scholarly journals The switch from etanercept originator to SB4: data from a real-life experience on tolerability and persistence on treatment in joint inflammatory diseases

2020 ◽  
Vol 12 ◽  
pp. 1759720X2096403
Author(s):  
Cosimo Bruni ◽  
Stefano Gentileschi ◽  
Giovanni Pacini ◽  
Caterina Baldi ◽  
Marco Capassoni ◽  
...  
Keyword(s):  
Life Experience ◽  
Musculoskeletal Diseases ◽  
Inflammatory Diseases ◽  
Real Life ◽  
Treatment Persistence ◽  
Real Life Data ◽  
Persistence Rates ◽  
Axial Spondylarthritis ◽  
Stable Clinical Condition

Aims: Switching from originator to biosimilar is part of current practice in inflammatory rheumatic musculoskeletal diseases (iRMDs) such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondylarthritis (axSpA), with evidences derived from both etanercept (ETN) to SB4-switching randomized controlled trials and real-life registries. We investigated the safety and treatment persistence of ETN/SB4 in a multi-iRMD cohort derived from two rheumatology departments in our region. Methods: Adult patients with iRMDs, treated with ETN for at least 6 months and switched to SB4 in stable clinical condition, were eligible for this retrospective evaluation. Retrospective data on adverse events, loss of efficacy and persistence on treatment were collected until latest available follow-up. Results: A total of 220 patients (85 RA, 81 PsA, 33 axSpA, 14 juvenile idiopathic arthritis and seven other conditions; 142 females, mean age 58 ± 7 years, disease duration 12 ± 4 years, ETN duration 7 ± 4 years) were enrolled, with median follow-up of 12.1 (9.7–15.8) months. A total of 50 patients (22.7%) presented with at least one adverse event, with 36 (16.4%) disease flares and 30 (13.6%: 11 for safety and 19 loss of efficacy) SB4 withdrawals. Cumulative SB4 treatment persistence was 99.1%, 88.6% and 64.6% at 6, 12 and 18 months respectively. Back-switch to ETN was performed in 17/30 cases, the remaining cases were managed with change of biologic disease modifying or conventional synthetic anti-rheumatic drug. Age was the only significant predictor of SB4 interruption at 6 months. Conclusion: Our real-life data confirm the safety profile of switching from ETN to SB4, with slightly higher treatment persistence rates compared with other real-life registries.

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.

Complete responses to two different anti-PD1 agents in a metastatic melanoma patient

2019 ◽  
Vol 26 (2) ◽  
pp. 496-499 ◽  
Author(s):  
Saadettin Kilickap ◽  
Deniz C Guven ◽  
Oktay H Aktepe ◽  
Burak Y Aktas ◽  
Omer Dizdar
Keyword(s):  
Metastatic Melanoma ◽  
Checkpoint Inhibitors ◽  
Real Life ◽  
Complete Response ◽  
Duration Of Treatment ◽  
Treatment Protocols ◽  
Real Life Data ◽  
Heavily Pretreated ◽  
Drug Free

In the last decade, immune checkpoint inhibitors changed the landscape of metastatic melanoma. However, the optimal duration of treatment and treatment cessation in responders is largely unknown. Herein, we represent a heavily pretreated metastatic melanoma case who had a complete response to pembrolizumab and also a complete response with nivolumab after progression during drug-free follow-up. We think that reinduction with a different anti-PD1 antibody may be used in patients with metastatic melanoma responders. Clinical trials with prespecified sequential treatment protocols and large real-life data can further delineate this subject.

scholarly journals O35 Efficacy & safety of tocilizumab in GCA: a multi-centre experience of NHS clinical practice

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Alwin Sebastian ◽  
Abdul Kayani ◽  
Chavini Ranasinghe ◽  
Frances Hall ◽  
Colin Ransom ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Life Experience ◽  
Real Life ◽  
Aneurysm Rupture ◽  
Research Support ◽  
Ischemic Disease ◽  
Abdominal Aortic ◽  
Relapsing Remitting ◽  
Sight Loss

