The impact of the SARS-CoV-2 pandemic on the workloads of UPMC advanced radiotherapy centers in Italy

GOALS The Advanced Radiotherapy Centers of UPMC San Pietro FBF of Rome (CC#1) and UPMC Villa Maria of Mirabella Eclano (CC#2) conducted a study to review variations in department workloads and workflows experienced during the pandemic. The potential relation between these variations and the new procedures introduced to prevent and contain the COVID-19 infection was also studied. MATERIALS AND METHODS The data used were obtained from reports present in the ARIA® system (v. 15.1 Varian Medical Systems, Palo Alto, CA, U.S.A.). To examine the workloads was used the Downtime, an indicator that directly quantifies the inactivity of the department, derived from the ratio between the daily stand-by time of the LINACs (TrueBeam STx®, Varian Medical Systems, Palo Alto, CA, U.S.A.) and the mean number of treatments performed every day. In order to examine the workflows and possible delays, we measured the time between the treatments ("Therapy intervals"). RESULTS The Downtime average at CC#1 slightly increased from 3.1% in 2019 to 3.8% in 2020. However, the monthly analysis shows significant reduction (March-April-May) and increase (November-December) peaks. At CC#2, the 2020 Downtime trend was fairly consistent (average value: 3.3%), with an increase during the first wave of the pandemic. The "5-10 min" Therapy intervals at CC#1, reviewed comparing the March-April-May 2020 quarter with 2019, were higher in the first months and lower in May; the "10-15 min" intervals were stable; the ">20 min" intervals slightly increased in March 2020. At CC#2, the trend in 2020 decreased during the months of higher health care emergency and increased during the summer months. CONCLUSIONS The fact that the trends of the indicators show peaks only during the periods of major health care emergency indicates an impact of the pandemic, both on the workload and on the workflow. However, they also highlight the staff's ability to rapidly adapt to the new procedures, without affecting the overall performance of the both centers

Impatto della pandemia da SARS-CoV-2 sui workload di due centri UPMC di radioterapia ad alta specializzazione in Italia

OBIETTIVI I Centri di Radioterapia UPMC San Pietro FBF di Roma (CC#1) e UPMC Villa Maria di Mirabella Eclano (CC#2) hanno condotto uno studio con l’obiettivo di analizzare le variazioni avvenute durante la pandemia sui workload e i workflow di reparto. È stato, inoltre, ricercato l’eventuale nesso tra queste e l’introduzione di nuove procedure per la prevenzione e il contenimento del contagio da Covid-19. MATERIALI E METODI I dati utilizzati sono stati ricavati da reports presenti nel sistema ARIA (V.15.1 Varian Medical System, CA, Palo Alto, USA). Per esaminare i workload è stato utilizzato il Downtime, un indicatore che quantifica direttamente l'inattività del reparto, ricavato dal rapporto tra il tempo di standby giornaliero dei LINAC (TrueBeam STx®, Varian Medical System, CA, Palo Alto, USA) e la media di trattamenti giornalieri effettuati. Per esaminare workflow ed eventuali ritardi tra le attività, sono stati valutati gli intervalli di tempo tra una terapia e la successiva (Intervalli di terapia). RISULTATI Il Downtime nel CC#1 ha subìto un leggero aumento del valore medio dal 3.1% del 2019 al 3.8% del 2020, tuttavia l’analisi mensile mostra consistenti picchi di riduzione (marzo-aprile-maggio) e di incremento (novembre-dicembre). Per il CC#2 il trend del Downtime nel 2020 è abbastanza regolare (valore medio del 3,3%), con un incremento durante la prima ondata della pandemia. Gli Intervalli di terapia di “5-10 min” nel CC#1, analizzati confrontando il trimestre marzo-aprile-maggio 2020 col 2019, risultano maggiori per i primi mesi e ridotti a maggio; quelli di “10-15” min risultano stabili; quelli “>20 min” sono leggermente aumentati a marzo 2020. Per il CC#2 il trend nel 2020 decresce nei mesi di maggiore emergenza sanitaria e incrementa nei mesi estivi. CONCLUSIONI Il fatto che i trend degli indicatori utilizzati abbiano dei picchi esclusivamente in corrispondenza dei periodi di maggiore emergenza sanitaria, è indice di un certo impatto – sia in termini di workload che di workflow – della pandemia, ma anche della capacità del personale di adattarsi in breve tempo alle nuove procedure da eseguire, senza inficiare sul rendimento generale dei Centri

Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab

Background and Aims: Several studies have found Golimumab (GOL) effective and safe in the short-term treatment of ulcerative colitis (UC), but few long-term data are currently available from real world. Our aim was to assess the long-term real-life efficacy and safety of GOL in managing UC outpatients in Italy. Methods: A retrospective multicenter study assessing consecutive UC outpatients treated with GOL for at least 3-month of follow-up was made. Primary endpoints were the induction and maintenance of remission in UC, defined as Mayo score ≤2. Several secondary endpoints, including clinical response, colectomy rate, steroid free remission and mucosal healing, were also assessed during the follow-up. Results: One hundred and seventy-eight patients were enrolled and followed up for a median (IQR) time of 9 (3-18) months (mean time follow-up: 33.1±13 months). Clinical remission was achieved in 57 (32.1%) patients: these patients continued with GOL, but only 6 patients (3.4%) were still under clinical remission with GOL at the 42nd month of follow-up. Clinical response occurred in 64 (36.4%) patients; colectomy was performed in 8 (7.8%) patients, all of them having primary failure. Steroid-free remission occurred in 23 (12.9%) patients, and mucosal healing was achieved in 29/89 (32.6%) patients. Adverse events occurred in 14 (7.9%) patients. Conclusions: Golimumab does not seem able to maintain long-term remission in UC in real life. The safety profile was good

Adalimumab Biosimilar GP2017 versus Adalimumab Originator in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study

The approval of adalimumab (ADA) biosimilars for inflammatory bowel disease (IBD) has reduced the cost of treatment. While several ADA biosimilars are currently available, comparative data on the ADA biosimilar GP2017 (HyrimozTM) and its originator (HumiraTM) in IBD are lacking. We compared the efficacy and safety of GP2017 versus originator in IBD outpatients in an Italian real-life setting. This retrospective analysis enrolled consecutive IBD patients with complete clinical, laboratory, and endoscopic data. Clinical activity was assessed with the Mayo score in ulcerative colitis (UC) and the Harvey–Bradshaw Index in Crohn’s disease (CD). The primary endpoints were the induction of remission and the safety of GP2017 versus ADA originator. One hundred and thirty-four patients (30.6% with UC and 69.4% with CD, median age 38 years) were enrolled: 62 (46.3%) patients were treated with GP2017, and 72 (53.7%) with ADA originator; 118 (88.1%) patients were naïve to ADA. Clinical remission was obtained in 105 (78.4%) patients, during a median follow-up of 12 months, 82.3% and 75% in the GP2017 and ADA originator groups, respectively (p = 0.311). Treatment was well tolerated in both groups. This analysis of real-world data suggests that GP2017 and its originator are equivalent in terms of efficacy and safety in patients with IBD

Prognostic performance of the 'DICA' endoscopic classification and the 'CODA' score in predicting clinical outcomes of diverticular disease: an international, multicentre, prospective cohort study

To investigate the predictive value of the Diverticular Inflammation and Complication Assessment (DICA) classification and to develop and validate a combined endoscopic-clinical score predicting clinical outcomes of diverticulosis, named Combined Overview on Diverticular Assessment (CODA)

Replacement of Adalimumab Originator to Adalimumab Biosimilar for a Non-Medical Reason in Patients with Inflammatory Bowel Disease: A Real-life Comparison of Adalimumab Biosimilars Currently Available in Italy

Background and aims: Adalimumab (ADA) biosimilars have been included into the therapeutic armamentarium of inflammatory bowel disease (IBD); however, comparative data on the efficacy and safety of the different ADA biosimilars after replacing the ADA originator for a non-medical reason remains scarce. We aimed to compare in a real-life setting the efficacy and safety of four ADA biosimilars SB5, APB501, GP2017, and MSB11022 in IBD patients after replacing the originator for a non-medical reason. Methods: A multicenter retrospective study was performed on consecutive IBD patients, analyzing clinical, laboratory, and endoscopic data. The primary endpoints of the study were maintenance of clinical remission and safety of the different biosimilars. Results: 153 patients were enrolled, 26 with UC and 127 with CD. Clinical remission was maintained in 124 out of 153 (81%) patients after a median (IQR) follow-up of 12 (6-24) months, without any significant difference between the four ADA biosimilars. ADA biosimilars dosage was optimized in five patients (3.3%). Loss of remission was significantly higher in UC patients (10/26 patients, 38.5%) than in CD patients (19/127 patients, 14.9%, p<0.025). Adverse events occurred in 12 (7.9%) patients; the large majority were mild. Conclusions: No difference in efficacy and safety was found between ADA biosimilars when used to replace the ADA originator for a non-medical reason. However, in UC patients the replacement of ADA originator for this reason should be carefully assessed

