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Background:Secukinumab is a human monoclonal antibody that selectively binds interleukin 17A, inhibiting its interaction with the interleukin 17 receptor and is prescribed for the treatment of psoriatic arthritis (PsA), plaque psoriasis, ankylosing spondylitis, axial spondyloarthritis, and juvenile idiopathic arthritis.Objectives:To retrospectively evaluate the drug retention rate (DRR) of secukinumab in a monocentric cohort of patients affected by spondyloarthritis.Methods:Patients with a diagnosis of spondyloarthritis and treated with secukinumab who were evaluated at our outpatient clinic from January 2017 to February 2023 were included in the study. Demographic, clinical characteristics, and comorbidities were recorded. DRR was evaluated by Kaplan-Meier method as time to drug discontinuation, and baseline factors predicting drug discontinuation were investigated through Cox regression after adjusting for baseline confounders.Results:One-hundred-seventy-eight patients were included in the study, with a median follow-up of 20.5 (IQR 10-39) months. Among these, 64.6% of patients were female, and 9.7% tested positive for HLAB27. 69.7% of patients presented peripheral involvement, 52.2% axial involvement, 40.4% enthesitis, and 52% psoriasis. Comorbidities were observed in 65.2% of patients, with the most common being hypertension (34.8%), cardiovascular diseases (18.5%), hepatic steatosis (22.5%), diabetes (11.8%), hyperlipemia (23%), kidney disease (6.2%), and a personal history of cancer (10.1%). The multivariable analysis identified the number of previous targeted synthetic or biological DMARD (ts/b DMARDs) (HR 1.44, 95% CI 1.01-2.06), hypertension at baseline (HR 2.56, 95% CI 1.08-6.11), and body mass index (BMI) (HR 1.08, 95% CI 1.01-1.17) as independent predictors of drug discontinuation. In contrast, old age at diagnosis was associated with a lower risk of discontinuation (HR 0.96, 95% CI 0.92-0.99) (Table 1). The drug retention rate at 12, 24 and 48 months was 79.4%, 69.3%, 55% respectively (Figure 1, panels A and B).Conclusion:In our cohort, secukinumab revealed a good DRR. An old age at diagnosis seemed to be protective against withdrawal, whereas the number of previous ts/b DMARDs, hypertension at baseline, and BMI were identified as predictors of drug discontinuation. Further studies are needed to confirm our findings.Table 1.Predictors of secukinumab withdrawal (Cox regression)VariableHR (95%CI)P valueNumber of previous ts/b DMARDs1.44 (1.01-2.06)0.045Hypertension2.56 (1.08-6.11)0.033BMI1.08 (1.01-1.17)0.036Age at diagnosis0.96 (0.92-0.99)0.038Variables in the model: gender, age at diagnosis, BMI, disease duration before secukinumab, number of previous ts/b DMARDs, psoriasis, SPA phenotype.Figure 1.Secukinumab retention rate.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of Interests:Elisa Bellis BMS, Mariele Gatto GSK, Astrazeneca, Janssen, GSK, Denise Donzella Janssen, Gloria Crepaldi Janssen, Galapagos, Eli Lilly, BMS, Novartis, Abbvie, Alfasigma, Valeria Data: None declared, Silvia Di Gregorio: None declared, Marinella Gammino: None declared, Valeria Guardo: None declared, Claudia Lomater Abbvie, BMS, Janssen, Eli Lilly, Novartis, Pfizer, Gaetano Liperoti: None declared, Elena Marucco: None declared, Ginevra Pastorin: None declared, Silvia Perrone: None declared, Marta Saracco: None declared, Annamaria Iagnocco Abbvie, Alfasigma, BMS, Celgene, Celltrion, Eli Lilly, Galapagos, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofy Genzyme, SOBI, Abbvie, Pfizer, Novartis.

BackgroundIxekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A and is indicated for psoriasis, psoriatic arthritis (PsA) and axial spondyloarthritis.Literature highlights efficacy and safety in real life in patients affected by psoriasis[1], instead little are data concerning PsA.[2]ObjectivesTo retrospectively evaluate the effectiveness and safety of ixekizumab, in a cohort of patients with PsA.MethodsPatients with a diagnosis of PsA and treated with ixekizumab who visited our outpatient clinic from October 2019 to December 2022 were included in the study. Clinical data were recorded since the first prescription of ixekizumab and at 6-month follow-up visit. Demographic, clinical and laboratory characteristics, treatment, and causes of discontinuation were analyzed. Differences between baseline and 6-months erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), tender joint count (TJC) and swollen joint count (SJC) were analysed.ResultsMain results are reported on Table 1. 76 patients were included in the study, with an average age at the prescription of ixekizumab (T0) of 57.1±13.0 years.Main comorbidities were: hypertension (44.7%), obesity and overweight (44.7%), cardiopathy (19.7%), hepatic steatosis (21.0%), diabetes (13.2%), and hyperlipemia (3.9%). 93.42% of patients presented peripheral arthritis, 30.6% axial involvement, and 42.1 % enthesitis.28,9% of patients were biologic-naïve, 34,0% received one biologic agent before, and 31.5% two or more biologic agents. 88,2% of patients initiated ixekizumab in combination with a csDMARDs, mainly methotrexate.The indications for the prescription of ixekizumab as a first biologic agent were: multiple comorbidities, severe psoriasis, and intolerance to csDMARDs.28.9% of patients stopped ixekizumab because of primary failure (31.8%), secondary failure (22.7%), or adverse events (45.5%). 40% of the adverse events were relevant skin reactions at the injection site. No severe adverse events were registered.60 patients completed 6 months of treatment (T6). In those patients, a statistically significant decrease between the SJC and TJC at baseline and T6 was found (p-value 0.0011 and 0.0006 respectively). No difference in the values of ESR and CRP values between T0 and T6 was present.ConclusionThere are few data in real life concerning efficacy and safety in patients affected by PsA. In our cohort, ixekizumab significantly improved peripheral arthritis, and it revealed a good safety profile, without severe adverse events during the follow up. Further real-life evaluations on axial involvement, which was not included in this study, are warranted.References[1]Malagoli P. et al. Real life long-term efficacy and safety of ixekizumab in moderate-to-severe psoriasis: A 192 weeks multicentric retrospective study-IL PSO (Italian landscape psoriasis). Dermatol Ther. 2022[2]Manfreda V. et al. Efficacy and safety of ixekizumab in psoriatic arthritis: a retrospective, single-centre, observational study in a real-life clinical setting. Clin Exp Rheumatol. 2020Table 1.General characteristics of our cohort and clinical and laboratory findings at baseline and follow-up for patients who completed 6 months of treatment with ixekizumab.Male/female n. (%)22 (28.9%)/54 (71.1%)Mean age at diagnosis (years)50.0Years from diagnosis at the first prescription of ixekizumab (years)6.7Patients: n. 60T0T6p-valueESR (mm/h)27.44±23.327.56±22.20.9741CRP (mg/dl)1.58±2.470.98±1.70.1569TJC9.17±6.985.02±6.650.0011SJC1.57±2.750.28±0.640.0006Acknowledgements:NIL.Disclosure of InterestsElisa Bellis Consultant of: Bristol-myers Squibb Srl - Temas, Grant/research support from: Pfizer, DENISE DONZELLA: None declared, Gloria Crepaldi Speakers bureau: Eli-Lilly, BMS, Consultant of: Galapagos, Janssen, Valeria Data: None declared, Marinella Gammino: None declared, Valeria Guardo: None declared, Claudia Lomater Speakers bureau: Eli-Lilly, Janssen, Formedica, Bristol-myers, Elena Marucco: None declared, Marta Saracco: None declared, Annamaria Iagnocco Speakers bureau: Abbvie, MSD, Alfasigma, Celltrion, BMS, Celgene, Eli-Lilly, -Sanofi Genzyme, Pfizer, Galapagos, Gilead, Novartis, SOBI, Janssen, Consultant of: Abbvie, MSD, Alfasigma, Celltrion, BMS, Celgene, Eli-Lilly, -Sanofi Genzyme, Pfizer, Galapagos, Gilead, Novartis, SOBI, Janssen, Grant/research support from: Pfizer, Abbvie.

