Omalizumab is frequently used as add-on treatment to inhaled corticosteroids (ICS) and long-acting β2-agonists in patients with suboptimal control of severe asthma. Patients with severe asthma will typically require chronic treatment, although due to the limited amount of data available there are still some concerns about the safety and efficacy of long-term therapy with omalizumab. Herein, in an extension of a previous 4-year study, we report disease-related outcomes of 8 patients with severe persistent allergic asthma who have been followed for a total of 9 years in a real-life setting. Both quality of life (QoL) (evaluated using the Juniper Asthma-Related QoL Questionnaire [AQLQ]) and forced expiratory volume in 1 second (FEV1) showed sustained improvement at 9 years. The median values of AQLQ and FEV1 at 4 years were 5.5 and 82.0% compared to 5.9 and 85.5%, respectively, at 9 years, which were all significantly increased from baseline. After 9 years, the mean annual number of severe exacerbations was 0.63 compared to 5 at baseline. There also appeared to be a trend toward use of a lower dose of ICS at longer follow-up times. After 9 years, there were no safety concerns for continued use of omalizumab, and no asthma-related hospitalizations or emergency department visits were documented over the last 5 years. The present analysis is the longest reported clinical follow-up of omalizumab. Long-term maintenance treatment with omalizumab for up to 9 years is associated with continued benefits in reducing symptoms, exacerbations, and medication burden without any safety concerns.
Adrenal Cortex Hormones ; Asthma ; Emergency Service, Hospital ; Follow-Up Studies* ; Forced Expiratory Volume ; Hospitalization ; Humans ; Juniperus ; Omalizumab* ; Quality of Life

The aim of the study was to evaluate the long-term outcomes of pelvic floor muscle (PFM) rehabilitation in males with lifelong premature ejaculation (PE), using intravaginal ejaculatory latency time (IELT) and the self-report Premature Ejaculation Diagnostic Tool (PEDT) as primary outcomes. A total of 154 participants were retrospectively reviewed in this study, with 122 completing the training protocol. At baseline, all participants had an IELT ≤60 s and PEDT score >11. Participants completed a 12-week program of PFM rehabilitation, including physio-kinesiotherapy treatment, electrostimulation, and biofeedback, with three sessions per week, with 20 min for each component completed at each session. The effectiveness of intervention was evaluated by comparing the change in the geometric mean of IELT and PEDT values, from baseline, at 3, 6, and 12 months during the intervention, and at 24 and 36 months postintervention, using a paired sample 2-tailed t-test, including the associated 95% confidence intervals. Of the 122 participants who completed PFM rehabilitation, 111 gained control of their ejaculation reflex, with a mean IELT of 161.6 s and PEDT score of 2.3 at the 12-week endpoint of the intervention, representing an increase from baseline of 40.4 s and 17.0 scores, respectively, for IELT and PEDT (P < 0.0001). Of the 95 participants who completed the 36-month follow-up, 64% and 56% maintained satisfactory ejaculation control at 24 and 36 months postintervention, respectively.
Adolescent ; Adult ; Biofeedback, Psychology ; Electric Stimulation ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Muscle, Skeletal/physiology* ; Pelvic Floor Disorders/rehabilitation* ; Premature Ejaculation/rehabilitation* ; Reflex/physiology* ; Retrospective Studies ; Treatment Outcome ; Young Adult