AB0641 MANAGING ANKYLOSING SPONDYLITIS (AS) WITH SHORT TERM BIOSIMILAR ADALIMUMAB REGIMEN IN A RESOURCE STRAPPED SETTING: A PROTOCOL DRIVEN COMMUNITY CLINIC ORIENTED STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1615.1-1615
Author(s):  
A. Chopra ◽  
N. Khadke ◽  
M. Saluja ◽  
T. Kianifard ◽  
A. Venugopalan

Background:We were handicapped by the exorbitant cost of innovator anti-Tumour Necrosis Factor (TNF) drugs. Despite limited use, we sometimes observed long-term benefits following short term induction like use. Emboldened by advent of biosimilars, we carried out an investigational study.Objectives:To evaluate the effectiveness of a short regimen of biosimilar (Bs) Adalimumab in ASMethods:50 consenting patients (86% B27+) naïve for biologics and negative for latent TB screen were enrolled into an observational design study of one year; Baseline mean values for age, duration, ASDAS and CRP was 31 years, 98.8 months, 4.6 and 64 mg per dl respectively. During the first year, patients were begun with 40 mg Bs Adalimumab (Bs-ADL) (Exemptia™), injected fortnight, for 12-16 weeks. No patient received DMARD or steroid in the first year of study. Patients continued standard of care follow up program in the clinic. The ASAS (Assessment Spondyloarthritis International Society) improvement indices were used. Standard intention-to-treat analysis was performed; significant p <0.05.Results:Optimum ASAS 40 improvement was observed at week 12 (68%); substantial improvement lasted till week 36. At one year, the ASAS 40 was 38%; ASAS partial remission 22% patients. Pro-inflammatory cytokines (IL-6, TNF α and IL-17) showed conspicuous reduction; maximum drop in IL-6 at week 24 (See Figure). 11 patients withdrew in the first year. 30 patients completed two years and 22 patients completed 3 year follow up. Over time, there was substantial loss in the ASAS 20 and 40 responses but patients seemed satisfied with the on-going symptomatic relief and improved function. Admittedly, patients showed more adherences to advice on physical exercise and stress reduction. Flares were more frequent after 1 year requiring short term round the clock NSAID; only 5 patients could afford to repeat a short term Bs-ADL regimen and one patient underwent hip arthroplasty. None received steroids and 5 patients were begun on Sulfasalazine in the second year and monitored. We could not evaluate structural modification (AS). Selected outcomes over 2 and 3 years from the current study will be compared to matched control (derived from the clinic database). None developed TB or any serious drug related toxicity. 2 patients developed recurrent uveitis.Conclusion:This real life documented experience unravelled impressive long term benefits following a kick start short term induction regimen of Biosimilar Adalimumab in AS. Though contrary to standard practice, this seemed a practical solution in our setting. We speculate a psychological and motivational boost rather than a prolonged real time biological effect (Bs-ADL) for this phenomenon. Our study has important socioeconomic bearing and merits validation.Acknowledgement:This was essentially a non-commercial investigator-initiated study. Zydus Cedilla India provided a generous research grant with free of cost Bs_ADL to several patients and a large concession in the cost to the rest.Disclosure of Interests:Arvind Chopra Grant/research support from: Zydus Pharamceutical Ltd India, Nagnath Khadke: None declared, Manjit Saluja: None declared, Toktam Kianifard: None declared, Anuradha Venugopalan: None declared

