Real-life Retrospective Analysis Research Articles

Organizational Benefits of Ultra-Low-Dose Chest CT Compared to Chest Radiography in the Emergency Department for the Diagnostic Workup of Community-Acquired Pneumonia: A Real-Life Retrospective Analysis.

Background and Objectives: Chest radiography remains the most frequently used examination in emergency departments (ED) for the diagnosis of community-acquired pneumonia (CAP), despite its poor diagnostic accuracy compared with ultra-low-dose (ULD) chest computed tomography (CT). However, although ULD CT appears to be an attractive alternative to radiography, its organizational impact in ED remains unknown. Our objective was to compare the relevant timepoints in ED management of CT and chest radiography. Materials and Methods: We conducted a retrospective study in two ED of a University Hospital including consecutive patients consulting for a CAP between 1 March 2019 and 29 February 2020 to assess the organizational benefits of ULD chest CT and chest radiography (length of stay (LOS) in the ED, time of clinical decision after imaging). Overlap weights (OW) were used to reduce covariate imbalance between groups. Results: Chest radiography was performed for 1476 patients (mean age: 76 years [63; 86]; 55% men) and ULD chest CT for 133 patients (mean age: 71 [57; 83]; 53% men). In the weighted population with OW, ULD chest CT did not significantly alter the ED LOS compared with chest radiography (11.7 to 12.2; MR 0.96 [0.85; 1.09]), although it did significantly reduce clinical decision time (6.9 and 9.5 h; MR 0.73 [0.59; 0.89]). Conclusion: There is real-life evidence that a strategy with ULD chest CT can be considered to be a relevant approach to replace chest radiography as part of the diagnostic workup for CAP in the ED without increasing ED LOS.

Treatment effectiveness and side effects of patients with hepatitis C in the prisons of Southern Taiwan: a real-life retrospective analysis

ObjectiveHepatitis C is an important risk factor for cirrhosis and liver cancer in the Taiwanese population. Domestic prisons reported a higher rate of hepatitis C infection than the national average....

Efficacy of Tildrakizumab for the Treatment of Difficult-to-Treat Areas: Scalp, Nail, Palmoplantar and Genital Psoriasis.

Tildrakizumab, an IL-23 inhibitor, is effective and safe for the improvement of moderate-to-severe chronic plaque psoriasis. However, little evidence is available on the use of this biologic in psoriasis in difficult-to-treat locations. In this retrospective analysis, we treated patients with 100 mg tildrakizumab at Day 0, after 4 weeks and every 12 weeks thereafter. Disease severity and treatment response was assessed by the Psoriasis Area and Severity Index (PASI), the static Physician’s Global Assessment of Genitalia (sPGA-G), the Psoriasis Scalp Severity Index (PSSI), Nail Psoriasis Severity Index (NAPSI) and the Palmoplantar Psoriasis Area and Severity Index (ppPASI) at baseline and after 4, 12 and 28 weeks. We followed 18 patients (mean age 49.1 ± 12.7 years, 61.1% male) with psoriasis localized to the genital region (N = 7), scalp (N = 6), nails (N = 5) and palmar/plantar areas (N = 7). PASI score decreased from 11.5 at baseline to 3.1 and 2.4 at 12 and 28 weeks. Tildrakizumab treatment decreased sPGA-G (3.3 to 0.2), PSSI (36.2 to 2.7), NAPSI (48.4 to 15.7) and ppPASI (5.3 to 0) from baseline to 28 weeks, respectively. Data from this real-life retrospective analysis shows that tildrakizumab is an effective option for the management of psoriasis in difficult-to-treat areas.

Adalimumab and ABP 501 in the Treatment of a Large Cohort of Patients with Inflammatory Arthritis: A Real Life Retrospective Analysis.

