Impact of Inflammatory Burden on Efficacy of Upadacitinib Maintenance Therapy in Ulcerative Colitis: Results From the Phase 3 U-ACHIEVE Study

Introduction: Upadacitinib (UPA) has demonstrated superior efficacy to placebo (PBO) and a favorable safety profile in patients with moderately to severely active ulcerative colitis (UC) in trial U-ACHIEVE Maintenance, in which two maintenance doses of UPA (30mg and 15mg once daily [QD]) were evaluated.1–3 However, data are limited on the impact of inflammatory burden on the efficacy of the two maintenance doses. Endoscopic improvement c at Week 52 BL Full Mayo score ≤9 BL Full Mayo score >9 8/74 (10.8) 14/75 (18.1) 45/75 (60.4) 27/73 (36.7) 44/73 (60.6) 50/79 (62.8) 0.2 26.1 Pancolitis at BL, no Pancolitis at BL, yes 16/79 (20.3) 6/70 (8.0) 33/66 (49.6) 39/82 (47.9) 43/68 (63.7) 52/86 (59.9) 14.1 12.0 EIM at BL, no EIM at BL, yes 15/112 (13.7) 6/37 (16.9) 57/112 (50.9) 15/36 (41.7) 68/113 (60.2) 27/41 (65.4) 9.3 23.7 Data are from the ITT population, defined as the first 450 randomized and treated patients with 8-week UPA 45 mg QD induction treatment who were enrolled in Cohort 1 under the protocol for the 52-week maintenance treatment period. Non-responder imputation incorporating multiple imputations was performed to handle missing data due to COVID-19 incidence. a Not part of the predefined statistical analyses. b Adapted Mayo score ≤2, with stool frequency subscore ≤1 (and not greater than induction baseline), rectal bleeding subscore of 0, and endoscopic subscore ≤1. c Endoscopic subscore ≤1.

Induction and Maintenance Treatment with Risankizumab Leads to Symptomatic Relief in Patients With Moderate to Severe Crohn’s Disease

