• Additionally, 47% of patients treated with SKYRIZI achieved endoscopic response at week 52 compared to 22% of patients receiving placebo. (lifesciencesbc.ca)
  • In the maintenance study, 28% and 41% of patients treated with 15 mg and 30 mg doses of Rinvoq, respectively, achieved endoscopic response at week 52. (yahoo.com)
  • During the ADVANCE and MOTIVATE induction studies, a significantly greater proportion of patients treated with SKYRIZI 600 mg IV achieved mucosal healing and endoscopic remission. (lifesciencesbc.ca)
  • Mucosal healing and endoscopic remission were observed during the FORTIFY maintenance trial in patients treated with SKYRIZI 360 mg SC. (lifesciencesbc.ca)
  • At week 8, patients (n=961) were evaluated for clinical remission, endoscopic healing, clinical response, change from baseline in the IBDQ score, and mucosal healing (an endpoint that includes both endoscopic healing and histologic healing). (jnj.com)
  • The induction trials showed mucosal healing & endoscopic remission in (21% & 14%) & (24% & 19%) of patients @12wks. (medphanut.com)
  • Clinical response (per Adapted Mayo Score), endoscopic improvement and histologic-endoscopic mucosal improvement were ranked secondary endpoints. (abbvie.com)
  • d Histologic-endoscopic mucosal improvement is defined as endoscopic subscore of 0 or 1 and Geboes score ≤3.1. (abbvie.com)
  • Taken together, our studies demonstrated that IFX is efficacious and safe in inducing clinical remission, promoting mucosal healing, and downregulating Th1/Th17-mediated immune response in short course CD patients with luminal lesions. (johnshopkins.edu)
  • Mucosal expression of TNFα and MIP-1β mRNA before treatment in the remission group and the mucosal healing group was significantly higher than non-responder to GMA treatment. (adacyte.com)
  • In the ADVANCE and MOTIVATE induction trials, a significantly greater proportion of patients treated with SKYRIZI 600 mg IV achieved the co-primary endpoints of clinical remission (per SF/AP) and endoscopic response. (lifesciencesbc.ca)
  • In the FORTIFY maintenance trial, a significantly greater proportion of patients treated with SKYRIZI 360 mg SC achieved the co-primary endpoints of clinical remission (per SF/AP) and endoscopic response. (lifesciencesbc.ca)
  • The company achieved both co-primary endpoints of endoscopic response and clinical remission, as well as key secondary endpoints of rapid clinical response and corticosteroid-free clinical remission, with statistical significance. (yahoo.com)
  • Rinvoq met its primary and key secondary endpoints with its 45-mg dose in the two induction studies, and with its 15-mg and 30-mg doses in the maintenance study. (biospace.com)
  • Major secondary endpoints including the proportion of patients in clinical response, endoscopic healing, as well as improvement in health-related quality of life, were also significantly higher at week 8 among patients receiving STELARA compared with patients receiving placebo. (jnj.com)
  • NORTH CHICAGO, Ill. , Dec. 9, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive results from the Phase 3 induction study, U-ACHIEVE, which showed upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 8, as well as all ranked secondary endpoints, in adult patients with moderate to severe ulcerative colitis. (abbvie.com)
  • As early as week 4 in the induction studies, clinical response and clinical remission were achieved by significantly more subjects treated with SKYRIZI versus placebo, as were co-primary endpoints of endoscopic response and clinical remission at week 12 and week 52. (chemrobotics.in)
  • Relationship Between Combined Histologic and Endoscopic Endpoints and Efficacy of Ustekinumab Treatment in Patients With Ulcerative Colitis. (uchicago.edu)
  • Co-primary endpoints: clinical remission per PMS (partial Mayo score) at Week 8, and clinical remission per FMS (full Mayo score) at Week 52 in patients who achieved clinical response per PMS at Week 8. (humirapro.com)