2019 ◽  
Vol 6 (2) ◽  
pp. 264
Author(s):  
Deniz Avci ◽  
Ali Cetinkaya

Background: The aim of this study was to determine how HbA1c, lipid, renal functions and such parameters were affected in the long term by adding dipeptidyl peptidase-4 inhibitors to the ongoing treatment regimens of patients with Type 2 diabetes mellitus.Methods: The study was conducted in diabetes mellitus outpatient clinic of Kayseri Training and Research Hospital between February 2012 and May 2017, with patients who did not achieve the sufficient success in diabetes their controls at the time of admission. From these patients, those who added (dipeptidyl peptidase-4 inhibitors) to their treatments were selected. Patients were followed up as long as they continued to these new treatments and the parameters at the baseline were compared with final values.Results: A total of 80 diabetic patients were followed in the study. The median age of the patients was 56.08±9.71 years. During this follow-up, an average decrease of 1.03% was noted when patients were compared with 9.53±1.87% of the initial hemoglobin A1c, and 8.50±1.48% of the Hemoglobin A1c values at the end of follow-up. This decrease was statistically significant (p <0.001). However, differences in the initial and final values of the lipid parameters of the patients were not statistically significant.Conclusions: Addition of dipeptidyl peptidase-4 inhibitors to patients' treatments causes significant decreases in Hemoglobin A1c mean values. This decline is long lasting. However, there are no positive or negative effects on biochemical parameters such as lipids, kidney and liver functions.


2017 ◽  
Vol 17 (1) ◽  
Author(s):  
Ana Isabel Penzlin ◽  
Kristian Barlinn ◽  
Ben Min-Woo Illigens ◽  
Kerstin Weidner ◽  
Martin Siepmann ◽  
...  

PeerJ ◽  
2021 ◽  
Vol 9 ◽  
pp. e12078
Author(s):  
Dannielle Post ◽  
Agnes Vitry ◽  
Katherine L. Baldock

The impacts of COVID-19 have been felt on a global scale, with associated physical distancing restrictions and economic downturn having flow-on effects for mental health and wellbeing across the community, and for university students in particular. First-year pharmaceutical and medical science students completing a common introductory population health course at an Australian university are routinely surveyed at the beginning of the semester as part of the course. Survey data inform teaching approaches based on understanding the ‘real life’ commitments and health profiles of students, and deidentified data form part of the teaching material. The 2020 student cohort was invited to complete a second follow-up survey during COVID-19 physical distancing restrictions. A total of n = 126 students completed both the initial and follow-up surveys (50.6% response rate), and n = 99 (39.8% of the total cohort) consented for their data to be included in research. There was a non-significant decrease in student employment; however, 22% of all students reported loss of work due to COVID-19. There was a statistically significant decrease in the proportion of students undertaking sufficient levels of physical activity, and a statistically significant increase in reported family stressors associated with loss of employment or an inability to gain employment between March and May 2020. Two-thirds of respondents reported increased stress as an impact of the transition to online learning. Implementation of holistic strategies, incorporating attention to additional factors influencing students’ capacity to engage in study, and which may have long-term impacts across the life of the degree program, should be considered.


2002 ◽  
Vol 8 (4) ◽  
pp. 349-366 ◽  
Author(s):  
LL Batista ◽  
J. Mahadevan ◽  
M. Sachet ◽  
H. Alvarez ◽  
G. Rodesch ◽  
...  

The purpose of the paper is the follow-up of embolised intradural saccular Arterial Aneurysms (AA), excluding giant, dissecting, inflammatory, fusiform or AA associated to BVAM. Since its introduction in 1991, the Guglielmi Detachable Coil has offered protection against aneurysmal rebleeding in the critical few days and months after SAH regardless of the grade. A number of questions remain: is complete angiographic obliteration necessary at first embolisation? What duration of clinical / angiographic follow-up (FU) is required to ensure the risk of haemorrhage has been eliminated? What is the long-term protection against rebleeding? One hundred and two patients with 160 intradural saccular AA embolised before april 1997 were selected for this study. They had at least 5-yrs clinical FU, of which 22 patients had a mid-term (3 years) and 45 patients had a 5-year or more angiographic FU (mean 67,7 months per patient). Twenty-eight embolised AAs with 100% occlusion at 1 year, remained unchanged on the 5-year angiograms. A further 14 patients with complete occlusion at 1 year showed persisting complete occlusion on angiogram at 3-years FU, which in our series means that complete occlusion after the first year post-embolisation implies that the aneurysm will remain completely occluded. All secondary spontaneous thromboses (27.6% of cases), occurred during the first year pos-embolisation. In six patients with subtotal or partial occlusion no change was seen for three consecutive years of FU; none showed later change at 5-year angiography. Below 80% occlusion our series does not provide enough information but we consider the situation instable. No mortality related to the procedure was observed in the unruptured AA group. No bleeding or re-bleeding has occurred since the beginning of our experience (1993) in saccular AA treated by GDC-Coil. Coil-embolisation of properly selected patients is effective in protecting against bleeding or re-bleeding at short and long-term with stable morphological results provided a strict follow-up control is established at short term.


