Carfilzomib-lenalidomide-dexamethasone therapy is tolerable and demonstrates high rates of MRD negativity in NDMM, translating into longer progression-free survival in patients achieving MRD negativity. Carfilzomib-lenalidomide-dexamethasone therapy also demonstrates efficacy in high-risk SMM.
Background Extracts of the medicinal plant Tripterygium wilfordii Hook F (TwHF) have been used in China for centuries to treat a spectrum of inflammatory diseases. Objective To compare the benefits and side effects of TwHF extract with those of sulfasalazine for the treatment of active rheumatoid arthritis. Design Randomized, controlled trial. A computer-generated code with random, permuted blocks was used to assign treatment. Setting 2 U.S. academic centers (National Institutes of Health, Bethesda, Maryland, and University of Texas, Dallas, Texas) and 9 rheumatology subspecialty clinics (in Dallas and Austin, Texas; Tampa and Fort Lauderdale, Florida; Arlington, Virginia; Duncanville, Pennsylvania; Wheaton and Greenbelt, Maryland; and Lansing, Michigan). Patients 121 patients with active rheumatoid arthritis and 6 or more painful and swollen joints. Intervention TwHF extract, 60 mg 3 times daily, or sulfasalazine, 1 g twice daily. Patients could continue stable doses of oral prednisone or nonsteroidal anti-inflammatory drugs but had to stop taking disease-modifying antirheumatic drugs at least 28 days before randomization. Measurements The primary outcome was the rate of achievement of 20% improvement in the American College of Rheumatology criteria (ACR 20) at 24 weeks. Secondary end points were safety; radiographic scores of joint damage; and serum levels of interleukin-6, cholesterol, cortisol, and adrenocorticotropic hormone. Results Outcome data were available for only 62 patients at 24 weeks. In a mixed-model analysis that imputed data for patients who dropped out, 65.0% (95% CI, 51.6% to 76.9%) of the TwHF group and 32.8% (CI, 21.3% to 46.0%) of the sulfasalazine group met the ACR 20 response criteria (P = 0.001). Patients receiving TwHF also had significantly higher response rates for ACR 50 and ACR 70 in mixed-model analyses. Analyses of only completers showed similar significant differences between the treatment groups. Significant improvement was demonstrated in all individual components of the ACR response, including the Health Assessment Questionnaire disability score. Interleukin-6 levels rapidly and significantly decreased in the TwHF group. Although not statistically significant, radiographic progression was lower in the TwHF group. The frequency of adverse events was similar in both groups. Limitations Only 62% and 41% of patients continued receiving TwHF extract and sulfasalazine, respectively, during the 24 weeks of the study. Long-term outcome data were not collected on participants who discontinued treatment. Conclusion In patients who continued treatment for 24 weeks and could also use stable oral prednisone and nonsteroidal anti-inflammatory drugs, attainment of the ACR 20 response criteria was significantly greater with TwHF extract than with sulfasalazine. Primary Funding Source National Institute of Arthritis and Musculoskeletal and Skin Diseases.
Background The incidence of multiple myeloma (MM) is markedly higher in blacks compared with whites. This may be related to a higher prevalence of monoclonal gammopathy of undetermined significance (MGUS), the premalignant lesion that precedes MM. Our objective was to define the prevalence and risk factors of MGUS in blacks, Hispanics, and whites using a large cohort representative of the United States (U.S.) population. Methods Of 13,278 adults age ≥50 years enrolled in National Health and Nutritional Examination Survey (NHANES) III or NHANES 1999–2004, stored serum samples to test for monoclonal proteins were available on 12,482 persons (2,331 non-Hispanic blacks considered “black”, 2,475 Hispanics, 7,051 non-Hispanic whites considered “white”, and 625 “others”). Agarose-gel electrophoresis, serum protein immunofixation, serum free light-chain assay, and typing of the M-protein was performed on sera from all subjects. Unadjusted and adjusted prevalence rates were computed from logistic regression analysis. Risk factors were studied using available survey information available from NHANES. Main outcomes and measures were prevalence of MGUS by age, gender, race, ethnicity, and risk factors from available survey information. Findings MGUS was identified in 365 participants, for an overall prevalence of 2.4%. Adjusted prevalence of MGUS was significantly higher (p<0.001) in blacks (3.7%) compared with whites (2.3%) (p=0.001) or Hispanics (1.8%). MGUS in blacks had characteristics that posed a greater risk of progression to MM. The prevalence of MGUS (adjusted for age, education, sex, race, smoking) was 3.1% and 2.1% for the North and Midwest versus South and West regions of the U.S., respectively (p=0.052). Interpretation MGUS is significantly more common in blacks, and more often has features associated with higher risk of progression to MM. We also find a strong geographic disparity in the prevalence of MGUS between the North/Midwest versus the South/West regions of the U.S., which has etiologic implications.
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