Characteristics and Outcomes for Recipients of NVX-CoV2373: A Real-World Retrospective Study in Germany.

Real-world evidence supports SARS-CoV-2 vaccination strategies during the COVID-19 pandemic. This real-world retrospective study utilized the German Disease Analyzer database to characterize recipients of NVX-CoV2373 and explore vaccination outcomes. Recipients (≥12 years) of NVX-CoV2373 as a primary series or booster in Germany were vaccinated between March and December 2022. Outcomes included demographics and clinical characteristics of recipients, tolerability/reactogenicity-related events within 7 and 14 days post-vaccination, and protection from COVID-19. Overall, there were 597 recipients (mean age ~60 years) of NVX-CoV2373; 81% were vaccinated by a general practitioner, and 68% had a Standing Committee on Vaccination (STIKO) high-risk factor. The most common baseline comorbidities were chronic neurological (36%) and chronic intestinal (21%) diseases. Among recipients with metabolic disease (~11%), 65% had diabetes. Tolerability/reactogenicity-related symptoms were recorded in ~1% of recipients. There were no sick-leave notes associated with NVX-CoV2373. After 10 months (median, 7 months) of follow-up, 95% (95% CI, 93-95) of recipients were estimated to be protected from COVID-19. Outcomes were similar across the primary series, booster, and STIKO populations. Tolerability and COVID-19 protection support the use of NVX-CoV2373 as a primary/booster vaccination for all authorized populations, including high-risk.

The Burden of a Multiple Myeloma Diagnosis on Patients and Caregivers in the First Year: Western European Findings.

Background: This research aimed to quantify the burden of illness (BoI) in transplant eligible (TE) and transplant non-eligible (TNE) newly diagnosed multiple myeloma (NDMM) patients and their caregivers, in the first year after diagnosis: at months 0, 3, and 12. Methods: Prospective, cross-sectional, observational NDMM study of TE and TNE patients and their caregivers from France, Germany, Italy, and Spain was conducted between May 2019 and January 2021. A structured, online questionnaire measuring disease burden, direct and costs, out-of-pocket expenses, and health-related quality of life (HRQoL) was used. Descriptive statistics were performed. Results: A total of 164, 160, and 190 NDMM patients [>65 years; self-described healthy; not working; living with caregiver] answered at months 0, 3, and 12. Patients lost independence to perform daily activities; mean pain intensity rose and opioid utilization increased, more significantly among TNE patients. Overall health status and HRQoL remained stable. Median 3-month direct medical costs peaked at month 3. Specialist consultations and hospital admissions were the greatest cost amongst TE and TNE patients. Home adaptations increased out-of-pocket expenditures amongst TNE patients. Patients describing themselves as working spent a median 0 hours in the office at all time points. A total of 131, 122, and 124 caregivers answered at months 0, 3, and 12. Mean self-rated burden score rose. By month 12, half of caregivers developed stress, anxiety or depression. Most employed caregivers continued working. Productivity was low at month 0 with a trend of recovering at month 12. Caregivers of TNE compared to TE patients reported greater time burden. Caregivers' HRQoL was stable over time. Conclusion: NDMM is burdensome for patients and caregivers in the first year after diagnosis. TNE patients are more dependent on caregivers and incur higher care costs than TE patients. Despite the financial, physical, and emotional burden, HRQoL remains stable possibly indicating resilience and illness adjustment amongst patients and caregivers.

Romiplostim and eltrombopag for immune thrombocytopenia: methods for indirect comparison.

OBJECTIVES: Immune thrombocytopenia (ITP) causes increased platelet destruction and suboptimal platelet production, increasing risk of bleeding. This analysis uses a Bayesian metaregression model to indirectly compare effectiveness of the thrombopoietin mimetics romiplostim and eltrombopag for increasing platelet counts, and contrasts the results with those of non-Bayesian approaches. METHODS: Ten databases were searched during 2010. Placebo-controlled trials of 24 weeks' duration were included. An indirect comparison was undertaken using Bayesian metaregression, which includes all trials in a single model. This was compared with previous analyses in which data for each intervention were combined using simple pooling, logistic regression or meta-analysis, followed by indirect comparison of pooled values using the Bucher method. RESULTS: Two trials of romiplostim and one of eltrombopag were included. The indirect evidence suggests romiplostim significantly improves overall platelet response compared with eltrombopag. Bayesian metaregression gave an odds ratio (OR) for eltrombopag versus romiplostim of 0.11 (95 percent credible interval 0.02-0.66); p values and Bayesian posterior probabilities ranged from 0.01 to 0.05 for all analyses. There was no significant difference in durable platelet response in any of the analyses, although the direction of effect favored romiplostim (OR = 0.15; 95 percent credible interval, 0.01-1.88); p values and Bayesian posterior probabilities ranged from 0.08 to 0.40 across analyses. Results were relatively consistent between analyses. CONCLUSIONS: Bayesian metaregression generated similar results to other indirect comparison methods, and may be considered the most robust as it incorporates all data in a single model and accounts appropriately for parameter uncertainty.