Here, the patient reported outcomes (PROs) of AP score (APS) and SF, and their correlation with endoscopic outcomes, were examined during induction and maintenance treatment. Methods: Pooled data from the ADVANCE/MOTIVATE induction studies (PBO, RZB 600 mg intravenous (IV) groups), and data from the FORTIFY maintenance study (180 mg, 360 mg and RZB withdrawal/PBO subcutaneous [SC] groups), were examined for AP and SF clinical outcomes. Patient Reported Outcomes of Abdominal Pain Score (APS) and Stool Frequency (SF) during Induction and Maintenance Dosing with RZB (ITT#) (NRI-NC&) Endpoint ADVANCE + MOTIVATE RZB 600 mg IV PBO RZB 600 mg IV PBO RZB 600 mg IV PBO Wk 4 Wk 8 Wk 12 Decrease in APS from BL 59.4 [54.3, 64.5] 71.7 [67.9, 75.6] P < 0.001 63.8 [58.9, 68.8] 75.9 [72.2, 79.6] P< 0.001 58.8 [53.8, 63.9] 76.9 [73.2, 80.5] P< 0.001 Decrease in SF from BL 65.7 [60.9, 70.6] 81.6 [78.3, 84.9] P< 0.001 63.5 [58.6, 68.5] 84.1 [80.9, 87.2] P< 0.001 58 [52.9, 63.1] 85.4 [82.4, 88.4] P< 0.001 AP =0 in patients with APS ≥1 at Baseline 2.6 [0.9, 4.3] 5.6 [3.6, 7.6] P= 0.052 3.2 [1.3, 5.0] 11.5 [8.7, 14.3] P< 0.001 6.4 [3.8, 8.9] 17.9 [14.5, 21.2] P<0.001 SF ≤1 in patients with SF >2.8 at Baseline 4.8 [2.5, 7.1] 9.8 [7.1, 12.5] P=0.004 6 [3.4, 8.5] 18.2 [14.7, 21.6] P<0.001 11.6 [8.2, 15.1] 26.1 [22.2, 30.0] P<0.001 Endpoint FORTIFY Withdrawal (PBO SC) RZB 180 mg SC RZB 360 mg SC Withdrawal (PBO SC) RZB 180 mg SC RZB 360 mg SC Withdrawal (PBO SC) RZB 180 mg SC RZB 360 mg SC Withdrawal (PBO SC) RZB 180 mg SC RZB 360 mg SC Withdrawal (PBO SC) RZB 180 mg SC RZB 360 mg SC Wk 8 Wk 16 Wk 24 Wk 32 Wk 52 APS Remission (APS ≤1) 67.7 [60.5, 74.8] 72.6 [65.6, 79.6] P=0.413 75.9 [68.8, 82.9] P= 0.033 70.1 [63.1, 77.1] 65.6 [58.2, 73.0] P= 0.311 70.2 [62.7, 77.8] P= 0.743 61 [53.5, 68.4] 66.2 [58.8, 73.6] P= 0.306 68.1 [60.4, 75.8] P= 0.052 54.3 [46.6, 61.9] 66.2 [58.8, 73.6] P = 0.027 63.1 [55.2, 71.1] P= 0.035 46.3 [38.7, 54.0] 57.3 [49.6, 65.1] P= 0.027 55.3 [47.1, 63.5] P= 0.028 SF Remission (SF ≤2.8) 66.5 [59.2, 73.7] 68.2 [60.9, 75.4] P= 0.807 67.4 [59.6, 75.1] P= 0.420 64.6 [57.3, 72.0] 66.2 [58.8, 73.6] P = 0.783 67.4 [59.6, 75.1] P = 0.266 59.8 [52.3, 67.3] 59.9 [52.2, 67.5] P = 0.990 63.8 [55.9, 71.8] P = 0.154 57.3 [49.7, 64.9] 58.6 [50.9, 66.3] P= 0.881 58.2 [50.0, 66.3] P= 0.437 44.5 [36.9, 52.1] 51.6 [43.8, 59.4] P= 0.113 56 [3.6, 24.3] P= 0.008 AP =0 18.3 [12.4, 24.2] 30.6 [23.4, 37.8] P= 0.009 30.6 [23.4, 37.8] P= 0.009 SF ≤1 28.7 [21.7, 35.6] 35.7 [28.2, 43.2] P=0.081 39.0 [31.0, 47.1] P=0.006 AP =0 and SF ≤1 14.6 [9.2, 20.0] 21.7 [15.2, 28.1] P=0.092 23.4 [16.4, 30.4] P=0.021 BL = baseline;Wk = Week;Endoscopic remission = SES-CD ≤4 and at least 2-point reduction from baseline;Ulcer-free endoscopy = SES-CD ulcerated surface subscore =0 in patients with subscore ≥1 at baseline;#Intent-to-treat (ITT) population Includes randomized patients who (ADVANCE/MOTIVATE) received at least one dose of study drug during the 12-Week Induction Period, and had an SES-CD of ≥6 (≥4 for isolated ileal disease) or who (FORTIFY) received IV risankizumab for 12 weeks in the induction study and at least one dose of study drug in FORTIFY sub-study 1 and had an SES-CD of ≥6 (≥ 4 for isolated ileal disease) at baseline of induction. &Calculations were based on non-responder imputation with no special data handling for missing data due to COVID-19 pandemic. 95% CI and p-value for adjusted response rate difference compared to PBO calculated according to the Cochran-Mantel-Haenszel test adjusted for strata.

Implementation and Short-term Adverse Events of Anti-SARS-CoV-2 Vaccines in Inflammatory Bowel Disease Patients: An International Web-based Survey.

INTRODUCTION: Anti-SARS-CoV-2 vaccine clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease [IBD]. We aimed to describe the implementation of anti-SARS-CoV-2 vaccination among IBD patients, patients' concerns, and the side effect profile of the anti-SARS-CoV-2 vaccines, using real-world data. METHODS: An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of the patient characteristics, concerns, vaccination status, and side effect profile were analysed. RESULTS: In all 3272 IBD patients completed the survey, 79.6% had received at least one dose of anti-SARS-CoV-2 vaccine, and 71.7% had completed the vaccination process. Patients over 60 years old had a significantly higher rate of vaccination [p < 0.001]. Patients' main concerns before vaccination were the possibility of having worse vaccine-related adverse events due to their IBD [24.6%], an IBD flare after vaccination [21.1%], and reduced vaccine efficacy due to IBD or associated immunosuppression [17.6%]. After the first dose of the vaccine, 72.4% had local symptoms and 51.4% had systemic symptoms [five patients had non-specified thrombosis]. Adverse events were less frequent after the second dose of the vaccine and in older patients. Only a minority of the patients were hospitalised [0.3%], needed a consultation [3.6%], or had to change IBD therapy [13.4%] after anti-SARS-CoV-2 vaccination. CONCLUSIONS: Although IBD patients raised concerns about the safety and efficacy of anti-SARS-CoV-2 vaccines, the implementation of vaccination in those responding to our survey was high and the adverse events were comparable to the general population, with minimal impact on their IBD.

