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Dear Editor,
We thank YanRan Qiu and Jing Sun for their interest in our work [1, 2]. They acknowledge problems associated with using race as the primary variable for understanding efficacy and safety of pharmacological treatments. In their letter, Qiu and Sun emphasize points we made in the article introduction and in the discussion of our results [2]. Thus, there is no disagreement between us. We also assert that the results presented need to be interpreted in the context of race as a social construct. As such, racial disparities in treatment outcomes most likely reflect broader differences in socioeconomic factors and access to care. We initially aimed to assess participants’ socioeconomic status and social determinants of health in our analyses. Unfortunately, such variables were not fully captured in the primary studies, and we could not design analyses that addressed this aim.
Several pharmaceutical companies have publicly committed to achieving racially and ethnically diverse participation in their global clinical trials [3]. This aligns with current guidance from key regulatory authorities 4,5,6]. The focus on diversity in clinical trials and better collection of more granular demographic data will allow for future studies on the impact of socioeconomic, cultural, and practice-based differences that underpin discrepancies in treatment outcomes.
References
Qiu YR, Sun J. Letter to the editor regarding impact of race on the efficacy and safety of tofacitinib in rheumatoid arthritis: post hoc analysis of pooled clinical trials. Rheumatol Ther. 2025. https://doi.org/10.1007/s40744-025-00750-0.
Wright GC, Mysler E, Kwok K, et al. Impact of race on the efficacy and safety of tofacitinib in rheumatoid arthritis: post hoc analysis of pooled clinical trials. Rheumatol Ther. 2024;11:1135–64.
Rottas M, Thadeio P, Simons R, et al. Demographic diversity of participants in Pfizer sponsored clinical trials in the United States. Contemp Clin Trials. 2021;106:106421.
FDA. Collection of race and ethnicity data in clinical trials and clinical studies for FDA-regulated medical products. 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials-and-clinical-studies-fda-regulated-medical. Accessed 16 Nov 2024.
FDA. Diversity action plans to improve enrollment of participants from underrepresented populations in clinical studies. 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improve-enrollment-participants-underrepresented-populations-clinical-studies. Accessed 16 Nov 2024.
EMA. Clinical trials regulation. 2022. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-regulation. Accessed 16 Nov 2024.
Funding
No funding or sponsorship was received for publication fees for this article. The manuscript referred to in the correspondence (Wright et al. [5]) was an analysis of studies sponsored by Pfizer (NCT00147498; NCT00413660; NCT00550446; NCT00603512; NCT00687193; NCT01164579; NCT00976599; NCT01359150; NCT00960440; NCT00847613; NCT00814307; NCT00856544; NCT00853385; NCT01039688; NCT02187055).
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Grace C. Wright, Eduardo Mysler, Arne Yndestad, Cassandra D. Kinch, and Alexis Ogdie contributed to drafting and revision of the letter and approved the letter’s content before submission.
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Grace C. Wright has acted as a consultant for AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Exagen, GSK, Janssen, Novartis, Pfizer Inc, Sanofi, Scipher Medicine, and UCB; is an officer/board member for the Association of Women in Rheumatology; and is a member of the speakers’ bureau for AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Novartis, Sanofi, and UCB. Eduardo Mysler has received grant/research support from Eli Lilly, Janssen, Pfizer Inc, and Roche; and is a member of the speakers’ bureau for AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, Roche, and Sanofi. Arne Yndestad is an employee and stockholder of Pfizer Inc. Cassandra D. Kinch was an employee and stockholder of Pfizer Inc at the time of the work referred to in this letter. Alexis Ogdie has acted as a consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, CorEvitas, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer Inc, and UCB; and has received grant/research support from AbbVie, Amgen, Janssen, Novartis, and Pfizer Inc.
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This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.
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Wright, G.C., Mysler, E., Yndestad, A. et al. A Response to: Letter to the Editor Regarding Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials. Rheumatol Ther 12, 595–596 (2025). https://doi.org/10.1007/s40744-025-00751-z
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DOI: https://doi.org/10.1007/s40744-025-00751-z