  • Abivax (Euronext Paris: FR0012333284 - ABVX), a clinical-stage biotechnology company modulating the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, today announced that the induction and long-term maintenance follow-up results of the phase 2a clinical study with ABX464 for the treatment of moderate-to-severe ulcerative colitis have been published online in the renowned journal "Gastroenterology" . (pharmiweb.com)
  • We are proud that "Gastroenterology" accepted the exciting results of our induction and long-term phase 2a maintenance study in moderate-to-severe ulcerative colitis patients with ABX464. (pharmiweb.com)
  • As principal investigator I am pleased to see that the scientific community confirmed the safety and durability of clinical efficacy of the phase 2a induction and long-term study results conducted with ABX464 in ulcerative colitis patients. (pharmiweb.com)
  • At the end of the eight-week induction of the phase 2a proof-of-concept clinical study in ulcerative colitis, 35% and 70% of patients in the ABX464 active group achieved clinical remission and clinical response versus 11.1% and 33.3% in the placebo group, respectively. (pharmiweb.com)
  • PHILADELPHIA, PENNSYLVANIA, October 9, 2018 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data showing treatment with a single intravenous (IV) dose of STELARA ® (ustekinumab) induces clinical remission and response in adults with moderate to severe ulcerative colitis (UC) who previously experienced an inadequate response or were intolerant to conventional or biologic therapies. (jnj.com)
  • Ulcerative colitis is a complex immune disease, and more than half of UC patients have not experienced remission with currently available conventional or biologic treatment options," said lead investigator Bruce E. Sands, MD, Dr. Burrill B. Crohn Professor of Medicine and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai. (jnj.com)
  • The studies indicated that tacrolimus was not only effective in the short-term induction therapy as well as anti-TNF-�� agents, such as infliximab, but also valuable in the long-term maintenance therapy of ulcerative colitis. (magtechjournal.com)
  • In a double-blind, placebo-controlled trial this antibody was more effective than placebo for the induction of clinical and endoscopic remission in patients with active ulcerative colitis (PMID: 15958805). (absoluteantibody.com)
  • 1 U-ACHIEVE is the first of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe ulcerative colitis. (abbvie.com)
  • We are encouraged by these results showing upadacitinib's potential to improve clinical, endoscopic and histologic outcomes in patients with ulcerative colitis. (abbvie.com)
  • A SER-287 Phase 1b placebo-controlled induction study in patients with mild-to-moderate active ulcerative colitis demonstrated a dose-dependent improvement of clinical remission rates and endoscopic scores and a favorable tolerability profile. (flagshippioneering.com)
  • As yet, no evidence suggests that regular endoscopic screening of patients with ulcerative colitis improves survival. (medscape.com)
  • Budesonide rectal foam was approved in October 2014 and is indicated for the induction of remission in adults with active mild-to-moderate distal ulcerative colitis extending up to 40 cm from the anal verge. (medscape.com)
  • Despite the development new agents for inflammatory bowel disease (IBD) therapy, azathioprine (AZA) is widely used as both as monotherapy and as combination therapy for induction and maintenance of remission both Crohn's disease (CD) and ulcerative colitis (UC). (ecco-ibd.eu)
  • Long-term use of mesalamine (Rowasa) suppositories in remission maintenance of ulcerative proctitis. (bigskyaz.com)
  • Ulcerative colitis treatment can help you manage your symptoms and achieve remission. (bigskyaz.com)
  • Ulcerative Colitis Remission Status After Induction With Mesalazine Predicts Maintenance Outcomes: the MOMENTUM Trial. (uchicago.edu)
  • Efficacy of Vedolizumab Induction and Maintenance Therapy in Patients With Ulcerative Colitis, Regardless of Prior Exposure to Tumor Necrosis Factor Antagonists. (uchicago.edu)
  • Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies. (uchicago.edu)
  • Fecal Calprotectin in Assessing Endoscopic and Histological Remission in Patients with Ulcerative Colitis. (uchicago.edu)
  • Efficacy and safety of induction therapy with calcineurin inhibitors followed by vedolizumab maintenance in 71 patients with severe steroid-refractory ulcerative colitis. (uchicago.edu)
  • Outcomes of Tofacitinib Dose Reduction in Patients with Ulcerative Colitis in Stable Remission from the Randomised RIVETING Trial. (uchicago.edu)
  • Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials. (uchicago.edu)
  • A Prospective Trial with Long Term Follow-up of Patients With Severe, Steroid-Resistant Ulcerative Colitis Who Received Induction Therapy With Cyclosporine and Were Maintained With Vedolizumab. (uchicago.edu)
  • Our group has been involved in randomized, placebo-controlled, double-blind trials of Vedolizumab for the induction and maintenance of clinical response & remission in patients with active Crohn's disease and an open-label study to determine it's long-term safety & efficacy in patients with ulcerative colitis & Crohn's disease. (dougsamuel.com.au)
  • Inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC), is a chronic inflammatory disease of the gastrointestinal tract characterized by episodes of relapse and remission. (frontiersin.org)
  • The aim of this study was to assess the efficacy and safety of adalimumab (ADA), a recombinant human monoclonal antibody against tumour necrosis factor α (TNF), for the induction of clinical remission in anti-TNF naïve patients with moderately to severely active ulcerative colitis. (digestivedashboard.nl)
  • ADA160/80 was safe and effective for induction of clinical remission in patients with moderately to severely active ulcerative colitis failing treatment with corticosteroids and/or immunosuppressants. (digestivedashboard.nl)
  • Ulcerative colitis long-term remission and maintenance with adalimumab 2 (ULTRA 2) was a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of adalimumab in induction and maintenance of clinical remission in 494 patients with moderate-to-severe ulcerative colitis who received concurrent treatment with oral corticosteroids or immunosuppressants. (digestivedashboard.nl)
  • Adalimumab was safe and more effective than placebo in inducing and maintaining clinical remission in patients with moderate-to-severe ulcerative colitis who did not have an adequate response to conventional therapy with steroids or immunosuppressants. (digestivedashboard.nl)
  • GMA is effective and safe as induction therapy in ulcerative colitis (UC) of moderate to severe patients, and commonly used in Asia and north Europe. (adacyte.com)
  • Oral Vancomycin Induced and Maintained Clinical and Endoscopic Remission in Ulcerative Colitis and Primary Sclerosing Cholangitis Post-liver Transplantation. (yale.edu)
  • The diagnosis of IBD was made based on endoscopic and histologic findings after ileocolonoscopy with biopsies. (ecco-ibd.eu)
  • Correlation of C-reactive protein with clinical, endoscopic, histologic, and radiographic activity in inflammatory bowel disease. (bigskyaz.com)
  • Additionally, a statistically significantly higher proportion of patients treated with filgotinib 200 mg achieved endoscopic, histologic and six-month, corticosteroid-free remission at week 58 compared with placebo. (gilead.com)
  • In addition to demonstrated efficacy for clinical, endoscopic and histological outcomes, targeting IL-12 and/or IL-23 is a safe treatment strategy. (nature.com)
  • We are very much looking forward to the top-line phase 2b induction results in UC that we expect to be available in Q2 2021 and we are confident that they will confirm the observations of the previous study in terms of safety and durable efficacy. (pharmiweb.com)
  • Upadacitinib demonstrated superior efficacy over placebo, with a statistically significant proportion of patients achieving clinical remission after induction therapy. (mountsinai.org)