Abstract Background Giant cell arteritis (GCA) has a relapsing, remitting course with ischemic/vascular damage in a number of cases. Glucocorticoids (GC) remain mainstay of treatment with SAEs e.g. diabetes and fractures commonly seen. The GiACTA trial of tocilizumab (TCZ) in GCA led to NICE approval for 12 month’s therapy in relapsing/ refractory disease. We report real life experience in 51 cases. Methods Multicentre retrospective data collected through ENRAD and individual centres across England (Table 1). Outcomes were as assessed by supervising clinicians. Results Fifty-one patients were treated with TCZ (26 cranial, 13 LVV, 11 both). 11 (22.0%) had prior permanent sight loss due to AION, CRAO or both. One died prior to TCZ, from recurrent cerebral infarcts. Mean age was 71 years with 66.7% females. Ultrasound (US) was used for diagnosis in 28 (56.0%), exclusively or in combination with other tests such as biopsy, PET-CT or CTA. 70% had prior DMARD (LEF/MTX/AZT/MMF/CYC, mean duration 58 weeks). MTX was used in 50% alone or combination. Initial TCZ was given as subcutaneous or intravenous (85.4% and 14.6%). TCZ indication in 89.8% was relapsing, refractory or ischemic disease. Steroid AEs that prevented optimal GC dosing constituted 10% of TCZ indication. Mean follow up was 31 weeks, 30 (58.8%) continuing TCZ uninterrupted, 4 completed 12 months, 4 discontinued due to SAEs. Ten had brief interruptions due to minor AEs. One restarted after 12 months due to flare but died 12 weeks later from abdominal aortic aneurysm rupture. At follow up, 37(74%) were in remission with a mean GC dose of 6.97 mg (mean GC dose pre-TCZ 33.2 mg), Thirty-two (65.3%) ≤ 5mg. In 4 (8%) outcome could not be assessed as either they started TCZ recently or about to start. In 53% lipids were not checked after commencing TCZ. AEs seen were 37.0%. Conclusion In clinical practice, TCZ is efficacious and safe in relapsing/refractory/ischemic GCA. I.V. route is an option awaiting NHSE approval in refractory visual symptoms. Infections and other AEs do occur but overall safety profile is acceptable. US is excellent in identifying patients at need and is a useful disease activity monitoring tool. Disclosures A. Sebastian: None. A. Kayani: None. C. Ranasinghe: None. F. Hall: Consultancies; Sobi, S. Grants/research support; Actelion. C. Ransom: None. D. Jayne: None. V. Quick: Honoraria; Roche. M. Hughes: None. J. Stack: Member of speakers’ bureau; Roche. C. Mukhtyar: None. F. Coath: None. A. Bharadwaj: None. V. Hajela: None. S. Butler: Consultancies; Lily. M. Lwin: None. C. Edwards: Consultancies; Roche, Chugai. Grants/research support; Roche, Chugai. M. Whitlock: None. B. Dasgupta: Consultancies; Roche, Sanofi, GSK. Grants/research support; Roche.

scholarly journals Adjuvant chemotherapy after surgery for pancreatic ductal adenocarcinoma: retrospective real-life data

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Sophia Chikhladze ◽  
Ann-Kathrin Lederer ◽  
Lampros Kousoulas ◽  
Marilena Reinmuth ◽  
Olivia Sick ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Performance Status ◽  
Real Life ◽  
Disease Free Survival ◽  
Biologically Active ◽  
Ductal Adenocarcinoma ◽  
Real Life Data ◽  
Number Of Cycles

Abstract Background The recommendation for postoperative chemotherapy in pancreatic ductal adenocarcinoma (PDAC) is based on prospective randomized trials. However, patients included in clinical trials do not often reflect the overall patient population treated in clinical practice. Materials and methods A retrospective review of all patients undergoing pancreas resection for PDAC between 2001 and 2013 was performed. Follow-up data from oncologists, general practitioners, or hospital patient files were available for 92% of patients. Results A total of 251 patients were included in our analysis. Chemotherapy was recommended for 223 patients, but 86 patients did not follow the recommendation. The application of the recommended chemotherapy, consisting of 6 cycles of gemcitabine, was only applied to 45 patients. Forty patients received the recommended number of cycles with dose reduction or prolonged intervals between cycles, and adjuvant chemotherapy was terminated prior to the intended completion of all 6 cycles in 54 patients. Survival of patients after adjuvant chemotherapy was increased compared to that of patients without chemotherapy (with recurrence 25.6 vs. 14.3 months, p = 0.001, and without recurrence 27.4 vs. 14.3 months, p <  0.001). Terminating chemotherapy prior to completion (p = 0.009) as well as a lower number of chemotherapy cycles (p = 0.026) was associated with a decreased survival. Conclusion Adjuvant chemotherapy improves overall and disease-free survival after curative pancreatic resection, but only a small fraction of patients completes the recommended 6 cycles of adjuvant chemotherapy. Our data indicates that performance status of patients after pancreas resections for PDAC requires not only highly biologically active but also well-tolerated adjuvant chemotherapy regimens.

