scholarly journals FRI0630-HPR ONE-YEAR FOLLOW-UP OF A NURSE-LED TEAM INTERVENTION EFFECTIVE IN REDUCING THE NOCEBO EFFECT WHEN SWITCHING FROM ORIGINATOR INFLIXIMAB TO A BIOSIMILAR.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 919.2-920
Author(s):  
J. Petit ◽  
M. Antignac ◽  
K. Louati ◽  
S. Desouches ◽  
N. Deparis ◽  
...  
Keyword(s):  
Retention Rate ◽  
Inflammatory Rheumatic Diseases ◽  
Nocebo Effect ◽  
Survival Curves ◽  
Short Term ◽  
Historical Cohort ◽  
One Year ◽  
Mean Time

Background:Nonspecific subjective adverse effects and symptoms (NSAE/NSS), usually considered as related to a nocebo effect (NE), have been identified as a barrier to the acceptability of switches from biologic originators (BO) to biosimilars (BS) in rheumatology. A multidisciplinary team intervention with a prominent role of nurses has provided a reduction of the NE assessed in the short-term during a systematic switch from originator Infliximab (OI) to the biosimilar infliximab SB2 (ref.1).Objectives:To assess the intervention outcomes after one-year follow up in comparison with a historical cohort.Methods:The intervention was developed after a literature search and semi-directive interviews of patients, and included consensual communication towards patients, with a prominent role of nurses (Ref.1). All patients with chronic inflammatory rheumatic diseases (CIRD) treated by OI were included and followed-up in routine care. The outcomes were I) SB2 retention rate (RR) II) SB2 discontinuation rate due to a presumed NE, defined as lack of efficacy with no objective criteria for increased inflammation or non-objective and non-specific adverse event, either occurring after the switch and disappearing after back-switch or change of biologic. Criteria for NSAE/NSS in the historical cohort were the same lack of efficacy or subjective adverse events and disappearance after change of biologic BD. Medium-term (12 months) SB2 outcomes were assessed and compared with I) the data obtained in the short-term (34 weeks) II) the data from an historical cohort of CIRD patients treated by OI in the same rheumatology department, using Kaplan-Meier survival curve.Results:Forty-five patients were prospectively included for the switch from March 2018 to August 2018: 17 with rheumatoid arthritis (RA), 28 with spondylarthritis (SpA); 55% were women, mean age was 53.2 (SD: 2,1), and mean time under OI was 113.5 (SD9.3). For the historical cohort, the 52 patients treated with OI between December 2016 and January 2017 were included and their data collected at baseline and one year. Fifty-nine percent were women, mean age at inclusion was 50.25 (1.2), and mean time under OI was 94.8 (9.4).SB2 RR did not differ from the OI RR in the historical cohort: 91.2% and 96.2% respectively at 34 weeks (p = 0.41); 84.4% and 88.5% respectively at 12 months (p = 0.52) (figure 1). The SB2 RR was significantly higher than in three other European cohorts at 34 weeks (mean RR 73.6%, p<0.05, ref.1) but not at 12 months (mean RR 80.9%, ref.2,3,4).SB2 and OI discontinuations due to NSAE/NSS at 34 weeks were 2,2 % and 1.9% respectively; at 12 months 6,6% and 1.9% respectively (p= 0.6).Conclusion:An intervention based on a tailored communication with a prominent role of nurses was effective in reducing the NE when switching from OI to SB2 in the short term, compared with an historical cohort and other European cohorts. The one-year follow-up showed no statistical difference in RR or NE compared with our historical cohort. The present study shows that appropriate interventions may be developed to improve the outcome of switches to biosimilars.Figure 1:Treatment withdrawal free survival curves (SB2 in switched cohort and OI in historical cohort).Kaplan Meir survival curves. Comparison with Log-Rank test between OI to SB2 cohort and historical OI cohort, p = 0.520. OI : original infliximab.References:[1] Petit J. Ann Rheum Dis, volume 78, supplement 2, year 2019, page A1447[2] Glintborg B. et al. Ann Rheum Dis 2017;76:1426–31.[3] Nikiphorou E. et al. Expert Opin Biol Ther 2015;15:1677–83.[4] Boone NW. et al. Eur J Clin Pharmacol 2018;:1–7.Acknowledgments:Dr Margaux Boisson Service de rhumatologie du Professeur Kahan, Hôpital Cochin, APHP.Disclosure of Interests:Juliette Petit: None declared, Marie Antignac: None declared, Karine Louati: None declared, Sandra Desouches: None declared, Nathalie DEPARIS: None declared, Regine Baratto: None declared, Rosemarie POILVERD: None declared, Sylvie Dartout: None declared, Francis Berenbaum Grant/research support from: TRB Chemedica (through institution), MSD (through institution), Pfizer (through institution), Consultant of: Novartis, MSD, Pfizer, Lilly, UCB, Abbvie, Roche, Servier, Sanofi-Aventis, Flexion Therapeutics, Expanscience, GSK, Biogen, Nordic, Sandoz, Regeneron, Gilead, Bone Therapeutics, Regulaxis, Peptinov, 4P Pharma, Paid instructor for: Sandoz, Speakers bureau: Novartis, MSD, Pfizer, Lilly, UCB, Abbvie, Roche, Servier, Sanofi-Aventis, Flexion Therapeutics, Expanscience, GSK, Biogen, Nordic, Sandoz, Regeneron, Gilead, Sandoz, Catherine Beauvais Speakers bureau: Abbvie, MSD, Roche, UCB, Mylan, Sanofi

