Teva Pharmaceuticals (Netherlands)

Electronic inhalers provide information about patterns of routine inhaler use. During a 12-week study, 360 asthma patients using albuterol Digihaler generated 53,083 inhaler events that were retrospectively analyzed. A total of 41,528 (78%) of the recorded inhalation events were suitable for flow analysis (having a PIF ≥ 18 L/min and <120 L/min). Median PIF, inhalation volume, inhalation duration, and time to PIF for these events steadily decreased between the first and last 10 days of the study, by 5.1%, 12.6%, 15.9%, and 6.4%, respectively. Continuous short-acting beta2-agonist (SABA) overuse, defined as ≥2 SABA inhalations/week throughout the study period, was seen in 29% (n = 104) of patients. Of 260 patients with ≥1 instance of acute short-term SABA overuse, 55 (21%) had a confirmed exacerbation. Electronic recording of real-life inhaler use can capture valuable, objective information that could inform disease management and clinical decision-making.

The subharmonic response of microbubble-based ultrasound contrast agents (UCAs) typically exhibits an inverse linear relationship with the surrounding ambient pressure. Although SHAPE has been clinically successful, the sensitivity of SHAPE at lower pressures is suboptimal. While previous studies optimized SHAPE using commercially available UCAs without considering their size distribution, in this study, two SHAPE-specific monodisperse microbubble (MMB) UCAs with different bubble diameters were compared with commercial polydisperse UCAs as well as their buoyancy-separated subpopulations. UCAs were imaged in a hydrostatic tank containing 350 ml of deionized water. The pressure within the tank was increased from 0–100 mmHg. Using a modified Logiq E10 scanner (GE HealthCare) with acoustic power optimization, SHAPE data was acquired using subharmonic imaging mode with a C1-6 curvilinear probe at 2.5 MHz (receiving at 1.25 MHz). After identification of the optimal acoustic output power, MMB with a mean diameter 1.66 mm demonstrated a mean SHAPE sensitivity of −0.207 dB/mmHg (r2 = 0.94). The second MMB with a mean diameter 3.45 mm demonstrated a mean SHAPE sensitivity of −0.300 dB/mmHg (r2 = 0.92). In contrast, this was 2.5–4 times more sensitive than the two polydisperse UCAs (slope range of −0.081 to −0.074 dB/mmHg) and 1.45–5 times more sensitive than the buoyancy-separated UCAs (ranging −0.061 to −0.142 dB/mmHg). These results suggest that SHAPE-optimized MMB are more sensitive to measuring changes in pressure.

Background: Concomitant fremanezumab, a calcitonin gene-related peptide (CGRP) pathway monoclonal antibody (mAb), and onabotulinumtoxinA (onabotA) improve treatment response compared with onabotA alone in patients with chronic migraine (CM). Methods: This was a single-center, retrospective, observational study that assessed treatment response (change over time in monthly headache days [MHD] and pain intensity [PI]) in adult patients with CM receiving fremanezumab as add-on therapy to onabotA for CM prevention. Results: In the study population ( N = 116, age 50.0 ± 13.1, female 85.3%, pre-index onabotA use 46.5 ± 34.2 months) receiving concurrent onabotA and fremanezumab for 17.5 ± 11.6 months, MHD decreased by 3.60 days (95% confidence interval [CI]: −5.26, −1.94, p &lt; 0.001) and PI was reduced by 0.43 (95% CI: −0.77, −0.09, p = 0.012) at the final visit. Statistically significant reductions were seen in both MHD (−4.61, 95% CI: −6.84, −2.39; p &lt; 0.001) and PI (−0.52, 95% CI: −0.84. −0.09; p = 0.017) among patients naïve to mAbs against CGRP or its receptor. No unexpected adverse events were observed. Conclusion: Concomitant fremanezumab and onabotA for CM prevention were effective at reducing the number of MHD and lessening PI, particularly in patients with difficult-to-treat CM who are naïve to mAbs against CGRP or its receptor.

Beperkingen van de bestuursbevoegdheid Het is niet altijd duidelijk of de dissertatie van De Roo een standpunt inneemt ten aanzien van een bepaalde soort rechtspersoon of ten aanzien van alle rechtspersonen. Daarnaast bespreekt het artikel de mogelijkheid dat een beperking van de bestuursbevoegdheid haar grondslag vindt buiten de statuten, bijvoorbeeld in een overeenkomst.

We assessed the occurrence of neutropenia and febrile neutropenia (FN) and the associated healthcare resource in cancer patients receiving myelosuppressive chemotherapy in combination with pegfilgrastim versus lipegfilgrastim. This is a retrospective analysis using a German health insurance claims database. Adults receiving chemotherapy with a prescription code for pegfilgrastim (n = 734) or lipegfilgrastim (n = 346) were observed over a 1-year follow-up period. Patient subgroups were analyzed according to cancer type and FN risk. FN risk was based on the chemotherapy regimen and any additional neutropenia risk factors. Outcomes were adjusted via regression analysis. Most patients were classified as high FN risk (70.0% pegfilgrastim; 65.6% lipegfilgrastim cohort). The mean age was 58.2years in the pegfilgrastim cohort and 58.0years in the lipegfilgrastim cohort, with more female patients than male patients (77.3% vs 79.8%, respectively), and the majority had breast cancer (64.9% and 68.8%, respectively). Overall, 10.0% and 10.4% of patients receiving pegfilgrastim or lipegfilgrastim experienced a neutropenia event (p = 0.82), with 4.4% and 3.5% of patients experiencing a FN event (p = 0.49). The mean neutropenia event-related healthcare costs were €604 and €441 for the pegfilgrastim and lipegfilgrastim cohorts; among patients with lymphoma, these costs were significantly greater (p = 0.03) with pegfilgrastim (€1,612) versus lipegfilgrastim (€382). The mean all-cause hospitalizations were significantly (p < 0.01) higher for lymphoma patients receiving pegfilgrastim (2.76) versus lipegfilgrastim (1.60). Overall, patients treated with pegfilgrastim and lipegfilgrastim were comparable in terms of neutropenia occurrences in the 1-year follow-up. In patients with lymphoma, neutropenia event-related healthcare costs and all-cause hospitalizations were significantly higher with pegfilgrastim compared with lipegfilgrastim in this study; however, this should be interpreted with caution in light of the limited sample size and the absence of clinical information.