ABSTRACT
Abstract Background Secukinumab has shown high efficacy in randomized controlled trials in both ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Here, we investigated its real-life effectiveness and tolerability in a cohort of AS and PsA patients. Methods We retrospectively analyzed medical records of outpatients with AS or PsA treated with secukinumab between December 2017 and December 2019. ASDAS-CRP and DAS28-CRP scores were used to measure axial and peripheral disease activity in AS and PsA, respectively. Data were collected at baseline and after 8, 24, and 52 weeks of treatment. Results Eighty-five adult patients with active disease (29 with AS and 56 with PsA; 23 males and 62 females) were treated. Overall, mean disease duration was 6.7 years and biologic-naïve patients were 85%. Significant reductions in ASDAS-CRP and DAS28-CRP were observed at all time-points. Body weight (in AS) and disease activity status at baseline (particularly in PsA) significantly affected disease activity changes. ASDAS-defined inactive disease and DAS28-defined remission were achieved in comparable proportions between AS and PsA patients, at both 24 weeks (45% and 46%) and 52 weeks (65.5% and 68%, respectively); male sex was found an independent predictor of positive response (OR 5.16, P = 0.027). After 52 weeks, achievement of at least low disease activity and drug retention were observed in 75% of patients. Secukinumab was well-tolerated and only mild injection-site reactions were recorded in 4 patients. Conclusion In a real-world setting, secukinumab confirmed great effectiveness and safety in both AS and PsA patients. The influence of gender on treatment response deserves further attention.
ABSTRACT
Aims: The introduction of HBV vaccination in Italy has reduced the incidence and prevalence of HBV infection. However, increasing immigration from countries in which HBV is endemic has led to a wave of new HBsAg-positive subjects and their clinical impact needs evaluation. We compared the serological, clinical and epidemiological data relating to Italian and non-Italian subjects referred to a hospital in Northern Italy. Study Design: We retrospectively analysed the laboratory and clinical records of 488 subjects, including 107 (21.9%) non-Italians, in order to find data concerning clinical diagnoses, possible routes of infection, anti-HCV and anti-HDV antibodies. Results: The differences in gender distribution and mean age between the non-Italian and Italian patients were statistically significant (p<.001). There were no significant differences in the prevalence of anti-HCV (2.9% vs 4.9%, p=.86) or anti-HDV (4.7% vs 5.0%, p=.89) co-infection, or the presence of HBeAg in chronic infection. There were no differences in the rates of acute (3.3% vs 5.1%; p=.68) or chronic infections (96.7% vs 94.9%; p=.68) infections, but there were statistically significant differences (p<.001) in the rates of prevalent (54.5% vs 85.3%) and incident cases (45.5% vs 14.7%). The differences in the rates of asymptomatic (70.6% vs 34.9%) and symptomatic patients (29.4% vs 65.1%) were also statistically significant (p<.001). The only significant differences in terms of risk factors related to transfusions (0% vs 6.8%; p=.04), and vertical/perinatal transmission (44.1% vs 6.8%; p<.001). Conclusion: The non-Italian HBsAg-positive subjects were mainly women and younger than their Italian counterparts, and had a recent diagnosis. They were predominantly asymptomatic and probably considered themselves healthy and fit to emigrate. Perinatal transmission among non-Italians is still an important risk factor that reflects the epidemiological situation of their countries of origin.