Background:Clinical remission is the main target in the management of Rheumatoid Arthritis (RA) patients. Different indexes are used to assess remission, among which the Boolean-based and index-based remission definitions (the latter using the simplified or clinical disease activity index SDAI, CDAI) and the less stringent Disease Activity Score on 28 joints (DAS28).Whatever the clinical remission definition applied, it frequently don‘t reflect a “complete” remission condition, indeed several authors found residual active synovitis at ultrasonography (US) and its presence is predictive of disease relapses. There is no consensus yet about which target joints should be included in the US assessment of RA patients in clinical remission, and consequently, several sets of joints have been evaluated so far.We have previously demonstrated that the US evaluation of only 4 target joints (wrists and II metacarpophalangeal (MCP) joints) allows to reach a high sensitivity in detecting subclinical active synovitis in RA patients in clinical remission. Upadacitinib is a selective JAK1 inhibitor that achieved significantly higher remission rates than adalimumab and abatacept in RA patients, however, real-life data are still scarce. Here we present the 24-weeks data of the UPAdacitinib Rheumatoid Arthritis REmission UltraSonography (UPARAREMUS) study.Objectives:The primary end-point of the study was the proportion of patients achieving “complete” remission at week 24. Secondary end-points were the proportion of patients achieving clinical remission with each composite measure (CDAI, DAS28crp, and SDAI) at week 12 and 24 the changes from baseline to week 12 and week 24 in the DAS28crp, CDAI, and SDAI.Methods:This is a longitudinal multicenter observational study, enrolling bio-naïve and bio-inadequate responders RA patients. Clinical assessment of disease activity and US of 4 target joints (wrists and II MCF bilaterally) were performed at baseline, week 12 and 24. US was carried ou by experts rheumatologists who had passed an inter-observer reliability test. US-detected synovitis and PD synovitis were scored according to a 0-3 semi-quantitative simplified score. Clinical remission was defined as: DAS28crp<2.6 or CDAI≤2.8 or SDAI≤3.3. US remission was defined as the absence of PD signal ≥ 2 in one target joints, or PD≥1 in two target joints. “Complete” remission was defined as clinical remission plus US remission. Median values at baseline, at week-12 and week-24, in the DAS28crp, CDAI and SDAI were calculated and compared using the Wilcoxon non-parametric test. Proportions, medians, and interquartile ranges were calculated as appropriate and logistic regression was used to evaluate if there were baseline factors associated with complete remission, adjusting for the effect of confoundersResults:A total of 60 RA patients were enrolled (clinical and demographic characteristics are resumed in Figure 1).After 12 weeks and 24 weeks respectively, 40% and 63.6% of patients achieved complete remission (Figure 2). The following parameters were associated with complete remission: being bio-naïve and having a shorter disease duration, although at multivariate analysis significant OR was found only for being bio-naïve [(aOR 4.09 (95%CI 1.05-15.9) p=0.04]. After 12 weeks, 45% of patients achieved clinical remission with at least one of the remission indices, three out of these patients did not reach US remission (13%). At 24 weeks, the percentage of patients achieving clinical remission improved to 65.4% and the proportion of patients w/o an associated US remission further decrease to 3%.A significant reduction in disease activity was registered during the follow-up with each composite measure (Figure 2).Conclusion:UPARAREMUS is the first study evaluating the efficacy of upadacitinib in reaching both clinical and US remission in RA patients. A 24-weeks upadacitinib treatment led to complete remission in a high percentage of enrolled patients. The only baseline parameter associated with a higher chance of reaching complete remission at multivariate analysis was being bio-naïveFigure 1.Baseline characteristics of enrolled rheumatoid arthritis (RA) patientsREFERENCES:NIL.Acknowledgements:NIL.Disclosure of Interests:Andrea Picchianti-Diamanti This is an Investigator Initiated Study externally supported by Abbvie, Maria Sofia Cattaruzza: None declared, Simonetta Salemi: None declared, Roberta Di Rosa: None declared, Giorgio Sesti: None declared, Maria Sole Chimenti: None declared, Arianna D’Antonio: None declared, Bruno Frediani: None declared, Caterina Baldi: None declared, Gloria Crepaldi: None declared, Michele Maria Luchetti: None declared, Valentino Paci: None declared, Alen Zabotti: None declared, Ivan Giovannini: None declared, Marco Canzoni: None declared, Gian Domenico Sebastiani: None declared, Chiara Scirocco: None declared, Carlo Perricone: None declared, Bruno Laganà: None declared, Annamaria Iagnocco: None declared.