scholarly journals Multidisciplinary team intervention to reduce the nocebo effect when switching from the originator infliximab to a biosimilar

RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001396
Author(s):  
Juliette Petit ◽  
Marie Antignac ◽  
Rose-Marie Poilverd ◽  
Régine Baratto ◽  
Sylvie Darthout ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Healthcare Professionals ◽  
Musculoskeletal Diseases ◽  
Retention Rate ◽  
Nocebo Effect ◽  
Historical Cohort ◽  
Tailored Communication ◽  
Secondary Outcomes ◽  
Patient Representative

ObjectivesTo evaluate an intervention to reduce the nocebo effect (NE) when switching from the originator infliximab (OI) to the infliximab biosimilar SB2 in chronic inflammatory rheumatic disease (CIRD).MethodsAn intervention was built with healthcare professionals (HPs) and a patient representative, based on a systematic review of interventions reducing the NE in musculoskeletal diseases and semi-directed questioning of five patients. Our strategy consisted of training HPs, switch information given by the nurses, a consistent vocabulary. All CIRD patients switched from OI to SB2 were included for the intervention. The primary outcome was the SB2 retention rate (RR) at 34 weeks. Secondary outcomes were the SB2 RR at 12 months, discontinuation rates due to a possible NE and comparison with a historical cohort of CIRD patients receiving the OI and 6 published European cohorts.Results45 patients were included from March 2018 (rheumatoid arthritis, n=17, spondylarthritis, n=28). After 34 weeks, the SB2 RR was 91.2%, similar to the historical cohort RR (p=0.41) but higher than the 3 European cohort RRs (p<0.05). At 12 months, the SB2 RR was 84.5% vs 88.4% for the historical cohort (p=0.52). SB2 discontinuation due to a possible NE was 6.6% after 12 months.ConclusionsA tailored communication with a prominent role of nurses reduced the NE in non-medical switches from the OI to SB2 as compared to published results. The RR was similar to the historical cohort RR. The methodology used to construct this intervention may help improve the outcomes of switches with upcoming biosimilars.

Catheter-directed foam sclerotherapy treatment of saphenous vein incompetence

VASA ◽  
2012 ◽  
Vol 41 (2) ◽  
pp. 120-124 ◽  
Author(s):  
Asciutto ◽  
Lindblad
Keyword(s):  
Saphenous Vein ◽  
Short Term ◽  
Foam Sclerotherapy ◽  
Results Of Treatment ◽  
Ulcer Healing Rate ◽  
Complete Obliteration ◽  
Ceap Classification ◽  
One Year ◽  
The One

Background: The aim of this study is to report the short-term results of catheter-directed foam sclerotherapy (CDFS) in the treatment of axial saphenous vein incompetence. Patients and methods: Data of all patients undergoing CDFS for symptomatic primary incompetence of the great or small saphenous vein were prospectively collected. Treatment results in terms of occlusion rate and patients’ grade of satisfaction were analysed. All successfully treated patients underwent clinical and duplex follow-up examinations one year postoperatively. Results: Between September 2006 and September 2010, 357 limbs (337 patients) were treated with CDFS at our institution. Based on the CEAP classification, 64 were allocated to clinical class C3 , 128 to class C4, 102 to class C5 and 63 to class C6. Of the 188 patients who completed the one year follow up examination, 67 % had a complete and 14 % a near complete obliteration of the treated vessel. An ulcer-healing rate of 54 % was detected. 92 % of the patients were satisfied with the results of treatment. We registered six cases of thrombophlebitis and two cases of venous thromboembolism, all requiring treatment. Conclusions: The short-term results of CDFS in patients with axial vein incompetence are acceptable in terms of occlusion and complications rates.

