Long Term Follow-up and Optimization of Infliximab in Refractory Uveitis Due to Behçet’s Disease. National Study of 103 Caucasian Patients

2020 ◽  
pp. jrheum.200300
Author(s):  
José Luis Martín-Varillas ◽  
Belén Atienza-Mateo ◽  
Vanesa Calvo-Rio ◽  
Emma Beltrán ◽  
Juan Sánchez-Bursón ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cost Effective ◽  
National Study ◽  
Serious Adverse Events ◽  
Oral Ulcers ◽  
Long Term Follow Up ◽  
Caucasian Patients ◽  
The Comparative Study

Objective In a large series of Caucasian patients with refractory uveitis due to Behçet disease (BD) treated with infliximab (IFX) we assessed: a) long-term efficacy and safety and b) IFX optimization when ocular remission was achieved. Methods Multicenter study of IFX-treated patients with BD uveitis refractory to conventional immunosuppressant agents.103 patients/185 affected eyes were treated with IFX as first biologic therapy as follows: 3-5 mg/kg i.v. at 0, 2, 6 and then every 4-8 weeks. a) The main outcome variables were analyzed at baseline, 1st week, 1st and 6th months and 1st and 2nd years of IFX therapy. b) After remission, based on a shared decision between patient and clinician, IFX optimization was performed. Efficacy, safety, and cost of IFX therapy were evaluated. Results In whole series (n=103), main outcome variables showed a rapid and maintained improvement, reaching remission in 78 patients after a mean IFX duration of 31.5 months. Serious adverse events were observed in 9 patients: infusional reactions (n=4), tuberculosis (n=1), Mycobacterium avium pneumonia (n=1), severe oral ulcers (n=1), palmoplantar psoriasis (n=1) and colon carcinoma (n=1). In the optimization subanalysis, the comparative study between optimized and nonoptimized groups showed: a) no differences in clinical characteristics at baseline; b) similar maintained improvement in most ocular outcomes; and c) lower severe adverse events, and d) lower mean IFX costs in optimized group (4,826.52 vs. 9,854.13 euros/patient/year). Conclusion IFX seems to be effective and relatively safe in Caucasian patients with refractory BD uveitis. IFX optimization is effective, safe, and cost-effective.

scholarly journals Long-term follow-up on effectiveness and safety of etanercept in juvenile idiopathic arthritis: the Dutch national register

2008 ◽  
Vol 68 (5) ◽  
pp. 635-641 ◽  
Author(s):  
F H M Prince ◽  
M Twilt ◽  
R ten Cate ◽  
M A J van Rossum ◽  
W Armbrust ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Adverse Events ◽  
Rheumatoid Factor ◽  
Serious Adverse Events ◽  
American College Of Rheumatology ◽  
Systemic Jia ◽  
Long Term Follow Up ◽  
Remission Criteria

Objective:We undertook an observational study to obtain a complete overview of the long-term effectiveness and safety of etanercept in patients with different juvenile idiopathic arthritis (JIA) subtypes.Methods:At baseline we collected patient and disease characteristics of all Dutch patients with JIA who started treatment with etanercept. Disease activity was evaluated (at start of the study, after 3 months and then yearly) according to the JIA core set of the American College of Rheumatology paediatric definition for 30, 50 and 70% improvement (ACR Pedi 30, 50 and 70). Use of etanercept and concomitant drugs was monitored. Adverse events were recorded.Results:We included 146 patients with JIA with a median follow-up of 2.5 years per patient (range 0.3–7.3). JIA subtypes represented: 27% systemic, 8% polyarticular rheumatoid factor positive, 38% polyarticular rheumatoid factor negative, 19% oligoarticular extended, 3% enthesitis-related and 5% psoriatica. Most patients (77%) met the criteria of the ACR Pedi 30 in the first 3 months of treatment. For the majority of patients this improvement was sustained; 53 (36%) of all patients met the remission criteria. No other second-line agents were needed in 43 patients. Although patients with systemic JIA responded initially less to etanercept therapy than patients from other subtypes, those who did respond showed equal effectiveness in the long term. Serious adverse events rate was low (0.029 per patient year).Conclusions:Etanercept is effective and safe in JIA, even for a large proportion of the patients with systemic JIA. The greatest improvement occurred in the first 3 months of treatment, and was sustained for a long time in most patients (up to 75 months).

scholarly journals Safety and Potential Risks with Fecal Microbiota Transplantation

2021 ◽  
Author(s):  
Pratyusha Gaonkar
Keyword(s):  
Adverse Events ◽  
Therapeutic Potential ◽  
Fecal Microbiota Transplantation ◽  
Standard Of Care ◽  
Fecal Microbiota ◽  
Serious Adverse Events ◽  
Recurrent Clostridium Difficile Infection ◽  
Long Term Follow Up