Summary Because delay in time to surgery beyond 24–48 h has been observed in many studies to be associated with adverse outcomes, a survey in nine centers in Italy was undertaken to examine the impact of time to surgery on mortality and disability at 6 months after hospitalization. Introduction Delays in surgery for hip fracture have been reported to be associated with negative outcomes. However, most studies are based on retrospective analysis of hospital discharge data, which cannot determine functional status or general health status of patients prior to the fracture. Methods Using a prospective cohort design, data were collected on 3,707 patients aged >50 years during hospitalization for hip fracture and in a 6-month postdischarge follow-up. Baseline information included age, gender, living arrangement, prefracture walking ability, walking aid, ASA grade, type and reason of fracture, time to surgery, type of surgery, date and destination at discharge, and osteoporosis treatment. Follow-up data included living arrangement, walking ability, and mortality. Results Six-month mortality was positively associated with increasing age, comorbidity, prefracture functional disability, and having surgery more than 48 h after admission. Higher levels of functional status at 6 months were independently associated with surgery occurring within 24 h of the fracture and with osteoporosis therapy at discharge. Walking disability was associated with older age, comorbidity, disability before fracture, and time to surgery after 24 h. Conclusions Delay in surgery is a major cause of mortality and disability at 6 months, and interventions to modify this pattern of care are urgently needed.

The aim of this study was to evaluate adherence to the Mediterranean Diet (MD) and its association with all-cause mortality in an elderly Italian population. Data analysis of a longitudinal study of a representative, age stratified, population sample. Study data is based upon the Italian Longitudinal Study on Aging (ILSA) a prospective, community-based cohort study. The baseline evaluation was carried out in 1992 and the follow-up in 1996 and 2000. Participant food intake assessment was available at baseline for 4,232 subjects; information on survival was available for 2,665 at the 2000 follow-up. Adherence to the MD was evaluated with an a priori score based on the Mediterranean pyramid components. Cox proportional hazard models were used to assess the relationship between the MD score and all-cause mortality. Six hundred and sixty five subjects had died at the second follow-up (identified up to the first and second follow-up together; mean follow-up: 7.1±2.6 years). At the 2000 follow-up, adjusting for other confounding factors, participants with a high adherence to MD (highest tertile of the MD score distribution) had an all-cause mortality risk that was of 34% lower with respect to the subjects with low adherence (Hazard Ratio=0.66; 95% CI: 0.49-0.90; p=0.0144). According to study results, a higher adherence to the MD was associated with a low all-cause mortality risk in an elderly Italian population.

Summary This study aimed to evaluate the prevalence of vertebral fractures to investigate the determinants of vertebral fracture risk in patients with COPD. The risk of vertebral fractures is strictly related to the severity of the disease. The use of glucocorticoids and the presence of low values of quantitative ultrasound (QUS) may represent additional risk factors. Introduction Chronic obstructive pulmonary disease (COPD) appears to be associated with osteoporosis. Our study aimed to evaluate the prevalence of vertebral fractures and to investigate the main determinants of vertebral fracture risk in patients with COPD. Methods In 3,030 ambulatory COPD patients (1,778 men and 1,262 women) aged 50 years or over, we evaluated: COPD severity, presence of vertebral fractures on lateral chest X-ray and bone status by using a quantitative ultrasound device. Results In men there was a strong association between COPD severity and fractures (p < 0.001), conversely in women the association between COPD severity and fractures was at limit (p = 0.049). In men, but not in women, glucocorticoid treatment was significantly associated with vertebral fractures. The patients with high or moderate risk of osteoporosis presented an increased risk of vertebral fracture (OR 2.71; 95% CI 2.04-3.60 and OR 1.54; 95% CI 1.26-1.88, respectively). Logistic regression analysis showed that COPD severity and glucocorticoid treatment, both inhaled and oral, were associated with increased risk of vertebral fractures. Conclusion In COPD patients the risk of vertebral fractures is strictly related to the severity of the disease. The use of glucocorticoids and reduced QUS at calcaneous may represent additional risk factors.