Sustained normoglycemia in newly diagnosed type I diabetic subjects. Short-term effects and one-year follow-up

Diabetes ◽  
1984 ◽  
Vol 33 (10) ◽  
pp. 995-1001 ◽  
Author(s):  
K. Perlman ◽  
R. M. Ehrlich ◽  
R. M. Filler ◽  
A. M. Albisser
Keyword(s):  
Type I ◽  
Newly Diagnosed ◽  
Short Term ◽  
One Year ◽  
Short Term Effects

scholarly journals ECMO in COVID-19—prolonged therapy needed? A retrospective analysis of outcome and prognostic factors

Perfusion ◽  
2021 ◽  
pp. 026765912199599
Author(s):  
Esther Dreier ◽  
Maximilian Valentin Malfertheiner ◽  
Thomas Dienemann ◽  
Christoph Fisser ◽  
Maik Foltan ◽  
...  
Keyword(s):  
Lung Compliance ◽  
Ecmo Support ◽  
Short Term ◽  
Single Center Study ◽  
Venovenous Extracorporeal Membrane Oxygenation ◽  
Baseline Characteristics ◽  
Ecmo Therapy ◽  
Vv Ecmo

Background: The role of venovenous extracorporeal membrane oxygenation (VV ECMO) in patients with COVID-19-induced acute respiratory distress syndrome (ARDS) still remains unclear. Our aim was to investigate the clinical course and outcome of those patients and to identify factors associated with the need for prolonged ECMO therapy. Methods: A retrospective single-center study on patients with VV ECMO for COVID-19-associated ARDS was performed. Baseline characteristics, ventilatory and ECMO parameters, and laboratory and virological results were evaluated over time. Six months follow-up was assessed. Results: Eleven of 16 patients (68.8%) survived to 6 months follow-up with four patients requiring short-term (<28 days) and seven requiring prolonged (⩾28 days) ECMO support. Lung compliance before ECMO was higher in the prolonged than in the short-term group (28.1 (28.8–32.1) ml/cmH2O vs 18.7 (17.7–25.0) ml/cmH2O, p = 0.030). Mechanical ventilation before ECMO was longer (19 (16–23) days vs 5 (5–9) days, p = 0.002) and SOFA score was higher (12.0 (10.5–17.0) vs 10.0 (9.0–10.0), p = 0.002) in non-survivors compared to survivors. Low viral load during the first days on ECMO tended to indicate worse outcomes. Seroconversion against SARS-CoV-2 occurred in all patients, but did not affect outcome. Conclusions: VV ECMO support for COVID-19-induced ARDS is justified if initiated early and at an experienced ECMO center. Prolonged ECMO therapy might be required in those patients. Although no relevant predictive factors for the duration of ECMO support were found, the decision to stop therapy should not be made dependent of the length of ECMO treatment.

Individualized Behavioural Treatment of Severe Stuttering

1991 ◽  
Vol 19 (4) ◽  
pp. 347-357 ◽  
Author(s):  
Willi Ecker ◽  
Victor Meyer
Keyword(s):  
Oral Reading ◽  
Reading Improvement ◽  
Behavioural Treatment ◽  
Communication Situations ◽  
Cognitive Techniques ◽  
One Year

This case study illustrates the reduction of severe stuttering by an individually tailored treatment programme. Interventions are derived from a tripartite analysis (Lang, 1971) and include EMG biofeedback, regulated breathing, exposure in vivo to stressful communication situations and cognitive techniques to reduce relapse risk. The role of dysfunctional response system interactions in stuttering is emphasized. Treatment resulted in a marked reduction of stuttering and associated facial contortions during videotaped conversations with strangers and oral reading. Improvement was maintained at one-year follow-up.