2009 ◽  
Vol 21 (6) ◽  
pp. 1148-1159 ◽  
Author(s):  
Josien Schuurmans ◽  
Hannie Comijs ◽  
Paul M. G. Emmelkamp ◽  
Ingrid J. C. Weijnen ◽  
Marcel van den Hout ◽  
...  

ABSTRACTBackground: Although anxiety disorders are prevalent in older adults, randomized controlled trials of treatment effectiveness for late-life anxiety are scarce and have focused primarily on the effectiveness of psychotherapeutic interventions. However, recent findings suggest that in some cases, pharmacological treatment may be more beneficial for late-life anxiety disorders. As yet, there have been no systematic studies investigating prognostic factors for the outcome of cognitive behavioral therapy (CBT) and pharmacotherapy for late-life anxiety. The objective of the present study was to study long-term treatment outcomes and to explore differential predictors for both short-term and long-term treatment outcomes of sertraline and CBT for late-life anxiety disorders.Methods: Participants of a randomized controlled trial (RCT) comparing sertraline and CBT for the treatment of late-life anxiety were contacted one year after completing their treatment, so that predictors for both short-term and long-term treatment outcome could be established.Results: Sertraline showed a greater reduction of symptoms than CBT on anxiety (Hamilton Anxiety Rating Scale; HARS) and worry (Worry Domain Questionnaire) ratings at one-year follow-up. The strongest predictor for short-term CBT outcome was poor perceived health, explaining 40% of the variance in post-treatment residual gain scores on the HARS. The strongest predictor for long-term CBT outcome was neuroticism, explaining 20% of the variance in residual gain scores at one-year follow-up. Analyses revealed no significant predictors for treatment outcome in sertraline participants.Conclusions: Our study suggests that long-term use of sertraline might be more beneficial for late-life anxiety than a 15-week CBT program. Poor perceived health and neuroticism are predictive of less improvement after CBT in anxious older adults. Implications of these findings are discussed.


1995 ◽  
Vol 7 (4) ◽  
pp. 683-695 ◽  
Author(s):  
Virginia Salzer Burks ◽  
Kenneth A. Dodge ◽  
Joseph M. Price

AbstractViewing social rejection from same-age peers as a source of stress for children, the current study sought to determine the most appropriate model of the effects of temporary versus consistent experiences with rejection for both short-term and long-term internalizing problems. Adopting a cross-sectional longitudinal design, the sociometric status of children in the first year of the study (when the children were in the first, second, or third grades), and then again in the next school year (when children were in the second, third, or fourth grades) was assessed to determine which children were rejected by their peers. Internalizing outcome measures were administered in the third and sixth years of follow-up. Results indicated that, for boys, the Threshold Model best represented the stressful effects of rejection. That is, only boys who were exposed to rejection for 2 consecutive years demonstrated both short-term and long-term internalizing problems in subsequent years. For girls, however, there appeared to be few significant differences among those who never experienced rejection, who had only temporary experiences with rejection, and girls who were consistently exposed to rejection. Results are discussed in terms of the significance of a Threshold Model as well as possible explanations for these gender differences.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S434-S435
Author(s):  
C G af Björkesten ◽  
T Ilus ◽  
T Hallinen ◽  
E Soini ◽  
A Eberl ◽  
...  

