One-year effectiveness and safety of ustekinumab in Ulcerative Colitis: a multicenter real-world study from Italy

Abstract Background Phase III trials have demonstrated the efficacy and safety of ustekinumab in moderate-to-severe ulcerative colitis (UC), but no real-life long-term data is currently available. Methods From January to September 2019, all consecutive patients with active UC treated with ustekinumab in a GETAID centre were included. Patients were evaluated at week 52. Remission was defined by a partial Mayo Clinic score ≤ 2. The aim of the present study was to assess long-term effectiveness and safety of ustekinumab in UC. Results 103 UC patients (62 men; mean age: 41.2 ± 16.2 years; 52% pancolitis E3) were included in 21 centres. History of immunomodulator, anti-TNF and vedolizumab therapies was noted in 84.5%, 99.0% and 85.4% of the cases, respectively. At week 54, 44 (43%) patients discontinued ustekinumab, for lack of efficacy (n=41), pregnancy (n=1), persistence of eczematiform lesions (n=1) or personal decision (n=1). Cumulative probabilities of ustekinumab persistence were 96.1%, 81.6%, 71.7%, and 58.4% after 3, 6, 9, and 12 months, respectively. In multivariate analysis, a CRP>5 mg/L at week 0 (OR=2.91, CI95%[1.15–7.36]; p=0.02) and concomitant steroids at week 0 (OR=3.05, CI95%[1.30–7.14]; p=0.01) were significantly associated with ustekinumab discontinuation within one year. The overall rate of steroid-free clinical remission at week 52 was 32% of whom 71% had null rectal bleeding and stool frequency subscores. Ten patients (9.7%) underwent colectomy within a median of 6.7 [4.3–10.6] months. Adverse events were observed in 15 (16.9%) patients, of whom 4 (4.5%) had severe adverse events including three patients with exacerbation of UC leading to hospitalization, and a 62 years-old men who died from a myocardial infarction four months after ustekinumab initiation. Conclusion In this real-world cohort study that included patients with refractory ulcerative colitis to multiple therapies, more than one-half of patients were still treated by ustekinumab and one-third were in steroid-free clinical remission, after 52 weeks.

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P517 One year effectiveness and safety of ustekinumab in Ulcerative Colitis: a multicentre real-world study from Italy

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.639 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S495-S496

Author(s):

M F Chiappetta ◽

A Viola ◽

M Mastronardi ◽

L Turchini ◽

S Carparellli ◽

...

Keyword(s):

Ulcerative Colitis ◽

Real World ◽

Clinical Remission ◽

Real Life ◽

Mucosal Healing ◽

Phase Iii ◽

Real World Data ◽

Phase Iii Clinical Trials ◽

Secondary Endpoints ◽

One Year

Abstract Background Efficacy and safety of ustekinumab for the treatment of Ulcerative colitis (UC) has been demonstrated in phase III clinical trials, but real world data are scarce. The aim of this study was to assess effectiveness and safety of ustekinumab in an Italian cohort of UC patients. Methods Data of patients with UC who started using ustekinumab were collected. Primary endpoint was steroid-free clinical remission at 24 and 52 weeks of therapy. Secondary endpoints were: treatment response, endoscopic remission, treatment persistence at 12 months and safety. Results A total of 68 patients (males 63.2 %; mean age (SD) 31 years (14.5)) were included. All patients were biologics experienced. At 24 and 52 weeks, 32 % and 50 % of patients achieved steroid-free clinical remission, 85% and 81% had clinical response, respectively. (Table 1) At the end of follow-up there were a significant reduction of pMS from baseline (p<0.001) and of steroid use (p<0.001) (Figure 1). Of the available endoscopies at 12 months (18/38), 22.2% showed mucosal healing. The probability to persist in therapy with ustekinumab after 12 months of treatment was of 89.7 %. Only one adverse event occurred (diagnosis of an hypophysis adenoma). No patients required colectomy. Conclusion Data from our small real-life cohort of treatment-refractory UC patients suggest satisfactory effectiveness of ustekinumab and an excellent safety. More data assessing mucosal healing after one year of treatment are needed

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Once-Weekly Dulaglutide (DU) and Canagliflozin (CAN) Combination Therapy in Obese T2 Diabetes (T2D) Patients—One Year Real-World Evidence from India

