scholarly journals Guselkumab Treatment Outcomes and Persistence in a Nationwide Real-world Cohort of Patients with Plaque Psoriasis

2021 ◽  
Author(s):  
Tarja Mälkönen ◽  
Pauliina Nuutinen ◽  
Taru Hallinen ◽  
Erkki Soini ◽  
Riikka Nissinen ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Real World ◽  
Plaque Psoriasis ◽  
Treatment Duration ◽  
Real Life ◽  
Severity Index ◽  
Biologic Therapies ◽  
Treatment Persistence ◽  
Real Life Setting

Guselkumab treatment outcomes and persistence were assessed in a real-world cohort of Finnish patients with difficult-to-treat plaque psoriasis over a median follow-up of 1 year. Data on 181 patients who initiated guselkumab at the 15 study centres were collected retrospectively from the patient charts. Prior exposure to biologic therapies was common with 56% and 35% having used at least 1 and 2 biologics, respectively. Median guselkumab treatment duration was 11 months with 21 patients (12%) discontinuing treatment during follow-up. Of 85 patients with a follow-up duration of at least 1 year, 73 (86%) were still on guselkumab at 1 year. Significant improvements during follow-up were seen in the absolute Psoriasis Area and Severity Index (PASI) scores with 32 patients (80%) having absolute PASI ≤ 2 after a 9–14-month treatment. Guselkumab treatment was effective and treatment persistence was high in the nationwide Finnish real-life setting.

scholarly journals Real-life Effectiveness and Safety of Risankizumab in Moderate-to-severe Plaque Psoriasis: A 40-week Multicentric Retrospective Study

2021 ◽  
Author(s):  
Riccardo G. Borroni ◽  
Piergiorgio Malagoli ◽  
Luigi Gargiulo ◽  
Mario Valenti ◽  
Giulia Pavia ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Plaque Psoriasis ◽  
Real Life ◽  
Severity Index ◽  
First Line ◽  
Life Effectiveness ◽  
Real Life Setting ◽  
Humanized Monoclonal Antibody ◽  
Previously Treated ◽  
Interleukin 23

Risankizumab is a humanized monoclonal antibody that binds the p19 subunit of interleukin-23. It is approved for treatment of moderate-severe chronic plaque psoriasis. This retrospective study included 66 consecutive adults with moderate-to-severe psoriasis vulgaris treated with risankizumab in monotherapy up to week 40 in a “real-life” setting. At week 40, 98.7%, 85.7% and 62.3% of patients achieved a Psoriasis Area and Severity Index (PASI) reduction ≥ 75% (PASI 75), PASI 90 and PASI 100, respectively. Patients who had not responded to 2 or more previous biologic treat­ments were significantly less likely to achieve PASI 75/90 at week 16 and PASI 90/100 at week 40 compared with those who had been previously treated with only 1 biologic, and compared with those treated with risankizumab as a first-line biologic. Increasing body mass index decreased the chances of reaching PASI 90 at week 40. No significant safety findings were recorded throughout the study, and none of the patients had to interrupt the treatment. These data suggest that the efficacy of risankizumab for plaque psoriasis in “real-life” clinical practice could differ from pivotal clinical trials data.

scholarly journals POS0693 EFFICACY AND SAFETY OF BELIMUMAB IN PATIENTS WITH LUPUS NEPHRITIS IN REAL-LIFE SETTING: RESULTS FROM A LARGE, NATIONWIDE, MULTICENTRIC, PROSPECTIVE COHORT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 594-595
Author(s):  
F. Saccon ◽  
M. Gatto ◽  
M. Zen ◽  
M. Fredi ◽  
F. Regola ◽  
...  
Keyword(s):  
Lupus Erythematosus ◽  
Independent Predictor ◽  
Rescue Therapy ◽  
Real Life ◽  
Multivariate Logistic Regression Analysis ◽  
Class Iii ◽  
Baseline Serum ◽  
Renal Response ◽  
Real Life Setting