  • Owing to the excellent efficacy of systemic administration of corticosteroids, most patients achieve remission even if they required second-line treatment. (hindawi.com)
  • Third approved indication for SKYRIZI (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical trials evaluating SKYRIZI in moderately to severely active Crohn's disease, ADVANCE, MOTIVATE and FORTIFY. (chemrobotics.in)
  • The FORTIFY study is a Phase 3, multicenter, randomized, double-blind, control group, 52-week maintenance study designed to evaluate the efficacy and safety of risankizumab 180 mg and 360 mg as maintenance therapy versus withdrawal in patients who responded to risankizumab induction treatment in the ADVANCE and MOTIVATE studies. (chemrobotics.in)
  • Endoscopic improvement will be measured as a secondary efficacy measure. (flagshippioneering.com)
  • This study was to investigate the efficacy of intensive GMA in combination with ADA as remission induction therapy in cases of CD refractory to medications including anti-TNF-α therapies. (adacyte.com)
  • CD activity index (CDAI), C-reactive protein (CRP), and endoscopic findings based on the simple endoscopic score for CD (SES-CD) at baseline and 10 weeks post 5 ADA injections were applied to determine treatment efficacy outcomes. (adacyte.com)
  • GMA treatment efficacy is 11 patients (34.4%) achieved clinical remission, 17 patients (53.1%) were response and 4 patients (12.5%) were non-response. (adacyte.com)
  • on the Simple Endoscopic Score for Crohn's Disease (SES-CD), the mean lower gastrointestinal score fell from 13 to 4 in the treatment group but remained unchanged in the control group. (medscape.com)
  • In remission group, significant changes were observed in CDAI, the Simple Endoscopic Score for Crohn's Disease (SES-CD), and serum indexes. (johnshopkins.edu)
  • a Clinical remission per Adapted Mayo Score is defined as stool frequency subscore (SFS) ≤1 and not greater than baseline, rectal bleeding subscore (RBS) of 0 and endoscopic subscore ≤1. (abbvie.com)
  • c Endoscopic improvement is defined as endoscopic subscore ≤1. (abbvie.com)
  • Evidence of friability during endoscopy in subjects with otherwise "mild" endoscopy activity will confer an endoscopic subscore of 2. (abbvie.com)
  • Endoscopic improvement at Week 52 measured by Mayo endoscopic subscore (defined as ≤1). (humirapro.com)
  • Methods: Clinical remission at week 52, defined as a partial Mayo score of ⩽2 with a combined rectal bleeding subscore and stool frequency subscore of ⩽1, was used as the primary outcome. (ewha.ac.kr)
  • Endoscopic remission rates at weeks 16 and 52 were 52.4% and 30.8% based on the Mayo endoscopic subscore and 20.7% and 15.2% based on the UC endoscopic index of severity (UCEIS), respectively. (ewha.ac.kr)
  • This 8-week, multicentre, randomised, double-blind, placebo-controlled study ( NCT00385736 ), conducted at 94 centres in North America and Europe, enrolled ambulatory adult patients with Mayo score of ≥ 6 points and endoscopic subscore of ≥ 2 points despite treatment with corticosteroids and/or immunosuppressants. (digestivedashboard.nl)
  • In ADVANCE and MOTIVATE, 43% and 35% of patients treated with SKYRIZI 600 mg IV achieved clinical remission at week 12, respectively, compared to 22% and 19% of patients receiving placebo. (lifesciencesbc.ca)
  • Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. (uchicago.edu)
  • Primary endpoint was clinical remission (per Adapted Mayo Score). (abbvie.com)
  • The study's primary endpoint will evaluate clinical remission measured after 10 weeks of SER-287 administration. (flagshippioneering.com)
  • The significant rates of remission observed through the 8-week induction, coupled with a safety profile that is well-documented through years of research and use in other immune diseases, demonstrate the potential for ustekinumab as an effective treatment for UC. (jnj.com)
  • Patients may have intermittent symptoms with varying periods of remission. (aafp.org)