The therapeutic potential of Fecal Microbiota Transplantation (FMT) is greatly proved worldwide in the recent years. The use of FMT is now an accepted treatment modality and effective standard of care for some patients owing to its success in treating recurrent Clostridium Difficile Infection (rCDI). However, it is still evolving and longer term follow-up data regarding safety are required. Post-FMT serious adverse events (SAEs) have been varied between studies, however have included significant morbidity necessitating hospital admission and mortality in the follow-up period. The follow-up of FMT recipients should be long enough to completely establish efficacy/adverse events. Furthermore, it is recommended that FMT should be offered with caution to immunosuppressed patients, in whom FMT appears efficacious without significant additional adverse effects. In the wake of COVID-19 situation, stringent policies in screening the FMT donors have to be put forth to ensure patient safety. There is a need for high-quality, large, prospective, randomized controlled trials and long-term follow-up investigating screened donors and recipients to evaluate the long term safety and the risk–benefit profile of this promising therapy.

scholarly journals Long-term follow-up results of medial opening wedge high tibia osteotomy with a pre-countered non-locking steel plate

2021 ◽  
Author(s):  
Simo S. A. Miettinen ◽  
Hannu J. A. Miettinen ◽  
Jussi Jalkanen ◽  
Antti Joukainen ◽  
Heikki Kröger
Keyword(s):  
Risk Factors ◽  
Adverse Events ◽  
Mechanical Axis ◽  
Steel Plate ◽  
Cox Regression ◽  
Opening Wedge ◽  
Cumulative Survival ◽  
Long Term Follow Up

Abstract Introduction This retrospective study investigated the long-term follow-up results of medial opening wedge high tibial osteotomy (MOWHTO) with a pre-countered non-locking steel plate implant (Puddu plate = PP) used for medial knee osteoarthrosis (OA) treatment. Materials and methods Consecutive 70 MOWHTOs (66 patients) were performed between 01.01.2004 and 31.12.2008 with the mean follow-up time of 11.4 (SD 4.5; range 1.2–16.1) years. The Kaplan–Meier survival analysis was used to evaluate the cumulative survival of the implant in terms of age (< 50 years old and ≥ 50 years old) and gender. Adverse events were studied and Cox regression analysis was used to evaluate risk factors [age, gender, body mass index (BMI), preoperative mechanical axis, severity of OA, use of bone grafting or substitution and undercorrection of mechanical axis from varus to valgus] for revisions. Results The estimates for the cumulative survival with no need for TKA after MOWHTO were 86% at 5 years, 67% at 10 years and 58% at 16.1 years (SE 0.6, CI 95% 11.1–13.5). A total of 33/70 (47%) adverse events occurred and 38/70 (54%) knees required some revision surgery during the follow-up. Cox regression did not show any statistically significant risk factors for revision. Conclusions The PP has feasible MOWHTO results with a cumulative survival of 67% at 10 years with no need for conversion to TKA. Many adverse events occurred and revision rate due to any reason was high. Age or gender did not have statistically significant differences in terms of survival.

scholarly journals Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone Receptor–Positive Breast Cancer: Long-Term Follow-Up of the BIG 1-98 Trial

2019 ◽  
Vol 37 (2) ◽  
pp. 105-114 ◽  
Author(s):  
Thomas Ruhstaller ◽  
Anita Giobbie-Hurder ◽  
Marco Colleoni ◽  
Maj-Britt Jensen ◽  
Bent Ejlertsen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adverse Events ◽  
Contralateral Breast Cancer ◽  
Disease Free Survival ◽  
Luminal Breast Cancer ◽  
Free Survival ◽  
Long Term Follow Up ◽  
Disease Free

Purpose Luminal breast cancer has a long natural history, with recurrences continuing beyond 10 years after diagnosis. We analyzed long-term follow-up (LTFU) of efficacy outcomes and adverse events in the Breast International Group (BIG) 1-98 study reported after a median follow-up of 12.6 years. Patients and Methods BIG 1-98 is a four-arm, phase III, double-blind, randomized trial comparing adjuvant letrozole versus tamoxifen (either treatment received for 5 years) and their sequences (2 years of one treatment plus 3 years of the other) for postmenopausal women with endocrine-responsive early breast cancer. When pharmaceutical company sponsorship ended at 8.4 years of median follow-up, academic partners initiated an observational, LTFU extension collecting annual data on survival, disease status, and adverse events. Information from Denmark was from the Danish Breast Cancer Cooperative Group Registry. Intention-to-treat analyses are reported. Results Of 8,010 enrolled patients, 4,433 were alive and not withdrawn at an LTFU participating center, and 3,833 (86%) had at least one LTFU report. For the monotherapy comparison of letrozole versus tamoxifen, we found a 9% relative reduction in the hazard of a disease-free survival event with letrozole (hazard ratio [HR], 0.91; 95% CI, 0.81 to 1.01). HRs for other efficacy end points were similar to those for disease-free survival. Efficacy of letrozole versus tamoxifen for contralateral breast cancer varied significantly over time (0- to 5-, 5- to 10-, and > 10-year HRs, 0.62, 0.47, and 1.35, respectively; treatment-by-time interaction P = .005), perhaps reflecting a longer carryover effect of tamoxifen. Reporting of specific long-term adverse events seemed more effective with national registry than with case-record reporting of clinical follow-up. Conclusion Efficacy end points continued to show trends favoring letrozole. Letrozole reduced contralateral breast cancer frequency in the first 10 years, but this reversed beyond 10 years. This study illustrates the value of extended follow-up in trials of luminal breast cancer.

