scholarly journals P536 Effectiveness, safety and persistence of treatment with ustekinumab in a cohort of patients with moderate-to-severe refractory Crohn’s Disease

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S509-S510
Author(s):  
A I Morales Bermúdez ◽  
A M Bravo Aranda ◽  
M Martinez Burgos ◽  
R Olmedo Martín
Keyword(s):  
Clinical Remission ◽  
Real Life ◽  
Fecal Calprotectin ◽  
University Hospital ◽  
Reactive Protein ◽  
Kaplan Meier ◽  
Regional University ◽  
History Of ◽  
One Year

Abstract Background Ustekinumab has proved its efficacy and safety in moderate-to-severe Crohn′s disease (CD). However, the real practice setting differs from clinical trials. Our aim was to evaluate the effectiveness and safety of ustekinumab in a cohort of real-life practice patients with CD mostly refractory to anti-TNF α agents. Methods Observational retrospective single-center study. All patients undergoing treatment with ustekinumab at the Digestive Diseases Department of the Regional University Hospital of Málaga and at least 16 weeks of follow-up after induction were included. The primary outcome was steroid-free clinical remission (Harvey-Bradshaw Index ≤4) at 24 and 52 weeks. Secondary objectives were combined biological remission (fecal calprotectin levels <250 mcg/g and C-reactive protein <10 mg/dl), safety and persistence of ustekinumab during the follow-up period. Results A total of 89 patients with CD treated with ustekinumab (59,6% women; median disease duration 10 years) were included. The median follow-up was 60 weeks and 55 patients reached one year of follow-up. A 39,3% of the patients had history of previous abdominal surgery and 27% had been treated with 2 or more biologics. A 25,8% and 12,4% of the patients were on steroids and immunosupresants at the induction. The percentages of steroid-free clinical remission at 24 and 52 weeks were 42% and 54% respectively (Figure 1). Combined biological remission at 24 and 52 weeks was achieved in 33% and 45% of the patients respectively. Ustekinumab persistence was 88% at 12 months of follow-up (Figure 2). There were 14 suspensions mainly due to lack of response. Only 13 adverse events were documented in 9 patients (11.5%), none of them serious. Figure 1. Steroid-free clinical and biological remission percentages of ustekinumab at 16,24,52,76 and 104 weeks. Figure 2. Kaplan-Meier curve showing the durability of ustekinumab throughout the follow-up period. Conclusion Ustekinumab was effective and safe in a high proportion of patients with CD that were resistant to conventional immunosuppressant and antitumor necrosis factor drugs in this real-life practice cohort.

scholarly journals Evaluation of efficacy and comparative frequency of adverse events in patients with ulcerative colitis receiving the original infliximab and its biosimilar. One year of observation

2019 ◽  
Vol 91 (8) ◽  
pp. 41-46
Author(s):  
O V Knyazev ◽  
T V Shkurko ◽  
A V Kagramanova ◽  
A A Lishchinskaya ◽  
M Yu Zvyaglova ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Real Life ◽  
Fecal Calprotectin ◽  
Biologic Drugs ◽  
Real Life Data ◽  
Bowel Diseases ◽  
Significant Clinical Improvement ◽  
One Year

Real - life data on the effectiveness and safety of biosimilar and biologic drugs licensed for treatment of inflammatory bowel diseases (IBD) is lacking. Aim. To investigate efficacy of original Infliximab (IFX) and its biosimilar in treating patients with ulcerative colitis (UC) and determine the frequency of adverse events during 1 year follow - up period. Materials and methods. Our cohort consisted of 98 ulcerative colitis patients, treated with original IFX and its biosimilar since December 2017 till December 2018 years. Original Infliximab was prescribed in 56 UC patients (57.1%) during 5 years and longer; 16 patients (16.3%) were switched to IFX biosimilar; 13 UC bio - naïve patients (13.3%) received original IFX, 29 (29.6%) patients - biosimilar IFX. In 14 patients (14.3%) original infliximab was rotated with biosimilar. We picked out 42 patients to assess efficacy of original IFX and biosimilar. Results and discussion. Twelve patients, received original IFX and 28 patients, treated with its biosimilar, showed significant clinical improvement by decreasing Mayo index from 9.7±0.4 and 10.2±0.2 points to 1.9±0.09 and 2.1±0.1 points, accordingly. Also we noticed positive change in laboratory markers - CRP decrease from 89.6±8.7 mg/l and 77.5±8.0 mg/l to 6.5±0.8 mg/l and 6.9±0.8 mg/l (p>0.05), albumin increase from 30.1±4.7 g/l and 29.6±3.6 g/l to 34.1±6.3 g/l and 32.8±5.9 g/l (p>0.05), increase of serum iron levels from 6.4±0.5 mcg/l and 7.1±0.65 mcg/l to 14.6±4.4 mcg/l and 15.9±5.1 mcg/l (p>0.05), hemoglobin increase from 104.7±9.8 g/l and 102.2±8.8 g/l till 124±11.3 g/l and 121±10.9 g/l (p>0.05), and fecal calprotectin decrease from 1680±134 mcg/g and 1720±126 mcg/g till 245.5±33.4 mcg/g and 230.5±29.8 mcg/g (p>0.05). During 1 year follow - up 12 UC patients, treated with original IFX and its biosimilar, developed adverse events. The majority of adverse events (n=8) were registered in patients, rotating administration of original IFX and its biosimilar. Conclusion. IFX biosimilar is effective as well as original IFX. Frequency of adverse events, occurred in patients, treated with original IFX, was comparable with adverse events frequency in patients, received biosimilar IFX. Frequency of adverse events was significantly higher in UC patients, rotating original IFX and its biosimilar.