  • Symptoms tend to present intermittently, and so patients usually experience flare-ups and periods of remission. (gilead.com)
  • 7. Proportion of subjects who discontinued corticosteroid use for 90 days and achieved clinical remission at Week 52 in subjects taking steroids at baseline (of induction). (who.int)
  • A secondary outcome was combined sustained steroid-free clinical and endoscopic remission by 18 months, defined as the absence of ulcers at follow-up colonoscopy when ulcers were present at baseline. (ecco-ibd.eu)
  • In every analysis, more of the aTNF group achieved sustained 18-month steroid-free clinical remission, despite more severe baseline disease (Figure 1). (ecco-ibd.eu)
  • A higher baseline score of the UC endoscopic index of severity, which is one of the endoscopic indices that evaluate the severity of inflammation of the colon, was negatively associated with clinical response (i.e. partial improvement of symptoms). (ewha.ac.kr)
  • NORTH CHICAGO, IL - AbbVie (NYSE: ABBV) announced the European Commission (EC) approved SKYRIZI ® (risankizumab, 600 mg intravenous [IV] induction and 360 mg subcutaneous [SC] maintenance therapy) as the first specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. (lifesciencesbc.ca)
  • The EC approval for SKYRIZI in Crohn's disease is supported by results from the global Phase 3 program, which included three studies: ADVANCE induction, MOTIVATE induction and FORTIFY maintenance. (lifesciencesbc.ca)
  • Corresponding author Jean-Frederic Colombel, MD , notes, "Upadacitinib addresses an unmet need in the treatment of Crohn's disease and allows patients access to an oral medication that could put them in clinical and endoscopic remission. (mountsinai.org)
  • Early initiation of TNF-antagonist (aTNF) therapy for Crohn's disease (CD) is associated with greater clinical and endoscopic improvement but trialing an immunomodulator (IM) first remains common in paediatrics. (ecco-ibd.eu)
  • In a phase II clinical trial, it was reported that this antibody is well tolerated in patients with active Crohn's disease and therapy with this antibody had a dose-dependent beneficial effect on clinical remission (PMID: 18829392). (absoluteantibody.com)
  • Etrolizumab, a humanized anti-β7 monoclonal antibody, was well tolerated and resulted in endoscopic and symptom improvements in patients with moderate-to-severe Crohn's disease, researchers reported. (medpagetoday.com)
  • Azathioprine and other immunosuppresant drugs can be used as adjunctive therapy for active Crohn's disease and may help to maintain remission. (aafp.org)
  • Adalimumab (ADA) is applied to induce remission in patients with Crohn's disease (CD) naïve to chimeric anti-tumor necrosis factor-α (anti-TNF-α), infliximab or patients with loss of response to scheduled maintenance infliximab. (adacyte.com)
  • In addition, statistically significantly more patients achieved six-month corticosteroid-free remission. (gilead.com)
  • To your point, at 6 or 9 months, if you do another colonoscopy and the patient was at Mayo [endoscopic score] 3 and now they're at Mayo 1 and looking much better, then I don't think that's a time to panic and switch to another therapy. (hcplive.com)
  • Thirty-two active UC patients (Mayo score ^ 5 and Mayo endoscopic score ^ 2) and 10 non-IBD control subjects were enrolled in this study. (adacyte.com)
  • Additionally, 40% and 29% of SKYRIZI treated patients achieved endoscopic response at week 12 compared to 12% and 11% of patients receiving placebo. (lifesciencesbc.ca)
  • Results of this Long-Term Extension (LTE) of the SELECT-COMPARE study show that RINVOQ plus MTX maintained higher levels of clinical response, including remission compared to adalimumab plus MTX, through week 72. (pharmiweb.com)
  • The endoscopic response was observed in 34% and 46% of patients treated with a 45 mg dose of Rinvoq, in the two induction studies at week 12, respectively, compared with 3% and 13% of patients receiving placebo. (yahoo.com)