Background:LN is still a severe manifestation of Systemic lupus erythematosus (SLE) and multitarget therapy is needed to control the disease especially in refractory cases.Objectives:To evaluate renal response in SLE patients with glomerulonephritis (GN) treated with Belimumab in real-life setting.Methods:Patients with proteinuria >0.5 g/24 h and/or active sediment at baseline enrolled in a multicentre Italian cohort of SLE patients (BeRLiSS study), treated with monthly iv Belimumab 10 mg/kg plus standard of care were considered in this study. Complete renal response (CRR) was defined as proteinuria <0.5 g/24 h, estimated glomerular filtration rate (eGFR)≥90ml/min/1.73m2 and no rescue therapy. Primary efficacy renal response (PERR) was defined as proteinuria ≤0.7 g/24 h, eGFR ≥60ml/min/1.73m2 and no rescue therapy. Prevalence and predictive factors of CRR and PERR at 12 and 24 months after Belimumab initiation were analyzed by multivariate logistic regression analysis.Results:A total of 91 patients were considered in this study, 79 female, mean age 40.51±9.03 years, mean disease duration 12.18±8.15 years, median follow-up time after Belimumab initiation 22 months. Twenty patients had baseline proteinuria ≥0.5 <1 g/day, 17 ≥1 <2 g/day, 13 ≥2 g/day. Belimumab was started at GN onset in 20 (22%) patients and at the time of a renal flare in all other cases. Seventy-five patients underwent a renal biopsy: 1 class I, 4 class II, 14 class III, 47 class IV and 9 class V. Baseline serum creatinine was 82.44±29.26 umol/L; 15 patients showed eGFR<60ml/min/1.73m2 at baseline. Immunosuppresants were taken by 70 (76.9%) patients: 47 micofenolate, 15 azathioprine and 5 ciclosporine. Sixty patients (65.9%) were on antimalarials. During follow-up 34 (37.4%) patients achieved CRR. Among them 5 (14.7%) patients relapsed and 29 (85.3%) patients maintained remission. Mean time to achieved CRR was 9.71±5.91 months.High levels of baseline proteinuria were a negative independent predictor of CRR and PERR at 6 months (OR 0.044 CI95% 0.006-0.320 p=0.002 and OR 0.232 CI95% 0.091-0.596 p=0.002) and 12 months (OR 0.029 CI95% 0.002-0.556 p=0.019 and OR 0.056 CI95% 0.009-0.327 p=0.001). High levels of baseline creatinine were a negative independent predictor of renal response. Renal response at 6 months was a strong predictive factor of renal response at 12 and 24 months.Conclusion:Belimumab is an effective add-on therapy in the treatment of GN in real-life practice setting.Disclosure of Interests:None declared

scholarly journals AB0369 EFFICACY AND SAFETY OF RITUXIMAB ORIGINATOR AND BIOSIMILAR IN PRIMARY SJÖGREN’S SYNDROME IN A REAL-LIFE SETTING

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1485.3-1485
Author(s):  
F. Carubbi ◽  
A. Alunno ◽  
P. Cipriani ◽  
V. Pavlych ◽  
C. DI Muzio ◽  
...  
Keyword(s):  
Disease Activity ◽  
Real Life ◽  
Primary Sjögren’S Syndrome ◽  
Efficacy And Safety ◽  
Research Support ◽  
Treatment Groups ◽  
Real Life Setting ◽  
Patient Reported ◽  
Time Point

Background:Over the last 2 decades rituximab (RTX) has been widely used, albeit off-label, in primary Sjögren’s syndrome (pSS). Several studies reported that B-lymphocyte depletion with RTX is effective in this disease not only by reducing disease activity but also by affecting the inflammation and the lymphoid organization that occur in target tissues. With the recent release of several RTX biosimilars (bRTX) on the market, the demonstration of their interchangeability with RTX originator (oRTX) is required.Objectives:To compare efficacy and safety of oRTX and bRTX in pSS patients in a real-life setting.Methods:Clinical records of pSS patients referring to a tertiary rheumatology clinic were retrospectively evaluated. Patients having received at least 2 courses of either oRTX or bRTX (1000 mg IV infusion, repeated after 2 weeks -1 course- and the course repeated after 24 weeks) with complete data at baseline and after 3, 6, 9 and 12 months of treatment were enrolled. Disease activity was assessed with the EULAR SS disease activity index (ESSDAI) and its clinical version without the biological domain (ClinESSDAI). Patient-reported symptoms were assessed with the EULAR SS Patient Reported Index (ESSPRI).Results:Seven patients that received oRTX and 7 patients that received bRTX were enrolled. Baseline clinical features, including ESSDAI and ESSPRI were similar in the 2 treatment groups. Both compounds significantly reduced ESSDAI and ESSPRI as early as 3 months and no difference between the groups was observed at any time point (Figure 1). Of interest, ESSDAI slowly decreased until month 6 when the most pronounced reduction was observed. Conversely, ESSPRI dropped to its lowest values already at month 3. With regard to safety, at 12 months of follow-up no adverse event was observed in any of the treatment groups.Conclusion:At 12 months of follow-up, oRTX and bRTX display similar efficacy and safety profiles. The improvement of patient reported outcomes is faster than the improvement of disease activity with both compounds. Our data support interchangeability of oRTX and bRTX in pSS.References:[1]Carubbi F et al. Arthritis Res Ther. 2013;15(5):R172[2]Carubbi F et al. Lupus. 2014;23(13):1337-49Figure 1 ESSDAI and ESSPRI values at every time point in the 2 treatment groups. Asterisks indicate p values <0.05 compared to the other treatment group at the same time pointDisclosure of Interests:Francesco Carubbi Speakers bureau: Francesco Carubbi received speaker honoraria from Abbvie and Celgene outside this work., Alessia Alunno: None declared, Paola Cipriani Grant/research support from: Actelion, Pfizer, Speakers bureau: Actelion, Pfizer, Viktoriya Pavlych: None declared, claudia di muzio: None declared, Roberto Gerli: None declared, Roberto Giacomelli Grant/research support from: Actelion, Pfizer, Speakers bureau: Abbvie, Roche, Actelion, BMS, MSD, Ely Lilly, SOBI, Pfizer