Inflammatory Bowel Disease Patients' Perspectives during COVID-19 Pandemic: Results from a Portuguese Survey.

INTRODUCTION: Patients with inflammatory bowel disease (IBD) do not seem to be at increased risk of infection by SARS-CoV-2, but there is a concern whether immunosuppressive therapy may be associated with more severe disease. Several clinical practice recommendations have been published to help guide IBD care during the COVID-19 pandemic. Nonetheless, few studies have addressed patients' perspectives and fears. We aimed to evaluate Portuguese IBD patients' perspectives on the clinical management of their disease during the SARS-CoV-2 pandemic as well as the impact on their professional life. METHODS: An anonymous electronic survey was created using REDCap and was distributed by the Portuguese Association of Inflammatory Bowel Disease (APDI) between May and August 2020. Patients' perspectives on immunosuppressive therapy, disease management, interaction with gastroenterology departments, and the impact of the pandemic in their professional life were assessed. Patients' proposals to improve medical care were also evaluated. Descriptive analysis and logistic regression were performed. RESULTS: A total of 137 participants answered the survey (79.6% females, mean age 41.7 ± 12.1 years). Although having IBD and receiving treatment with immunosuppressors (thiopurines, steroids, or biologics) were considered promotors of anxiety, most patients (85.4%) agreed that disease remission was a priority and only a minority of patients interrupted their treatment during the pandemic. In multivariate analysis, active disease, biologic treatment, and use of corticosteroids in the last 3 months were perceived by the patients as high-risk features for increased risk of SARS-Cov-2 infection and more severe disease. Fifty-nine patients (44%) believed that their follow-up was influenced by the pandemic and only 58.8% felt that they had the opportunity to discuss their therapeutic options with their doctor. Sixty-three patients (46.0%) were working from home during the pandemic, although this decision was related to IBD and immunosuppressive therapy in only 36.5 and 39.7% of the cases, respectively. Areas where care could have been improved during the pandemic were identified by patients, namely enhancement of the communication with IBD professionals, conciliation of telemedicine with face-to-face appointments, and facilitation of the interaction between patients and employers. CONCLUSION: Most patients agreed that maintaining IBD remission is crucial, and only a minority of the patients stopped their treatment as per their own initiative. IBD status only had a small influence on patients' professional activity during the COVID-19 outbreak, with most changes being related to the pandemic itself.

Mental health of youth and COVID-19: speeches producing the eduactional care mediated on the webradio Saúde mSalud mental de la juventud y COVID-19: discursos productores de webcuidado educativo mediados en webradio

Objetivo: Analisar os discursos das juventudes como produtores do webcuidado clínico e educativo sobre saúde mental no contexto da COVID-19. Método: Pesquisa exploratório-descritiva com abordagem qualitativa realizada por síntese dos conteúdos e interações do Programa "Em Sintonia com a Saúde", produzido na WebRádio AJIR em conexão com juventudes de escolas públicas e Instituições de Nível superior do Estado do Ceará, Brasil. Resultados: Foram realizadas 40 perguntas-discursos sobre COVID-19, sendo questões indagativas que coadunam com o medo de contrair a doença, possibilitando elevação da ansiedade e sintomas depressivos identificados em colegas, amigos e familiares e preocupações com as informações seguras sobre a doença. Conclusão: A comunicação produzida na webrádio ajudou os jovens escolares e universitários no desenvolvimento de estratégias de aproximação, escuta e interações no contexto do isolamento social, auxiliando- os nas tomadas de decisões para prevenção e contenção da pandemia da COVID-19.(AU) Objective: To analyze the speeches of youths as producers of clinical and educational web-care about mental health in the context of COVID-19. Method: Exploratory-descriptive research with a qualitative approach carried out by synthesizing the contents and interactions of the Program "Em Sintonia com Saúde", produced at WebRádio AJIR in connection with youths from public schools and Higher Education Institutions in the State of Ceará, Brazil. Results: 40 questions-speeches about COVID-19 were carried out, being questioning questions that are in line with the fear of contracting the disease, enabling an increase in anxiety and depressive symptoms identified in colleagues, friends and family and concerns about safe information about the disease. Conclusion: The communication produced on the web radio helped young schoolchildren and university students in the development of strategies for approaching, listening and interacting in the context of social isolation, assisting them in decision-making to prevent and contain the pandemic of COVID-19.(AU) Objetivo: Analizar los discursos de los jóvenes como productores de web-cuidado clínico y educativo sobre salud mental en el contexto del COVID-19. Método: Investigación exploratorio-descriptiva con enfoque cualitativo realizada mediante la síntesis de los contenidos e interacciones del programa "Em Sintonia com a Saúde", producido en WebRádio AJIR en relación con jóvenes de escuelas públicas e Instituciones de Educación Superior del Estado de Ceará, Brasil. Resultados: se realizaron 40 preguntas-discursos sobre COVID-19, siendo cuestionamientos que están en línea con el miedo a contraer la enfermedad, posibilitando un aumento de los síntomas de ansiedad y depresión identificados en colegas, amigos y familiares y preocupaciones sobre información segura sobre la enfermedad. Conclusión: La comunicación producida en la radio web ayudó a jóvenes escolares y universitarios en el desarrollo de estrategias para acercarse, escuchar e interactuar en el contexto de aislamiento social, ayudándolos en la toma de decisiones para prevenir y contener la pandemia de COVID-19.(AU)