scholarly journals Single dose nonavalent HPV vaccine – need of the hour

2020 ◽  
Vol 10 (2) ◽  
pp. 871-873
Author(s):  
Soma Bandyopadhyay ◽  
Manidip Pal
Keyword(s):  
Single Dose ◽  
Hpv Vaccine ◽  
Hpv Vaccination ◽  
Herd Immunity ◽  
Cost Effective ◽  
Quadrivalent Vaccine ◽  
Carcinoma Cervix ◽  
Long Term Follow Up

HPV vaccination of the 9-14 years girl children is the answer to eradicate carcinoma cervix. Nonavalent vaccine provides wider coverage than the quadrivalent vaccine. On long-term follow-up, even after single dose HPV vaccination, antibody titre remains good. Herd immunity also achieved by HPV vaccine. Hence single dose nonavalent HPV vaccination of mass people (sexually naive 9-14 years girl children) can provide almost 100% protections and this will be cost-effective also for developing country.  

scholarly journals 959 LONG-TERM FOLLOW-UP OF ADVERSE EVENTS AND CLOSURE AFTER EUS-DIRECTED TRANSGASTRIC ERCP (EDGE PROCEDURE) BY ACCESS ROUTE: A MULTI-CENTER EXPERIENCE

2020 ◽  
Vol 91 (6) ◽  
pp. AB79-AB80
Author(s):  
Austin L. Chiang ◽  
Monica Gaidhane ◽  
David E. Loren ◽  
Michel Kahaleh ◽  
Alexander Schlachterman ◽  
...  
Keyword(s):  
Adverse Events ◽  
Access Route ◽  
Long Term Follow Up

P5237Continued financial benefits of LATIN telemedicine program from avoiding unnecessary transfer of patients

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Mehta ◽  
R Botelho ◽  
S Niklitschek ◽  
F Fernandez ◽  
J Cade ◽  
...  
Keyword(s):  
Cost Savings ◽  
Cost Effective ◽  
Population Based ◽  
Benefit Analysis ◽  
Financial Benefits ◽  
Indirect Care ◽  
Long Term Follow Up ◽  
Cost And Benefit Analysis

Abstract Background Latin America Telemedicine Infarct Network (LATIN) employed telemedicine to construct a population-based AMI program in Brazil, Colombia, Mexico, and Argentina. It increased access, accuracy and guidelines-based care and addressed fiscal issues. Previously, we demonstrated a cost and benefit analysis (CBA) of LATIN based upon avoiding unnecessary transfers and hospitalization. We have performed a scrupulous follow up of this initial observation with a long-term follow up from all expanded LATIN sites. Purpose To demonstrate that telemedicine avoids unnecessary transfer of patients. Methods 784,947 patients at LATIN spokes (small clinics in remote areas) were screened and CBA measured at hubs, spokes and telemedicine centers. Technology, transfer, inpatient, and procedure-related costs were included. A sensitivity analysis was performed for worst and best scenarios of costs, revenues, and savings. A comparison with Avera e-Emergency (Sioux Falls, SD) Telemedicine program, involving 85 rural hospitals in 7 states, is provided (13% transfer avoidance). Results Of 784,947 screened patients, 8,448 had STEMI (1.08%); 3,911 (46.3%) were urgently reperfused, 3,049 (78%) with PPCI. Time to Telemedicine Diagnosis was 3 min. With efficient triage, costs for non-AMI patients was controlled. LATIN expenses, including for IT and experts, were $272, and for transfer and indirect care, $1,068. Net savings/patient were $796. Savings, till date, range between $187.4 million and $62.4 million (Best scenario −30% transfer avoidance; Worse scenario −10% transfer avoidance). Conclusions Longitudinal analysis firms the trend of enormous cost savings with LATIN. Telemedicine avoids unnecessary transfers and hospitalization and it is a cost-effective strategy for population-based AMI programs.

Sign in / Sign up

Export Citation Format

Share Document