scholarly journals Applications of Wearable Technology in a Real-Life Setting in People with Knee Osteoarthritis: A Systematic Scoping Review

2021 ◽  
Vol 10 (23) ◽  
pp. 5645
Author(s):  
Tomasz Cudejko ◽  
Kate Button ◽  
Jake Willott ◽  
Mohammad Al-Amri
Keyword(s):  
Knee Osteoarthritis ◽  
Real World ◽  
Real Life ◽  
Wearable Technology ◽  
Physical Activity Assessment ◽  
Activity Assessment ◽  
Real World Setting ◽  
Real Life Setting ◽  
Clinical Potential ◽  
Provision Of Care

With the growing number of people affected by osteoarthritis, wearable technology may enable the provision of care outside a traditional clinical setting and thus transform how healthcare is delivered for this patient group. Here, we mapped the available empirical evidence on the utilization of wearable technology in a real-world setting in people with knee osteoarthritis. From an analysis of 68 studies, we found that the use of accelerometers for physical activity assessment is the most prevalent mode of use of wearable technology in this population. We identify low technical complexity and cost, ability to connect with a healthcare professional, and consistency in the analysis of the data as the most critical facilitators for the feasibility of using wearable technology in a real-world setting. To fully realize the clinical potential of wearable technology for people with knee osteoarthritis, this review highlights the need for more research employing wearables for information sharing and treatment, increased inter-study consistency through standardization and improved reporting, and increased representation of vulnerable populations.

scholarly journals Improving social function with real-world social-cognitive remediation in schizophrenia: Results from the RemedRugby quasi-experimental trial

2020 ◽  
Vol 63 (1) ◽  
Author(s):  
Julien Dubreucq ◽  
Franck Gabayet ◽  
Bernard Ycart ◽  
Megane Faraldo ◽  
Fanny Melis ◽  
...  
Keyword(s):  
Real World ◽  
Symptom Severity ◽  
Social Cognitive ◽  
Real Life ◽  
Cognitive Remediation ◽  
Social Function ◽  
Post Treatment ◽  
Quasi Experimental ◽  
Social Cognitive Remediation

Abstract Background. Functional capacity (FC) has been identified as a key outcome to improve real-world functioning in schizophrenia. FC is influenced by cognitive impairments, negative symptoms, self-stigma and reduced physical activity (PA). Psychosocial interventions targeting FC are still under-developed. Methods. we conducted a quasi-experimental study evaluating the effects of an exercise-enriched integrated social cognitive remediation (SCR) intervention (RemedRugby [RR]) compared with an active control group practicing Touch Rugby (TR). To our knowledge, this is the first trial to date evaluating the effectiveness of such a program provided in a real-life environment. Results. Eighty-seven people with schizophrenia were included and allocated to either the RR group (n = 57) or the TR group (n = 30) according to the routine clinical practice of the recruiting center. Outcomes were evaluated at baseline and post-treatment in both groups and after 6 months of follow-up in the RR group using standardized scales for symptom severity, social functioning, self-stigma, and a large cognitive battery. After treatment we observed moderate to large improvements in social function (Personal and Social Performance Scale [PSP], p < 0.001, d = 1.255), symptom severity (Positive and Negative Syndrome Scale [PANSS] negative, p < 0.001, d = 0.827; PANSS GP, p < 0.001, d = 0.991; PANSS positive, p = 0.009, d = 0.594), verbal abstraction (p = 0.008, d = 0.554), aggression bias (p = 0.008, d = 0.627), and self-stigma (stereotype endorsement, p = 0.019, d = 0.495; discrimination experiences, p = 0.047; d = 0.389) that were specific to the RR group and were not observed in participants playing only TR. Effects were persistent over time and even larger between post-treatment and follow-up. Conclusions. Exercise-enriched integrated SCR appears promising to improve real-life functioning in schizophrenia. Future research should investigate the potential effects of this intervention on neuroplasticity and physical fitness.