scholarly journals P552 Assessing adherence to objective disease monitoring and outcomes with adalimumab in a real-world IBD cohort

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S519-S519
Author(s):  
Y Xiao ◽  
A Al Khoury ◽  
P Golovics ◽  
R Kohen ◽  
W Afif ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Clinical Symptoms ◽  
Fecal Calprotectin ◽  
Dose Optimization ◽  
Early Assessment ◽  
Mayo Score ◽  
Objective Monitoring ◽  
Kaplan Meier ◽  
One Year

Abstract Background Data suggests that tight objective monitoring may improve clinical outcomes in IBD. Methods The aim of this study is to assess the adherence to serial tight objective monitoring(clinical and biomarkers) and its effect on clinical outcomes. We retrospectively reviewed the chart of 428 consecutive IBD patients started on adalimumab between January 1,2015–January 1,2019 [338 Crohn’s disease(CD), 90 ulcerative colitis(UC)]. Clinical symptoms (assessed by Harvey-Bradshaw-Index, partial Mayo score), C-Reactive Protein(CRP), and fecal calprotectin(FCAL) assessments were captured at treatment initiation and at 3, 6, 9, and 12 months. Dose optimization and drug sustainability curves were plotted by Kaplan-Meier method Results Clinical evaluation was available in nearly all patients at 3(CD-UC:95-94%), 6(90-83%), 9(86-85%) and 12(96-89%) months. CRP was also available in nearly all patients but testing frequency decreased in CD patients over time. Compliance to serial FCAL testing was low. Clinical remission at one-year was higher in patients adherent to early assessment visit at 3 months (p=0.001 for CD and UC). Adherence to early follow-up resulted in earlier dose optimisation in CD and UC patients (pLogrank=0.026 for UC & p=0.09 for CD). Overall drug sustainability did not differ. Conclusion Clinical and CRP, but not FCAL, were frequently assessed in patients starting adalimumab. Adherence to early objective combined follow-up visits resulted in earlier dose optimization, improved one-year clinical outcomes but did not change drug sustainability.

scholarly journals P583 Real-life efficacy and safety of Ustekinumab as second- or third-line therapy in Crohn’s disease: results from a large Italian cohort study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S536-S537
Author(s):  
G Mocci ◽  
A Cuomo ◽  
L Allegretta ◽  
G Aragona ◽  
R Colucci ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Remission ◽  
Large Population ◽  
Real Life ◽  
Previous Treatment ◽  
Fecal Calprotectin ◽  
Concomitant Treatment ◽  
Efficacy And Safety

Abstract Background Ustekinumab (UST) is an anti-IL12/23 antibody for the treatment of Crohn’s Disease (CD). The aim of this study was to compare the efficacy and safety of UST in a large population-based cohort of CD patients who failed previous treatment with other biologics Methods 194 CD patients (108 males and 86 females, mean age 48 years (range 38–58 years) were retrospectively reviewed. 147 patients were already treated with anti-TNFα (75.8%), and 47 (24.2%) patients were already treated with anti-TNFα and vedolizumab. Concomitant treatment with steroids was present in 177 (91.2%) patients Results At week 12, clinical remission was achieved in 146 (75.2%) patients. After a mean follow-up of 6 months, clinical remission was maintained in 135 (69.6%) patients; at that time, mucosal healing was assessed in 62 (31.9%) patients, and it was achieved in 33 (53.2) patients. Three (1.5%) patients were submitted to surgery. Steroid-free remission was achieved in 115 (59.3%) patients. Both serum C-Reactive Protein and Fecal Calprotectin (FC) levels were significantly reduced with respect to baseline levels during follow-up. A logistic regression, UST therapy as thirdline therapy (after both anti-TNFα and vedolizumab), FC >200 μg/g, and HBI ≥8 were significantly associated with lack of remission. Adverse events occurred in 5 (2.6%) patients, and four of them required suspension of treatment Conclusion Ustekinumab seemed to be really effective and safe in CD patients unresponsive to other biologic treatments, especially when used as second-line treatment.