Summary A score for identifying post-hip-fracture surgery patients at various levels (high, medium, and low) of risk for unsuccessful recovery of pre-fracture walking ability was developed. Three hundred ninety-eight HF patients were enrolled in the study. The score significantly and independently predicted failure to walk independently at discharge, failure to walk independently after 12 months, and death after 12 months. The score may be useful for clinicians and healthcare administrators to target populations for rehabilitative programs. Introduction To develop a model predicting at the time that elderly hip-fracture (HF) patients undergo rehabilitation if they will have recovered walking independence at discharge. Methods Data from all patients admitted to a Department of Rehabilitation in Italy between January 2001 and June 2008 after HF surgery were used. Variables concerning cognitive, clinical, functional, and social parameters were evaluated. Predominant measures were identified through correspondence analysis, and a variable score was defined. Three risk classes (minimum, moderate, and high) were identified and univariate and multivariate logistic regressions were used to assess the model's predictivity and risk classes for the various outcomes. Results Three hundred ninety-eight HF patients were enrolled. The variables selected to construct the score were age, gender, body mass index, number of drugs being taken, the Mini Mental State Examination, the Instrumental Activity of Daily Living, and the pre-fracture Barthel index. According to univariate analysis, the score was not better than the pre-fracture Barthel's index, but, according to multivariate analysis, it was an independent predictor for all the outcomes, while the pre-fracture Barthel index predicted only outcomes at discharge. In particular, the score significantly predicted failure to walk independently at discharge, failure to walk independently after 12 months, and death after 12 months. Conclusions A method of identifying post-HF surgery patients at various levels (high-, medium-, and low-) of risk for unsuccessful recovery of pre-fracture walking ability has been designed. The method may be useful for clinicians and healthcare administrators to target populations for rehabilitative programs.

Objective To investigate the possibility that statins reduce blood pressure as well as cholesterol concentrations through clinic and 24 hour ambulatory blood pressure monitoring.Design Randomised placebo controlled double blind trial.Setting 13 hospitals in ItalyParticipants 508 patients with mild hypertension and hypercholesterolaemia, aged 45 to 70 years.Intervention Participants were randomised to antihypertensive treatment (hydrochlorothiazide 25 mg once daily or fosinopril 20 mg once daily) with or without the addition of a statin (pravastatin 40 mg once daily).Main outcome measures Clinic and ambulatory blood pressure measured every year throughout an average 2.6 year treatment period.Results Both the group receiving antihypertensive treatment without pravastatin (n=254) (with little change in total cholesterol) and the group receiving antihypertensive treatment with pravastatin (n=253) (with marked and sustained reduction in total cholesterol and low density lipoprotein cholesterol) had a clear cut sustained reduction in clinic measured systolic and diastolic blood pressure as well as in 24 hour, and day and night, systolic and diastolic blood pressure. Pravastatin performed slightly worse than placebo, and between group differences did not exceed 1.9 (95% confidence interval −0.6 to 4.3, P=0.13) mm Hg throughout the treatment period. This was also the case when participants who remained on monotherapy with hydrochlorothiazide or fosinopril throughout the study were considered separately.Conclusions Administration of a statin in hypertensive patients in whom blood pressure is effectively reduced by concomitant antihypertensive treatment does not have an additional blood pressure lowering effect.Trial registration BRISQUI_*IV_2004_001 (registered at Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali—National Monitoring Centre on Clinical Research with Medicines).