Epidemiology and patterns of care of intrahepatic cholangiocarcinoma (iCCA) in France: Real-life data from the French National Hospital‐Discharge Summaries Database System (PMSI).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16624-e16624
Author(s):  
Cindy Neuzillet ◽  
Corinne Emery ◽  
Clément Teissier ◽  
Stéphane Bouée ◽  
Astrid Lièvre
Keyword(s):  
Intrahepatic Bile Duct ◽  
Real Life ◽  
High Volume ◽  
Cancer Registries ◽  
Best Supportive Care ◽  
Patterns Of Care ◽  
University Hospitals ◽  
Life Data ◽  
Real Life Data

e16624 Background: Little is known about epidemiology and patterns of care of iCCA in daily clinical practice. The aims of this study were to estimate from real-life data the incidence of iCCA in France and to describe the healthcare pathways of these patients (pts). Methods: A retrospective analysis was carried out using the nationwide prospective French PMSI database. All pts with a new diagnosis of "carcinoma of the intrahepatic bile duct" who had a 1st hospital stay in Medicine, Surgery and Obstetrics departments (MSO) between 2014 and 2015 with a 2-year follow-up were included. Data related to the 1st identified stay (S1) in MSO and on all subsequent stays in MSO, Aftercare and Rehabilitation (SSR) or Home Hospitalizations (HAD) were analyzed. Results: A total of 3,650 new iCCA cases were identified. At S1 (admission via emergency room [ER] in 28%), median age of pts was 73y, 57% were male and 35% had metastases. Jaundice/anemia/ascites/cholangitis were reported in 17%/16%/12%/7%, respectively. Pts care at S1 was mainly provided in general hospitals (CHG, 60%), rather than university hospitals (CHU, 15%), private (20%) or cancer centers (CLCC, 6%). 896 (24%) pts died during S1: they were more frequently hospitalized via ER (48% vs 23%), metastatic (52% vs 35%) and symptomatic. Subsequent stays were identified for 2,507 pts (69%). Similarly to S1, most pts were managed in CHG during their follow-up (70% vs 20% in CHU and 12% in CLCC). Based on the number of pts treated over the study period, centers were classified as low (≤5 pts, 68%), intermediate (5-20 pts, 26%) and high volume ( > 20 pts, 6%). 47% of the high-volume centers were CHU/CLCC. Three healthcare pathways were defined: surgery (n = 519; 14%), chemotherapy (CT) without surgery (n = 812; 22%) and best supportive care (BSC) (n = 2,319; 63%). CT, surgery and BSC were most frequently performed in CLCC, CHU and CHG, respectively. Pts who received CT (mean time between S1 and start of CT: 1.9 months) were younger, less frequently hospitalized via ER and less symptomatic at S1. A palliative care code was associated with S1 in 25% of pts and with a subsequent MSO/SSR/HAD stay in 60%. Conclusions: This real-life, medico-administrative study, covering all hospitalized patients in France, reveals a higher incidence of iCCA than that previously reported by cancer registries. It also highlights the severity of this disease, the central role of CHG in the management of pts and the expertise of CHU and CLCC for surgery and CT, respectively.

scholarly journals 65 Antiphospholipid syndrome long term follow up: real life experience of a single centre

2017 ◽  
Author(s):  
RM Serrano Morales ◽  
G Pons-Estel ◽  
R Quintana ◽  
G Espinosa Garriga ◽  
R Cervera Segura
Keyword(s):  
Antiphospholipid Syndrome ◽  
Life Experience ◽  
Real Life ◽  
Single Centre ◽  
Long Term Follow Up

scholarly journals Real-life experience with 4 years of golimumab persistence in ulcerative colitis patients

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Marisa Iborra ◽  
Natalia García-Morales ◽  
Saoia Rubio ◽  
Federico Bertoletti ◽  
Marta Calvo ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Duration ◽  
Life Experience ◽  
Real Life ◽  
Efficacy And Safety ◽  
Dose Intensification ◽  
Factors Associated ◽  
Mean Time