Comparison of Performances of Adalimumab Biosimilars SB5, APB501, GP2017, and MSB11022 in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study

Background Adalimumab (ADA) biosimilars have entered the therapeutic armamentarium of inflammatory bowel disease (IBD), allowing for the treatment of a greater number of patients for their reduced cost than the originator. However, comparative data on the efficacy and safety of the various ADA biosimilars remains scarce. We compare the efficacy and safety of ADA biosimilars SB5, APB501, GP2017, and MSB11022 in treating IBD outpatients in a real-life Italian setting. Methods A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data. Clinical activity was measured using the Mayo score in ulcerative colitis (UC) and the Harvey-Bradshaw Index in Crohn's disease (CD). The primary endpoints were the following: (1) induction of remission in patients new to biologics and patients new to ADA but previously exposed to other anti-tumor necrosis factor agents or other biologics; (2) maintenance of remission in patients switched from the ADA originator to an ADA biosimilar; and (3) safety of various biosimilars. Results A total of 533 patients were enrolled according to the inclusion criteria: 162 patients with UC and 371 patients with CD. Clinical remission was obtained in 79.6% of patients new to biologics and 59.2% of patients new to ADA but not to other biologics; clinical remission was maintained in 81.0% of patients switched from the originator, and adverse events were recorded in 6.7% of patients. There was no significant difference between the 4 ADA biosimilars for each predetermined endpoint. Conclusions Adalimumab biosimilars are effective and safe in IBD treatment, both in new patients and in patients switched from the ADA originator. No difference in efficacy and safety was found between ADA biosimilars.Lay Summary We treated 533 IBD patients with adalimumab (ADA) biosimilars SB5, APB501, GP2017, and MSB11022. No differences between these 4 ADA biosimilars were found for reaching remission in naive patients, maintaining remission for nonmedical switching, clinical response, steroid-free remission, surgery rate, mucosal healing, or safety

Comparison of Performances of Adalimumab Biosimilars SB5, ABP501, GP2017, and MSB11022 in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study

Background Adalimumab (ADA) biosimilars have entered the therapeutic armamentarium of inflammatory bowel disease (IBD), allowing for the treatment of a greater number of patients for their reduced cost than the originator. However, comparative data on the efficacy and safety of the various ADA biosimilars remains scarce. We compare the efficacy and safety of ADA biosimilars SB5, APB501, GP2017, and MSB11022 in treating IBD outpatients in a real-life Italian setting. Methods A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data. Clinical activity was measured using the Mayo score in ulcerative colitis (UC) and the Harvey-Bradshaw Index in Crohn's disease (CD). The primary endpoints were the following: (1) induction of remission in patients new to biologics and patients new to ADA but previously exposed to other anti-tumor necrosis factor agents or other biologics; (2) maintenance of remission in patients switched from the ADA originator to an ADA biosimilar; and (3) safety of various biosimilars. Results A total of 533 patients were enrolled according to the inclusion criteria: 162 patients with UC and 371 patients with CD. Clinical remission was obtained in 79.6% of patients new to biologics and 59.2% of patients new to ADA but not to other biologics; clinical remission was maintained in 81.0% of patients switched from the originator, and adverse events were recorded in 6.7% of patients. There was no significant difference between the 4 ADA biosimilars for each predetermined endpoint. Conclusions Adalimumab biosimilars are effective and safe in IBD treatment, both in new patients and in patients switched from the ADA originator. No difference in efficacy and safety was found between ADA biosimilars.Lay Summary We treated 533 IBD patients with adalimumab (ADA) biosimilars SB5, APB501, GP2017, and MSB11022. No differences between these 4 ADA biosimilars were found for reaching remission in naive patients, maintaining remission for nonmedical switching, clinical response, steroid-free remission, surgery rate, mucosal healing, or safety