The First Unprovoked Seizure in Typically Developing Children: A Real-Life Setting in Southern Brazil

2020 ◽  
pp. 155005942096539
Author(s):  
Mayara de Rezende Machado ◽  
Isac Bruck ◽  
Luciano de Paola ◽  
Mônica Nunes Lima Cat ◽  
Sérgio Antonio Antoniuk ◽  
...  
Keyword(s):  
Risk Factor ◽  
Recurrence Rate ◽  
Real Life ◽  
Typically Developing ◽  
Southern Brazil ◽  
Seizure Recurrence ◽  
Typically Developing Children ◽  
Unprovoked Seizure ◽  
Real Life Setting

Aim To describe the first unprovoked seizure in typically developing children, its clinical characteristics, recurrence rate, and possible risk factors in a real-life setting in Southern Brazil. Method In this retrospective cohort study, medical records of typically developing children aged 28 days to 14 years who had a first unprovoked seizure in a single tertiary care center were reviewed, in a 10-year period (2006-2016). Results Seventy-four children were included, 41 males and 33 females. The most frequent age group of the first seizure was 5 to 10 years and seizure main type was focal (50%). Most seizures occurred while children were awake (70%). All patients underwent an electroencephalogram (EEG), which was normal in 44.6%. Neuroimaging was performed in 81%, in 2 cases the etiology was considered structural, the remaining was classified as unknown. Median follow-up period was 32.5 months. Seizure recurrence rate was 56.7% and age younger than 5 years was a possible risk factor. Interpretation In the subpopulation of Brazilian typically developing children with a first unprovoked epileptic seizure there is a high recurrence rate. An abnormal EEG was a common finding, although it was not associated with a higher risk of seizure recurrence. A possible risk factor was age younger than 5 years, which may suggest a more rigorous follow-up of these patients.

scholarly journals Occurrence of adverse events in patients with JIA receiving biologic agents: long-term follow-up in a real-life setting

Rheumatology ◽  
2014 ◽  
Vol 54 (7) ◽  
pp. 1170-1176 ◽  
Author(s):  
Maarit Tarkiainen ◽  
Pirjo Tynjälä ◽  
Paula Vähäsalo ◽  
Pekka Lahdenne
Keyword(s):  
Adverse Events ◽  
Real Life ◽  
Biologic Agents ◽  
Real Life Setting ◽  
Long Term Follow Up

Analysis according to prognostic factors in patients (pts) treated with first-line bevacizumab (BEV) combined with paclitaxel (PAC) for HER2-negative metastatic breast cancer (mBC) in a routine oncology practice study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1077-1077 ◽  
Author(s):  
Iris Schrader ◽  
Frank Gerhard Foerster ◽  
Andreas Schneeweiss ◽  
Matthias Geberth ◽  
Lars Hahn ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Real Life ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Real Life Setting ◽  
Long Term Follow Up ◽  
Practice Study ◽  
Oncology Practice

1077 Background: 1st-line BEV combined with weekly PAC significantly improves progression-free survival (PFS) and response rate (RR) vs PAC alone in HER2-negative mBC, as shown in E2100. We analyzed data from a German routine oncology practice study of 1st-line BEV–PAC according to prognostic factors. Methods: Pts who had received no prior chemotherapy for mBC received BEV–PAC according to the European label. Efficacy and safety were documented for up to 1 y (or until progression, death, or BEV discontinuation if earlier) with additional long-term follow-up. Efficacy was analyzed in clinically important subgroups. Results: Efficacy data were available for 818 pts. The median duration of follow-up was 11.4 mo. The composition of the pt population with respect to the subgroups below was generally similar to the population treated in E2100, except for a higher proportion of pts with visceral disease or metastases in <3 organs. RR was very similar across all subgroups analyzed. Differences in median PFS and OS were generally in line with the differing prognoses according to clinical characteristics. Conclusions: These data suggest that 1st-line BEV–PAC is typically associated with median PFS >9 mo in the real-life setting, irrespective of baseline characteristics. [Table: see text]

Real-world treatment with abiraterone acetate in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC).