The recent introduction of ABP 501, an adalimumab biosimilar, in the treatment of rheumatic diseases was supported by a comprehensive comparability exercise with its originator. On the other hand, observational studies comparing adalimumab and ABP 501 in inflammatory arthritis are still lacking. The main aim of this study is to compare the clinical outcomes of the treatment with adalimumab, both the originator and ABP 501, in a large cohort of patients affected by autoimmune arthritis in a real life setting. We retrospectively analysed the baseline characteristics and the retention rate in a cohort of patients who received at least a course of adalimumab (originator or ABP 501) from January 2003 to December 2020. We stratified the study population according to adalimumab use: naive to original (oADA), naive to ABP 501 (bADA) and switched from original to ABP 501 (sADA). The oADA, bADA and sADA groups included, respectively, 724, 129 and 193 patients. In each group, the majority of patients had a diagnosis of rheumatoid arthritis. The total observation period was 9805.6 patient-months. The 18-month retentions rate in oADA, bADA and sADA was, respectively, 81.5%, 84.0% and 88.0% (p > 0.05). The factors influencing the adalimumab retention rate were an axial spondylarthritis diagnosis (Hazard Ratio (HR) 0.70; p = 0.04), switch from oADA to ABP 501 (HR 0.53; p = 0.02) and year of prescription (HR 1.04; p = 0.04). In this retrospective study, patients naive to the adalimumab originator and its biosimilar ABP 501 showed the same retention rate. Patients switching from the originator to biosimilar had a higher retention rate, even though not statistically significant, when compared to naive.

Outcomes of Abrupt Switch to Bevacizumab of Patients Undergoing Aflibercept Intravitreal Injections for Neovascular Age-Related Macular Degeneration in a Tertiary Center in Lombardy, Italy: A Real-Life Retrospective Analysis.

Purpose To assess real-life anatomical and functional outcomes of switch to bevacizumab in patients undergoing aflibercept intravitreal injections for nAMD. Methods Retrospective chart review of all patients diagnosed with nAMD and undergoing intravitreal injections of aflibercept who switched to bevacizumab after the resolution XI/1986 of Lombardy Region. Results Among 128 patients undergoing intravitreal injections, a total of 29 eyes of 29 patients met all inclusion criteria and were included in the statistical analysis. Best corrected visual acuity and central macular thickness did not change significantly (p > 0.05) between baseline, after the loading phase, and at the last follow-up. Conclusion Switching to bevacizumab has been safe and efficacious in patients responding to the loading phase. According to our results, the restrictions imposed by Lombardy Region did not cause any harm to patients undergoing intravitreal anti-VEGF injections.

Clinical Categorization Algorithm (CLICAL) and Machine Learning Approach (SRF-CLICAL) to Predict Clinical Benefit to Immunotherapy in Metastatic Melanoma Patients: Real-World Evidence from the Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy

Simple SummaryImmune checkpoint inhibitors have improved the prognosis for patients with advanced melanoma. Despite the recent success of immunotherapy, many patients still do not benefit from these treatments, and their real-life application may yield different outcomes compared to the advantage presented in clinical trials. There is therefore a need to select patients who can really benefit from these treatments. We have focused our study on a real-life retrospective analysis of metastatic melanoma patients treated with immunotherapy at a single institution—the Istituto Nazionale Tumori IRCCS Fondazione “G. Pascale” of Napoli, Italy. With the help of AI and machine learning we validated an algorithm based on clinical variables of patients—namely, the Clinical Categorization Algorithm (CLICAL)—that defines five predictable cohorts of benefit to immunotherapy with 95% accuracy. It can be a useful tool for the stratification of metastatic melanoma patients who may or may not improve from immunotherapy treatment.The real-life application of immune checkpoint inhibitors (ICIs) may yield different outcomes compared to the benefit presented in clinical trials. For this reason, there is a need to define the group of patients that may benefit from treatment. We retrospectively investigated 578 metastatic melanoma patients treated with ICIs at the Istituto Nazionale Tumori IRCCS Fondazione “G. Pascale” of Napoli, Italy (INT-NA). To compare patients’ clinical variables (i.e., age, lactate dehydrogenase (LDH), neutrophil–lymphocyte ratio (NLR), eosinophil, BRAF status, previous treatment) and their predictive and prognostic power in a comprehensive, non-hierarchical manner, a clinical categorization algorithm (CLICAL) was defined and validated by the application of a machine learning algorithm—survival random forest (SRF-CLICAL). The comprehensive analysis of the clinical parameters by log risk-based algorithms resulted in predictive signatures that could identify groups of patients with great benefit or not, regardless of the ICI received. From a real-life retrospective analysis of metastatic melanoma patients, we generated and validated an algorithm based on machine learning that could assist with the clinical decision of whether or not to apply ICI therapy by defining five signatures of predictability with 95% accuracy.