  • Patients who had a clinical response to upadacitinib induction therapy were then randomly assigned in the U-ENDURE maintenance trial to receive 15 mg or 30 mg of upadacitinib, or placebo (1:1:1) once daily for 52 weeks. (mountsinai.org)
  • In U-EXCEED and U-EXCEL, from 35% to 46% of Rinvoq-treated patients achieved endoscopic response after 12 weeks of treatment, as compared with only 3% to 13% of placebo comparators. (biospace.com)
  • In U-ENDURE, 28% and 41% of patients treated with the 15-mg and 30-mg dose showed endoscopic response at week 52, relative to only 7% in the placebo group. (biospace.com)
  • Percentage of participants with endoscopic response at Week 52. (who.int)
  • The patients treated with Skyrizi (600mg, IV) in the induction trials depicted a clinical remission of (43% & 35%) & an endoscopic response in (40% & 29%) @12wks vs (22% & 19%) & (12% & 11%) in PBO whereas those treated with Skyrizi (360mg, SC) in the maintenance trial depicted a clinical remission of 52% & an endoscopic response of 47% @52wks. (medphanut.com)
  • There was no significant difference in the colectomy-free rate, clinical remission rate, and clinical response rate at 2 months between the groups. (hindawi.com)
  • Ten weeks after therapy, 61 (57.5%) patients achieved clinical remission, 17 (16.0%) had clinical response, and the remaining 28 (26.4%) were failed. (johnshopkins.edu)
  • IFX markedly downregulated Th1/Th17-mediated immune response but promoted IL-25 production in intestinal mucosa from remission group. (johnshopkins.edu)
  • Current data seems to show that only selective blockade of α4β7 can induce clinical response and remission in IBD, while blocking MAdCAM or β7 integrin has little clinically effect. (dougsamuel.com.au)
  • Existing treatment options often fall short in achieving sustained remission and controlling symptoms. (mountsinai.org)
  • Several medications are used to treat symptoms and bring about and maintain remission, including aminosalicylates such as mesalazine or sulfasalazine, steroids, immunosuppressants such as azathioprine, and biologic therapy. (wikipedia.org)
  • A substantial proportion (up to 45%) of people with a history of UC without any ongoing symptoms (clinical remission) have objective evidence of ongoing inflammation. (wikipedia.org)
  • Severity of disease is defined by symptoms, objective markers of inflammation (endoscopic findings, blood tests), disease course, and the impact of the disease on day-to-day life. (wikipedia.org)
  • Clinical remission (i.e. complete improvement of symptoms) was achieved in 60.6% and 52.8% of patients at weeks 16 and 52, respectively. (ewha.ac.kr)
  • Antibiotics can decrease anal fistula discharge and may induce remission in Crohn disease. (medscape.com)
  • Between December 2010 and February 2012, 5 consecutive cases with refractory CD were treated with intensive GMA (2 sessions per week) plus ADA to induce remission. (adacyte.com)
  • The maintenance phase evaluated the drug's ability to sustain remission and prevent relapse. (mountsinai.org)
  • The development of biologic anti-tumor necrosis factor (anti-TNF) agents (eg, infliximab, adalimumab, certolizumab pegol, and natalizumab) has significantly advanced the treatment of Crohn disease and improved the induction and maintenance of clinical remission in patients with moderate to severe disease, especially in those who are corticosteroid dependent. (medscape.com)
  • On the other hand, anti-TNF antibodies, such as infliximab (IFX) or adalimumab, and calcineurin inhibitors, such as cyclosporin A (CsA) or tacrolimus (Tac), have shown good salvage therapeutic efficacies for inducing remission in steroid-refractory UC. (hindawi.com)
  • Two months after induction therapy with adalimumab, the CDAI decreased from 175 to 107 without side effects. (adacyte.com)
  • At week 8, 18.5% of patients in the ADA160/80 group (p = 0.031 vs placebo) and 10.0% in the ADA80/40 group (p = 0.833 vs placebo) were in remission, compared with 9.2% in the placebo group. (digestivedashboard.nl)