scholarly journals Treatment Failure Among Infected Periprosthetic Total Hip Arthroplasty Patients

2014 ◽  
Vol 8 (1) ◽  
pp. 118-124 ◽  
Author(s):  
Ran Schwarzkopf ◽  
Bassem Mikhael ◽  
Elizabeth Wright ◽  
Daniel M Estok ◽  
Jeffrey N Katz
Keyword(s):  
Joint Infection ◽  
Deep Infection ◽  
Prior History ◽  
Two Stage ◽  
Reactive Protein ◽  
Prosthetic Joint ◽  
History Of ◽  
Eradication Of Infection ◽  
One Year

Two-stage revision has been shown to be the most successful treatment in eradicating deep infection following total hiparthroplasty. We identified 62 patients treated by a two-stage revision. We defined “successful revision” as negative intraoperative cultures and no further infection-related procedure. We defined “eradication of infection” on the basis of negative cultures and clinical diagnosis at least one year after 2ndstage procedure. After a mean follow up of 2.7 years, eradication of the infection was documented in 91.1%, and a successful two-stage revision in 85.7% of patients. We observed no association between higher pre-reimplantation levels of ESR and C-reactive protein and lower likelihood of successful two-stage revision. We found an association between a history of another previous infected prosthetic joint and a failed 2ndstage procedure. Failure to achieve eradication of infection and successful two-stage revision occurs infrequently. Patients with prior history of a previous prosthetic joint infection are at higher risk of failure.

Effectiveness and Safety of Golimumab in Treating Outpatient Ulcerative Colitis: A Real-Life Prospective, Multicentre, Observational Study in Primary Inflammatory Bowel Diseases Centers

2017 ◽  
Vol 26 (3) ◽  
pp. 239-244 ◽  
Author(s):  
Antonio Tursi ◽  
Leonardo Allegretta ◽  
Nello Buccianti ◽  
Nicola Della Valle ◽  
Walter Elisei ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Diseases ◽  
Real Life ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Background & Aims: Golimumab (GOL) has been recently approved in Italy for the treatment of ulcerative colitis (UC) unresponsive to standard treatments. Our aims were to assess the real-life efficacy and safety of GOL in managing UC outpatients in Italian primary Inflammatory Bowel Diseases (IBD) centres.Methods: Consecutive UC outpatients with at least 3-months follow-up were enrolled. Primary end-point was the induction and maintenance of remission in UC, defined as Mayo score ≤2, at 6-month follow-up.Results: Ninety-three patients were enrolled. At 6-month follow-up, remission was obtained in 34 (36.5%) patients. Shorter duration of disease was the only significant predictive factor of remission. Clinical response was achieved in 60 (64.5%) patients, while mucosal healing (MH) was obtained in 18 (19.3%) patients. Sixteen (47.0%) patients under remission were still under therapy with steroids. C-reactive protein and fecal calprotectin significantly dropped during the follow-up (p<0.001 for both proteins). Adverse events occurred in 4 (4.3%) patients and 3 of them stopped treatment. Colectomy was performed in only one patient (1.1%).Conclusions: Golimumab seems to be safe and effective in inducing and maintaining remission in real life UC outpatients.Abbreviations: ADA: Adalimumab; CRP: C-reactive Protein; GOL: Golimumab; FC: Fecal calprotectin; IBD: Inflammatory Bowel Diseases; IFX: Infliximab; IQR: Interquartile range; MH: Mucosal Healing; SC: Subcutaneously; TBC: Tuberculosis; TNFα: Tumor necrosis factor α; UC: Ulcerative Colitis.    

scholarly journals P328 Ustekinumab is an effective and safe therapy in anti-TNF refractory Crohn’s Disease: a two year real-life observational study from Spain