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 239-239 ◽  
Author(s):  
Martin Boegemann ◽  
Martin Hatzinger ◽  
Dirko Hercher ◽  
Geoffrey Matus ◽  
Els Grieta Everaert ◽  
...  
Keyword(s):  
Real World ◽  
Treatment Duration ◽  
Radiographic Progression ◽  
Real Life ◽  
Retrospective Chart Review ◽  
Progression Free Survival ◽  
Abiraterone Acetate ◽  
Rank Test ◽  
Castration Resistant Prostate Cancer ◽  
Similar Treatment

239 Background: In the COU-AA-302 trial, abiraterone acetate plus prednisone (AAP) resulted in extension of radiographic progression-free survival (rPFS) and overall survival in chemotherapy-naïve mCRPC patients compared to prednisone alone. However, limited data on AAP treatment and outcomes is available in the real-world in this setting. The aim of this study is to describe the duration of AAP treatment in routine clinical practice in mCRPC patients prior to chemotherapy. Methods: The study was designed as a retrospective chart review of mCRPC patients identified through oncology and urology practice in Belgium, France, Germany and the UK. This first analysis reports baseline patient characteristics at AAP initiation for the first 224 patients. Treatment duration, PFS and rPFS were estimated using Kaplan-Meier curves. Potential factors associated with treatment duration were explored using the log-rank test. Results: Data from 224 mCRPC patients treated with AAP (Belgium: 67; Germany: 150; UK: 7; none from France) across 19 centres was considered in this initial analysis. At baseline, the median age was 75.5 years (interquartile range [IQR]: 69.0-82.0) and the median PSA level was 50.0 ng/mL (IQR: 21.0-121.0). Patients with visceral metastases (9.8%) and ECOG 2-3 (9.4%) were included in this study, in contrast to those included in the COU-AA-302 study. Median duration of AAP treatment was 11.6 months (95% confidence interval [CI]: 10.2-12.8), whilst median PFS and rPFS were 11.9 months (95% CI: 10.8-13.3) and 16.5 months (95% CI: 13.5-20.0), respectively. Reasons for discontinuing AAP involved PSA progression (52.2%), radiographic progression (38.9%), symptomatic progression (27.8%), non-toxic death (19.4%) and toxicity (2.2%). Treatment duration was significantly longer in mCRPC patients with either baseline ECOG status 0, lower PSA, alkaline phosphatase, aspartate aminotransferase, or lactate dehydrogenase levels (p < 0.05). Conclusions: The results of this study suggest similar treatment duration and rPFS for mCRPC patients in this real-life cohort with poorer clinical features compared to those observed in the COU-AA-302 trial population.

Psoriatic Nail Disease: Quality of Life and Treatment

2009 ◽  
Vol 13 (5_suppl) ◽  
pp. S102-S106 ◽  
Author(s):  
Aditya K. Gupta ◽  
Elizabeth A. Cooper
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Plaque Psoriasis ◽  
Large Scale ◽  
Severity Index ◽  
Biologic Therapies ◽  
Nail Psoriasis ◽  
Psoriatic Nail Disease

Nail psoriasis is common among patients with plaque psoriasis or psoriatic arthritis and has a detrimental effect on quality of life. However, there are currently no standardized therapeutic regimens for nail psoriasis. Traditional treatments for nail psoriasis, which include topical, intralesional, and oral therapies, may be time-consuming, painful, or unsafe when administered long term. Biologic therapies have demonstrated efficacy for plaque psoriasis and psoriatic arthritis; these therapies may be particularly promising for the treatment of nail psoriasis as both groups of patients have an elevated incidence of nail dystrophy. The biologic therapies adalimumab, alefacept, efalizumab, etanercept, and infliximab have demonstrated clinically important nail psoriasis improvements using the Nail Psoriasis Severity Index, a helpful tool that, upon validation, will allow comparison across treatments and trials. Large-scale, long-term trials using standardized outcome measures are needed to further evaluate biologic therapies for the treatment of nail psoriasis.

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