  • Rinvoq likewise led to significantly better clinical remission rates, which ranged from 36% to 46% in the two induction studies and 18% to 23% in the maintenance study. (biospace.com)
  • Results from the induction phase of the Phase 3 UNIFI study show that treatment with a single IV dose of STELARA induced clinical remission in a significantly greater proportion of UC patients at week 8, compared with placebo, at both doses studied. (jnj.com)
  • The EMA application is supported by data from the Phase 2b/3 SELECTION study, which showed a statistically significantly higher proportion of patients treated with once-daily, oral, filgotinib 200 mg achieved clinical remission at week 10 and maintained remission at week 58 compared with placebo. (gilead.com)
  • The SELECTION trial demonstrated that a statistically significantly higher proportion of patients treated with filgotinib 200 mg versus placebo achieved clinical remission at week 10 and maintained remission at week 58. (gilead.com)
  • Participants were randomly assigned to receive 45 mg of upadacitinib or placebo (2:1) for induction therapy to assess its effectiveness in achieving remission in two double-blind phase 3 trials, U-EXCEL and U-EXCEED. (mountsinai.org)
  • Data from three trials supported the FDA's regulatory greenlight: the induction studies U-EXCEED and U-EXCEL, and the maintenance study U-ENDURE. (biospace.com)
  • When we're looking at the trials, maybe half our patients hit endoscopic remission. (hcplive.com)
  • Approval was based on 2 randomized, placebo-controlled trials (n=546) that showed more participants who received the budesonide rectal foam achieved remission and a rectal bleeding score of 0 at 6 weeks of therapy. (medscape.com)
  • The Phase 3 program will combine two induction trials and one single maintenance trial, involving a total of 1,200 patients and over 600 clinical study centers, mainly in North America, Europe, Latin America and Asia Pacific. (q4web.com)
  • In FORTIFY, 52% of patients treated with SKYRIZI 360 mg SC achieved clinical remission at week 52 compared to 40% of patients receiving placebo. (lifesciencesbc.ca)
  • Additionally, during the induction studies, 24% and 19% of patients treated with SKYRIZI 600 mg IV achieved endoscopic remission at week 12, respectively, compared to 9% and 4% of patients receiving placebo. (lifesciencesbc.ca)
  • The peer-reviewed article scientifically confirms the quality and robustness of the data generated in Abivax's randomized placebo-controlled, double-blind clinical study that consisted of an eight-week induction phase followed by an open-label long-term extension phase . (pharmiweb.com)
  • During induction (through week 10), biologic-naive patients in both cohorts generally responded better to ozanimod than those who had received at least one prior biologic. (medscape.com)
  • U-EXCEED had an additional 12-week open-label, active single-group induction period to allow for the accrual of enough patients for entry into U-ENDURE. (mountsinai.org)
  • At week 10 post ADA treatment, clinical remission together with normal CRP levels were achieved in all 5 cases, while SES-CD scores reflected marked improvement in 3 cases and partial improvement in 2 cases who had extensive deep longitudinal CD lesions. (adacyte.com)
  • Subsequently, at the request of European regulatory authorities, the protocol was amended to include a second induction group (ADA80/40: 80 mg at week 0, 40 mg at weeks 2, 4 and 6). (digestivedashboard.nl)
  • I am now impatient to see the outcome of the phase 2b induction study and the subsequent maintenance trial to confirm these positive observations in a larger set of patients. (pharmiweb.com)
  • The FDA approval was based on positive data from two induction studies, U-EXCEED and U-EXCEL and one maintenance study, U-ENDURE. (yahoo.com)
  • In the induction studies, 45 mg dose of Rinvoq was used and dose strengths of 15 mg and 30 mg of Rinvoq were used in the maintenance study, compared with placebo. (yahoo.com)