A Real Life Evaluation of Efficacy and Safety of Ponatinib Therapy in CML Patients

Ponatinib, an oral tyrosine kinase inhibitor with potent activity against native and mutant BCR-ABL1, is approved for patients with refractory chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated, or for patients with the T315I mutation.Aim The aim of study was to assess real life efficacy and safety of ponatinib in a retrospective analysis of 49 patients with resistant/refractory CML from 9 Italian Hematological Institution.Results: At baseline, median age was 55 years and median time since diagnosis was 4,4 years; BCR-ABL1 kinase domain mutations were reported in 30,6 % of patients, with T315I only in 4 (26,6%) patients. The majority of Patients were heavily pretreated, with 26,5% having received 2 prior TKIs and 46,9% having received ≥3 prior TKIs; 28,2 % of patients were in 2nd line treatment due to resistance. At Ponatinb start, 42 patients were in chronic phase, 4 in accelerate phase and 3 in blastic phase. 18 pts showed comorbidities, no cardiovascular and/or cerebrovascular eventswere present at diagnosis and before starting Ponatinib. Baseline cardiovascular risk factors for all patients were Diabetes 3/18, hypertension 12/18, hypercholesterolemia 1/18; general history of cardiovascular disease,(not ischemic) was reported in 3/18 patients at baseline. Concomitant medications were: Antihypertensives in 12/18, aspirin in 1/18, antidiabetes agents in 3/18, lipid-modifying agents in 1/18. The 91,8% patients performed cardiovascular evaluation before starting treatment resulting in normal cardiovascular function in the majority of them. Abnormalities were present in only 4 pts: one lower ejection fraction, one pericardic effusion and two hypertensive cardiomyopathies.The initial dose was 45 mg/day in 24 (48,9%), 30 mg/day in 16 pts (32,6%) and 15 mg/day in 9 pts (18,3%).31 out of 49 patients obtained a response to Ponatinib. The cumulative response rates was: major cytogenetic response (MCyR), 4%; complete cytogenetic response (CCyR), 59.1%; molecular response 32,6% (major molecular response (MMR) 12,2%; Deep MR (MR4, MR 4.5, MR5) 20,4%. Characteristics of response to Ponatinib therapy are reported in table 1. Interestingly, almost all molecular responder patients maintained Ponatinib response.At the time of analysis, 36 patients are still on therapy. Ponatinib was discontinued in5 of the 31 responders patients due to side effects (n= 2), death (n=2), lost to follow-up (n=1). The side effects reported were vascular CNS stoke and back pain with bad compliance. The two deaths occurred after bone marrow transplantation in one patient and for causes not disease related for the other.Dose reduction was performed in 11 out of 31 responder patients because side effects (n=8: 5 dermatological, 1 atrial fibrillation, 1 hematological, 1hypertension ) or optimal response (n=3 ).The adverse events were reported in 21 of 49 patients. Non hematological side effects were: 9 dermatological, and 2 arthralgia , 1 patients developed diabetes, 2 patients ipercolesterolemia; 5 patients had hematological side effects (1 piastrinopenia, 3 pancitopenia, 1 MDS with trysomy 8). About cardiovascular events, only 5 patients showed these effects (1 atrial fibrillation, 3 hypertension, 1carotid thrombosis, 1 ischemic cardiopathy ), no one severe.CONCLUSION As in 5-yr long term results of PACE trial, also in our real life retrospective analysis, Ponatinib continues to show deep, lasting response in heavily-pretreated pts with CP-CML. In our analysis, almost all patients who obtained the molecular response, maintained it during the treatment, despite dose reduction, which should be associated to improved survival, also in a heavily-pretreated pts. [Display omitted] DisclosuresSpecchia:Incyte: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; BMS: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria. Pane:Novartis: Honoraria, Speakers Bureau.