Abstract Golimumab has demonstrated its long-term efficacy and safety in ulcerative colitis in clinical trials, but no data of long-term persistence has been published from real world. To estimate long-term persistence of golimumab, as well as factors associated with longer persistence, in patients with ulcerative colitis in real life. Observational multicentre study including adult patients with ulcerative colitis treated with golimumab and with at least twelve months of follow-up. We included 190 patients, 105 (55.26%) naive to anti-TNF, with mean disease duration of 9.32 ± 8.09 years. Probability of persistence was 63%, 46%, 39% and 27% at 1, 2, 3 and 4 years, respectively. Persistence was lower in patients with primary failure to previous anti-TNF. Eighty-two (43.16%) patients needed dose intensification during follow-up, with a mean time until intensification of 8.03 ± 8.64 months. Dose intensification and lower disease duration predicted higher persistence with golimumab (p = 0.037 and p = 0.008, respectively). During a follow-up of 17.25 ± 15.83 months, 32 (16.5%) patients needed hospitalisation and 11 (6%) underwent colectomy. No unexpected adverse events were reported. Golimumab has demonstrated good persistence and safety profile for long treatment in ulcerative colitis patients.

Adjuvant treatment with paclitaxel plus trastuzumab for node-negative breast cancer: real-life experience

2021 ◽  
Author(s):  
Omer Diker ◽  
Burak Yasin Aktas ◽  
Recep Ak ◽  
Bahadır Koylu ◽  
Onur Bas ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Life Experience ◽  
Real Life ◽  
Disease Free Survival ◽  
Invasive Disease ◽  
Breast Cancers ◽  
Node Negative ◽  
Her2 Breast Cancer ◽  
Node Negative Breast Cancer

Background: In node-negative HER2-overexpressed breast cancers, adjuvant paclitaxel plus trastuzumab treatment is a successful de-escalation approach with excellent survival outcomes. Methods: All patients with HER2+ breast cancer treated in our centers were retrospectively reviewed. Results: We analyzed 173 patients who were treated with adjuvant paclitaxel plus trastuzumab. The mean tumor size was 2.2 cm. There were eight invasive disease events or death: four distant recurrences (2.3%), three locoregional recurrences (1.7%) and one death without documented recurrence after a 52 month follow-up. The 3-year disease-free survival and recurrence-free interval rate was 96.6%. Conclusion: This real-life experience with adjuvant paclitaxel plus trastuzumab demonstrated few distant recurrences and is compatible with the APT trial findings.

Direct-acting antiviral agents in the treatment of chronic Hepatitis C – “Real-life” experience from an academic centre and two specialized clinical practices

2017 ◽  
Vol 56 (04) ◽  
pp. 351-360 ◽  
Author(s):  
Manuel Groß ◽  
Georg Härter ◽  
Johanna Backhus ◽  
Eugen Zizer ◽  
Thomas Seufferlein ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Life Experience ◽  
Antiviral Agents ◽  
Real Life ◽  
Clinical Practices ◽  
Genotype 3 ◽  
Svr12 Rate ◽  
Real Life Data

AbstractThe introduction of the new direct antiviral agents has revolutionized the therapy of chronic hepatitis C. Today we are able to cure the vast majority of our patients with an 8- to 12-week therapy course of an antiviral combination therapy with an excellent safety profile. Real-life data are very important to further develop our experience with the new therapeutics and help us to improve the care of our patients in our everyday clinical practice.In our study, we present the retrospective analysis of a representative German cohort of 344 patients with chronic hepatitis C treated with the new direct antiviral agents. The patients were recruited in an academic center of southern Germany (University Clinic of Ulm, Clinic of Internal Medicine I) and in 2 highly specialized clinical practices in the city center and the near region of Ulm. Within this in-detail characterized study cohort, we analyzed the efficacy and safety of antiviral therapy under real-life conditions.In 322 patients, we could document SVR12 data and found an excellent overall SVR12 rate of 97.8 % across all genotypes. In more detail, we could show comparable SVR12 results of 99 % and 99.2 % in patients with the hepatitis C virus subtypes 1a and 1b of and an excellent SVR12 rate of 93.1 % in genotype 3 patients without liver cirrhosis. Nevertheless, SVR12 rates tend to be lower in patients with the presence of liver cirrhosis, especially in genotype 3 patients with the lowest SVR12 rate in the whole study group of only 80 %. In general, there were no major safety issues except of 1 patient treated with a protease-inhibitor-based regimen who developed a generalized skin reaction and needed hospitalization and premature end of antiviral therapy.In summary, our analysis of this well characterized representative cohort of 344 patients adds more information in the field of real-life experience with the new antiviral therapeutics and could therefore contribute to improve the care of our patients. Together with the existing real-life data, we now can proceed in achieving the aim of viral eradication of hepatitis C virus within our population.

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