scholarly journals Role of methyleprednisolone succinate in the management of acute spinal cord injury

1970 ◽  
Vol 9 (3) ◽  
pp. 168-172
Author(s):  
NK Karn ◽  
BP Shrestha ◽  
GP Khanal ◽  
R Rijal ◽  
P Chaudhary ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Neurological Status ◽  
Acute Spinal Cord Injury ◽  
Cord Injury ◽  
And Gender ◽  
One Year

Objective: To see the role of methyleprednisolone succinate in the management of acute spinal cord injury. Methods: A randomized control trial was done including the patients with acute spinal cord injury. They were divided into age and gender matched two groups. Patients with presence of active infection, associated open fracture, those on long term steroid and those who did not give consent to participate in the trial were excluded. One group received methyleprednisolone succinate within 8 hours of injury and another group did not receive the drug. Both the groups were managed nonoperatively. The neurological status of the patients was assessed at presentation, once spinal shock was over, at 6th week and 6th month and after one year according to ASIA scoring. Frankel grading was also assessed in every follow up. Conclusion: Methylprednisolone succinct prevents secondary cord injury to a great extent and hence its administration within 8 hours of injury results in a better functional (motor and sensory) outcome. Keywords: acute spinal cord injury; methyleprednisolone succinate DOI: http://dx.doi.org/10.3126/hren.v9i3.5585   HR 2011; 9(3): 168-172

scholarly journals Effect of short-term heart rate variability biofeedback on long-term abstinence in alcohol dependent patients – a one-year follow-up

2017 ◽  
Vol 17 (1) ◽  
Author(s):  
Ana Isabel Penzlin ◽  
Kristian Barlinn ◽  
Ben Min-Woo Illigens ◽  
Kerstin Weidner ◽  
Martin Siepmann ◽  
...  
Keyword(s):  
Heart Rate ◽  
Heart Rate Variability ◽  
Short Term ◽  
Heart Rate Variability Biofeedback ◽  
One Year ◽  
Alcohol Dependent

MANAGING CHALLENGING BEHAVIOUR IN AN ADULT WITH LEARNING DISABILITIES: THE USE OF LOW AROUSAL APPROACH

1998 ◽  
Vol 26 (2) ◽  
pp. 163-171 ◽  
Author(s):  
Andrew McDonnell ◽  
Simon Reeves ◽  
Amanda Johnson ◽  
Alan Lane
Keyword(s):  
Learning Disabilities ◽  
Behaviour Change ◽  
Single Case ◽  
Challenging Behaviour ◽  
Single Case Study ◽  
Short Term ◽  
One Year ◽  
Challenging Behaviours

Behaviour change is often a desired outcome for carers and professionals who work with people with learning disabilities and challenging behaviours. Managing these behaviours in the short term is an important step towards this goal. This single case study presents the use of a low arousal approach in managing challenging behaviours in a young man labelled with severe challenging behaviour. This strategy focuses on the interaction of the carers with the client and how their approach has an important impact on the behaviour of the client. The study documents the incidents of challenging behaviour and shows a decline in their frequency from baseline over a one-year period. These gains were maintained at five-month follow-up. The implications for services of these findings are discussed.

TREATMENT OF TRIGGER FINGERS BY INJECTION OF METHYLPREDNISOLONE ACETATE AND LIDOCAINE (DEPO-MEDROL®)

Hand Surgery ◽  
1996 ◽  
Vol 01 (02) ◽  
pp. 103-105
Author(s):  
J. Joris Hage ◽  
Jaap D.K. Munting
Keyword(s):  
Side Effects ◽  
Prospective Study ◽  
Success Rate ◽  
Adult Patients ◽  
Methylprednisolone Acetate ◽  
Short Term ◽  
Local Injections ◽  
One Year ◽  
A Prospective Study

Thirty-six adult patients with 44 trigger fingers of less than four months' duration entered a prospective study on the efficiency of treatment with local injections of a combination of corticosteroids and lidocaine. From this study it may be concluded that the short-term success rate (93%) of one to three injections of methylprednisolone and lidocaine 2% (Depo-Medrol®) is comparable to that achieved by surgical or percutaneous tenolysis. At one year of follow-up, this success rate still amounted to 86%. In our hands, this therapy is without complications or side effects.

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