  • Moreover, 42% and 55% of patients treated with Rinvoq 15 mg and 30 mg achieved clinical remission at 52 weeks in the maintenance study, compared with 14% of patients receiving placebo. (yahoo.com)
  • [ 84 ] Anti-TNF agents are effective for induction and maintenance of remission in patients with Crohn disease and active inflammation. (medscape.com)
  • Patients with luminal inflammatory disease receiving IM or aTNF-based first maintenance therapy, following induction with steroids, exclusive enteral nutrition (EEN), or aTNF, were included. (ecco-ibd.eu)
  • The primary outcome was sustained steroid-free clinical remission, defined by the short Pediatric CD Activity Index, at 6, 12, and 18 months, while continuing initial maintenance. (ecco-ibd.eu)
  • Among children with CD enrolled in the inception cohort study between 01/2014 and 12/2018, 464 met inclusion criteria and received IM (n=284) or aTNF (n=180 of whom 88 received steroids or EEN induction) as first maintenance therapy (Table 1). (ecco-ibd.eu)
  • After remission, long-term maintenance therapy is encouraged, but compliance rates are low. (medscape.com)
  • Furthermore, the main indication for AZA treatment was the maintenance of remission both in UC and CD. (ecco-ibd.eu)
  • Objective: To investigate the real-life effectiveness and safety of tofacitinib induction and maintenance treatment in Korean patients with UC. (ewha.ac.kr)
  • Conclusions: Tofacitinib was an effective induction and maintenance treatment with an acceptable safety profile in Korean patients with UC. (ewha.ac.kr)
  • Overall, the incidence of adverse events (AEs), serious AEs and discontinuations due to AEs were similar in the filgotinib and placebo groups in both the induction and maintenance periods of the study. (gilead.com)
  • Optimal doses of methotrexate combined with anti-TNF therapy to maintain clinical remission in inflammatory bowel disease. (uchicago.edu)
  • Thiopurines such as azathioprine and 6-mercaptopurine are commonly used to maintain remission and are also suitable for reducing the dose of corticosteroids in patients with steroid-dependent UC. (hindawi.com)
  • Only the high induction dose is depicted. (humirapro.com)
  • We are proud to offer the first new treatment option in six years for moderately to severely active CD, which may provide patients with a meaningful level of endoscopic improvement," said Thomas Hudson , M.D., senior vice president, research and development, chief scientific officer, AbbVie. (chemrobotics.in)
  • However, calcineurin inhibitors are used mainly for inducing remission. (hindawi.com)
  • Other drugs such as thiopurines are used for maintaining remission when the remission was achieved with calcineurin inhibitors because of the absence of long-term treatment data. (hindawi.com)
  • Data from a phase 3 trial published today in The New England Journal of Medicine show that upadacitinib-a breakthrough, once-daily oral medication-helps patients achieve and maintain clinical and endoscopic remission. (mountsinai.org)
  • Since moderate to severe patients with UC sometimes become fulminant, it is important to select an appropriate induction therapy. (adacyte.com)
  • Because elderly patients with UC sometimes become refractory to treatment, it is important to select an appropriate induction therapy for elderly patients at the early phase of UC disease. (adacyte.com)
  • The primary outcome was analyzed in the whole cohort, and in the subgroup receiving steroids or EEN as induction, using a Chi-square test, as well as in the matched group with a McNemar's test, generalized estimating equation (GEE), and with a mixed model to account for clustering by centre. (ecco-ibd.eu)
  • However, 20-40% of patients fail to respond to corticosteroids (steroid-refractory UC) or fail to maintain remission without them (steroid-dependent UC) [ 1 - 5 ]. (hindawi.com)
  • Sandborn WJ, Mallon P, Lindgren S, Sandler RS, Azathioprine is an option for patients who require corticosteroids or cyclosporine for induction of remission or in whom remission is not adequately maintained with 5-ASA. (bigskyaz.com)