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S352-S353
Author(s):  
J Rueda Sanchez ◽  
M Cabello Ramirez ◽  
S Camara Baena ◽  
A Keco Huerga ◽  
J Garcia de la Borbolla Serres ◽  
...  
Keyword(s):  
Adverse Events ◽  
Observational Study ◽  
Clinical Remission ◽  
Real Life ◽  
Dose Interval ◽  
Fecal Calprotectin ◽  
Perianal Disease ◽  
Real World Data ◽  
Tertiary Center

Abstract Background Ustekinumab is a monoclonal antibody targeting IL-12/23 and was proved efficacious during the registration clinical trials. However real-world data in a day to day setting is still scarce. The aim of our study was to evaluate the effectiveness, durability and safety of ustekinumab in our real-life cohort. Methods We present a retrospective, observational study from a single tertiary center. We included adult CD patients that had received the standard ustekinumab intravenous induction and with at least 12-month follow-up. We assessed clinical (HBI) and biomarker (CRP, calprotectin) response at 3, 6, 12, 18 and 24 months. Adverse events, perianal disease response and corticosteroid (CS) use were also recorded. Results We observed a significant decrease in median HBI in all visits. Clinical response was observed in 72.7% of patients at 12 months and 66.7% at 24 months. Clinical remission was achieved in 57.6% and 58.3% of patients at 12 and 24 months respectively. CS-free clinical remission rates were 45.5% at 12 months and 54.2% at 24 months. The most frequent maintenance dose interval was q8w, with only 6/35 patients (17,14%) requiring dose escalation due to inefficacy of standard q8w interval. Drug survival at 2 years was 93.9%. Perianal disease clinical improvement was noted in 16 out of 17 patients with perianal disease at baseline. Fecal calprotectin decreased significantly from baseline, with a median change of -66 ug/g at 12 months and -253 ug/g at 24 months. Ustekinumab was generally well-tolerated. Two adverse events were recorded during the follow-up period, an herpes zoster and an uveitis, none of them required Ustekinumab discontinuation. Conclusion According to our results, Ustekinumab was effective, durable, and safe for moderate-severe CD in a real-life clinical setting, with more than half of patients achieving CS-free clinical remission at 24 months in an anti-TNF refractory cohort.

scholarly journals A157 REAL-WORLD TIGHT OBJECTIVE MONITORING WITH ADALIMUMAB LEADS TO EARLIER DOSE OPTIMIZATION AND HIGHER CLINICAL REMISSION RATES AT 12 MONTHS.

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 163-164
Author(s):  
Y Xiao ◽  
A Al Khoury ◽  
P Golovics ◽  
R Kohen ◽  
W Afif ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Clinical Remission ◽  
Clinical Symptoms ◽  
Fecal Calprotectin ◽  
Dose Optimization ◽  
Early Assessment ◽  
Objective Monitoring ◽  
Bowel Diseases ◽  
One Year

Abstract Background Data suggests that tight objective monitoring of inflammatory bowel diseases (IBD) may improve one-year clinical outcomes. Aims The goal of this study is to assess the adherence to serial tight objective monitoring, via clinical symptoms and biomarkers, and the effect of such tight monitoring on one year outcome in IBD patients at an academic and an university-affiliated center. Methods We retrospectively reviewed the chart of 428 consecutive IBD patients who started adalimumaby at the McGill University Health Center and Jewish General Hospital (Montreal, Canada) between January 1, 2015 and January 1, 2019 [338 Crohn’s disease(CD), 90 ulcerative colitis(UC)]. Clinical symptoms (assessed by Harvey-Bradshaw-Index and partial Mayo), C-Reactive Protein(CRP), and fecal calprotectin(FCAL) were captured at treatment initiation and at 3, 6, 9, and 12 months. Combined adherence was defined as the evaluation of ≥2 of 3 parameters(clinical, CRP, FCAL). Dose optimization and drug sustainability curves were plotted by Kaplan-Meier method. Results Clinical symptoms were assessed in nearly all patients at 3 (CD-UC:95-94%), 6 (90-83%), 9 (86-85%) and 12 (96-89%) months. CRP was also available for most patients but the frequency of assessment decreased in CD patients over the study period. In comparison, compliance to serial FCAL testing was low throughout the follow-up period. Clinical remission at one-year was significantly higher in patients who were adherent to early assessment visit at 3 months (p=0.001 both for CD and UC). Adherence to early follow-up also resulted in earlier dose optimisation in both CD and UC patients(pLogrank=0.026 for UC and p=0.09 for CD). However, the overall drug sustainability did not differ. Conclusions Clinical assessment and CRP, but not FCAL, were frequently assessed in patients starting adalimumab. Adherence to early objective combined follow-up visits resulted in earlier dose optimization and improved one-year clinical outcomes but did not change drug sustainability rates. Funding Agencies None

