Objective. To evaluate the effect of golimumab on sleep disturbance in patients with active ankylosing spondylitis (AS).Methods. Golimumab was studied in a multicenter, randomized, placebo-controlled study (GO-RAISE). At baseline, 356 patients were randomly assigned in a 1.8:1.8:1 ratio to subcutaneous golimumab 50 mg, 100 mg, or placebo every 4 weeks. Sleep disturbance was assessed using the Jenkins Sleep Evaluation Questionnaire (JSEQ), which was administered at baseline, week 14, and week 24. Treatment effect was evaluated using analysis of variance on the van der Waerden normal scores.
Patients with active RA despite MTX had significant improvement in physical function, general health, and fatigue following golimumab + MTX therapy; improvements in physical function and general health were maintained through Week 52. (Clinical Trials Registration NCT00264550).
Aims: Bone complications (also known as skeletal-related events [SREs]) pose significant health and financial burdens on patients with bone metastases. Denosumab demonstrated superiority over zoledronic acid in delaying the time to first SRE. This study examined the lifetime cost-effectiveness of denosumab vs zoledronic acid from both US payer and societal perspectives. Methods: This analysis used a lifetime Markov model and included patients with breast cancer, prostate cancer, and other solid tumors and bone metastases. The societal perspective included direct medical, direct non-medical, and indirect costs associated with denosumab and zoledronic acid; the payer perspective included direct medical costs only. Bone complication rates for each tumor type were estimated from three pivotal phase 3 studies and modified to reflect real-world incidence.
Once monthly, golimumab is a cost-effective treatment alternative for patients with active PsA. With its patient-focussed attributes, golimumab is likely to offer additional choice in PsA treatment.
Multiple myeloma treatment has evolved with approvals of new immunomodulatory imide drugs (IMiDs), monoclonal antibodies (MoABs), and proteasome inhibitors (PIs). We characterized U.S. treatment trends and survival from 2011 to 2019 using Flatiron data from multiple myeloma patients followed from treatment index until death/end of data. Patients (n ¼ 10,553) were primarily (88%) treated in community centers. Frontline PI-IMiD-dexamethasone use increased over time, while IMiD-dexamethasone and PI-dexamethasone use decreased. MoAB-IMiD-dexamethasone use increased in relapsed/refractory disease. In all lines, use of doublets decreased and triplets increased, with triplets becoming the most prescribed combination by 2018-2019, especially in first line (62%). Monotherapy use decreased in first line (19% to 10%) but remained steady in relapsed/refractory disease (20%). With each increasing line of therapy, median overall survival decreased (60, 48, 36, 29, 23 months). Survival increased with more recent diagnosis. Our results indicate that the multiple myeloma landscape has evolved significantly in the last decade.
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