Mental health of youth and COVID-19: speeches producing the eduactional care mediated on the webradio Saúde mSalud mental de la juventud y COVID-19: discursos productores de webcuidado educativo mediados en webradio

Objetivo: Analisar os discursos das juventudes como produtores do webcuidado clínico e educativo sobre saúde mental no contexto da COVID-19. Método: Pesquisa exploratório-descritiva com abordagem qualitativa realizada por síntese dos conteúdos e interações do Programa "Em Sintonia com a Saúde", produzido na WebRádio AJIR em conexão com juventudes de escolas públicas e Instituições de Nível superior do Estado do Ceará, Brasil. Resultados: Foram realizadas 40 perguntas-discursos sobre COVID-19, sendo questões indagativas que coadunam com o medo de contrair a doença, possibilitando elevação da ansiedade e sintomas depressivos identificados em colegas, amigos e familiares e preocupações com as informações seguras sobre a doença. Conclusão: A comunicação produzida na webrádio ajudou os jovens escolares e universitários no desenvolvimento de estratégias de aproximação, escuta e interações no contexto do isolamento social, auxiliando- os nas tomadas de decisões para prevenção e contenção da pandemia da COVID-19.(AU) Objective: To analyze the speeches of youths as producers of clinical and educational web-care about mental health in the context of COVID-19. Method: Exploratory-descriptive research with a qualitative approach carried out by synthesizing the contents and interactions of the Program "Em Sintonia com Saúde", produced at WebRádio AJIR in connection with youths from public schools and Higher Education Institutions in the State of Ceará, Brazil. Results: 40 questions-speeches about COVID-19 were carried out, being questioning questions that are in line with the fear of contracting the disease, enabling an increase in anxiety and depressive symptoms identified in colleagues, friends and family and concerns about safe information about the disease. Conclusion: The communication produced on the web radio helped young schoolchildren and university students in the development of strategies for approaching, listening and interacting in the context of social isolation, assisting them in decision-making to prevent and contain the pandemic of COVID-19.(AU) Objetivo: Analizar los discursos de los jóvenes como productores de web-cuidado clínico y educativo sobre salud mental en el contexto del COVID-19. Método: Investigación exploratorio-descriptiva con enfoque cualitativo realizada mediante la síntesis de los contenidos e interacciones del programa "Em Sintonia com a Saúde", producido en WebRádio AJIR en relación con jóvenes de escuelas públicas e Instituciones de Educación Superior del Estado de Ceará, Brasil. Resultados: se realizaron 40 preguntas-discursos sobre COVID-19, siendo cuestionamientos que están en línea con el miedo a contraer la enfermedad, posibilitando un aumento de los síntomas de ansiedad y depresión identificados en colegas, amigos y familiares y preocupaciones sobre información segura sobre la enfermedad. Conclusión: La comunicación producida en la radio web ayudó a jóvenes escolares y universitarios en el desarrollo de estrategias para acercarse, escuchar e interactuar en el contexto de aislamiento social, ayudándolos en la toma de decisiones para prevenir y contener la pandemia de COVID-19.(AU)