What drives inhaler prescription for asthma patients? Results from a real-life retrospective analysis.

The choice of inhaler device for asthma patients depends upon multiple attributes. We investigated factors that may drive general practitioners (GPs) and respiratory specialists in the prescription of inhaler devices for asthma patients who initiated inhalation therapy. We retrospectively analysed prescriptions by GPs and respiratory specialists to asthma patients commencing inhaled corticosteroid/long-acting β2-agonist combination therapy available as both pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs). Patient characteristics were compared by device and multivariate analysis was used to model the likelihood of receiving a pMDI as opposed to a DPI in order to identify drivers for prescription. A sample of the respiratory specialists completed an ad-hoc survey of their perceived success in achieving asthma control in their patients and barriers to attaining full control. Prescription of a particular inhaler device was unrelated to the characteristics of the patients. Multivariate analysis revealed that the main driver for the choice of inhaler device was the medication (Odds Ratio and 95% Confidence Interval, respectively for GPs and specialists: 0.19 [0.16-0.23]; 0.17 [0.08-0.37]). Specialists perceived asthma as being inadequately controlled in 41% of their patients, and considered patients' difficulties in using DPIs and pMDIs as instrumental in this, citing a need for a novel, more effective inhaler technology. Physicians choose inhaler devices according to the prescribed drugs and not to the characteristics of the individual patient. This may reflect a lack of confidence in existing inhaler devices and underlines the need for technologies, which are more reliable and easier to use by patients.

166P - Thymoma and thymic carcinoma: A real-life retrospective analysis

166P - Thymoma and thymic carcinoma: A real-life retrospective analysis

Real-life experience of using conventional disease-modifying anti-rheumatic drugs (DMARDs) in psoriatic arthritis (PsA). Retrospective analysis of the efficacy of methotrexate, sulfasalazine, and leflunomide in PsA in comparison to spondyloarthritides other than PsA and literature review of the use of conventional DMARDs in PsA.

With the aim of assessing the response to treatment with conventional disease-modifying anti-rheumatic drugs (DMARDs) used in patients with psoriatic arthritis (PsA), data on methotrexate, sulfasalazine (SSZ), and leflunomide were analyzed from baseline and subsequent follow-up (FU) questionnaires completed by patients with either PsA or other spondyloarthritides (SpAs). A single-center real-life retrospective analysis was performed by obtaining clinical data via questionnaires administered before and after treatment. The indices used were erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Function Index (BASFI), wellbeing (WB), and treatment effect (TxE). The indices measured at baseline were compared with those measured on one occasion in a FU visit at least 1 year later. A total of 73 patients, 51 with PsA (mean age 49.8±12.8 years; male-to-female ratio [M:F]=18:33) and 22 with other SpAs (mean age 50.6±16 years; M:F=2:20), were studied. BASDAI, BASFI, and WB displayed consistent improvements during FU assessments in both PsA patients and controls in comparison to baseline values. SSZ exhibited better efficacy as confirmed by TxE in both PsA patients and controls. ESR and CRP displayed no differences in either the PsA or the SpA group between the cases before and after treatment. Real-life retrospective analysis of three DMARDs used in PsA (and SpAs other than PsA) demonstrated that all three DMARDs that were used brought about improvements in BASDAI, BASFI, TxE, and WB. However, the greatest improvements at FU were seen with SSZ use in both PsA and control cohorts.