Diabetes ◽

10.2337/db18-103-lb ◽

2018 ◽

Vol 67 (Supplement 1) ◽

pp. 103-LB

Author(s):

ANANT NIGAM

Keyword(s):

Combination Therapy ◽

Real World ◽

Real World Evidence ◽

One Year

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One-Year Outcomes of the Paclitaxel-Eluting Stent for TASC C and D Femoropopliteal Lesions in Real World

10.1055/s-0041-1729010 ◽

2020 ◽

Author(s):

Lyo Min Kwon ◽

Saebeom Hur

Keyword(s):

Real World ◽

One Year

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Real-World Experience of the One-Year Efficacy of Rifaximin Add-On to Lactulose Is Superior to Lactulose Alone in Patients with Cirrhosis Complicated with Recurrent Hepatic Encephalopathy in Taiwan

Journal of Personalized Medicine ◽

10.3390/jpm11060478 ◽

2021 ◽

Vol 11 (6) ◽

pp. 478

Author(s):

Ching Chang ◽

Chien-Hao Huang ◽

Hsiao-Jung Tseng ◽

Fang-Chen Yang ◽

Rong-Nan Chien

Keyword(s):

Hepatic Encephalopathy ◽

Real World ◽

Ammonia Level ◽

Decompensated Cirrhosis ◽

Control Group ◽

Multivariable Logistic Regression Model ◽

Before And After ◽

One Year ◽

The One ◽

Serum Ammonia

Background: Hepatic encephalopathy (HE), a neuropsychiatric complication of decompensated cirrhosis, is associated with high mortality and high risk of recurrence. Rifaximin add-on to lactulose for 3 to 6 months is recommended for the prevention of recurrent episodes of HE after the second episode. However, whether the combination for more than 6 months is superior to lactulose alone in the maintenance of HE remission is less evident. Therefore, the aim of this study is to evaluate the one-year efficacy of rifaximin add-on to lactulose for the maintenance of HE remission in Taiwan. Methods: We conducted a real-world single-center retrospective cohort study to compare the long-term efficacy of rifaximin add-on to lactulose (group R + L) versus lactulose alone (group L, control group). Furthermore, the treatment efficacy before and after rifaximin add-on to lactulose was also analyzed. The primary endpoint of our study was time to first HE recurrence (Conn score ≥ 2). All patients were followed up every three months until death, and censored at one year if still alive. Results and Conclusions: 12 patients were enrolled in group R + L. Another 31 patients were stratified into group L. Sex, comorbidity, ammonia level, and ascites grade were matched while age, HE grade, and model for end-stage liver disease (MELD) score were adjusted in the multivariable logistic regression model. Compared with group L, significant improvement in the maintenance of HE remission and decreased episodes and days of HE-related hospitalizations were demonstrated in group R + L. The serum ammonia levels were significantly lower at the 3rd and 6th month in group 1. Concerning changes before and after rifaximin add-on in group R + L, mini-mental status examination (MMSE), episodes of hospitalization, and variceal bleeding also improved at 6 and 12 months. Days of hospitalization, serum ammonia levels also improved at 6th month. Except for concern over price, no patients discontinued rifaximin due to adverse events or complications. The above results provide evidence for the one-year use of rifaximin add-on to lactulose in reducing HE recurrence and HE-related hospitalization for patients with decompensated cirrhosis.

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Mortality in older adults following a fragility fracture: real-world retrospective matched-cohort study in Ontario

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-03960-z ◽

2021 ◽

Vol 22 (1) ◽

Cited By ~ 2

Author(s):

Jacques P. Brown ◽

Jonathan D. Adachi ◽

Emil Schemitsch ◽

Jean-Eric Tarride ◽

Vivien Brown ◽

...