Abstract Background Real-life long-term evidence on ustekinumab treatment response in patients with Crohn’s disease (CD) is scarce. We performed a retrospective non-interventional nationwide chart review study of dosing and long-term clinical outcomes in Finnish CD patients treated with ustekinumab (FINUSTE2, EUPAS30920). Methods FINUSTE2 involved 17 Finnish centres. Eligible patients were adults with CD, receiving an intravenous first dose of ustekinumab during 2017 or 2018. Disease activity data, such as C-reactive protein (CRP), faecal calprotectin (fCal), and the Simple Endoscopic Score for Crohn’s disease (SES-CD) were collected at baseline, 16 weeks, and one year from treatment initiation. A local gastroenterologist at each centre collected the data from health records in an electronic standardised health questionnaire. Results One hundred and fofty-five patients (48% female) with a mean age of 44 and disease duration of 14 years initiated ustekinumab treatment for CD. Table 1 summarises patient characteristics at baseline. After induction consisting of one intravenous dose and one to two subcutaneous doses at 8 to 16 weeks, 140 patients (93%) continued to maintenance treatment with subcutaneous ustekinumab. Of 93 patients with a follow-up of at least one year, 77 were still on ustekinumab. During ustekinumab treatment, SES-CD (10 at baseline, 3 at 1 year, medians, p = 0.033) and CRP (7 mg/l at baseline, 5 mg/l at 1 year, medians, p &lt; 0.001) and fCal (776 μg/g at baseline, 305 μg/g at 1 year, medians, p &lt; 0.001) decreased significantly in those patients with data available. Figure 1 describes changes in fCal levels over time. Conclusion In this nationwide real-life long-term follow-up study, covering all major centres in Finland, ustekinumab treatment of patients with highly refractory and long-standing CD effectively reduced inflammatory activity, assessed by endoscopy, CRP, and fCal.


2022 ◽  
Author(s):  
Anagha Champakanath ◽  
Halis Kaan Akturk ◽  
G. Todd Alonso ◽  
Janet K Snell-Bergeon ◽  
Viral N Shah

Objective: To evaluate long-term glycemic outcomes of CGM initiation within the first year of type 1 diabetes. <p>Research Design and Methods: 396 patients with type 1 diabetes were divided into three groups; 1) CGM [CGM use within one year of diabetes and continued through the study], 2) no-CGM [no CGM use throughout the study], 3) new-CGM [CGM use after 3 years of diabetes] and were followed up to 7-years. </p> <p>Results: A1c was significantly lower in CGM compared to no-CGM group throughout 7 years of follow-up [LS mean A1cs (%): 6-month 7.3 vs 8.1, 1-year 7.4 vs 8.6, 2-year 7.7 vs 9.1, 3-year 7.6 vs 9.3, 4-year 7.4 vs 9.6, 5-year 7.6 vs 9.7, 6-year 7.5 vs 10.0 and 7-year 7.6 vs 9.8, all p<0.001] adjusting for age at diagnosis, sex, and insulin delivery method. </p> <p>Conclusion: CGM initiation within first year of type 1 diabetes results in long-term improvement in A1c. </p>


Circulation ◽  
2001 ◽  
Vol 104 (suppl_1) ◽  
Author(s):  
Keith A. Horvath ◽  
Sary F. Aranki ◽  
Lawrence H. Cohn ◽  
Robert J. March ◽  
O. Howard Frazier ◽  
...  

