Publications by authors named "Ute Massow"
Objective: To assess the effect of bimekizumab on pain, morning stiffness, and fatigue in patients with nonradiographic and radiographic axial spondyloarthritis (axSpA) in the phase III BE MOBILE studies (ClinicalTrials.gov: NCT03928704 and NCT03928743).
Methods: Patients were randomized to bimekizumab 160 mg or placebo every 4 weeks; and all patients received bimekizumab from week 16.
Background: Fatigue is an important symptom for most patients with axial spondyloarthritis (axSpA). The FACIT-Fatigue is a 13-item patient-reported outcome (PRO) instrument that has been used in axSpA clinical trials to measure fatigue severity and impact on daily activities. However, the psychometric properties of the FACIT-Fatigue are not fully evaluated across the entire spectrum of axSpA including non-radiographic axSpA (nr-axSpA) and radiographic axSpA (r-axSpA).
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- Acute anterior uveitis is a common issue in patients with axial spondyloarthritis, and IL-17 plays a role in its development, but there's mixed evidence on how well IL-17A inhibitors work in treating it.
- This study pooled data from various clinical trials comparing the effects of bimekizumab (a monoclonal antibody that targets both IL-17A and IL-17F) and a placebo on the incidence of uveitis.
- Results showed that patients on bimekizumab had a significantly lower rate of uveitis compared to those receiving placebo, suggesting that bimekizumab may provide protective effects against uveitis in these patients.
Article Synopsis
- The study aimed to evaluate the effects of bimekizumab on physical function, sleep quality, work productivity, and overall health-related quality of life in patients with non-radiographic and radiographic axial spondyloarthritis. !* -
- Patients were randomly assigned to receive either bimekizumab or a placebo, with significant improvements observed in physical functioning and quality of life measures at Week 16, which were maintained or improved by Week 52. !* -
- The findings suggest that bimekizumab can provide early and sustained benefits across various aspects of health and well-being for patients with axial spondyloarthritis. !*
Article Synopsis
- Rozanolixizumab, a neonatal Fc receptor inhibitor, was tested for managing chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in a phase 2a study, where patients received either the drug or a placebo.
- The study involved 34 participants who were assessed for changes in disability scores over 85 days, but results indicated no significant difference in efficacy between the drug and placebo.
- Despite the lack of efficacy, rozanolixizumab was generally well tolerated with an acceptable safety profile, and most patients experienced treatment-emergent adverse events similar to the placebo group.
Article Synopsis
- The study aimed to evaluate how meeting specific clinical response criteria affects patient-reported outcomes in individuals with non-radiographic and radiographic axial spondyloarthritis after 52 weeks.
- It found that patients who achieved higher levels of clinical response (like ASAS40) experienced significantly greater improvements in core health areas such as pain, fatigue, and overall functioning compared to those with lower responses.
- The findings indicated that similar levels of improvement were seen in both non-radiographic and radiographic patients, suggesting effective treatment across different stages of the disease.
Article Synopsis
- Bimekizumab (BKZ) is an antibody that targets IL-17A and IL-17F, showing better effectiveness compared to a placebo in treating both non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA) at Week 16, with a focus on its continued performance and safety by Week 52.
- In the BE MOBILE studies, patients were initially in a placebo-controlled phase for 16 weeks, followed by 36 weeks where all received BKZ, leading to sustained improvements in symptoms and inflammatory markers up to Week 52.
- At Week 52, the adverse event profiles showed no significant new safety concerns, with common issues including fungal infections
Article Synopsis
- Axial spondyloarthritis (axSpA) is a complex condition that requires new treatments, prompting two phase 3 trials (BE MOBILE 1 and BE MOBILE 2) to assess the effectiveness and safety of bimekizumab, a new drug targeting two interleukins (IL-17A and IL-17F).
- In these 52-week trials, patients with active nr-axSpA and r-axSpA were randomized to receive either bimekizumab or a placebo, with significant improvements observed at 16 weeks in the primary endpoint (ASAS40) and other measures of disease activity and inflammation.
- While bimekizumab showed positive effects, it was
Article Synopsis
- Primary immune thrombocytopenia (ITP) is an autoimmune disorder causing low platelet counts, primarily driven by IgG antibodies, and this study explored the safety and effectiveness of rozanolixizumab, a new treatment targeting the neonatal Fc receptor to reduce IgG levels.
- In a multicenter trial with 66 patients, mild to moderate adverse events like headaches were reported in 77.3% of participants, but no serious side effects led to treatment discontinuation, confirming a favorable safety profile.
- Patients receiving rozanolixizumab experienced significant increases in platelet counts and reductions in IgG levels, with over 50% reaching clinically relevant platelet counts within days after treatment, promoting further development into phase 3 trials.
Purpose: We evaluated the efficacy, tolerability and safety of the new antimuscarinic agent fesoterodine relative to placebo for overactive bladder syndrome.
Materials And Methods: This was a randomized, double-blind, placebo controlled, multicenter trial performed in the United States. Overall 836 subjects with urinary frequency, urinary urgency or urgency urinary incontinence were randomized to placebo (274), 4 mg fesoterodine (283) or 8 mg fesoterodine (279) once daily for 12 weeks.
Objective: To determine the efficacy, tolerability, and safety of fesoterodine in subjects with overactive bladder (OAB).
Methods: This was a multicentre, randomised, double-blind, placebo- and active-controlled trial with tolterodine extended release (ER) to assess the efficacy and safety of fesoterodine. Eligible subjects (> or =18 yr) with increased micturition frequency and urgency and/or urgency urinary incontinence (UUI) were randomised to placebo, fesoterodine 4 mg, fesoterodine 8 mg, or tolterodine ER 4 mg for 12 wk.