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KESTREL and KITE: 52-week results from two Phase III pivotal trials of brolucizumab for diabetic macular edema

Brown DM, Emanuelli A, Bandello F, Barranco JJE, Figueira J, Souied E, et al.

Am J Ophthalmol, 2022 Jan 13.
PMID: 35038415 DOI: 10.1016/j.ajo.2022.01.004

PURPOSE: To compare the efficacy and safety of brolucizumab with aflibercept in patients with diabetic macular edema (DME).
DESIGN: Double-masked, 100-week, multicenter, active-controlled, randomized trials.
METHODS: Subjects were randomized 1:1:1 to brolucizumab 3mg/6mg or aflibercept 2mg in KESTREL (N=566) or 1:1 to brolucizumab 6mg or aflibercept 2mg in KITE (N=360). Brolucizumab groups received 5 loading doses every 6 weeks (q6w) followed by q12w dosing, with optional adjustment to q8w if disease activity was identified at pre-defined assessment visits; aflibercept groups received 5xq4w followed by fixed q8w dosing. The primary endpoint was best-corrected visual acuity (BCVA) change from baseline at Week 52; secondary endpoints included the proportion of subjects maintained on q12w dosing, change in DRSS score and anatomical and safety outcomes.
RESULTS: At Week 52, brolucizumab 6mg was noninferior (NI margin 4 letters) to aflibercept in mean change in BCVA from baseline (KESTREL: +9.2 letters versus +10.5 letters; KITE: +10.6 letters versus +9.4 letters; p<0.001), more subjects achieved central subfield thickness (CSFT) <280µm and fewer had persisting subretinal and/or intraretinal fluid versus aflibercept, with >50% of brolucizumab 6mg subjects maintained on q12w dosing after loading. In KITE, brolucizumab 6mg showed superior improvements in change of CSFT from baseline over Week 40-Week 52 versus aflibercept (p=0.001). The incidence of ocular serious adverse events was 3.7% (brolucizumab 3mg), 1.1% (brolucizumab 6mg), 2.1% (aflibercept) in KESTREL; 2.2% (brolucizumab 6mg), 1.7% (aflibercept) in KITE.
CONCLUSION: Brolucizumab 6mg showed robust visual gains and anatomical improvements with an overall favorable benefit/risk profile in patients with DME.
To which world regions does the valence-dominance model of social perception apply?

Jones BC, DeBruine LM, Flake JK, Liuzza MT, Antfolk J, Arinze NC, et al.

Nat Hum Behav, 2021 01;5(1):159-169.
PMID: 33398150 DOI: 10.1038/s41562-020-01007-2

Over the past 10 years, Oosterhof and Todorov's valence-dominance model has emerged as the most prominent account of how people evaluate faces on social dimensions. In this model, two dimensions (valence and dominance) underpin social judgements of faces. Because this model has primarily been developed and tested in Western regions, it is unclear whether these findings apply to other regions. We addressed this question by replicating Oosterhof and Todorov's methodology across 11 world regions, 41 countries and 11,570 participants. When we used Oosterhof and Todorov's original analysis strategy, the valence-dominance model generalized across regions. When we used an alternative methodology to allow for correlated dimensions, we observed much less generalization. Collectively, these results suggest that, while the valence-dominance model generalizes very well across regions when dimensions are forced to be orthogonal, regional differences are revealed when we use different extraction methods and correlate and rotate the dimension reduction solution. PROTOCOL REGISTRATION: The stage 1 protocol for this Registered Report was accepted in principle on 5 November 2018. The protocol, as accepted by the journal, can be found at https://doi.org/10.6084/m9.figshare.7611443.v1 .
Fulltext Author Correction: A multi-country test of brief reappraisal interventions on emotions during the COVID-19 pandemic

Wang K, Goldenberg A, Dorison CA, Miller JK, Uusberg A, Lerner JS, et al.

Nat Hum Behav, 2022 Sep;6(9):1318-1319.
PMID: 36002766 DOI: 10.1038/s41562-022-01441-4
Fulltext A multi-country test of brief reappraisal interventions on emotions during the COVID-19 pandemic

Wang K, Goldenberg A, Dorison CA, Miller JK, Uusberg A, Lerner JS, et al.

Nat Hum Behav, 2021 Aug;5(8):1089-1110.
PMID: 34341554 DOI: 10.1038/s41562-021-01173-x

The COVID-19 pandemic has increased negative emotions and decreased positive emotions globally. Left unchecked, these emotional changes might have a wide array of adverse impacts. To reduce negative emotions and increase positive emotions, we tested the effectiveness of reappraisal, an emotion-regulation strategy that modifies how one thinks about a situation. Participants from 87 countries and regions (n = 21,644) were randomly assigned to one of two brief reappraisal interventions (reconstrual or repurposing) or one of two control conditions (active or passive). Results revealed that both reappraisal interventions (vesus both control conditions) consistently reduced negative emotions and increased positive emotions across different measures. Reconstrual and repurposing interventions had similar effects. Importantly, planned exploratory analyses indicated that reappraisal interventions did not reduce intentions to practice preventive health behaviours. The findings demonstrate the viability of creating scalable, low-cost interventions for use around the world. PROTOCOL REGISTRATION: The stage 1 protocol for this Registered Report was accepted in principle on 12 May 2020. The protocol, as accepted by the journal, can be found at https://doi.org/10.6084/m9.figshare.c.4878591.v1.
Fulltext In COVID-19 Health Messaging, Loss Framing Increases Anxiety with Little-to-No Concomitant Benefits: Experimental Evidence from 84 Countries

Dorison CA, Lerner JS, Heller BH, Rothman AJ, Kawachi II, Wang K, et al.

Affect Sci, 2022 Sep;3(3):577-602.
PMID: 36185503 DOI: 10.1007/s42761-022-00128-3

The COVID-19 pandemic (and its aftermath) highlights a critical need to communicate health information effectively to the global public. Given that subtle differences in information framing can have meaningful effects on behavior, behavioral science research highlights a pressing question: Is it more effective to frame COVID-19 health messages in terms of potential losses (e.g., "If you do not practice these steps, you can endanger yourself and others") or potential gains (e.g., "If you practice these steps, you can protect yourself and others")? Collecting data in 48 languages from 15,929 participants in 84 countries, we experimentally tested the effects of message framing on COVID-19-related judgments, intentions, and feelings. Loss- (vs. gain-) framed messages increased self-reported anxiety among participants cross-nationally with little-to-no impact on policy attitudes, behavioral intentions, or information seeking relevant to pandemic risks. These results were consistent across 84 countries, three variations of the message framing wording, and 560 data processing and analytic choices. Thus, results provide an empirical answer to a global communication question and highlight the emotional toll of loss-framed messages. Critically, this work demonstrates the importance of considering unintended affective consequences when evaluating nudge-style interventions.