Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).

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Objective To evaluate fenebrutinib, an oral and highly selective noncovalent inhibitor of Bruton's tyrosine kinase (BTK), in patients with active rheumatoid arthritis (RA). Methods Patients with RA and an inadequate response to methotrexate (MTX) (cohort 1; n = 480) were randomized to receive fenebrutinib (50 mg once daily, 150 mg once daily, or 200 mg twice daily), adalimumab (40 mg every other week), or placebo. Patients with RA and an inadequate response to tumor necrosis factor inhibitors (cohort 2; n = 98) received fenebrutinib (200 mg twice daily) or placebo. Both cohorts continued MTX therapy. Results In cohort 1, the percentages of patients in whom American College of Rheumatology 50% improvement criteria (ACR50) was achieved at week 12 were similar in the fenebrutinib 50 mg once daily and placebo groups, and were higher in the fenebrutinib 150 mg once daily group (28%) and 200 mg twice daily group (35%) than in the placebo group (15%) (P = 0.016 and P = 0.0003, respectively). Fenebrutinib 200 mg twice daily and adalimumab (36%) were comparable (P = 0.81). In cohort 2, ACR50 was achieved in more patients receiving fenebrutinib 200 mg twice daily (25%) than placebo (12%) (P = 0.072). The most common adverse events in the fenebrutinib groups included nausea, headache, anemia, and upper respiratory tract infections. Fenebrutinib had significant effects on myeloid and B cell biomarkers (CCL4 and rheumatoid factor). Fenebrutinib and adalimumab caused overlapping as well as distinct changes in B cell and myeloid biomarkers. Conclusion Fenebrutinib demonstrates efficacy comparable to adalimumab in patients with an inadequate response to MTX, and safety consistent with existing immunomodulatory therapies for RA. These data support targeting both B and myeloid cells via this novel mechanism for potential efficacy in the treatment of RA.

Background Type D personality is a risk indicator in cardiac patients. The validity and reliability of the Type D Scale (DS14) have been confirmed in Western Europe but not outside this context. Purpose We examined the structural, convergent, and divergent validity and the reliability of the DS14 in the Ukrainian setting. Method Healthy Ukrainian respondents (n=250) completed the DS14, the Eysenck Personality Questionnaire, the State Trait Anxiety Inventory, and the Beck Depression Inventory. A subsample (n=57) completed the DS14 again after 4 weeks. Results The prevalence of Type D personality was 22.4%. The two-factor structure and the validity of the DS14 were confirmed. The DS14 subscales were internally consistent (Cronbach's α=0.86/0.71; mean inter-item correlation= 0.48/0.27) and stable over a 4-week period (r=0.85/0.63). Type D individuals had significantly higher mean scores on anxiety (p<0.001), depressive symptoms (p<0.001), and negative affect (p<0.001), and lower scores on positive affect (p<0.001) compared to non-Type D individuals. Conclusion Preliminary evidence suggests that the Ukrainian DS14 is a valid and reliable measure. Future studies are warranted to test the utility of the scale in cardiac patients in the Ukraine, including whether Type D also predicts adverse health outcomes beyond the boundaries of Western Europe.

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