Summary This study aimed to evaluate the prevalence of vertebral fractures in elderly women with a recent hip fracture. The burden of vertebral fractures expressed by the Spinal Deformity Index (SDI) is more strictly associated with the trochanteric than the cervical localization of hip fracture and may influence short-term functional outcomes. Introduction This study aimed to determine the prevalence and severity of vertebral fractures in elderly women with recent hip fracture and to assess whether the burden of vertebral fractures may be differently associated with trochanteric hip fractures with respect to cervical hip fractures. Methods We studied 689 Italian women aged 60 years or over with a recent low trauma hip fracture and for whom an adequate X-ray evaluation of spine was available. All radiographs were examined centrally for the presence of any vertebral deformities and radiological morphometry was performed. The SDI, which integrates both the number and the severity of fractures, was also calculated. Results Prevalent vertebral fractures were present in 55.7 % of subjects and 95 women (13.7 %) had at least one severe fracture. The women with trochanteric hip fracture showed higher SDI and higher prevalence of diabetes with respect to those with cervical hip fracture, p  = 0.017 and p  = 0.001, respectively. SDI, surgical menopause, family history of fragility fracture, and type2 diabetes mellitus were independently associated with the risk of trochanteric hip fracture. Moreover, a higher SDI was associated with a higher percentage of post-surgery complications ( p  = 0.05) and slower recovery ( p  < 0.05). Conclusions Our study suggests that the burden of prevalent vertebral fractures is more strictly associated with the trochanteric than the cervical localisation of hip fracture and that elevated values of SDI negatively influence short term functional outcomes in women with hip fracture.

BackgroundThe reduction of the diagnostic delay in patients with early arthritis, in order to start treatment as early as possible and to improve outcomes, has required a considerable effort during the last 15 years.ObjectivesTo evaluate the diagnostic delay, between 2004 and 2015, at our Early Arthritis Clinic (EAC).Methods943 patients with rheumatoid arthritis (RA) (according to 1987 and/or 2010 classification criteria) or undifferentiated arthritis (UA) evaluated at our EAC between September 2004 to September 2015 were recruited (disease duration <12 months) and divided into 2 groups according to the time of diagnosis (group 1: 2004–2009; group 2: 2010–2015). A comparison among demographic features, diagnostic delay and disease activity (DAS28) at first evaluation was performed.ResultsA total of 943 patients were evaluated: 469 patients into the group 1 (74.4% women, mean age 58 ys) vs. 474 patients into the group 2 (74.7% women, mean age 57 ys). No differences were found in terms of serologic positivity and diagnosis. At baseline, patients in the group 2 showed lower disease activity as for DAS28 (4.86±1.17 vs. 4.32±1.24; p=0.0001), number of tender joints (6 IQR 2–11 vs. 4 IQR 2–8; p=0.0001), swollen joints (6 IQR 4–11 vs. 4 IQR 2–7; p=0.0001), ESR (22 IQR 13–40 vs. 16,5 IQR 8–33; p=0.0001). In contrast, patients in the group 1 showed lower time from the onset of symptoms to the diagnosis (111 days IQR 67–200 vs. 129 IQR 77–228; p=0.008). Data about the diagnostic delay comparing DAS28 categories are showed in figure 1: particularly in the group 2 there was a reduction in the number of patients in high disease activity-DAS28 who have the diagnosis established within the first 90 days after the onset of the disease (p=0,0026). 40% of patients in group 1 vs. 31% in group 2 had the diagnosis established within 90 days (p=0.005); however, the delay from the referral to the first evaluation at our EAC was similar in the two groups (21 days IQR 12–31 vs. 21 IQR 14–29; p=ns).Figure 1ConclusionsCurrently, about 70% of the diagnosis is still not made within the so-called window of opportunity (90 days from the onset of symptoms). Moreover, a slight but significant worsening in the diagnostic delay has been observed; the delay doesn't seem to be related neither with time elapsing from referral to the first evaluation at the EAC nor to a lower disease activity at the beginning. Education programs at patients' and general practitioners' level should be implemented in order to reduce the delay and further improve the outcome.ReferencesNell VP, et al. Benefit of very early referral and very early therapy with disease-modifying anti-rheumatic drugs in patients with early rheumatoid arthritis. Rheumatology 2004;43:906–14.Van der Linden MP, et al. Long-term impact of delay in assessment of patients with early arthritis. Arthritis Rheum. 2010;62:3537–46.Disclosure of InterestNone declared