Keyword(s):

Cohort Study ◽

Hip Fracture ◽

Fragility Fracture ◽

Mortality Risk ◽

Real World ◽

First Year ◽

Matched Cohort ◽

Matched Cohort Study ◽

Fracture Cohort ◽

One Year

Abstract Background Recent studies are lacking reports on mortality after non-hip fractures in adults aged > 65. Methods This retrospective, matched-cohort study used de-identified health services data from the publicly funded healthcare system in Ontario, Canada, contained in the ICES Data Repository. Patients aged 66 years and older with an index fragility fracture occurring at any osteoporotic site between 2011 and 2015 were identified from acute hospital admissions, emergency and ambulatory care using International Classification of Diseases (ICD)-10 codes and data were analyzed until 2017. Thus, follow-up ranged from 2 years to 6 years. Patients were excluded if they presented with an index fracture occurring at a non-osteoporotic fracture site, their index fracture was associated with a trauma code, or they experienced a previous fracture within 5 years prior to their index fracture. This fracture cohort was matched 1:1 to controls within a non-fracture cohort by date, sex, age, geography and comorbidities. All-cause mortality risk was assessed. Results The survival probability for up to 6 years post-fracture was significantly reduced for the fracture cohort vs matched non-fracture controls (p < 0.0001; n = 101,773 per cohort), with the sharpest decline occurring within the first-year post-fracture. Crude relative risk of mortality (95% confidence interval) within 1-year post-fracture was 2.47 (2.38–2.56) in women and 3.22 (3.06–3.40) in men. In the fracture vs non-fracture cohort, the absolute mortality risk within one year after a fragility fracture occurring at any site was 12.5% vs 5.1% in women and 19.5% vs 6.0% in men. The absolute mortality risk within one year after a fragility fracture occurring at a non-hip vs hip site was 9.4% vs 21.5% in women and 14.4% vs 32.3% in men. Conclusions In this real-world cohort aged > 65 years, a fragility fracture occurring at any site was associated with reduced survival for up to 6 years post-fracture. The greatest reduction in survival occurred within the first-year post-fracture, where mortality risk more than doubled and deaths were observed in 1 in 11 women and 1 in 7 men following a non-hip fracture and in 1 in 5 women and 1 in 3 men following a hip fracture.

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Superior treatment persistence with ustekinumab in Crohn’s disease and vedolizumab in ulcerative colitis compared with anti‐TNF biological agents: real‐world registry data from the Persistence Australian National IBD Cohort (PANIC) study

Alimentary Pharmacology & Therapeutics ◽

10.1111/apt.16436 ◽

2021 ◽

Author(s):

Yanna Ko ◽

Sudarshan Paramsothy ◽

Yunki Yau ◽

Rupert W. Leong

Keyword(s):

Ulcerative Colitis ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Real World ◽

Biological Agents ◽

Registry Data ◽

Treatment Persistence

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19 Colectomy Rate for Moderate to Severe Ulcerative Colitis with Biologics

British Journal of Surgery ◽

10.1093/bjs/znab134.188 ◽

2021 ◽

Vol 108 (Supplement_2) ◽

Author(s):

J W H Koh ◽

C H Ng ◽

M H Lee ◽

Y H Chin ◽

Z H Ong ◽

...

Keyword(s):

Ulcerative Colitis ◽

Current Literature ◽

Biologic Therapy ◽

Meta Analysis ◽

Severe Ulcerative Colitis ◽

Before And After ◽

Arcsine Transformation ◽

One Year

Abstract Introduction Biologics are recommended by both the ACG and ECCO community for the treatment of ulcerative colitis. Yet, current literature has yet to estimate the rate of colectomies after biologic therapy, and thus a pooled meta-analysis was conducted the rate of colectomies in 1month, 6 months, 1 year, 2years and five years after biologics. Method Medline and Embase were searched for articles examining biologics use in moderate to severe UC or acute severe UC (ASUC) from inception to 21st May 2020. Analysis of proportions were undertaken after a freeman-tukey double arcsine transformation. Results The pooled overall colectomy rates of ASUC and moderate to severe UC were 9% (CI: 4% - 14%) at one month, 18% (CI: 13% - 25%) at six months, 21% (CI:16% - 27%) at one year, 29% (CI:24% - 34%) at two years and 38% (CI:30% - 45%) at five years. Additionally, colectomy rates were consistently lower comparing between articles before and after 2010. At one-year, overall colectomy rate following infliximab use was at 25%, golimumab at 15%, vedolizumab at 14%, and adalimumab at 3%. Conclusions Colectomy rates in the era of biologics ranged from 8% to 38% and lower post-2010 showing significant improvement in management and supporting the utility of biologics in Ulcerative colitis management.

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