Treatment of varicose tributaries with sclerotherapy with polidocanol 0.5 % foam

VASA ◽  
2010 ◽  
Vol 39 (2) ◽  
pp. 169-174 ◽  
Author(s):  
Reich-Schupke ◽  
Weyer ◽  
Altmeyer ◽  
Stücker
Keyword(s):  
Scientific Evidence ◽  
Daily Practice ◽  
Severe Adverse Effect ◽  
Safe Procedure ◽  
Efficacy And Safety ◽  
Foam Sclerotherapy ◽  
History Of ◽  
One Year ◽  
Additional Therapy

Background: Although foam sclerotherapy of varicose tributaries is common in daily practice, scientific evidence for the optimal sclerosant-concentration and session-frequency is still low. This study aimed to increase the knowledge on foam sclerotherapy of varicose tributaries and to evaluate the efficacy and safety of foam sclerotherapy with 0.5 % polidocanol in tributaries with 3-6 mm in diameter. Patients and methods: Analysis of 110 legs in 76 patients. Injections were given every second or third day. A maximum of 1 injection / leg and a volume of 2ml / injection were administered per session. Controls were performed approximately 6 months and 12 months after the start of therapy. Results: 110 legs (CEAP C2-C4) were followed up for a period of 14.2 ± 4.2 months. Reflux was eliminated after 3.4 ± 2.7 injections per leg. Insufficient tributaries were detected in 23.2 % after 6.2 ± 0.9 months and in 48.2 % after 14.2 ± 4.2 months, respectively. Only 30.9 % (34 / 110) of the legs required additional therapy. In 6.4 % vein surgery was performed, in 24.5 % similar sclerotherapy was repeated. Significantly fewer sclerotherapy-sessions were required compared to the initial treatment (mean: 2.3 ± 1.4, p = 0.0054). During the whole study period thrombophlebitis (8.2 %), hyperpigmentation (14.5 %), induration in the treated region (9.1 %), pain in the treated leg (7.3 %) and migraine (0.9 %) occurred. One patient with a history of thrombosis developed thrombosis of a muscle vein (0.9 %). After one year there were just hyperpigmentation (8.2 %) and induration (1.8 %) left. No severe adverse effect occurred. Conclusions: Foam sclerotherapy with injections of 0.5 % polidocanol every 2nd or 3rd day, is a safe procedure for varicose tributaries. The evaluation of efficacy is difficult, as it can hardly be said whether the detected tributaries in the controls are recurrent veins or have recently developed in the follow-up period. The low number of retreated legs indicates a high efficacy and satisfaction of the patients.

Prospective evaluation for gastrointestinal bleedings at the University Hospital St. Pölten – one year of follow-up

2019 ◽  
Author(s):  
M Stättermayer ◽  
F Riedl ◽  
S Bernhofer ◽  
A Stättermayer ◽  
A Mayer ◽  
...  
Keyword(s):  
University Hospital ◽  
Prospective Evaluation ◽  
One Year ◽  
The University

scholarly journals Early recognition of PIMS-TS: a single centre retrospective review

2021 ◽  
Vol 5 (1) ◽  
pp. e001011
Author(s):  
Roshni Mistry ◽  
Nicola Scanlon ◽  
James Hibberd ◽  
Fionnghuala Fuller
Keyword(s):  
Early Recognition ◽  
Febrile Illness ◽  
Final Diagnosis ◽  
University Hospital ◽  
Single Centre ◽  
Retrospective Case ◽  
Reactive Protein ◽  
Review Reports ◽  
Specific Symptoms

IntroductionResearch into paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS) has focused on tertiary level management. This review reports on symptoms and investigations at presentation.MethodsSingle centre retrospective case note analysis of patients fulfilling PIMS-TS diagnostic criteria from March to May 2020 in a London district level university hospital.ResultsSix patients presented in the week prior to their final diagnosis with fever and non-specific symptoms. Raised C-reactive protein (CRP), lymphopenia and hyponatraemia were noted. Kawasaki-like symptoms were under-represented in all patients.InterpretationThe results suggest that a proportion of children with early PIMS-TS present with a non-specific febrile illness and abnormal blood results. Further research is needed to determine the most appropriate identification and follow-up of these children.

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