Demographic Characteristics of Participants in Rheumatoid Arthritis Randomized Clinical Trials

Strait, Adrienne; Castillo, Francine T.; Choden, Sonam; Li, Jing; Whitaker, Evans; Falasinnu, Titilola; Schmajuk, Gabriela; Yazdany, Jinoos

doi:10.1001/jamanetworkopen.2019.14745

Cited by 52 publications

(50 citation statements)

References 29 publications

(71 reference statements)

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“…Nonwhite groups comprise approximately 40% of the US population [22], but represented only 13.4% of all NP participants in studies with ≥1 US-based site. Systematic reviews assessing the racial/ethnic composition of clinical trials on cancer [23], rheumatoid arthritis [24], Alzheimer’s disease [25], and cardiovascular disease [26] have also shown underrepresentation of racial/ethnic minority groups. In a recent systematic review examining the racial/ethnic composition of RCTs on various skin diseases, psoriasis studies were least diverse, with 84.3% of subjects being white [21].…”

Section: Discussionmentioning

confidence: 99%

Racial, Ethnic, and Sex Disparities in Nail Psoriasis Clinical Trials: A Systematic Review

Ricardo

Qiu

Lipner

2022

Skin Appendage Disord

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Introduction: Nail psoriasis (NP) disproportionally affects quality of life in females versus males. Demographics of NP research cohorts are not well characterized. In this systematic review, we characterize the representation of racial/ethnic groups and women in NP randomized clinical trials (RCTs). Methods: A systematic search of MEDLINE was performed; RCTs of NP pharmacologic treatments or cutaneous psoriasis/psoriatic arthritis with the number of NP patients described were included. Results: Overall, 45 RCTs were analyzed, with 91.1% reporting sex, and 67.9% of participants were men. 7/41 (17%) studies reporting sex included ≥45% female participants. Of 45 RCTs, 35.6% reported race and/or ethnicity. Of the 22 studies with ≥1 US-based site, 13 (59%) reported race/ethnicity; 3 out of 23 (13%) studies with <1 US-based site reported these data. Enrollment of nonwhite participants was significantly lower than representation within the US census (13.4% vs. 39.9%; p < 0.001). Treatment type, route of administration, location with ≥1 US-based site, funding, and journal type were significantly associated with race/ethnicity reporting (p < 0.05 all comparisons). Discussion/Conclusion: Reporting of racial/ethnic demographics is lacking in NP RCTs. Women and racial/ethnic minorities remain underrepresented in NP research. There is a need for increased reporting and diversification of NP clinical trial participants.

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Section: Discussionmentioning

confidence: 99%

Racial, Ethnic, and Sex Disparities in Nail Psoriasis Clinical Trials: A Systematic Review

Ricardo

Qiu

Lipner

2022

Skin Appendage Disord

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“…This population of patients may limit extrapolation of the results to other ethnicities or patients outside of Mexico and Latin America. A recent systematic review found that out of 126 randomized clinical trials for RA, only 4.4% included Hispanic subjects; therefore, it is not clear whether the results would have been similar if the study were conducted in a more diverse population of patients with RA [ 26 ].…”

Section: Discussionmentioning

confidence: 99%

Post Hoc Analysis of Predictors of Clinical Response to Repository Corticotropin Injection in Persistently Active Rheumatoid Arthritis

et al. 2022

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Introduction: A phase IV clinical trial confirmed the safety and efficacy of repository corticotropin injection (RCI, Acthar Ò Gel) in patients with refractory rheumatoid arthritis (RA) that was nonresponsive to standard-of-care therapies. The objective of this post hoc analysis was to identify baseline demographics and clinical characteristics that may be predictors of response to RCI. Methods: The phase IV trial was a two-part, randomized, placebo-controlled withdrawal study. Post hoc analysis was conducted with the open-label portion of the trial data, in which all 258 subjects received RCI (80 U

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“…Ethnicity associated with remission at three months, which is consistent with findings from observational studies in the United States where non-white participants were less likely to achieve remission [ 24 ]. There is under-representation of ethnic minorities in RCTs, and the evidence base for therapies may not be valid for some ethnic groups [ 25 ]. It is crucial that RCT sample demographics reflect target populations so there can be confidence in the external validity of the findings to clinical practice in areas serving heterogeneous populations.…”

Section: Discussionmentioning

confidence: 99%

Disease activity and its predictors in early inflammatory arthritis: findings from a national cohort

et al. 2021

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Objectives We set out to characterise patient factors that predict disease activity during the first year of treatment for early inflammatory arthritis (EIA). Methods We used an observational cohort study design, extracting data from a national clinical audit. All NHS organisations providing secondary rheumatology care in England and Wales were eligible to take part, with recruitment from 215/218 (99%) clinical commissioning groups (CCGs)/Health Boards. Participants were greater than 16 years old and newly diagnosed with rheumatoid arthritis pattern EIA between May 2018 and May 2019. Demographic details collected at baseline included age, gender, ethnicity, work status, and postcode, which was converted to an area level measure of socioeconomic position (SEP). Disease activity scores (DAS28) were collected at baseline, three and 12 months follow up. Results A total of 7,455 participants were included in analyses. Significant levels of CCG/Health board variation could not be robustly identified from mixed effects modelling. Gender and SEP were predictors of low disease activity at baseline, three and 12 months follow up. Mapping of margins identified a gradient for SEP, whereby those with higher degrees of deprivation had higher disease activity. Black, Asian and Minority Ethnic patients had a lower odds of remission at three months follow up. Conclusion Patient factors (gender, SEP, ethnicity) predict disease activity. The rheumatology community should galvanise to improve access to services for all members of society. More data are required to characterise area level variation in disease activity.

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Demographic Characteristics of Participants in Rheumatoid Arthritis Randomized Clinical Trials

Cited by 52 publications

References 29 publications

Racial, Ethnic, and Sex Disparities in Nail Psoriasis Clinical Trials: A Systematic Review

Racial, Ethnic, and Sex Disparities in Nail Psoriasis Clinical Trials: A Systematic Review

Post Hoc Analysis of Predictors of Clinical Response to Repository Corticotropin Injection in Persistently Active Rheumatoid Arthritis

Disease activity and its predictors in early inflammatory arthritis: findings from a national cohort

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