Background Although transmyocardial laser revascularization (TMR) has provided symptomatic relief of angina over the short term, the long-term efficacy of the procedure is unknown. Angina symptoms as assessed independently by angina class and the Seattle Angina Questionnaire (SAQ) were prospectively collected up to 7 years after TMR. Methods Seventy-eight patients with severe angina not amenable to conventional revascularization were treated with a CO 2 laser. Their mean age was 61±10 years at the time of treatment. Preoperatively, 66% had unstable angina, 73% had had ≥1 myocardial infarction, 93% had undergone ≥1 CABG, 42% had ≥1 PTCA, 76% were in angina class IV, and 24% were in angina class III. Their average pre-TMR angina class was 3.7±0.4. Results After an average of 5 years (and up to 7 years) of follow-up, the average angina class was significantly improved to 1.6±1 ( P =0.0001). This was unchanged from the 1.5±1 average angina class at 1 year postoperatively ( P =NS). There was a marked redistribution according to angina class, with 81% of the patients in class II or better, and 17% of the patients had no angina 5 years after TMR. A decrease of ≥2 angina classes was considered significant, and by this criterion, 68% of the patients had successful long-term angina relief. The angina class results were further confirmed with the SAQ; 5-year SAQ scores revealed an average improvement of 170% over the baseline results. Conclusions The long-term efficacy of TMR persists for ≥5 years. TMR with CO 2 laser as sole therapy for severe disabling angina provides significant long-term angina relief.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
L Fauchier ◽  
C Semaan ◽  
G Fauchier ◽  
J Herbert ◽  
T Genet ◽  
...  

Abstract Background Diabetes mellitus (DM) is a factor of increased mortality in patients with acute myocardial infarction (AMI). DM is also associated with a higher risk of heart failure (HF) in patients with coronary artery disease as in the general population. The aim of the present study was to assess the incidence of HF developing at the acute stage of MI and of HF occurring in the year following hospital discharge, according to presence of DM. We also assessed the association between DM, HF and long-term mortality in this AMI population. Methods We used the French administrative hospital-discharge database, including all patients without history of HF admitted for AMI between 2010 and 2019 (n=797,212, mean age 69 years, 66% male). Among them, 520,258 patients (65%) had ST-segment elevation myocardial infarction (STEMI), 276,954 (35%) had non-STEMI, 192,456 patients (24%) had a history of DM. Occurrence of HF during the initial hospital stay was analysed in the whole population. In patients without HF during the index hospitalisation, discharged and alive at day 8 (n=535,813), we collected all hospitalisations for HF occurring during the year after discharge and analysed subsequent long-term mortality in those alive at one year (n=270,534) (length of follow-up 2.0±2.5 years, median 0.9, IQR 0.1–3.5). Results Overall, DM patients were older than non-DM patients (71±12 vs 67±15 years) and had more frequent comorbidities. At the acute stage, DM was associated with a higher risk of HF (28.7% vs 20.5% adjusted OR 1.40, 1.38–1.42, p&lt;0.0001). In patients without HF at the acute stage and discharged alive at day 8, DM was associated with a higher risk of being hospitalised with HF in the first year (5.6% vs 2.8%, adjusted HR 1.52, 1.49–1.56, p&lt;0.0001). In patients alive at one year, rates of all-cause death per year during subsequent follow-up were 2.2% in those without DM or HF during the first year (reference), 3.4% in those with DM and no HF during the first year (adjusted HR 1.22, 1.18–1.25, p&lt;0.0001), 7.7% in those without DM and with HF during the first year (adjusted HR 1.92, 1.83–2.02, p&lt;0.0001) and 8.9% in those with DM hospitalised with HF during the first year (adjusted HR 2.23, 2.09–2.37, p&lt;0.0001) (see figure). Conclusion After AMI, patients with diabetes are at increased risk of heart failure both at the acute stage and in the year following myocardial infarction, compared with non-diabetic patients. Non-fatal HF developing in the year following discharge is associated with noticeably higher subsequent mortality, and the combination of DM and HF is particularly at risk. Improved management is needed in diabetic patients following an AMI to avoid development of heart failure and its longer-term consequences. FUNDunding Acknowledgement Type of funding sources: None.


Sign in / Sign up

Export Citation Format

Share Document