Hypothalamic-Pituitary-Gonadal Axis Hormones and Male Rheumatoid Arthritis: Novel Perspectives

Abstract

<b>Introduction:</b> Efficacy and safety of omalizumab in patients with severe allergic asthma has been established in both randomized controlled trials and real-life studies <b>Aim:</b> To evaluate the sustained effectiveness and safety of long-term treatment with omalizumab in a real-world setting <b>Methods:</b> In this retrospective study, we included patients treated with omalizumab for at least 8 years, in 4 asthma clinics in Greece. Pulmonary function, asthma control, OCS dose and exacerbations were recorded before treatment, 6months later and annually thereafter. Adverse events were also recorded <b>Results:</b> 45 patients(66.7% women), mean age 55.3±12.2years, were included. Duration of treatment with omalizumab was 11.0±1.2years. Annual exacerbation rate decreased from 4.1 before omalizumab initiation to 0.8 after one year of treatment and remained low up to the 8th year of treatment(p&lt;0.001). From the 19 patients who were receiving OCS at baseline 21.1% patients discontinued after 6 months, 47.4% were still on OCS after 4 years of therapy and 31.6% after 8 years. Regarding OCS dose 36.8% of patients reduced the dose ≥50% after 6 months and 68.4% achieved 50% reduction after 2 years. Mean daily OCS dose before omalizumab initiation was 7.8mg prednisolone or equivalent, reduced to 4.7mg/day after 6 months, reaching 1.6mg/day after 8 years(p&lt;0.001). Treatment with omalizumab resulted in significant improvements of asthma control and lung function. No severe adverse events were reported <b>Conclusions:</b> In this real-life study omalizumab resulted in significant and sustained improvements in asthma exacerbations, asthma control and lung function, had a steroid sparing effect and a good safety profile