Clinical Performance of Toris K Contact Lens in Patients with Moderate to Advanced Keratoconus: A Real Life Retrospective Analysis.

Objectives. To evaluate the visual performance of Toris K soft contact lenses in patients with moderate-to-advanced keratoconus and also to compare the results according to cone types, cone location, and severity of keratoconus. Materials and Methods. Sixty eyes of 40 participants were included in this retrospective study. Uncorrected visual acuity (UCVA), best-spectacle corrected visual acuity (BCVA), best-contact lens corrected visual acuity (BCLCVA), and comfort rating via visual analogue scales (VAS) were measured. Results. The mean age was 27.3 ± 8.6 years (range: 18 to 54). The mean logMAR UCVA, BCVA, and BCLCVA were 0.85 ± 0.38 (range: 0.30–1.30), 0.47 ± 0.27 (range: 0.10–1.30), and 0.16 ± 0.20 (range: 0–1.00). There were significant increases in visual acuities with contact lenses (p < .05). BCLCVA was significantly better in oval type than globus type (p = .022). UCVA and BCLCVA were significantly better in moderate keratoconus group (p = .015, p = .018). The mean line gain in Snellen was 3.6 ± 1.8 lines (range: 0–7 lines). The mean line gain was higher in central cone group than paracentral cone group and oval group than globus group (p = .014, p = .045). The mean VAS score was 8.14 ± 1.88 (range: 6–10). Conclusions. Toris K can improve visual acuity of patients with keratoconus. Toris K is successful even in the moderate and advanced form of the disease.

Efficacy of trabectedin for advanced soft tissue sarcoma (ASTS): A retrospective single center analysis.

e21509 Background: Trabectedin (Yondelis) is the first marine-derived antineoplastic drug approved in Europe for the treatment of patients with recurrent ASTS or for patients unsuited to receive anthracyclines and ifosfamide. We retrospectively analyzed patients with ASTS treated with trabectedin from Nov. 2006 to April 2012. Methods: Trabectedin was given at the approved dose of 1.5 mg/m2as a 24-h infusion every 3 weeks. An analysis of response rate, time to progression (TTP) and overall survival (OS) and univariate analyses of prognostic factors were performed. Results: Overall,39 patients (24 men) with mostly high-grade (n=29) ASTS with a median age of 57 years (range 20-81) were analyzed. Most had L-type STS (leiomyosarcoma n=10; liposarcoma n=3), undifferentiated pleomorphic sarcoma (n=11), sarcoma NOS (n=5), or synovial STS (n=2). Eight had one of 6 very rare STS. At baseline patients had metastatic (n=21), bulky (n=4) or metastatic/bulky (n=14) disease and were pretreated with a median of 2 prior chemotherapy lines (range: 0-3; 4 patients received adjuvant chemotherapy only), including anthracycline-based chemotherapy (n=30), gemcitabine plus dacarbazine (GEM-DTIC; n=18), other (n=20). Patients received a median of 4 trabectedin cycles (range 1-34). Among 37 evaluable patients best responses as per RECIST were partial response (PR, n=7), stable disease (SD &gt;3 months, n=9, 5 had SD &gt;6 months) and disease progression (n=19), and 5 patients had a decrease in tumor density. Responses to trabectedin and GEM-DTIC did not exclude responses to the other regimen suggesting the feasibility of sequential treatment. After a median follow-up of 9.37 months, median TTP and OS were 4.4 months (95% CI: 3.5-5.4) and 9.7 months (95% CI: 4.5-14.9), respectively. Univariate analyses identified low/medium-grade STS and growth modulation index &gt;1.13 as favorable prognostic factors for TTP, and retroperitoneal/visceral localization, L-type and rare STS and low/medium-grade STS for OS. Conclusions: The results of this real-life retrospective analysis confirmed the findings of previous trials showing that trabectedin is active drug for ASTS.