1093/ecco-jcc/jjab012. Please enable it to take advantage of the complete set of features! All the authors had full access to the data. Selmaj KW, Steinman L, Comi G, et al. 2021;385(14):1280-1291. Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis N Engl J Med. This potent. publisher = "Massachussetts Medical Society", Ozanimod as induction and maintenance therapy for ulcerative colitis. ozanimod (rpc1063) is a new oral s1p1-receptor and s1p5-receptor modulator with no activity on s1p2, s1p3, and s1p4. The incidence of clinical remission was significantly higher among patients who received ozanimod than among those who received placebo during both induction (18.4% vs. 6.0%, P<0.001) and maintenance (37.0% vs. 18.5% [among patients with a response at week 10], P<0.001). One patient receiving ozanimod had a hypertensive crisis on day 1 of the induction period; the event was moderate and resolved on the same day without treatment interruption. The three-component Mayo score is defined as the sum of the rectal-bleeding subscore, the stool-frequency subscore, and the endoscopy subscore; overall scores range from 0 to 9 (with each subscore ranging from 0 to 3), with higher scores indicating greater activity. L Kappos, A Bar-Or, BAC Cree, et al. Sphingosine-1 Phosphate Receptor Modulators: The Next Wave of Oral Therapies in Inflammatory Bowel Disease. We aim to describe the trial design of the YELLOWSTONE phase 3 program evaluating the . Background: Only one head-to-head comparison of advanced treatments in moderately to severely active ulcerative colitis (UC) has been published; therefore, there remains a need for further comparisons. Blinded central reading of endoscopic videos and histologic findings was performed. Confidentiality agreements were in place between the sponsor and all the authors. In the 10-week induction period, patients in cohort 1 were assigned to receive oral ozanimod hydrochloride at a dose of 1 mg (equivalent to 0.92 mg of ozanimod) or placebo once daily in a double-blind manner, and patients in cohort 2 received open-label ozanimod at the same daily dose. Presented at the Annual Meeting of the European Committee for Treatment and Research in Multiple Sclerosis, Stockholm, September 1113, 2019. abstract. METHODS: We conducted a double-blind, placebo-controlled phase 2 trial of ozanimod in 197 adults with moderate-to-severe ulcerative colitis. From December 2012 through April 2015, we conducted this randomized, double-blind, placebo-controlled phase 2 trial of induction and maintenance therapy at 57 centers in 13 countries. Ozanimod for the Treatment of Ulcerative Colitis. At week 8, a total of 30% of the patients in the group that received 0.5 mg of ozanimod and 53% of those in the group that received 1 mg of ozanimod had absolute lymphocyte counts that were below the lower limit of the normal range, with the majority of patients in each ozanimod group having grade 1 or grade 2 reductions in the lymphocyte count. DHaens G, Sandborn WJ, Feagan BG, et al. Exploratory Efficacy Outcomes at Week 32 in the Trial of Ozanimod as Maintenance Therapy. 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. 2022 Jan 13;386(2):194. doi: 10.1056/NEJMc2117224. Ozanimod appears to be an effective treatment for moderate to severe ulcerative colitis (UC), according to research presented at the Advances in Inflammatory Bowel Diseases (AIBD) 2021 Annual Meeting, held from December 9 to 11, 2021, in Orlando, Florida and virtually. Ozanimod induction and maintenance treatment for ulcerative colitis. RESULTS In the induction period, 645 patients were included in cohort 1 and 367 in cohort 2; a total of 457 patients were included in the maintenance period. In the maintenance phase, we typically rely on the drug to maintain the remission that was induced in the initial induction phase. 1. Durable remission was defined as remission at both weeks 10 and 52. In cohort 1, a total of 401 patients (93.5%) who had been assigned to receive ozanimod and 192 (88.9%) who had been assigned to receive placebo completed the induction period. Safety Findings in Induction and Maintenance Phases, According to Trial Group. As noted previously, S1P-receptor modulators have been associated with cardiac and hepatic effects.15 Elevations in hepatic aminotransferase levels were observed in four patients (3%) receiving ozanimod and require further evaluation. sharing sensitive information, make sure youre on a federal Of the 1831 patients who underwent screening, 1012 were enrolled in the trial. Rosen H, Gonzalez-Cabrera PJ, Sanna MG, Brown S. Sphingosine 1-phosphate receptor signaling. Moderately to severely active ulcerative colitis (UC) in adults. Cohen JA, Arnold DL, Comi G, et al. Finally, the trial was limited to patients receiving ozanimod as monotherapy or in combination with glucocorticoids or aminosalicylates. Analysis in the induction period was based on the two-sided CochranMantelHaenszel test and stratified according to glucocorticoid use at screening and previous use of a TNF antagonist. Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BACKGROUND: Ozanimod, an oral sphingosine 1-phosphate receptor modulator currently approved for the treatment of moderately to severely active ulcerative colitis and relapsing multiple sclerosis, showed clinical, endoscopic, and histological benefit in the phase 2 STEPSTONE trial for Crohn's disease (CD). N Engl J Med 2013;369:699-710, 3. N Engl J Med, 374 (2016), pp. The incidence of clinical remission was significantly higher among patients who received ozanimod than among those who received placebo during both induction (18.4% vs. 6.0%, P<0.001) and maintenance (37.0% vs. 18.5% [among patients with a response at week 10], P<0.001). Ulcerative colitis is a chronic immune-mediated disease of the colon that is currently treated with mesalamine, glucocorticoids, thiopurines, and biologic agents.1,2 A lack of universal response, the risks of infection and neoplasia, a requirement for parenteral administration, and the development of antidrug antibodies have created a need for safe and effective oral therapies. Percentages in this category are based on the subgroup of patients who were treated with a TNF inhibitor. Lancet Neurol 2016;15:373-381. The incidence of clinical response was also significantly higher with ozanimod than with placebo during induction (47.8% vs. 25.9%, P<0.001) and maintenance (60.0% vs. 41.0%, P<0.001). 2020 Sep;5(9):819-828. doi: 10.1016/S2468-1253(20)30188-6. Alternatively, small molecules can be less selective than monoclonal antibodies, and off-target binding may result in adverse effects. A total of 91 of the 103 patients who entered the maintenance phase (88%) completed the trial. The most trusted, influential source of new medical knowledge and clinical best practices in the world. All patients included had to have failed prior treatment for ulcerative colitis, and were generally not allowed to be on other ulcerative colitis treatments during the trial. Stay connected to what's important in medical research and clinical practice, Subscribe to the most trusted and influential source ofmedical knowledge. The total Mayo score is defined as the sum of the rectal-bleeding subscore, the stool-frequency subscore, the physicians global assessment subscore, and the endoscopy subscore. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. Dive into the research topics of 'Ozanimod as induction and maintenance therapy for ulcerative colitis'. Mehling M, Brinkmann V, Antel J, et al. This trial was not large enough or of sufficiently long duration to assess the safety of ozanimod. Ozanimod-Dependent Activation of SIRT3/NF-B/AIM2 Pathway Attenuates Secondary Injury After Intracerebral Hemorrhage. TNF inhibitors (TNFi) (TA 329) Adalimumab# Review at 8 weeks Infliximab# (S/C or IV) Review at 14 weeks Information, resources, and support needed to approach rotations - and life as a resident. Patients were randomly assigned, in a 1:1:1 ratio, to receive ozanimod at a dose of 0.5 mg or 1 mg or placebo daily for up to 32 weeks. Ozanimod-treated patients who had a clinical response (defined as a reduction in the total Mayo score of 3 points and 30% from baseline or in the three-component Mayo score of 2 points and 35% from baseline, as well as a reduction in the rectal-bleeding subscore of 1 point or an absolute rectal-bleeding subscore of 1 point) at week 10 were eligible to undergo randomization again, in a 1:1 ratio, to receive either ozanimod or placebo in a double-blind manner through week 52 (maintenance period). In conclusion, in this preliminary trial, ozanimod at a dose of 1 mg was associated with a slightly higher rate of clinical remission among patients with moderately to severely active ulcerative colitis than the rate with placebo. Editorial assistance was funded by Bristol Myers Squibb. Ozanimod: A Review in Ulcerative Colitis. Additional eligibility criteria and the exclusion criteria are provided in the Supplementary Appendix. Danese S, Roda G, Peyrin-Biroulet L. Evolving therapeutic goals in ulcerative colitis: towards disease clearance. Long-term . These data should be interpreted cautiously given that the usefulness of these markers is highly dependent on clinical context.22. In this trial that required patients to have a documented presence of varicellazoster virus IgG antibody or complete varicellazoster vaccination, herpes zoster infection occurred in 3 of 796 ozanimod-treated patients (0.4%) during the induction period and in 5 of 230 (2.2%) during the maintenance period (these events did not lead to hospitalization). and Feagan, {Brian G.} and Geert D'Haens and Wolf, {Douglas C.} and Igor Jovanovic and Hanauer, {Stephen B.} The European Commission (EC) has has granted a marketing authorisation for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.. Zeposia, an oral medication taken once daily and made by Bristol Myers Squibb, is a . The demographic and clinical characteristics of the patients were similar in the two groups (Table 1). Proportions of patients with clinical remission at week 8 were compared with the use of the CochranMantelHaenszel chi-square test, stratified according to status with respect to previous receipt of TNF-antagonist therapy. Pai RK, Jairath V, Vande Casteele N, Rieder F, Parker CE, Lauwers GY. Peyrin-Biroulet L, Hart A, Bossuyt P, Long M, Allez M, Juillerat P, Armuzzi A, Loftus EV Jr, Ostad-Saffari E, Scalori A, Oh YS, Tole S, Chai A, Pulley J, Lacey S, Sandborn WJ; HICKORY Study Group. To compare the consistency of the effect of the regimen on clinical remission with placebo and with ozanimod at a dose of 0.5 mg or 1 mg once daily, we performed prespecified subgroup analyses (in subgroups defined according to previous use of TNF antagonists [yes or no], age [
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